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NUROFEN COLD & FLU RELIEF 200MG/5MG TABLETS

Active substance(s): IBUPROFEN / PHENYLEPHRINE HYDROCHLORIDE / IBUPROFEN / PHENYLEPHRINE HYDROCHLORIDE / IBUPROFEN / PHENYLEPHRINE HYDROCHLORIDE

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Reckitt Benckiser

0045 541 RFI article 31 ibup

LEMSIP MAX ALL DAY FLU RELIEF 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 DAY FLU RELIEF TABLETS carefully to get the best results from it.
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- Before taking this medicine
3- How to take this medicine
4- Possible side-effects
5- How to store
6- Further information
1. What is this medicine and what is it used for?
LEMSIP MAX ALL DAY FLU RELIEF TABLETS 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. Before taking 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 ulcer, perforation or bleeding
• have had a worsening of asthma, skin rash, itchy runny nose or facial swelling when
previously taking ibuprofen, aspirin or similar medicines
• have had gastrointestinal bleeding or perforation when previously taking NSAIDs
(NonSteroidal AntiInflammatory Drugs)
• are taking other NSAID painkillers
• are taking more than 75mg of aspirin a day. If you are on lowdose aspirin (up to
75mg daily) speak to your doctor or pharmacist before you take this medicine
• have severe liver or kidney problems
• have heart problems, high blood pressure or blood coagulation disorder
• have breathing difficulties
• have an overactive thyroid

1.3.1 Package Leaflet
Lemsip Max All Day Cold & Flu tablets Initial application 200mg 5mg 0166405

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Reckitt Benckiser

0045 541 RFI article 31 ibup

• are taking or have taken within the last 14 days a medicine called monoamine oxidase
inhibitor (usually used to treat depression)
• are in the last 3 months of pregnancy
• are under 12 years old
Warnings and Precautions
Talk to your doctor or pharmacist before taking Lemsip if you have:
• have or have had asthma
• have kidney, heart, liver or bowel problems
• have high cholesterol or previously have had a heart attack or stroke
• have an history of gastrointestinal disease (such as ulcerative colitis, Crohn’s disease)
• have Systemic Lupus Erythematosus (a condition of the immune system causing joint
pain, skin changes or other organ disorders)
• are a smoker
• are in the first 6 months of pregnancy
Other warnings
• Anti-inflammatory/pain-killer medicines such as ibuprofen may be associated with a small
increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed
the recommended dose or duration of treatment.
• You should discuss your treatment with your doctor or pharmacist before taking Lemsip if
you:
- have heart problems including heart failure, angina (chest pain), or if you have had a
heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due
to narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient
ischaemic attack “TIA”).
- have high blood pressure, diabetes, high cholesterol, have a family history of heart
disease or stroke, or if you are a smoker.
Other medicines and Lemsip Max All Day Flu Relief Tablets
To reduce the risk of side effects, do not take this product with other NSAID containing
products (e.g., aspirin, ibuprofen…). If you are on low-dose aspirin (up to 75mg daily)
speak to your doctor or pharmacist before you take this medicine. Lemsip may affect or
be affected by some other medicines. For example: Avoid taking this product with
corticosteroids tablets, quinolone antibiotics or medicines that are:
• anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid,
warfarin, ticlopidine)
• to stimulate your heart (e.g., glycosides including digoxin)
• to reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as
atenolol medicines, angiotensin-II receptor antagonists such as losartan)
• to help you passing water (diuretics),
• for the temporary suppression of your immune system (e.g., methotrexate,
cyclosporine, tacrolimus)
• for mania or depression (e.g., lithium or SSRIs)
• for pregnancy termination (e.g., mifepristone)
• for HIV treatment (e.g., zidovudine)
Some other medicines may also affect or be affected by the treatment of Lemsip. You
should therefore always seek the advice of your doctor or pharmacist before you use
Lemsip with other medicines.

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0045 541 RFI article 31 ibup

