PACKAGE LEAFLET: INFORMATION FOR THE USER Amlodipine 5 mg Tablets Amlodipine 10 mg Tablets

Amlodipine

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 is and what it is used for.

2.    Before you take Amlodipine.

3.    How to take Amlodipine.

4.    Possible side effects.

5.    How to store Amlodipine.

6.    Further information.

1. WHAT AMLODIPINE IS AND WHAT IT IS USED FOR

Amlodipine belongs to a group of medicines called calcium antagonists.

Amlodipine is used to treat:

•    high blood pressure

•    chest pain due to narrowing of the coronary arteries of the heart muscle (angina pectoris) or the more rare form of chest pain caused by

cramping of the coronary arteries of the heart muscle (vasospastic 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.

2. BEFORE YOU TAKE AMLODIPINE

•    Rifampicin and rifabutin (antibiotics) may

reduce the effect of Amlodipine.

•    St. John's wort (Hypericum perforatum; herbal medicine for depression) may reduce the effect of Amlodipine.

•    Dexamethasone (cortisone) may reduce the effect of Amlodipine.

•    Phenobarbital, phenytoin and carbamazepine (medicines for epilepsy) may reduce the effect of Amlodipine.

•    Nevirapine (antiviral medicine) may reduce the effect of Amlodipine.

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

Taking Amlodipine with food and drink

Amlodipine should be taken with a glass of liquid (e.g. a glass of water) with or without food.

Simultaneous intake of grapefruit or grapefruit juice has no influence on the effect of amlodipine.

Pregnancy and breast-feeding

If you are pregnant or become pregnant during treatment, do not take Amlodipine unless specifically prescribed by your doctor.

There are insufficient data to evaluate the risk for the baby when you take amlodipine during pregnancy.

If you are breast-feeding, do not take Amlodipine. Please contact your doctor.

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

Driving and using machines

Be careful if you drive or operate machinery if you take this medicine. Amlodipine may not directly affect your ability to drive or operate machinery. However, some patients experience side effects such as dizziness or sleepiness related to the fall in the blood pressure (see section 4 of this leaflet). Such side effects are more likely to occur after beginning to take Amlodipine or after dose increases. If you experience these side effects, you should refrain from driving and other activities requiring alertness.

Do not take Amlodipine

•    if you are allergic to amlodipine or similar calcium channel blockers (the so-called dihydropyridine derivates) or to any of the other ingredients (for a full list of ingredients, see section 6)

•    if you have very low blood pressure

•    if you are suffering from insufficient blood supply to your tissues with symptoms like e.g. low blood pressure, low pulse, fast heartbeat (shock, including cardiogenic shock). Cardiogenic shock means shock due to severe heart troubles.

•    if you have heart failure after a heart attack within the last four weeks

•    if you are suffering from narrowing of the aorta (aortic stenosis)

•    if you get heart-associated chest pain also at rest or with minimal effort (unstable angina pectoris)

•    if you are pregnant or breast-feeding

Take special care with Amlodipine

Tell your doctor before you start treatment:

•    if you have heart failure

•    if you have reduced liver function

•    if you have reduced kidney function

Elderly

The dose should be increased with caution.

Children and adolescents (below 18 years)

Amlodipine should not be used in children and adolescents because of insufficient experience.

Taking other medicines

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.

It is therefore important to tell your doctor if you take any of the following medicines:

•    Medicines that can lower blood pressure, e.g. beta-blockers, ACE-inhibitors, alpha-1-blockers and diuretics. Amlodipine may enhance the blood pressure lowering effects of these medicines.

•    Diltiazem (cardiac medicine) may intensify the effect of Amlodipine.

•    Ketoconazole and itraconazole (antifungal medicines) may intensify the effect of Amlodipine.

•    HIV-proteinase-inhibitors (antiviral medicines to treat HIV infections, e.g. ritonavir) may intensify the effect of Amlodipine.

•    Clarithromycin, erythromycin and telithromycin (antibiotics) may intensify the effect of Amlodipine.

•    Nefazodone (medicine to treat depression)

may intensify the effect of Amlodipine.

3. HOW TO TAKE AMLODIPINE

Dosage

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

Adults

The usual starting dose is 5 mg once daily. If necessary, your doctor may increase the dose to 10 mg once daily.

Children and adolescents (younger than 18 years)

Amlodipine should not be given to children and adolescents.

Elderly patients

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

If you have kidney problems

The normal dosage is recommended.

Amlodipine cannot be removed from the blood by dialysis (artificial kidney). Amlodipine should be administered with particular caution to patients undergoing dialysis.

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”).

Methods and routes of administration

Swallow the tablets with a glass of water. Do not chew. You can take them with or without food.

If you take more Amlodipine than you should

If you or someone else has taken too much Amlodipine, contact your doctor, an emergency department or a poisoning centre 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.

105816/1

pgi/2

FILE NAME : Amlodipine_Leaflet_105816-1.ai

ARTWORK (DETAILS) RECEIVED ON : 12th & 17th December, 2011

PROOF REVISION :

1st PDF sent on -2nd PDF sent on -3rd PDF sent on -4th PDF sent on -5th PDF sent on -6th PDF sent on -7th PDF sent on -8th PDF sent on -9th PDF sent on -10th PDF sent on -

13TH JAN. 2012 18TH JAN. 2012 31ST JAN. 2012 2ND FEB. 2012 14TH FEB. 2012 15TH FEB. 2012 28TH FEB. 2012 5TH JULY 2012 9TH AUG. 2012 23RD AUG. 2012

SOFTWARE : ADOBE ILLUSTRATOR CS3

PROCESS

BLACK

TYPEFACES : MYRIAD PRO REGULAR / BOLD

CHANGE CONTROL :

Version changes due to change in: |Tf Size/Layout [Tf Regulatory [Tf Non-Regulatory ^Changes in detail: • Product transfer to India    ^

If you stop taking Amlodipine tablets

Your doctor has told you 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.

