Tritace Plus 10 mg. /12.5 mg. 30 tablets

WHAT Tritace Plus AND WHAT IT IS USED
Tritace Plus is a combination of two medicines called ramipril and hydrochlorothiazide.
Ramipril belongs to a group of medicines called "ACE inhibitors" (Angiotensin Converting Enzyme). It acts as:
Reduces your body's production substances that can raise blood pressure;
It helps to relax and widen your blood vessels;
Helps the heart easier to pump blood around your body.
Hydrochlorothiazide belongs to a group of medicines called "thiazide diuretics" or water tablets. It works by increasing the amount of urine you produce. This lowers your blood pressure.
Triteys Plus is used to treat high blood pressure. The two active substances work together to lower your blood pressure. They are used together when treatment with just one of the two is not enough.

2. BEFORE YOU TAKE Tritace Plus
Do not take Tritace Plus
if you are allergic (hypersensitive) to ramipril, hydrochlorothiazide or any of the other ingredients of Triteys Plus (see section 6).;
if you are allergic (hypersensitive) to medicines similar to Triteys Plus (other ACE inhibitors or sulphonamide derived medicines). Signs of an allergic reaction may include rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue;
if you have ever had a serious allergic reaction called "angioodem." 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 Plus may not be suitable for you;
if you have liver problems;
If the quantity of salts (calcium, potassium, sodium) in your blood is abnormal;
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 you are breastfeeding (see. section below on "Pregnancy and lactation").
Do not take Triteys Plus if any of the above, the following apply to you. If you're not sure, ask your doctor before taking Triteys Plus.

Take special care with Tritace Plus
Ask your doctor or pharmacist before taking your medicine:
if you have heart problems;
if you lost a lot of body salts or fluids (through vomiting, diarrhea, sweating more offensive than usual, if you are on a diet low in salt; if you are taking diuretics (water tablets) or 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. It may need to stop treatment with Triteys plus 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. Triteys Plus 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").
Children and adolescents
Trteys Plus is not recommended in children and adolescents under 18 years of age, 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 Trnteys Plus.

Taking Triteys Plus with other drugs
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). Triteys Plus can affect the operation of some other medicines. And some medicines can affect the way of Triteys Plus.

Please ask your doctor if you are taking any of these medicines. They may weaken the effect of Tritace Plus
Drugs used to relieve pain and inflammation (eg non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or indometacin 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 Triteys Plus:
Drugs used to relieve pain and inflammation (e.g. NSAIDs (NSAIDs) such as ibuprofen or indomethacin, and aspirin);
Drugs that may decrease the amount of potassium in the blood. These include medicines for constipation, diuretics (water tablets, amphotericin B (used for fungal infections) and ACTH (used to test the function of the adrenal glands);
Medicines for cancer treatment (chemotherapy);
Medicines for heart problems, including heart palpitations;
Drugs used to prevent organ rejection after a transplant such as ciclosporin;
Diuretics (water pills) such as furosemide;
Drugs that can increase the amount of potassium in your blood such as spironolaktok, triamterene, amiloride, potassium salts and heparin (blood thinning);
Steroid medicines for inflammation such as prednisolone;
Calcium supplements;
Allopurinol (used to lower the uric acid in the blood);
Procainamide (for heart rhythm disturbances);
Cholestyramine (to reduce the amount of fat in the body);
Carbamazepine (for epilepsy).
Please tell your doctor if you are taking any of these medicines. They can be influenced by Triteys Plus:
Medicines for diabetes, blood sugar, which is taken orally and insulin. Triteys Plus can lower your blood sugar. Check your blood sugar closely while taking Triteys Plus;
Lithium (for mental health problems). Triteys Plus can increase the amount of lithium in your blood. The amount of lithium should be closely monitored by your doctor;
Medications to relax the muscles;
Quinine (for malaria);
Medicines that contain iodine, they can be used in a hospital in a scan or X-ray;
Penicillin (for infections);
Medication to thin the blood that you take by mouth (oral anticoagulants) such as warfarin.
If any of the above applies to you (or are not sure), talk to your doctor before taking Triteys Plus.

Research
Consult your doctor or pharmacist before taking this medicine.
If you will be a test for parathyroid function Triteys Plus can affect the results of this study;
If you are an athlete and an anti-doping tests Triteys Plus can give a positive result.
Taking Triteys Plus with food and drink
Drinking alcohol with Triteys Plus can cause dizziness and fainting. If you take Triteys plus discuss with your doctor how much you can drink as drugs used to lower blood pressure and alcohol can have additive effects;
Triteys Plus 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 Triteys Plus 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 Triteys Plus, tell your doctor. It must be implemented switch to a suitable alternative treatment of a planned pregnancy.
You should not take Triteys Plus if you are breastfeeding.
Ask your doctor or pharmacist before taking any medicine.

Driving and using machines
Some side effects (eg. The symptoms of low blood pressure such as dizziness) may impair the ability to concentrate and react. This leads to a risk in situations where these abilities are of special importance (driving or operating machinery). You may feel dizzy while taking Triteys Plus. More likely is that to happen at the beginning of treatment Triteys Plus 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 Plus
Always take Triteys Plus exactly as you have been told by your doctor. If you're not sure, ask your doctor or pharmacist.

