LOSAR Film-coated tablet (2017)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Losar 50 mg film-coated tablets. Losar 100 mg film-coated tablets.

2. Qualitative and quantitative composition

Each Losar 50 mg film-coated tablet contains losartan potassium 50 mg. Each Losar 100 mg film-coated tablet contains losartan potassium 100 mg. Excipient(s) with known effect: Each Losar 50 mg film-coated ...

3. Pharmaceutical form

Film-coated tablet. Losar 50 mg film-coated tablets: White, round, biconvex, film-coated tablets, scored on one side. The tablet can be divided into equal doses. Losar 100 mg film-coated tablets: ...

4.1. Therapeutic indications

Treatment of essential hypertension in adults and in children and adolescents 6-18 years of age. Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus with proteinuria 0.5 ...

4.2. Posology and method of administration

Posology Hypertension The usual starting and maintenance dose is 50 mg once daily for most patients. The maximal antihypertensive effect is attained 3-6 weeks after initiation of therapy. Some patients ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 4.4 and 6.1. 2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6). Severe hepatic impairment. ...

4.4. Special warnings and precautions for use

Hypersensitivity Angiooedema: Patients with a history of angiooedema (swelling of the face, lips, throat, and/or tongue) should be closely monitored (see section 4.8). Hypotension and Electrolyte/Fluid ...

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

Other antihypertensive agents may increase the hypotensive action of losartan. Concomitant use with other substances which may induce hypotension as an adverse reaction (like tricyclic antidepressants, ...

4.6. Pregnancy and lactation

Pregnancy The use of losartan is not recommended during the first trimester of pregnancy (see section 4.4). The use of losartan is contra-indicated during the 2nd and 3rd trimester of pregnancy (see section ...

4.7. Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. However, when driving vehicles or operating machinery it must be borne in mind that dizziness or drowsiness may occasionally ...

4.8. Undesirable effects

Losartan has been evaluated in clinical studies as follows: In a controlled clinical trial in > 3,000 adult patients 18 years of age and older for essential hypertension. In a controlled clinical trial ...

4.9. Overdose

Symptoms of intoxication Limited data are available with regard to overdose in humans. The most likely manifestation of overdose would be hypotension and tachycardia. Bradycardia could occur from parasympathetic ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, Angiotensin II receptor antagonists, plain ATC code: C09CA01 Losartan is a synthetic oral angiotensin-II receptor ...

5.2. Pharmacokinetic properties

Absorption Following oral administration, losartan is well absorbed and undergoes first-pass metabolism, forming an active carboxylic acid metabolite and other inactive metabolites. The systemic bioavailability ...

5.3. Preclinical safety data

Preclinical data reveal no special hazard for humans based on conventional studies of general pharmacology, genotoxicity and carcinogenic potential. In repeated dose toxicity studies, the administration ...

6.1. List of excipients

Core: Cellulose, microcrystalline Lactose monohydrate Starch, pregelatinised Sodium starch glycolate (Type A) Magnesium stearate Coating: Hydroxypropylcellulose (E463) Hypromellose Titanium ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 25°C. Protect from light and moisture.

6.5. Nature and contents of container

Losar 50 mg film-coated tablets: Aluminium-PVC/PE/PVDC blisters. Pack-sizes of 30 and 100 film-coated tablets. Losar 100 mg film-coated tablets: Aluminium-PVC/PE/PVDC blisters. Pack-sizes ...

6.6. Special precautions for disposal and other handling

No special precautions.

7. Marketing authorization holder

Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

8. Marketing authorization number(s)

Losar 50 mg film-coated tablets: 20786 Losar 100 mg film-coated tablets: 20787

9. Date of first authorization / renewal of the authorization

Date of first authorization: 04 October 2010 Date of latest renewal: 16 September 2015

10. Date of revision of the text

28/12/2017

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