Summary of Product Characteristics (SmPC) - Merazol 2% shampoo
1 NAME OF THE MEDICINAL PRODUCT
Merazol 2% Shampoo
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ketoconazole 20mg/g.
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Shampoo.
Clear, pink solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Prevention and treatment of infections in which the yeast Malassezia (previously called Pityrosporum) is likely to be involved, such as dandruff and seborrhoeic dermatitis.
4.2 Posology and method of administration
Merazol 2% shampoo is for use in adolescents and adults.
Adults and adolescents aged over 12:
Shake the bottle well. Wash the hair or the infected areas of the skin with the Merazol shampoo. Leave in contact for 3-5 minutes before rinsing thoroughly.
Treatment
Wash hair every 3 or 4 days for 2 to 4 weeks.
Prophylaxis
Use once every 1-2 weeks.
Do not use more often than directed.
Paediatric population
The safe and effective use of Merazol 2% Shampoo in infants and children under the age of 12 years has not been established.
Method of administration
For topical administration. Usually, a palmful of shampoo suffices for one wash.
4.3 Contraindications
Known hypersensitivity to ketoconazole or any of the other excipients listed in section 6.1.
4.4 Special warnings and precautions for use
To prevent a rebound effect after stopping prolonged treatment with topical corticosteroids, it is recommended to continue applying the topical corticosteroid together with Merazol shampoo and to subsequently and gradually withdraw the steroid therapy over a period of 2-3 weeks.
Keep out of the eyes. If the shampoo should get into the eyes, they should be bathed with cold water.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
There are no adequate and well-controlled studies in pregnant or lactating women. Data on a limited number of exposed pregnancies indicate no adverse effects of topical ketoconazole on pregnancy or on the health of the foetus/newborn child. Animal studies have shown reproductive toxicity at doses that are not relevant to the topical administration of ketoconazole. No effects on the breastfed newborn/infant are anticipated (See Pharmacokinetic properties, section 5.2)
Plasma concentrations of ketoconazole were not detectable after topical administration of ketoconazole shampoo 2% to the scalp of non-pregnant humans. Plasma levels were detected after topical administration of ketoconazole shampoo 2% on the whole body. There are no known risks associated with the use of ketoconazole shampoo 2% in pregnancy or lactation.
4.7 Effects on ability to drive and use machines
Not relevant.
4.8 Undesirable effects
Seborrhoeic dermatitis and dandruff are often associated with increased hair shedding, and this has also been reported, although rarely, with the use of ketoconazole containing shampoos.
As with other shampoos, a local burning sensation, itching, irritation and oily/dry hair may occur, but are rare, when using shampoos containing ketoconazole.
In rare instances, mainly in patients with chemically damaged hair or grey hair, discolouration of the hair has been observed.
The safety of ketoconazole 2% shampoo was evaluated in 2890 subjects who participated in 22 clinical trials. Ketoconazole 2% shampoo was administered topically to the scalp and/or skin. Based on pooled safety data from these clinical trials, there were no ADRs reported with an incidence ≥1%.
The following table displays ADRs that have been reported with the use of Ketoconazole 2% Shampoo from either clinical trial or postmarketing experiences.
The displayed frequency categories use the following convention:
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1,000 to <1/100)
Rare (≥1/10,000 to <1/1,000)
Very rare (<1/10,000)
Not known (cannot be estimated from the available clinical trial data).
| System Organ Class | Adverse Drug Reactions Frequency Category | ||
Uncommon (≥1/1,000 to <1/100) | Rare (≥1/10,000 to <1/1,000) | Not Known | |
| Immune System disorders | Hypersensitivity | ||
| Nervous System disorders | Dysgeusia | ||
| Infection and Infestations | Folliculitis | ||
| Eye disorders | Increased lacrimation | Eye irritation | |
Skin and subcutaneous tissue disorders | Alopecia Dry skin Hair texture abnormal Rash Skin burning sensation | Acne Dermatitis contact Skin disorder Skin exfoliation | Angioedema Urticaria Hair colour changes |
| General disorders and administration site conditions | Application site erythema Application site irritation Application site pruritus Application site reaction | Application site hypersensitivity Application site pustules |
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reaction via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
In the event of accidental ingestion, only supportive measures should be carried out. In order to avoid aspiration, neither emesis nor gastric lavage should be instigated.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Imidazole and triazole derivatives.
ATC Code: D01A C08.
Ketoconazole is an imidazole-dioxolane antimycotic, active against pathogenic dermatophytes and yeasts including Malassezia. Its broad spectrum of activity is already well known.
5.2 Pharmacokinetic properties
Ketoconazole does not appear to be appreciably absorbed systemically following topical application of a 2% shampoo to skin. Ketoconazole was not detected in plasma of patients receiving topical application of 2% shampoo 4-10 times weekly for 6 months, or in patients using 2% shampoo 2-3 times weekly for an average of 16 months. Following single topical application, substantial amounts of the drug were detected in hair 12 hours after application; however only 5% of the applied ketoconazole was detected in hair keratin. Following repeated (twice weekly for 2 months) application, 20% of the applied dose was detected in hair keratin.
Plasma levels were detected after topical administration of ketoconazole 2% shampoo on the whole body.
5.3 Preclinical safety data
Effects in non-clinical studies were observed only at exposure considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
In vitro studies using ketoconazole in a microbial system (i.e. Ames test) have not shown the drug to be mutagenic. In addition, there was no evidence of mutagenicity in any stage of germ cell development in a dominant lethal mutation test in mice who received single oral doses of ketoconazole as high as 80mg/kg. There was no evidence of carcinogenicity in a long-term feeding study in mice and rats. Hepatotoxicity featured prominently in high dose toxicology studies in animals and occurs in about 1 in 10,000 patients.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium laureth sulphate, Disodium laureth sulphosuccinate, PEG-120 Methyl glucose dioleate, PEG-7 Glyceryl cocoate, Imidurea, Lauryldimonium hydroxypropyl hydrolysed collagen, Cocamide DEA, Sodium hydroxide, Sodium chloride, Erythrosine C.I. 45430 (E127), Hydrochloric acid concentrated, Purified water
6.2 Incompatibilities
None known
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25ºC
6.5 Nature and contents of container
White opaque HDPE bottle with PP closure Pack sizes 60, 80, 100, 120ml
6.6 Special precautions for disposal
No special instructions
7 MARKETING AUTHORISATION HOLDER
RUDIPHARM LIMITED
Unit 6, Salbrook Road Industrial Estate Salbrook Road, Redhill
Surrey, RH1 5GJ
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 49565/0146
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
24/06/2008
10 DATE OF REVISION OF THE TEXT
13/02/2025