Solpadeine tablets

البلد: أرمينيا

اللغة: الإنجليزية

المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

العنصر النشط:

paracetamol, caffeine, codeine (codeine phosphate)

متاح من:

GlaxoSmithKline Dungarvan Limited

ATC رمز:

N02BE51

INN (الاسم الدولي):

paracetamol, caffeine, codeine (codeine phosphate)

جرعة:

500mg+ 30mg+ 8mg

الشكل الصيدلاني:

tablets

الوحدات في الحزمة:

(8/1x8/) in blister

نوع الوصفة الطبية :

Prescription

الوضع إذن:

Registered

تاريخ الترخيص:

2017-05-04

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Solpadeine
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500 mg, Codeine Phosphate 8 mg and
Caffeine 30.0 mg.
3. PHARMACEUTICAL FORM
Tablets
4. CLINICAL
PARTICULARS
4.1. THERAPEUTIC INDICATIONS
TREATMENT OF ACUTE MODERATE PAIN, AND RELIEF OF PAIN ASSOCIATED WITH
FEVER, INCLUDING:
Headache
Migraine
Toothache, including pain after dental procedures/ tooth extraction_ _
Muscle ache and pain of osteoarthritis_ _
Musculoskeletal pain
Neuralgia
Dysmenorrhoea
Sciatica
Pain associated with sinusitis
Sore throat
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Oral administration only.
Adults older than 18 years (including the eldery:
1-2 tablets taken every 4-6 hours as required. Minimum dosing
interval: 4 hours. Maximum daily
dose is 8 tablets (4000 mg paracetamol /240 mg caffeine /64 mg
codeine).
Do not exceed the recommended dose or take for more than 3 days
without consulting your
doctor. Do not exceed the stated dose.
The lowest dose necessary to achieve efficacy should be used.
Children (under 18 years):
Paracetamol-caffeine-codeine must not be used in patients under 18
years.
4.3. CONTRAINDICATIONS
This product is contraindicated in patients:

with a previous history of hypersensitivity to paracetamol, caffeine,
codeine, opioid
analgesics or any excipients

under the age of 18 years because of the risk of opioid toxicity due
to the variable and
unpredictable metabolism of codeine to morphine

who are breastfeeding

who are known to be CYP2D6 ultra-rapid metabolisers because of
increasing risk of
developing symptoms of opioid toxicity, even at commonly prescribed
doses.
General symptoms of opioid toxicity include confusion, somnolence,
shallow breathing,
small pupils, nausea, vomiting, constipation and lack of appetite. In
severe cases this may
include symptoms of circulatory and respiratory depression which may
be life threatening
and very rarely fatal.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Contains par