ZOFENIL Film-coated tablet (2021)
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Περιεχόμενα
1. Name of the medicinal product
ZOFENIL 7.5 mg film-coated tablets.
2. Qualitative and quantitative composition
Each ZOFENIL 7.5 mg tablet contains 7.5 mg of zofenopril calcium as 7.2 mg of zofenopril. <u>Excipients with known effect:</u> Each ZOFENIL 7.5 mg film-coated tablet contains 17.35 mg of lactose monohydrate. ...
3. Pharmaceutical form
Film-coated tablet. White round film-coated tablets with convex faces.
4.1. Therapeutic indications
Hypertension ZOFENIL is indicated for the treatment of mild to moderate essential hypertension. Acute Myocardial Infarction ZOFENIL is indicated for the treatment initiated within the first 24 hours of ...
4.2. Posology and method of administration
Posology Hypertension Adults The need for dosage titration should be determined by measurement of blood pressure just before the next dose. The dose should be increased at an interval of four weeks. Patients ...
4.3. Contraindications
Hypersensitivity to zofenopril calcium, any other ACE inhibitor or any of the excipients listed in section 6.1. History of angioneurotic oedema associated with previous ACE inhibitor therapy. Concomitant ...
4.4. Special warnings and precautions for use
Hypotension As with other ACE inhibitors, ZOFENIL may cause a profound fall in blood pressure especially after the first dose, although. symptomatic hypotension is seen rarely in uncomplicated hypertensive ...
4.5. Interaction with other medicinal products and other forms of interaction
Medicines increasing the risk of angioedema Concomitant use of ACE inhibitors with sacubitril/valsartan is contraindicated as this increases the risk of angioedema (see section 4.3 and 4.4). Concomitant ...
4.6. Pregnancy and lactation
Pregnancy The use of ACE inhibitors is not recommended during the first trimester of pregnancy (see section 4.4). The use of ACE inhibitors is contraindicated during the second and third trimester of pregnancy ...
4.7. Effects on ability to drive and use machines
There are no studies on the effect of ZOFENIL on the ability to drive. When driving vehicles or operating machines it should be remembered that occasionally drowsiness, dizziness or weariness may occur. ...
4.8. Undesirable effects
Tabulated list of adverse reactions The table below shows all the adverse reactions that have been reported during clinical practice in patients treated with ZOFENIL. They are listed by body-system and ...
4.9. Overdose
Symptoms of overdosage are severe hypotension, shock, stupor, bradycardia, electrolyte disturbances and renal failure. After ingestion of an overdose, the patients should be kept under close supervision, ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> ACE inhibitor <b>ATC code:</b> C09AA15 The beneficial effects of ZOFENIL in hypertension and acute myocardial infarctionappear to result primarily from the suppression ...
5.2. Pharmacokinetic properties
Zofenopril calcium is a prodrug, since the active inhibitor is the free sulfhydryl compound, zofenoprilat, resulting from thio-ester hydrolysis. Absorption Zofenopril calcium is rapidly and completely ...
5.3. Preclinical safety data
In repeat oral dose toxicity studies conducted in three mammalian species most of the treatment related effects where those usually reported for ACE inhibitors. These changes included a decrease in erythrocytic ...
6.1. List of excipients
<u>Core:</u> Microcrystalline cellulose Lactose monohydrate Croscarmellose sodium Magnesium stearate Colloidal anhydrous silica <u>Coat:</u> Hypromellose Titanium dioxide (E171) Macrogol 400 Macrogol 6000 ...
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
No special precautions for storage.
6.5. Nature and contents of container
Blister PVDC /PVC/aluminium or Aclar/Aluminium or PVC/PE/PVDC/Aluminium, packs of: 12, 14, 15, 28, 30, 48, 50, 50 unit doses, 56, 56 unit doses, 90 or 100 film coated tablets. Not all pack sizes may be ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Menarini International Operations Luxembourg S.A., 1 Avenue de la Gare, 1611 Luxembourg
8. Marketing authorization number(s)
PA0865/003/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 04 March 1999 Date of last renewal: 30 July 2008
10. Date of revision of the text
September 2021
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