Triapin 5 mg/5 mg and Triapin Mite 2.5 mg/2.5 mg prolonged-release tablets (ramipril + felodipine) – for high blood pressure

Triapin is a fixed combination of two active substances: ramipril, an ACE inhibitor that relaxes and widens blood vessels by blocking the formation of substances that raise blood pressure, and felodipine, a calcium antagonist that also widens blood vessels. Together they lower high blood pressure.

In Serbia two strengths of prolonged-release tablets are registered: Triapin 5 mg/5 mg and Triapin Mite 2.5 mg/2.5 mg, 28 tablets each. The medicine is intended for adults whose blood pressure cannot be adequately controlled with ramipril alone or felodipine alone.

What is Triapin used for and how should it be taken?

Basic information about the medicine

What is Triapin used for?

According to the summary of product characteristics, Triapin and Triapin Mite are used for the treatment of essential hypertension (high blood pressure) in patients whose blood pressure cannot be adequately controlled with felodipine alone or ramipril alone.

Lowering high blood pressure reduces the risk of heart disease, kidney disease and stroke.

How is Triapin used and dosed?

The dosage differs by strength – follow the strength prescribed:

The tablets are swallowed whole with enough liquid (half a glass of water or another drink) – they must not be broken, crushed or chewed. They are taken on an empty stomach or after a light meal, without grapefruit juice or alcohol. If you take diuretics, the doctor may reduce or temporarily stop them at the start of treatment. The doctor may also consider switching directly from the single medicines to the fixed combination.

Special patient groups

• Children: the medicine is not used.
• Elderly patients: use the same dose as other adults; the doctor may check blood sodium more often.
• Kidney or liver impairment: the medicine must not be taken in severe kidney disease, dialysis or severe liver disease; in milder forms the doctor assesses its use and monitors tests.

Contraindications – when the medicine must not be used

• allergy to ramipril or another ACE inhibitor, to felodipine or another calcium antagonist, or to the excipients;
• a history of angioedema (serious allergic reaction with swelling of the face, tongue and throat);
• taking or having recently taken sacubitril/valsartan;
• serious heart disease – heart failure, obstruction in the heart, unstable angina, second- or third-degree AV block, heart attack or stroke;
• severe kidney disease, dialysis or severe liver disease;
• pregnancy, planning pregnancy and breastfeeding;
• diabetes or impaired kidney function with concomitant aliskiren-containing medicines.

Precautions and warnings

• With kidney problems, diabetes or medicines that increase potassium, the doctor may order potassium tests; with medicines or diseases that lower sodium – sodium tests.
• The risk of angioedema is increased by mTOR inhibitors (temsirolimus, everolimus, sirolimus), vildagliptin, racecadotril and sacubitril/valsartan.
• Tell your doctor about kidney artery problems, aortic stenosis, hypertrophic cardiomyopathy or other heart disease, lupus or scleroderma, liver disease, upcoming anaesthesia or surgery, desensitisation to bee or wasp stings and LDL apheresis.
• In black patients the medicine may be less effective and cause more side effects.
• Gums: swollen gums may be a sign of gingivitis or periodontitis – careful dental hygiene helps avoid gum enlargement.
• Concomitant use with sartans or aliskiren requires regular monitoring of the kidneys, blood pressure and electrolytes.
• The medicine contains lactose and polyoxyl hydrogenated castor oil (may cause stomach cramps and diarrhoea).

Interactions with other medicines, food and drink

• Do not combine with sacubitril/valsartan; caution with sartans and aliskiren.
• Increased blood potassium: potassium-sparing diuretics (amiloride, spironolactone, triamterene), potassium salts, heparin, trimethoprim (alone or with sulfamethoxazole).
• Greater fall in blood pressure: other antihypertensives, nitrates, antipsychotics, narcotics, anaesthetics, alcohol.
• Weaker effect of the medicine: NSAIDs (pain and anti-inflammatory medicines), sympathomimetics, phenytoin, carbamazepine, barbiturates, rifampicin, St John's wort; increased salt intake.
• Stronger effect of felodipine: erythromycin, itraconazole, ketoconazole, HIV medicines, grapefruit juice.
• Also tell your doctor about lithium, theophylline, procainamide, allopurinol, immunosuppressants, tacrolimus, sirolimus, everolimus, temsirolimus, racecadotril, cytostatics, glucocorticoids and diabetes medicines (insulin, glibenclamide, metformin, vildagliptin).

Pregnancy and breastfeeding

• Do not take the medicine if you are pregnant, think you may be pregnant or are planning pregnancy – it may harm the baby. If you become pregnant, stop taking it and contact your doctor immediately.
• Do not take the medicine if you are breastfeeding or plan to breastfeed – small amounts pass into milk.

