Anthisan Cream 2% w/w

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Nunua Sasa

Taarifa za kipeperushi Taarifa za kipeperushi (PIL)
11-12-2017
Tabia za bidhaa Tabia za bidhaa (SPC)
12-12-2017

Viambatanisho vya kazi:

Mepyramine maleate

Inapatikana kutoka:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC kanuni:

D04AA; D04AA02

INN (Jina la Kimataifa):

Mepyramine maleate

Kipimo:

2 percent weight/weight

Dawa fomu:

Cream

Dawa ya aina:

Product not subject to medical prescription

Eneo la matibabu:

Antihistamines for topical use; mepyramine

Idhini hali ya:

Marketed

Idhini ya tarehe:

1979-04-01

Taarifa za kipeperushi

                                ANTHISAN
®
_cream 2%w/w _
_mepyramine maleate_
IS THIS LEAFLET HARD TO SEE OR READ? PHONE 01 403 5600 FOR HELP.
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR
YOU.
This medicine is available without prescription. However, you still
need to use Anthisan
Cream carefully to get the best results from it.
– Keep this leaflet. You may need to read it again.
– Ask your pharmacist if you need more information or advice.
– You must contact a doctor if your symptoms worsen or do not
improve after 3 days.
– If any of the side effects gets serious, or if you notice any side
effect not listed in this
leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Anthisan Cream is and what it is used for
2. What you need to know before you use Anthisan Cream
3. How to use Anthisan Cream
4. Possible side effects
5. How to store Anthisan Cream
6. Contents of the pack and other information
1. WHAT ANTHISAN CREAM IS AND WHAT IT IS USED FOR
WHAT ANTHISAN CREAM IS AND WHAT IT IS USED FOR
Anthisan Cream contains a medicine called mepyramine maleate. This
belongs to a
group of medicines called antihistamines. It worksby blocking a
natural substance
(histamine) that your body makes during an allergic reaction.
ANTHISAN CREAM IS USED FOR TREATING:
• Pain, itch and inflammation caused by insect stings, bites and
nettle rash.
2. B
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ANTHISAN CREAM
EFORE YOU USE ANTHISAN CREAM
DO NOT USE THIS MEDICINE AND TELL YOUR DOCTOR OR PHARMACIST IF:
• You are allergic (hypersensitive) to mepyramine maleate or any of
the other
ingredients of Anthisan Cream (listed in Section 6 below).
The signs of an allergic reaction include: rash, swallowing or
breathing problems,
swelling of your lips, face, throat or tongue.
• If you are pregnant, might become pregnant, or think you may be
pregnant.
• If you are breast feeding or planning to breast feed.
DO NOT USE THIS MEDICINE:
• In premature infants and neonates.
• With adhesive dressings.
DO NOT APPLY THE CR
                                
                                Soma hati kamili
                                
                            

Tabia za bidhaa

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Anthisan Cream 2% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Mepyramine maleate 2% w/w
Also contains Methyl Parahydroxybenzoate (E 218) and Cetostearyl
Alcohol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
Smooth homogeneous cream of fairly firm consistency, off-white to pale
in colour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Anthisan has analgesic, anti-histaminic and anti-pruritic properties.
Symptomatic relief in insect bites, stings and nettle rash.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The route of administration is topical.
Recommended Dosage
Apply to affected area 2 to 3 times daily for up to 3 days or as
directed by the physician.
4.3 CONTRAINDICATIONS
Acute vesicular and exudative dermatoses.
Use in eczematous conditions or on broken skin.
Use with occlusive dressings.
Use in patients hypersensitive to mepyramine maleate or any of the
excipients of Anthisan Cream.
Use in premature infants and neonates.
Pregnancy and lactation.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Repeated application for periods longer than a few days is not
recommended and treatment should be discontinued
immediately if skin sensitization occurs.
If symptoms persist, consult a doctor.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None.
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                                Soma hati kamili
                                
                            

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