ZACIN Cream (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Zacin 0.025% w/w Cream.

2. Qualitative and quantitative composition

Capsaicin 0.025% w/w. Excipient(s) with known effect: Each cream tube contains 450 mg benzyl alcohol which is equivalent to 0.01 mg/mg. Each cream tube contains 3.6g Cetyl alcohol which is equivalent ...

3. Pharmaceutical form

Cream for topical application.

4.1. Therapeutic indications

For the symptomatic relief of pain associated with osteoarthritis.

4.2. Posology and method of administration

Adults and the elderly For topical administration to unbroken skin. Apply only a small amount of cream (pea size) to affected area 4 times daily. These applications should be evenly spaced throughout the ...

4.3. Contraindications

Zacin cream is contra-indicated on broken or irritated skin. Zacin Cream is contra-indicated in patients with hypersensitivity to the active substance or to any of the excipients listed in section 6.1. ...

4.4. Special warnings and precautions for use

Skin irritation has been reported following application of Zacin. The hands should be washed immediately after application of the cream, unless the hands are the treated areas, in which case, they should ...

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

No interaction studies have been performed.

4.6. Pregnancy and lactation

The safety of Zacin during pregnancy and lactation has not been established, in either humans or animals. However, in the small amounts absorbed transdermally from Zacin Cream, it is considered unlikely ...

4.7. Effects on ability to drive and use machines

Not applicable.

4.8. Undesirable effects

Zacin may cause skin irritation or transient burning on application. This burning is observed more frequently when application schedules of more than 4 times daily are utilised. The burning can be enhanced ...

4.9. Overdose

Not applicable.

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Topical products for joint and muscular pain, Capsaicin and similar agents ATC code: M02AB01 Although the precise mechanism of action of capsaicin is not fully ...

5.2. Pharmacokinetic properties

Absorption after topical application is unknown. Average consumption of dietary spice from capsicum fruit has been estimated at 2.5 g/person/day in India and 5.0 g/person/day in Thailand. Capsaicin content ...

5.3. Preclinical safety data

The available animal toxicity data relating to capsicum, capsicum extracts and capsaicin do not suggest that, in usual doses, they pose any significant toxicity hazard to man. Thus, in both single and ...

6.1. List of excipients

Purified water Sorbitol solution Isopropyl myristate Cetyl alcohol White soft paraffin Glyceryl stearate and Peg-100 Stearate (Arlacel 165) Benzyl alcohol

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

2 years.

6.4. Special precautions for storage

Store below 25°C. Return any unused cream to your doctor or pharmacist.

6.5. Nature and contents of container

Aluminium tubes with epoxyphenolic lining and polypropylene spiked cap containing 45 g of Zacin Cream 0.025%.

6.6. Special precautions for disposal and other handling

No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Cephalon UK Limited, Ridings Point, Whistler Drive, Castleford, West Yorkshire, WF10 5HX, United Kingdom

8. Marketing authorization number(s)

PL 16260/0028

9. Date of first authorization / renewal of the authorization

22 March 2010

10. Date of revision of the text

24/11/2020

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