Tritace 2,5 comb

Leaflet accompanying the packaging: information for the user

Tritace 2.5 comb, 2.5 mg + 12.5 mg, tablets

Tritace 5 comb, 5 mg + 25 mg, tablets

Ramipril + Hydrochlorothiazide

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

You should keep this leaflet, so that you can read it again if you need to.
In case of any doubts, you should consult a doctor or pharmacist.
This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Tritace comb and what is it used for
• 2. Important information before taking Tritace comb
• 3. How to take Tritace comb
• 4. Possible side effects
• 5. How to store Tritace comb
• 6. Contents of the packaging and other information

1. What is Tritace comb and what is it used for

Tritace comb is a combination of two medicines, called ramipril and hydrochlorothiazide.
Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors). The way ramipril works:

• reduces the production of substances in the body that increase blood pressure,
• reduces tension and widens blood vessels,
• makes it easier for the heart to pump blood throughout the body.

Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics or "water pills". It works by increasing the amount of water excreted (increasing the amount of urine) and thus lowering blood pressure.
Tritace comb is used to treat high blood pressure. The two active substances work together to lower blood pressure. They are used together if treatment with only one medicine does not produce a beneficial effect.

2. Important information before taking Tritace comb

When not to take Tritace comb:

• If the patient is allergic to ramipril, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic to medicines similar to Tritace comb (other ACE inhibitors or sulfonamide derivatives).
• Symptoms of an allergic reaction may include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• If the patient has ever had a severe allergic reaction called "angioedema". Its symptoms include: itching, hives, red spots on the palms, soles and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.
• If the patient has taken or is taking sacubitril in combination with valsartan, a medicine used to treat chronic (long-term) heart failure in adults.
• If the patient is undergoing dialysis or blood filtration of another type. Depending on the type of device used, Tritace comb may not be a suitable medicine.
• If the patient has severe liver function disorders.
• If the patient has abnormal levels of substances such as calcium, potassium, sodium in the blood.
• If the patient has kidney disease related to reduced blood flow to the kidney (renal artery stenosis).
• During the last 6 months of pregnancy(see "Pregnancy and breastfeeding").
• During breastfeeding (see "Pregnancy and breastfeeding").
• If the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to the patient, they should not take Tritace comb.
In case of doubts related to the use of the medicine, the patient should consult a doctor before starting to take Tritace comb.

Warnings and precautions

Before starting to take Tritace comb, the patient should discuss it with their doctor or pharmacist.

• If the patient has heart, liver or kidney disease.
• If the patient has recently lost a significant amount of electrolytes or fluids (through vomiting, diarrhea, excessive sweating, taking a low-sodium diet, taking diuretics for a long time, or dialysis).
• If the patient is to undergo desensitization treatment to reduce allergic reactions to bee or wasp stings.
• If the patient is to receive medicines used in anesthesia. They may be used during surgical or dental procedures. It may be necessary to stop taking Tritace comb on the day before the procedure, in case of doubts, the patient should consult their doctor.
• If the patient has high levels of potassium in the blood (in blood test results).
• If the patient is taking medicines or has conditions that may lower sodium levels in the blood. The doctor may prescribe regular blood tests, in particular to check sodium levels in the blood, especially in elderly patients.
• If the patient is taking medicines that may increase the risk of angioedema (severe allergic reaction), such as mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus), vildagliptin, neprilysin inhibitors (NEP) (such as racecadotril) or sacubitril in combination with valsartan (sacubitril with valsartan - see section 2 "When not to take Tritace comb").
• If the patient has had breathing or lung problems in the past after taking hydrochlorothiazide (including pneumonia or fluid accumulation in the lungs). If the patient experiences severe shortness of breath or difficulty breathing after taking Tritace comb, they should seek medical help immediately.
• If the patient has collagenosis, such as scleroderma or systemic lupus erythematosus.
• The patient should tell their doctor about pregnancy, suspected pregnancy or planned pregnancy. It is not recommended to take Tritace comb during the first 12 weeks of pregnancy. It is not recommended to take this medicine from the 13th week of pregnancy, as it may harm the baby. If the patient becomes pregnant while taking Tritace comb, they should tell their doctor immediately. A change in treatment is recommended before planned pregnancy.
  Breastfeeding
  Tritace comb should not be taken during breastfeeding.
  Before taking any medicine, the patient should consult their doctor or pharmacist.

  Children and adolescents

  Tritace comb should not be used in children and adolescents under 18 years of age due to lack of information on the use of the medicine in this group of patients.
  If any of the above situations apply (or if there are any doubts), the patient should consult their doctor before starting to take Tritace comb.

