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Artw#rl< • • Creative Desipne	Artwork No.		240311/1			Colours Used
	Customer		Ennogen		■	Black
	Descri ption		Ramipril Leaflet		■	Keyline
	Market		UK
	Language		English
	Size		1 70 x 370 mm
	Min. Font Size		Arial, 9 pt
	Page No.		1 of 2
e-mail : artworkcd@yahoo.com Ph : +91-09845609386	Version No.		3
	Date		24-03-11
	Software		Coreldraw 1 2
Prepared By Regulatory Affairs		Checked By Regulatory Affairs		Checked By Quality Assurance		Approved By EU Head - QA

they used for

Before you take Ramipril Capsules How to take Ramipril Capsules Possible side effects How to store Ramipril Capsules Further information

1. WHAT ARE RAMIPRIL CAPSULES AND WHATARETHEYUSED FOR

Ramipril Capsules contain Ramipril which belongs |to a group of medicines called ACE (angiotensin converting enzyme) Inhibitors. They work by Widening the blood vessels which makes it easier for the heart to pump blood through them, to all parts of the body. This helps to reduce blood pressure. It can also help to make the heart work better if it does not pump as well as needed.

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are usedto:-

i risk of a heart attack, heart disease | and stroke and decrease the risk of requiring surgery to increase blood flow to the heart.

• Treat high blood pressure

2. BEFORE YOU TAKE RAMIPRIL CAPSULES

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Take special care with Ramipril Capsules

fconsult your doctor or pharmacist before taking Ramipril Capsules if you:

Have heart, liver or kidney disease Have collagen vascular disease such as scleroderma or systemic lupus erythematous Are going to have treatment to reduce your allergy to bee or wasp stings (desensitization) Are going to have an anesthetic. This may be given for an operation or any dental work. You may need to stop taking your ramipril treatment one day beforehand. Ask your doctor for advice.

Are taking diuretics (water tablets). Your doctor may stop your diuretic medication and correct volume and/or sodium depletion before starting you on ramipril capsules.

Have high amounts of potassium in your blood Have lost a lot of body salts or fluids (through being sick, diarrhoea, sweating more than usual, being on a low salt diet, or on dialysis)

• Are elderly

bhildren: Ramipril Capsules are not recommended for use in children and adolescents Delow 18 years of age because there is no information available in this population.

ff any of the above applies to you, or you are not pure, talk to your doctor before taking this medicine.

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Taking other medicines

Please inform your doctor or pharmacist if you are Jaking or have recently taken any other medicines, including medicines obtained without a

nnogen limited

Ramipril 2.5mg Capsules    I

Ramipril 10mg Capsules    I

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prescription (including herbal medicines). This i^ because Ramipril Capsules can affect the way some other medicines work. Also, some medicines can affect the way Ramipril Capsules work.

In particular tell your doctor if you are takinqj any of the following:

Diuretics (water tablets) such as furosemide | Antihypertensives to treat high blood pressure Diabetic medication e.g insulin and metformin Gout treatment such as allopurinol medicines used to relieve pain and inflammation (e.g. Non-Steroidal AntiH Inflammatory Drugs (NSAIDs) such ast ibuprofen, ketoralac, indomethacin and aspirin)

•    Corticosteroids used to treat a variety o^ conditions such as prednisolone

•    Immunosuppressants medicines used aftei organ transplant such as ciclosporin or tacrolimus

•    Medicines containing potassium, includinai potassium sparing diuretics, potassium supplements and potassium containing sail substitutes

•    Lithium used to treat certain mental healthl illnesses

•    Medicines used to treat heart rhythm problems¹

such as procainamide    |

•    Chemotherapy drugs used to treat cancer

•    Sympathomimetic medicines to treat shock) such as adrenaline

•    Oestrogens

•    Medicines used to treat indigestion an^| heartburn antacids

•    Epoetin used to treat red blood cell production I

•    medicines which can increase the amount of.

potassium in your blood such a? spironolactone, triamterene, amiloridej potassium salts and heparin (for thinning, blood)    I

•    Medicines used to treat depression such as. Mono amine oxidase inhibitors

•    Medicines used to help relax muscles such as| baclofen and trizanidine

•    Medicines used to treat circulatory problemsl such as moxisylyte

•    Medicines used to treat erectile dysfunction¹

such asalprostadil    |

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You must tell your doctor if you think that you are (or might become) pregnant.

You should not take Ramipril capsules in the first 1^| 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 Ramiprif capsules, tell your doctor immediately. Aswitch to a suitable alternative treatment should be carried out in advance ofa planned pregnancy.    I

You should not take Ramipril capsules if you are. breast-feeding.

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

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Food and alcohol

Drinking alcohol with Ramipril capsules 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. Ramipri) capsules may be taken with or without food.

Driving and using machines    |

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

3. HOWTOTAKERAMIPRILCAPSULES

Always take Ramipril capsules exactly as your doctor has told you.    |

You should check with your doctor or pharmacist if you are not sure.

Take this medicine by mouth at the same time o^ the day each day.

Swallowthe capsules with liquid.

Doses:

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• Treatmentof high blood pressure

The usual starting dose is 1.25mg or 2.5mg once [daily. Your doctor will adjust the amount you take until your blood pressure is controlled. The maximum dose is 10mg 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.

