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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE; Diphenhydramine hydrochloride

Available from:

Johnson & Johnson (Ireland) Limited

ATC code:

N02BE; N02BE51

INN (International Name):

Paracetamol; PSEUDOEPHEDRINE HYDROCHLORIDE; Diphenhydramine hydrochloride

Dosage:

500 mg/12.5 mg/22.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Anilides; paracetamol, combinations excl. psycholeptics

Authorization status:

Marketed

Authorization date:

1998-06-02

Patient Information leaflet

Package leaflet: Information for the patient
BENYLIN® 4 FLU™ FILM COATED TABLETS
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.
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 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 Benylin 4 Flu tablets are and what they are 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.
■ I

Summary of Product characteristics

Health Products Regulatory Authority
22 December 2022
CRN00CT21
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
22 December 2022
CRN00CT21
Page 2 of 9
Concomitant use of o