Beechams Active Cold Relief caplets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

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Active ingredient:

Paracetamol; Phenylephrine hydrochloride; Caffeine

Available from:

Haleon UK Ltd

ATC code:

N02BE51

INN (International Name):

Paracetamol; Phenylephrine hydrochloride; Caffeine

Dosage:

500mg ; 5mg ; 25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 04070100; GTIN: 5000347028670

Patient Information leaflet

                                FLU PLUS
CAPLETS
Paracetamol, Phenylephrine, Caffeine
PLEASE READ RIGHT THROUGH THIS LEAFLET BEFORE
YOU START USING THIS MEDICINE.
This medicine is available without
prescription, but you still need to use
Beechams Flu-Plus Caplets carefully to get
the best results from it.
• Keep this leaflet you may need to read it
again.
• If you have any questions, or if there is
anything you do not understand, ask your
pharmacist.
IN THIS LEAFLET:
1.
What Beechams Flu-Plus Caplets do
2.
Check before you take Beechams
Flu-Plus Caplets
3.
How to take Beechams Flu-Plus Caplets
4.
Possible side effects
5.
How to store Beechams Flu-Plus Caplets
6.
Further information
1.
What Beechams Flu-Plus
Caplets do
BEECHAMS FLU-PLUS CAPLETS PROVIDE EFFECTIVE
RELIEF FROM THE MAJOR COLD AND FLU SYMPTOMS.
These symptoms include headache, shivers,
aches and pains, blocked nose and painful
sinuses, catarrh, sore throat, fatigue and
tiredness. This medicine contains three active
ingredients. Paracetamol is a painkiller and
reduces your temperature when you have
a fever. Phenylephrine hydrochloride
unblocks your nose and sinuses helping you
to breathe more easily. Caffeine is present as
a mild stimulant to relieve fatigue and
tiredness.
2.
Check before you take Beechams
Flu-Plus Caplets
DO NOT TAKE BEECHAMS FLU-PLUS
CAPLETS:
• IF YOU HAVE EVER HAD AN ALLERGIC REACTION
to paracetamol, phenylephrine
hydrochloride, caffeine or any of the
other ingredients (listed in Section 6).
Colour SUNSET YELLOW (E 110) can cause
allergic type reactions including asthma.
• if you have KIDNEY or LIVER PROBLEMS,
OVERACTIVE THYROID, DIABETES, HIGH BLOOD
PRESSURE or HEART DISEASE.
• if you have PHAEOCHROMOCYTOMA or
GLAUCOMA
• if you are taking TRICYCLIC ANTIDEPRESSANTS
(e.g. imipramine or amitriptyline) or if you
are taking or have taken within the last
2 weeks MONOAMINE OXIDASE INHIBITORS
(MAOIs) (e.g. moclobemide) prescribed for
DEPRESSION.
• if you are taking BETA-BLOCKERS
(e.g. atenolol).
DO NOT TAKE ANYTHING ELSE CONTAINING
PARACETAMOL WHILE TAKING T
                                
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Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Beechams Flu-Plus Caplets
Beechams Active Cold Relief Caplets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each caplet contains Paracetamol 500 mg, Caffeine 25 mg and
Phenylephrine
Hydrochloride 5 mg.
Excipients with known effect:
Sodium
0.06mg
(as sodium laurilsulfate)
Sunset Yellow
0.62mg
(E 110)
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film coated tablet
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
The product is recommended for the relief of sinus pain and the
symptoms of
colds and influenza, including fatigue and drowsiness.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults (including elderly) and children aged 16 years and over:
2 caplets every 4 to 6 hours as required. Do not take more than 8
caplets in 24
hours.
Do not take continuously for more than 7 days without medical advice
Do not exceed the stated dose.
Use the lowest amount needed to achieve benefit for the shortest
duration of
treatment.
Not recommended for children under the age of 16 years.
4.3
CONTRAINDICATIONS
Concomitant use of other sympathomimetic decongestants
Phaeochromocytoma
Closed angle glaucoma
Known hypersensitivity to paracetamol or any of the other
constituents.
Hepatic or severe renal impairment, hypertension, hyperthyroidism,
diabetes,
and heart disease. Patients taking tricyclic antidepressants, or
beta-blocking
drugs and those who are taking or who have taken within the last two
weeks
monoamine oxidase inhibitors (see section 4.5).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Contains paracetamol. Patients should be advised not to take other
paracetamol-containing products concurrently. The concomitant use with
other
products containing paracetamol may lead to an overdose. Paracetamol
overdose may cause liver failure which may require liver transplant or
lead to
death. Concomitant use of other decongestants or cold and flu
medicines
should be avoided.
The hazard of overdose is greater in those with non-cirrhotic
alcoholic liver
dis
                                
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