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IBUPROFEN 200MG COATED TABLETS

Active substance(s): IBUPROFEN / IBUPROFEN / IBUPROFEN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

IBUPROFEN COATED
TABLETS 200mg






PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU
START TO TAKE YOUR MEDICINE.
Keep this leaflet. You may want to read it again.
If you have any further questions, ask your pharmacist.
This medicine has been prescribed for you. Do NOT
pass it on to others. It may harm them even if their
symptoms are the same as yours.
If any of the side effects become severe, or if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

In this leaflet:
1. What Ibuprofen tablets are and what they are used for.
2. Before you take Ibuprofen.
3. How to take Ibuprofen tablets.
4. Possible side effects.
5. How to store Ibuprofen tablets.
6. Further information.

1. What Ibuprofen tablets are and what they are
used for
Ibuprofen is one of a group of medicines called non-steroidal
anti-inflammatory drugs or NSAIDs, which work by changing
the body’s response to pain, swelling and high temperature.
These tablets are used to provide relief of headache,
muscular pain, rheumatic pain, backache, neuralgia (nerve
pain), migraine, period pain, dental pain, feverishness and the
symptoms of colds and flu.

2. Before you take Ibuprofen Tablets

Do not take these tablets if:
• you have had gastrointestinal bleeding or perforation
when previously taking NSAIDS
• you have had an allergic reaction to aspirin, Ibuprofen,
any other NSAIDs or any of the ingredients (see section 6
for further information).
• you have had worsening of asthma, developed an allergic
rash, facial swelling or an itchy runny nose when taking
Ibuprofen, aspirin or similar medicines.
• you have had liver, kidney or severe heart problems.
• you have (or have had two or more episodes of ) a stomach
ulcer, perforation or bleeding.
• you are in the last 3 months of pregnancy.
• you are under 12 years of age.
Take special care and tell your doctor or pharmacist if:
• you have high blood pressure.
• you have asthma or have suffered from asthma.
• you have kidney, heart, bowel or liver problems.
• you have a condition known as Systemic Lupus
Erythematosus (SLE) – an illness which affects your immune
system. It causes joint pain, skin changes and problems
with other parts of your body.
• you are elderly.
• you are pregnant or breastfeeding (see section You are
pregnant or breastfeeding).
• you have heart problems, previous stroke or think that
you might be at risk of these conditions (for example if you
have high blood pressure, diabetes or high cholesterol or
are a smoker), in which case, you should discuss your
treatment with your doctor or pharmacist.

Important warning
Medicines such as Ibuprofen may be associated with a small
increased risk of heart attack (“myocardial infarction”) or
stroke. Any risk is more likely with high doses and prolonged
treatment. Do not take more medicine than the label/leaflet
tells you to. Do not use for a duration of more than (10 days).
There is a risk of renal impairment in dehydrated children
and adolescents.
Taking other medicines
Do not take this medicine if you are taking aspirin at doses
above 75mg daily. If you are on low dose aspirin (up to
75mg daily) speak to your doctor or pharmacist before you
take Ibuprofen.
Tell your doctor if you are taking other medicines
especially the following
• other pain relievers or products containing aspirin,
Ibuprofen or other NSAIDs.
• medicines for high blood pressure e.g. diuretics
(frusemide, bendroflumethiazide, hydrochlorothiazide),
ACE inhibitors (enalapril, Ramipril), Angiotensin II receptor
blockers (losartan), beta blockers (atenolol), calcium
channel blockers (amlodipine).
• medicines for treating heart conditions e.g. digoxin for
atrial fibrillation (a condition with an irregular heart beat)
• medicines for thinning the blood (e.g. warfarin and
ticlopidine).
• corticosteroids (e.g. prednisolone).
• mifepristone (a medicine which is used to start labour).
• medicines which weaken the immune system (ciclosporin).
• methotrexate (a medicine for cancer) and rheumatoid
arthritis.
• medicines for depression and mood stabilising drugs
(lithium, citalopram and fluoxetine).
• quinolone antibiotics and zidovudine (medicines used to
treat bacterial and viral infection).
You should therefore always seek the advice of your doctor or
pharmacist before you take lbuprofen with other medicines,
including herbal and homeopathic remedies.
You are pregnant or breast-feeding
Ibuprofen belongs to a group of medicines which may impair
fertility in women. This effect is reversible on stopping Ibuprofen. It is unlikely that Ibuprofen, when used occasionally,
will affect your chances of becoming pregnant, however, tell
your doctor before taking this medicine if you have problems
becoming pregnant.
Speak to your doctor or pharmacist before taking Ibuprofen,
if you are pregnant, think you are pregnant, are planning to
become pregnant or are breastfeeding.
Driving and using machinery
Taking Ibuprofen will not affect your ability to drive or use
machines.
Important information about the ingredients in
Ibuprofen Tablets
Ibuprofen tablets contain lactose monohydrate and sucrose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this
medicinal product.
Taking with food and drink
Ibuprofen tablets should be taken with water, preferably with
or after food.

3. How to take Ibuprofen

Rare side effects (less than 1 per 1000 but more than 1 per
10,000) which may occur are as follows:
• Diarrhoea.
• Flatulence (passing wind).
• Constipation.
• Vomiting.

