Lemsip Max cold & flu Blackcurrent Oral Powder 1000mg/10mg

Nchi: Malta

Lugha: Kiingereza

Chanzo: Medicines Authority

Viambatanisho vya kazi:

PHENYLEPHRINE, PARACETAMOL

Inapatikana kutoka:

Reckitt Benckiser Healthcare (UK) Limited 103-105 Bath Road Slough SL1 3UH, United Kingdom

ATC kanuni:

N02BE51

INN (Jina la Kimataifa):

PHENYLEPHRINE 10 mg PARACETAMOL 1000 mg

Dawa fomu:

POWDER FOR ORAL SOLUTION

Tungo:

PHENYLEPHRINE 10 mg PARACETAMOL 1000 mg

Dawa ya aina:

OTC

Eneo la matibabu:

ANALGESICS

Idhini hali ya:

Withdrawn

Idhini ya tarehe:

2012-03-01

Taarifa za kipeperushi

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lemsip Max Cold and Flu Blackcurrant
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENTS
MG/SACHET
SPECIFICATION
Paracetamol
1000.00
Ph Eur
Phenylephrine hydrochloride*
12.20
Ph Eur
* Equivalent to phenylephrine (base) 10.0 mg.
3
PHARMACEUTICAL FORM
Oral powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For relief of the symptoms of colds and influenza, including the
relief of aches
and
pains,
sore
throat,
headache,
nasal
congestion
and
lowering
of
temperature.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oral administration after dissolution in water.
Adults and children over 12_:_ One sachet dissolved by stirring in hot
water and
sweetened to taste.
The dose may be repeated in 4-6 hours.
No more than four doses should be taken in 24 hours.
Not to be given to children under 12 without medical advice.
There is no indication that dosage need be modified in the elderly.
4.3
CONTRAINDICATIONS

Hypersensitivity to paracetamol, phenylephrine or any other
ingredient.

Severe coronary heart disease and cardiovascular disorders.

Hypertension.
Page 2 of 7

Hyperthyroidism.

Contraindicated in patients currently receiving or within two weeks of
stopping therapy with monoamine oxidase inhibitors (see section 4.5).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Use with caution in patients with Raynaud's phenomenon or diabetes
mellitus.
Care is advised in the administration of paracetamol to patients with
severe
renal or severe hepatic impairment. The hazard of overdose is greater
in those
with non-cirrhotic alcoholic liver disease. Patients should be advised
not to
take other paracetamol-containing products concurrently.
Each
sachet
contains
approximately
2.3
g
of
carbohydrate.
Due
to
its
aspartame
content
this
product
should
not
be
given
to
patients
with
phenylketonuria.
Phenylephrine
Phenylephrine
should
be
used
with
care
in
patients
with
cardiovascular
disease, diabetes mellitus, closed angle glaucoma, prostatic
e

Tabia za bidhaa

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lemsip Max Cold and Flu Blackcurrant
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENTS
MG/SACHET
SPECIFICATION
Paracetamol
1000.00
Ph Eur
Phenylephrine hydrochloride*
12.20
Ph Eur
* Equivalent to phenylephrine (base) 10.0 mg.
3
PHARMACEUTICAL FORM
Oral powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For relief of the symptoms of colds and influenza, including the
relief of aches
and
pains,
sore
throat,
headache,
nasal
congestion
and
lowering
of
temperature.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oral administration after dissolution in water.
Adults and children over 12_:_ One sachet dissolved by stirring in hot
water and
sweetened to taste.
The dose may be repeated in 4-6 hours.
No more than four doses should be taken in 24 hours.
Not to be given to children under 12 without medical advice.
There is no indication that dosage need be modified in the elderly.
4.3
CONTRAINDICATIONS

Hypersensitivity to paracetamol, phenylephrine or any other
ingredient.

Severe coronary heart disease and cardiovascular disorders.

Hypertension.
Page 2 of 7

Hyperthyroidism.

Contraindicated in patients currently receiving or within two weeks of
stopping therapy with monoamine oxidase inhibitors (see section 4.5).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Use with caution in patients with Raynaud's phenomenon or diabetes
mellitus.
Care is advised in the administration of paracetamol to patients with
severe
renal or severe hepatic impairment. The hazard of overdose is greater
in those
with non-cirrhotic alcoholic liver disease. Patients should be advised
not to
take other paracetamol-containing products concurrently.
Each
sachet
contains
approximately
2.3
g
of
carbohydrate.
Due
to
its
aspartame
content
this
product
should
not
be
given
to
patients
with
phenylketonuria.
Phenylephrine
Phenylephrine
should
be
used
with
care
in
patients
with
cardiovascular
disease, diabetes mellitus, closed angle glaucoma, prostatic
e