CLINDAHEXAL Capsule (2022)

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Περιεχόμενα

1. Name of the medicinal product

CLINDAHEXAL150 (capsules). CLINDAHEXAL 300 (capsules).

2. Qualitative and quantitative composition

Each CLINDAHEXAL 150 capsule contains: clindamycin hydrochloride equivalent to 150 mg clindamycin base. Each CLINDAHEXAL 300 capsule contains: clindamycin hydrochloride equivalent to 300 ...

3. Pharmaceutical form

CLINDAHEXAL 150: Opaque brown/red-brown hard gelatine capsules, size 1, filled with homogenous powder. CLINDAHEXAL 300: Opaque brown hard gelatine capsules, size 0, filled with homogenous ...

4.1. Therapeutic indications

Clindamycin is indicated in serious infections caused by organisms susceptible to its action. In vitro susceptibility studies should be performed. Infections due to susceptible organisms, which ...

4.2. Posology and method of administration

Adults Mild to moderately severe infection: 150 mg every six hours. Severe infections: 300 mg to 450 mg every six hours. Clindamycin should be taken with meals. Should clindamycin be taken between meals, ...

4.3. Contraindications

CLINDAHEXAL is contraindicated in patients previously found to be hypersensitive to clindamycin. Patients with a hypersensitivity to, lincomycin or to any excipients of CLINDAHEXAL listed in section 6.1. ...

4.4. Special warnings and precautions for use

Cross-resistance has been demonstrated between lincomycin hydrochloride and clindamycin. Antagonism has been demonstrated with erythromycin. Severe hypersensitivity reactions, including severe skin reactions ...

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

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, it should be used with caution in patients receiving ...

4.6. Fertility, pregnancy and lactation

Pregnancy Oral and subcutaneous reproductive toxicity studies in rats and rabbits revealed no evidence of impaired fertility or harm to the foetus due to clindamycin, except at doses that caused maternal ...

4.7. Effects on ability to drive and use machines

CLINDAHEXAL has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

The evaluation of side effects is based on the following information on frequencies: Frequent, less frequent and not known (cannot be estimated from available data): Infections and infestations Frequent: ...

4.9. Overdose

The incidence of gastrointestinal side effects increase with increased dose. Treatment is supportive and symptomatic. The serum biological half-life of clindamycin is 2,4 hours. Haemodialysis and peritoneal ...

5.1. Pharmacodynamic properties

Pharmacological classification: A 20.1.1 Broad and medium spectrum antibiotics Pharmacotherapeutic group: Anti-infectives for systemic use ATC code: J01FF01 Mode of action Clindamycin ...

5.2. Pharmacokinetic properties

General characteristics of active substance About 90% of a dose of clindamycin hydrochloride is absorbed from the gastro-intestinal tract; concentrations of 2 to 3 micrograms per ml occur within one hour ...

5.3. Preclinical safety data

None stated.

6.1. List of excipients

Lactose monohydrate, magnesium stearate, pregelatinised maize starch, talc. The hard gelatine capsules are composed of: Black iron oxide (E172), gelatine, red iron oxide (E172), titanium dioxide ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

60 months.

6.4. Special precautions for storage

Store at or below 25°C.

6.5. Nature and contents of container

White opaque PVC/Aluminium blisters containing 10 capsules each. 2 (10) blister strips to be packed into a carton i.e. 20 capsules per carton or 10 (10) blister strips to be packed into a carton i.e. 100 ...

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

Sandoz SA (Pty) Ltd1, Waterfall 5-lr, Magwa Crescent West, Waterfall City, Jukskei View, 2090 1 Company Reg. No.: 1990/001979/07

8. Marketing authorization number(s)

CLINDAHEXAL 150: 32/20.1.1/0038 CLINDAHEXAL 300: 32/20.1.1/0039

9. Date of first authorization / renewal of the authorization

Date of first authorisation: CLINDAHEXAL 150 mg: 29 March 1999 CLINDAHEXAL 300 mg: 15 February 2000

10. Date of revision of the text

31 January 2022

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