RAMIPRIL 1.25 mg Tablet

Зміст інструкції

1. RAMIPRIL GIT
2. Ramipril
   1. WHAT IS RAMIPRIL GIT AND WHAT IS IT USED FOR
   2. BEFORE TAKING RAMIPRIL GIT
   3. HOW TO TAKE RAMIPRIL GIT
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE RAMIPRIL GIT
   6. OTHER INFORMATION

RAMIPRIL GIT

1.25 mg, 2.5 mg, 5 mg or 10 mg tablets

Ramipril

Generic medicine
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. In fact, this medicine may be dangerous for other individuals, even if their symptoms are the same as yours.
• If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, tell 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 IS RAMIPRIL GIT AND WHAT IS IT USED FOR

RAMIPRIL GIT contains a medicine called ramipril which belongs to a group of drugs called
ACE inhibitors (Angiotensin Converting Enzyme Inhibitors).
RAMIPRIL GIT works by:

• decreasing the production, by the body, of substances that can cause an increase in blood pressure
• relaxing and widening its blood vessels
• making it easier for its heart to pump blood around the body.

RAMIPRIL GIT can be used:

• to treat high blood pressure (hypertension)
• to reduce the risk or delay the worsening of kidney problems (whether or not diabetes is present)
• to treat its heart when it cannot pump a sufficient volume of blood to the rest of the body (heart failure)

As treatment after a heart attack (myocardial infarction) if 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 drugs or to any of the other ingredients of RAMIPRIL GIT listed in section 6.

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

• If you have had a severe allergic reaction called “angioedema”. These signs include itching, skin rash (urticaria), red patches on the hands, feet and in the throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty in breathing and swallowing.
• If you are undergoing dialysis or are undergoing any other type of blood filtration. Depending on the machinery 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 pregnant for more than three months. (It is best to avoid RAMIPRIL GIT even in the early stages of pregnancy - see the Pregnancy section)
• If your blood pressure is excessively low or unstable. Your doctor will need to make this assessment.

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 a lot of salts or body fluids (due to an illness such as vomiting, diarrhea, excessive sweating, or following a low-salt diet, or after taking diuretics for a long time or having undergone dialysis).
• If you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitization).
• If you are about to undergo anesthesia. This may be administered for surgery or dental treatment. It may be necessary to stop treatment with RAMIPRIL GIT the day before, ask your doctor for advice.
• If you have a high level of potassium in your blood (shown by a blood test).
• If you have a connective tissue disease such as scleroderma or systemic lupus erythematosus.
• You should inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). RAMIPRIL GIT is not recommended in early pregnancy, and should not be taken if you are pregnant for more than three months, as it can cause serious harm to the baby if taken during this period (see the Pregnancy section).

Children
The use of RAMIPRIL GIT is not recommended in children and adolescents under the age of 18 years
because there is no information available for this population.
If any of the above conditions occur (or if you are unsure), consult your doctor before
taking RAMIPRIL GIT.

Taking RAMIPRIL GIT with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription (including herbal medicines). This is because RAMIPRIL GIT can affect the mechanism of action of some other
medicines. Also, some medicines can affect the mechanism of action of RAMIPRIL GIT.
Tell your doctor if you are taking any of the following medicines. These medicines may interfere
with RAMIPRIL GIT by altering its action:

• 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 check your blood pressure. Tell your doctor if you are taking any of the following medicines. These medicines may increase the likelihood of side effects if taken in combination with RAMIPRIL GIT:
• medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as ibuprofen, indometacin or aspirin)
• medicines for cancer treatment (chemotherapy)
• medicines to prevent organ rejection after a transplant such as cyclosporine
• diuretics such as furosemide
• medicines that can increase the level of potassium in the blood such as spironolactone, triamterene, amiloride, potassium salts and heparin (used to make the blood more fluid)
• steroid medicines for the treatment of inflammation such as prednisolone
• allopurinol (used to decrease the content of uric acid in the blood)
• procainamide (for heart rhythm problems).

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

• medicines for diabetes such as oral hypoglycemic agents and insulin. RAMIPRIL GIT may lower the amount of sugar in the blood. Carefully monitor your blood sugar levels when taking RAMIPRIL GIT.
• Lithium (for psychiatric problems). RAMIPRIL GIT may increase the amount of lithium in the blood. Your doctor should carefully monitor the level of lithium in your blood. If any of the above conditions occur (or you are unsure), ask your doctor before taking RAMIPRIL GIT.

