Lemsip Max All in One Cold & Flu capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Paracetamol; Guaifenesin; Phenylephrine hydrochloride

Available from:

Reckitt Benckiser Healthcare (UK) Ltd

ATC code:

N02BE51

INN (International Name):

Paracetamol; Guaifenesin; Phenylephrine hydrochloride

Dosage:

500mg ; 100mg ; 6.1mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: ; GTIN: 5000158067110

Patient Information leaflet

PACKAGING LEAFLET: INFORMATION FOR THE USER
LEMSIP MAX ALL IN ONE COLD & FLU CAPSULES
Paracetamol, Guaifenesin and Phenylephrine Hydrochloride
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 this medicine 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 contract your doctor if your symptoms worsen or do not
improve after 3 days.
•
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
1. WHAT THIS MEDICINE IS AND WHAT IT IS USED FOR
Capsules for oral use.
This Medicine is a combination of active ingredients which are
effective in relieving the symptoms
associated with colds and flu, including relief of aches and pains,
sore throats, headache, nasal
congestion, lowering of temperature and chesty cough.
Paracetamol is a well known painkiller (analgesic). It is effective
against aches and pains including
headache and can also reduce a fever (antipyretic). Guaifenesin
(expectorant) allows you to cough up
phlegm when suffering from a chesty cough. Phenylephrine hydrochloride
(nasal decongestant)
reduces swelling in the passages of the nose, relieving nasal
congestion and reducing pressure which
may cause a headache.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS MEDICINE
DO NOT TAKE THIS MEDICINE IF:
•
You are allergic to paracetamol, guaifenesin, phenylephrine
hydrochloride or any of the other
ingredients listed in section 6.
•
You have a serious heart condition, or an overactive thyroid.
•
You have a high blood pressure (hypertension).
•

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lemsip Max All in One Cold & Flu Capsules
Lemsip Cough Max for Mucus Cough & Cold 500mg/100mg/6.1mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains paracetamol 500mg, phenylephrine hydrochloride
6.1mg and
guaifenesin 100mg
Excipient with known effect:
Sodium, 1.4428 mg (0.063555 mmol) per capsule
For a full list of excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard
Capsules with a red cap and green body, printed ‘Lemsip’ on the
cap in white
ink, containing white, free flowing powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of symptoms of cold and influenza, including the relief
of aches and
pains, sore throat, headache, nasal congestion, lowering of
temperature and chesty
coughs.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Patients should consult a doctor or pharmacist if symptoms persist for
more than 3
days, or worsen.
Posology
Adults, the elderly and children aged 16 years and over: Two capsules
every 4-6
hours, as required.
Do not take more than 8 capsules (4 doses) in 24 hours.
DO NOT GIVE TO CHILDREN UNDER 16 YEARS OF AGE.
Elderly Population: No dosage adjustment is considered necessary in
the elderly.
Method of Administration
For oral administration. Swallow whole with water. Do not chew.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to any of the active substances or any of the
excipients listed in section 6.1.
•
Severe coronary heart disease and cardiovascular disorders.
•
Hypertension.
•
Hyperthyroidism.
•
Contraindicated in patients currently receiving or within two weeks of
stopping therapy with monoamine oxidase inhibitors (MAOI).
•
Concomitant use of other sympathomimetic decongestants.
•
Avoid in patients with prostatic enlargement.
•
Contraindicated in patients with phaeochromocytoma
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Use with caution in patients with Raynaud's phenomenon or diabetes
mellitus.
Care is advised in the administration of paracetamo