1. what tamsumac is and what it is used for

The active ingredient in Tamsumac is tamsulosin hydrochloride. It acts by relaxing the muscles in the prostate and urethra (the tube that carries urine to the outside), and lets urine pass more readily through the urethra and aids urination.

In the prostate gland, bladder 11111 llllll |U and urethra there are U44tTTT1T11 11 specialised cells containing alpha1A-receptors that cause the muscles in the urethra to tighten. Tamsumac is an alpha1A-adrenoceptor blocker, which reduces the action of these specialised cells and relaxes the muscles making it easier to pass water.

Tamsumac is used in men for the treatment of the complaints of the lower urinary tract associated with an enlarged prostatic gland (benign prostatic hyperplasia). These symptoms include difficulty in starting to pass water, frequent trips to the toilet to pass water, a feeling of not completely emptying the bladder and having to get up several times in the night to pass water.

2. what you need to know before you take tamsumac

Do not take Tamsumac:

• If you are allergic (hypersensitive) to tamsulosin or any of the other ingredients of Tamsumac (listed in section 6).
• if you have a severe liver condition.
• if you have ever fainted or felt dizzy when suddenly sitting or standing up. Dizziness can sometimes occur when taking Tamsumac, particularly if you are also taking other alpha – blockers. If you do feel weak or dizzy make sure you sit or lie down straight away until the symptoms have disappeared.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tamsumac.

Take special care with Tamsumac (and speak to your doctor)

• If you have kidney problems
• If you are undergoing or have been scheduled for eye surgery because of cloudiness of the lens (cataract) or increased pressure in the eye (glaucoma).

Please inform your eye specialist that you have previously used, are using or are planning to use tamsulosin. The specialist can then take appropriate precautions with respect to medication and surgical techniques to be used. Ask your doctor whether or not you should postpone or temporarily stop taking this medicine when undergoing eye surgery because of a cloudy lens (cataract) or to increased pressure in the eye (glaucoma).

Children and adolescents

Do not give this medicine to children or adolescent under 18 years because it does not work in this population.

Other medicines and Tamsumac

• – Taking Tamsumac together with other medicines from the same class (ar adrenoceptor antagonists) may cause an unwanted decrease in blood pressure.

• – It is especially important to inform your doctor if you are being treated at the same time with medicines that may decrease the removal of Tamsumac from the body (for example, ketoconazole, erythromycin).

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Tamsumac with food and drink

Tamsumac must be taken after breakfast or the first meal of the day.

Pregnancy, breast-feeding and fertility Tamsumac is not indicated for use in women.

In men, abnormal ejaculation has been reported (ejaculation disorder). This means that semen does not leave the ____

body via the urethra, but 111111 |||IU|

instead goes into the bladder UttitTI 11111 (retrograde ejaculation) or ejaculate volume is reduced or absent (ejaculatory failure). This phenomenon is harmless.

Driving and using machines

There is no evidence that Tamsumac affects the ability to drive or to operate machinery or equipment. However, you should bear in mind that dizziness can occur, in which case you should not undertake activities that require attentiveness.

3. how to take tamsumac

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is 1 capsule per day to be taken after breakfast or the first meal of each day. The capsule must be swallowed whole and not be crunched or chewed. Usually, Tamsumac is prescribed for long periods of time. The effects on the bladder and on urination are maintained during longterm treatment with Tamsumac.

If you take more Tamsumac than you should

Taking too much Tamsumac may lead to an unwanted decrease in blood pressure and an increase in heart rate, with feelings of faintness. Contact your doctor immediately if you have taken too much Tamsumac.

If you forget to take Tamsumac

You may take your daily Tamsumac later the same day if you have forgotten to take it as recommended. If you have missed a day, just continue to take your daily capsule as prescribed. Never take a double dose to make up for a forgotten capsule.

If you stop taking amsumac

When treatment with Tamsumac is stopped prematurely, your original complaints may return. Therefore take Tamsumac as long as your doctor prescribes, even if your complaints have disappeared already. Always consult your doctor, if you consider stopping this therapy.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

• Common (may affect up to 1 in 10 people) Dizziness, particularly when going to sit or stand up.
• Abnormal ejaculation (ejaculation disorder). This means that semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or ejaculate volume is reduced or absent (ejaculatory failure). This phenomenon is harmless.

