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TRITACE COMP
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- Stock: Zabrana online prodaje
- Brand: SANOFI
- Model: BR-604425124620403
Tritace comp LS 2.5 mg + 12.5 mg and Tritace comp 5 mg + 25 mg are prescription medicines containing two active substances: ramipril and hydrochlorothiazide.
Ramipril is an ACE inhibitor that relaxes and widens blood vessels and helps the heart pump blood. Hydrochlorothiazide is a thiazide diuretic that increases urine production and contributes to lowering blood pressure.
Tritace comp is available only with a medical prescription. The fixed combination is usually prescribed when blood pressure has not been adequately controlled with ramipril or hydrochlorothiazide alone. Do not start, stop or change the dose without the prescribing doctor’s approval.
Tritace comp – strengths, use and important warnings
| Information | Tritace comp LS | Tritace comp |
|---|---|---|
| Strength | Ramipril 2.5 mg + hydrochlorothiazide 12.5 mg | Ramipril 5 mg + hydrochlorothiazide 25 mg |
| Dosage form | Scored tablet | Scored tablet |
| Tablet marking | HNV | HNW |
| Pack size | 28 tablets – two blisters of 14 | 28 tablets – two blisters of 14 |
| Approved use | Treatment of high blood pressure in adults when treatment with one component alone has not provided adequate control | |
| Legal status | Prescription-only medicine | |
What is Tritace comp used for?
Tritace comp is used to treat arterial hypertension. The fixed combination is generally prescribed when ramipril or hydrochlorothiazide used alone has not adequately controlled the patient’s blood pressure.
High blood pressure often causes no obvious symptoms, but uncontrolled hypertension may increase the risk of stroke, heart attack, heart failure and kidney or blood-vessel damage.
How is Tritace comp taken?
- It is normally taken once daily.
- Take it at the same time each day, usually in the morning.
- It may be taken before, during or after a meal.
- Swallow the tablet with sufficient liquid.
- Do not crush or chew it.
The score line allows the tablet to be divided into equal doses when this has been specifically prescribed. Do not independently change the strength or number of tablets.
The maximum total daily dose of the combination is 10 mg of ramipril and 25 mg of hydrochlorothiazide. This does not mean that two 5 mg + 25 mg tablets may be taken, because that would provide an excessive hydrochlorothiazide dose.
Monitoring during treatment
The doctor may monitor blood pressure, kidney function, creatinine, potassium, sodium, magnesium, calcium, blood glucose, uric acid, liver function and blood-cell counts.
A marked fall in blood pressure is more likely at the beginning of treatment, after a dose increase or in patients with dehydration, vomiting, diarrhoea, restricted salt intake or concurrent diuretic treatment.
Who must not take Tritace comp?
- people allergic to ramipril, another ACE inhibitor, hydrochlorothiazide, another thiazide, a sulfonamide or another ingredient;
- patients with a history of angioedema;
- patients taking sacubitril/valsartan or within the required interval after its use;
- patients undergoing certain dialysis or blood-filtration procedures;
- patients with severe narrowing of both renal arteries or the artery supplying a single functioning kidney;
- patients with severe kidney impairment and creatinine clearance below 30 mL/min;
- patients with severe liver impairment or hepatic encephalopathy;
- patients with a clinically significant electrolyte disorder that may be worsened by hydrochlorothiazide;
- patients using aliskiren who also have diabetes or impaired kidney function;
- women during the second or third trimester of pregnancy;
- women who are breastfeeding.
The medicine is not recommended for children or adolescents younger than 18 years.
Angioedema and severe allergy
ACE inhibitors may cause angioedema at any stage of treatment, even after a period of apparently good tolerance.
- swelling of the face, lips, tongue or throat;
- difficulty breathing or swallowing;
- hoarseness, choking or tightness in the throat;
- severe abdominal pain with or without nausea and vomiting;
- a severe rash, hives or sudden deterioration in your general condition.
Kidney function, dehydration and electrolytes
Ramipril and hydrochlorothiazide may affect kidney function and blood-electrolyte levels. Additional caution is required in older people, heart failure, renal-artery narrowing, dehydration, vomiting, diarrhoea and concurrent diuretic treatment.
Do not use potassium supplements, potassium-containing salt substitutes, potassium-sparing diuretics or high-dose mineral preparations without medical approval.
Skin and sun exposure
Long-term cumulative exposure to hydrochlorothiazide has been associated with an increased risk of non-melanoma skin and lip cancer. Protect the skin from excessive sunlight and UV exposure and show new or changing skin lesions to a doctor.
Sudden vision or breathing problems
Hydrochlorothiazide may rarely cause sudden visual impairment, eye pain, choroidal effusion or acute angle-closure glaucoma. Symptoms may occur within hours to several weeks after starting treatment.
Severe acute breathing difficulty has also been reported very rarely. Sudden eye pain, blurred vision or marked breathing difficulty requires urgent medical assessment.
Interactions with other medicines
Tell the doctor if you use:
- sacubitril/valsartan, aliskiren or an angiotensin receptor blocker;
- ibuprofen, diclofenac, naproxen or another NSAID;
- another diuretic, potassium supplement or medicine that increases potassium;
- lithium;
- insulin or an oral diabetes medicine;
- corticosteroids or long-term laxatives;
- digoxin or medicines that affect heart rhythm;
- an anticoagulant;
- allopurinol, procainamide, a cytotoxic medicine or an immunosuppressant;
- a muscle relaxant;
- an iodinated contrast agent.
