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Vascalpha 10mg Prolonged Release Tablets (Felodipine)

Informations for option: Vascalpha 10mg Prolonged Release Tablets (Felodipine), show other option

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

In this leaflet:

T| What Vascalpha tablets are and what they are used for

"2 Before you take Vascalpha tablets "3 How to take Vascalpha tablets "4 Possible side effects "5| How to store Vascalpha tablets "6 Further information

_1 What Vascalpha tablets are and what they are used for

Vascalpha tablets contain the active substance felodipine which belongs to a group of medicines called dihydropyridine-type calcium channel blockers. These work by relaxing the smooth muscle in the blood vessel walls and opening the blood vessels. This then lowers the blood pressure.

Vascalpha tablets are used:

-    to treat patients with high blood pressure (essential hypertension).

-    to treat certain types of chest pain that occur during exercise (stable angina pectoris) or at rest (Prinzmetal angina)

High blood pressure often causes no symptoms, but if it is not treated it can damage blood vessels in the long-term. In some cases this can lead to heart attacks, kidney failure, stroke or blindness. That is why it is important not to stop taking this medicine without talking to your doctor.

2| Before you take Vascalpha tablets

Do not take Vascalpha tablets if you

•    are allergic (hypersensitive) to felodipine, other similar compounds (dihydropyridine-type calcium channel blockers) or any of the other ingredients in the tablets (see section 6)

•    have a very low pulse and blood pressure (cardiogenic shock)

•    have severe narrowing (stenosis) of the aorta or of the heart valves (mitral or aortic valve)

•    suffer from an enlarged heart muscle (hypertrophic cardiomyopathy)

•    get chest pain caused by coronary heart disease also at rest or with minimal effort (so called unstable angina pectoris)

•    have suffered a heart attack within the last two months

•    have untreated heart failure, causing swelling of the extremities, weakness, and shortness of breath

•    have severely reduced liver function

•    are or may be pregnant (see “Pregnancy" below).

Take special care with Vascalpha tablets if you

•    have severely reduced kidney function

•    have reduced liver function

•    suffer with stable heart failure

•    suffer with fast heart beat (tachycardia)

•    suffer with narrowing (stenosis) of the aorta or of the heart valves (mitral or aortic valve)

•    have conduction disturbances in the heart (2nd or 3rd degree atrioventricular block)

•    have poor oral hygiene, as it can increase the risk of inflammation of the gums during Vascalpha treatment.

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, herbal medicines, or natural

products. Especially:

•    other medicines that lower blood pressure such as hydrochlorothiazide, beta blockers (to treat high blood pressure), nitrates (to control coronary heart disease and chest pain), tricyclic antidepressants (to treat depression) or phenothiazines (to treat psychoses)

•    amiodarone, diltiazem or verapamil (to treat heart problems)

•    digoxin (to treat heart failure)

•    fluconazole, itraconazole, ketoconazole, miconazole, or voriconazole (to treat fungal or yeast infections)

•    erythromycin, clarithromycin, or telithromycin (antibiotics)

•    rifampicin or rifabutin (to treat tuberculosis)

•    fluoxetine or fluovoxamine (to treat depression)

•    tacrolimus or ciclosporin (to suppress immune system e.g. after organ transplantation)

•    phenobarbital, phenytoin, or carbamazepine (to treat epilepsy)

•    cimetidine (to treat heartburn and stomach ulcers)

•    nevirapine, ritonavir, sakinavir (to treat HIV infection)

•    herbal medicines containing St. John's wort (Hypericum perforatum).

Taking Vascalpha tablets with food and drink

See section 3 “Taking the tablets'!

Pregnancy and breastfeeding

Felodipine must not be taken during the whole pregnancy. If you think you are pregnant, plan to get pregnant or become pregnant while using Vascalpha tablets stop using the medicine immediately and consult the doctor as soon as possible. Felodipine is excreted in breast milk, therefore the use of Vascalpha tablets is not recommended while breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine.

Continued top of next column

Driving and using machines

Vascalpha tablets can cause dizziness or tiredness. These effects are more likely to occur at the start of treatment, after dose increases, or after taking alcohol at the same time. If you are affected, do not drive or operate machinery.

Sugar intolerance

If a doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains lactose.

_3| How to take Vascalpha tablets

Always take Vascalpha tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Usual doses Adults:

High blood pressure:

Initially 5mg once daily. If needed, the doctor may increase the dose to 10mg daily or may prescribe an additional medicine to lower blood pressure.

Angina:

Initially 5mg once daily. If needed, the doctor may increase the dose to 10mg once daily.

