Pharmacy Support Staff Training Guidemyilearn.co.uk/flomax/resources/documents/BOEH0014 AW 07... ·...

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Pharmacy Support Staff

Training Guide

P2. Pharmacy Support Staff Training Guide. P2

Contents

Introduction P3

Section 1: What is BPH? P5

Section 2: What is tamsulosin? P9

Section 3: The role of Pharmacy P11

Section 4: Self assessment questions and case studies P20

Appendix: Glossary of terms P23 Symptoms-check Questionnaire P24 Patient information leaflet P25 Registration card P26 References Back cover

P4P3. Pharmacy Support Staff Training Guide.

To equip pharmacy support staff (medicines counter assistants and dispensary staff) with the knowledge and skills to create the right environment for dealing with BPH in the pharmacy, and to refer potential sufferers to the pharmacist for BPH treatment advice.

The training will also help you develop the skills to screen customers with sensitivity and help in the consulting process.

Learning objectives

• To ensure you have the appropriate level of relevant knowledge to be able to talk about the supply of Flomax Relief (tamsulosin), engage potential sufferers and refer them to the pharmacist

• To be aware of an individual’s role in dealing with BPH in the pharmacy

• To help equip you with the communication skills required for engaging men with BPH and their partners

• To raise awareness of prostate health among customers

Estimated number of hours to complete: 1.5 hours

Around 1 in 4 men over the age of 40 years experience symptoms.4 These lower urinary tract symptoms (LUTS) can seriously affect a man’s quality of life.5 However, relatively few men ask their GP for help.7

Flomax Relief (tamsulosin) is a P medicine for BPH, which means that the pharmacy can offer sufferers a proven effective treatment to relieve their urinary symptoms.6

As a member of the pharmacy support team, you can make an immense contribution to helping men with BPH by encouraging them to seek help and treatment advice from the pharmacist.

Benign prostatic hyperplasia (BPH) is a very common condition in older men, which causes them to experience difficulties when urinating (peeing).

IntroductionAim of training

Prostate

UrineBladder

Urethra


Section 1:

What is BPH?

Benign prostatic hyperplasia (BPH) is an overgrowth of cells of the prostate gland, causing it to become larger. The gland is found only in men and is involved in the production of semen.

The prostate gland is normally about the size and shape of a walnut. It sits at the base of the bladder and wraps around the urethra, which is the tube that carries urine away from the bladder to the outside.8

In many men the prostate gradually gets bigger after the age of about 50.8 It is rare in the under 40s. The cause of BPH is unknown but research suggests that ageing and the male hormone testosterone both play a part.9

Signs and symptoms

As the prostate gland gets bigger it can squeeze the urethra and interfere with the flow of urine, causing a variety of difficulties when urinating. The table below lists some of the words that men are likely to use to describe their symptoms:9

Impact of symptoms

BPH symptoms may start as simply an inconvenience but then can get worse as the condition progresses. Many men try to adjust their lives and develop coping strategies, such as ‘toilet mapping’ to deal with the problem.7 Some men may be unable to leave home without worrying about where the next toilet will be, and many may know the location of every single service station on the motorway or toilet along a particular tube line for their journey to work.

Men with BPH and their partners often find the consequences of the condition bothersome and that it impacts their quality of life. For example, if a man is woken several times at night this can affect sleep. Quality of life is included in the questionnaire (SQ). Some men find their symptoms more of a problem than others, and how bothered they are can influence which treatment they are given.

What the sufferer might say:

• Having to wait before I start to pee

• Stopping and starting when peeing

• Having to push or strain to pee

• Having a weak flow or weak stream of urine

• Feeling like my bladder is never quite empty

• Dribbling at the end of passing water

• Having to pee more often than before

• Finding it difficult to put off peeing

• Having to get up at night to pee

• Being desperate to pee.

Normal prostate

Enlarged prostate

Section 1:


The symptoms of BPH can often be relieved by lifestyle changes, with medication, and if necessary by surgery.1

Not all men with LUTS will require treatment. Management should include a combination of reassurance, lifestyle advice and assessment of the need for medication. The pharmacist is well placed to give sufferers lifestyle tips to help manage their symptoms. However, if the man has taken the time to seek advice from a healthcare professional it is likely that he is bothered or concerned by his symptoms and may benefit from treatment.

If medicine is required, BPH is usually treated with a drug known as an alpha1- blocker, such as tamsulosin (the active ingredient in Flomax Relief). This relaxes the muscle of the prostate and bladder outlet. Another type of drug called a 5-alpha-reductase inhibitor, such as finasteride and dustasteride (available on prescription), may also be used for men with larger prostates with urinary symptoms. It works by shrinking the prostate. In some cases both types of drugs are used together.8

There are some alternative therapies, such as herbal remedies, homeopathy and acupuncture, that are available without prescription for treating urinary symptoms. However, these have not been clinically proven to be effective for LUTS in men.

BPHtreatments

General notes:


Section 2:

What is tamsulosin?

