Metronidazole 0.75% gel

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Metronidazole

Disponível em:

Sigma Pharmaceuticals Plc

Código ATC:

D06BX01

DCI (Denominação Comum Internacional):

Metronidazole

Dosagem:

7.5mg/1gram

Forma farmacêutica:

Cutaneous gel

Via de administração:

Cutaneous

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 13100102

Folheto informativo - Bula

• Zyomet Gel should be applied twice a day, in the morning and
evening, usually three to four months. Your doctor may recommend
a longer treatment depending on the severity of your condition.
• Wash your hands before and after using the gel.
• First, wash and dry the affected area of the skin.
• Using you fingertips, apply a thin layer of gel to the affected
area of
the skin. If it does not rub into your skin easily, you are using too
much.
• If you accidentally get some gel in your eye, wash it carefully
and
thoroughly with warm water.
Your doctor or pharmacist will tell you how long to use Zyomet Gel for
to keep your condition under control.
IF YOU ACCIDENTALLY SWALLOW ZYOMET GEL:
You should contact your doctor or pharmacist immediately for advice.
IF YOU FORGET TO USE ZYOMET GEL:
Apply it when you remember then carry on as normal.
IF YOU STOP USING ZYOMET GEL:
Ensure that you use Zyomet Gel for the full length of time
recommended by your doctor.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Zyomet Gel can cause side effects, although not
everybody gets them.
COMMON SIDE EFFECTS (OCCUR IN LESS THAN 1 IN 10 PATIENTS):
• dry skin
• redness of the skin (erythema)
• itching of the skin (pruritus)
• skin discomfort (burning, pain of skin / stinging)
• skin irritation
• worsening of rosacea
UNCOMMON SIDE EFFECTS (OCCUR IN LESS THAN 1 IN 100 PATIENTS):
• numbness (hypothesia) and tingling (paraesthesia) in the fingers
or toes
• metallic taste (dysgeusia)
• feeling sick (nausea)
UNKNOWN FREQUENCY OF OCCURRENCE (CANNOT BE ESTIMATED FROM THE
AVAILABLE DATA):
• contact dermatitis
• watering of the eyes(if used too closely to the eyes )
If skin irritation should occur either use the gel a little less often
or
even stop using it until the irritation settles down.
IF YOU GET ANY SIDE EFFECTS, TALK TO YOUR DOCTOR OR PHARMACIST OR
NURSE. THIS INCLUDES ANY POSSIBLE SIDE EFFECTS NOT LISTED IN THIS
LEAFLET.
5. HOW TO STORE ZYOMET GEL
Keep this medicine out of the sight and reach of children.
Do not

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zyomet 0.75%w/w Gel
Metronidazole 0.75%w/w Gel
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Metronidazole 0.75% w/w.
3
PHARMACEUTICAL FORM
Gel for cutaneous use.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Metronidazole Gel is indicated for the treatment of acute inflammatory
exacerbations of acne rosacea.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Metronidazole should be applied in a thin layer to the affected areas
of the skin twice
daily, morning and evening. Areas to be treated should be washed with
a mild
cleanser before application. Patients may use non comedogenic and non
astringent
cosmetics after application of metronidazole. The dosage does not need
to be adjusted
for elderly patients. Metronidazole is not recommended for use in
children due to a
lack of data on safety and efficacy. The average period of treatment
varies according
countries. It is usually of three to four months. The recommended
duration of
treatment should not be exceeded. However, if a clear benefit has been
demonstrated
continued therapy for a further three to four months period may be
considered by the
prescribing physician depending upon the severity of the condition. In
clinical
studies, topical metronidazole therapy for rosacea has been continued
for up to 2
years. In the absence of a clear clinical improvement, therapy should
be stopped.
4.3
CONTRAINDICATIONS
Topical metronidazole therapy is contraindicated in individuals with a
history of
hypersensitivity to metronidazole or other ingredients of the
formulation.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Metronidazole Gel has been reported to cause lacrimation of the eyes,
contact with
eyes and mucous membranes should be avoided.
If eye contact does occur the gel should be washed out carefully with
water.
If irritation does occur the patient should be advised to use
metronidazole less
frequently or to stop temporarily and to seek medical advice if
necessary. The UV
exposure (sunbathing, solarium, sunlamp)