Ramipril Git

Italy
Brand name Ramipril Git
Form tablets
Active substance / Dosage
RAMIPRIL
Prescription type Prescription only
ATC code
C09AA05
Registration number 037785
Manufacturer S.F. GROUP S.R.L.

RAMIPRIL GIT
1.25 mg, 2.5 mg, 5 mg or 10 mg tablets
Ramipril
Generic medicine
Please read this leaflet carefully before taking this medicine.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you personally. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
  • If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

  1. What RAMIPRIL GIT is and what it is used for
  2. Before you take RAMIPRIL GIT
  3. How to take RAMIPRIL GIT
  4. Possible side effects
  5. How to store RAMIPRIL GIT
  6. Further information

1. WHAT RAMIPRIL GIT IS AND WHAT IT IS USED FOR

RAMIPRIL GIT contains a medicine called ramipril, which belongs to a group of medicines known as ACE inhibitors (Angiotensin-Converting Enzyme inhibitors).
RAMIPRIL GIT works by:

  • reducing the body's production of substances that can cause an increase in blood pressure
  • relaxing and widening your blood vessels
  • helping your heart pump blood more effectively throughout the body.

RAMIPRIL GIT may be used:

  • to treat high blood pressure (hypertension)
  • to reduce the risk or delay the progression of kidney problems (with or without diabetes)
  • to treat heart failure (when the heart is unable to pump sufficient blood to the rest of the body)

As treatment following a heart attack (myocardial infarction), when associated with heart failure.

2. BEFORE TAKING RAMIPRIL GIT

Do not take RAMIPRIL GIT

  • If you are allergic (hypersensitive) to ramipril, to other ACE inhibitor medicines, or to any of the other excipients of RAMIPRIL GIT listed in section 6.

Signs of an allergic reaction may include skin rash, difficulty swallowing or breathing, or swelling of the lips, face, throat, or tongue.

  • If you have previously experienced a severe allergic reaction called "angioedema". Symptoms include itching, skin rash (hives), red patches on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing or swallowing.
  • If you are undergoing dialysis or any other type of blood filtration. Depending on the equipment used, RAMIPRIL GIT may not be suitable for you.
  • If you have kidney problems due to insufficient blood supply to the kidney (renal artery stenosis).
  • If you are more than three months pregnant. (It is also advisable to avoid RAMIPRIL GIT during early pregnancy – see section on Pregnancy.)
  • If your blood pressure is excessively low or unstable. Your doctor must assess this.

Do not take RAMIPRIL GIT if any of the above conditions apply to you. If in doubt, consult your doctor before taking RAMIPRIL GIT.

Take special care with RAMIPRIL GIT:
Consult your doctor or pharmacist before taking this medicine:

  • If you have heart, liver, or kidney problems.
  • If you have lost significant amounts of salts or body fluids (due to illness such as vomiting, diarrhoea, excessive sweating, following a low-salt diet, prolonged use of oral diuretics, or after dialysis).
  • If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitisation).
  • If you are about to receive anaesthesia, which may be administered during surgery or dental procedures. You may need to stop taking RAMIPRIL GIT the day before – consult your doctor.
  • If you have high levels of potassium in your blood (shown by a blood test).
  • If you have a vascular connective tissue disorder such as scleroderma or systemic lupus erythematosus.
  • You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). RAMIPRIL GIT is not recommended during early pregnancy and must not be taken after the first three months of pregnancy, as it may cause serious harm to the unborn baby if taken during this period (see section on Pregnancy).

Children
The use of RAMIPRIL GIT is not recommended in children and adolescents under 18 years of age, as there is insufficient information available for this population.

If any of the above conditions apply (or if you are unsure), consult your doctor before taking RAMIPRIL GIT.

Taking RAMIPRIL GIT with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription (including herbal remedies). This is because RAMIPRIL GIT may affect the action of certain other medicines, and some medicines may affect the action of RAMIPRIL GIT.

Inform your doctor if you are taking any of the following medicines. These may interfere with RAMIPRIL GIT and alter its effect:

  • Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as ibuprofen, indometacin, or aspirin);
  • Medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. Your doctor will need to monitor your blood pressure.

Inform your doctor if you are taking any of the following medicines. These may increase the likelihood of side effects when taken together with RAMIPRIL GIT:

  • Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as ibuprofen, indometacin, or aspirin);
  • Cancer medicines (chemotherapy);
  • Medicines used to prevent organ rejection after transplantation, such as ciclosporin;
  • Diuretics such as furosemide;
  • Medicines that may increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, and heparin (used to thin the blood);
  • Steroid medicines used to treat inflammation, such as prednisolone;
  • Allopurinol (used to reduce uric acid levels in the blood);
  • Procainamide (used for heart rhythm problems).