Amlodipine is usually used for long term treatment.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

If any of the following side effects occur, stop taking the tablets and contact an emergency room or a doctor immediately:

Very rare: allergic reaction with swelling of the skin of face or extremities, swelling of lips or tongue, swelling of the mucous membranes in the mouth and throat, resulting in shortness of breath and difficulty to swallow (angioedema).

In isolated cases allergic skin rash with irregular red spots, caused by medicines (erythema exsudativum multiforme) or severe allergic reactions with blistering eruptions of the skin and mucous membranes (exfoliative dermatitis, Stevens-Johnson Syndrome) have been observed.

Contact an emergency room or a doctor immediately if this occurs.

For the assessment of side effects, the following descriptions of frequency have been used:

Skin (skin and subcutaneous tissue disorders)

Very common: swollen ankles Common: facial redness and feeling hot (especially at the beginning of treatment) Uncommon: prickling and tingling sensation of the skin (exanthema), itching, nettle rash, hair loss, discolouration of the skin

Muscles and bones (musculoskeletal and bone disorders)

Uncommon: muscle cramps, back pain, muscle and joint pain

Kidneys (renal and urinary disorders)

Uncommon: increased need to urinate (increased urination frequency), the need to wake up in the night to urinate

Sexual organs and breast (reproductive system and breast disorders)

Uncommon: impotence, enlarged breasts in men

General disorders

Uncommon: increase or decrease in weight

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.

5. HOW TO STORE AMLODIPINE

Keep out of the reach and sight of children.

Do not use Amlodipine after the expiry date "EXP" which is stated on the packaging. The expiry date refers to the last day of that month.

This medicinal product requires no special

precautions for

storage.

Keep the tablets in the original packaging.

Medicinal product 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.

The following side effects have been observed during treatment with Amlodipine:

Blood and lymph (blood and lymphatic system disorders)

Very rare:

•    reduced number of white blood cells, which may cause unexplained fever, sore throat, and flu-like symptoms (leukopenia)

•    reduced number of blood platelets in blood, which may cause easy bruising or nasal bleeding (thrombocytopenia)

Metabolism disorders

Very rare: increase of the blood sugar level

Mind (psychiatric disorders)

Uncommon: sleep disorders, irritability, depression Rare: confusion, mood changes including anxiety

Nerves (nervous system disorders)

Common: headache (especially at the beginning of treatment), sleepiness, dizziness, weakness Uncommon: feeling unwell, dry mouth, uncontrolled shaking (tremor), pins and needles (paraesthesia), increased sweating Rare: change in taste

Very rare: pain or numbness in hands and feet (peripheral neuropathy)

Eyes (eye disorders)

Uncommon: problems with your eyesight (visual disturbances)

Ears (ear and labyrinth disorders)

Uncommon: ringing or buzzing in the ears (tinnitus)

Heart (cardiac disorders)

Common: a quicker or irregular heart beat (palpitations)

Uncommon: fainting, increased heart rate (tachycardia), chest pain, aggravation of angina may occur at the beginning of the treatment In isolated cases the following side effects have occured, but the relationship to treatment with Amlodipine is uncertain: heart attack (myocardial infarction), irregular heartbeat and chest pain (angina pectoris)

Circulation (vascular disorders)

Uncommon: low blood pressure, inflammation of the blood vessels

Lungs, breathing and chest (respiratory, thoracic and mediastinal disorders)

Uncommon: breathing difficulties, inflammation of the nasal mucosa (rhinits), cough

Stomach and bowel (gastrointestinal disorders)

Common: nausea, digestive problems, stomach pain

Uncommon: vomiting, diarrhoea, constipation, swollen gums (gingival hyperplasia)

Very rare: inflammation of the stomach lining (gastritis), inflammation of the pancreas (pancreatitis)

Liver and bile (hepatobiliary disorders)

Very rare: increase of certain liver enzymes; yellowing of the skin or whites of the eyes, this could be the result of abnormal liver function or inflammation of the liver

6. FURTHER INFORMATION

What Amlodipine contains

Amlodipine 5 mg Tablet

•    The active substance is amlodipine. Each tablet contains 5 mg of amlodipine (as besilate).

•    The other ingredients are microcrystalline cellulose (E460), sodium starch glycollate, sodium acid citrate (E331), magnesium stearate (E572), croscarmellose sodium, crospovidone.

Amlodipine 10 mg Tablet

•    The active substance is amlodipine. Each tablet contains 10 mg of amlodipine (as besilate).

•    The other ingredients are microcrystalline cellulose (E460), sodium starch glycollate, sodium acid citrate (E331), magnesium stearate (E572), croscarmellose sodium, crospovidone.

What Amlodipine looks like and contents of the pack

Amlodipine 5 mg Tablet

A white, circular, biconvex, uncoated tablet with 5 on one side and plain on the other side.

Amlodipine 10 mg Tablet A white, circular, biconvex, uncoated tablet with 10 on one side and plain on the other side.

Your tablets come in:

•    Blister packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder Wockhardt UK Limited Ash Road, Wrexham Industrial Estate Wrexham, CLWYD, LL13 9UF, UK

Manufacturer

CP Pharmaceuticals Limited,

Ash Road North, Wrexham, LL13 9UF, UK

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only)

Please be ready to give the following information:

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in August 2012.

105816/1

214675

DD/DRUGS/DD/61

WOCKHARDT

pg2/2