Tamsulosin treats the symptoms of BPH,2 so that men do not need to urinate as often and it is made easier for them when they do. As with most medicines side effects may occur but the pharmacist is able to provide Flomax to suitable individuals.

Tamsulosin is the most widely recommended drug for BPH in the UK3 and has been a POM (Prescription Only Medicine) for over 15 years. It is also available as a pharmacy medicine under the brand name Flomax Relief, allowing it to be sold under the supervision of a pharmacist to appropriate patients.

The dose is one 0.4mg capsule, taken after the same meal each day. The capsule should be swallowed whole, not crunched or chewed as this will interfere with the modified release of the drug.2 Modified release means that the drug is released over an extended period of time.

Tamsulosin works quickly, with most men noticing improvement within a week or two of starting treatment,6 but if symptoms do not improve within 14 days of starting treatment the man should visit his GP.2

Certain conditions apply to the pharmacy sale of Flomax Relief:2

• It is only for men aged 45 to 75 years

• Customers cannot buy more than 6 weeks’ supply without checking with their GP that the doctor is happy for them to continue long-term with over-the-counter (OTC) tamsulosin treatment

• Customers who are taking the medicine are advised to have a consultation with their GP every 12 months.

In some people, tamsulosin may cause drowsiness, blurred vision and in rare cases fainting, so men taking this treatment should take extra care if they will be driving or operating machinery.2

Action point

Ask your pharmacist or pharmacy technician:

a) How many of our customers are getting prescriptions for BPH? How many receive tamsulosin on prescription?

b) How many of our male customers might suffer from BPH?

Notes

Certain groups of men with BPH should not be supplied with tamsulosin OTC. These include:2

• Men who are experiencing symptoms that might point to a more serious condition (for example, pain on urination, bloody or cloudy urine, and unexplained fever)

• Men who experience urinary incontinence (uncontrolled leaking of urine)

• Men with unstable diabetes

• Men who have had a prostate operation

• Men with liver, kidney or heart problems

• Men with a history of postural hypotension (when suddenly standing causes a feeling of dizziness or weakness)

• Men who are about to have an operation on the eye for a cataract or for glaucoma

• Men who have recently had blurred or cloudy vision that has not been examined by a GP or optician (because this could be an undiagnosed cataract or glaucoma)

• Men who are allergic (hypersensitive) to tamsulosin or any other ingredients of Flomax Relief

• Men taking the following drugs: doxazosin, indoramin, prazosin, terazosin or verapamil

• Men already diagnosed with BPH who are taking tamsulosin on prescription, or are taking another prescribed drug for BPH.


Section 3:

Men do not generally take an active interest in their health and are reluctant to seek help from their GP for a number of reasons, including fear or embarrassment.

By raising awareness of men’s health issues such as BPH, you can help these men to see your pharmacy as the first port of call for their health concerns. If men are aware that they can purchase an effective OTC treatment for their symptoms, they have another opportunity to seek healthcare advice by asking for help at the pharmacy rather than doing nothing about it.

Role of support staff:

• Learn about BPH and Flomax Relief (tamsulosin)and refer appropriate customers to the pharmacist

• Give appropriate customers the Symptoms check Questionnaire and help them fill it in if necessary

• Give customers Flomax Relief reading materials where appropriate

• Check customer’s registration card when they ask for further supplies of Flomax Relief and refer to the pharmacist if necessary

• After the pharmacist has assessed the patient with the SQ, found them to be suitable for OTC treatment and offered lifestyle advice, sell customers supplies of Flomax Relief

• Bring customers to the attention of the pharmacist who are asking for further supplies of Flomax Relief and whose doctor has said that they are happy for them to continue OTC treatment long-term. Sell customers supplies of Flomax Relief where appropriate

• Display information leaflets on BPH

• Learn communications skills to help you deal with customers sensitively

• Make the pharmacy more ‘male friendly’.

Action point

Read all the Flomax Relief materials available so that you are familiar with the medicine and the symptoms it treats and the paperwork that may be given out to customers. Think about the language you are comfortable using when talking to sufferers. The materials include:

• The customer Symptoms-check Questionnaire (SQ), which is used to identify the severity of the urinary symptoms, any reasons why Flomax Relief (tamsulosin) should not be given, and where men need immediate referral to a GP

• A GP referral slip from the pharmacist – found on the customer SQ which the customer can use to inform their GP that they are taking Flomax Relief or if they are considered unsuitable to take it

• Men’s Health Booklet – found inside each pack of Flomax Relief, it gives information on prostate health and where to get more information

• Registration card – found on the back cover of the Men’s Health Booklet, it shows the date the customer started taking Flomax Relief and can remind them of when they need to have a check up with their doctor. The customer can also use it to record any other medicines they are taking.

The role of Pharmacy

Dealing with BPH in the pharmacy

The symptoms of BPH can have a significant impact on the quality of life of a sufferer,5 and their partner too, yet many men are reluctant to talk about their symptoms because they find them embarrassing. Should your male customers look uncomfortable, it may be appropriate to make them aware that a consulting room is available where they can discuss their symptoms with the pharmacist discretely and in confidence.

