ORELOX Film-coated tablet / Granules

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Περιεχόμενα

1. Name of the medicinal product

ORELOX 100 (tablets). ORELOX 200 (tablets). ORELOX JUNIOR (granules for oral suspension).

2. Qualitative and quantitative composition

ORELOX 100 Each film-coated tablet contains 130,45 mg of cefpodoxime proxetil equivalent to 100 mg of cefpodoxime. Contains sugar (lactose monohydrate): 21,55 mg. Excipients: Carboxymethylcellulose ...

3. Pharmaceutical form

ORELOX 100: Biconvex, cylindrical practically white tablets, 9 mm in diameter with 208 and beneath A engraved on one side. A broken tablet shows a pale yellow core surrounded by a white film-coating. ...

4.1. Therapeutic indications

In adults: Orelox 100 and Orelox 200 are indicated for use in the short-term treatment of upper and lower respiratory tract infections due to susceptible micro-organisms (sensitivity tests must ...

4.2. Posology and method of administration

In adults Each film-coated tablet contains 100 mg or 200 mg of cefpodoxime. The dosage depends on the condition being treated. Tonsillitis, pharyngitis and acute bronchitis One ORELOX 100 tablet (100 mg) ...

4.3. Contraindications

Known sensitivity to cephalosporin antibiotics (see WARNINGS and SPECIAL PRECAUTIONS). Safety of use in pregnancy and lactation has not been established. ORELOX JUNIOR must not be given to children with ...

4.4. Special warnings and precautions for use

Anaphylactic reactions Preliminary enquiry as to an allergic diathesis and particularly hypersensitivity of betalactam antibiotics should precede treatment with ORELOX. The use of ORELOX is strictly contraindicated ...

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

The bioavailability of ORELOX is increased if the product is administered during meals (acid pH). Histamine H2 antagonists (such as ranitidine) and antacids reduce the bioavailability of ORELOX. ...

4.6. Pregnancy and lactation

Safety of ORELOX in pregnant women has not been established, it is therefore advisable not to administer ORELOX during pregnancy (see CONTRAINDICATIONS). Since ORELOX is excreted in human breast milk, ...

4.7. Effects on ability to drive and use machines

Dizzy sensations may occur, which should be taken into account when driving a vehicle or operating machinery.

4.8. Undesirable effects

The following side effects have been reported: Blood and the lymphatic system disorders Less frequent: reduction of haemoglobin, thrombocytosis, thrombocytopenia, leucopenia, haemolytic anaemia ...

4.9. Overdose

Treatment should be symptomatic and supportive. In cases of overdosage, particularly in patients with renal insufficiency, there is a risk of encephalopathy. Convulsions have also been reported with very ...

5.1. Pharmacodynamic properties

A 20.1.1 Broad and medium spectrum antibiotics Pharmacodynamic properties Cefpodoxime proxetil is a semisynthetic β-lactam antibiotic belonging to the third generation oral cephalosporin group. Cefpodoxime ...

5.2. Pharmacokinetic properties

The bioavailability of cefpodoxime proxetil is increased when the product is administered with meals, or when there is a decrease in gastric pH. An increase in gastric pH results in decreased bioavailability. ...

6.5. Nature and contents of container

ORELOX 100: film-coated tablets are available in polyamide/aluminium/polyvinyl chloride/aluminium blister packs, inserted into an outer printed cardboard carton containing 10 tablets (1 strip x ...

6.6. Special precautions for disposal and other handling

ORELOX 100 and ORELOX 200: Store in a cool, dry place, at or below 25°C. Protect from light and humidity. Keep blister pack in carton until required for use. KEEP OUT OF REACH OF CHILDREN. ORELOX ...

7. Marketing authorization holder

sanofi-aventis south africa (pty) ltd., 2 Bond Street, Midrand, 1685, South Africa

8. Marketing authorization number(s)

ORELOX 100: Z/20.1.1/7 ORELOX 200: A38/20.1.1/0406 ORELOX JUNIOR: 27/20.1.1/0564

9. Date of first authorization / renewal of the authorization

Date on the registration certificates (original registration): ORELOX 100: 9 September 1991 ORELOX 200: 12 June 2009 ORELOX JUNIOR: 10 November 1993

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