Lemsip Max Sinus capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Caffeine; Phenylephrine hydrochloride; Paracetamol

Available from:

Reckitt Benckiser Healthcare (UK) Ltd

ATC code:

N02BE51

INN (International Name):

Caffeine; Phenylephrine hydrochloride; Paracetamol

Dosage:

25mg ; 6.1mg ; 500mg

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: 5000158064973

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LEMSIP MAX SINUS CAPSULES
(PARACETAMOL, CAFFEINE AND PHENYLEPHRINE HYDROCHLORIDE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist have
told
you.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects
not listed in this leaflet. See section 4.
You must talk to a doctor if you do not feel better or if you feel
worse after 3 days.
WHAT IS 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
Lemsip Max Sinus Capsules
contain a combination of
ingredients which are effective in relieving the
symptoms associated with colds & flu, including relief
of aches and pains, sore throats, headache, nasal
congestion and lowering of temperature.
Paracetamol is a well-known painkiller (analgesic). It is effective
against aches and pains, including a
headache, and can also reduce a fever (antipyretic). Caffeine (a mild
stimulant), helps relieve fatigue
and
drowsiness through the day. Phenylephrine hydrochloride (nasal
decongestant) reduces swelling in
the
passages of the nose, relieving nasal congestion and reducing the
pressure which may cause a
headache.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS MEDICINE
As with all medicines Lemsip Max Sinus Capsules may not
be suitable for some people.
DO NOT TAKE THIS MEDICINE IF:
You are allergic to paracetamol, caffeine or phenylephrine
hydrochloride or any of the other
ingredients of this medicine (listed in section 6)
You have a serious heart condition
You have high blood pressure

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lemsip Max Sinus Capsules
Lemsip Max Plus Sinus Relief Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENTS
MG/CAPSULE
Paracetamol
500
Caffeine anhydrous
25
Phenylephrine
hydrochloride
6.1
For excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, hard.
Red/blue hard gelatine capsules
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
For the relief of symptoms associated with the pain and congestion of
sinusitis,
including relief of aches and pains, headache, nasal congestion and
lowering
of temperature
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:
Take two capsules every 4-6 hours as required to a maximum of four
doses in any 24
hours, or up to a maximum of three doses in any 24 hours if a
night-time
paracetamol-containing product is taken before bedtime.
Do not take more than 8 capsules (4 doses) in any 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 paracetamol, phenylephrine, caffeine or to any of
the
excipients listed in section 6.1.
Due to the presence of phenylephrine, use of the product is
contraindicated in:
-
Patients with severe coronary heart disease and cardiovascular
disorder.
-
Patients with hypertension.
-
Patients with hyperthyroidism.
-
Patients currently receiving or within two weeks of stopping therapy
with
monoamine oxidase inhibitors (MAOIs).
-
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 and diabetes
mellitu