Urinary difficulties must be discussed sensitively, yet honestly. Remember that:

• Some men simply accept their symptoms as an inevitable part of getting older

• Many men are unaware that something can be done to relieve their condition

• Some men may be concerned about their chances of developing prostate cancer, and although this will need to be checked out by their GP, they can be reassured that men with urinary symptoms due to BPH are no more likely to develop prostate cancer than those without symptoms8

• Many men will use colourful terms to describe their symptoms. It can be helpful to repeat some of the words they use in conversation e.g. ‘problems peeing’ to put them more at ease.

Man presents with urinary symptoms

Prostate health counselling by pharmacist with

Symptoms-check Questionnaire

Suitable

Suitable

Suitable

Flomax Relief 2 week supply

Refer to GP

Refer to GP

Refer to GP

Flomax Relief 4 week supply

Week 2 symptoms and side effect review

Week 6 symptoms and side effect review

Check BPH diagnosis has been confirmed by GP

Flomax Relief up to 52 week supply

Pharmacist to remind patient to visit GP for

annual prostate and general health check

Unsuitable

Unsuitable

Unsuitable

Pharmacist to remind patient to visit GP by

week 6 for confirmation of BPH diagnosis if not already

done so

Week 0

Week 2

Week 6

Week 52

Pharmacist consultation is to rule out red flag conditions and assess severity & duration of LUTS*

*Lower urinary tract symptoms


Section 3:

Supplying Flomax Relief

Pharmacist supervision model

If a customer asks about Flomax Relief (tamsulosin) or wants to discuss urinary symptoms, they should be quickly but sensitively referred to the pharmacist.

Although Flomax Relief is used to treat urinary symptoms in men only, female customers wanting treatment for their male partners should still be referred to the pharmacist for advice, and the pharmacist may want to talk to the customer confidentially.

A strict protocol must be followed when selling Flomax Relief. Follow the Flomax Relief guideline and keep it near the pharmacy counter in case you need to refer to it. Speak to your pharmacist to find out what level of involvement they would like you to have.


Section 3:

Communicating with men on embarrassing problems

Typical statements about the impact of urinary difficulties on quality of life of sufferers

“ It is embarrassing”

“ This condition controls me and my life”

“ It makes me feel angry”

“ I am afraid that it is a sign of something more serious”

“ It is depressing”

“ It is just part of getting older and I just have to live with it”

Action point

• Discuss with colleagues the best approach to discussing the subject of urinary problems if it is raised in the pharmacy

• Create your own script that you feel comfortable following when speaking to a man with LUTS

A piece of communication material, such as a consumer leaflet on BPH or Flomax Relief, can help to take the focus away from the male customer’s personal symptoms. Alternatively, some men would prefer to initially take away a leaflet to read at home rather than discuss a health issue that they are unsure or uncomfortable about. You could also recommend that the man visits the www.flomaxrelief.co.uk website, which contains information about BPH and advice on how to manage symptoms.

If you sense that a man wants to discuss something but is embarrassed, offer him the opportunity to talk to the pharmacist privately, perhaps in the consultation room.

• Be aware when your colleagues are talking to an embarrassed customer so that you can move out of earshot

• Using the language that men use to talk about their urinary symptoms can make them feel more comfortable. Using technical terms they don’t understand may make them feel awkward


Section 3:Section 3:

• Discuss with your pharmacist the possibility of advertising health services such as blood pressure monitoring, cholesterol testing, and MURs to men

• Use Flomax Relief point-of-sale material and information leaflets to encourage male customers to ask the pharmacist about BPH

• Use your window displays to encourage men into the pharmacy by including, for example, sporting items

• Display as many leaflets as you can on men’s health issues in a place where they are easily visible and make sure that Flomax Relief Symptom-check Questionnaires and information packs are kept in the consultation room

• Display men’s toiletries more prominently, for example, on a gondola end

Action point

Write down three things you could do to make your pharmacy more ‘male-friendly’

Tips to make your pharmacy more men friendly

WWHAM questions for Flomax Relief

• Whenever a female customer asks for Flomax Relief or advice on behalf of a male partner or family member politely suggest that if the man himself could spare the time to drop by, the pharmacist would be happy to talk about any health concerns. However, ensure she picks up literature to take away for her partner or family member

WWHAM question Flomax Relief Considerations

Who is the product for? Flomax Relief is only for men aged 45 to 75 who have symptoms of BPH.

What are the symptoms?

Men with BPH will have difficulties urinating which include needing to go more often than before and being desperate to go, finding it difficult to put off urinating and having to get up at night to urinate.

A customer with any of these symptoms (or those mentioned earlier) should be referred to the pharmacist.

How long have symptoms been present?

Symptoms can start at any time after the age of 40 and usually get gradually worse. Some men may have been suffering for years before they come to the pharmacy. Men should have the symptoms for longer than 3 months, to rule out acute conditions that may have similar symptoms e.g. urinary tract infections. Refer to the pharmacist if customers have been suffering from symptoms for less than 3 months.

