Package leaflet: Information for the user

Istin 5 mg and 10 mg hard capsules Amlodipine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Istin is and what it is used for

2.    What you need to know before you take Istin

3.    How to take Istin

4.    Possible side effects

5.    How to store Istin

6.    Contents of the pack and other information

1. What Istin is and what it is used for

Istin contains the active substance amlodipine which belongs to a group of medicines called calcium antagonists.

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 this medicine 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. This medicine does not provide immediate relief of chest pain from angina.

2. What you need to know before you take Istin Do not take Istin

•    If you are allergic (hypersensitive) to amlodipine, or any of the other ingredients of this medicine listed in section 6, or to any other calcium antagonists. This may be itching, reddening of the skin or difficulty in breathing.

•    If you have severe low blood pressure (hypotension).

•    If you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body).

•    If you suffer from heart failure after a heart attack.

Warnings and precautions

Talk to your doctor or pharmacist before taking Istin.

You should inform your doctor if you have or have had any of the following conditions:

•    Recent heart attack

•    Heart failure

•    Severe increase in blood pressure (Hypertensive crisis)

•    Liver disease

• You are elderly and your dose needs to be increased Children and adolescents

Istin has not been studied in children under the age of 6 years. Istin should only be used for hypertension in children and adolescents from 6 years to 17 years of age (see section 3).

For more information, talk to your doctor.

Other medicines and Istin

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Istin may affect or be affected by other medicines, such as:

•    ketoconazole, itraconazole (anti-fungal medicines)

•    ritonavir, indinavir, nelfinavir (so called protease inhibitors used to treat HIV)

•    rifampicin, erythromycin, clarithromycin (antibiotics)

•    hypericum perforatum (St. John’s Wort)

•    verapamil, diltiazem (heart medicines)

•    dantrolene (infusion for severe body temperature abnormalities)

•    tacrolimus (medicine used to alter the way your immune system works)

•    simvastatin (cholesterol lowering medicine)

•    cyclosporine (an immunosuppressant)

Istin may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure.

Istin with food and drink

Grapefruit juice and grapefruit should not be consumed by people who are taking Istin. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Istin.

Pregnancy and breast-feeding

Pregnancy

The safety of amlodipine in human pregnancy has not been established. If you think you might be pregnant, or are planning to get pregnant, you must tell your doctor before you take Istin.

Breast-feeding

It is not known whether amlodipine is passed into breast milk. If you are breast-feeding or about to start breast-feeding you must tell your doctor before taking Istin.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Istin may affect your ability to drive or use machines. If the capsules make you feel sick, dizzy or tired, or give you a headache, do not drive or use machines and contact your doctor immediately.

Istin contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule, which means it is essentially ‘sodium-free’.

3. How to take Istin

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

The recommended initial dose is Istin 5 mg once daily. The dose can be increased to Istin 10 mg once daily.

This medicine can be used before or after food and drinks. You should take this medicine at the same time each day with a drink of water. Do not take Istin with grapefruit juice.

Use in children and adolescents

For children and adolescents (6-17 years old), the recommended usual starting dose is 2.5 mg a day. The maximum recommended dose is 5 mg a day. Istin capsules 2.5 mg are currently not available.

It is important to keep taking the capsules. Do not wait until your capsules are finished before seeing your doctor.

If you take more Istin than you should

Taking too many capsules may cause your blood pressure to become low or even dangerously low. You may feel dizzy, lightheaded, faint or weak. If blood pressure drop is severe enough shock can occur. Your skin could feel cool and clammy and you could lose consciousness. Seek immediate medical attention if you take too many Istin capsules.

If you forget to take Istin

Do not worry. If you forget to take a capsule, leave out that dose completely. Take your next dose at the right time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Istin

Your doctor will advise you how long to take this medicine. Your condition may return if you stop using this medicine before you are advised.

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.

Visit your doctor immediately if you experience any of the following side effects after taking this medicine.