Inform your doctor if you are taking any of the following medicines. The action of these medicines may be affected by RAMIPRIL GIT:

  • Medicines for diabetes, such as oral hypoglycaemics and insulin. RAMIPRIL GIT may lower blood sugar levels. Monitor your blood sugar levels carefully when taking RAMIPRIL GIT.
  • Lithium (used for psychiatric conditions). RAMIPRIL GIT may increase lithium levels in the blood. Your doctor must closely monitor your blood lithium levels.

If any of the above apply (or if you are uncertain), consult your doctor before taking RAMIPRIL GIT.

Taking RAMIPRIL GIT with food and alcohol

  • Drinking alcohol while taking RAMIPRIL GIT may cause dizziness or lightheadedness. Discuss with your doctor how much alcohol you may consume while taking RAMIPRIL GIT, as blood pressure-lowering medicines and alcohol may have additive effects.
  • RAMIPRIL GIT may be taken with or without food.

Pregnancy and Breast-feeding
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will normally advise you to stop taking RAMIPRIL GIT before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine to RAMIPRIL GIT.
RAMIPRIL GIT is not recommended during early pregnancy and must not be taken after the first three months of pregnancy, as it may cause serious harm to the unborn baby if taken beyond the third month of pregnancy.

Breast-feeding:
Inform your doctor if you are breast-feeding or planning to breast-feed.
RAMIPRIL GIT is not recommended for women who are breast-feeding. Your doctor may choose an alternative treatment if you wish to breast-feed, especially if your baby is a newborn or was born prematurely.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
You may experience dizziness while taking RAMIPRIL GIT. This is more likely when you first start taking RAMIPRIL GIT or when your dose has just been increased. If this occurs, do not drive or operate tools or machinery.

Important information about some excipients in RAMIPRIL GIT
RAMIPRIL GIT contains lactose.
Consult your doctor before taking this medicine if you have been told that you have an intolerance to certain sugars.

3. HOW TO TAKE RAMIPRIL GIT

Always take RAMIPRIL GIT exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Taking this medicine

  • Take the medicine by mouth every day at the same time.
  • Swallow the tablets whole with liquid.
  • Do not break or chew the tablets.

How much you should take

Treatment of high blood pressure

  • The usual starting dose is 1.25 mg or 2.5 mg once daily.
  • Your doctor will adjust your dose until your blood pressure is under control.
  • The maximum daily dose is 10 mg.
  • If you are already taking diuretics, your doctor may stop or reduce them before starting your treatment with RAMIPRIL GIT.

Treatment to reduce or prevent 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 your dose accordingly.
  • 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 your dose.
  • The maximum dose is 10 mg per day. It is preferable to divide the dose into two daily administrations.

Treatment after a heart attack

  • The usual starting dose ranges from 1.25 mg once daily to 2.5 mg twice daily.
  • Your doctor will adjust your dose accordingly.
  • The usual dose is 10 mg per day. It is preferable to divide the dose into two daily administrations.

Elderly patients
Your doctor will reduce the starting dose and adjust treatment more slowly.

If you take more RAMIPRIL GIT than you should
Inform your doctor or go immediately to the nearest hospital emergency department. Do not drive to the hospital; have someone accompany you or call an ambulance. Bring the medicine pack with you, as the doctor needs to know what you have taken.

If you forget to take RAMIPRIL GIT

  • If you miss a dose, take your usual dose at the next scheduled time.
  • Do not take a double dose to make up for the missed dose.
    If you have any further questions or doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, RAMIPRIL GIT can cause adverse effects, although not everybody will experience them.
Stop taking RAMIPRIL GIT and contact your doctor immediately if you notice any of the following serious adverse effects – you may need urgent medical treatment:

  • Swelling of the face, lips, or throat causing difficulty swallowing or breathing, as well as itching or skin rash. This could be a sign of a serious allergic reaction to RAMIPRIL GIT.
  • Severe skin reactions including rash, mouth ulcers, worsening of pre-existing skin disorders, redness, blistering or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

Contact your doctor immediately if you experience:

  • Rapid heartbeat, irregular or forceful heartbeat (palpitations), chest pain, tightness in the chest, or more serious problems including heart attack and stroke.
  • Shortness of breath or cough. These may be signs of lung problems.
  • Easy bruising, prolonged bleeding more than usual, any sign of bleeding (e.g. bleeding gums), purple spots on the skin, or increased susceptibility to infections, sore throat and fever, feeling tired, weakness, dizziness or pale appearance. These may be signs of blood or bone marrow problems.
  • Severe stomach pain that may extend to the back. This could be a sign of pancreatitis (inflammation of the pancreas).
  • Fever, chills, fatigue, loss of appetite, stomach pain, feeling unwell, yellowing of the skin or eyes (jaundice). These may be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage.