Has any Action been taken so far?

Men may have been trying to cope by drinking less and never straying far from a toilet. Some may have tried a herbal remedy, and others may already have been treated by their GP with a prescription medicine. Refer to the pharmacist if the customer has tried anything previously.

Are any Medicines being taken?

Customers taking certain medicines should not take tamsulosin. Refer to the pharmacist if the customer is on any other medication. The pharmacist can ask the customer or he or she may be able to check on their Patient Medication Record (PMR).


Section 3:

For more information on BPH and Flomax Relief visit www.flomaxrelief.co.uk www.1in4men.com

The following websites may also be helpful:

Men’s Health Forum

www.menshealthforum.org.uk

NICE Clinical Knowledge Summaries

www.cks.nice.org.uk

Prostate Cancer Research Centre

www.prostate-cancer-research.org.uk

Prostate UK

www.prostateuk.org/

More information

General notes:

Please answer TRUE or FALSE to the following statements:1) A man’s prostate gland is the size and shape

of a peanut

2) If a man has LUTS, it is most probably due to prostate cancer

3) Tamsulosin capsules should be swallowed whole

4) Flomax Relief can be used in men under 45 years old

5) All sufferers must complete a questionnaire before they can purchase Flomax Relief

6) Customers suitable for Flomax Relief can only purchase 14 capsules at first visit

7) If a customer has seen his GP but has lost his registration card he can still purchase Flomax Relief from you, without seeing the pharmacist

8) Men who want to discuss their urinary symptoms should be given the chance to talk to the pharmacist in a private area

9) All leaflets on men’s health issues should be kept in the dispensary where they can’t be seen

10) If a man cannot come to the pharmacy for an initial consultation about their urinary symptoms, their partner can buy the first pack on their behalf

Section 4:

Self assessment questions and case studies

T

T

T

T

T

T

T

T

T

T

F

F

F

F

F

F

F

F

F

F

Answers : Q1:T Q2:T Q3:T Q4:F Q5:F Q6:T Q7:F Q8:T Q9:F Q10:T


Example 1Mr Smith, a regular customer of about 60 years old, looks anxious and is taking a rather long time to choose some cough medicine. When the only other customer in the shop leaves, he says very quietly: “I’m having some problems peeing, I need to go several times a night!”

Considerations:

• Mr Smith is obviously embarrassed about his symptoms, so try to deal with the matter as quickly and efficiently as you can

• Reassure Mr Smith that you can probably help and show him to a private area, such as the consultation room where the pharmacist will discuss his concerns

• Tell the pharmacist that Mr Smith is waiting to discuss a concern about his urinating problems in the consultation room. Give Mr Smith a leaflet on BPH or Flomax Relief while he is waiting for the pharmacist consultation

• Having completed a questionnaire and discussed the matter with Mr Smith, the pharmacist tells you that you can sell him a 14 day starter pack of Flomax Relief

• Tell Mr Smith that he should make an appointment to see his GP, in order to check out his prostate

• Tell Mr Smith that there is more information inside the booklet and to phone the pharmacist if he has any questions. Advise him to read the Flomax Relief ‘Men’s Health Booklet’. Remind him that he will need to return in two weeks’ time for a further supply and that he should bring his registration card (from the Men’s Health Booklet) when he comes.

Example 2A man in his twenties who you have never seen before asks for some Flomax Relief and he tells you he has blood in his urine and pain on urination.

Considerations:

• This man is unsuitable for Flomax Relief because of his age alone, but should still be referred to the pharmacist to discuss his symptoms

• Offer the man the opportunity to talk to the pharmacist in private

• The pharmacist will refer any man with ‘red flag’ symptoms, which include blood in the urine and pain on urination or urinary symptoms occurring in young men (below 45 years), to their GP and give them a referral letter to take with them.

Example 4A man who looks like he is in 60s asks you if there is something he can buy to stop him feeling like he needs to go to the loo all the time.

Considerations:

• The man may be referring to an urge to urinate all the time or he may be referring to a problem with his bowels, so this needs to be confirmed

• Explain to the man that you can probably help and ask him if he wants to go to a private area, such as the consultation room where the pharmacist will further discuss his symptoms

• Tell the pharmacist that the man is waiting to discuss a concern about needing to go to the toilet

• After the man has completed a Symptoms-check Questionnaire and discussed the matter, the pharmacist tells you that you can sell him a 14 day starter pack of Flomax Relief

• Tell the man that he should now make an appointment to see his GP in order to get a prostate check

• Tell the man that there is more information inside the pack for him to read, and to phone the pharmacy or come back if he has any questions. Tell him that he needs to return in two weeks time to review his medication and maybe get a further supply, and remind him to bring his registration card when he comes in.

Example 3Mr Smith, your regular customer of about 60 years old has now been taking Flomax Relief for the past 8 months. He would like to buy another pack but wants to know if he should see his GP soon?

