Benylin Four Flu Film-Coated Tablets. Paracetamol 500mg Diphenhydramine hydrochloride 12.5mg Pseudoephedrine hydrochloride 22.5mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE; Diphenhydramine hydrochloride

Available from:

JNTL Consumer Health I (Ireland) Limited

ATC code:

N02BE; N02BE51

INN (International Name):

Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE; Diphenhydramine hydrochloride

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Anilides; paracetamol, combinations excl. psycholeptics

Authorization status:

Marketed

Authorization date:

1998-06-02

Patient Information leaflet

_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

Summary of Product characteristics

Health Products Regulatory Authority
28 March 2024
CRN00DGVL
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benylin Four Flu Film-Coated Tablets. Paracetamol 500mg
Diphenhydramine hydrochloride 12.5mg Pseudoephedrine
hydrochloride 22.5mg
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.
Health Products Regulatory Authority
28 March 2024
CRN00DGVL
Page 2 of 9
Concomitant use of other s