PATIENT INFORMATION LEAFLET

What is in ISTIN?

ISTIN tablets come in two strengths, 5mg and 10mg.

The 5mg tablets are white, emerald shaped and marked AML-5 on one side and the Pfizer logo on the other. They contain 5mg amlodipine besilate.

The 10mg tablets are white, emerald shaped and marked AML-10 on one side and the Pfizer logo on the other. They contain 10mg amlodipine besilate.

Each tablet also contains inactive ingredients: dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose and sodium starch glycollate.

ISTIN comes in packs of 28 tablets.

The active ingredient in this medicine is amlodipine besilate. This is the new name for amlodipine besylate. The ingredient itself has not changed.

Manufacturer

What type of medicine is ISTIN?

ISTIN is one of a group of medicines called calcium antagonists.

What is ISTIN for?

ISTIN is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, a rare form of which is Prinzmetal's or variant angina.

In patients with high blood pressure ISTIN works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina ISTIN works by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. ISTIN does not provide immediate relief of chest pain from angina.

ISTIN is well tolerated in patients with heart failure and a history of high blood pressure or angina.

Before you use ISTIN

ISTIN should not be used if you have any of the following conditions:

• allergy to ISTIN or other calcium antagonists or to the other ingredients in ISTIN tablets. This may have been itching, reddening of the skin or difficulty in breathing.
• cardiogenic shock, aortic stenosis (narrowing of the aortic heart valve) or unstable angina.
• during pregnancy or breast feeding. If you are a woman of child-bearing potential effective contraception is advised.

If the answer is YES to any of these questions below, then tell your doctor before taking ISTIN:

• Have you just had a heart attack or are in hypertensive crisis?
• Do you have liver disease?
• Are you under 18 years of age?

Your doctor may still want you to take the tablets.

How to take ISTIN

• The usual dose of ISTIN is one tablet daily.
• Take your tablet as your doctor told you and as written on the label on the pack.
• It is best to take ISTIN tablets at the same time each day with a drink of water.
• Continue to take your tablet each day following the days and arrows on the pack.
• If you are still not sure, ask your doctor or pharmacist.
• It is important to keep taking the tablets. They may help you to remain well.
• Do not wait until your tablets are finished before seeing your doctor. Your doctor may wish to give you more ISTIN tablets.

Does ISTIN cause undesirable effects?

ISTIN, like all medicines may cause some undesirable effects. The most common are:

headache, oedema (for example ankle swelling), skin rash, feeling tired, feeling sick, flushing, dizziness and swelling or soreness of the gums.

Tell your doctor if these effects cause you any problems or if they last for more than one week.

Rare undesirable effects:

itchy skin, hair loss, palpitations (a quicker or irregular heart beat), shortness of breath, abdominal pain, back pain, indigestion, muscle cramps, weakness, sleepiness, sleeplessness, altered bowel habit, muscle or joint pain, mood changes, increased need to urinate especially during the night, excess sugar in blood, dry mouth, loss of pain sensation, inflamed pancreas, increased sweating, fainting, red blood cell damage (unusual bruising and bleeding), red patches on skin, inability to obtain an erection, visual disturbances, weight increase or decrease, increased sensitivity particularly of the skin, pins and needles, trembling, bruising more easily or purplish marks on the skin, coughing, taste abnormalities, ringing in the ears, sneezing/ running nose and hives.

Very rarely abnormal liver function, inflammation of the liver, yellowing of the skin, severe skin reactions and enlargening of the male breasts have been reported.

The following effects have occurred in patients but the relationship to treatment with ISTIN or the disease state is uncertain: heart attack (myocardial infarction), irregular heart beat (arrhythmia) and chest pain.

All medicines can cause allergic reactions. Serious allergic reactions are very rare and seldom life-threatening. Any sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body) should be reported to a doctor immediately.

 

Tell your doctor or pharmacist if you notice any other unwanted effect.

Look after your medicine

This treatment is for YOU. DO NOT give it to others. It may not suit them.

If your doctor stops your treatment - take any tablets left, back to the pharmacist.

Do not take this medicine after the date stamped on the pack.