Considerations:

• As long as Mr Smith is still happy that his medication is working and there aren’t any other symptoms disturbing him, he can continue to take Flomax Relief. Customers who are taking Flomax Relief must be advised to consult a doctor every 12 months for a prostate check

• Ask Mr Smith if he has any other concerns he would like to discuss with the pharmacist

• Inform the pharmacist that Mr Smith is asking for a further supply of Flomax Relief and that he has been taking it for 8 months

• Give Mr Smith a further supply of Flomax Relief and explain that if he is worried at all he should come back and talk to the pharmacist or visit his GP.

Example 5Mrs Wells has come in for her regular prescription but says she feels quite tired. She asks you if there is something you can recommend to help her sleep because she keeps getting woken up by her husband who gets up to pee three or four times a night.

Considerations:

• Mrs Wells is probably only having trouble sleeping and feeling tired because her husband keeps waking her up when he visits the toilet, and this is something that needs to be tackled. Her husband probably suffers from disturbed sleep as well

• Politely ask that if her husband could spare the time to drop by, the pharmacist may be able to give him something to stop him needing to urinate so frequently, and perhaps this will help them both get a better night’s sleep

• Explain to Mrs Wells that her husband can pop in at any time or book an appointment to see the pharmacist. Ask her to reassure him that any discussion is confidential and can be carried out in a private area or consulting room in the pharmacy

• Give Mrs Wells some appropriate men’s health leaflets, the Flomax Relief reading material and the customer Symptoms-check Questionnaire. Mr Wells can fill in the questionnaire and bring it with him when he comes to see the pharmacist.

Case studies

Section 4:


Glossary of terms

BPH: Benign Prostatic Hyperplasia

LUTS: Lower Urinary Tract Symptoms

MUR: Medicines Use Review

OTC: Over-The-Counter

PIL: Patient Information Leaflet

POM: Prescription Only Medicine

PMR: Patient Medication Record

SPC: Summary of Product Characteristics

SQ: Symptoms-check Questionnaire

Appendix:

Symptoms-check Questionnaire (SQ)

Appendix:

Q2 ABOUT YOUR URINARY SYMPTOMS…

Q2a Has your doctor already diagnosed you as having an enlarged prostate gland otherwise known as BPH(benign prostatic hyperplasia)?

Yes No

Q2b If you have answered Yes to Q2a are you currently taking any prescribed medicines for your BPH from your GP? Yes No

Q2c Have you had these urinary (peeing) symptoms for at least 3 months? Yes No

Please answer the questions below by ticking the boxes that apply to you. If you are not sure about any of the questions, leave them blank and the pharmacist will help you.

Q1 ABOUT YOU…

Q1a Are you under the age of 45 years? Yes No

Q1b Are you over the age of 75 years? Yes No

Q1c Have you had prostate surgery? Yes No

Q1d Has your doctor ever diagnosed you as having diabetes? Yes No

If Yes to any of the above, consult your pharmacist before proceeding further with the questionnaire

Symptoms-checkQuestionnaire

Q3 DO YOU EXPERIENCE ANY OF THE FOLLOWING SYMPTOMS?

Not at all Less than 1

time in 5

Less than half the time

About half the

time

More than half the time

Almost always

Your score

Please note your score for each symptom in the last column and then add up the total symptoms score.

Incomplete emptying. Over the past month, how often have you had a sensation of not emptying your bladder completely after you finish urinating (peeing)?

0 1 2 3 4 5

Frequency. Over the past month, how often have youhad to urinate (pee) again less than 2 hours after you lasturinated (peed)?

0 1 2 3 4 5

Intermittency. Over the past month, how often have youfound you stopped and started again several times whenyou urinated (peed)?

0 1 2 3 4 5

Urgency. Over the past month, how difficult have you foundit to postpone urination (peeing)? 0 1 2 3 4 5

Weak stream. Over the past month, how often have you had a weak urinary (pee) stream? 0 1 2 3 4 5

Straining. Over the past month, how often have you had topush or strain to begin urination (peeing)? 0 1 2 3 4 5

Nocturia. Over the past month, how many times did you most typically get up to urinate (pee) from the time you went to bed until the time you got up in the morning?

Never 1 time 2 times 3 times 4 times 5 times or more

0 1 2 3 4 5

Total Symptoms Score:

Q4 QUALITY OF LIFE SCORE (QOL) Delighted Pleased Mostly satisfied

Mixed - about equally

satisfied & dissatisfied

Mostly dissatisfied

Unhappy Terrible

If you were to spend the rest of your life with your urinary(peeing) condition the way it is now, how would you feelabout that?

0 1 2 3 4 5 6

Date of preparation: September 2014/UK/FMX-141006

Symptoms-checkQuestionnaire

Q5 DO ANY OF THESE STATEMENTS APPLY TO YOU?

