Lemsip Max All Night Cold & Flu tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Phenylephrine hydrochloride; Ibuprofen

Available from:

Reckitt Benckiser Healthcare (UK) Ltd

INN (International Name):

Phenylephrine hydrochloride; Ibuprofen

Dosage:

5mg ; 200mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03100000; GTIN: 5000158101944

Patient Information leaflet

LEMSIP MAX ALL NIGHT COLD & FLU TABLETS
200mg/5mg Tablets
Contain ibuprofen and phenylephrine hydrochloride
INFORMATION FOR THE USER
Read all of this leaflet carefully because it contains important
information for you. This
medicine is available without prescription. However, you still need to
use LEMSIP MAX
ALL NIGHT COLD & FLU TABLETS carefully to get the best results from
it. LEMSIP MAX
ALL NIGHT COLD & FLU TABLETS will be referred to as this medicine
throughout this
leaflet.
Keep this leaflet. You may want to read it again.
If you have any further questions after you have read it, ask your
doctor or pharmacist.
YOU MUST CONTACT A DOCTOR IF YOUR SYMPTOMS WORSEN OR DO NOT IMPROVE
AFTER 10
DAYS.
If any side effects get serious, or if you notice any side effect not
listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1- What is this medicine and what is it 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 IS THIS MEDICINE AND WHAT IS IT USED FOR
This medicine contains ibuprofen and phenylephrine hydrochloride,
which are effective
in relieving the symptoms associated with colds and flu, including
relief of aches and
pains, sore throats, headache, nasal congestion (blocked nose) and
lowering of
temperature.
Ibuprofen belongs to a group of medicines known as non-steroidal
anti-inflammatory
drugs (NSAIDs) and is effective against aches and pains (including
headache), swelling
and can also reduce a fever.
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
DO NOT TAKE THIS MEDICINE IF YOU:
• are allergic to ibuprofen, phenylephrine hydrochloride or any
other ingredients of this
medicine (see section 6) or to aspirin or other painkillers
• have ever had a stomach

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lemsip Max All Night Cold & Flu Tablets, or
Lemsip Max All Night Flu Relief Tablets, or
Nurofen Day & Night Cold & Flu 200mg/5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients
Quantity
Ibuprofen BP
200.0mg
Phenylephrine hydrochloride
5.0mg
For full list of excipients, see Section 6.1.
Excipients with known effect:
Sunset Yellow E 110.
3
PHARMACEUTICAL FORM
Yellow film coated tablet, printed with an identifying motif (IPE) in
black ink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of symptoms of cold and 'flu with associated
congestion,
including aches and pains, headache, fever, sore throat, blocked nose
and
sinuses.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For short-term use only.
The lowest effective dose should be used for the shortest duration
necessary to relieve
symptoms (see section 4.4). The patient should consult a doctor if
symptoms persist or
worsen, or if the product is required for more than 10 days.
Adults, the elderly and children over 12 years:
Two tablets up to 3 times a day. Leave at least four hours between
doses and do not
take more than 6 tablets in any 24hour period.
Not to be given to children under 12 years.
Method of administration
For oral administration.
4.3
CONTRAINDICATIONS
Hypersensitivity to ibuprofen, phenylephrine or any of the excipients
listed in section
6.1.
Patients who have previously shown hypersensitivity reactions (e.g.
asthma, rhinitis,
angioedema or urticaria) in response to ibuprofen, acetylsalicylic
acid (aspirin), or
other non-steroidal anti-inflammatory drugs (NSAIDs).
Active
or
history
of
recurrent
peptic
ulcer/haemorrhage
(two
or
more
distinct
episodes or proven ulceration or bleeding).
History
of
gastrointestinal
bleeding
or
perforation,
related
to
previous
NSAIDs
therapy.
Hypertension and severe coronary heart disease or cardiovascular
disorder (see
section 4.4).
Severe heart failure (NYHA Class IV), renal failure or hepatic failure
(see Section
4.4).
L