IFIRMASTA Film-coated tablet (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Ifirmasta 75 mg film-coated tablets. Ifirmasta 150 mg film-coated tablets. Ifirmasta 300 mg film-coated tablets.

2. Qualitative and quantitative composition

Ifirmasta 75 mg film-coated tablets: Each film-coated tablet contains 75 mg irbesartan (as hydrochloride). Ifirmasta 150 mg film-coated tablets: Each film-coated tablet contains 150 mg irbesartan (as hydrochloride). ...

3. Pharmaceutical form

Film-coated tablet. White, oval tablets.

4.1. Therapeutic indications

Ifirmasta is indicated in adults for the treatment of essential hypertension. It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as ...

4.2. Posology and method of administration

Posology The usual recommended initial and maintenance dose is 150 mg once daily, with or without food. Ifirmasta at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Second and third trimesters of pregnancy (see sections 4.4 and 4.6). The concomitant use of Ifirmasta with aliskiren-containing ...

4.4. Special warnings and precautions for use

Intravascular volume depletion Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, ...

4.5. Interaction with other medicinal products and other forms of interaction

Diuretics and other antihypertensive agents Other antihypertensive agents may increase the hypotensive effects of irbesartan; however Ifirmasta has been safely administered with other antihypertensive ...

4.6. Fertility, pregnancy and lactation

Pregnancy The use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4). The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see sections ...

4.7. Effects on ability to drive and use machines

Based on its pharmacodynamic properties, irbesartan is unlikely to affect the ability to drive and use machines. When driving vehicles or operating machines, it should be taken into account that dizziness ...

4.8. Undesirable effects

In placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did not differ between the irbesartan (56.2%) and the placebo groups (56.5%). Discontinuation due to ...

4.9. Overdose

Experience in adults exposed to doses of up to 900 mg/day for 8 weeks revealed no toxicity. The most likely manifestations of overdosage are expected to be hypotension and tachycardia; bradycardia might ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: angiotensin II antagonist, plain ATC code: C09CA04 Mechanism of action Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist. ...

5.2. Pharmacokinetic properties

Absorption After oral administration, irbesartan is well absorbed: studies of absolute bioavailability gave values of approximately 60-80%. Concomitant food intake does not significantly influence the ...

5.3. Preclinical safety data

There was no evidence of abnormal systemic or target organ toxicity at clinically relevant doses. In non-clinical safety studies, high doses of irbesartan (≥250 mg/kg/day in rats and ≥100 mg/kg/day in ...

6.1. List of excipients

Tablet core: Mannitol Hydroxypropylcellulose Low-substituted Hydroxypropyl Cellulose (LH-21) Low-substituted Hydroxypropyl Cellulose (LH-11) Talc Macrogol 6000 Castor oil, hydrogenated Film coating: ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Do not store above 30°C. Store in the original package in order to protect from moisture.

6.5. Nature and contents of container

Blister (PVC/PE/PVDC/Alu): 14, 28, 30, 56, 84, 90 or 98 film-coated tablets in box are available. Blister (PVC/PE/PVDC/Alu): 56 1 film-coated tablets in perforated unit dose blisters in box. Not all pack ...

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

8. Marketing authorization number(s)

Ifirmasta 75 mg film-coated tablets: 14 tablets: EU/1/08/480/001 28 tablets: EU/1/08/480/002 30 tablets: EU/1/08/480/019 56 tablets: EU/1/08/480/003 56 1 tablets: EU/1/08/480/004 84 tablets: EU/1/08/480/005 ...

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 1 December 2008 Date of latest renewal: 26 August 2013

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