Taking RAMIPRIL GIT with food and alcohol

• Drinking alcoholic beverages with RAMIPRIL GIT can cause dizziness or lightheadedness. If you want to know how much alcohol to drink when taking RAMIPRIL GIT, discuss it with your doctor, as medicines used to lower blood pressure and alcohol can have additive effects.
• Taking RAMIPRIL GIT can be done with or without food.

Pregnancy and Breastfeeding
You should inform your doctor if you think you may be pregnant (or if there is a possibility of
becoming pregnant). As a rule, your doctor will advise you to stop taking RAMIPRIL GIT before starting
pregnancy or as soon as you become aware of being pregnant and will advise you to take another medicine instead of RAMIPRIL GIT.
RAMIPRIL GIT is not recommended in early pregnancy, and should not be taken if you are pregnant for more than three months, as it can cause serious harm to the baby if taken after the
third month of pregnancy.

Breastfeeding:
Tell your doctor if you are breastfeeding or are about to start breastfeeding.
RAMIPRIL GIT is not recommended for women who are breastfeeding and your doctor may choose a
different treatment if you wish to breastfeed, especially if your baby is newborn or premature.
Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
You may feel dizzy while taking RAMIPRIL GIT. This is more likely
when you have just started taking RAMIPRIL GIT or have just increased the dose. If this
happens, do not drive or use tools or machinery.

Important information about some of the ingredients of RAMIPRIL GIT
RAMIPRIL GIT contains lactose.
Consult your doctor before taking the medicine if you have been told that you are intolerant to certain
types of sugars.

3. HOW TO TAKE RAMIPRIL GIT

Always take RAMIPRIL GIT following the doctor's instructions carefully. Consult your doctor or pharmacist if you have any doubts.

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 to take

Treatment of high blood pressure

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

Treatment to reduce or prevent worsening of kidney problems

• You may be given an initial dose of 1.25 mg or 2.5 mg once a day.
• The doctor will adjust the amount you are taking.
• The usual dose is 5 mg or 10 mg once a day.

Treatment of heart failure

• The usual starting dose is 1.25 mg once a day.
• The doctor will adjust the amount you take.
• 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 is from 1.25 mg once a day to 2.5 mg twice a day.
• The doctor will adjust the amount you take.
• The usual dose is 10 mg per day. It is preferable to divide the dose into two daily administrations.

Elderly patients
The doctor will reduce the initial dose and adjust the treatment more slowly.

If you take more RAMIPRIL GIT than you should
Inform your doctor or go to the nearest hospital emergency room. Do not drive to the hospital, have someone accompany you or call an ambulance. Bring the medicine box with you.
This is because the doctor needs to know what you have taken.

If you forget to take RAMIPRIL GIT

• If you forget a dose, take your normal dose when it is time.
• Do not take a double dose to make up for a missed one. If you have further questions or doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

Stop taking RAMIPRIL GITand contact your doctor immediately if you notice any of the following serious side effects – you may need urgent medical treatment:

• Swelling of the face, lips or throat which makes it difficult to swallow or breathe, as well as itching or rash. This could be a sign of a severe allergic reaction to RAMIPRIL GIT.
• Severe skin reactions including rash, mouth sores, worsening of a pre-existing skin condition, redness, blistering or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

Tell your doctor immediately if you experience:

• Fast heartbeat, irregular or strong heartbeat (palpitations), chest pain, feeling of tightness in the chest, or more serious problems including heart attack and stroke.
• Shortness of breath or cough. These can be signs of lung problems.
• Easier bruising, prolonged bleeding more than usual, any sign of bleeding (e.g. bleeding gums) purple spots on the skin or easy development of infections, sore throat and fever, feeling tired, weak, dizziness or pale skin. These can be signs of problems with the blood circulation or bone marrow.
• Severe stomach pain that may spread to your back. This can 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 can be signs of liver problems such as hepatitis (inflammation of the liver) or liver damage.

Other side effects include:
Tell your doctor if any of the following becomes severe or lasts for more than a few
days.

