Uniflu Tablets, film coated oblong tablet

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE, CAFFEINE, DIPHENHYDRAMINE HYDROCHLORIDE, CODEINE PHOSPHATE

Available from:

Alliance Pharma (Ireland) Ltd

ATC code:

N02BE51

INN (International Name):

PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE, CAFFEINE, DIPHENHYDRAMINE HYDROCHLORIDE, CODEINE PHOSPHATE

Pharmaceutical form:

FILM-COATED TABLET

Composition:

PARACETAMOL 500 milligram(s) ; PHENYLEPHRINE HYDROCHLORIDE 10 milligram(s) ; CAFFEINE 30 milligram(s) ; DIPHENHYDRAMINE HYDROCHLORIDE 15 milligram(s) ; CODEINE PHOSPHATE 10 milligram(s)

Prescription type:

OTC

Therapeutic area:

ANALGESICS

Authorization status:

Authorised

Authorization date:

2007-03-02

Patient Information leaflet

Uniflu with Gregovite C PIL MT 010
PATIENT INFORMATION LEAFLET
UNIFLU
™ TABLETS
WITH GREGOVITE ‘C’
™ (VITAMIN C) TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist
has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If
you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Uniflu with Gregovite ‘C’ (Vitamin C) tablets are and what
they are used for
2. What you need to know before you take Uniflu with Gregovite ‘C’
(Vitamin C) tablets
3. How to take Uniflu with Gregovite ‘C’ (Vitamin C) tablets
4. Possible side effects
5.
How to store Uniflu with Gregovite ‘C’ (Vitamin C) tablets
6.
Contents of the pack and other information
1. WHAT UNIFLU WITH GREGOVITE ‘C’ (VITAMIN C) TABLETS ARE AND WHAT
THEY ARE USED
FOR
Uniflu with Gregovite ‘C’ (Vitamin C) tablets should be taken to
relieve the symptoms of colds,
and flu such as nasal and sinus congestion, headache, fever, aching
limbs, coughing and runny
nose. Uniflu with Gregovite ‘C’ (Vitamin C) tablets can also be
taken to relieve the symptoms of
allergic conditions like hayfever, such as nasal congestion.
This medicine should be taken at the first signs of sneezing, dry
throat, aching limbs, coughing,
headache and cold shivers.
HOW UNIFLU WITH GREGOVITE ‘C’ (VITAMIN C) TABLETS WORK
•
PARACETAMOL: an analgesic which acts as a painkiller and reduces
fever.
•
CODEINE PHOSPHATE: an antitussive which acts as a cough suppressant.
•
DIPHENHYDRAMINE HYDROCHLORIDE: an antihistamine which stops a runny
nose and
reduces irritation of the nasal passages and thus provides relief from
sneezing.
•
PHENYLEPHRINE HYDROCHLORIDE: a decongestant which reduces inflammat

Summary of Product characteristics

Uniflu SPC Malta 010
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Uniflu Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Caffeine
30.0 mg
Codeine Phosphate
10.0 mg
Diphenhydramine Hydrochloride
15.0 mg
Paracetamol
500.0 mg
Phenylephrine Hydrochloride
10.0 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
White, film coated, oblong tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic relief from the discomforts associated with
influenza
and colds _i.e_. nasal and sinus congestion, headache, fever, aching
limbs,
coughing and runny nose; and for the symptomatic relief of nasal
congestion in allergic conditions such as hay fever.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS:
One Uniflu Tablet to be swallowed whole with water, followed by one
tablet every six hours until the symptoms disappear.
Not more than four tablets of Uniflu to be taken in 24 hours.
ELDERLY:
As adult dose.
PAEDIATRIC POPULATION:
Children aged less than 12 years:
Uniflu Tablets are contraindicated in children below the age of 12
years
Uniflu SPC Malta 010
(see section 4.3).
Children aged 12 years to 18 years:
Uniflu Tablets are not recommended for use in children aged 12 years
to
18 years with compromised respiratory function (see section 4.4).
For those children aged 12 to 18 years who do not have compromised
respiratory function the following is recommended:
One tablet every eight hours until symptoms disappear.
Not more than three tablets of Uniflu to be taken in 24
hours.
For longer term use, the risk benefit should be assessed regularly by
the
prescriber.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed
in section 6.1.
Phenylephrine
Hyperthyroidism, hypertension, cardiovascular disorders coronary heart
disease. Patients treated with monoamine oxidase inhibitors (MAOIs) or
within fourteen days of stopping such treatment.
Caffeine
Patients with history of peptic ulceration
Codeine
Chronic obstructive airways dise