  Tritace comb and other medicines

  The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Tritace comb may affect the action of other medicines, and other medicines may affect the action of Tritace comb.
  The patient should tell their doctor about taking the following medicines. They may reduce the effect of Tritace comb:

  • Pain-relieving and anti-inflammatory medicines (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, and aspirin),
  • Medicines used to treat low blood pressure, shock, heart failure, asthma or allergies, such as ephedrine, noradrenaline or adrenaline. The doctor will check the patient's blood pressure.

  The patient should tell their doctor about taking the following medicines. They may increase the risk of side effects when used with Tritace comb:

  • sacubitril in combination with valsartan - used to treat chronic (long-term) heart failure in adults (see section 2 "When not to take Tritace comb");
  • pain-relieving and anti-inflammatory medicines (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, and aspirin);
  • medicines that may lower potassium levels in the blood. These include medicines used to treat constipation, diuretics, amphotericin B (used to treat fungal infections) and ACTH (a hormone given in a test to assess whether the adrenal glands are working properly);
  • medicines used to treat cancer (chemotherapy);
  • medicines used to treat heart conditions, including rhythm disorders;
  • medicines used to prevent transplant rejection, such as cyclosporine;
  • diuretics, such as furosemide;
  • medicines that increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim used alone or in combination with sulfamethoxazole (used to treat bacterial infections), and heparin (a blood-thinning medicine);
  • corticosteroid anti-inflammatory medicines, such as prednisolone;
  • calcium preparations;
  • allopurinol (used to reduce uric acid levels in the blood);
  • procainamide (used to treat rhythm disorders);
  • cholestyramine (used to reduce blood lipid levels);
  • carbamazepine (used to treat epilepsy);
  • heparin (used to thin the blood);
  • temsirolimus (used to treat cancer);
  • sirolimus, everolimus (used to prevent transplant rejection);
  • vildagliptin (used to treat type 2 diabetes);
  • racecadotril (used to treat diarrhea);
  • the doctor may prescribe a change in dose and/or take other precautions if the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also subsections "When not to take Tritace comb" and "Warnings and precautions").

  The patient should tell their doctor about taking the following medicines. Their action may be changed when used with Tritace comb:

  • antidiabetic medicines, such as oral medicines that lower blood glucose levels and insulin. Tritace comb may lower blood glucose levels. When taking Tritace comb, the patient should regularly check their blood glucose levels;
  • lithium (used to treat mental illnesses). Tritace comb may increase lithium levels in the blood. The doctor will prescribe regular checks of lithium levels in the blood;
  • muscle relaxants;
  • quinine (used to treat malaria);
  • iodine-containing medicines: they may be used in X-ray examinations - traditional and during computed tomography in the hospital;
  • penicillin (used to treat infections);
  • oral anticoagulants, such as warfarin.

  If any of the above conditions apply to the patient (or if the patient has any doubts), they should consult their doctor before starting to take Tritace comb.

  Tests

  Before taking this medicine, the patient should consult their doctor or pharmacist if:

  • they are scheduled to undergo a test to assess parathyroid function. Tritace comb may affect the test results;
  • they are an athlete and may be subject to a doping test. Tritace comb may cause a positive test result.

  Tritace comb with food and drink

  • Drinking alcohol while taking Tritace comb may cause dizziness and drowsiness. In case of doubts about the amount of alcohol allowed while taking Tritace comb, the patient should discuss with their doctor the possibility of combining the effects of blood pressure-lowering medicines and alcohol.
  • Tritace comb can be taken with or without food.

  Pregnancy and breastfeeding

  Pregnancy
  If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a baby, they should consult their doctor before taking this medicine. Tritace comb should not be taken during the first 12 weeks of pregnancy. It should not be taken from the 13th week of pregnancy, as it may harm the baby. If the patient becomes pregnant while taking Tritace comb, they should tell their doctor immediately. A change in treatment is recommended before planned pregnancy.
  Breastfeeding
  Tritace comb should not be taken during breastfeeding.
  Before taking any medicine, the patient should consult their doctor or pharmacist.

  Driving and using machines

  While taking Tritace comb, the patient may experience dizziness. The risk of dizziness is higher at the beginning of treatment with Tritace comb and after increasing the dose. If the patient experiences dizziness, they should not drive vehicles, use tools, or operate machines.

