Amlodipine 1 mg/ml Oral Suspension (PL 00427/0277)

• 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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Amlodipine 1 mg/ml Oral Suspension is and what it is used for
2. What you need to know before you take Amlodipine 1 mg/ml Oral Suspension
3. How to take Amlodipine 1 mg/ml Oral Suspension
4. Possible side effects
5. How to store Amlodipine 1 mg/ml Oral Suspension
6. Contents of the pack and other information.

Amlodipine 1 mg/ml Oral Suspension will be referred to as Amlodipine throughout this package leaflet.

• 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.

Talk to your doctor or pharmacist before taking Amlodipine. 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.

Amlodipine has not been studied in children under the age of 6 years.

Amlodipine 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.

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

Amlodipine 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, sirolimus,temsirolimus, and everolimus (medicines used to alter the way your immune system works)
• simvastatin (cholesterol lowering medicine)
• cyclosporine (an immunosuppressant)

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

Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipine.

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 Amlodipine.

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 Amlodipine.

Breast-feeding

Amlodipine has been shown to pass into breast milk in small amounts. If you are breast-feeding or about to start breast-feeding you must tell your doctor before taking Amlodipine.

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

Amlodipine may affect your ability to drive or use machines. If the suspension makes you feel sick, dizzy or tired, or gives you a headache, do not drive or use machines and contact your doctor immediately.

For children and adolescents (6-17 years old), the recommended usual starting dose is 2.5 mg (2.5 ml) a day.

The maximum recommended dose is 5 mg (5 ml) a day.

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

Taking too much Amlodipine 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 much Amlodipine.

Excess fluid may accumulate in your lungs (pulmonary oedema) causing shortness of breath that may develop up to 24-48 hours after intake.

Do not worry. If you forget to take your medicine, 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.

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

If you get any side effects, talk to your doctor, 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 Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Each ml of Oral Suspension contains 1 mg of amlodipine (as amlodipine besilate).

The other ingredients are medium chain triglyceride, sucralose and colloidal anhydrous silica.

Amlodipine is a colourless, clear to slightly hazy suspension.

Amlodipine is available in a 150 ml amber glass bottle with a child-resistant cap and a double-ended measuring spoon. One end of the spoon will give you 5 ml of the suspension and the other will give you 2.5 ml.