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VASCALPHA 5MG PROLONGED RELEASE TABLETS (FELODIPINE)

Active substance: FELODIPINE

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Vascalpha 5mg and 10mg
prolonged release tablets
Felodipine
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:
1 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)
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• 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 over page



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: The doctor 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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AAAD6592 50526537



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.

6 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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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