Twynsta Tablet 80mg/5mg

4.1 Indications

Treatment of essential hypertension.

Replacement Therapy

Patients receiving telmisartan and amlodipine from separate tablets may instead receive TWYNSTA containing the same component doses.

Add on therapy

TWYNSTA is indicated in patients whose blood pressure is not adequately controlled on telmisartan or amlodipine monotherapy.

Initial therapy

TWYNSTA may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of TWYNSTA as initial therapy for hypertension should be based on an assessment of potential benefits and risks.

4.3 Contraindications

• Hypersensitivity to the active substances, or to any of the excipients.
• Hypersensitivity to dihydropyridine derivatives
• Second and third trimesters of pregnancy
• Lactation
• Biliary obstructive disorders
• Severe hepatic impairment
• Severe hypotension
• Shock (including cardiogenic shock)
• Obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis)
• Haemodynamically unstable heart failure after acute myocardial infarction
• The concomitant use of TWYNSTA with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2)

In case of rare hereditary conditions that may be incompatible with an excipient of the product (see section List of excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), the use of the product is contraindicated.

4.2 Dosage and Administration

DOSAGE

Adults

TWYNSTA should be taken once daily.

Replacement therapy

Patients receiving telmisartan and amlodipine from separate tablets can instead receive TWYNSTA containing the same component doses in one tablet once daily, e.g. to enhance convenience or compliance.

Add on therapy

TWYNSTA may be administered in patients whose blood pressure is not adequately controlled with amlodipine or telmisartan alone.

Patients treated with 10 mg amlodipine who experience any dose limiting adverse reactions such as oedema, may be switched to TWYNSTA 40/5mg once daily, reducing the dose of amlodipine without reducing the overall expected antihypertensive response.

Initial therapy

A patient may be initiated on TWYNSTA if it is unlikely that control of blood pressure would be achieved with a single agent. The usual starting dose of TWYNSTA is 40/5 mg once daily. Patients requiring larger blood pressure reductions may be started on TWYNSTA 80/5 mg once daily.

If additional blood pressure lowering is needed after at least 2 weeks of therapy, the dose may be titrated up to a maximum of 80/10 mg once daily.

TWYNSTA can be administered with other antihypertensive drugs.

Special populations

Geriatric Patients

No dose adjustment is necessary for geriatric patients.

Normal amlodipine dosage regimens are recommended in the elderly, but increase of dosage should take place with care (see sections Special warnings and precautions, and Pharmacokinetics – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric patients

TWYNSTA is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.

Renal impairment

No posology adjustment is required for patients with renal impairment, including those on haemodialysis. Telmisartan is not removed from blood by hemofiltration and is not dialyzable. Amlodipine is not dialyzable. (see section Special Warnings and Precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment

In patients with mild to moderate hepatic impairment TWYNSTA should be administered with caution. For telmisartan the posology should not exceed 40 mg once daily (see sections Contraindications and Special Warnings and Precautions for use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of Administration

TWYNSTA tablets are for once-daily oral administration and should be swallowed whole with liquid. TWYNSTA can be taken with or without food.

HANDLING INSTRUCTIONS

Due to the hygroscopic property of the tablets they should be taken out of the sealed blister shortly before administration.