Benylin Four Flu tablets

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Pseudoephedrine hydrochloride; Diphenhydramine hydrochloride; Paracetamol

Boleh didapati daripada:

McNeil Products Ltd

Kod ATC:

N02BE51

INN (Nama Antarabangsa):

Pseudoephedrine hydrochloride; Diphenhydramine hydrochloride; Paracetamol

Dos:

22.5mg ; 12.5mg ; 500mg

Borang farmaseutikal:

Oral tablet

Laluan pentadbiran:

Oral

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Never Valid To Prescribe As A VMP

Ringkasan produk:

BNF: 04070100; GTIN: 5010123655969

Risalah maklumat

TABLETS
FLU
FLU
44
FOUR
™™
– 1 –
DIPHENHYDRAMINE, PARACETAMOL,
PSEUDOEPHEDRINE
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
This medicine is available without prescription.
However you still need to take Benylin 4 Flu tablets
carefully to get the best results from it.
„
Keep this leaflet. You may need to read it again.
„
Ask your pharmacist if you need more information
or advice.
„
You must stop use and contact a doctor if your
symptoms worsen or do not improve.
„
If any of the side effects get serious or if you notice
any side effects not listed in this leaflet, please
consult your doctor or pharmacist.
WHAT IS IN THIS LEAFLET
1. What are Benylin 4 Flu tablets and what are they
used for
2. Before taking Benylin 4 Flu tablets
3. How to take this medicine
4. Possible side effects
5. How to store Benylin 4 Flu tablets
6. Further information
7. Information about treating cough and cold in
children
1. WHAT BENYLIN 4 FLU TABLETS ARE
AND WHAT THEY ARE USED FOR
Benylin 4 Flu Tablets are used to help relieve cold
and flu symptoms. The tablets contain paracetamol
which helps to relieve aches and pains and fever
(high temperature), diphenhydramine, which is an
antihistamine that helps relieve coughing, sneezing
and runny nose and pseudoephedrine, which is a
decongestant that helps unblock stuffy noses.
The medicine is for use in adults and children aged
10 years and over.
2. BEFORE TAKING BENYLIN 4 FLU
TABLETS
This medicine is suitable for most people, but a few
should not use it. If you are in any doubt, talk to your
doctor or pharmacist.
DO NOT TAKE THIS MEDICINE…
„
If you are taking any other COUGH AND
COLD MEDICINES or medicines containing
PARACETAMOL.
„
If you have ever had a BAD REACTION
to paracetamol, pseudoephedrine or
diphenhydramine or any of the other
ingredients in this medicine (listed in section 6).
„
If you have HEART DISEASE or HIGH BLOOD
PRESSURE.
„
If you have DIABETES.
„
If you have an OVERACTIVE THYROID GLAND.
„
If you have PHAEOCHROMOCYTOMA

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Benylin Four Flu tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Diphenhydramine hydrochloride 12.5 mg
Paracetamol 500 mg
Pseudoephedrine hydrochloride 22.5 mg
Also contains:
Sunset yellow E110
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Orange, oval, biconvex, film coated tablets (tablets)
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of symptoms associated with colds and flu; including
relief of
nasal
congestion
and
congestion
of
mucous
membranes
of
the
upper
respiratory tract, sneezing, runny nose, coughing, fever, headache,
muscular
aches and pains.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use
ADULTS, THE ELDERLY AND CHILDREN AGED 16 YEARS AND OVER:
Two tablets, up to four times daily, as required. Do not take more
frequently
than every four hours.
CHILDREN 10 TO 15 YEARS
One tablet, up to four times daily, as required. Do not take more
frequently
than every four hours. Not to be used for more than five days without
the
advice of a doctor. Parents or carers should seek medical attention if
the
child’s condition deteriorates during treatment.
CHILDREN UNDER 10 YEARS
Benylin Four Flu Tablets are contraindicated in children under the age
of 10
years (see section 4.3).
Do not exceed the stated dose.
HEPATIC DYSFUNCTION
Caution should be exercised when administrating this medicine to
patients
with severe hepatic impairment.
RENAL DYSFUNCTION
Caution should be exercised when administering this medicine to
patients with
moderate to severe renal impairment.
4.3
CONTRAINDICATIONS
Known hypersensitivity to diphenhydramine, paracetamol,
pseudoephedrine
or to any of the excipients listed in section 6.1.
Concomitant use of other sympathomimetic decongestants, beta-blockers
(see
section 4.5) or monoamine oxidase inhibitors (MAOIs), or within 14
days of
stopping MAOI treatment (see section 4.5). The concomitant use of
MAOIs
may cause a rise in blood pressure and/or hypertensiv