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PIL-670UK_RAM_V1.qxp 16/05/2012    13:22 Page 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ramipril 1.25mg, 2.5mg, 5mg and 10mg Capsules

(Ramipril)

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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

| 1. WHAT RAMIPRIL CAPSULES ARE AND WHAT THEY ARE USED FOR |

Ramipril Capsules contain a medicine called ramipril. This belongs to a group of medicines called ACE inhibitors (Angiotensin Converting Enzyme Inhibitors). Ramipril works by:

•    Decreasing your body's production of substances that could raise your blood pressure

•    Making your blood vessels relax and widen

•    Making it easier for your heart to pump blood around your body.

Ramipril Capsules can be used:

•    To treat high blood pressure (hypertension)

•    To reduce the risk of you having a heart attack or stroke

•    To reduce the risk or delay the worsening of kidney problems (whether or not you have diabetes)

•    To treat your heart when it cannot pump enough blood to the rest of your body (heart failure)

•    As treatment following heart attack (myocardial infarction) complicated with heart failure.

| 2.BEFORE YOU TAKE RAMIPRIL CAPSULES    |

Do not take Ramipril Capsules:

•    If you are allergic (hypersensitive) to ramipril, any other ACE inhibitor medicine or any of the ingredients of Ramipril Capsules listed in section 6. Signs of an allergic reaction may include a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

•    If you have ever had a serious allergic reaction called "angioedema". The signs include itching, hives (urticaria), red marks on the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips and difficulty in breathing and swallowing

•    If you are having dialysis or any other type of blood filtration. Depending on the machine that is used, Ramipril Capsules may not be suitable for you

•    If you have kidney problems where the blood supply to your kidney is reduced (renal artery stenosis)

•    During the last 6 months of pregnancy (see section below on "Pregnancy and breast-feeding")

•    If your blood pressure is abnormally low or unstable. Your doctor will need to make this assessment.

Do not take Ramipril Capsules if any of the above apply to you. If you are not sure, talk to your doctor before taking this medicine.

Take special care with Ramipril Capsules:

Check with your doctor or pharmacist before taking your medicine:

•    If you have heart, liver or kidney problems

•    If you have lost a lot of body salts or fluids (through being sick (vomiting), having diarrhoea, sweating more than usual, being on a low salt diet, taking diuretics (water tablets) for a long time or having had dialysis)

•    If you are going to have treatment to reduce your allergy to bee or wasp stings (desensitization)

•    If you are going to receive an anaesthetic. This may be given for an operation or any dental work. You may need to stop your treatment with Ramipril Capsules one day beforehand; ask your doctor for advice

•    If you have high amounts of potassium in your blood (shown in blood test results)

•    If you have collagen vascular disease such as scleroderma or systemic lupus erythematosus

•    You must tell your doctor if you think that you are (or might become) pregnant. Ramipril Capsules are not recommended in the first 3 months of pregnancy and may cause serious harm to your baby after 3 months of pregnancy (see section "Pregnancy and breast-feeding").

Children

Ramipril is not recommended for use in children and adolescents below 18 years of age because safety and efficacy of Ramipril Capsules in children is not established.

If any of the above apply to you (or you are not sure), talk to your doctor before taking Ramipril Capsules.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription (including herbal medicines). This is because ramipril can affect the way some other medicines work and some medicines can affect the way ramipril works.

Please tell your doctor if you are taking any of the following medicines. They can make ramipril work less well:

•    Medicines used to relieve pain and inflammation (e.g. Non-Steroidal AntiInflammatory Drugs (NSAIDs) such as ibuprofen or indometacin and aspirin)

•    Medicines used for the treatment of low blood pressure, shock, cardiac failure, asthma or allergies such as ephedrine, noradrenaline or adrenaline. Your doctor will need to check your blood pressure.

Please tell your doctor if you are taking any of the following medicines as they can increase the chance of getting side effects if you take them with Ramipril Capsules:

•    Medicines used to relieve pain and inflammation (e.g. Non-Steroidal AntiInflammatory Drugs (NSAIDs) such as ibuprofen or indometacin and aspirin)

•    Medicines for cancer (chemotherapy)

•    Medicines to stop the rejection of organs after a transplant such as ciclosporin

•    Diuretics (water tablets) such as furosemide

•    Medicines which can increase the amount of potassium in your blood such as spironolactone, triamterene, amiloride, potassium salts and heparin (for thinning blood)

•    Steroid medicines for inflammation such as prednisolone

•    Allopurinol (used to lower the uric acid in your blood)

•    Procainamide (for heart rhythm problems).

