Amlodipine 5mg Tablets, Amlodipine 10mg Tablets

Read all of this leaflet carefully before you start taking this medicine.

• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Amlodipine Tablets are and what are they used for?
• 2. Before you take Amlodipine Tablets
• 3. How to take Amlodipine Tablets
• 4. Possible side effects
• 5. How to store Amlodipine Tablets
• 6. Further information

Amlodipine is used for:

• High blood pressure
• Various types of angina except for unstable angina

Amlodipine may be used to treat angina on its own or together with other medicines.

Do not take Amlodipine Tablets

• If you are allergic to amlodipine or similar calcium-channel blockers (the so-called dihydropyridine derivatives), or to any of the other ingredients.
• If you have very low blood pressure.
• If you are suffering from shock (a very severe lowering of blood pressure by which you become unconscious).
• If you have heart failure in the first 28 days after an acute heart attack.
• If the blood flow from the left side of your heart is obstructed.
• If you suffer from unstable angina pectoris.

If you are not sure whether any of the above applies to you, ask your pharmacist or your doctor.

Take special care with Amlodipine Tablets

• If you have heart failure.
• If you have liver problems; amlodipine must be used very carefully because the required dosage is not known exactly in this situation.

If you are under 18 years of age; amlodipine should not be given to children because there is not enough experience with its use in children.

Using other medicines

Tell your doctor or pharmacist if you are taking other medicines or if you have recently taken other medicines. This includes medicines that you can buy without a prescription.

• Diltiazem (a medicine to treat high blood pressure and problems with heartbeat rhythm): diltiazem slows the breakdown of amlodipine in the liver and this can lead to a stronger effect of amlodipine. Other medicines that slow the breakdown of amlodipine in the liver even more, such as ketoconazole, itraconazole (medicines for fungal infections) and ritonavir (a medicine for HIV/AIDS), can lead to an even stronger effect of amlodipine.
• The effect of amlodipine may be reduced by medicines that increase the breakdown of amlodipine, such as rifampicin (used for certain infections) and St. John’s Wort (a product for depression that can be bought without a prescription).
• Grapefruit juice, cimetidine, aluminium/magnesium (medicines for indigestion) or sildenafil (a medicine for impotence) do not change the effect of amlodipine.
• Amlodipine may increase the effect of other medicines used to lower blood pressure (such as beta-blockers, ACE inhibitors, alpha-blockers and water tablets). In patients at risk (for example, people who have recently had a heart attack), the combination of a calcium antagonist with a beta-blocker can cause heart failure, low blood pressure, and a (new) heart attack.
• Amlodipine does not change the effect of atorvastatin, digoxin, warfarin or ciclosporin.

Taking Amlodipine Tablets with food and drink

Amlodipine can be taken with or without food.

Pregnancy

There is very little information on whether it is harmful to take amlodipine during pregnancy. Amlodipine should only be used during pregnancy if your doctor decides that it is absolutely necessary. Ask your doctor or pharmacist for advice before taking any medicine.

Breast-feeding

There is no information on the use of amlodipine while breast-feeding. You are advised not to breastfeed when using amlodipine. Ask your doctor or pharmacist for advice before taking any medicine.

Children

If you are under 18 years of age; amlodipine should not be given to children because there is not enough experience with its use in children.

Driving and using machines

Amlodipine may cause dizziness, tiredness, or make you feel sick. If you have any of these side effects, you should keep in mind that this can affect your ability to drive and/or use machinery.

Important information about some of the ingredients of Amlodipine Tablets

Not relevant.

Adults

Starting dose for high blood pressure and angina: 5 mg once a day.

Maximum dose for high blood pressure and angina: if there has been insufficient effect after 2-4 weeks, the dose may be increased to a maximum of 10 mg once a day.

Children

Amlodipine should not be used in children.

Elderly

There is no special dosage for the elderly; however, care must be taken when the dose is increased.

If you have kidney problems

If you have kidney problems, the dose does not need to be changed. Amlodipine cannot be removed from the blood by dialysis (artificial kidney).

If you go for kidney dialysis, amlodipine should be taken with particular caution.

If you have liver problems

The exact dose needed for patients with liver problems has not been determined. If you have liver problems, amlodipine should be used very carefully (see also the section Take special care with Amlodipine Tablets).

If you think that Amlodipine Tablets do not work or have a too potent effect, discuss this with your doctor or pharmacist.

If you take more Amlodipine Tablets than you should

If you or someone else has taken too much amlodipine, contact your doctor or pharmacist immediately.

The person concerned should be made to lie down with their arms and legs up (resting on a couple of cushions, for example). Symptoms of an overdose are: extreme dizziness and/or feeling very light-headed, problems with breathing, having to urinate very often.

If you forget to take Amlodipine Tablets:

If you have forgotten to take a tablet, you can still take it up to 12 hours after you usually take your tablet. If it is more than 12 hours after the time that you should have taken the tablet, you should not take the missed dose and you should take the next tablet at the usual time. Never take a double dose of Amlodipine Tablets to make up for the dose that you have missed.

If you stop taking Amlodipine Tablets

Your doctor has told you for how long you should take amlodipine. If you stop the treatment suddenly, your symptoms may come back. Do not stop the treatment earlier than agreed without discussing this with your doctor or pharmacist. If you have further questions on the use of this product, ask your doctor or pharmacist.

Blood

very rare: low numbers of white blood cells giving a higher risk of infections (leucopenia); low numbers of platelets with the risk of bruising (thrombocytopaenia)

Hormones

uncommon: enlargement of male breasts (gynaecomastia)

Eating patterns and metabolism

very rare: increase in blood sugars (hyperglycaemia)

Psychological

uncommon: problems with sleeping; feeling irritable; depression
rare: feeling confused; mood changes including anxiety

Central nervous system

common: headache (especially at the start of treatment); tiredness; dizziness; feeling weak
uncommon: feeling unwell; dry mouth; uncontrolled shaking (tremor); unpleasant tingling feeling in arms or legs (paraesthesias); increased sweating
rare: changes in sense of taste
very rare: numbness, tingling, a burning sensation or weakness of hands and feet (peripheral neuropathy)

Eyes

uncommon: problems with sight

Ears

uncommon: ringing or buzzing in the ears (tinnitus)

Heart

common: awareness of your heartbeat (palpitations)
uncommon: fainting (syncope); increased heart rate; chest pain; increased chest pain, especially at the start of treatment; in patients with heart problems involving the coronary artery, isolated cases of heart attack and irregular heart beat (including missed heart beats (extrasystole), increased heart rate, decreased heart rate) have been reported, but this has not been clearly shown to be caused by amlodipine

Blood vessels

uncommon: decreased blood pressure (hypotension)
very rare: inflamed blood vessel (vasculitis)

Lungs and airways

uncommon: shortness of breath (dyspnoea); inflammation inside the nose with a runny nose (rhinitis)
very rare: coughing

Stomach and digestive system

common: feeling sick; indigestion (dyspepsia); stomach ache
uncommon: vomiting; diarrhoea; constipation; swelling of the gums
very rare: inflammation of the stomach lining (gastritis)

Liver and gall bladder

rare: increase of liver enzymes in the blood indicating abnormal liver function; jaundice; inflammation of the liver
very rare: inflammation of the pancreas, together with extreme pain in the upper abdomen (below the ribs) that spreads to the back (pancreatitis)

Skin

very common: swelling of the ankles
common: flushing of the face (especially at the start of treatment)
uncommon: rash; itching; rash with itching and spots; hair loss; discolouration of the skin, skin rash resulting from bleeding into the skin from small blood vessels
very rare: sudden swelling of the skin or mucous membranes (e.g. throat or tongue) with difficulty breathing and/or itching and rash (angio-oedema); allergic reactions, including itching; suddenly appearing redness of the skin (rash); angio-oedema; skin rash with irregular red patches (erythema multiforme); serious allergic reaction with fever, red patches, joint pain and/or eye problems (Stevens Johnson syndrome); extreme redness and scaling of the skin (exfoliative dermatitis)

Muscles and connective tissue

uncommon: muscle cramps; backache; muscle pain; joint pain

Kidneys and bladder

uncommon: increased need to urinate

Reproductive system and breasts

uncommon: impotence

General disorders

uncommon: increase or decrease in weight

What Amlodipine Tablets contain

The active substance is amlodipine (as besilate).

Amlodipine 5 mg Tablets:

• Each tablet contains 5 mg of amlodipine (as besilate)

Amlodipine 10 mg Tablets:

• Each tablet contains 10 mg of amlodipine (as besilate).
• The other ingredients are: povidone K30, microcrystalline cellulose (E460), anhydrous calcium hydrogen phosphate (E341), crospovidone, magnesium stearate (E470b).

What Amlodipine Tablets look like and contents of the pack

Amlodipine 5 mg Tablets:

Amlodipine 5 mg Tablets are white, round tablets.

The tablets are available in blister strips as packs of 10, 20, 28, 30, 50, 98, 100 and 300 (10 x30) tablets and in bottles of 100, 300 and 500 tablets. Not all pack sizes may be marketed.

Amlodipine 10 mg Tablets:

Amlodipine 10 mg Tablets are white, round tablets with a break score on both sides. The tablet can be divided into equal halves.

The tablets are available in blister strips as packs of 10, 20, 28, 30, 50, 98, 100 and 300 (10 x30) tablets and in bottles of 100, 300 and 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The manufacturer is: