Benylin Four Flu Film-Coated Tablets Paracetamol 500mg

Երկիր: Մալթա

Լեզու: անգլերեն

Աղբյուրը: Medicines Authority

Ակտիվ բաղադրիչ:

DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE

Հասանելի է:

Johnson & Johnson (Ireland) Limited Airton Road Tallaght, Dublin 24, Dublin, Ireland

ATC կոդը:

N02BE51

INN (Միջազգային անվանումը):

DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg PARACETAMOL 500 mg PSEUDOEPHEDRINE HYDROCHLORIDE 22.5 mg

Դեղագործական ձեւ:

FILM-COATED TABLET

Կազմը:

DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg PARACETAMOL 500 mg PSEUDOEPHEDRINE HYDROCHLORIDE 22.5 mg

Ռեկվիզորի տեսակը:

OTC

Թերապեւտիկ տարածք:

ANALGESICS

Լիազորման կարգավիճակը:

Authorised

Հաստատման ամսաթիվը:

2016-05-06

Տեղեկատվական թերթիկ

_FILM-COATED TABLETS_
TM
_FOUR_
®
■
If you have ALCOHOL DEPENDENCE.
■
If you have difficulty with passing water and / or an
enlarged prostate (which may mean you need to pass
water more often).
■
If you are SUSCEPTIBLE TO GLAUCOMA (increased
pressure in the eye).
■
If you have BLOCKED ARTERIES OR VEINS (occlusive
vascular disease).
■
If you have BRONCHITIS, EMPHYSEMA or ASTHMA, or
have had a COUGH FOR A FEW WEEKS, OR A COUGH
WITH A LOT OF MUCUS (PHLEGM).
■
If you are being treated for a THYROID DISORDER.
TAKING OTHER MEDICINES
If you are taking any OTHER MEDICINES including:
■
_Tricyclic antidepressants_ (drugs to treat MOOD DISORDERS).
■
_Anticholinergic drugs_ (drugs used to treat CRAMPS
and SPASMS such as _atropine_).
■
_Hypnotics_ (SLEEPING TABLETS including _barbiturates_).
■
_Tranquillisers_ (drugs used to RELAX MUSCLES or DECREASE ANXIETY).
■
_Opioid analgesics_ (drugs used to RELIEVE PAIN e.g.
codeine, tramadol, morphine).
■
_Antipsychotics_ (drugs used to treat MOOD DISORDERS).
■
_Antihypertensives_ (drugs used to treat HIGH BLOOD
PRESSURE such as _guanethidine, methyldopa, adrenergic _
_neurone blockers, debrisoquine, bretylium_ and _betanidine_).
■
_Moclobemide_ (used to treat MOOD DISORDERS).
■
_Cardiac glycosides_ (drugs used to CONTROL HEART RHYTHMS OR CONTRACTIONS such as _digoxin_).
■
_Ergot alkaloids_ (drugs used to TREAT MIGRAINE such
as _ergotamine_ and _methysergide_).
■
_Oxytocin_ (drug used to help CONTRACTIONS during CHILDBIRTH).
■
_Oral contraceptives_ (“THE PILL”).
■
_Metoclopramide_ or _domperidone_ (used to treat NAUSEA and VOMITING).
■
_Cholestyramine_ (used to LOWER BLOOD CHOLESTEROL).
■
_Anticoagulants_ (drugs used to THIN THE BLOOD, such
as _warfarin_).
■
_Anticonvulsants_ (drugs to treat EPILEPSY).
■
Flucloxacillin (used to treat infections).
turn over
Paracetamol 500 mg, Diphenhydramine hydrochloride
12.5 mg, Pseudoephedrine hydrochloride 22.5 mg
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Ապրանքի հատկությունները

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Benylin Four Flu Film-Coated Tablets
Paracetamol 500 mg
Diphenhydramine hydrochloride 12.5 mg
Pseudoephedrine hydrochloride 22.5 mg
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
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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