Q5a I am currently experiencing pain on urination (peeing) Yes No

Q5b I have had blood in my urine (pee) in the last 3 months Yes No

Q5c I have had cloudy urine (pee) in the last 3 months Yes No

Q5d I have got a fever at the moment Yes No

Q5e I have got leaking of urine (incontinence) Yes No

Q6 ABOUT YOUR MEDICAL HISTORY...

At the moment, do you have:

Q6a Any problem with your liver? Yes No

Q6b Any problem with your kidneys? Yes No

Q6c Any problem with your heart? Yes No

Q6d Any fainting, dizziness or weakness when you stand up? Yes No

Q6e Any eye operation planned? Yes No

Q6f Any blurred or cloudy vision that has not been examined by your GP or optician? Yes No

Q8 What medicines are you currently taking, either prescribed by your doctor, or that you are buying?If you are unsure of the names please ask your pharmacist.

Please list your medicines here (including herbal supplements).

Q7 Have you ever had an allergy to tamsulosin or a bad reaction to it? Yes No

Pharmacy stamp Date

GP Referral Slip

q I have supplied Flomax Relief to this man. Please review his condition as symptoms of BPH.

q Flomax Relief is not suitable for this man and I have advised him to see you. I would be grateful if you could assess him.


Patient information leaflet (PIL)

Registration card

Appendix: Appendix:

Registration card can be found on the reverse of the Men’s Health Booklet

Package Leaflet: Information for the User

Read all of this leaflet carefully because it contains important information for you. This medicine is available from your pharmacist without prescription. You will need to see your doctor within 6 weeks of starting treatment, in order to confirm that you can take FLOMAX RELIEF long-term from your pharmacist. You need to take FLOMAX RELIEF as instructed in this leaflet to get the best results from it. • Keep this leaflet. You may need to read it again• Ask your pharmacist if you need more information or advice, or you do not understand the instructions • You must contact your pharmacist or doctor if your symptoms worsen or do not improve after 2 weeks of treatment• If a side effect occurs and gets troublesome, or seems serious, or if you experience any side effect not listed in this leaflet, tell your doctor or pharmacist

In this leaflet1. What FLOMAX RELIEF is and what it is used for2. Before you take FLOMAX RELIEF3. How to take FLOMAX RELIEF4. Possible side effects5. How to store FLOMAX RELIEF6. Further information

The name of your medicine is FLOMAX RELIEF MR. FLOMAX RELIEF is a modified release capsule which contains a medicine called tamsulosin. This belongs to a group of medicines called ‘alpha blockers’ (or alpha1A-adrenoceptor antagonists).

FLOMAX RELIEF is used to treat the lower urinary tract symptoms (LUTS) of a common condition called benign prostatic hyperplasia (BPH). This is when the prostate gland gets bigger. The prostate gland is found just below a man’s bladder. When your prostate gland gets bigger, it can:• Make it difficult for you to start urinating (peeing)• Mean you take longer or have to urinate more often• Lead to the feeling that you still need to urinate again, even though you have just done so• Cause you to get up several times in the night to urinate

FLOMAX RELIEF relieves these problems by: • Relaxing the muscles in the prostate gland• Relaxing the muscles in the urethra (the tube from the bladder to the outside of the body). This lets urine pass more freely through the urethra, making it easier to urinate.

FLOMAX RELIEF should be used only by men who are 45 to 75 years of age.

Do not take these capsules if:• You are allergic (hypersensitive) to tamsulosin or any of the other ingredients of this medicine (listed in Section 6 below)• You are taking certain medicines prescribed by your doctor (see “Taking other medicines” below)• You have problems with your heart, liver, or kidneys• You faint or get dizzy or weak when you sit or stand up suddenly• You have had your symptoms for less than three months• You have pain when you urinate, or your urine was cloudy or bloody, at sometime in the last three months• You have a fever due to an infection of your kidneys or bladder (urinary tract infection) • You have leaking of your urine which you are unable to control (incontinence)

• You think you have diabetes and it is not properly controlled• You have had prostate surgery• You have recently had blurred or cloudy vision and have not been examined by your doctor or optician• You are about to undergo eye surgery for cataract or glaucoma (see Eye surgery below)

Do not take FLOMAX RELIEF if any of the above apply to you, without first consulting your doctor. If you are not sure, talk to your doctor or pharmacist before taking these capsules.

Taking other medicinesPlease tell your pharmacist or doctor if you are taking or have recently taken any other medicines. This includes medicines that you can buy without a prescription, including herbal medicines. This is because FLOMAX RELIEF can affect the way that some other medicines work and some other medicines can affect the way that FLOMAX RELIEF works.

In particular, tell your pharmacist or doctor if you are taking:• Medicines to lower your blood pressure such as verapamil and diltiazem• Medicines to treat HIV such as ritonavir or indinavir• Medicines to treat a fungal infection such as ketoconazole or itraconazole• Other alpha-blockers such as doxazosin, indoramin, prazosin, or alfuzosin• Erythromycin, an antibiotic used to treat infections

Tell your doctor or dentist that you are on FLOMAX RELIEF before any operation or dental procedure as there is a potential that your medicine may interfere with the effects of the anaesthetic.