NSAIDs may reduce the blood-pressure-lowering and diuretic effects of Tritace comp while increasing the risk of kidney injury and potassium disturbances.
Pregnancy and breastfeeding
Women planning a pregnancy should discuss an alternative antihypertensive treatment with their doctor.
Tritace comp should not be used during the first 12 weeks of pregnancy and must not be used from week 13 onwards, because it may seriously harm the unborn baby.
Contact the doctor immediately if pregnancy occurs during treatment. The medicine must not be used while breastfeeding.
Possible side effects
Possible adverse effects include:
- headache, dizziness, tiredness or weakness;
- low blood pressure, particularly when standing up;
- a persistent dry cough;
- nausea, abdominal discomfort, indigestion, diarrhoea or constipation;
- muscle weakness or cramps;
- changes in potassium, sodium, magnesium, calcium, glucose or uric-acid levels;
- rash, itching or increased sensitivity to sunlight;
- kidney or liver dysfunction;
- changes in blood-cell counts;
- worsening of gout in susceptible patients.
- swelling of the face, tongue or throat or difficulty breathing;
- fainting or severe low blood pressure;
- a rapid or irregular heartbeat;
- a marked reduction in urination or blood in the urine;
- yellowing of the skin or eyes;
- a severe rash, blistering or peeling skin;
- unexplained bruising, bleeding, recurrent infections or high temperature;
- sudden eye pain or blurred vision;
- severe breathing difficulty;
- severe abdominal pain with or without nausea and vomiting.
Driving and alcohol
Dizziness is more likely when treatment begins or the dose is increased. Do not drive or operate machinery if dizziness, light-headedness, weakness or impaired concentration occurs.
Alcohol may further lower blood pressure and worsen dizziness.
Missed dose and stopping treatment
If a dose is missed, take the next dose at the usual time. Do not take a double dose.
Do not stop treatment simply because home measurements have become normal. Normal readings usually mean that the prescribed treatment is working.
Tritace comp contains a diuretic. Tell the doctor if you have prolonged vomiting or diarrhoea, sweat heavily, drink very little fluid or use another water tablet. These situations may cause excessive blood-pressure reduction, dehydration and kidney injury. Do not independently add potassium, potassium-based salt substitutes, herbal diuretics or supplements marketed for lowering blood pressure.
Ljubica Barbulović, Master of Pharmacy
Availability and price
Home blood-pressure monitoring
Regular home monitoring may help the doctor assess treatment. View the blood pressure monitors category.
Record the date, time, blood-pressure reading, pulse and any symptoms. Do not change the dose because of a single high or low reading.
Related blog topic: How to lower high blood pressure without medication? Lifestyle measures complement prescribed treatment and are not a reason to stop it independently.
Composition, appearance and packaging
Tritace comp LS: each tablet contains 2.5 mg of ramipril and 12.5 mg of hydrochlorothiazide. It is an oblong, white to almost white scored tablet marked “HNV”.
Tritace comp: each tablet contains 5 mg of ramipril and 25 mg of hydrochlorothiazide. It is an oblong, white to almost white scored tablet marked “HNW”.
Other ingredients include hypromellose, pregelatinised maize starch, microcrystalline cellulose and sodium stearyl fumarate.
Both packs contain 28 tablets in two blisters of 14 tablets.
Marketing authorisation holder: AMICUS SRB d.o.o., Belgrade.
Storage
Keep out of the sight and reach of children. No special storage conditions are required. Do not use after the expiry date stated on the packaging.
Frequently asked questions
What is the difference between Tritace comp LS and Tritace comp?
Both contain ramipril and hydrochlorothiazide in different doses. The doctor selects the appropriate strength.
Should it be taken before or after food?
It may be taken before, during or after a meal, usually once daily in the morning.
Can the tablet be divided?
The scored tablet may be divided into equal doses when prescribed. Do not crush or chew it.
Can Tritace comp cause a dry cough?
A persistent dry cough may be caused by ramipril. Contact the doctor if it becomes troublesome, but do not stop treatment independently.
Can potassium supplements be used?
Not without medical advice. Ramipril may increase potassium, while hydrochlorothiazide may reduce it. The individual effect should be assessed through laboratory monitoring.
Official sources:
ALIMS – Tritace comp LS Patient Information Leaflet |
ALIMS – Tritace comp Patient Information Leaflet.
Marketing authorisations renewed on 4 January 2024. Tritace comp LS leaflet corrected on 12 April 2024. Content checked: July 2026.
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For all orders received up to 12h from Monday to Friday, the approximate delivery time is 2-4 business days for the whole territory of the Republic of Serbia. In case the order is placed on weekends (Saturdays and Sundays), the delivery is done as well as for the orders received on Monday - so next business day.
Deliveries are not made on Saturdays and Sundays.
Additional information
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Shipping cost
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For goods ordered up to 5.000,00 RSD, delivery charge is 260.00 RSD (VAT included). For goods over 5.000,00 RSD, shipping is free of charge.
For international delivery:
For the export of goods abroad through the PostExport service of Post of Serbia, the shipping price is for:
- Zone I (Slovenia, Croatia, Bosnia and Herzegovina, Montenegro, Northern Macedonia) - 1,280.00 RSD
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- Zone III (Asia, Africa, America, Australia and other countries) - 2,650.00 RSD
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