Elderly    will decide your starting dose.

Children: Not recommended.

Kidney and/or liver problems: patients with severe liver problems must not take Vascalpha tablets and patients with severe kidney problems should not take Vascalpha tablets.

If you have liver disease, your doctor will monitor your condition and may prescribe you a smaller dose.

Taking the tablets

•    Swallow these tablets whole at the same time of the day (e.g. in the morning) with a glass of water. Do not crush or chew them.

   Do not take with grapefruit juice, as this may make Vascalpha tablets work too strongly.

•    Take the tablets on an empty stomach or with a light meal. The tablets should not be taken with a high fat meal.

•    Take this medicine for as long as your doctor tells you to. It may be dangerous to stop without your doctor's advice.

If you take more Vascalpha tablets than you should

Do not take more tablets than your doctor tells you to. If you ever take too many go to the nearest hospital casualty department or tell your doctor immediately. Take the container and any remaining tablets with you to show to the doctor. An overdose may lead to light-headedness, fainting and dizziness caused by very low blood pressure and in rare cases slowed heartbeat (bradycardia).

If you forget to take Vascalpha tablets

If you forget to take a dose, take one as soon as you remember. Then go on as before. Do not take two doses at the same time to make up for a forgotten dose. If you are worried, ask your pharmacist or doctor for advice.

If you stop taking Vascalpha tablets

Do not stop treatment early because felodipine can be associated with withdrawal symptoms. If you stop taking the tablets too quickly you may develop high blood pressure again. Talk to your doctor before you stop taking the tablets and follow the advice.

4 Possible side effects

Like all medicines, Vascalpha tablets may cause side effects, although not everyone gets them.

Stop taking Vascalpha tablets and contact your doctor if you have an allergic reaction such as swelling of the face, lips, tongue, mouth and throat, which may cause shortness of breath or difficulty swallowing.

Tell your doctor if you notice any of the following side effects.

Very common (occurs in more than 1 in 10 users): headache, tinnitus (ringing or buzzing in the ears), or flushing - these effects are more likely to occur at the start of treatment or after dose increases and may settle with continued use. Swelling of extremities (in particular the ankles).

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Common (occurs in less than 1 in 10 users): chest pain or worsening of chest pain (angina pectoris) more likely after beginning of treatment, Uncommon (occurs in less than 1 in 100 users): 'pins and needles', dizziness, fatigue, restlessness, palpitations, fast heart beat (tachycardia), very low blood pressure, fainting, shortness of breath, feeling sick (nausea) or being sick (vomiting), diarrhoea, constipation, stomach pain, itching skin, hives (urticaria), rash, sensitivity to light, increased sweating, inflammation or swelling of the gums, joint or muscle pain, tremors, increased need to pass urine, weight gain.

Rare (occurs in less than 1 in 1,000 users): purple colouration of the skin. Very rare (occurs in less than 1 in 10,000 users): heart attack, liver function problems seen as raised transaminase levels in blood tests, scaling skin reactions (exfoliative dermatitis), erection disorders, enlargement of breast tissue in males, heavy menstruation, fever.

If you have any of these side effects, they get worse, or if you notice any side effects not listed, please tell your doctor or pharmacist.

_5 How to store Vascalpha tablets

Keep out of the reach and sight of children.

Do not store the tablets above 25°C.

Do not use Vascalpha tablets after the expiry date which is stated on the carton and blister.

The expiry date refers to the last day of that month.

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.

4 Further information

What Vascalpha tablets contain

•    the active substance (the ingredient that makes the tablets work) is felodipine. One prolonged release tablet contains either 5mg or 10mg of felodipine.

•    the other ingredients are microcrystalline cellulose, hypromellose, lactose monohydrate, povidone K25, propylene glycol, propyl gallate (Ph.Eur.), magnesium stearate (Ph.Eur.), colloidal anhydrous silica, talcum, iron oxide red (E172), iron oxide yellow (E172), titanium dioxide (E171).

What Vascalpha tablets look like and contents of the pack

Vascalpha 5mg tablets are light pink, round, biconvex, film-coated prolonged release tablets with 5 on one side.

Vascalpha 10mg tablets are reddish brown, round, biconvex, film-coated prolonged release tablets with 10 on one side.

Vascalpha 5mg or 10mg are available in packages of 10,

14, 20, 28, 30, 50, 56, 60, 90, 98, 100, 250, 500 and 1000 prolonged release tablets. Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer

Actavis, Barnstaple, EX32 8NS, UK.

This leaflet was last revised in April 2012.