PACKAGE LEAFLET: INFORMATION FOR THE USER    koooooltooo

Faramsil 400 microgram Prolonged-release Tablets

tamsulosin hydrochloride    A SANDOZ

Read all of this leaflet carefully before you

start taking this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    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.

before you start taking the medicine. These tests may continue afterwards, to see how the medicine is working.

If you are undergoing eye surgery because of cloudiness of the lens (cataract), please inform your eye specialist that you are using or have previously used 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.

In this leaflet:

1.    What Faramsil is and what it is used for

2.    Before you take Faramsil

3.    How to take Faramsil

4.    Possible side effects

5.    How to store Faramsil

6.    Further information

IWhat Faramsil is and what it is ■ used for

Faramsil contains an active substance tamsulosin hydrochloride, which belongs to a group of medicines called alpha adrenoceptor blockers.

Faramsil relaxes:

•    the muscles in the prostate gland, and

•    the tube from the bladder to the outside (the urethra). This lets urine pass more easily through the urethra, making it easier to urinate.

Children

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

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

In particular, tell your doctor or pharmacist if you are taking:

•    Medicines that 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 ketaconazole or itraconazole

Other alpha blockers such as doxazosin, indoramin, prazosin or alfuzosin

•    Erythromycin, an antibiotic used to treat infections

Faramsil is for men who have benign prostate enlargement (benign prostatic hyperplasia, BPH). This is when the prostate gland increases in size. This can make it difficult to pass urine. This means you may have to pass urine often or during the night. You may also feel that you still need to pass urine even after having done so. You may also dribble after passing urine.

2. Before you take Faramsil

Do not take Faramsil if

•    you are allergic (hypersensitive) to tamsulosin or any of the other ingredients of Faramsil (see list in section 6 ‘Further information’).

•    you have a serious liver problem.

•    you feel dizzy or faint when you suddenly sit or stand up.

Take special care with Faramsil

If you have a serious kidney problem. You should consult your doctor, before taking Faramsil.

As with other medicines in the same group, dizziness can occur in individual cases, when taking Faramsil. If you feel weak or dizzy, when taking Faramsil, you should sit or lie down straight away until the symptoms have disappeared.

Before you start taking Faramsil your doctor may need to examine you. This is to check that you do not have another condition with the same symptoms as BPH. Your doctor may also use a blood test

Taking Faramsil with food and drink

Faramsil can be taken independently of food.

Pregnancy and breast-feeding

Tamsulosin is not indicated for use in women.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. However you should be aware of the fact that drowsiness, blurred vision, dizziness and fainting can occur. If you feel weak or dizzy, do not drive or use machines.

Important information about some of the ingredients of Faramsil

Faramsil contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Faramsil

Always take Faramsil exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The usual dose is one tablet each day. It can be taken with or without food. Swallow the tablet whole. Do not crush or chew it.

If you take more Faramsil than you should

•    Talk to your doctor or pharmacist or go to the nearest hospital straight away.

•    Take this leaflet and any of the remaining tablets with you.

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Taking too much Faramsil may make you feel dizzy or faint and cause headache.

If you forget to take Faramsil

If you forget to take your Faramsil at your usual time, take it later the same day.

If you miss a whole day, just take your normal tablet the next day. Do not take an extra tablet to make up for the one you missed.

If you stop taking Faramsil

If you stop taking Faramsil your original symptoms may return. You should keep taking Faramsil as advised by your doctor, even if your symptoms have gone away. Always talk to your doctor if you are thinking about stopping taking this medicine.

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

(erythema multiforme, dermatitis exfoliative)

• dry mouth

As with other medicines that belong to the same group (alpha-blockers), Faramsil can also cause drowsiness, blurred vision, dry mouth or oedema.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system the Yellow Card Scheme: www.mhra.gov.uk/yellowcard. By reporting side affects you can help provide more information on the safety of this medicine.

5. How to store Faramsil

4. Possible side effects

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

You should contact your doctor immediately if you notice any of the following side effects (it may be an allergic reaction):

•    lumpy skin rash (urticaria)

•    swollen feet, hands, lips, tongue or throat and difficulty breathing.

[jjjjjl If you feel weak or dizzy, when taking Faramsil, you should sit or lie down straight away until the symptoms have disappeared.

Common (affect more than 1 person in 100 and less than 1 person in 10):

•    feeling dizzy

•    abnormal ejaculation (ejaculation disorders). This means that semen does not leave the body via the urethra, but instead goes into the bladder (retrograde ejaculation) or the ejaculation volume is reduced or absent (ejaculation failure). This phenomenon is harmless.

Uncommon (affect more than 1 person in 1,000 and less than 1 person in 100):

•    headache

•    fast or uneven heart beat (palpitations)

•    a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting

•    runny or blocked nose

•    feeling sick or being sick

•    diarrhoea or constipation

•    allergic reactions (skin rash, itchy or inflamed skin)

•    feeling weak.

Rare (affect 1 to 10 users in 10,000):

•    fainting

•    lumpy skin rash (urticaria) with swollen feet, hands, lips, tongue or throat and difficulty breathing. In this case, see a doctor immediately.

Very rare (affect less than 1 person in 10,000):

•    long-lasting and painful erection (priapism), normally not during sexual activity

•    serious illness with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome).

Frequency not known (cannot be estimated from the available data):

•    irregular heart beat, faster heart beat

•    shortness of breath

•    vision blurred, visual impairment

•    bleeding from the nose

•    rash, inflammation and blistering of the skin

Keep out of the reach and sight of children.

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

Store in the original package.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information

What Faramsil contains

•    The active substance is 0.4 mg tamsulosin hydrochloride.

•    The other ingredients are:

-    Tablet core: cellulose, microcrystalline, hydroxypropylcellulose, lactose monohydrate, polyethylene oxide, butylhydroxytoluene, magnesium stearate, silica, colloidal anhydrous

-    Tablet film-coating: hypromellose, hydroxypropylcellulose, macrogol 400, titanium dioxide (E171), talc, quinoline yellow (E104), carmine (E120), iron oxide, black (E172).

What Faramsil looks like and contents of the pack

Faramsil 400 microgram Prolonged-release Tablets are brown, round, bi-convex film-coated tablets marked “0.4” on one side and “SZ” on the other side.

Faramsil is packed in aluminium/aluminium blisters: 10, 14, 20, 28, 30, 50, 56, 60, 80, 90, 100 or 200 film-coated prolonged-release tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

Manufacturer

Lek Pharmaceuticals d.d., Verovskova 57,1526 Ljubljana, Slovenia or Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia or

Salutas Pharma GmbH, Otto-von-Guericke Allee 1, 39179 Barleben, Germany or Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen, Germany or

Lek S.A., Ul. Domaniewska 50C, 02- 672 Warszawa, Poland.

This leaflet was last revised in April 2014

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