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BRUFEN 200 MG EFFERVESCENT GRANULES

Active substance(s): IBUPROFEN

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Package leaflet: Information for the user

Ibuprofen
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.
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
The full name of your medicine is . In this leaflet
the shorter name is used.

1.

What is and what it is used for

belongs to a group of medicines called ‘non-steroidal anti-inflammatory drugs’
or NSAIDs. Each sachet of medicine contains 200 mg of ibuprofen.
This medicine is used:
 to relieve pain in conditions such as toothache, period pain and headache
 to reduce fever (high temperature) and pain when you have the common cold.
It can be used in adults and children over 30 kg in body weight (over 8 years old).
You must talk to a doctor if you do not feel better or if you feel worse after 3 days.
2.

What you need to know before you take

Do not take if:
 you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in
section 6)

BRUFEN 200 mg Effervescent Granules











you have ever had an allergic reaction to ibuprofen, acetylsalicylic acid (e.g. Aspirin) or
other NSAIDs - the signs include a reddening or rash of the skin, swollen face or lips or
shortness of breath
you have (or have had two or more episodes of) a stomach ulcer or bleeding of the
stomach
you have a history of gastrointestinal bleeding or perforation related to previous NSAID
therapy
you have severe liver or kidney problems
you have severe heart failure or coronary heart disease
you have active bleeding or an illness that may make you more likely to bleed
you have disturbances in the formation of blood cells of unknown cause
you are very dehydrated - this may be due to being sick, diarrhoea or not drinking enough
fluid
you are in the last 3 months of pregnancy. See ‘Pregnancy, breast-feeding and fertility’
below for more information.

Do not take if any of the above apply to you. If you are not sure, talk to your
doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking if you:














have Systemic Lupus Erythematosus (SLE, an illness that affects connective tissue,
including your joints and skin) or other autoimmune diseases, because of increased risk
of aseptic meningitis (stiff neck, headache, nausea, vomiting, fever or disorientation)
have disturbances in the formation of blood cells
have problems with normal blood clotting mechanism
have ever had stomach or gut problems (such as ulcerative colitis or Crohn’s disease)
have kidney or liver problems
have recently had a major operation
have had allergic reactions to other medicines for other conditions in the past
have hay fever, nasal polyps (loss of smell, runny or blocked nose) or breathing
problems, because there is also an increased risk of allergic reactions for you, which may
present as asthma attacks, swelling of the skin or hives
are elderly (over 65 years) - this is because you may be more likely to get serious side
effects
have chicken pox or shingles (varicella)
are dehydrated
have ever had asthma
are taking other pain relieving drugs regularly - particularly if you are physically active
which can lead to a loss of salt or dehydration.

Talk to your doctor or pharmacist before taking if any of the above apply to you.
Heart attack and stroke
Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small
increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed

BRUFEN 200 mg Effervescent Granules

the recommended dose or duration of treatment. You should discuss your treatment with your
doctor or pharmacist before taking 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 of
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.
Renal effects
There is a risk of kidney damage in dehydrated children, adolescents and elderly.
Do not take more than the recommended dose of this medicine.
Also, do not take this medicine for longer than recommended in this leaflet (3 days).
General information on prolonged use of painkillers
In general the habitual use of (several sorts of) analgesics can lead to lasting severe kidney
problems. This risk may be increased under physical strain associated with loss of salt and
dehydration. Therefore it should be avoided.
On prolonged use of painkillers, headache may occur that must not be treated with increased
doses of the medicinal product.
may hide the symptoms of an infection, for example headache, and high
temperature.
Consult a doctor before using if any above mentioned conditions concern you.
Children
This medicine should not be given to children with a body weight of less than 30 kg (under 8
years old).
Other medicines and
may affect or be affected by some other medicines. For example:
medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g.
aspirin/acetylsalicylic acid, warfarin, ticlopidine)
medicines that reduce high blood pressure (ACE-inhibitors such as captopril, betablockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
Some other medicines may also affect or be affected by the treatment of .
You should therefore always seek the advice of your doctor or pharmacist before you use
with other medicines.
Please tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription. In particular, tell them if you
are taking:

BRUFEN 200 mg Effervescent Granules

acetylsalicylic acid (e.g. Aspirin) - do not use
if you are taking more than 75 mg
of acetylsalicylic acid (e.g. Aspirin) per day.

since this may increase the risk of
gastrointestinal ulcers or bleeding

other NSAIDs (anti-inflammatories and
analgesics) including Cox-2 inhibitors (such as
celecoxib)

since this may increase the risk of
gastrointestinal ulcers or bleeding

other medicines containing ibuprofen, such as
those you can buy without a prescription

since this may increase the risk of
gastrointestinal ulcers or bleeding

acetylsalicylic acid (e.g. Aspirin), Low dose - if
you are on low-dose acetylsalicylic acid (up to 75
mg daily) speak to your doctor or pharmacist
before you take .

since the blood-thinning effect may be
impaired

medicines for heart problems - such as digoxin

since the effect of digoxin may be enhanced

corticosteroids - used for inflammatory
conditions

since this may increase the risk of
gastrointestinal ulcers or bleeding

medicines to stop blood clots - such as
acetylsalicylic acid (e.g. Aspirin) or ticlopidine

since this may increase the risk of bleeding

medicines for thinning the blood (such as
warfarin)

since ibuprofen may enhance the effects of
these medicines

phenytoin (for epilepsy)

since the effect of phenytoin may be
enhanced

selective serotonin reuptake inhibitors (SSRIs)
such as fluoxetine, used for depression

as these may increase the risk of
gastrointestinal bleeding

lithium - used for some forms of depression

since the effect of lithium may be enhanced

probenecid and sulfinpyrazones (medicines for
gout)

since the excretion of ibuprofen may be
delayed

medicines for high blood pressure - including
ACE-inhibitors (such as captopril), beta blockers
(such as atenolol) or angiotensin-II receptor
antagonists (such as losartan) and diuretics (water
tablets)

since ibuprofen may diminish the effects of
these medicines and there could be a
possible increased risk for the kidney

Potassium-sparing diuretics

since this may lead to hyperkalaemia

methotrexate - used for some cancers or
rheumatism

since the effect of methotrexate may be
enhanced

medicines that suppress your immune system such as ciclosporin or tacrolimus

since kidney damage may occur

zidovudine - used for HIV or AIDS

since the use of may result in
an increased risk of bleeding into a joint or
a bleeding that leads to swelling in HIV (+)
haemophiliacs

medicines for diabetes - such as glibenclamide

interactions may be possible

BRUFEN 200 mg Effervescent Granules

quinolone antibiotics for infection (such as
ciprofloxacin)

since the risk for convulsions may be
increased

some antibiotics for infections, like
aminoglycosides (such as gentamicin)

since their elimination may be decreased

cholestyramine - used to lower cholesterol

since the absorption of ibuprofen may be
reduced.
Do not take two hours

before or after you take cholestyramine.
mifepristone - used for medical termination of
pregnancy

since a decrease in the effect of
mifepristone may occur

Ginkgo biloba - a herbal medicine often used in
dementia

There is a chance you may bleed more
easily if you are taking this with
.

voriconazole or fluconazole - used for fungal
infections

since the risk of higher concentration of
ibuprofen in the blood is increased

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before
taking .
with alcohol
If you drink alcohol while taking this medicine you may be more likely to get side effects.
Pregnancy, breast-feeding and fertility
 Do not take this medicine if you are in the last 3 months of pregnancy.
 Talk to your doctor or pharmacist before taking this medicine if you are in the first 6
months of pregnancy or you are breast-feeding. You should only take this medicine on
the advice of your doctor.
belongs to a group of medicines which may impair fertility in women. This
effect is reversible on stopping the medicine. It is unlikely that ibuprofen, used occasionally,
will affect your chances of becoming pregnant, however, tell your doctor before taking this
medicine if you have problems becoming pregnant.
Driving and using machines
This medicine may make you feel dizzy or sleepy. If this happens, do not drive or use any
tools or machines. Also, do not do anything else where you need to be alert.
contains sucrose and sodium
Sucrose
Sucrose is a sugar. contains 1111 mg sucrose per sachet. This should be taken
into account in patients with diabetes mellitus. If you have been told by your doctor that you
cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
Sodium
contains 2.9 mmol (66 mg) of sodium per sachet. This should be taken into
account if you are on a low sodium diet. You may need to have less sodium in your diet
because of the sodium in this medicine.
BRUFEN 200 mg Effervescent Granules

3.