Driving and using machinesIf you feel weak or dizzy or have blurred vision while taking this medicine, do not drive or use machines.

Eye surgery• Do not start taking FLOMAX RELIEF now if you are about to have an operation on your eye for cloudiness of the lens (cataract) or glaucoma (high pressure inside the eye)• Please tell your eye specialist if you have ever taken tamsulosin. The operation may need to be performed differently• If you are currently taking FLOMAX RELIEF, ask your doctor if you should stop taking it for a short time

Taking this medicine• Take one capsule each day• Take it at the same time each day, after a meal• Swallow the capsule whole with water• Do not crush, chew, or open the capsules

Make a note of the date you start taking FLOMAX RELIEF.

After 2 weeksIf you are using FLOMAX RELIEF for the first time and you have not got any better after 2 weeks, or if you get worse, you must stop taking this medicine and ask your pharmacist or doctor for further advice.

Within 6 weeksYou should see your doctor within 6 weeks of starting treatment to confirm that your symptoms are due to BPH.

Every 12 monthsYou should see your doctor every 12 months to check your prostate. See the doctor sooner if your symptoms change or get worse.

abcd

1. What FLOMAX RELIEF is and what it is used for

2. Before you take FLOMAX RELIEF3. How to take FLOMAX RELIEF

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If you forget to take this medicine• Take your capsule later the same day after food• If you have missed a dose, just take your daily capsule on the next day at the usual time• Do not take two capsules to make up for a forgotten capsule

If you take more of this medicine than you should, talk to a doctor or pharmacist straight away.

Like all medicines, FLOMAX RELIEF can cause side effects, although not everybody gets them.

Serious side effects are rare or very rare. Stop taking this medicine and see a doctor straight away if you experience any of the following symptoms - you may need medical treatment:• Allergic reaction - (affects less than 1 in 1,000 people). The signs may include finding it difficult to breathe, having an itchy rash, having a swollen face, throat, or tongue• Long-lasting and painful erection (usually not during sexual activity) - affects less than 1 in 10,000 people• A severe skin reaction with symptoms that could include skin blistering and exfoliation (known as Stevens-Johnson syndrome, erythema multiforme, or exfoliative dermatitis). It is very rare, affecting less than 1 in 10,000 people (or of unknown frequency).

The following side effects have also been reported:

Especially when you sit or stand up• Feeling dizzy (common - affects less than 1 in 10 people)• Feeling weak (uncommon - affects less than 1 in 100 people)If this happens, sit or lie down straight away until you feel better.

Common (affects less than 1 in 10 people)• Little or no semen during ejaculation. This phenomenon is harmless.

Uncommon (affects less than 1 in 100 people)• Headache• Fast or uneven heart beat (palpitations) • Runny or blocked nose • Feeling sick or being sick • Diarrhoea or constipation • Itching or lumpy rash (urticaria)

Rare (affects less than 1 in 1,000 people)• Feeling faint

Very rare (affects less than 1 in 10,000 people)• During an operation on the eye for cloudiness of the lens (cataract) or high pressure in the eye (glaucoma), the pupil (the black circle in the middle of your eye) may not increase in size as needed. Also, the iris (the coloured part of the eye) may become floppy during surgery.

Not Known (frequency cannot be estimated from the available data)• Blurred vision or impaired vision• Nose bleeds• Dry mouth

Other possible side effects• Drowsiness• Swollen hands or feet• Shortness of breath• Heart rhythm disorders

Reporting of side effectsIf you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

• Keep out of the reach and sight of children• Do not use the capsules after the expiry date which is stated on the base of the pack• FLOMAX RELIEF does not require any special storage conditions

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

What FLOMAX RELIEF contains• The active substance is tamsulosin hydrochloride. Each capsule contains 0.4 mg• The other ingredients are microcrystalline cellulose, methacrylic acid-ethyl acrylate copolymer, polysorbate, sodium laurilsulfate, triacetin, calcium stearate, and talc. These all help to make the granules which are in the capsule • The capsule shell contains gelatin, and is coloured with indigotin (E132), titanium dioxide (E171), and yellow and red iron oxide (E172); printing ink is shellac, propylene glycol, and black iron oxide (E172)

What FLOMAX RELIEF looks like and contents of the packFLOMAX RELIEF capsules have an orange body and an olive-green cap. The capsules come in packs of 14 and 28 capsules, suitable for 14 and 28 days treatment, respectively.

The marketing authorisation for FLOMAX RELIEF is held by:Boehringer Ingelheim Limited, Consumer Healthcare, Ellesfield Avenue, Bracknell, Berkshire, RG12 8YS, UK.

The capsules are manufactured by:Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands.

This leaflet was last revised in February 2014.

Assessing your symptomsYour urinary symptoms can be assessed using a questionnaire which you will be asked to complete when you first purchase FLOMAX RELIEF.

