Tritace 5 comb

Package leaflet: Information for the user

Tritace 2.5 comb, 2.5 mg + 12.5 mg, tablets
Tritace 5 comb, 5 mg + 25 mg, tablets
Ramiprilum + Hydrochlorothiazidum
Please read this leaflet carefully before taking this medicine, because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Leaflet contents

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

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

Tritace comb is a combination of two medicines called ramipril and hydrochlorothiazide.
Ramipril belongs to a group of medicines known as 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 dilates blood vessels,
• helps the heart pump blood more easily.

Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics or "water tablets". It works by increasing the amount of water eliminated from the body (increases urine output), thereby lowering blood pressure.
Tritace comb is used in the treatment of high blood pressure (hypertension). The two active substances work together to lower blood pressure. They are used in combination when treatment with only one medicine does not produce the desired effect.

2. Important information before using Tritace comb

When not to use 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 experienced a severe allergic reaction called "angioedema". 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 is taking or has taken sacubitril in combination with valsartan, a medicine used to treat chronic (long-term) heart failure in adults.
• If the patient is undergoing dialysis or other types of blood filtration. Depending on the type of equipment used, Tritace comb may not be suitable.
• If the patient has severe liver dysfunction.
• If the patient has abnormal blood levels of substances such as calcium, potassium, or sodium.
• If the patient has kidney disease associated with reduced blood flow to the kidneys (renal artery stenosis).
• During the last 6 months of pregnancy (see section "Pregnancy and breastfeeding").
• During breastfeeding (see section "Pregnancy and breastfeeding").
• If the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply, Tritace comb must not be used.
If in doubt about using this medicine, consult a doctor before starting treatment with Tritace comb.
Warnings and precautions
Before starting Tritace comb, discuss this with your doctor or pharmacist if:

• The patient has heart, liver, or kidney disease.
• The patient has recently lost a significant amount of electrolytes or fluids (due to vomiting, diarrhoea, excessive sweating, a low-sodium diet, long-term use of diuretics [water tablets], or dialysis).
• The patient is due to undergo treatment to reduce allergic reactions to bee or wasp venom (desensitisation).
• The patient is scheduled to receive anaesthetic medicines. These may be used during surgical or dental procedures. It may be necessary to stop taking Tritace comb one day before the procedure; consult your doctor if in doubt.
• The patient has high potassium levels in the blood (as shown in blood tests).
• The patient is taking medicines or has conditions that may lower sodium levels in the blood. The doctor may recommend regular blood tests, particularly to check blood sodium levels, especially in elderly patients.
• 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 use Tritace comb").
• The patient has previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient develops severe shortness of breath or difficulty breathing after taking Tritace comb, seek immediate medical help.
• The patient has collagenosis, such as scleroderma or systemic lupus erythematosus.
• The patient is pregnant, suspects pregnancy, or plans to become pregnant. Use of Tritace comb is not recommended during the first 3 months of pregnancy, and after the third month of pregnancy, the medicine may severely harm the unborn child (see section below "Pregnancy and breastfeeding").
• The patient experiences vision disturbances or eye pain, especially if the patient is at risk of developing glaucoma or is allergic to penicillin or sulfonamide medicines.
• The patient is taking any of the following medicines used to treat high blood pressure:
  • An angiotensin II receptor antagonist (AIIRA), also known as a sartan – for example, valsartan, telmisartan, irbesartan – especially if the patient has kidney problems related to diabetes,
  • Aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also subsection "When not to use Tritace comb".
• The patient has previously had skin cancer or develops unexpected skin changes during treatment. Treatment with hydrochlorothiazide, especially in high doses over a long period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. While taking Tritace comb, protect the skin from sunlight and UV radiation.

Children and adolescents
Tritace comb is not recommended for use in children and adolescents under 18 years of age due to lack of data on safety and efficacy in this patient group.

If any of the above situations apply (or if there is any uncertainty), consult a doctor before starting Tritace comb.
Tritace comb and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use. Tritace comb may affect the action of other medicines, and other medicines may affect the action of Tritace comb.

Inform your doctor if you are taking the following medicines. These may reduce the effectiveness 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 monitor the patient's blood pressure.

Inform your doctor if you are taking the following medicines. These may increase the risk of adverse effects when used together with Tritace comb:

• Sacubitril in combination with valsartan – used to treat chronic (long-term) heart failure in adults (see section 2 "When not to use Tritace comb");
• Pain-relieving and anti-inflammatory medicines (e.g. non-steroidal anti-inflammatory drugs [NSAIDs], such as ibuprofen or indometacina, and aspirin);
• Medicines that may reduce potassium levels in the blood, including laxatives, diuretics (water tablets), amphotericin B (used in fungal infections), and ACTH (a hormone used in tests to assess adrenal gland function);
• Medicines used in cancer treatment (chemotherapy);
• Medicines used for heart conditions, including heart rhythm disorders;
• Medicines used to prevent organ transplant rejection, such as cyclosporine;
• Diuretics (water tablets), 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 for bacterial infections), and heparin (a blood-thinning medicine);
• Steroidal anti-inflammatory medicines, such as prednisolone;
• Calcium supplements;
• Allopurinol (used to reduce uric acid levels in the blood);
• Procainamide (used for heart rhythm disorders);
• Cholestyramine (reduces 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 diarrhoea);
• The doctor may adjust the dose and/or take additional precautions if the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also subsections "When not to use Tritace comb" and "Warnings and precautions").