How to take

Always take this medicine exactly as described in this leaflet or as your pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
The product is intended for short-term use only. You should take the lowest dose for the
shortest time necessary to relieve your symptoms.
How much to take
Adults and young people over 40 kg body weight (over 12 years old):
 Take one or two sachets (200 – 400 mg ibuprofen) every 4-6 hours, as required.
More than 400mg at a time does not give a better analgesic effect.
Do not take more than a total of 6 sachets (1200mg) in any 24 hours.
Children over 30 kg body weight (from 8 to 12 years old):
If you are giving this medicine to a child, you should use the following dosing
instructions:
Body
weight of
child
Children
30 kg to 39
kg
(8-12 years)



Recommended dose
1 sachet
(200 mg ibuprofen)

How often?
 Doses should be given
every 6-8 hours, if
required.
 Do not take more than 3
sachets (up to 600 mg
ibuprofen) in any 24
hours.

The recommended dose of ibuprofen each day is 20 mg per kg of body weight.
- This is taken in 3 separate doses throughout the day.
- Please see the table above.

Do not take more than a total of 600 mg (3 sachets) in any 24 hours.
Children under 30 kg body weight (under 8 years old):
This medicine should not be given to children with a body weight of less than 30 kg
(under 8 years old).

Taking this medicine
In order to achieve a faster onset of action, the dose may be taken on an empty stomach.
If you have a sensitive stomach, take this medicine with or just after food.



Empty the granules from one sachet into a small glass of water (about 125 ml).
Make sure that you use all of the granules in the sachet.
BRUFEN 200 mg Effervescent Granules




Stir the medicine until it stops bubbling and the granules have dissolved - this will make
an orange flavoured, fizzy drink.
If you use more than one sachet at one time, you should use more water. Use about
125 ml for each sachet of medicine.

How long to continue treatment
If you need to take for more than 3 days or if your symptoms worsen, consult
your doctor.
If you take more than you should
If you have taken more than you should, contact a doctor or go to the nearest
hospital straightaway. Take the medicine pack with you.
The signs of an overdose can include feeling sick, stomach pain, being sick (may be blood in
it), headache, ringing in the ears, confusion and shaky eye movement. At high doses, there
may be loss of consciousness, fits (mainly in children), feeling weak or dizzy, blood in urine,
feeling cold and breathing problems.
If you forget to take
 If you forget a dose, take it as soon as you remember it. However, if it is nearly time for
your next dose, skip the missed dose.
 Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Stop taking this medicine and see your doctor straightaway if you notice any of the
following serious side effects - you may need urgent medical attention:








pass blood in your faeces (stools/motions)
pass black tarry stools
vomit any blood or dark particles that look like coffee grounds
swelling of the face, tongue or throat
difficulty swallowing or breathing
hives
severe infection with destruction (necrosis) of skin, subcutaneous tissue and muscle; this
may occur in exceptional cases during chicken pox.

Stop taking this medicine and see your doctor straightaway if you notice any of the side
effects above.
Stop taking this medicine and tell your doctor if you notice any of the following:
 indigestion or heartburn
 abdominal (stomach) pains or other abnormal stomach symptoms.
BRUFEN 200 mg Effervescent Granules