•    Sudden wheeziness, chest pain, shortness of breath or difficulty in breathing

•    Swelling of eyelids, face or lips

•    Swelling of the tongue and throat which causes great difficulty breathing

•    Severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome) or other allergic reactions

•    Heart attack, abnormal heart beat

•    Inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell

The following very common side effect has been reported. If this causes you problems or if it lasts for more than one week, you should contact your doctor.

Very common: may affect more than 1 in 10 people

•    Ankle swelling (oedema)

The following common side effects have been reported. If any of these cause you problems or if they last for more than one week, you should contact your doctor.

Common: may affect up to 1 in 10 people

•    Headache, dizziness, sleepiness (especially at the beginning of treatment)

•    Palpitations (awareness of your heart beat), flushing

•    Abdominal pain, feeling sick (nausea)

•    Altered bowel habits, diarrhoea, constipation, indigestion

•    Tiredness, weakness

•    Visual disturbances, double vision

•    Muscle cramps

Other side effects that have been reported include the following list.If any of these get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Uncommon: may affect up to 1 in 100 people

•    Mood changes, anxiety, depression, sleeplessness

•    Trembling, taste abnormalities, fainting

•    Numbness or tingling sensation in your limbs, loss of pain sensation

•    Ringing in the ears

•    Low blood pressure

•    Sneezing/running nose caused by inflammation of the lining of the nose (rhinitis)

•    Cough

•    Dry mouth, vomiting (being sick)

•    Hair loss, increased sweating, itchy skin, red patches on skin, skin discolouration

•    Disorder in passing urine, increased need to urinate at night, increased number of times of passing urine

•    Inability to obtain an erection, discomfort or enlargement of the breasts in men

•    Pain, feeling unwell

•    Joint or muscle pain, back pain

•    Weight increase or decrease

Rare: may affect up to 1 in 1,000 people

•    Confusion

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

•    Decreased numbers of white blood cells, decrease in blood platelets which may result in unusual bruising or easy bleeding (red blood cell damage)

•    Excess sugar in blood (hyperglycaemia)

•    A disorder of the nerves which can cause weakness, tingling or numbness

•    Swelling of the gums

•    Abdominal bloating (gastritis)

•    Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), liver enzyme increase which may have an effect on some medical tests

•    Increased muscle tension

•    Inflammation of blood vessels, often with skin rash

•    Sensitivity to light

•    Disorders combining rigidity, tremor, and/or movement disorders Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Istin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the pack after ‘EXP’. The expiry date refers to the last day of that month.

Capsules

Do not store above 30°C.

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 will help protect the environment.

6. Contents of the pack and other information What Istin contains

The active substance in Istin 5 mg capsules is amlodipine (as besilate).

The active substance in Istin 10 mg capsules is amlodipine (as besilate).

The other ingredients are microcrystalline cellulose, maize starch, magnesium stearate.

The capsule shell contains:

- 5 mg: gelatin, quinoline yellow, black iron oxide, titanium dioxide.

-10 mg: gelatin, black iron oxide, yellow iron oxide, titanium dioxide.

The capsule shell printing inks contain: Shellac glaze, black iron oxide.

What Istin looks like and contents of the pack

5 mg hard capsules: Yellow and white capsules with black imprint AML 5 on one side and Pfizer logo on the other.

10 mg hard capsules: Grey capsules with black imprint AML 10 on one side and Pfizer logo on the other.

Istin 5 mg capsules are available in blisters containing 14, 28, 30, 56, 90, 98 and 100 capsules and in unit dose blister strips containing 28x1, 30x1, 56x1 and 100x1 capsules.

Istin 10 mg capsules are available in blisters containing 14, 28, 30, 56, 90, 98 and 100 capsules and in unit dose blister strips containing 30x1, 56x1 and 100x1 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Pfizer Limited Ramsgate Road Sandwich Kent

CT139 NJ United Kingdom

Manufacturer

Fareva Amboise, Zone Industrielle 29 route des Industries

37530 Poce-sur-Cisse France

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

Capsules:

Cyprus, Greece, Lithuania, Romania: Norvasc Belgium, France, Luxembourg: Amlor United Kingdom: Istin

This leaflet was last revised in 03/2015.

Ref: IS 8 0

Ref IS 8 0 Pfleet number : 2014-0005920 Page 6 of 6