Inform your doctor if you are taking the following medicines. Their effects may be altered when taking Tritace comb:

• Antidiabetic medicines, such as oral glucose-lowering agents and insulin. Tritace comb may lower blood glucose levels. Blood glucose levels should be monitored regularly during treatment with Tritace comb;
• Lithium (used for psychiatric disorders). Tritace comb may increase lithium levels in the blood. The doctor will monitor blood lithium levels;
• Medicines with muscle-relaxant effects;
• Quinine (used to treat malaria);
• Iodine-containing medicines: these may be used in X-ray examinations – conventional or during CT scans in hospital;
• Penicillin (used for infections);
• Oral anticoagulants (blood thinners), such as warfarin.

If any of the above conditions apply (or if there is any uncertainty), consult a doctor before starting Tritace comb.
Tests
Before using this medicine, consult your doctor or pharmacist if:

• The patient is scheduled for a test assessing parathyroid function. Tritace comb may affect test results;
• The patient is an athlete and may be subject to doping tests. Tritace comb may cause a positive test result.

Tritace comb with food and alcohol

• Drinking alcohol while taking Tritace comb may cause dizziness and lightheadedness. If in doubt about the amount of alcohol that may be consumed during treatment with Tritace comb, discuss with your doctor the potential additive 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, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine. Tritace comb should not be used during the first 12 weeks of pregnancy. This medicine must not be used from week 13 of pregnancy onwards, as it may harm the unborn child. If pregnancy occurs while taking Tritace comb, inform the doctor immediately. A change in treatment is recommended before planned pregnancy.
Breastfeeding
Tritace comb must not be used during breastfeeding.
Before taking any medicine, consult a doctor or pharmacist.
Driving and using machines
Dizziness may occur while taking Tritace comb. The risk of dizziness is higher at the beginning of treatment and after increasing the dose. If the patient experiences dizziness, driving, using tools, or operating machinery should be avoided.

3. How to use Tritace comb

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Dosage
Treatment of high blood pressure
Your doctor will adjust the dose until the appropriate blood pressure control is achieved.
Elderly patients
Your doctor will prescribe a lower than usual starting dose, which will then be gradually increased.
How to take the medicine

• This medicine should be taken orally, every day at the same time, preferably in the morning.
• Swallow the tablets whole with liquid.
• Do not crush or chew the tablets. Taking more than the recommended dose of Tritace comb If a patient takes more than the recommended dose of Tritace comb, contact a doctor or go to the nearest hospital emergency department immediately. Do not drive—ask someone to take you to the hospital or call an ambulance. Bring the medicine packaging with you so the doctor knows which medicine has been taken.

If you miss a dose of Tritace comb

• If you miss a dose, take the next dose at your usual time.
• Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient notices any of the following adverse reactions, treatment with Tritace 5 comb must be stopped immediately and the patient should contact a doctor without delay – urgent medical assistance may be required:

• Swelling of the face, lips, or throat causing difficulty in swallowing or breathing, together with itching and rash. These may be symptoms of a severe allergic reaction to Tritace 5 comb.
• Severe skin reactions, including rash, mouth ulcers, worsening of pre-existing skin disease, redness, blistering, or peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

If any of the following conditions occur, inform the doctor immediately:

• Rapid heartbeat, irregular or stronger heartbeat (palpitations), chest pain, feeling of chest tightness, or more severe circulatory disturbances, including myocardial infarction or stroke.
• Shortness of breath, cough, or fever lasting 2 to 3 days, and reduced appetite. These may be symptoms of respiratory disorders, including pneumonia.
• Easy bruising, prolonged bleeding time, any signs of bleeding (e.g. bleeding gums), purple skin spots, or increased frequency of infections, sore throat, fever, fatigue, weakness, dizziness, or pale skin. These may indicate blood or bone marrow disorders.
• Severe abdominal pain, possibly radiating to the back. These may be symptoms of pancreatitis.
• Fever, chills, weakness, loss of appetite, upper abdominal pain, nausea, yellowing of the skin or eyes (jaundice). These may be symptoms of liver disorders, such as hepatitis or liver damage.
• Severe eye pain, blurred vision, or seeing halos around lights, headache, excessive tearing, or nausea and vomiting, which may be symptoms of a condition called glaucoma; visual disturbances, short-sightedness, which may be a condition known as myopia.

