Demiflu Forte tablets

Država: Armenija

Jezik: angleščina

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktivna sestavina:

paracetamol

Dostopno od:

Farmalabor - Produtos Farmaceuticos

Koda artikla:

N02BE01

INN (mednarodno ime):

paracetamol

Odmerek:

1000mg

Farmacevtska oblika:

tablets

Enote v paketu:

(20/2x10/) in blister, (40/4x10/) in blister, (60/6x10/) in blister

Tip zastaranja:

Prescription

Status dovoljenje:

Registered

Datum dovoljenje:

2019-09-23

Navodilo za uporabo

INFORMATION LEAFLET: INFORMATION FOR THE USER
DEMIFLU FORTE, 1000 MG, TABLET
Paracetamol
Read all of this leaflet carefully before you start taking this
medicine because it contains important
information for you.
Keep this leaflet. You may need to read it again.
if you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
If you get any side effects, including any possible side effects not
listed in this leaflet, please tell
your doctor or pharmacist. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Demiflu Forte is and what it is used for
2. What you need to know before you take Demiflu Forte
3. How to take Demiflu Forte
4. Possible side effects
5. How to store Demiflu Forte
6. Contents of the pack and further information
1. WHAT DEMIFLU FORTE IS AND WHAT IT IS USED FOR
Demiflu Forte is a medicine used for pain relief and to reduce fever
(analgesic and antipyretic).
It is used for the symptomatic treatment of clinical situations such
as:
- flu-like or feverish conditions due to infections
- feverish reactions associated to vaccination
- headache and migraine
- toothache, earache, menstrual period, traumatic, muscle and joint
pain, and osteoarthritis
- pain relief before and after surgery.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEMIFLU FORTE
DO NOT TAKE DEMIFLU FORTE
- if you are allergic (hypersensitive) to paracetamol or any of the
ingredients of this medicine (see
section 6)
- if you have a severe liver disease.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Demiflu Forte.
TAKE SPECIAL CARE:
if you have a liver disease (for example, inflammation of the liver
caused by abuse of alcoholic
drinks) or kidney disease.
if you are taking other medicines containing paracetamol
if you have severe haemolytic anaemia (abnormal decrease of the number
of red blood cells)
if
you
have
a
hereditary
and
rare
metabolic
disease
called
Gilbert's
syndrome
which
is
a

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Demiflu Forte, 1000 mg, tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1000 mg paracetamol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White oblong tablets, scored on one side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Demiflu Forte is indicated for the symptomatic treatment of clinical
conditions that require an
analgesic and/or antipyretic such as:
- Symptoms associated to flu states or other infectious hyperthermia
- Febrile reactions to vaccination
- Headaches and migraines
- Toothaches, earaches, menstrual period, traumatic, muscle and joint
pain, and osteoarthritis
- Analgesic before and after surgery.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Demiflu Forte is for oral administration in adults aged 18 or over.
POSOLOGY
The usual dosage for Demiflu Forte is 1 tablet 2 to 4 times per day.
The
administration
can
be
repeated
with
4-8
hours
intervals,
depending
on
the
clinical
condition.
The maximum daily dose is 4 tablets (i.e., 4 g paracetamol/day).
SPECIAL PATIENT GROUPS
It is not necessary to adjust the dose in elderly patients.
In patients with hepatic or renal impairment or with Gilbert's
disease, the dose must be reduced
or the dosing interval prolonged.
_ _
METHOD OF ADMINISTRATION
The tablets may be swallowed whole or dissolved in water.
The administration after meals can delay the onset of action.
Except on medical advice, medicines containing paracetamol should not
be taken for more than
a few days, or at high doses.
4.3
CONTRAINDICATIONS
Demiflu Forte is contraindicated in the following situations:
- hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
- severe liver disease.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
At therapeutic doses, paracetamol is relatively non-toxic. However,
the appearance of allergic
skin reac