Package leaflet: Information for the user

Contiflo XL 400 micrograms capsules

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, askyour 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 Contiflo XL is and what it is used for

2.    What you need to know before you take Contiflo XL

3.    How to take Contiflo XL

4.    Possible side effects

5.    How to store Contiflo XL

6.    Contents of the pack and other information

1. What Contiflo XL is and what it is used for

The active ingredient in Contiflo XL is tamsulosin. This is a selective a_w1D-adrenoceptor antagonist. It reduces tension of the smooth muscles in the prostate and the urethra, enabling urine to pass more readily through the urethra and facilitating urination. In addition, itdiminishes sensations of urge.

Contiflo XL 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 complaints may include difficulty urinating (poor stream), dribbling, urgency and having to urinate frequently at night as well as during the day.

2. What you need to know before you take Contiflo XL

Do not take Contiflo XL:

-    if you are allergic to tamsulosin hydrochloride or to any of the other ingredients of this medicine (listed in section 6). Hypersensitivity may present as sudden local swelling of the soft tissues of the body (e.g. the throat ortongue), difficult breathing and/or itching and rash (angioedema).

-    if you sufferfrom severe liver problems.

-    if you suffer from fainting due to reduced blood pressure when changing posture (going to sit or stand up).

Warnings and precautions

Talkto your doctor or pharmacist before taking Contiflo XL.

-    Periodic medical examinations are necessary to monitorthe development of the condition you are being treated for.

-    Rarely, fainting can occur during the use of Contiflo XL as with other medicinal products of this type.

Atthe first signs of dizziness or weakness you should sit or lie down until they have disappeared.

-    ifyou sufferfrom severe kidney problems, tell your doctor.

-    if you are undergoing or have been scheduled for eye surgery because of cloudiness of the lens (cataract), please inform your eye specialist that you have previously used, are using , or are planning to use Contiflo XL. 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.

Children

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

Other medicines and Contiflo XL

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

Taking Contiflo XL 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 Contiflo XL from the body (for example, ketoconazole, erythromycin).

Contiflo XL with food, drink or alcohol

Contiflo XL must be taken after breakfast orthe first meal of the day.

Pregnancy, breast-feeding and fertility

This section is not relevant, because Contiflo XL is not indicated for use in women.

Impaired sexual functions in males have been reported with Contiflo XL.

Driving and using machines

There is no evidence that Contiflo XL affects the ability to drive orto 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.

Contiflo XL contains sunset yellow, azorubine and ponceau 4R

Allergic reactions may occur due to the presence of colouring agents used in this product: sunset yellow (E110), azorubine (E122) and ponceau 4R (E124).

3. How to take Contiflo XL

If you stop taking Contiflo XL

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

Ifyou 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 (less than 1 in 10, more than 1 in 100 (1-10%)):

Dizziness, particularly when going to sit or stand up.

Ejaculation disorders.

Retrograde ejaculation; this means that semen does not leave the body via the urethra, but instead goes into the bladder. This phenomenon is harmless.

Ejaculation failure.

Uncommon (morethanl in 1000, less than 1 in 100 (0,1-1%)):

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 (morethanl in 10,000, lessthan 1 in 1000 (0,01 -0,1%)):

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

Very rare (lessthan 1 in 10,000 (<0,01 %):

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 based on available data)

Vision blurred, visual impairment Nosebleed

Severe condition of the skin that may affect the mouth and other parts of the body Skin disease Dry mouth

Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficult breathing (dyspnoea).

If you are undergoing eye surgery because of cloudiness of the lens (cataract) and are already taking or have previously taken Contiflo XL, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the procedure.

Reporting of side effects

If you get any side effects, talkto 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.

5. Howto store Contiflo XL

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

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

6. Contents of the pack and other information

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

The dosage is one capsule per day to be taken after breakfast orthe first meal of each day. The capsule must be swallowed whole and not be crunched or chewed. Usually, Contiflo XL is prescribed for long periods of time. The effects on the bladder and on urination are maintained during long-term treatment with Contiflo XL.

If you take more Contiflo XL than you should

Taking too many capsules of Contiflo XL 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 Contiflo XL.

If you forget to take Contiflo XL

You may take your daily Contiflo XL 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. Do not take a double dose to make up for a forgotten capsule.

What Contiflo XL contains

The active substance is tamsulosin hydrochloride. One prolonged release capsule contains 400 micrograms of tamsulosin hydrochloride.