Please tell your doctor if you are taking any of the following medicines. They may be affected by ramipril:

•    Medicines for diabetes such as oral glucose lowering medicines and insulin. Ramipril may lower your blood sugar amounts. Check your blood sugar amounts closely while taking Ramipril Capsules

•    Lithium (for mental health problems) as ramipril may increase the amount of lithium in your blood. Your lithium amount will need to be closely checked by your doctor.

If any of the above apply to you (or you are not sure), talk to your doctor before taking Ramipril Capsules.

Taking Ramipril Capsules with food and alcohol

•    Drinking alcohol with ramipril may make you feel dizzy or light-headed. If you are concerned about how much you can drink while you are taking Ramipril Capsules, discuss this with your doctor as medicines used to reduce blood pressure and alcohol can have additive effects.

•    Ramipril Capsules may be taken with or without food.

Pregnancy and breast-feeding

You must tell your doctor if you think that you are (or might become) pregnant. You should not take Ramipril Capsules in the first 12 weeks of pregnancy, and you must not take them at all after the 13th week as their use during pregnancy may possibly be harmful to the baby. If you become pregnant while on Ramipril Capsules, tell your doctor immediately. A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy. You should not take Ramipril Capsules if you are breast-feeding.

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

Driving and using machines

You may feel dizzy, while taking Ramipril Capsules. This is more likely to happen when you start taking them or start taking a higher dose. If this happens, do not drive or use any tools or machines.

Important information about some of the ingredients of Ramipril Capsules

Colourants sunset yellow FCF (E-110), carmoisine (E-122) and ponceau 4R (E-124) can cause allergic reactions including asthma. Allergies are more common in those people who are allergic to aspirin.

| 3 HOW TO TAKE RAMIPRIL CAPSULES    \

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

Taking this medicine

•    Take this medicine orally at the same time each day.

•    Swallow the capsules whole with liquid.

•    Do not crush or chew the capsules.

How much to take

Treatment of high blood pressure

•    The usual starting dose is 1.25 mg or 2.5 mg once daily.

•    Your doctor will adjust the amount you take until your blood pressure is controlled.

•    The maximum dose is 10 mg once daily.

•    If you are already taking diuretics (water tablets), your doctor may stop or reduce the amount of the diuretic you take before beginning treatment with Ramipril Capsules.

To reduce the risk of you having a heart attack or stroke

•    The usual starting dose is 2.5 mg once daily.

•    Your doctor may then decide to increase the amount you take.

•    The usual dose is 10 mg once daily.

Treatment to reduce or delay the worsening of kidney problems

•    You may be started on a dose of 1.25 mg or 2.5 mg once daily.

•    Your doctor will adjust the amount you are taking.

•    The usual dose is 5 mg or 10 mg once daily.

Treatment of heart failure

•    The usual starting dose is 1.25 mg once daily.

•    Your doctor will adjust the amount you take.

•    The maximum dose is 10 mg daily. Two administrations per day are preferable.

Treatment after you have had a heart attack

•    The usual starting dose is 1.25 mg once daily to 2.5 mg twice daily.

•    Your doctor will adjust the amount you take.

•    The usual dose is 10 mg daily. Two administrations per day are preferable. Elderly

Your doctor will reduce the initial dose and adjust your treatment more slowly.

If you take more Ramipril Capsules than you should

Tell a doctor or go to the nearest hospital casualty department straight away. Do not drive to the hospital, get somebody else to take you or call for an ambulance. Take the medicine pack with you. This is so the doctor knows what you have taken.

If you forget to take Ramipril Capsules

•    If you miss a dose, take your normal dose when it is next due.

•    Do not take a double dose to make up for a forgotten capsule.

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

| 4.POSSIBLE SIDE EFFECTS

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

Stop taking Ramipril Capsules and see a doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment:

•    Swelling of the face, lips or throat which make it difficult to swallow or breathe, as well as itching and rashes. This could be a sign of a severe allergic reaction to Ramipril Capsules

•    Severe skin reactions including rash, ulcers in your mouth, worsening of a pre-existing skin disease, reddening, blistering or detachment of skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiform).

