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IBUPROFEN 200 MG EFFERVESCENT GRANULES

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Rockspring Healthcare Limited
Ibuprofen 200 mg Effervescent Granules
UK/H/4995/01/DC

Package leaflet: Information for the user
Ibuprofen 200 mg Effervescent Granules
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 Ibuprofen is and what it is used for
2.
What you need to know before you take Ibuprofen
3.
How to take Ibuprofen
4.
Possible side effects
5.
How to store Ibuprofen
6.
Contents of the pack and other information
The full name of your medicine is Ibuprofen 200 mg Effervescent Granules. In this leaflet the
shorter name Ibuprofen is used.

1.

What Ibuprofen is and what it is used for

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

Rockspring Healthcare Limited
Ibuprofen 200 mg Effervescent Granules
UK/H/4995/01/DC










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 an illness that may make you more likely to bleed
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 Ibuprofen 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 Ibuprofen if you:












have something called ‘systemic lupus erythematosus’ or SLE (an illness that affects
connective tissue, including your joints and skin)
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
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 Ibuprofen if any of the above apply to you.
Heart attack and stroke
Talk to a doctor or pharmacist before taking this medicine if you have heart problems, have
had a stroke or if you think that you are likely to get these conditions (for example, if you
have high blood pressure, diabetes, high cholesterol levels or if you smoke).
This medicine may lead to a small increased risk of heart attack or stroke. This increased risk
is more likely with high doses and long-term treatment.
Do not take more than the recommended dose of this medicine.

Rockspring Healthcare Limited
Ibuprofen 200 mg Effervescent Granules
UK/H/4995/01/DC

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.
Consult a doctor before using Ibuprofen 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 Ibuprofen
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:
acetylsalicylic acid (e.g. Aspirin) - do not use
Ibuprofen 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 Ibuprofen.

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

Rockspring Healthcare Limited
Ibuprofen 200 mg Effervescent Granules
UK/H/4995/01/DC
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 Ibuprofen 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

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

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 Ibuprofen.

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 Ibuprofen.
Ibuprofen 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.

Rockspring Healthcare Limited
Ibuprofen 200 mg Effervescent Granules
UK/H/4995/01/DC

Ibuprofen 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.
Ibuprofen contains sucrose and sodium
Sucrose
Sucrose is a sugar. 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
Ibuprofen contains 50 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.

3.

How to take Ibuprofen

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.
Do not take more than a total of 6 sachets 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.

Rockspring Healthcare Limited
Ibuprofen 200 mg Effervescent Granules
UK/H/4995/01/DC



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
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.
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 Ibuprofen for more than 3 days or if your symptoms worsen, consult your
doctor.
If you take more Ibuprofen than you should
If you have taken more Ibuprofen 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 Ibuprofen
 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

Rockspring Healthcare Limited
Ibuprofen 200 mg Effervescent Granules
UK/H/4995/01/DC

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.

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.
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
 loss of appetite, diarrhoea, feeling sick, being sick, wind, constipation.
Uncommon (may affect up to 1 in 100 people):
 feeling drowsy
 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)
 stomach ulcer, inflammation of your stomach lining
 small bruises on your skin or inside your mouth, nose or ears
 difficulty breathing, wheezing or coughing, asthma or worsening of asthma
 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.
Rare (may affect up to 1 in 1,000 people):
 loss of vision
 reduced liver function
 ringing in ears (tinnitus)
 feeling depressed or confused
 fluid retention (oedema).

Rockspring Healthcare Limited
Ibuprofen 200 mg Effervescent Granules
UK/H/4995/01/DC

Very rare (may affect up to 1 in 10,000 people):
 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
 skin problems (which can also affect inside your mouth, nose or ears) such as
‘Stevens-Johnson syndrome’, ‘toxic epidermal necrolysis’ or ‘erythema multiforme’.
Not known (we do not know how often these happen):
 prolonged bleeding time
 ulcerative colitis or Crohn’s disease
 burning feeling in the throat or mouth - this may happen briefly after taking this
medicine.
The following side effects have also been reported with other NSAIDs:
 high blood pressure or heart failure
 worsening of ulcers in the large intestine and Crohn’s disease (bowel disease).
Medicines such as Ibuprofen may be associated with a small increased risk of heart attack
(‘myocardial infarction’) or stroke.
If you get any side effects talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet.
Also you can help to make sure that medicines remain as safe as possible by reporting any
unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can
call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in
a paper form available from your local pharmacy.

5.

How to store Ibuprofen

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.

Rockspring Healthcare Limited
Ibuprofen 200 mg Effervescent Granules
UK/H/4995/01/DC

6.

Contents of the pack and other information

What Ibuprofen contains
 The active substance is ibuprofen. Each sachet of medicine contains 200 mg of
ibuprofen.
 The other ingredients are malic acid, saccharin sodium, sucrose, povidone, orange
flavour, sodium laurilsulfate, sodium hydrogen carbonate and sodium carbonate,
anhydrous.

What Ibuprofen looks like and contents of the pack
Ibuprofen 200 mg Effervescent Granules 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:
Rockspring Healthcare Limited
38/40 Chamberlayne Road
London
United Kingdom
NW10 3JE
Manufacturer:
Abbott S.r.L., Via Pontina, Km 52, Campoverde, Italy 04010
This medicinal product is authorised in the Member States of the EEA under the
following names:
United Kingdom
Austria
Belgium
Bulgaria
Czech Republic
Estonia
Finland
France
Hungary
Ireland
Italy
Latvia
Lithuania
Luxembourg
Netherlands
Norway

Ibuprofen 200 mg Effervescent Granules
Ibuprofen Rockspring 200 mg Brausegranulat
Ibuprofen Rockspring 200 mg Bruisgranulaat / Granulés Effervescents
Ibuprofen Rockspring 200 mg Ефервесцентна Гранули
Ibuprofen Rockspring 200 mg šumivé granule
Ibuprofen Rockspring
Ibuprofen Rockspring 200 mg Porerakeet
Ibuprofene Rockspring 200 mg Granulés effervescents
Ibuprofen 200 mg Pezsgőgranulátum
Ibuprofen 200 mg Effervescent Granules
Ibuprofene Rockspring Healthcare
Ibuprofen Rockspring 200 mg putojošās granulas
Ibuprofen Rockspring 200 mg Šnypščiosios granulės
Ibuprofen 200 mg Granulés Effervescents / Brausegranulat
Ibuprofen 200 mg Bruisgranulaat
Ibuprofen Rockspring 200 mg Brusegranulat

Rockspring Healthcare Limited
Ibuprofen 200 mg Effervescent Granules
UK/H/4995/01/DC

Poland
Romania
Slovak Republic
Slovenia
Sweden

Ibuprofen Rockspring
Ibuprofen Rockspring 200 mg granule efervescente
Ibuprofen Rockspring 200 mg šumivý granulát
Ibuprofen Rockspring 200 mg šumeča zrnca
Ibuprofen Rockspring 200 mg Brusgranulat

This leaflet was last revised in 01/2013

+ 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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