Nifedin Dexcel 10 and 20 Retard Nifedipine Tablets

NIFEDIN DEXCEL 10 RETARD

NIFEDIN DEXCEL 20 RETARD

(Nifedipine 10 mg)

(Nifedipine 20 mg)

 

WHAT YOU SHOULD KNOW ABOUT NIFEDIN DEXCEL 10 RETARD AND NIFEDIN DEXCEL 20 RETARD

Please read this leaflet carefully before you start taking your tablets. This leaflet provides a summary of the information available on your medicine. Please do not throw it away until you have finished your medicine. If you have any questions or are not sure about anything ask your doctor or pharmacist.

 

IDENTIFICATION OF THE MEDICINAL PRODUCT

Name of the medicinal product

NIFEDIN DEXCEL 10 RETARD.

NIFEDIN DEXCEL 20 RETARD.

 

Quantitative and qualitative composition

The active ingredient in NIFEDIN DEXCEL 10 RETARD tablets and NIFEDIN DEXCEL2O RETARD tablets is Nifedipine Ph. Eur.

Each NIFEDIN DEXCEL 10 RETARD tablet contains 10 mg of Nifedipine.

Each NIFEDIN DEXCEL2O RETARD tablet contains 20mg of Nifedipine.

 

Pharmaceutical form

Sustained release, pink, round, film coated tablets.

 

Presentation

NIFEDIN DEXCEL 10 RETARD is available in packs of: 100 tablets in foil blister strips (10 blisters of 10 tablets); NIFEDIN DEXCEL 20 RETARD is available in packs of: 30 tablets in foil blister strips (3 blisters of 10 tablets).

 

What does your medicine do?

Nifedipine is one of a group of medicines called calcium channel blockers. It lowers blood pressure and has anti-anginal properties. Nifedipine relaxes the muscle lining of small blood vessels throughout the body and in this way brings high blood pressure down to normal. Nifedipine also reduces the pain (angina pectoris) which occurs when the heart is starved of oxygen, by improving oxygen supply to the heart muscle.

 

INDICATIONS

What is your medicine for?

NIFEDIN DEXCEL RETARD tablets are used to treat all grades of high blood pressure (hypertension) and to prevent the condition called angina pectoris.

 

BEFORE TAKING ANY OF THE TABLETS, ASK YOURSELF THE FOLLOWING QUESTIONS:

Contraindications

• Have you taken products containing nifedipine before and reacted badly to them, e.g. developed wheezing or rash?

• Are you sensitive to calcium antagonists (e.g. verapamil, diltiazem, amlodipine, felodipine)?

• Do you suffer from the heart conditions known as aortic stenosis (a narrowing of the aorta, which is the largest blood vessel leading from the heart, resulting in reduced blood flow through the aorta) or unstable angina (unpredictable chest pains of varying levels of severity)?

• Have you had a myocardial infarction (heart attack) during the past twelve hours or within the past month?

• Do you suffer from acute attacks of angina?

• Do you suffer from malignant hypertension (rapid rise in blood pressure requiring medical treatment)?

 

If the answer to any of these questions is yes, you should not take NIFEDIN DEXCEL. RETARD tablets.

• If you have ever had a myocardial infarction NIFEDIN DEXCEL 10 RETARD and NIFEDIN DEXCEL 20 RETARD should not be used to prevent a second myocardiaI infarction.

• Are you pregnant or trying to become pregnant? Nifedipine should not be taken by pregnant women, nor by women who could become pregnant because there is a risk of damage to the unborn baby.

• Are you breast-feeding? Nifedipine should not be taken by breast-feeding women as it passes into the breast milk.

 

Precautions

– Do you suffer from poor cardiac reserve (a reduced output from the heart)?

– Do you suffer from severe low blood pressure (hypotension)?

– Are you a diabetic (Nifedipine may cause temporary high blood sugar level)? Your doctor may need to change your treatment for diabetes.

– Do you suffer from a liver disease (see the ‘How should you take your medicine” section)?

If the answer to any of these questions is yes, NIFEDIN DEXCEL RETARD tablets should be used with caution therefore tell your doctor before you use these tablets.

Treatment with this medicine should be discontinued should cardiac ischaemic pain (chest pain) be experienced within 1-4 hours of the introduction of therapy and you should consult your doctor.

If you are on kidney dialysis and you have very high blood pressure and a low blood volume, you may experience a sudden drop in blood pressure so consult your doctor before taking this medicine.