The other ingredients are: capsule contents: cellulose microcrystalline PH101, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion, sodium hydroxide, triacetin, titanium dioxide (E171), purified talc.

Capsule body: gelatine, sunset yellow, ponceau 4R (E124), quinoline yellow (E104), brilliant blue (E133), titanium dioxide (E171).

Cap composition: gelatine, yellow iron oxide (E172), brilliant blue (E133), azorubine (E122), titanium dioxide (E171).

Printing ink: shellac, black Iron oxide (E172), potassium Hydroxide.

What Contiflo XL looks like and contents of the pack

Contiflo XL 400 micrograms prolonged release capsules comprise of Brown cap/Orange body of size '2' imprinted with 'R¹ on cap and 'TSN400' on body in black edible ink containing white to off-white granules.

Packs of 1,2,4,7,10,14,20,28,30,50,56,60,90,98,100 or 200 prolonged release capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Ranbaxy (UK) Limited Building 4, Chiswick Park,

566 Chiswick High Road,

London, W45YE United Kingdom

Manufacturers

Ranbaxy Ireland Limited

Spafield, Cork Road, Cashel, Co-Tipperary

Republic of Ireland

Terapia, S.A.

124, Fabricii Street, Zip Code 400632,

Cluj Napoca, Cluj Romania

This leaflet was last revised in October 2015    g

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and an increase in heart rate, with feelings of faintness. Contact your doctor immediately if you have taken too much Contiflo XL.

If you forget to take Contiflo XL

You may take your daily Contiflo XL 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. Do not take a double dose to make up for a forgotten capsule.

If you stop taking Contiflo XL

When treatment with Contiflo XL is stopped prematurely, your original complaints may return. Therefore use Contiflo XL 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 (less than 1 in 10,more than 1 in 100(1-10%)):

Dizziness, particularly when going to sit or stand up.

Ej aculation disorders

■ Retrograde ejaculation; this means that semen does not leave the body via the urethra, but i instead goes into the bladder. This phenomenon is harmless.

Ejaculation failure.

Uncommon (more than 1 in 1000, less than 1 in 100 (0,1 -1 %)):

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 (more than 1 in 10,000, less than 1 in 1000 (0,01-0,1%)):

Faintness 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 (less than 1 in 10,000 (<0,01%):

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 based on available data)

Vision blurred, visual impairment Nosebleed

Severe condition of the skin that may affect the mouth and other parts of the body Skin disease Dry mouth

Abnormal irregular heart rhythm (atrial fibrillation, arrhythmia, tachycardia), difficult breathing (dyspnoea).

If you are undergoing eye surgery because of cloudiness of the lens (cataract) and are already taking or have previously taken Contiflo XL, the pupil may dilate poorly and the iris (the coloured circular part of the eye) may become floppy during the procedure.

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 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.

5.    How to store Contiflo XL

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions

Do not use this medicine after the expiry date which is stated on the label. 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 Contiflo XL contains

The active substance is tamsulosin hydrochloride. One prolonged release capsule contains 400 micrograms of tamsulosin hydrochloride.

The other ingredients are: capsule contents: cellulose microcrystalline PH101, magnesium stearate, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion, sodium hydroxide, triacetin, titanium dioxide (E171), purified talc.

Capsule body: gelatine, sunset yellow, ponceau 4R (El 24), quinoline yellow (El 04), brilliant blue (E133), titanium dioxide (E171).

Cap composition: gelatine, yellow iron oxide (E172), brilliant blue (E133), azorubine (E122), titanium dioxide (E171).

Printing ink: shellac, black Iron oxide (El72), potassium Hydroxide.

What Contiflo XL looks like and contents of the pack

Contiflo XL 400 micrograms prolonged release capsules comprise of Brown cap/Qrange body of size '2' imprinted with ’R' on cap and 'TSN400' on body in black edible ink containing white to off-white granules.

Packs of 1,2,4,7,10,14,20,28,30,50,56,60,90,98,100 or 200 prolonged release capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Ranbaxy (UK) Limited Building 4, Chiswick Park,

566 Chiswick High Road,

London, W4 5 YE

United Kingdom

Manufacturers

Ranbaxy Ireland Limited

Spafield, Cork Road, Cashel, Co - Tipperary

Republic of Ireland

Terapia, S.A.

124, Fabricii Street, Zip Code 400632,

Cluj Napoca, Cluj

Romania    _07UK

This leaflet was last revised in October 2015.    5119522