RAMIGAMMA 10 mg. 30 tablets

WHAT RAMIGAMMA AND WHAT IT IS USED
Ramigamma contains a medicine called ramipril. It belongs to a group of medicines called ACE inhibitors (angiotensin converting enzyme).

Ramigamma acts as:
Reduces your body's production substances that can raise blood pressure;
It helps to relax and widen your blood vessels;
It helps the heart to move blood around your body.
Ramigamma can be used:
For the treatment of high blood pressure (hypertension);
To reduce the risk of getting a heart attack or stroke;
To reduce the risk or delay the worsening of kidney problems (if you have or do not have diabetes);
To treat your heart when it can not pump enough blood to the body (heart failure);
As treatment following heart attack (myocardial infarction) complicated with heart failure.

2. BEFORE accept RAMIGAMMA
Do not take Ramigamma:
if you are allergic (hypersensitive) to ramipril, or other medicines - ACE inhibitor or any of the other ingredients of Ramigamma listed in section 6. Signs of an allergic reaction may include rash, trouble breathing or swallowing, swelling of the lips, face, throat or tongue;
if you have ever had a serious allergic reaction called "angioedema". The signs include itching, hives (urticaria), redness of the hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing;
if you are on dialysis or any other type of blood filtration. Depending on the apparatus used, Ramigamma 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 six months of pregnancy (see section below on "Pregnancy and lactation");
if your blood pressure is abnormally low or unstable. Your doctor needs to make that assessment.
Do not take Ramigamma if any of the above, the following apply to you. If you're not sure, ask your doctor before taking Ramigamma.

Take special care with Ramigamma
Ask your doctor or pharmacist before taking your medicine:
if you have heart problems, liver or kidney;
if you lost a lot of body salts or fluids (through vomiting, diarrhea, sweating more than usual, if you are on a diet low in salt; if you are taking diuretics (water tablets) for a long time or having had dialysis);
If you are going to have treatment to reduce sensitivity to stings bee or wasp (desensitization);
if you will be given general anesthesia. It can be given for an operation or dental work. You may need to stop treatment with Ramigamma one day earlier, ask your doctor for advice;
if you have high amounts of potassium in the blood (detected by blood tests);
if you have collagen as scleroderma or systemic lupus erythematosus;
You should tell your doctor if you think you are (or might become) pregnant. Ramigamma not recommended during the first three months of pregnancy and may cause serious harm to your baby after the third month of pregnancy (see. Section below on "Pregnancy and lactation").
Children
Ramigamma not recommended for use in children and adolescents under the age of 18 because the drug has never been applied in this age group.
If any of the above applies to you (or are not sure), talk to your doctor before taking Ramigamma.

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 medicinal products plant-based). Ramigamma may affect the operation of some other medicines. And some medicines can affect the way of Ramigamma.

Please ask your doctor if you are taking any of these medicines. They may weaken the effect of Ramigamma:
drugs used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin);
drugs used for the treatment of low blood pressure, shock, heart 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 these medicines. They can increase the chance of getting side effects if you take them together with Ramigamma:
drugs used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin);
drugs for the treatment of cancer (chemotherapy), drugs used to prevent rejection of organs after transplantation, such as cyclosporin;
diuretics (water pills) such as furosemide;
drugs which can increase the amount of potassium in your blood such as spironolactone, triamterene, amiloride, potassium salts and heparin (to reduce the blood's ability to clot);
steroidal anti inflammatory drugs such as prednisolone;
Allopurinol (used to lower the uric acid in your blood);
procainamide (abnormal heart rhythm).
Tell your doctor if you are taking any of these medicines. They can be influenced by Ramigamma:
medicines to treat diabetes, lowering blood sugar, which is taken orally and insulin. Ramigamma can lower your blood sugar. Check your blood sugar closely while taking Ramigamma;
lithium (for mental health problems). Ramigamma can increase the amount of lithium in your blood. The amount of lithium should be closely monitored by your doctor.
If any of the above applies to you (or are not sure), talk to your doctor before taking Ramigamma.

Taking Ramigamma with food and drink
Drinking alcohol with Ramigamma can cause dizziness and fainting. If you take Ramigamma discuss with your doctor how much you can drink as drugs used to lower blood pressure and alcohol can have complementary effects.
Ramigamma can be taken with or without food.
Pregnancy and lactation
Pregnancy
You should tell your doctor if you think you are (or might become) pregnant.
You should not take Ramigamma the first 12 weeks of pregnancy and did not have to take it after the 13th week as possible use during pregnancy can harm the baby. If you become pregnant while taking Ramigamma, tell your doctor. It must be implemented switch to a suitable alternative treatment of a planned pregnancy.

Breastfeeding
You should not take Ramigamma if you are breastfeeding.
Ask your doctor or pharmacist before taking any medicine.

Driving and using machines
You may feel dizzy while taking Ramigamma. More likely is that to happen at the beginning of treatment Ramigamma or if you 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 Ramigamma
Ramigamma contains milk sugar (lactose). Consult your doctor before using this medicine if your doctor told you that you have an intolerance to some sugars.

3. HOW TO TAKE RAMIGAMMA
Always use Ramigamma exactly as directed by your doctor. If you're not sure, ask your doctor or pharmacist.