 

Drug Interactions

Are you receiving any other medical treatment, particularly any of the following drugs: cimetidine, digoxin, quinidine, rifampicin, beta blocking drugs, diltiazem or other drugs to lower blood pressure? Do not take NIFEDIN DEXCEL RETARD tablets until you have discussed all these other medicines with your doctor. Your doctor will decide whether you can take NIFEDIN DEXCEL RETARD as well. Do not eat or drink products containing grapefruit juice at the same time as you take NIFEDIN DEXCEL RETARD tablets.

 

How should you take your medicine?

It is important that you take your medicine at the right time.

You must take it as directed by your doctor. If you are not sure, ask your doctor or pharmacist.

Treatment may be continued indefinitely.

You should take the tablets only as directed by your doctor. The usual dose for adults is one NIFEDIN DEXCEL 20 RETARD tablet (20 mg) twice a day.

Your doctor may advise a different dose within the range 10 mg twice daily to 40 mg twice daily; e.g. if you suffer from liver problems, therapy should be started with NIFEDIN DEXCEL 10 RETARD (10mg) twice daily; or if your condition requires a higher dosage, therapy could be increased to two NIFEDIN DEXCEL 20 RETARD (40 mg) twice a day (only if your doctor has advised it). Usually, NIFEDIN DEXCEL 10 RETARD is recommended as initial dosage.

Ideally take your doses at twelve hour intervals. NIFEDIN DEXCEL RETARD tablets should be swallowed whole with water and should not be broken or chewed. NIFEDIN DEXCEL RETARD tablets are not recommended for treatment of children.

 

What should you do it you forget to take a dose?

It you forget to take a dose take it as soon as you remember and continue, as prescribed, on the next day allowing at least twelve hours before taking the following dose.

 

What should you do in case of an overdose?

In case of an accidental overdose, contact your nearest hospital casualty department or tell your doctor immediately.

Remember to take the following to show the doctor: the leaflet and containers, any remaining NIFEDIN DEXCEL RETARD tablets, any other medicines which you are taking.

If you have to see another doctor or visit a hospital for another complaint, remember to tell them what medicines you are already taking.

 

SIDE EFFECTS THAT MIGHT HAPPEN AFTER TAKING YOUR MEDICINE

As in most medicines some people may experience side effects after taking NIFEDIN DEXCEL RETARD tablets. These are usually minor, but you should tell your doctor if they become more serious, or if you are worried about them.

A number of side effects are known for Nifedipine. Headache, flushing, fast heartbeat (tachycardia) and palpitations may occur, particularly on commencement of treatment with Nifedipine.

Swelling of ankles or legs has been observed. A sensation of numbness, prickling or tingling, or heightened sensitivity may occur occasionally; a sensation of dizziness and tiredness may also develop. Skin reactions may occur such as rash, itching and urticaria (itching wheals). Other skin reactions such as sensitivity to light, peeling or reddening of the skin may occur in isolated cases; usually, they regress after discontinuation of the drug. Systemic allergic reactions (these may appear as yellowing of the skin (jaundice), or they may cause symptoms such as a rash or fever) which also usually regress after discontinuation of the drug may occur in isolated cases. Gastrointestinal disorders such as nausea and altered bowel habit may occur occasionally. Other less frequently reported side effects include muscle pain, trembling and visual disturbance. You may feel the need to pass urine more often. Rarely, mood changes may occur.

If you experience any other side effects, and especially the following, discuss them immediately with your doctor: chest pain, thickening of gums, yellowish discoloration of the skin and, perhaps, the whites of the eyes (this is called jaundice). These side effects should disappear when treatment with Nifedipine is stopped. Occasionally, the treatment of high blood pressure may lead to breast enlargement, particularly in older men. See your doctor if it occurs.

If you are a diabetic, you must talk to your doctor before taking NIFEDIN DEXCEL RETARD tablets (seethe “before taking any of the tablets” section).

If you experience any unusual symptoms when taking these tablets consult your doctor.

 

HOW SHOULD YOU STORE YOUR MEDICINE?

Nifedipine is sensitive to light. For this reason, the tablets should be protected from light and stored in the manufacturer’s original container, which has been designed to protect the tablets from light. Do not remove the tablets from the blister or carton except when ready to take them.

You should store the tablets in a cool and dry place, out of the reach of children.

Check the expiry date of the label. Do not use the tablets if the expiry date has passed.

If your doctor decided to stop treatment return any tablets you have left to the pharmacist. Only keep them if the doctor tells you to.

 

REMEMBER

This medication is for you. Only a doctor can prescribe it for you. Never give it to others.

It may harm them even if their symptoms appear to be the same as yours.

Keep out of the reach of children.

 

DATE OF PREPARATION OR LAST REVISION

May 1999

 

The manufacturer is

Dexcel® Ltd.,

Southern Industrial Zone,

Or-Akiva 30600, Israel.