BETAMOX Capsule, Suspension (2021)

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Περιεχόμενα

1. Name of the medicinal product

BETAMOX 250 capsules. BETAMOX 500 capsules. BETAMOX S 125 mg/5 ml suspension. BETAMOX SF 250 mg/5 ml suspension.

2. Qualitative and quantitative composition

BETAMOX 250: Each capsule contains amoxycillin trihydrate equivalent to 250 mg amoxycillin. Sugar free. BETAMOX 500: Each capsules contains amoxycillin trihydrate equivalent to 500 mg amoxycillin. ...

3. Pharmaceutical form

BETAMOX 250: Capsules Size 2 capsule, with an opaque maroon cap and an opaque flesh coloured body. The name BETAMOX 250 mg is imprinted on the flesh body, and the Be-Tabs logo on the maroon cap. ...

4.1. Therapeutic indications

BETAMOX is indicated for the treatment of iInfections caused by susceptible, non-penicillinase-producing organisms including: Upper and lower respiratory tract infections: sinusitis, pharyngitis, epiglottitis, ...

4.2. Posology and method of administration

The average adult dose for BETAMOX is 750 mg to 1,5 g per day. General dosages Adults: 250 mg (1 250 mg capsule or 5 ml of 250 mg/5 ml suspension) three times a day. Children 2 to 10 years: ...

4.3. Contraindications

Hypersensitivity to penicillins (e.g. amoxycillin) or to another beta-lactam agent (e.g. cephalosporin, carbapenem or monobactam), or to any of the excipients listed in section 6.1. Patients with infectious ...

4.4. Special warnings and precautions for use

Hypersensitivity reactions Before initiating therapy with any penicillin, careful enquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other beta-lactam ...

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

Probenecid Concomitant use of probenecid is not recommended. Probenecid decreases the renal tubular secretion of BETAMOX. Concomitant use of probenecid may result in increased and prolonged blood levels ...

4.6. Fertility, pregnancy and lactation

Pregnancy Reported animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. Limited data on the use of amoxycillin during pregnancy in humans do not indicate ...

4.7. Effects on ability to drive and use machines

BETAMOX may cause an allergic reaction, dizziness or convulsions, which may influence the ability to drive and use machines (see section 4.8).

4.8. Undesirable effects

The most commonly reported adverse drug reactions (ADRs) are diarrhoea, nausea and skin rash. Body System Frequent Less Frequent Frequency Unknown Infections and infestations   Mucocutaneous ...

4.9. Overdose

See section 4.4 and 4.8. Treatment is symptomatic and supportive. Should a serious anaphylactic reaction occur, BETAMOX should be discontinued and the patient treated with adrenalin, corticosteroids and ...

5.1. Pharmacodynamic properties

Category and class: A 20.1.2 Penicillins Pharmacotherapeutic group: penicillins with extended spectrum ATC code: J01CA04 Mechanism of action Amoxycillin is a semisynthetic, broad-spectrum, ...

5.2. Pharmacokinetic properties

Absorption Amoxycillin is well absorbed orally. After oral administration, there is no significant difference between the peak serum levels in fasting and non-fasting subjects. The presence of food does ...

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development. Carcinogenicity studies ...

6.1. List of excipients

BETAMOX 250 and BETAMOX 500 Capsule contents: Magnesium stearate, purified talc and sodium lauryl sulphate Capsule shell: Flesh opaque body: erythrosine (CI no. 45430), gelatin, quinoline ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

BETAMOX 250: 36 months 15 months (for Patient Ready Packs) BETAMOX 500: 48 months (for the 500s pack size packed in amber PVC bottle) 60 months (for 15s and 100s packed a in white polypropylene securitainer ...

6.4. Special precautions for storage

Store at or below 25°C, in a dry place. The reconstituted suspension must be used within 14 days if stored in a refrigerator or within 7 days if stored below 25°C.

6.5. Nature and contents of container

BETAMOX 250: Canisters containing 15, 100 or 500 250 mg amoxycillin capsules. Patient ready packs of different pack sizes. BETAMOX 500: Canisters containing 15, 100 or 500 500 mg amoxycillin ...

6.6. Special precautions for disposal and other handling

Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).

7. Marketing authorization holder

Ranbaxy Pharmaceuticals (Pty) Ltd, 14 Lautre Road, Stormill Ext. 1, Roodepoort 1724, South Africa

8. Marketing authorization number(s)

BETAMOX 250: Y/20.1.2/127 (S.A.), Botswana: S2 BOT0500765, Namibia: NS2 04/20.1.2/1625 BETAMOX 500: Y/20.1.2/128 (S.A.), Namibia: NS2 04/20.1.2/1626 BETAMOX S: Y/20.1.2/129 (S.A.), Botswana: S2 BOT0500763, ...

9. Date of first authorization / renewal of the authorization

May 1991

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