Adults, the elderly and adolescents of 12 to 17 years:
Dose for Ibuprofen:
• take one to two tablets with water to start with, preferably
with or after food, followed by one to two tablets every
four hours if necessary up to three times a day.
• do not take more than six tablets in any twenty-four hour
period.
Adults and the elderly:
If this medicinal product is required for more than 10 days,
or if symptoms persist or worsen, contact your doctor.
Adolescents:
If this medicinal product is required for more than 3 days,
or if symptoms worsen a doctor should be consulted.
Children under 12 years:
Do not give Ibuprofen to children under 12 years old.

Very rare side effects (less than 1 per 10,000) which may
occur are as follows:
• Kidney or liver problems.
• Symptoms of aseptic meningitis (stiff neck, headache,
feeling sick, vomiting, fever or disorientation).

This product is intended for short term use only. You should
take the lowest dose for the shortest time necessary to relieve
your symptoms. You should not take Ibuprofen for longer than
10 days unless your doctor tells you to. If symptoms persist or
worsen consult your doctor.

If you think you have taken more Ibuprofen than you
should:
If you take too many Ibuprofen tablets talk to your doctor
straight away or go to the nearest hospital casualty unit.
Take your medicine and this leaflet with you.
If you forget to take Ibuprofen:
If you have missed a dose, do not double up on a dose to make
up for the forgotten dose. Take the next dose at the usual time.
If you stop using Ibuprofen:
Please speak to your doctor or pharmacist before stopping this
or any medicine.

4. Possible Side effects

Like all medicines Ibuprofen can have side effects, although
not everybody gets them.
If you are elderly you may be more likely to have some of these
side effects.

The following side effects may also occur but it is not
known how frequently they occur:
• Worsening of a previous asthmatic condition.
• High blood pressure.
• Abnormal fluid accumulation in tissues of the body
(oedema).
• Heart failure, a condition in which the heart is unable to
pump blood and oxygen to the rest of the body.
• Worsening of inflammatory bowel conditions such as
ulcerative colitis and Crohn’s disease.
Medicines such as Ibuprofen may be associated with a
small increased risk of heart attack (myocardial infarction)
or stroke.
If you experience any of these symptoms, or have any
other unusual symptoms or concerns with your medicine,
stop taking Ibuprofen and see your doctor.
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 the
package 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.
Ingredients: See Further information section.

If you get any of these SERIOUS side effects, stop taking
the tablets and go to your nearest casualty department at
once:
• Yellowing of the skin and eyes or pale stools
• Worsening of existing severe skin infections (you may
notice a rash, blistering and discolouration of the
skin, fever, drowsiness, diarrhoea and sickness), or
worsening of other infections including chicken pox or
shingles
• Vomit any blood or dark particles that look like coffeegrounds.
• Pass blood in your faeces (stools/motions).
• Pass black tarry stools.
• Stomach problems including pain, indigestion or
heartburn.
• Severe skin conditions, causing peeling and blistering
of the skin, mouth and eyes.
• Unexplained wheezing, shortness of breath, swelling
of the lips, face or neck, skin rash or itching, fast heart
beat, or low blood pressure, as these may be signs of an
allergic reaction.
• Meningitis (e.g. stiff neck, fever, disorientation).

Hazard information/Safety warnings: All information
included in the leaflet.

These other effects are LESS SERIOUS. If they bother you
talk to a doctor or pharmacist:
• Kidney or liver problems.
• Nausea (feeling sick).
• Headaches.
• Abdominal pain (pains in your stomach) or other abdominal stomach symptoms.
• Indigestion or heartburn.
• Fever, sore throat, mouth ulcers, flu-like symptoms, severe
exhaustion, unexplained bleeding and bruising.

What is in the pack: The product contains white round
sugar coated tablets.
Ibuprofen is available in blister packs of 6, 12 and 16 tablets*.

Uncommon side effects (less than 1 per 100 but more than
1 per 1000) which may occur are as follows:
• Headaches.
• Nausea (feeling sick).
• Various skin rashes.

*not all pack sizes may be marketed.
PL03105/0086

5. How to store Ibuprofen

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN
• do not store above 25°C.
• store in the original package to protect from moisture.
• do not use after the expiry date shown on the package.
Recycling information:
Paper – widely recycled.
Country of production: India.

6. Further Information

What does each Ibuprofen tablet contain: Each tablet
contains the active ingredient Ibuprofen BP 200mg.
Other ingredients are lactose monohydrate, microcrystalline
cellulose, sodium starch glycollate, starch, colloidal anhydrous
silica, magnesium stearate, sucrose, talc, titanium dioxide
(E171) and carnauba wax.

Marketing Authorisation Holder and Manufacturer:
Ibuprofen 200mg Coated Tablets are manufactured by
Marksans Pharma Ltd. Lotus Business Park, 21st Floor,
Off New Link Road, Andheri (West), Mumbai for the Marketing
Authorisation Holder Bell, Sons & Co. (Druggists) Ltd.,
Southport, PR9 9AL, England.

D24-0349

C73-0005 Ver. C Revised November 2016
GULT301
Specially produced for Aldi Stores Ltd.,
PO Box 26, Atherstone, Warwickshire CV9 2SH.

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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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