Uncommon (may affect up to 1 in 100 people)

• Headache
• Palpitations (the heart beats more rapidly than normal and it is also noticeable)
• Reduced blood pressure e.g. when getting

Reporting of side effects

If 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.

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store tamsumac

Keep this medicine out of the sight and reach of children

Tamsumac does not require any special storage conditions

Do not use this medicine after the expiry date which is stated on the blister pack and on the carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Tamsumac contains

The active substance is tamsulosin hydrochloride.

The other ingredients are Polysorbate 80, Methacrylic acid copolymer dispersion, Triacetin, Sodium lauryl sulfate, Purified

up quickly from a seating or lying position sometimes associated with dizziness.

• Runny or blocked nose (rhinitis). water, Microcrystalline cellulose and Calcium stearate. These all help to make the granules which are in the capsule The capsule shell
• Diarrhoea.
• Feeling sick and vomiting.
• Constipation.
• Weakness (asthenia).
• Rashes, itching and hives (urticaria).

Rare (may affect upto 1 in 1,000 people)

• Faintiness and sudden local swelling of the soft tissues of the body (e.g. the throat or tongue) difficult breathing and / or itching and rash, often as an allergic reaction (angioedema).

Very rare (may affect up to 1 in 10,000 people)

• Priapism (painful prolonged unwanted erection for which immediate medical treatment is required).
• Rash, inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (Stevens-Johnson syndrome).

Not Known (frequency cannot be estimated from the available data)

• Blurred vision or impaired vision
• Nose bleeds
• Dry mouth
• Serious skin rashes (erythema multiforme, dermatitis exfoliative)
• Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia),
• Difficult breathing (dyspnoea).
• If you are undergoing eye surgery because of cloudiness of the lens (cataract) or increased pressure in the eye (glaucoma) and are already taking or have previously taken Tamsumac, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the procedure.

contains FD & C Blue 2

(E 132), Iron oxide black (E 172), Iron oxide red (E 172), Iron oxide yellow (E 172), Titanium dioxide (E 171), Gelatin, Purified water, Sodium lauryl sulfate;

Printing ink is Shellac (E904), Dehydrated alcohol, Isopropyl alcohol, Butyl alcohol, Propylene glycol, Strong ammonia solution, Black iron oxide (E172), Potassium hydroxide and Purified water.

What Tamsumac looks like and contents of the pack

Tamsumac capsules are Olive green opaque / Orange opaque, Size „2“, hard gelatin capsules, containing free flowing white to off white spheroids with „CL 23“ on cap and „0.4“ on the body imprinted with black ink.

The capsules are packaged in Clear PVC/PE/PVdC – Aluminium Blister.

The capsules are supplied in blister packs of 14, 20, 28, 30, 50, 56, 90, 98 and 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

lilACLEOD}

.............­.inn.........

Macleods Pharma UK Limited

Wynyard Park House, Wynyard Avenue, Wynyard, Billingham, TS22 5TB United Kingdom

Q O

PL 34771/0170

I This leaflet was last revised in {04/2020}

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Front Side

1. what tamsumac is and what it is used for

The active ingredient in Tamsumac is tamsulosin hydrochloride. It acts by relaxing the muscles in the prostate and urethra (the tube that carries urine to the outside), and lets urine pass more readily through the urethra and aids urination.

In the prostate gland, bladder 11111 UHttl and urethra there are UHIII 11111 specialised cells containing alpha1A-receptors that cause the muscles in the urethra to tighten. Tamsumac is an alpha1A-adrenoceptor blocker, which reduces the action of these specialised cells and relaxes the muscles making it easier to pass water.

Tamsumac is used in men for the treatment of the complaints of the lower urinary tract associated with an enlarged prostatic gland (benign prostatic hyperplasia). These symptoms include difficulty in starting to pass water, frequent trips to the toilet to pass water, a feeling of not completely emptying the bladder and having to get up several times in the night to pass water.