Tell your doctor immediately if you experience:

•    Faster heart rate, uneven or forceful heartbeat (palpitations), chest pain, tightness in your chest or more serious problems including heart attack and stroke

•    Shortness of breath or a cough. These could be signs of lung problems

•    Bruising more easily, bleeding for longer than normal or any sign of bleeding (e.g. bleeding from the gums). Purple spots blotching on the skin, getting infections more easily than usual, sore throat and fever, feeling tired, faint, dizzy or having pale skin. These can be signs of blood or bone marrow problems

•    Severe stomach pain which may reach through to your back. This could be a sign of pancreatitis (inflammation of the pancreas).

•    Fever, chills, tiredness, loss of appetite, stomach pain, feeling sick, yellowing of your skin or eyes (jaundice). These can be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage.

Other side effects include:

Please tell your doctor if any of the following gets serious or lasts longer than a few days.

Common (affects less than 1 in 10 people)

•    Headache or feeling tired

•    Feeling dizzy. This is more likely to happen when you start taking ramipril or start taking a higher dose

•    Fainting, hypotension (abnormally low blood pressure), especially when you stand or sit up quickly

•    Stomach or gut pain, diarrhoea, indigestion, feeling or being sick

Uncommon (affects less than 1 in 100

•    Balance problems (vertigo)

•    Itching and unusual skin sensations such as numbness, tingling, pricking, burning or creeping on your skin (paraesthesia)

•    Loss or change in the way things taste

•    Sleep problems

•    Feeling depressed, anxious, more nervous than usual or restless

•    Blocked nose, difficulty breathing or worsening of asthma

•    A swelling in your gut called "intestinal angioedema" giving symptoms such as stomach pain, vomiting and diarrhoea

•    Heartburn, constipation or dry mouth

•    Passing more water (urine) than usual over the day

Rare (affects less than 1 in 1,000 people)

•    Feeling shaky or confused

•    Red and swollen tongue

•    Severe flaking or peeling of the skin, itchy, lumpy rash

•    Nail problems (e.g. loosening or separation of a nail from its bed)

•    Skin rash or bruising

•    Blotches on your skin and cold extremities

Very rare (affects less than 1 in 10,000 people) • Being more sensitive to the sun than usual.

Difficulty concentrating Swollen mouth

Blood tests showing too few blood cells in your blood Fingers and toes changing colour when you are cold and then tingling or feeling painful when you warm up (Raynaud's phenomenon)

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

| 5.HOW TO STORE RAMIPRIL CAPSULES_

Keep out of the reach and sight of children.

Do not use Ramipril Capsules after the expiry date which is stated on the carton after EXP:

Do not store above 25°C.

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.

| 6.FURTHER INFORMATION What Ramipril Capsules contain

The active substance is ramipril (each capsule contains 1.25mg, 2.5mg, 5mg or 10mg of ramipril). The other ingredients are pregelatinized maize starch, gelatin and titanium dioxide (E-171).

In addition the capsules also contain the following colourants in the capsule shell:

-    1.25mg capsules: yellow iron oxide (E-172)

-    2.5mg capsules: ponceau 4R (E-124), patent blue V (E-131) and sunset

yellow (E-110)

-    5mg capsules:    sunset yellow (E-110), carmoisine (E-122) and quinoline

yellow (E-104)

-    10mg capsules: ponceau 4R (E-124), indigo carmine (E-132) and black iron

oxide (E-172).

The black printing ink contains shellac, ethanol, isopropanol, butanol, propylene glycol, purified water, strong ammonia solution, potassium hydroxide and black iron oxide (E-172).

What Ramipril Capsules look like and contents of the pack

Your medicine is in the form of hard gelatin capsules.

The 1.25mg capsules have a white body and yellow cap with 'RP 1.25' and '>' both printed in black.

The 2.5mg capsules are orange with 'RP 2.5' and '>' both printed in black.

The 5mg capsules are red with 'RP 5' and '>' both printed in black.

The 10mg capsules are blue with 'RP 10' and '>' both printed in black.

Ramipril Capsules are available in blister packs or containers of 7, 14, 20, 21, 28, 30, 50, 56, 98, 100, 500 and 1000 capsules (not all pack sizes/types may be marketed).

Marketing Authorisation Holder: Arrow Generics Limited,

Unit 2, Eastman Way, Stevenage, Hertfordshire, SG1 4SZ, U.K.

Manufacturer: Arrow Pharm (Malta) Limited,

HF 62, Hal Far Industrial Estate, Birzebbugia BBG06, Malta This leaflet was last revised on 05-2012.