Stop taking this medicine and tell your doctor if you notice any of the side effects above.
Other side effects
Common (may affect up to 1 in 10 people):
 feeling dizzy or tired
 feeling drowsy
 agitation, irritability
 loss of appetite, diarrhoea, feeling sick, being sick, wind, constipation.
 headache - if this happens while you are taking this medicine it is important not to take
any other medicines for pain to help with this
Uncommon (may affect up to 1 in 100 people):
 feeling anxious
 difficulty sleeping
 rash, hives, itching
 skin becomes sensitive to light
 visual disturbances, hearing problems
 hepatitis, yellowing of your skin or eyes
 sneezing, blocked, itchy or runny nose (rhinitis)
 mouth ulcer
 stomach ulcer, inflammation of your stomach lining
 small bruises on your skin or inside your mouth, nose or ears
 pins and needles
 difficulty breathing, wheezing or coughing, asthma or worsening of asthma
Rare (may affect up to 1 in 1,000 people):
 loss of vision
 reduced liver function
 ringing in ears (tinnitus)
 spinning sensation, loss of balance (vertigo)
 feeling depressed or confused
 hallucinations
 fluid retention (oedema)
 Lupus erythematosus syndrome or SLE (an illness that affects connective tissue,
including your joints and skin).
Very rare (may affect up to 1 in 10,000 people):
 unpleasant awareness of heart beat, heart failure, heart attack, high blood pressure,
acute oedema in the lung
 liver failure
 reduced kidney function
 inflammation of the pancreas
 a brain infection called ‘non-bacterial meningitis’
 changes in blood count - the first signs are: high temperature, sore throat, mouth
ulcers, flu-like symptoms, feeling very tired, bleeding from the nose and the skin

BRUFEN 200 mg Effervescent Granules







skin problems (which can also affect inside your mouth, nose or ears) such as
‘Stevens-Johnson syndrome’, ‘exfoliative dermatitis’or ‘erythema multiforme’. This
can get even more severe, where the blisters get larger and spread out and parts of the
skin may slough off (toxic epidermal necrolysis). There may also be severe infection
with destruction (necrosis) of skin, subcutaneous tissue and muscle.
prolonged bleeding time
inflammation of the oesophagus, intestinal strictures
hair loss (alopecia)

Not known (we do not know how often these happen):
 ulcerative colitis or Crohn’s disease
 burning feeling in the throat or mouth - this may happen briefly after taking this
medicine.

Medicines such as may be associated with a small increased risk of heart attack
(‘myocardial infarction’) or stroke.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 this medicine out of the sight and reach of children.
Do not store above 25C.
Store in the original package in order to protect from light and moisture.
Do not use after the expiry date stated on the sachet and carton. The expiry date refers to the
last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help to protect the
environment.

6.

Contents of the pack and other information

What contains
 The active substance is ibuprofen. Each sachet of medicine contains 200 mg of
ibuprofen.

BRUFEN 200 mg Effervescent Granules



The other ingredients are croscarmellose sodium, malic acid, microcrystalline cellulose,
saccharin sodium, sucrose, povidone, orange flavour, sodium laurilsulfate, sodium
hydrogen carbonate and sodium carbonate, anhydrous.

What looks like and contents of the pack
are a white powder with an orange flavour. Your
medicine will be in a sachet.
Each carton contains 12, 20 or 30 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
BGP Products Ltd. , Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead,
Berkshire, SL6 4XE, United Kingdom.
Manufacturer:
AbbVie S.r.l. S.R. 148 Pontina km 52 snc, 04011 Campoverde di Aprilia (LT) Italy
This medicinal product is authorised in the Member States of the EEA under the
following names:
United Kingdom
Austria
Bulgaria
Czech Republic
Estonia
Ireland
Italy
Latvia
Lithuania
Romania
Slovak Republic
Slovenia

BRUFEN 200 mg Effervescent Granules
BRUFEN 200 mg Brausegranulat
BRUFEN 200 mg Ефервесцентна Гранули
BRUFEDOL 200 mg šumivé granule
BRUFEN
BRUFEN 200 mg Effervescent Granules
Froben Dolore e Febbre
BRUFEN 200 mg putojošās granulas
BRUFEN 200 mg Šnypščiosios granulės
ABFEN 200 mg granule efervescente
BRUFEDOL 200 mg šumivý granulát
Brufen Gran 200 mg šumeča zrnca.

This leaflet was last revised in May 2016

BRUFEN 200 mg Effervescent Granules

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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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