2. what you need to know before you take tamsumac

Do not take Tamsumac:

• If you are allergic (hypersensitive) to tamsulosin or any of the other ingredients of Tamsumac (listed in section 6).
• if you have a severe liver condition.
• if you have ever fainted or felt dizzy when suddenly sitting or standing up. Dizziness can sometimes occur when taking Tamsumac, particularly if you are also taking other alpha1– blockers. If you do feel weak or dizzy make sure you sit or lie down straight away until the symptoms have disappeared.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tamsumac.

Take special care with Tamsumac (and speak to your doctor)

If you have kidney problems

• If you are undergoing or have been scheduled for eye surgery because of cloudiness of the lens (cataract) or increased pressure in the eye (glaucoma).

Please inform your eye specialist that you have previously used, are using or are planning to use tamsulosin. The specialist can then take appropriate precautions with respect to medication and surgical techniques to be used. Ask your doctor whether or not you should postpone or temporarily stop taking this medicine when undergoing eye surgery because of a cloudy lens (cataract) or to increased pressure in the eye (glaucoma).

Children and adolescents

Do not give this medicine to children or adolescent under 18 years because it does not work in this population.

Other medicines and Tamsumac

• – Taking Tamsumac together with other medicines from the same class (a1-adrenoceptor antagonists) may cause an unwanted decrease in blood pressure.

• – It is especially important to inform your doctor if you are being treated at the same time with medicines that may decrease the removal of Tamsumac from the body (for example, ketoconazole, erythromycin).

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Tamsumac with food and drink

Tamsumac must be taken after breakfast or the first meal of the day.

Pregnancy, breast-feeding and fertility Tamsumac is not indicated for use in women.

In men, abnormal ejaculation has been reported (ejaculation disorder). This means that semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or ejaculate volume is reduced or absent (ejaculatory failure). This phenomenon is harmless.

Driving and using machines

There is no evidence that Tamsumac affects the ability to drive or to operate machinery or equipment. However, you should bear in mind that dizziness can occur, in which case you should not undertake activities that require attentiveness.

3. how to take tamsumac

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is 1 capsule per day to be taken after breakfast or the first meal of each day. The capsule must be swallowed whole and not be crunched or chewed. Usually, Tamsumac is prescribed for long periods of time. The effects on the bladder and on urination are maintained during longterm treatment with Tamsumac.

If you take more Tamsumac than you should

Taking too much Tamsumac may lead to an unwanted decrease in blood pressure and an increase in heart rate, with feelings of faintness. Contact your doctor immediately if you have taken too much Tamsumac.

If you forget to take Tamsumac

You may take your daily Tamsumac later the same day if you have forgotten to take it as recommended. If you have missed a day, just continue to take your daily capsule as prescribed. Never take a double dose to make up for a forgotten capsule.

Back Side

If you stop taking Tamsumac

When treatment with Tamsumac is stopped prematurely, your original complaints may return. Therefore take Tamsumac as long as your doctor prescribes, even if your complaints have disappeared already. Always consult your doctor, if you consider stopping this therapy.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 people)

• Dizziness, particularly when going to sit or stand up.
• Abnormal ejaculation (ejaculation disorder). This means that semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or ejaculate volume is reduced or absent (ejaculatory failure). This phenomenon is harmless.
• Uncommon (may affect up to 1 in 100 people) Headache
• Palpitations (the heart beats more rapidly than normal and it is also noticeable)
• Reduced blood pressure e.g. when getting

up quickly from a seating or lying position sometimes associated with dizziness.

Runny or blocked nose (rhinitis).

Diarrhoea.

• Feeling sick and vomiting.
• Constipation.
• Weakness (asthenia).
• Rashes, itching and hives (urticaria).

Rare (may affect upto 1 in 1,000 people)

• Faintiness and sudden local swelling of the soft tissues of the body (e.g. the throat or tongue) difficult breathing and / or itching and rash, often as an allergic reaction (angioedema).