Fertility, pregnancy and breastfeeding
LEMSIP MAX ALL DAY FLU RELIEF TABLETS belongs to a group of medicines which
may affect fertility in women. Fertility goes back to normal when you stop taking the
medicine. It is unlikely that if you only take LEMSIP MAX ALL DAY FLU RELIEF
TABLETS occasionally it will affect your chances of becoming pregnant. If you have
problems becoming pregnant talk to your doctor before taking this medicine.
Tell your doctor if you become pregnant whilst taking LEMSIP MAX ALL DAY FLU
RELIEF TABLETS.
Do not take this medicine in the last 3 months of pregnancy. Avoid the use of this
medicine in the first 6 months of pregnancy unless the doctor advises otherwise.
Speak to your doctor or pharmacist before taking this medicine if you are
breast-feeding.
3. How to take this medicine
Tablets must be taken with water and swallowed whole.
It is important to drink plenty of fluids when suffering from colds and flu.
Adults, the elderly and children over 12 years:
This medicine is for short-term use only. Take the lowest dose for the shortest time
necessary. Do not take LEMSIP MAX ALL DAY FLU RELIEF TABLETS for longer
than 10 days. If you do not get better, or get worse, talk to your doctor. They will tell you
if it is safe to carry on taking the medicine.
Take 2 tablets every 8 hours. Leave at least 4 hours between doses and do not exceed 6
tablets in any 24 hour period.
Do not give to children under 12 years.
If you take more LEMSIP MAX ALL DAY FLU RELIEF TABLETS than you should:
You may feel drowsy or nauseous.
You should seek immediate medical advice in the event of an overdose, even if you feel
well.
If you forgot to take LEMSIP MAX ALL DAY FLU RELIEF TABLETS
Simply refer to the directions above on how to take the medicine and do not take more
than is advised.
4. Possible side effects
Like all medicines, LEMSIP MAX ALL DAY FLU RELIEF TABLETS can cause side effects,
although not everybody gets them. Side effects may be minimised by taking the lowest
dose for the shortest time necessary to relieve the symptoms. You may suffer one of the
known side effects of NSAIDs (see below). If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
If you get any of the following at any time during your treatment STOP TAKING the
medicine and seek immediate medical help if you develop:
• signs of intestinal bleeding such as: bright red faeces (stools/motions), black tarry
stools, vomiting blood or dark particles that look like coffee grounds.
• signs of serious allergic reaction such as:
- difficulties in breathing or unexplained wheezing
- dizziness or faster heartbeat
- severe forms of skin reactions such as itchiness, skin rash with redness, peeling,
flaking or blistering (e.g.: Steven-Johnson syndrome)
- swelling of your face, tongue or throat
• signs of kidney problems such as:
- passing less or more urine

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Lemsip Max All Day Cold & Flu tablets Initial application 200mg 5mg 0166405

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0045 541 RFI article 31 ibup

- cloudy urine or blood in urine
- pain in the back and/or swelling (particularly in the legs)
• signs of aseptic meningitis with neck stiffness, headache, feeling sick, being sick, fever
or consciousness. Patients with autoimmune disorders (lupus, mixed connective-tissue
disease) may be more likely to be affected.
• signs of blood disorder resulting in unexplained or unusual bruising or bleeding, fever,
sore throat, mouth ulcers, flu-like symptoms and sever exhaustion.
• signs of liver problems such as stomach pain, jaundice (yellowing of skin and whites of the
eyes) or passing dark brown urine.
STOP TAKING the medicine and tell your doctor if you experience the following
uncommon side effects which affect 1 to 10 users in 1,000:
• indigestion, heartburn or feeling sick
• pains in your stomach (abdomen) or other abnormal stomach problems
TELL YOUR DOCTOR if you have any of the following side effects, they become worse
or you notice any effects not listed:
Uncommon side effects which affect 1 to 10 users in 1,000:
• allergic reactions, such as skin rashes (urticaria), itching, peeling
• headaches, dizziness, tinnitus (ringing in the ears)
Rare side effects which affect 1 to 10 users in 10,000:
• flatulence (wind), diarrhoea, constipation and vomiting
Very rare side effects which affect less than 1 user in 10,000:
• drop in blood pressure or irregular heart beat
Side effects
for which the frequency can not be estimated from available data:
• worsening of asthma or bronchospasm
• swelling (oedema), high blood pressure, heart failure or attack
• worsening of colitis and Crohn’s disease
• difficulties in passing urine (in men only)
Medicines such as LEMSIP MAX ALL DAY FLU RELIEF TABLETS may be associated with
a small increased risk of heart attack (myocardial infarction) or stroke. See section 2
"Other warnings".
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more information on the safety of this
medicine.
5. How to store
Keep all medicines out of the sight and reach of children.
Do not use after the end of the month of the expiry date (EXP month/year) shown on
the pack.
Do not store above 25°C (77°F). Store in a dry place. Store in the original package.
6. Further information
Each tablet contains the active ingredients ibuprofen (200mg) and phenylephrine
hydrochloride (5mg). The other ingredients are cellulose, sodium starch glycoate,

1.3.1 Package Leaflet
Lemsip Max All Day Cold & Flu tablets Initial application 200mg 5mg 0166405

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Reckitt Benckiser

0045 541 RFI article 31 ibup

hypromellose, magnesium stearate, talc, purifed water, industrial methylated spirit,
Mastercote yellow and black printing ink (contains shellac, iron oxide black (E172) and
propylene glycol).
The product is available in cartons of 4, 6, 8, 10, 12, 14 and 16 tablets. Not all packs may
be marketed.
Alternative format patient information for the visually impaired is available on request
from the Marketing Authorisation Holder.
Licence Holder: Reckitt Benckiser Healthcare (UK) Ltd, Hull, HU8 7DS.
Manufacturer: Reckitt Benckiser Healthcare International Ltd, Nottingham, NG90 2DB.
Product licence number: PL 00063/0541
Leaflet was last revised in November 2015.

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Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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