Solpadeine Active tablets soluble

Land: Armenien

Sprache: Englisch

Quelle: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Wirkstoff:

paracetamol, caffeine

Verfügbar ab:

Famar A.V.E. Anthoussa Plant

ATC-Code:

N02BE51

INN (Internationale Bezeichnung):

paracetamol, caffeine

Dosierung:

500mg+ 65mg

Darreichungsform:

tablets soluble

Einheiten im Paket:

(12/2x6/) in strip

Verschreibungstyp:

OTC

Berechtigungsstatus:

Registered

Berechtigungsdatum:

2019-12-30

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Solpadeine Active
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Paracetamol 500.0 mg and Caffeine 65.0 mg.
3.
PHARMACEUTICAL FORM
Soluble tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TREATMENT OF MILD TO MODERATE INTENSITY PAIN AND RELIEF OF FEVER
INCLUDING:
Headache
Migraine
Muscle ache
Dysmennorhoea
Sore throat
Musculoskeletal pain
Fever and pain after vaccination
Pain after dental procedures/ tooth extraction
Toothache
Pain of osteoarthritis
_For Colds and Flu:_
For the relief of symptoms of the common cold and influenza for
example headache, fever,
sore throat, muscular aches and pains reduced alertness and
drowsiness.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Oral administration only. Should be dissolved in at least half a
tumbler of water.
Adults (including the elderly) and children aged 12 years and over:
1-2 tablets every 4 to 6 hours as required. Do not exceed 8 tablets in
24 hours. Minimum
dosing interval: 4 hours. The lowest dose necessary to achieve
efficacy should be used.
Children:
not recommended for children under the age of 12 years.
Do not exceed the stated dose. If symptoms continue consult the
doctor.
4.3
CONTRAINDICATIONS
Hypersensitivity to paracetamol, caffeine or excipients.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
CONTAINES PARACETAMOL. Do not use with any other
paracetamol-containing
products. The concomitant use with other products containing
paracetamol may lead to an
overdose. Paracetamol overdose may cause liver failure which can lead
to liver transplant
or death.
Underlying liver disease increases the risk of paracetamol-related
liver damage. Patients
who have been diagnosed with liver or kidney impairment must seek
medical advice
before taking this medication.
Cases of hepatic dysfunction/failure has been reported in patients
with depleted glutathione
levels, such as those who are severely malnourished, anorexic, have
low body mass index or
are chronic heavy users of alcohol.