Very rare (may affect up to 1 in 10,000 people)

• Priapism (painful prolonged unwanted erection for which immediate medical treatment is required).
• Rash, inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (Stevens-Johnson syndrome).

Not Known (frequency cannot be estimated from the available data)

• Blurred vision or impaired vision
• Nose bleeds
• Dry mouth
• Serious skin rashes (erythema multiforme, dermatitis exfoliative)
• Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia),
• Difficult breathing (dyspnoea).
• If you are undergoing eye surgery because of cloudiness of the lens (cataract) or increased pressure in the eye (glaucoma) and are already taking or have previously taken Tamsumac, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the procedure.

5. how to store tamsumac

Keep this medicine out of the sight and reach of children

Tamsumac does not require any special storage conditions

Do not use this medicine after the expiry date which is stated on the blister pack and on the carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Tamsumac contains

The active substance is tamsulosin hydrochloride.

The other ingredients are Polysorbate 80, Methacrylic acid copolymer dispersion, Triacetin, Sodium lauryl sulfate, Purified water, Microcrystalline cellulose and Calcium stearate. These all help to make the granules which ■■II are in the capsule

The capsule shell contains FD & C Blue 2

(E 132), Iron oxide black (E 172), Iron oxide red (E 172), Iron oxide yellow (E 172), Titanium dioxide (E 171), Gelatin, Purified water, Sodium lauryl sulfate;

Printing ink is Shellac (E904), Dehydrated alcohol, Isopropyl alcohol, Butyl alcohol, Propylene glycol, Strong ammonia solution, Black iron oxide (E172), Potassium hydroxide and Purified water.

What Tamsumac looks like and contents of the pack

Tamsumac capsules are Olive green opaque / Orange opaque, Size „2“, hard gelatin capsules, containing free flowing white to off white spheroids with „CL 23“ on cap and „0.4“ on the body imprinted with black ink.

The capsules are packaged in Clear PVC/PE/PVdC – Aluminium Blister.

The capsules are supplied in blister packs of 14, 20, 28, 30, 50, 56, 90, 98 and 100 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

lilACLEOD}

.............­.inn.........

Macleods Pharma UK Limited

Wynyard Park House, Wynyard Avenue, Wynyard, Billingham, TS22 5TB United Kingdom

Q O

PL 34771/0170

I This leaflet was last revised in {04/2020}

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Front Side

Package Leaflet: Information for the user

Tamsumac 0.4 mg prolonged release capsules, hard tamsulosin hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Tamsumac is and what it is used for 2. What you need to know before you take Tamsumac

• 3. How to take Tamsumac

• 4. Possible side effects

• 5. How to store Tamsumac

• 6. Contents of the pack and other information

1. what tamsumac is and what it is used for

The active ingredient in Tamsumac is tamsulosin hydrochloride. It acts by relaxing the muscles in the prostate and urethra (the tube that carries urine to the outside), and lets urine pass more readily through the urethra and aids urination.

In the prostate gland, bladder 11111 UHttl and urethra there are UHIII 11111 specialised cells containing alpha1A-receptors that cause the muscles in the urethra to tighten. Tamsumac is an alpha1A-adrenoceptor blocker, which reduces the action of these specialised cells and relaxes the muscles making it easier to pass water.

Tamsumac is used in men for the treatment of the complaints of the lower urinary tract associated with an enlarged prostatic gland (benign prostatic hyperplasia). These symptoms include difficulty in starting to pass water, frequent trips to the toilet to pass water, a feeling of not completely emptying the bladder and having to get up several times in the night to pass water.

2. what you need to know before you take tamsumac

Do not take Tamsumac:

• If you are allergic (hypersensitive) to tamsulosin or any of the other ingredients of Tamsumac (listed in section 6).
• if you have a severe liver condition.
• if you have ever fainted or felt dizzy when suddenly sitting or standing up. Dizziness can sometimes occur when taking Tamsumac, particularly if you are also taking other alpha1– blockers. If you do feel weak or dizzy make sure you sit or lie down straight away until the symptoms have disappeared.

Warnings and precautions

Talk to your doctor or pharmacist before taking Tamsumac.