Taking this medicine:
Take this medicine by mouth at the same time each day, usually in the morning;
Swallow the tablets with liquid;
Do not crush or chew the tablets.
How much to take
Treatment of high blood
Your doctor will adjust the amount you take until your blood pressure is controlled.

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

If you take more dose Tritace Plus
Talk to your doctor or go immediately to the nearest hospital ward. 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 Plus
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 Plus can cause side effects, although not everybody gets them.
Stop taking Triteys Plus 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 Triteys Plus;
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 acre, if you get:
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, cough, fever lasting two to three days and decreased appetite. These may be signs of lung problems including inflammation;
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, feeling faint, dizzy or having pale skin. These can be signs of problems with the blood or bone marrow;
Acute 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 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, feeling of weakness or fatigue;
Feeling dizzy. More likely to happen when you start taking Triteys Plus or increasing the dose;
Dry tickly cough or bronchitis;
Blood tests showing a greater amount of sugar in the blood than normal. If you have diabetes, it may worsen your condition;
Blood tests showing a larger amount of uric acid or a greater amount of fat than usual in the blood;
Painful, red and swollen joints.
Uncommon (affects less than 1 in 100 people):
Skin rash with or without swelling;
Flushing, fainting, hypotension (abnormally low blood pressure), especially when you stand up from a lying or sitting position;
Balance disorders (vertigo);
Itching and unusual skin sensations such as numbness, tingling, pricking, burning or crawling skin (paresthesia);
Loss or change in sense of taste;
Sleep problems;
Feeling depressed, anxious, more nervous or shaky than usual;
Clogged moose, inflammation of the sinuses (sinusitis), shortness of breath;
Inflammation of the gums (gingivitis), swollen mouth;
Red, itchy, swollen or watery eyes;
Noise in the ears;
Blurred vision;
Hair loss;
Chest pain;
Muscle aches;
Constipation, stomach or intestinal pain;
Indigestion or nausea;
Passing more urine than usual for the day;
More sweating more than usual or thirst;
Loss or decrease of appetite (anorexia), less hunger;
Fast or irregular heartbeat;
Swelling of the hands and feet. This is a sign to retain more fluid in the body;
Fever;
Sexual inability in men;
Blood tests showing a reduction in red blood cells, white blood cells or platelets or amount of hemoglobin;
Blood tests showing changes in the function of the liver, pancreas or kidneys;
Blood tests showing less than normal amount of potassium in the blood.
Very rare (affects less than 1 in 10,000 people):
Nausea, diarrhea, or heartburn;
Red swollen tongue or dry mouth;
Blood tests showing more than normal amount of potassium in the blood.
Other reported side effects:
Please tell your doctor if any of these side effects become severe or last longer than a few days:
Difficulty concentrating, anxiety or confusion;
Discoloration of the fingers and toes when you are cold and then tingling or painful when you warm up. This could be Raynaud's phenomenon;
Breast enlargement in men;
Blood clots;
Impaired hearing;
Less than normal eyes watering;
Seeing objects in yellow;
Dehydration;
Swelling, pain and redness in your cheek (inflammation of the salivary gland);
Swelling in your gut called "intestinal angioedema" presenting with symptoms like abdominal pain, vomiting and diarrhea;
More sensitive to sunlight than usual;
Severe flaking or peeling of the skin, itchy, bumpy rash or other skin reactions such as red rash on your face or forehead;
Skin rash or bruising;
Spots on the skin and cold extremities;
Nail problems (eg loss or separation of the nail from the nail bed);
Musculoskeletal stiffness or inability to move your jaw (tetany)
Weakness or numbness of the muscles;
Reduced sexual desire in men or women;
Blood in the urine. This may be a sign of a kidney problem (interstitial nephritis);
A large amount of sugar in the urine;
Increased number of certain white blood cells (eosinophilia), detected in blood tests;
Blood tests showing too few blood cells in the blood (pancytopenia);
Blood tests showing changes in the amount of salts such as sodium, calcium, magnesium and chloride in the blood;
Slowed or impaired reactions;
Changes in sense of smell;
Difficulty breathing or worsening of asthma.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE TRITEYS PLUS
Keep out of reach of children.
Do not use Triteys Plus after the expiry date stated on the carton and blister after "EXP". 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 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 Tritace Plus
The active substances are ramipril and hydrochlorothiazide.
Each tablet contains 10 mg of ramipril and 25 mg of hydrochlorothiazide.
The other ingredients are hypromellose 5mPa.sa, pregelatinised maize starch, microcrystalline cellulose, sodium stearyl fumarate, ferric oxide red (E172).

Tritace Plus looks like and contents of the pack
Pink, oblong tablets with dimensions of 10 mm x 5.6 mm, engraved with "39 / AV" on one side, scored on both sides. Delitepnata feature is designed to facilitate breaking the tablet for ease of swallowing and not to divide equal doses.
Triteys Plus 10 mg / 25 mg is available in pack sizes of 10, 14, 28, 30, 56, 60 and 100 tablets in white opaque PVC / Aluminium blisters.