Amlodipine 5mg Tablets

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

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

• If you are allergic to amlodipine or any of the other ingredients of this medicine (listed in section 6), or to any other calcium antagonists. Signs of allergy 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, have recently taken or might take 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 (medicine 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 .

If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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. If you are breast-feeding or about to start breast-feeding you must tell your doctor before taking Amlodipine .

Amlodipine may affect your ability to drive or use machines. If the medicine 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 a day. The maximum recommended dose is 5 mg a day. Amlodipine 5 mg tablets can be divided into halves to provide a 2.5 mg dose.

Taking too many tablets may cause your blood pressure to become low or even dangerously low. You may feel dizzy, lightheaded, faint or weak. If the drop in blood pressure 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 Amlodipine tablets.

Do not worry. If you forget to take a tablet, 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 this 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 or pharmacist. 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 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.

• The active substance is amlodipine (as besilate).
• The other ingredients are: calcium hydrogen phosphate dihydrate, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica and sodium starch glycolate Type A.

Amlodipine 5 mg tablets: White to off-white, round (8.73 mm – 8.93 mm), biconvex uncoated tablets with ‘5’ debossing on one side.

Amlodipine 10 mg tablets: White to off-white, round (10.5 mm – 10.7 mm), biconvex uncoated tablets with ‘10’ debossing on one side.

Amlodipine 5 mg tablets are supplied in opaque PVC/PVDC/Aluminium blister of 10 and 14 tablets. Pack size: 28, 30, 50, 56, 84, 100 and 112 tablets.

Amlodipine 10 mg tablets are supplied in opaque PVC/PVDC/Aluminium blister of 10 and 14 tablets. Pack size: 28, 30, 50, 56, 84, 100 and 112 tablets.

Not all pack sizes may be marketed.