Other adverse reactions:
Inform the doctor if any of the following symptoms worsen significantly or persist for more than a few days.
Common (may affect less than 1 in 10 patients)

• Headache, feeling of weakness and fatigue,
• Dizziness. These occur more frequently at the beginning of treatment with Tritace 5 comb or after dose increase,
• Dry, irritating cough or bronchitis,
• Blood tests show higher than normal glucose levels. In patients with diabetes, the condition may worsen,
• Blood tests show higher than normal levels of uric acid or fats (lipids),
• Pain, redness, and swelling of joints.

Uncommon (may affect less than 1 in 100 patients)

• Rash with or without raised lesions,
• Sudden flushing of the face and neck, fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting down quickly,
• Difficulty maintaining balance (dizziness),
• Itching and unusual skin sensations such as numbness, tingling, pricking, burning, or stinging (paresthesia),
• Loss or change in taste perception,
• Sleep disturbances,
• Low mood, anxiety, increased nervousness or irritability,
• Stuffy nose, sinusitis, shortness of breath,
• Gum inflammation, lip swelling,
• Redness, itching, or tearing of the eyes, eyelid swelling,
• Ringing in the ears,
• Blurred vision,
• Hair loss,
• Chest pain,
• Muscle pain,
• Constipation, upper abdominal pain or generalized abdominal pain,
• Indigestion or nausea,
• Passing larger than usual amounts of urine during the day,
• Increased sweating or thirst,
• Loss of or reduced appetite (anorexia), decreased hunger,
• Rapid or irregular heartbeat,
• Swelling of hands and feet, which may indicate greater than usual fluid retention,
• Fever,
• Reduced sexual ability in men,
• Blood tests: decreased number of red blood cells, white blood cells, or platelets, and decreased hemoglobin concentration,
• Blood tests showing abnormalities indicating impaired liver, pancreas, or kidney function,
• Blood tests showing decreased potassium levels.

Rare (may affect less than 1 in 10,000 patients)

• Nausea, diarrhea, or heartburn,
• Redness and swelling of the tongue or dry mouth,
• Blood tests showing increased potassium levels,
• Acute respiratory failure (symptoms include severe shortness of breath, fever, weakness, and confusion).

Other reported adverse reactions:
If any of the symptoms listed below worsen or persist for more than a few days, inform the doctor.

• Difficulty concentrating, restlessness, or confusion,
• Color change of fingers and toes upon cold exposure, together with tingling and pain. This may be a sign of Raynaud's phenomenon,
• Breast enlargement in men,
• Blood clots,
• Hearing disturbances,
• Reduced tear production,
• Yellow vision,
• Dehydration,
• Swelling, pain, and redness of the cheek (sialadenitis),
• Intestinal swelling, known as "angioedema of the intestine", causing symptoms such as abdominal pain, vomiting, and diarrhea,
• Increased sensitivity to sunlight,
• Intense skin peeling, itchy papular rash, or other skin reactions such as red rash on the face or forehead,
• Rash or bruising,
• Skin spots and cold extremities,
• Nail changes (e.g. loosening or separation of the nail from the nail bed),
• Musculoskeletal stiffness or inability to move the lower jaw (tetany),
• Muscle weakness or cramps,
• Reduced sexual drive in men and women,
• Presence of blood in the urine (hematuria). This may be a sign of kidney disease (interstitial nephritis),
• Sugar in the urine (glucosuria),
• Blood tests showing increased number of a certain type of white blood cells (eosinophilia),
• Blood tests showing low number of blood cells (pancytopenia),
• Changes in blood electrolyte levels, such as sodium, calcium, magnesium, and chloride,
• Concentrated urine (dark-colored), nausea or vomiting, muscle cramps, confusion, and seizures, which may result from inappropriate ADH secretion (antidiuretic hormone - vasopressin). If any of these symptoms occur, contact the treating physician immediately,
• Slowed or impaired reflexes,
• Changes in smell perception,
• Difficulty breathing or worsening of asthma,
• Malignant skin and lip tumors (non-melanoma skin cancers).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to
the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder or its representative in Poland.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tritace comb

Keep this medicine out of the 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 stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Tritace comb contains
The active substances in this 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 maize starch, microcrystalline cellulose, sodium stearyl fumarate.

What Tritace comb looks like and contents of the pack
Tritace 2.5 comb: tablets are white or almost white, elongated, divisible, measuring 8 x 4.4 mm, with the imprint "HNV" and "company logo" on both sides. The tablet can be divided into equal doses.
Tritace 2.5 comb tablets are packed in packs containing 28 tablets in PVC/Aluminium blisters.

Tritace 5 comb: tablets are white or almost white, elongated, divisible, measuring 10 x 5.6 mm, with the imprint "HNW" and "company logo" on both sides. The tablet can be divided into equal doses.
Tritace 5 comb tablets are packed in packs containing 28 tablets in PVC/Aluminium blisters.
Not all pack sizes may be marketed.

Marketing Authorisation 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,
Bucuresti, 032266 – Romania
Sanofi Aventis Deutschland GmbH
Industriepark Höchst Brüningstrasse 50
D-65926 Frankfurt am Main
Germany

For further information about this medicine and its names in the European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder in Poland:
Sanofi Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
tel.: +48 22 280 00 00