To learn more about BPH visit www.1in4men.com and call the helpline free-of-charge on 0800 731 9070

To request this leaflet free-of-charge in formats such as audio, Braille or large print, please call the Royal National Institute of the Blind (RNIB) freephone on 0800 198 5000. When prompted, please provide the following information:

Product code number 00015/0280

and be ready to confirm the name of this medicine (FLOMAX RELIEF).

©Boehringer Ingelheim Limited 2014

®Registered trade mark.

Under licence from Astellas Pharma Europe Ltd.

4. Possible side effects

5. How to store FLOMAX RELIEF

6. Further information

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References1. National Institute for Health and Clinical Excellence (NICE) Clinical

Guideline CG97. Lower urinary tract symptoms - the management of lower urinary tract symptoms in men. May 2010.

2. Flomax Relief MR Summary of Product Characteristics.

3. Health and Social Care Information Centre. Prescription Cost Analysis, England -2013. Available at: http://www.hscic.gov.uk/catalogue/PUB13887/pres-cost-anal-eng-2013-rep.pdf

4. Garraway WM, et al. High prevalence of benign prostatic hypertrophy in the community. Lancet 1991;338(8765):469-471.

5. Welch G, et al. Quality-of-life impact of lower urinary tract symptom severity: results from the health professionals follow-up study. Urology 2002;59:245-250.

6. Narayan P, et al. A second phase III multicentre placebo-controlled study of tamsulosin in benign prostatic hyperplasia. J Urol 1998;160:1701-1706.

7. Simpson RJ, et al. Consultation patterns in a community survey of men with benign prostatic hyperplasia. Br J Gen Pract 1994;44:499-502.

8. Patient.co.uk: Prostate Gland Enlargement. Available at: www.patient.co.uk/health/Prostate-Gland-Benign-Enlargement.htm [Accessed 07 August 2014]

9. NHS Choices Prostate Enlargement. Available at: http://www.nhs.uk/conditions/prostate-enlargement/pages/introduction.aspx [Accessed 08 August 2014]

10. Patel AK & Chapple CR. Benign prostatic hyperplasia: treatment in primary care. BMJ 2006;333:535-539.

Date of preparation: September 2014/UK/FMX-141005a

F4/UK/PI/5

Flomax Relief® MR – Product Information. Presentation: Flomax Relief MR containing 0.4mg of tamsulosin hydrochloride in a modified release capsule. Indication: Treatment of functional symptoms of benign prostatic hyperplasia (BPH). Dosage: For men aged 45-75 years. For oral use. One capsule daily. Contraindications: Hypersensitivity to any ingredients of the product; a history of orthostatic hypotension; severe hepatic insufficiency. Warnings and Precautions: Men taking an antihypertensive alpha1-adrenoceptor blocker should consult a doctor before taking Flomax Relief; in individual cases a fall in blood pressure can occur. Do not give to a man who experiences postural hypotension. Do not use in combination with strong inhibitors of CYP3A4 (e.g. ketoconazole) in patients with poor metaboliser CYP2D6 phenotype. Use with caution in combination with strong (e.g. ketoconazole) and moderate (e.g. erythromycin) inhibitors of CYP3A4). Consult a doctor before taking Flomax Relief if a man has heart, renal, or liver disease, uncontrolled diabetes, urinary incontinence, or has had prostate surgery. Do not supply Flomax Relief to a man whose symptoms are of less than 3 months’ duration. Do not supply to a man who reports dysuria, haematuria, or cloudy urine, in the previous 3 months, or who has a fever that might be related to urinary tract infection. Do not initiate treatment in a man planning cataract or glaucoma surgery, or who has recently experienced blurred or cloudy vision not examined by a doctor or optician. If urinary symptoms have not improved within 14 days of starting treatment the patient should be referred to a doctor. Medical review is required for diagnosis of BPH: Patients must see their doctor within 6 weeks of starting treatment for assessment of their symptoms and confirmation to continue taking Flomax Relief long-term from their pharmacist. Every 12 months, patients should be advised to consult a doctor. Adverse Effects: Common: dizziness, ejaculation disorders. Uncommon: headache, palpitations, orthostatic hypotension, rhinitis, constipation, diarrhoea, nausea, vomiting, rash, pruritus, urticaria, asthenia. Rare: syncope, angioedema. Very rare: Stevens-Johnson syndrome, priapism. Drowsiness or oedema can occur. Blurred vision, vision impairment, dry mouth, epistaxis, erythema multiforme, dermatitis exfoliative, atrial fibrillation, arrhythmia, tachycardia, and dyspnoea have been reported. IFIS has occurred in some patients during cataract or glaucoma surgery. RRP (ex VAT): 14 capsules £7.65, 28 capsules £14.46 Legal Category: P Product Licence Number: PL 00015/0280. Date of revision: April 2014. Further Information available from: Boehringer Ingelheim Limited, Ellesfield Avenue, Bracknell, Berkshire RG12 8YS.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard Adverse events should also be reported to Boehringer Ingelheim Drug Safety on 0800 328 1627 (freephone).

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