VASRAN XL 10 MG PROLONGED-RELEASE TABLETS - patient leaflet, side effects, dosage

2. What you need to know before you take Vasran XL 10 mg prolonged release tablets

Do not take Vasran XL 10 mg prolonged release tablets

• – if you are allergic to alfuzosin or any of the other ingredients of this medicine (listed in section 6).

• – if you have had in the past, a drop in blood pressure when sitting or standing up.

• – if you are already taking another alpha-l-blocker.

• – if you have liver problems.

• – if you are younger than 16 years old.

Warnings and precautions

Talk to your doctor or pharmacist before taking Vasran XL 10 mg prolonged release tablets: – if you have a condition of the coronary arteries. Any treatment of reduced blood supply

to the heart muscle should be continued.

• – if symptoms of chest pain (angina pectoris) recur or worsen. The use of Vasran XL 10 mg prolonged release tablets should be discontinued.

• – if you are elderly, if you have an increased sensitivity to alpha-1 blockers or if you are being treated for high blood pressure.

• – if a fall in blood pressure occurs when sitting or standing up in the first hours after taking

the tablet. This effect can possibly occur with symptoms such as: dizziness, tiredness or sweating. In such a case you must lie down until the symptoms have completely

disappeared. These symptoms are usually transient and may occur at the beginning of

treatment. As a rule, treatment can be continued.

– if you have an eye surgery for cataract (cloudiness of the lens) planned, tell your eye

specialist before the surgery that you are using or have used Vasran XL 10 mg prolonged release tablets. This is because Vasran XL 10 mg prolonged release tablets may cause complications during your operation which can be managed if your eye specialist is aware of this information before carrying out the operation.

– if you continue to have a prolonged erection of the penis without being sexually aroused.

This is a serious condition that can lead to permanent impotence if not treated properly.

Consultyour doctor if one of the above warnings applies to you, or has done in the past.

Children

Alfuzosin is not to be used in children.

Other medicines and Vasran XL 10 mg prolonged release tablets

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

This also applies to medicines that you can get without a prescription.

Some medicines may affect each other's actions or may not be used at the same time for other reasons.

– Use with other alpha-1 -blockers at the same time should be avoided.

– When combined with medicines for elevated blood pressure, it may be necessary to

adjust the dosage of your medicine, due to the possible occurrence of a fall in blood pressure.

– If you have to undergo surgery, you must tell your doctor that you are taking Vasran XL 10 mg prolonged release tablets.

– When combined with nitrates (medicines to relieve pain on the chest), it may be

necessary to adjust the dosage of your medicine, due to the possible occurrence of a fall in blood pressure.

– It may be necessary to adjust the dose when used at the same time with medicines that

inhibit the CYP3 A4 liver enzyme, such as ketoconazole, itraconazole and ritonavir.

Vasran XL 10 mg prolonged release tablets with food and drink

• Take VasranXL lOmgprolongedre­leasetabletsjus­tafterameal
• Drinking alcohol may increase the unpleasant effects of alfuzosin. You may feel dizzy

and weak while taking Vasran XL 10 mg prolonged release tablets. If this happens do not drink any alcohol .

Pregnancy and breast-feeding

Not applicable. Vasran XL 10 mg prolonged release tablets is only prescribed for men.

Driving and using machines

No known data are available on the effect on the ability to drive or use machines. Complaints such as dizziness or general weakness may occur. This should be taken into account when driving vehicles or using machines.

Vasran XL 10 mg prolonged release tablets contain lactose.

This medicine contains lactose. If your doctor has told you that you cannot tolerate certain sugars, contact your doctor before you take this medicine.

3. How to take Vasran XL 10 mg prolonged release tablets

For oral use.

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

Use in children and adolescents

The efficacy of Vasran XL 10 mg prolonged release tablets has not been established in children aged 2 to 16 years. Therefore Vasran XL 10 mg prolonged release tablets is not indicated for children and adolescents (2 to 16 years old).

The tablets should be swallowed whole.

Take one tablet of Vasran XL 10 mg prolonged release tablet after the evening meal.

Take the tablet with plenty of fluid (for instance a glass of water). The prolonged-release tablet should not be ground, chewed or divided.

Taking the tablet at the same time every day provides the best effect. It also helps you to remember when to take the tablet.

Vasran XL 10 mg prolonged release tablet should not be used in patients with liver problems. However in mild to moderate liver problems other products containing low dose of alfuzosin can be used according to the appropriate dosage regimen. Your doctor will inform you about this.

If you take more Vasran XL 10 mg prolonged release tablets than you should

If you take too much Vasran XL 10 mg prolonged release tablets, contact your doctor or pharmacist immediately.

