Benylin Four Flu Tablet, film coated

Страна: Малта

Език: английски

Източник: Medicines Authority

Активна съставка:

DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE

Предлага се от:

McNeil Products Limited

АТС код:

N02BE51

INN (Международно Name):

DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE

Лекарствена форма:

FILM-COATED TABLET

Композиция:

DIPHENHYDRAMINE HYDROCHLORIDE 12.5 milligram(s) ; PARACETAMOL 500 milligram(s) ; PSEUDOEPHEDRINE HYDROCHLORIDE 22.5 milligram(s)

Вид предписание :

OTC

Терапевтична област:

ANALGESICS

Статус Оторизация:

Authorised

Дата Оторизация:

2016-05-06

Листовка

_FLU_
TABLETS
TM
FOUR
Q
This medicine is used for the treatment of cold and flu
symptoms, including aches, pains and fever (high
temperature), cough and congestion.
Q
This medicine is for use by adults and children aged 10 years
and over.
Q
DO NOT USE THIS MEDICINE:

Q
There are some people who should not use this medicine.
To find out if you are one of them _see section 2_

Q
If you have ever had a BAD REACTION to any of the
ingredients. For the list of ingredients _see section 6_
Q
SPEAK TO YOUR DOCTOR:

Q
If you suffer from any of the conditions mentioned in
section 2. _See section 2_

Q
If you are taking ANY OTHER MEDICINES. _See section 2_
Q
FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. Children and
adults need different amounts. _See section 3_
1 WHAT THE MEDICINE IS 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 USING THIS MEDICINE
This medicine is suitable for most people, but a few people
should not use it. If you are in any doubt, talk to your doctor
or pharmacist.
DO NOT USE THIS MEDICINE…
Q
If you are taking any other medicines containing
PARACETAMOL.
Q
If you have ever had a BAD REACTION to any of
the ingredients.
Q
If you have HEART DISEASE or HIGH BLOOD PRESSURE.
Q
If you have DIABETES.
Q
If you have an OVERACTIVE THYROID.
Q
If you have PHAEOCHROMOCYTOMA (rare tumour
which affects your heart rate and blood pressure).
Q
If you are taking, or have taken in the last two
weeks, DRUGS FOR DEPRESSION known as Monoamine
Oxidase Inhibitors (MAOIs) or Reversible Inhibitors
of Monoamine Oxidase (RIMAs).
Q
If you SUFFER FROM OR HAVE HAD CLOSED ANGLE
GLAUCOMA (increased pressure in the eye).
Q
If you are taking BETA BLOCKER

Данни за продукта

1
SUMMARY OF PRODUCT CHARACTERISTICS
BENYLIN FOUR FLU TABLETS
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
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.
2
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.
4.3
CONTRAINDICATIONS
Known hypersensitivity to diphenhydramine, paracetamol,
pseudoephedrine or to
any of the excipients.
Concomitant use of other sympathomimetic agents including those given
by other
routes, beta-blockers (see section 4.5) and monoamine oxidase
inhibitors (MAOIs), or
within 14 days of stopping MAOI treatment (see section 4.5)
Cardiovascular disease including hypertension
Diabetes mellitus
Phaeochromocytoma
Hyperthyroidism
Closed angle glaucoma
Severe renal impairment
Not to be used in children under the age of 10 years.
4.4_ _
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As both diphenhydramine and pseudoephedrine have been associate