Common(affect less than 1 in 10 people)

• Headache or feeling tired.
• Feeling dizzy. This is more likely to happen when you first start taking RAMIPRIL GIT or when your dose is increased.
• Weakness, low blood pressure (unusually low blood pressure), especially when standing up or getting up quickly.
• Dry, irritating cough, sinus inflammation (sinusitis) or bronchitis, shortness of breath.
• Stomach or intestinal pain, diarrhoea, indigestion, feeling sick or unwell.
• Rash with or without swelling.
• Chest pain.
• Cramps or muscle pain.
• Blood tests may show a higher than normal level of potassium.

Not common(affect less than 1 in 100 people)

• Problems with balance (dizziness)
• Itching and unusual skin sensations such as numbness, tingling, burning, prickling or creeping (paresthesia)
• Loss or changes to your sense of taste
• Sleep disturbances
• Feeling down, anxious, more nervous than usual or irritability
• Blocked nose, difficulty breathing or worsening of asthma
• Swelling of the intestine called “intestinal angioedema” which presents with symptoms such as abdominal pain, vomiting and diarrhoea
• Heartburn, constipation or dry mouth
• Increased amount of urine during the day
• Increased sweating than usual
• Loss or decrease of appetite (anorexia)
• Fast or irregular heartbeat, swollen arms and legs. This can be a sign that your body is retaining more water than usual
• Hot flushes
• Blurred vision
• Joint pain
• Fever
• Impotence in men, reduced sexual desire in men and women
• Increased number of white blood cells (eosinophilia) found during blood tests
• Changes in liver, pancreas or kidney function revealed by blood tests

Rare(affect less than 1 in 1000 people)

• Feeling faint or confused
• Swollen and red tongue
• Severe flaking or peeling of the skin, itching, rash with pustules
• Problems with your nails (e.g. loss or separation of the nail from its bed)
• Rash or bruising
• Spotted skin and cold extremities
• Red, swollen, watery or itchy eyes
• Hearing problems and ringing in the ears
• Feeling weak
• Decrease in the number of red blood cells, white blood cells or platelets or concentration of haemoglobin revealed by blood tests.

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

• Increased sensitivity to the sun

Other side effects reported:
Tell your doctor if any of the following becomes severe or lasts for more than a few
days.

• Difficulty concentrating
• Swelling of the mouth
• Blood tests showing a low number of cells in the blood
• Blood tests showing a low level of sodium in the blood
• Fingers and toes changing colour when exposed to cold and tingling or hurting when warmed (Raynaud’s phenomenon)
• Increase in breast volume in men
• Slowed or altered reactions
• Burning sensation
• Change in the perception of smells
• Hair loss

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

5. HOW TO STORE RAMIPRIL GIT

Keep RAMIPRIL GIT out of the reach and sight of children.
Do not store at a temperature above 25°C.
Do not use RAMIPRIL GIT after the expiry date indicated on the packaging. The expiry date
refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines that are no longer used. These
methods will help to not pollute the environment.

6. OTHER INFORMATION

What RAMIPRIL GIT contains
The active ingredient is ramipril.
The excipients are: sodium hydrogen carbonate, lactose monohydrate, sodium croscarmellose, pregelatinized
starch, sodium stearylfumarate, yellow iron oxide (E172) (only in 2.5 and 5 mg tablets), red iron oxide (E 172) (only in 5 mg tablets).

Description of the appearance of RAMIPRIL GIT and contents of the pack
Packs of: 10, 14, 20, 28, 30, 42, 50, 98 and 100 tablets (Not all pack sizes may be marketed).
Appearance of the tablets:
1.25 mg: tablets from white to off-white, capsule-shaped, flat, uncoated, 8.0x4.0 mm.
2.5 mg: yellow tablets, capsule-shaped, flat, imprinted uncoated, 10.0 x 5.0 mm with a fracture line on one side and on the edge, imprinted with “R2”.
5 mg: pink tablets, capsule-shaped, flat, uncoated, 8.8x4.4 mm with a fracture line on one side and on the edge, imprinted with “R3”.
10 mg: tablets from white to off-white, capsule-shaped, flat, uncoated, 11.0x5.5 mm with a fracture line on one side and on the edge, imprinted with “R4”.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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