Benylin Four Flu Liquid

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE

Available from:

McNeil Products Limited Foundation Park, Roxborough Way, Maidenhead, Berkshire SL6 3UG, United Kingdom

ATC code:

R05X

INN (International Name):

DIPHENHYDRAMINE HYDROCHLORIDE 25 µg/dose PARACETAMOL 1000 µg/dose PSEUDOEPHEDRINE HYDROCHLORIDE 45 µg/dose

Pharmaceutical form:

ORAL SOLUTION

Composition:

DIPHENHYDRAMINE HYDROCHLORIDE 25 µg/dose PARACETAMOL 1000 µg/dose PSEUDOEPHEDRINE HYDROCHLORIDE 45 µg/dose

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Withdrawn

Authorization date:

2006-08-10

Patient Information leaflet

■
 If you are taking ANY OTHER MEDICINES, 
including:
■
  _Antimuscarinic_ drugs e.g.:
-  _tricyclic_ _antidepressants _(drugs to treat MOOD 
DISORDERS).
-  _atropine _(used to treat some EYE CONDITIONS 
and occasionally BOWEL CONDITIONS).
■
  CNS depressants e.g.:
- _hypnotics_ (SLEEPING TABLETS including 
barbiturates).
-  _minor 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 including alpha and beta 
blockers).
■
  _Moclobemide_ (used to TREAT MOOD 
DISORDERS)._ _
■
  _Cardiac glycosides _(drugs used to CONTROL HEART 
RHYTHMS OR CONTRACTIONS) e.g. 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)_._
■
 _ Colestyramine_ (used to treat HIGH 
CHOLESTEROL)_._
■
 _ Anticoagulants_ (drugs that THIN THE BLOOD, 
such as warfarin)_._
■
 _ Anticonvulsants_ (drugs to treat EPILEPSY)_._
If you are not sure about the medicine you are taking, 
show the bottle or pack to your pharmacist.  
If any of these bullet points apply, TALK TO A DOCTOR 
OR PHARMACIST.
IF YOU ARE PREGNANT OR BREAST-FEEDING
■
 Ask your doctor or pharmacist for advice 
before taking this medicine if you might be 
pregnant or are breast-feeding.
SPECIAL WARNINGS ABOUT THIS MEDICINE
■
 You can use this medicine while you are taking 
oral contraceptives (“the pill”) or anticonvulsant 
tablets used to treat epilepsy, but the medicine 
may not work so well on your pain or fever. 
2
  BEFORE TAKING THIS    
 MEDICINE 
This medicine is suitable for most people b

Summary of Product characteristics

1 

SUMMARY OF PRODUCT CHARACTERISTICS

BENYLIN FOUR FLU LIQUID

1.

NAME OF THE MEDICINAL PRODUCT 
Benylin Four Flu liquid 
2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION  
Each 20 ml contains: 
Diphenhydramine hydrochloride 25 mg 
Paracetamol 1000 mg 
Pseudoephedrine hydrochloride 45 mg 

3. 
PHARMACEUTICAL FORM  
Oral solution 

A clear orange to brown oral solution 

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 AGED12 YEARS AND OVER: 

One 20 ml dose up to four times daily, as required. Do not
take more 
frequently than every four hours. 

CHILDREN UNDER 12 YEARS: 

Benylin Four Flu Liquid is contra-indicated in children under
the age of 12 
years (see section 4.3). 

Do not exceed the stated dose. 

Keep out of the reach and sight of children. 

2 

4.3 
CONTRAINDICATIONS 

Known hypersensitivity to any of the ingredients. 

Concomitant use of other sympathomimetic decongestants,
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 12 years. 

4.4 
SPECIAL WARNINGS AND PRECAUTIONS FOR USE 

Use with caution in occlusive vascular disease 
If any of the following occur, Benylin Four Flu Liquid should
be stopped 

  Hallucinations 

  Restlessness 

  Sleep