Take special care with Tamsumac (and speak to your doctor)

If you have kidney problems

• If you are undergoing or have been scheduled for eye surgery because of cloudiness of the lens (cataract) or increased pressure in the eye (glaucoma).

Please inform your eye specialist that you have previously used, are using or are planning to use tamsulosin. The specialist can then take appropriate precautions with respect to medication and surgical techniques to be used. Ask your doctor whether or not you should postpone or temporarily stop taking this medicine when undergoing eye surgery because of a cloudy lens (cataract) or to increased pressure in the eye (glaucoma).

Children and adolescents

Do not give this medicine to children or adolescent under 18 years because it does not work in this population.

Other medicines and Tamsumac

• – Taking Tamsumac together with other medicines from the same class (a1-adrenoceptor antagonists) may cause an unwanted decrease in blood pressure.

• – It is especially important to inform your doctor if you are being treated at the same time with medicines that may decrease the removal of Tamsumac from the body (for example, ketoconazole, erythromycin).

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Tamsumac with food and drink

Tamsumac must be taken after breakfast or the first meal of the day.

Pregnancy, breast-feeding and fertility Tamsumac is not indicated for use in women.

In men, abnormal ejaculation has been reported (ejaculation disorder). This means that semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or ejaculate volume is reduced or absent (ejaculatory failure). This phenomenon is harmless.

Driving and using machines

There is no evidence that Tamsumac affects the ability to drive or to operate machinery or equipment. However, you should bear in mind that dizziness can occur, in which case you should not undertake activities that require attentiveness.

3. how to take tamsumac

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is 1 capsule per day to be taken after breakfast or the first meal of each day. The capsule must be swallowed whole and not be crunched or chewed. Usually, Tamsumac is prescribed for long periods of time. The effects on the bladder and on urination are maintained during longterm treatment with Tamsumac.

If you take more Tamsumac than you should

Taking too much Tamsumac may lead to an unwanted decrease in blood pressure and an increase in heart rate, with feelings of faintness. Contact your doctor immediately if you have taken too much Tamsumac.

If you forget to take Tamsumac

You may take your daily Tamsumac later the same day if you have forgotten to take it as recommended. If you have missed a day, just continue to take your daily capsule as prescribed. Never take a double dose to make up for a forgotten capsule.

Back Side

If you stop taking Tamsumac

When treatment with Tamsumac is stopped prematurely, your original complaints may return. Therefore take Tamsumac as long as your doctor prescribes, even if your complaints have disappeared already. Always consult your doctor, if you consider stopping this therapy.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 people)

• Dizziness, particularly when going to sit or stand up.
• Abnormal ejaculation (ejaculation disorder). This means that semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or ejaculate volume is reduced or absent (ejaculatory failure). This phenomenon is harmless.
• Uncommon (may affect up to 1 in 100 people) Headache
• Palpitations (the heart beats more rapidly than normal and it is also noticeable)
• Reduced blood pressure e.g. when getting

up quickly from a seating or lying position sometimes associated with dizziness.

Runny or blocked nose (rhinitis).

Diarrhoea.

• Feeling sick and vomiting.
• Constipation.
• Weakness (asthenia).
• Rashes, itching and hives (urticaria).

Rare (may affect upto 1 in 1,000 people)

• Faintiness and sudden local swelling of the soft tissues of the body (e.g. the throat or tongue) difficult breathing and / or itching and rash, often as an allergic reaction (angioedema).

Very rare (may affect up to 1 in 10,000 people)

• Priapism (painful prolonged unwanted erection for which immediate medical treatment is required).
• Rash, inflammation and blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (Stevens-Johnson syndrome).

Not Known (frequency cannot be estimated from the available data)

• Blurred vision or impaired vision
• Nose bleeds
• Dry mouth
• Serious skin rashes (erythema multiforme, dermatitis exfoliative)
• Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia),
• Difficult breathing (dyspnoea).
• If you are undergoing eye surgery because of cloudiness of the lens (cataract) or increased pressure in the eye (glaucoma) and are already taking or have previously taken Tamsumac, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the procedure.