Amlodipine

• Used to treat high blood pressure
• Also used to treat angina pectoris
• Tablets for oral use
• Do not consume grapefruit or grapefruit juice
• May affect your ability to drive

Amlodipine belongs to a group of medicines called calcium antagonists. This medicine works by relaxing blood vessels, so that blood passes through them more easily, lowering blood pressure. In patients with angina, Amlodipine works by improving blood supply to the heart muscle which then receives more oxygen. As a result, angina pectoris (chest pain) and Prinzmetal’s angina (chest pain at rest) is prevented.

Amlodipine is also used for hypertension in children and adolescents from six years of age.

Amlodipine should be taken every day, at the same time each day. The tablet should be swallowed with a drink of water. Amlodipine can be taken with or without food. Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipine. This is because grapefruit and grapefruit juice can influence the effect of this medicine.

Dosage

Dosage varies per person and is determined by a doctor depending on the symptoms. The general dosage guidelines are as follows:

• Adults: 5 mg once a day. This dose can be increased to 10 mg once a day.
• Children aged 6 to 17 years (for hypertension): the recommended starting dose is 2.5 mg a day. The maximum recommended dose is 5 mg a day.

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

Alcohol/driving

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

If you use too much/forget to use/stop using Amlodipine

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 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 Amlodipine tablets.

If you forget to take a dose of Amlodipine, do not worry. Just leave out that dose completely and take your next dose at the right time. Do not take a double dose to make up for a forgotten one.

Do not stop using Amlodipine without talking to your doctor.

Amlodipine is not suitable for everyone. Do not use this medicine if:

• You are allergic (hypersensitive) to amlodipine, or any of the other ingredients in this medicine (see section 'What Amlodipine contains'), or to any other calcium antagonists. This may cause itching, reddening of the skin or difficulty in breathing.
• You have severe low blood pressure (hypotension).
• 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).
• You suffer from heart failure after a heart attack.

When should this medicine be used with caution?

You should inform your doctor if any of the following applies to you:

• You have had a heart attack recently.
• You have, or have had, heart failure.
• You have, or have had, a severe increase in blood pressure (hypertensive crisis).
• You have, or have had, a liver disease.
• You are elderly and your dose needs to be increased.

Pregnancy and breastfeeding

The safety of amlodipine in human pregnancy has not been established. It is not known if amlodipine is excreted in the breast milk. If you are pregnant or breastfeeding, think you may be pregnant or are planning to get pregnant, you must tell your doctor before you take Amlodipine.

Other medicines and Amlodipine

Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.

Amlodipine may affect or be affected by other medicines, including:

• Ketoconazole, itraconazole (used to treat infections caused by a fungus).
• 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).
• Simvastatin (a cholesterollowering medicine).

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

Like all medicines, Amlodipine can cause side effects, although not everybody gets them.

See your doctor immediately if you experience any of the following very rare but serious 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 (StevensJohnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Heart attack, abnormal heart rate.
• Inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell.

Other side effects of Amlodipine include:

Common (may affect up to 1 in 10 people):

• Headache, dizziness, sleepiness (especially at the beginning of treatment).
• Palpitations (awareness of your heartbeat), flushing.
• Abdominal pain, feeling sick (nausea).
• Ankle swelling (oedema), tiredness.

If any of these side effects persist for longer than a week, please contact your doctor.

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.
• Visual disturbances, double vision, ringing in the ears.
• Low blood pressure.
• Sneezing/running nose caused by inflammation of the lining of the nose (rhinitis).
• Changes in stool, diarrhoea, constipation, indigestion, 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 weak or unwell.
• Joint or muscle pain, muscle cramps, back pain.
• Weight loss or weight gain.

For a list of rare side effects, see the package leaflet. If the side effects are severe or if you get any side effects that are not listed in the package leaflet, contact your doctor or pharmacist.

The active substance is amlodipine. Each tablet contains 5 mg amlodipine or 10 mg amlodipine (as maleate).

Read the package leaflet before use.