CO-MIDIS TABLETS 80MG/5MG [SIN16647P]

Product Info

CO-MIDIS TABLETS 80MG/5MG

[SIN16647P]

Indication

4.1 Indications

Treatment of essential hypertension.

Replacement Therapy
Patients receiving telmisartan and amlodipine from separate tablets may instead receive Co-Midis containing the same component doses.

Add on therapy
Co-Midis is indicated in patients whose blood pressure is not adequately controlled on telmisartan or amlodipine monotherapy.

Initial therapy
Co-Midis 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 Co-Midis as initial therapy for hypertension should be based on an assessment of potential benefits and risks.

Dosing

4.2 Dosage and Administration

DOSAGE

Adults
Co-Midis should be taken once daily.

For patients requiring the 40/5mg, 40/10mg and 80mg/10mg strengths, there are other brands available.

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

Add on therapy
Co-midis 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 telmisartan/amlodipine 40/5mg once daily, reducing the dose of amlodipine without reducing the overall expected antihypertensive response.

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

Co-Midis can be administered with other antihypertensive drugs.

Special populations

Renal impairment
No posology adjustment is required for patients with renal impairment, including those on haemodialysis. Amlodipine and telmisartan are not dialyzable.

Hepatic impairment
In patients with mild to moderate hepatic impairment Co-Midis should be administered with caution. For telmisartan the posology should not exceed 40 mg once daily.

Elderly Patients
No dose adjustment is necessary for elderly 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 population
Co-Midis is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.

Method of Administration

Tablet for Oral administration
Co-Midis may be taken with or without food

Contraindications

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 Co-Midis 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 "Special warnings and precautions" – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information) the use of the product is contraindicated.