Other adverse effects include:
Inform your doctor if any of the following conditions become severe or persist for more than a few days.
Common (affects less than 1 in 10 people)

  • Headache or feeling tired.
  • Dizziness. This is more likely to occur when treatment with RAMIPRIL GIT has just started or the dose has recently been increased.
  • Weakness, hypotension (unusually low blood pressure), especially when standing up or rising quickly.
  • Dry, persistent cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath.
  • Stomach or intestinal pain, diarrhoea, indigestion, feeling unwell or malaise.
  • Skin rash with or without swelling.
  • Chest pain.
  • Muscle cramps or muscle pain.
  • Blood tests show higher than normal potassium levels.

Uncommon (affects less than 1 in 100 people)

  • Balance problems (dizziness)
  • Itching and unusual skin sensations such as numbness, tingling, burning, prickling or crawling sensations (paraesthesia)
  • Loss or changes in taste
  • Sleep disturbances
  • Depressed mood, anxiety, increased nervousness or irritability
  • Stuffy nose, difficulty breathing or worsening of asthma
  • Intestinal swelling called "intestinal angioedema" presenting with symptoms such as abdominal pain, vomiting and diarrhoea
  • Heartburn, constipation or dry mouth
  • Increased amount of urine during the day
  • Increased sweating
  • Loss or decrease in appetite (anorexia)
  • Rapid or irregular heartbeat, swollen arms and legs. This may be a sign that your body is retaining more fluid than usual
  • Hot flushes
  • Blurred vision
  • Joint pain
  • Fever
  • Impotence in men, reduced sexual desire in both men and women
  • Increase in the number of white blood cells (eosinophilia) detected in blood tests
  • Changes in liver, pancreas or kidney function shown by blood tests

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

  • Feeling faint or confused
  • Swollen and red tongue
  • Severe peeling or shedding of the skin, itching, rash characterized by pustules
  • Nail problems (e.g. nail loss or separation of the nail from its bed)
  • Skin rash or bruising
  • Skin spots and cold extremities
  • Red, swollen, watery or itchy eyes
  • Hearing problems and ringing in the ears (tinnitus)
  • Feeling weak
  • Decrease in the number of red blood cells, white blood cells or platelets, or haemoglobin concentration, as shown by blood tests.

Very rare (affects less than 1 in 10,000 people)

  • Increased sensitivity to sunlight

Other reported adverse effects:
Inform your doctor if any of the following conditions become severe or persist for more than a few days.

  • Difficulty concentrating
  • Mouth swelling
  • Blood tests showing too low a number of blood cells
  • Blood tests showing low sodium levels in the blood
  • Fingers of hands and feet that change colour when cold and tingle or hurt when warmed (Raynaud's phenomenon)
  • Breast enlargement in men
  • Slowed or altered reactions
  • Burning sensation
  • Changes in the perception of smells
  • Hair loss

If you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

5. HOW TO STORE RAMIPRIL GIT

Keep RAMIPRIL GIT out of the reach and sight of children.
Do not store above 25°C.
Do not use RAMIPRIL GIT after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist for advice on how to dispose of medicines no longer in use. These measures will help prevent environmental pollution.

6. OTHER INFORMATION

What RAMIPRIL GIT contains
The active substance is ramipril.
The excipients are: sodium hydrogen carbonate, monohydrate lactose, sodium croscarmellose, pregelatinized starch, sodium stearyl fumarate, yellow iron oxide (E172) (only in the 2.5 mg and 5 mg tablets), red iron oxide (E172) (only in the 5 mg tablets).

Description of the appearance of RAMIPRIL GIT and contents of the pack
Pack sizes: 10, 14, 20, 28, 30, 42, 50, 98 and 100 tablets (It is possible that not all pack sizes are marketed).

Appearance of the tablets:
1.25 mg: white to off-white, capsule-shaped, flat, uncoated tablets, 8.0 x 4.0 mm.
2.5 mg: yellow, capsule-shaped, flat, scored, uncoated tablets, 10.0 x 5.0 mm, with a break line on one side and on the edge, imprinted with "R2".
5 mg: pink, capsule-shaped, flat, uncoated tablets, 8.8 x 4.4 mm, with a break line on one side and on the edge, imprinted with "R3".
10 mg: white to off-white, capsule-shaped, flat, uncoated tablets, 11.0 x 5.5 mm, with a break line on one side and on the edge, imprinted with "R4".

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
SF GROUP Srl – Via Tiburtina 1143, 00156 Rome (Italy)

Manufacturer
Actavis hf.
Reykjavikurvegur 76-78, 220 Hafnarfjörður
Iceland

Actavis Ltd.
B16, Bulebel Industrial Estate, Zejtun ZTN 08
Malta

Date of latest revision of this leaflet: January 2016