CO-MIDIS TABLETS 80MG5MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Amlodipine besylate eqv Amlodipine; Telmisartan

Available from:

NOVEM HEALTHCARE PTE LTD

ATC code:

C09DB04

Pharmaceutical form:

TABLET

Composition:

Amlodipine besylate eqv Amlodipine 5 mg; Telmisartan 80 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Standard Chem. & Pharm. Co. Ltd.

Authorization status:

ACTIVE

Authorization date:

2022-11-24

Summary of Product characteristics

1
CO-MIDIS
®
1. NAME OF THE MEDICINAL PRODUCT
Co-Midis Tablets 80mg/5mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as
amlodipine besilate). For the full list of excipients, see
section 6.1.
3. PHARMACEUTICAL FORM
Telmisartan / amlodipine layered tablets 80/5 mg are white tablets of
oval, biconvex shape; engraved with “747” on one
side and “SCP” on the other side. The tablets are for oral
administration.
4. CLINICAL PARTICULARS
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.
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.
2
Initial therapy
A patient may be initiated on telmisartan/amlodipine if it is unlikely
that control of blood