Taking the medicine
Take this medicine by mouth at the same time every day;
Swallow the tablets whole with liquid;
Do not crush 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 daily;
Your doctor will adjust the dosage until your blood pressure is well 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 Ramigamma.
To reduce the risk of 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 can start with doses of 1,25 mg or 2,5 mg once daily;
Your doctor will adjust the amount you take;
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. Preferably, administration twice daily.
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. Preferably, administration twice daily.
Elderly
Your doctor will reduce the initial dose and adjust your treatment more slowly.

If you take more dose Ramigamma
Talk to your doctor immediately or go to the nearest hospital emergency department. Do not drive to the hospital, get somebody else to take you or call for an ambulance. Take the medicine pack with you to the doctor to understand what you have taken.

If you forget to take Ramigamma
If you miss a dose, take your normal dose when the next intake.
Do not take a double dose to make up for a forgotten tablet.

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

4. POSSIBLE SIDE EFFECTS
Like all medicines, Ramigamma can cause side effects, although not everybody gets them.

Stop taking Ramigamma and see a 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 make it difficult to swallow or breathe, as well as itching and rash. This may be a sign of a severe allergic reaction to Ramigamma;
Severe skin reactions including rash, mouth ulcers, worsening of pre-existing skin disease, reddening, blistering or peeling of the skin (eg. Stevens-Johnson, toxic epidermal necrolysis and erythema multiforme).
Immediately contact your doctor if you:
fast 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 cough. These may be signs of lung problems;
easy bruising, prolonged bleeding, any bleeding (eg bleeding from the gums), purple spots blotching on the skin; easier off infections, sore throat and fever, feeling tired, dizzy or having pale skin. These can be signs of problems with the blood or bone marrow;
severe pain in the stomach, which can spread to the back. This may be a sign of pancreatitis (inflammation of the pancreas);
fever, chills, tiredness, loss of appetite, stomach pain, nausea, yellowing of the skin or whites of the eyes (jaundice). These may 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 patients):
Headache or tiredness;
Feeling dizzy. More likely to happen in the beginning of taking Ramigamma or increasing the dose;
Fainting, hypotension (abnormally low blood pressure), especially when you stand up from a lying or sitting position;
Dry tickly cough, inflammation of the sinuses (sinusitis) or bronchitis, shortness of breath;
Stomach or gut pain, diarrhea, indigestion, nausea or vomiting;
Skin rash with or without swelling;
Chest pain;
Cramps or muscle pain;
Laboratory studies showing increased levels of potassium in the blood.
Uncommon (affects less than 1 in 100 patients):
Balance disorders (vertigo);
Itching and unusual skin sensations such as numbness, tingling, pricking, burning or creeping on your skin (paraesthesia);
Loss or change in taste;
Sleep problems;
Feeling depressed, anxious, more nervous than usual or anxiety;
Stuffy nose, difficulty breathing or worsening of asthma;
Swelling in your gut called "intestinal angioedema" presenting with symptoms like abdominal pain, vomiting and diarrhea;
Heartburn, constipation or dry mouth;
Passing more urine than usual for the day;
More abundant than usual sweating;
Loss or reduction of appetite (anorexia);
Fast or irregular heartbeat. Swelling of the hands and feet. This may be a sign of retaining more fluid in the body;
Flushing;
Blurred vision;
Joint pain;
Fever;
Sexual inability in men, reduced sexual desire in men or women;
Increased number of certain white blood cells (eosinophilia), detected in laboratory tests;
Laboratory tests showing changes in the function of the liver, pancreas or kidneys.
Rare (affects less than 1 in 1000 patients):
Feelings of uncertainty or confusion;
Red and swollen tongue;
Flaking or peeling of large areas of the skin, itchy, bumpy rash;
Nail problems (eg loosening or detachment of the nail from the nail bed);
Skin rash or bruising;
Spots on the skin and cold extremities;
Red, itchy, swollen or watery eyes;
Impaired hearing or ringing in the ears;
A feeling of weakness;
Laboratory studies showing a reduction in red blood cells, white blood cells or platelets or the amount of hemoglobin.
Very rare (occurring in 1 in 10,000 patients):
More sensitive to sunlight than usual.
Other reported side effects
Please tell your doctor if any of the following gets serious or lasts longer than a few days.
Poor concentration;
Swollen mouth;
Laboratory tests showing too few blood cells in the blood;
Laboratory tests show less than normal amount of sodium in the blood;
Discoloration of the fingers and toes when you are cold and then tingling or painful when you warm up (Raynaud's phenomenon);
Breast enlargement in men;
Slowed or impaired reactions;
Burning sensation;
Change in smell;
Hair loss.
If you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE RAMIGAMMA
Keep out of reach of children.
Do not store above 25 ° C.
Do not use the medicinal product after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. ADDITIONAL INFORMATION
What Ramigamma
Active substance: ramipril.
Each tablet contains 10 mg of ramipril.
The other ingredients are: sodium bicarbonate, lactose monohydrate, croscarmellose sodium, corn starch, pregelatinized, sodium stearyl fumarate.

How Ramigamma tablets look like and contents of the pack
Pack sizes: 10, 14, 20, 28, 30, 42, 50, 98 and 100 tablets in aluminum / aluminum blisters.
Not all pack sizes may be marketed.