Driving and using machines

• The medicine may cause dizziness or fainting, especially at the start of treatment or when switching to a higher dose. If so, do not drive or use machines.

Possible side effects

• Very common (more than 1 in 10): swelling of the hands and legs (fluid retention).
• Common (up to 1 in 10): headache, tiredness, dizziness, fainting and low blood pressure (especially on standing up quickly), flushing, dry irritating cough, sinusitis, bronchitis, shortness of breath, stomach pain, diarrhoea, indigestion, nausea, rash, chest pain, muscle cramps or pain, raised blood potassium.
• Uncommon (up to 1 in 100): vertigo, itching, tingling, taste changes, sleep problems, low mood, anxiety, stuffy nose, worsening of asthma, intestinal angioedema, heartburn, constipation, dry mouth, frequent urination, sweating, appetite changes, fast heartbeat, blurred vision, joint pain, fever, reduced sexual desire, changes in liver, pancreas or kidney tests.
• Rare (up to 1 in 1,000): unsteadiness or confusion, red swollen tongue, skin peeling, nail problems, bruising, skin ulcers, red watery eyes, ringing in the ears, weakness, reduced blood cell counts.
• Very rare: sensitivity to sunlight, mild swelling or bleeding of the gums, raised blood sugar. Low sodium, Raynaud's phenomenon, breast enlargement in men and hair loss have also been reported.

Overdose, missed dose and stopping treatment

• Overdose: contact a doctor or the nearest medical facility immediately and take the pack with you; dizziness or fainting due to a fall in blood pressure may occur.
• Missed dose: if you remember on the same day, take it as soon as you remember and your usual dose the next day. If you remember only the next day, take only the dose for that day – do not take a double dose.
• Stopping treatment: keep taking the medicine until your doctor tells you otherwise – if you stop, your blood pressure may rise again.

Related information

Alongside treatment, regular blood pressure measurement, reduced salt intake and checks of potassium and kidney function as agreed with your doctor are important. For home blood pressure monitoring, see also the category Blood pressure monitors – products in this category do not replace the medicine prescribed for you.

Composition, pack and manufacturer

• Active substances: Triapin – 5 mg ramipril and 5 mg felodipine; Triapin Mite – 2.5 mg ramipril and 2.5 mg felodipine per tablet.
• Excipients: microcrystalline cellulose; hydroxypropylcellulose; hypromellose; yellow and red iron oxide (E172); anhydrous lactose; macrogol 6000; polyoxyl 40 hydrogenated castor oil; pregelatinised maize starch; synthetic paraffin; propyl gallate; sodium aluminosilicate; sodium stearyl fumarate; titanium dioxide (E171).
• Appearance: Triapin – red-brown round tablets marked H/OE and 5; Triapin Mite – yellow-orange round tablets marked H/OD and 2.5 (diameter about 9 mm). PVC/PVDC blister of 14 tablets, 2 blisters per carton.
• Marketing authorisation holder: Amicus SRB d.o.o., Milorada Jovanovića 9, Belgrade. Manufacturer according to the ALIMS renewal list: Sanofi Winthrop Industrie, Tours, France. Authorisations dated 27.02.2025: Triapin 001694498 2024, Triapin Mite 001694396 2024.

Storage

• Store below 25 °C.
• Shelf life: 3 years; do not use after the expiry date stated on the pack.
• Keep out of the sight and reach of children. Return unused medicine to a pharmacy that collects unused medicines.

Frequently asked questions

What is the difference between Triapin and Triapin Mite?

They differ in strength: Triapin contains 5 mg ramipril and 5 mg felodipine, and Triapin Mite 2.5 mg of each. The maximum daily dose of Triapin is 1 tablet, and of Triapin Mite 2 tablets a day.

Why must I not drink grapefruit juice?

The leaflet does not recommend taking the medicine with grapefruit juice, because grapefruit can increase the effect of felodipine and side effects such as low blood pressure and swelling.

I have had a dry cough since starting Triapin – is it the medicine?

A dry irritating cough is a common side effect of ACE inhibitors such as ramipril. Tell your doctor – do not stop the medicine on your own.

Can I halve the tablet?

No. Prolonged-release tablets must be swallowed whole, without breaking, crushing or chewing.

Sources

• ALIMS – Patient information leaflet Triapin 5 mg/5 mg (PIL)
• ALIMS – Summary of product characteristics Triapin 5 mg/5 mg (SmPC)
• ALIMS – Patient information leaflet Triapin Mite 2,5 mg/2,5 mg (PIL)
• ALIMS – Summary of product characteristics Triapin Mite 2,5 mg/2,5 mg (SmPC)

Sources checked on: 25 October 2026.