If you forget to take Vasran XL 10 mg prolonged release tablets

You may forget to take a tablet. In that case it is not necessary to take the forgotten tablet. You can continue to take the prescribed dose the next day.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Vasran XL 10 mg prolonged release tablets

You should not interrupt or stop taking Vasran XL 10 mg prolonged release tablets without speaking to your doctor first. Take your tablets as directed and for as long as directed. Do not stop taking them even if you feel better, as otherwise the symptoms may return.

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.

Serious side effects:

If any of the following happen, stop taking Vasran XL 10 mg prolonged release tablets and tell your doctor immediately or go to your nearest hospital emergency department:

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

• Rapid swelling of the eyelids, face, lips, mouth and tongue, difficulty in breathing or swallowing, rashes, hives and itching. These are symptoms of a very serious allergic reaction (the medical term for these symptoms is angioedema).
• Feeling of tightness, heaviness, discomfort, or crushing pain that is felt behind the breastbone and may spread to the arms, neck and jaw [these may be manifestations of angina]. Normally, this only happens if you have had angina before.

Other side effects:

Common (may affect up to 1 in 10 people)

• Headache
• Feeling sick (nausea)
• Stomach pain
• Dryness of mouth
• Weakness or tiredness
• Feeling unwell (malaise)
• Full body weakness (asthenia)

Uncommon: (may affect up to 1 in 100 people)

• Fast heart beat (tachycardia), fast or irregular heart beat (palpitations)
• Sudden loss of consciousness (syncope)
• Fainting
• Chest pain
• Drowsiness
• Skin rash
• Itching
• Getting warm, blushing (flushing)
• Water retention (may cause swollen arms or legs)
• Problems with your vision
• Runny or blocked nose, sneezing, facial pressure or pain (rhinitis)
• Loose stools (diarrhoea)
• Sensation of spinning or whirling when you are not actually moving (vertigo)
• Feeling dizzy or light headed when you stand or sit up quickly (postural hypotension).

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

• Damage or injury to the liver caused by a drug or chemical (hepatotoxicity)
• Itchy, lumpy rash also called hives or nettle rash (urticaria)

Not known: frequency cannot be estimated from the available data

• Lack of white blood cells (neutropenia) may manifest as frequent infections with symptoms such as fever, severe chills, sore throat or mouth ulcers
• Increased risk of bleeding (including nose bleeds and/or bleeding gums) and bruising. This could be a blood problem called ‚thrombocytopenia‘ which is a reduced number of platelets in the blood
• Being Sick (vomiting)
• Loss of appetite, nausea, vomiting, feeling generally unwell, fever, itching, yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine (these may be due to a liver problem)
• Irregular and often rapid heart rhythm (atrial fibrillation)
• Prolonged and painful erection of the penis, unrelated to sexual activity (these may be due to a medical condition called priapism)
• If you are having an operation on your eyes because of cataracts (where the lens of the eye is cloudy) and are already taking or have taken Vasran XL 10 mg prolonged release tables in the past, the pupil may dilate poorly and the iris (the coloured part of the eye) may become floppy during the procedure. This only happens during the operation and it is important for the eye specialist to be aware of this as the operation may need to be carried out differently (See section “Warnings and precautions”).

Reporting of side effects

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 Yellow Card Scheme at:

or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store vasran xl 10 mg prolonged release tablets

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 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 are to help protect the environment.

6. contents of the pack and other information

What Vasran XL 10 mg prolonged release tablets contain

• – The active substance is alfuzosin hydrochloride.

Each prolonged release tablet contains 10 mg of alfuzosin hydrochloride.

• – The other ingredients are: lactose anhydrous, colloidal anhydrous silica, povidone, talc, magnesium stearate, hypromellose, hydroxypropyl cellulose.

What Vasran XL 10 mg prolonged release tablets look like and contents of the pack

Vasran XL 10 mg prolonged release tablets are white to off-white, round, uncoated, biconvex tablets with flattened edges, marked with ‚RY 10‘ on one side.

Vasran XL 10 mg prolonged release tablets are available in boxes of 10, 30 or 90 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Ranbaxy (UK) Limited

5th floor, Hyde Park, Hayes 3

11 Millington Road

Hayes, UB3 4AZ

United Kingdom

Manufacturer:

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132 JHHoofddorp

The Netherlands

Terapia S.A.

Str. Fabricii Nr. 124

Cluj-Napoca 400 632

Romania

Please contact the marketing authorisation holder if you require more information about this medicine.

This medicinal product is authorised in the Member States of the EEA under the following names:

Alfuzosine RPG LP 10 mg, comprime a liberation proIongee

Alfudex 10 mg, tablets prolonged-release

Alfuzosina Ranbaxy

Alfuzosine HC1 SUN 10 mg tabletten, tabletten met verlengde afgifte

Alfabax

United Kingdom Vasran XL 10 mg Prolonged-release Tablets

This leaflet was last revised in July 2018.