  3. How to take Tritace comb

  This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

  Dosage

  Treatment of high blood pressure
  The doctor will adjust the dose until the desired blood pressure control is achieved.
  Elderly patients
  The doctor will prescribe a lower than usual initial dose, which will then be gradually increased.

  Taking the medicine

  • This medicine should be taken orally, once a day, at the same time, preferably in the morning.
  • The tablets should be swallowed with a liquid.
  • The tablets should not be crushed or chewed.

  Taking a higher than recommended dose of Tritace comb

  If the patient takes a higher dose of Tritace comb than recommended, they should consult their doctor or go to the nearest hospital emergency department. They should not drive a vehicle themselves, but ask someone to drive them to the hospital or call an ambulance.
  They should take the medicine packaging with them, so that the doctor knows what medicine has been taken.

  Missing a dose of Tritace comb

  • In case of a missed dose, the patient should take the next dose at the usual time.
  • The patient should not take a double dose to make up for the missed dose.

  In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

  4. Possible side effects

  Like all medicines, this medicine can cause side effects, although not everybody gets them.

  If the patient notices any of the following side effects, they should stop taking Tritace comb and consult their doctor immediately – they may need urgent medical attention:

  • Swelling of the face, lips or throat, making it difficult to swallow or breathe, as well as itching and rash. These may be symptoms of a severe allergic reaction to Tritace comb.
  • Severe skin changes, including rash, ulcers in the mouth, worsening of existing skin conditions, redness, blistering or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

  If the patient experiences any of the following, they should tell their doctor immediately:

  • Increased heart rate, irregular or stronger heartbeat (palpitations), chest pain, feeling of pressure in the chest or more severe circulatory disorders, including heart attack or stroke.
  • Shortness of breath, cough or fever lasting 2 to 3 days and decreased appetite. These may be symptoms of respiratory disorders, including pneumonia.
  • Easy bruising, longer than usual bleeding time, any signs of bleeding (e.g. bleeding from the gums), purplish spots on the skin or more frequent infections, sore throat and fever, fatigue, weakness, dizziness or paleness of the skin. These may indicate blood or bone marrow disorders.
  • Severe abdominal pain, which may radiate to the back. This may be a symptom of pancreatitis.
  • Fever, chills, weakness, loss of appetite, abdominal pain, nausea, yellowing of the skin or eyes (jaundice). These may be symptoms of liver disease, such as hepatitis or liver damage.
  • Severe eye pain, blurred vision or seeing halos around lights, headache, excessive tearing and nausea and vomiting, which may be symptoms of a condition called glaucoma; vision loss, myopia.

  Other side effects:

  The patient should tell their doctor if any of the following symptoms worsen or persist for more than a few days.
  Common(may affect up to 1 in 10 people)

  • headache, feeling of weakness and fatigue,
  • dizziness. This occurs more frequently at the beginning of treatment with Tritace comb or after increasing the dose,
  • dry, irritating cough or bronchitis,
  • blood tests show higher than usual glucose levels. In patients with diabetes, the disease may worsen,
  • blood tests show higher than usual levels of uric acid or lipids (fats),
  • joint pain, redness and swelling.

  Uncommon(may affect up to 1 in 100 people)

  • rash with or without hives,
  • sudden redness of the face and neck, fainting, low blood pressure (abnormally low blood pressure),
  • difficulty balancing (dizziness),
  • itching and abnormal skin sensations, such as numbness, tingling, prickling, burning or tingling (paresthesia),
  • loss or change of taste,
  • sleep disorders,
  • depression, anxiety or increased nervousness or irritability,
  • stuffy nose, sinusitis, shortness of breath,
  • gingivitis, swelling of the lips,
  • redness, itching or tearing of the eyes, swelling of the eyelids,
  • ringing in the ears,
  • blurred vision,
  • hair loss,
  • chest pain,
  • muscle pain,
  • constipation, abdominal pain or discomfort,
  • nausea or vomiting,
  • increased urination or thirst,
  • loss or decreased appetite (anorexia), decreased hunger,
  • rapid or irregular heartbeat,
  • swelling of the hands and feet, which may be a sign of excessive water retention in the body,
  • fever,
  • decreased sexual potency in men,
  • blood tests show a decrease in the number of red blood cells, white blood cells or platelets and a decrease in hemoglobin levels,
  • blood tests show changes indicating liver, pancreas or kidney function disorders,
  • blood tests show a decrease in potassium levels. Rare(may affect up to 1 in 1,000 people)
  • nausea, diarrhea or heartburn,
  • redness and swelling of the tongue or dryness of the mouth,
  • blood tests show an increase in potassium levels,
  • acute respiratory failure (symptoms include severe shortness of breath, fever, weakness and confusion).

