Tritace 10 mg. 28 tablets
Tritace contains a medicine called ramipril. It belongs to a group of medicines called ACE inhibitors (angiotensin converting enzyme).
Tritace works by:
Reduces your body's production substances that may increase blood pressure;
Helps to relax and widen your blood vessels;
Helps the heart to pump blood around your body.
Tritace can be used:
For the treatment of high blood pressure (hypertension);
To reduce the risk of having 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 YOU TAKE Tritace
Do not take Tritace
if you are allergic (hypersensitive) to ramipril or any other medicine - an ACE inhibitor or any of the other ingredients of Tritace, 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 equipment, Tritace 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 lactation");
If your blood pressure is abnormally low or unstable. Your doctor needs to make that assessment.
Do not take Tritace if any of the above applies to you. If you are not sure, ask your doctor before taking Tritace.
Take special care with Tritace
Ask your doctor or pharmacist before taking your medicine:
if you have heart problems, liver or kidney;
If you have lost a lot of body salts or fluids (through vomiting, diarrhea, sweating more than usual, if you are on a diet low in salt, taking diuretics (water tablets) for a long time or having had dialysis);
If you are going to have treatment to reduce your allergy to stings from bees or wasps (desensitization);
If you are going to receive an anesthetic. It can be given for an operation or dental work. You may need to stop treatment with Tritace one day earlier - ask your doctor for advice;
If you have high amounts of potassium in your blood (shown in the results of blood tests);
If you have collagen vascular disease such as scleroderma or systemic lupus erythematosus;
you should tell your doctor if you think you are (or might become) pregnant. Tritace is 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").
Tritace is not recommended for use in children and adolescents under the age of 18, because the drug has never been used in this age group.
If any of the above applies to you (or are not sure), talk to your doctor before taking Tritace.
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). Tritace can affect the operation of some other medicines. And some medicines can affect the way of Tritace.
Please ask your doctor if you are taking any of these medicines. They may weaken the effect of Tritace:
Drugs used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin and aspirin);
Medicines 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 with Tritace:
Drugs used to relieve pain and inflammation [for example, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indomethacin, and aspirin];
Medicines to treat cancer (chemotherapy);
Medicines used to prevent organ rejection after transplantation, for example cyclosporin;
Diuretics (water pills) such as furosemide;
Drugs that can increase the amount of potassium in the blood, such as spironolactone, triamterene, amiloride, potassium salts and heparin (for thinning the 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 these medicines. They can be influenced by Tritace:
Medicines for diabetes, blood sugar, which is taken orally, and insulin. Tritace can lower your blood sugar. Check your blood sugar closely while taking Tritace;
Lithium (for mental health problems). Tritace 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 Tritace.
Taking Tritace with food and drink
Drinking alcohol with Tritace can cause dizziness and fainting. If you are taking Tritace, discuss with your doctor how much you can drink as drugs used to lower blood pressure and alcohol can have additive effects.
Tritace can be taken with or without food.
Pregnancy and lactation
You should tell your doctor if you think you are (or might become) pregnant. You should not take Tritace in 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 Tritace, tell your doctor. Advance must be made switch to a suitable alternative treatment of a planned pregnancy.
You should not take Tritace if you are breastfeeding.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
You may feel dizzy while taking Tritace. More likely is that to happen at the beginning of treatment with Tritace or if you start taking a higher dose. If this happens, do not drive or use any tools or machines.
3. HOW TO TAKE Tritace
Always take Tritace exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
Taking the medicine
Take this medicine by mouth at the same time each day;
Swallow the tablets 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 dose until your blood pressure is not 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 Tritace.
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, the twice daily regimen.
Treatment after you have had a heart attack:
The usual initial 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, the twice daily regimen.
Your doctor will reduce the initial dose and adjust your treatment more slowly.
If you take more dose Tritace
Contact your doctor immediately or go to the nearest hospital casualty 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 Tritace
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, Tritace can cause side effects, although not everybody gets them.
Stop taking Tritace 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 Tritace;
Severe skin reactions including rash, ulcers in your mouth, worsening of pre-existing skin disease, reddening, blistering or peeling of the skin (eg. Stevens-Johnson, toxic epidermal necrolysis and erythema multiforme).
Immediately contact a doctor if you experience:
Increased 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;
At easy bruising, prolonged bleeding, any bleeding (eg bleeding from the gums), purple spots blotching on the skin; easier susceptibility to infection, sore throat and fever, feeling tired, dizzy or having pale skin. These may be signs of problems with blood or bone marrow;
Severe stomach pain, 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 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 people):
Headache or tiredness;
Feeling dizzy. More likely to happen when you start taking Tritace 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;
Cramps or muscle pain;
Blood test showing increased levels of potassium in the blood.
Uncommon (affects less than 1 in 100 people):
Itching and unusual skin sensations such as, numbness, tingling, pricking, burning or creeping on your skin (paraesthesia);
Loss or change of taste;
Feeling depressed, anxious, more nervous or shaky than usual;
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 heart rate. Swelling of the hands and feet. This may indicate to retain more liquids to the body;
Sexual inability in men, reduced sexual desire in men or women;
An increased number of certain white blood cells (eosinophilia), detected in blood tests;
Blood tests showing changes in the function of the liver, pancreas or kidneys.
Rare (affects less than 1 in 1000 people):
Sense of uncertainty or confusion;
Red and swollen tongue;
Severe flaking or peeling of the skin, itchy, bumpy rash;
Nail problems (eg loosening or separation 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;
Blood tests showing a decrease in the number of red blood cells, white blood cells or platelets or the amount of hemoglobin.
Very rare (affects 1 in 10,000 people):
More sensitive to sunlight than usual.
Other reported side effects
Please tell your doctor if any of the following gets serious or lasts more than a few days.
Blood tests showing too few blood cells in the blood;
Blood tests showing less than usual 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;
Change in sense of smell;
If you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE Tritace
Keep out of the reach and sight of children.
Tritace not use after the expiry date stated on the carton, blister and bottles. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions. 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
The active substance is ramipril. Each tablet contains 10 mg.
The other ingredients of the tablets are as follows:
pregelatinised maize starch;