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f Treatment to reduce or delay the worsening of kidney problems

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

^our doctor will adjust the amount you are taking. The usual dose is 5mg or 10mg once daily.

• Treatment of heart failure

The usual starting dose is 1.25mg once daily. Your [doctor will adjust the amount you take. The maximum dose is 10mg daily.

Two administrations per day are preferable.

• Treatment after you have had a heart attack [The usual starting dose is 1.25mg once daily to 2.5mg twice daily. Your doctor will adjust the |amount you take. The usual dose is 10mg daily. Two administrations per day are preferable.

• Elderly

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

|f 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 nospital, 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 tablet.

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

If you stop taking Ramipril Capsules

Do not stop taking Ramipril Capsules without first consulting your doctor, as your original symptoms will return

feeling or being sick, changes in liver enzymes (including jaundice) have been reported. Rarel reports of pancreatitis (inflammation of the. pancreas).

•    Reddening of the skin areas withj accompanying heat sensation

•    Hairloss    |

•    Reduced circulation to the hands and/or feet (Raynaud's phenomenon)

•    Sensitivity of the skin to light and effects on the. nails (loosening) has been observed

•    Dry, tickling cough, bronchitis and a runny oi| stuffy nose

•    Conjunctivitis (eye infection)    I

•    Disturbance of balance    .

•    Headache

•    Nervousness    |

•    Restlessness

•    Tremor    |

•    Problems with sleeping

•    Confusion

•    Loss of appetite

•    Depressed mood

•    Feeling of anxiety    |

•    Pins and needles

•    Muscle cramps, muscle and joint pains    I

•    Fever

•    Vasculitis (inflammation of the blood vessels)

•    Sexual inability in men, and reduced sexua[ desire (libido)

•    Change in sense of taste    |

•    Blood tests may show an increase in some liver test results

•    An increase in blood urea nitrogen, creatinine] levels, serum potassium levels and a decrease¹ in serum sodium levels may also be observed |

•    An increase in the number of eosinophilia blood cells has also been reported

If you notice any side effects not listed in this leaflet

please inform your doctor or pharmacist.

5. STORING RAMIPRIL CAPSULES

Keep out of the reach and sight of children.

Do not store above 25°C.

Store in the original container.

Do not use Ramipril capsules after the expiry date| which is stated on the carton and the blister or the tablet container. The expiry date refers to the Iasi day of that month.

Medicines should not be disposed via wastewater¹ or household waste. Ask your pharmacist how tc| dispose of medicines no longer required. These measures will help to protect the environment. I

4. POSSIBLE SIDE EFFECTS

6. FURTHER INFORMATION

As with all medicines Ramipril Capsules may cause undesirable effects in some people.

4f you experience any of the following side [effects STOP taking Ramipril and seek immediate medical help:

• Your breathing becomes difficult and noisy

fYou get any swelling of the face, tongue or throat

^These could be signs of an allergic reaction and urgent medical help should be sought.

Talk to your doctor immediately if:

f You feel ill after your first dose (a few people

*    may react to their first dose and feel very dizzy, | weak, faint and sick)

•    You get a lot of infections with a lot of sore | throats and mouth ulcers

fYou notice a rash, skin eruption or their effects on your skin or eyes, itching or a high temperature

• You notice swelling of the face, tongue orthroat [Ask your doctor if you should continue to take Ramipril Capsules.

The most common side effects include feeling sick, dizziness and headache. Other possible, but less common side effects are described below:

• Angioneurotic (Quincke's oedema): in very rare cases this condition has occurred which ' includes symptoms such as swelling of the | face, tongue and throat. Itchy skin, rash, shortness of breath sometimes fever |> Low blood pressure with dizziness, weakness and feeling sick L Fainting

f Rare reports of chest pain, fast or changing heart beat and angina

|> Ramipril may affect the kidneys. Pre-existing proteinurea (elevated protein levels) may I deteriorate

f Dry mouth, irritation or swelling in the mouth, ‘ stomach pains, diarrhoea or constipation,

What Ramipril Capsules contain:

Ramipril capsules contain 1.25mg, 2.5mg, 5mg| and 10mg of active substance ramipril.

The other ingredients are: starch pregelatinisedi gelatin and the colourings black iron oxide (E172j and titianium dooxide (E171). The 2.5mg, 5mg and 10mg also contain the colourings FD&C Blue (E132) and yellow iron oxide (E172).    I

What Ramipril Capsules look like and contents! of the pack    |

For Ramipril 1.25mg: Hard gelatin capsule. Capsule body: light grey. Capsule cap: light greyj Marked with “R” on cap and “1.25” on body_1| Capsule contains white or almost white powder

Ramipril 2.5mg: Hard gelatin capsule. Capsule^ body: light grey. Capsule cap: light green. Capsule| contains white or almost white powder. Marked with “R” on the cap and “2.5” on the body.    I

Ramipril 5mg: Hard gelatin capsule. Capsule body! light grey. Capsule cap: green. Capsule contains] white or almost white powder. Marked with “R” on the cap and "5” on the body    I

Ramipril 10mg : Hard gelatin capsule. Capsule) body: light grey. Capsule cap: darkgreen. Capsuls contains white or almost white powder. Markea

This leaflet was last amended in March 2011.

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