Amlodipine tablets contain amlodipine as active ingredient, which belongs to a group of medicines called calcium antagonists.

Amlodipine tablets are used to treat:

• high blood pressure (hypertension)
• chest pain due to narrowing of the blood vessels of the heart muscle (angina pectoris) or the more rare form of chest pain caused by cramping of the blood vessels of the heart muscle called Prinzmetal or variant angina.

If you suffer from high blood pressure, Amlodipine works by relaxing blood vessels, so that blood passes through them more easily.

If you suffer from angina, Amlodipine works by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. Amlodipine does not provide immediate relief of chest pain from angina.

Do not take Amlodipine tablets, if you

• are allergic (hypersensitive) to amlodipine or any of the other ingredients of this medicine, or to any other calcium antagonists (the so-called dihydropyridine derivates like felodipine, nifedipine, nimodipine). This may be itching, reddening of the skin or difficulty in breathing.
• are suffering from low blood pressure.
• are suffering from 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) or if
• you suffer from heart failure after a heart attack.

Talk to your doctor or pharmacist before taking Amlodipine.

Before taking Amlodipine tablets, tell your doctor if you

• have heart failure or have suffered a heart attack during the past month.
• Heart failure
• Severe increase in blood pressure (Hypertensive crisis)
• have liver problems
• are elderly, your doctor may monitor you closely.

Children and adolescents

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.

For more information, talk to your doctor.

Other medicines and Amlodipine tablets

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

Some medicines (including medicines obtained without prescription, herbal medications or natural products) may interact with Amlodipine. This means that the action of both medicines can be changed.

In particular, tell your doctor if you are taking any of the following medicines:

• Ketoconazole and itraconazole (antifungal medicines used to treat skin and fungal infections)
• HIV-protease-inhibitors (antiviral medicines used to treat HIV infections, e.g. ritonavir)
• Rifampicin, erythromycin, clarithromycin (antibiotics)
• St. John’s wort (Hypericum perforatum; herbal medicine for depression)
• Medicines that can lower blood pressure (e.g. verapamil, diltiazem)
• 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)

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

Taking Amlodipine tablets with food and drink

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

Breast-feeding

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

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

Amlodipine tablets 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.

Amlodipine tablets contain sodium

Tablets contain less than 1 mmol/tablet sodium (23 mg) i. e. practically does not contain sodium.

Dosage

Always take Amlodipine tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual starting dose is 5 mg once daily. If necessary, your doctor may increase the dose to 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 Amlodipine with grapefruit juice.

Use in 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.

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

Amlodipine tablets 5 mg are allowed to break into two equal halves.

If you take more Amlodipine tablets than you should

Taking too many tablets can cause low blood pressure up to life-treatening conditions.

Symptoms of an overdose are: extreme dizziness and/or feeling very light-headed, faint or weak, problems with breathing, having to urinate very often. If blood pressure drop is severe enough shock can occur. Your skin could feel cool and clammy and you could lose consciousness. If you or someone else has taken too much Amlodipine, contact your nearest hospital casualty department.

If you forget to take 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.

If you stop taking Amlodipine tablets

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 product, ask your doctor or pharmacist.

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

Tell your doctor immediately if you experience any of the following symptoms after taking this medicine. Although they are very rare, the symptoms can be severe.

• 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) toxic epidermal necrolysis or other allergic reaction
• 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)

• Oedema (fluid retention)

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
• Swollen ankles

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 orpharmacist.

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 or buzzing in the ears
• Low blood pressure, inflammation of the blood vessels
• Sneezing/running nose caused by inflammation of the lining of the nose (rhinitis)
• Breathing difficulties, inflammation of the nasal mucosa
• Cough
• Dry mouth, vomiting (being sick)
• Prickling and tingling sensation of the skin , itching, red patches on skin, nettle rash, hair loss, discolouration of the skin
• Disorder in passing urine, increased need to urinate at night, increased number of times of passing urine
• Enlarged breasts or discomfort in men, impotence
• Pain,feeling unwell, dry mouth, uncontrolled shaking, pins and needles, increased sweating
• Muscle cramps, back pain, muscle and joint pain
• Increase or decrease in weight

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

• Store at a temperature 15-25°C, out of the reach of children. Protect from light and moisture.
• Shelf life – 3 years. Do not use this medicine after the expiry date. The expiry date refers to the last day of the month.
• If the tablets show signs of ‘going off’ such as discolouration do not take this drug.
• 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.

What Amlodipine tablet contains

Each tablet of Amlodipine, 5 mg tablet contains:

active ingredient: amlodipine (as besylate) – 5 mg;

other ingredients: calcium phosphate dibasic, microcrystalline cellulose, sodium starch glycolate, magnesium stearate.

White or off white flat scored tablets.

3 blister packets with 10 tablets in each with insert leaflet in the cardboard box.

Prescription drug.