  Other reported side effects:

  If any of the following symptoms worsen or persist for more than a few days, the patient should tell their doctor.

  • difficulty concentrating, anxiety or confusion,
  • change in skin color of the fingers and toes after cooling and a feeling of tingling and pain. This may be a symptom of Raynaud's disease,
  • breast enlargement in men,
  • blood clots,
  • hearing disorders,
  • reduced tear production,
  • yellow vision,
  • dehydration,
  • swelling, pain and redness of the cheek (parotitis),
  • intestinal swelling, called "angioedema of the intestine", which can cause symptoms such as abdominal pain, vomiting and diarrhea,
  • increased sensitivity to sunlight,
  • intensive skin peeling, itchy rash or other skin reactions, such as red rash on the face or forehead,
  • rash or bruising,
  • spots on the skin and cold limbs,
  • changes in the nails (e.g. loosening or separation of the nail from the nail bed),
  • stiffness or inability to move the lower jaw (trismus),
  • muscle weakness or cramps,
  • decreased sexual potency in men and women,
  • presence of blood in the urine (hematuria). This may be a symptom of kidney disease (interstitial nephritis),
  • sugar in the urine (glycosuria),
  • blood tests show an increased number of a certain type of white blood cell (eosinophilia),
  • blood tests show a decrease in the number of blood cells (pancytopenia),
  • change in the levels of salt ions in the blood, such as sodium, calcium, magnesium and chlorides,
  • concentrated urine (dark in color), nausea or vomiting, muscle cramps, confusion and seizures, which may be due to abnormal secretion of ADH (antidiuretic hormone). If the patient experiences any of the above symptoms, they should consult their doctor immediately,
  • slowed or disturbed reflexes,
  • change in the sense of smell,
  • difficulty breathing or worsening of asthma,
  • malignant skin and lip tumors (non-melanoma skin cancer).

  Reporting side effects

  If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist or nurse.
  Side effects can be reported directly to the
  Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
  Jerozolimskie Avenue 181 C

  • 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder or its representative in Poland.

  Reporting side effects will help to gather more information on the safety of the medicine.

  5. How to store Tritace comb

  The medicine should be stored out of sight and reach of children.
  Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month stated.
  There are no special precautions for storing the medicine.
  Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

  6. Contents of the packaging and other information

  What Tritace comb contains

  The active substances of the medicine are ramipril and hydrochlorothiazide.
  Tritace 2.5 comb: each tablet contains 2.5 mg of ramipril and 12.5 mg of hydrochlorothiazide.
  Tritace 5 comb: each tablet contains 5 mg of ramipril and 25 mg of hydrochlorothiazide.
  The other ingredients are: hypromellose, modified cornstarch, microcrystalline cellulose, sodium stearylfumarate.

  What Tritace comb looks like and contents of the pack

  Tritace 2.5 comb: the tablets are white or almost white, oblong, scored, 8 x 4.4 mm in size, with the inscription "HNV" and "company logo" on both sides. The tablet can be divided into equal doses.
  Tritace 2.5 comb tablets are packaged in packs containing 28 tablets in PVC/Aluminum blisters.
  Tritace 5 comb: the tablets are white or almost white, oblong, scored, 10 x 5.6 mm in size, with the inscription "HNW" and "company logo" on both sides. The tablet can be divided into equal doses.
  Tritace 5 comb tablets are packaged in packs containing 28 tablets in PVC/Aluminum blisters.
  Not all pack sizes may be marketed.

  Marketing authorization holder

  Sanofi-Aventis Deutschland GmbH
  Brüningstrasse 50

  • D-65926 Frankfurt am Main, Germany

  Manufacturer / Importer

  Sanofi S.r.l.
  Strada Statale 17, Km 22
  67019 Scoppito (L'Aquila)
  Italy
  S.C. ZENTIVA S.A.,
  B-dul Theodor Pallady nr. 50, Sector 3,
  Bucharest, 032266 – Romania
  Sanofi Aventis Deutschland GmbH
  Industriepark Höechst Brüningstrasse 50
  D-65926 Frankfurt am Main
  Germany

  To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, the patient should contact the representative of the marketing authorization holder in Poland:

  Sanofi Sp. z o.o.
  ul. Marcina Kasprzaka 6
  01-211 Warsaw
  tel.: +48 22 280 00 00

  Date of last revision of the leaflet: