Free Bahamas: Amlodipine Tablets 5mg, 10mg

Amlodipine 5mg and 10mg tablets

Amlodipine mesilate monohydrate

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, please 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.

Index

1 What Amlodipine tablets are and what they are used for

2 Before you take

3 How to take

4 Possible side effects

5 How to store

6 Further information

What Amlodipine tablets are and what they are used for

Amlodipine belongs to a group of medicines called calcium antagonists.

It is used to treat:

high blood pressure

angina pectoris (pain in the chest caused by blockages in the arteries leading to the heart) or chest pain classed as vasospastic angina pectoris (or Prinzmetal’s angina).

Before you take

Do not take Amlodipine tablets and tell your doctor if you:

are allergic (hypersensitive) to Amlodipine tablets, dihydropyridine derivatives, amlodipine or any of the other ingredients (see section 6)

are in shock including shock caused by heart problems

suffer from an obstruction in the heart caused by an extreme narrowing of the heart valves (aortic stenosis)

suffer from chest pain when sitting or lying down (unstable angina pectoris)

have developed heart failure within 28 days of having a heart attack

have porphyria (a genetic disorder of the blood - causing skin blisters and abdominal pain)

have severe low blood pressure.

Take special care with Amlodipine tablets and tell your doctor if you:

have liver problems

have heart failure, poor heart function (low cardiac reserve) or had a heart attack within the last 28 days

are giving this medicine to a child under 18 years of age

are elderly, your doctor may monitor you closely.

Taking other medicines

Before taking Amlodipine tablets, tell your doctor if you are taking or have taken recently any of the following medicines or are taking any non-prescribed medicines:

medicines used to treat high blood pressure such as ACE inhibitors e.g. captopril, beta blockers e.g. atenolol or propranolol, diuretics (water tablets) e.g. bendroflumethiazide or alpha-1-blockers e.g. prazosin

ketoconazole or itraconazole (antifungal drugs)

ritonavir (antiviral drug)

rifampicin (antibiotic drug)

St. John’s wort (used for depression)

diltiazem (to treat heart diseases)

Pregnancy and breastfeeding

Amlodipine tablets are not recommended during pregnancy or breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Amlodipine tablets may cause dizziness, headaches, tiredness or feeling sick. Any of these side effects would reduce your ability to react, do not drive or use machinery if you are affected.

How to take

Always take Amlodipine tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Take the tablets with a glass of water.

Usual doses:

Adults (including the elderly and children 18 years or over): 5mg once a day, up to a maximum of 10mg a day as a single dose depending on your response. If you are elderly, your doctor will closely monitor your response to any dose increase.

Children (under 18 years old): not recommended

Patients with impaired liver function: your doctor may prescribe you a different dose.

If you take more than you should

If you have accidentally taken more than the prescribed dose, contact your nearest casualty department or tell your doctor or pharmacist at once. Overdose causes flushing and a significant and lasting fall in blood pressure.

If you forget to take the tablets

If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. Then go on as before. Never double up on the next dose to make up for the one missed.

If you stop taking Amlodipine tablets

Do not interrupt or stop treatment with Amlodipine tablets without consulting your doctor, as your symptoms could return or ‘flare-up’.

Possible side effects

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

Stop treatment and contact a doctor at once if you have the following:

symptoms of an allergic reaction: swelling of the face, lips, tongue or throat (Quincke oedema)

itching, a rash, circular, irregular red patches on the skin of the hands and arms (erythema exsudativum multiforme)

skin that is red, flaky and peeling (exfoliative dermatitis)

severe form of a skin rash with flushing, fever, blisters or ulcers (Stevens Johnson syndrome)

heart attack (severe chest pain).

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

Very common: (occurs in more than 1 in 10 patients):

ankle swelling.

Common: (occurs in less than 1 in 10 patients):

tiredness, dizziness, weakness

palpitations (a quick or irregular heartbeat)

hot flushing in the face or headache (especially at the start of treatment)

feeling sick, indigestion, stomach pain.

Uncommon: (occurs in less than 1 in 100 patients):

enlarged breasts in men

a feeling of general discomfort and illness, weight loss or gain, sleeplessness, irritability, depression

visual disturbances, ringing in the ears (tinnitus), low blood pressure (lightheadedness or dizziness)

breathing difficulties, runny nose

dry mouth, tremor, ‘pins and needles’, increased sweating

fainting, racing heart beat, chest pain, worsening of angina (at start of treatment)

being sick, diarrhoea, constipation, swollen gums

skin rash accompanying a disease or fever (exanthema), pale or red irregular raised patches with severe itching (hives), hair loss, skin discolouration

muscle cramps, muscle, back or joint pain

urinating more often

reduced sexual performance.

Rare: (occurs in less than 1 in 1000 patients):

confusion, mood changes, anxiety

raised liver enzymes (detected in a blood test), inflammation of the liver (hepatitis causing tiredness, pain in abdomen, joints or muscles), yellowing of the skin or whites of the eyes (jaundice).

Very rare: (occurs in less than 1 in 10,000 patients including isolated cases):

reduction in the number and type of some blood cells (leukocytopenia, thrombocytopenia) which increases the risk of infections, sore throats, nosebleeds and bruising

disorder of the nerves causing tingling and numbness (peripheral neuropathy)

inflammation of blood vessels (vasculitis causing rash, fever, sweating, fatigue), the pancreas (pancreatitis causing pain and tenderness in the abdomen or back) and stomach (gastritis causing stomach pain, feeling or being sick, diarrhoea, indigestion)

raised blood sugar levels (thirst, excessive urinating, weakness, tiredeness)

cough

heart attack, heart beat problems (including a premature, racing, slow and irregular heart beat) or chest pain (in those who already have coronary artery disease)

If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.

How to store Amlodipine tablets

Keep Amlodipine tablets out of the sight and reach of children.

Do not store the tablets above 30°C.

Do not take the tablets after the expiry date which is stated on the carton. The expiry date is also stated on the back of the strip after ‘Exp’.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Amlodipine tablets contain:

the active substance is amlodipine (as amlodipine mesilate monohydrate). Each tablet contains either 5mg or 10mg of the active substance.

the other ingredients are: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium starch glycollate type A, magnesium stearate

What Amlodipine tablets look like and the contents of the pack:

Amlodipine 5mg and 10mg tablets are white to off-white, round, biconvex tablets.

Pack size is 28.

Marketing Authorisation Holder and Manufacturer

Actavis

Barnstaple

EX32 8NS

This leaflet was last revised in November 2008.