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ABFEN 600 MG EFFERVESCENT GRANULES

Active substance(s): IBUPROFEN / IBUPROFEN / IBUPROFEN

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PACKAGE LEAFLET

Abfen 600 mg Effervescent Granules– COA Mylan and CCDS 2014

Package leaflet: Information for the user
Abfen 600 mg Effervescent Granules
Ibuprofen
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.





Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.See section 4.

What is in this leaflet
1.
What Abfen is and what it is used for
2.
What you need to know before you take Abfen
3.
How to take Abfen
4.
Possible side effects
5.
How to store Abfen
6.
Contents of the pack and other information
The full name of your medicine is Abfen 600 mg Effervescent Granules. In this leaflet the shorter
name Abfen is used.

1.

What Abfen is and what it is used for

Abfen belongs to a group of medicines called ‘non-steroidal anti-inflammatory drugs’ or NSAIDs.
Each sachet of medicine contains 600 mg ibuprofen.
This medicine is used:
• to relieve pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis,
arthritis of the spine (ankylosing spondylitis), swollen joints, frozen shoulder, bursitis,
tendinitis, tenosynovitis, lower back pain, sprains and strains.
• to treat other painful conditions such as toothache, pain after operations, period pain and
headache, including migraine.
2.

What you need to know before you take Abfen

Do not take Abfen if:
• you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section
6)
• 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 or stuffy and runny nose (rhinitis)
• you have ever had bleeding or a tear in your stomach or gut when taking other NSAIDs
• you have had two or more episodes of a stomach ulcer (peptic ulcer) or bleeding in your
stomach or gut
• you have an illness that may make you more likely to bleed

Abfen 600 mg Effervescent Granules– COA Mylan and CCDS 2014





you have severe liver or kidney problems
you have severe heart failure or coronary heart disease
you are in the last 3 months of pregnancy. See ‘Pregnancy, breast-feeding and fertility’ below
for more information.

Warnings and precautions
Talk to your doctor or pharmacist before taking Abfen.
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
the recommended dose or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking Abfen 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.
Gastrointestinal bleeding, ulceration or perforation
Patients who have previously had gastrointestinal tract problems, especially elderly patients, should
contact a doctor in the event of abdominal symptoms (especially gastrointestinal bleeding),
particularly at the start of treatment.
Treatment must be stopped and a doctor consulted when gastrointestinal bleeding or ulceration occurs
during treatment with Abfen.
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.
Prolonged use of any type of painkiller for headaches can make them worse. If you think this applies
to you stop taking this medication or any other painkillers and talk to your doctor or pharmacist.
Renal effects
There is a risk of renal impairment in dehydrated patients (especially in children, adolescents and the
elderly).
Tell your doctor if you :
- have or have had asthma (difficulty breathing), chronic rhinitis (chronic stuffy and runny
nose) or allergic reactions (hives)
- have kidney, heart or liver problems
- have ever had stomach or gut problems (such as ulcerative colitis or Crohn’s disease)
- 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)

-

are in the first 6 months of pregnancy
Abfen 600 mg Effervescent Granules– COA Mylan and CCDS 2014

-

are planning to become pregnant
are elderly (65 years and above) - this is because you may be more likely to get serious side
effects, especially bleeding and perforation in the digestive tract, which may be fatal

Like other anti-inflammatory drugs, Abfen may hide the symptoms of an infection, for example
headache and high temperature.
Talk to your doctor or pharmacist before taking Abfen if any of the above applies to you.
Children and adolescents
Abfen is not suitable for children and adolescents under 18 years of age.
Other medicines and Abfen
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. This is because Abfen 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, beta-blockers
such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
In particular you should tell your doctor or pharmacist if you are taking any of the following
medicines in addition to those above.
- diuretics (water tablets)
- cardiac glycosides such as digoxin (used to treat heart conditions)
- lithium (used to treat certain forms of depression)
- phenytoin (used in the treatment of epilepsy)
- zidovudine (an anti-viral drug)
- probenecid (used in the treatment of gout)
- steroids (used in the treatment of inflammatory conditions)
- methotrexate (used to treat certain cancers)
- medicines known as immunosupressants such as ciclosporin and tacrolimus (used to dampen
down your immune response)
- medicines known as selective serotonin reuptake inhibitors (SSRIs) (used for the treatment of
depression)
- antibiotics called quinolones such as ciprofloxacin
- aminoglycosides (a type of antibiotic)
- mifepristone (used for medical termination of pregnancy)
- any other ibuprofen preparations, such as those you can buy without a prescription
- any other anti-inflammatory pain killer including acetylsalicylic acid (e.g. Aspirin)
- cholestyramine (a drug used to lower cholesterol)
- medicines known as sulphonylureas such as glibenclamide (used to treat diabetes)
- voriconazole or fluconazole (types of anti-fungal drugs)
- ginkgo biloba herbal medicine (there is a chance you may bleed more easily if you are taking
this with ibuprofen).
Some other medicines may also affect or be affected by the treatment of Abfen. You should therefore
always seek the advice of your doctor or pharmacist before you use Abfen with other medicines.

Abfen with alcohol
If you drink alcohol while taking this medicine you may be more likely to get side effects.
Abfen 600 mg Effervescent Granules– COA Mylan and CCDS 2014

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.




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.
Tell your doctor or pharmacist before taking this medicine if you are planning to become
pregnant or if you are having problems getting pregnant. This is because this medicine may
make it more difficult to get pregnant when used over a long period of time. However, it is
unlikely that using this medicine occasionally will affect your chances of getting pregnant. This
effect usually goes away when you stop taking the medicine.

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. This particularly applies in
combination with alcohol.

Abfen contains 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. Each sachet contains 3.3 g sucrose. This
should be taken into account in patients with diabetes mellitus.
Abfen contains sodium
Abfen contains 8.6 mmol (197 mg) 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 Abfen

Always take this medicine exactly as your doctor or 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 (of 18 years and older):

The recommended dose is 1 sachet (600 mg) taken two or three times a day.

Your doctor may choose to increase or decrease this depending on what you are being treated
for. Do not take more than 4 sachets (2,400 mg) in any 24 hours.
Children and adolescents:
Abfen is not recommended for children and adolescents under 18 years of age.
People with liver or kidney problems:
If you have liver or kidney problems, your doctor will tell you the correct dose to take. This will be
Abfen 600 mg Effervescent Granules– COA Mylan and CCDS 2014

the lowest dose possible.
The elderly (over 65 years):
If you are elderly, your doctor will tell you the correct dose to take. This will be the lowest dose
possible.
Taking this medicine
If you have a sensitive stomach, take this medicine with or just after food. If taken shortly after eating,
the onset of action of Abfen may be delayed.





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.

If you take more Abfen than you should
If you have taken more of this medicine than you should, contact a doctor or go to the nearest hospital
straight away. Take the medicine pack with you.
The signs of an overdose can include: feeling sick, stomach pain, being sick (may have 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 Abfen

If you forget a dose, take it as soon as you remember. 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 medicine, 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 straight away if you notice any of the following
serious side effects - you may need urgent medical attention:
Common (may affect up to 1 in 10 people):

signs of bleeding from the stomach or gut such as passing blood in your faeces
(stools/motions), passing black tarry stools or vomiting any blood or dark particles that look
like coffee grounds
Uncommon (may affect up to 1 in 100 people):

swelling of the face, tongue or throat (larynx) which can cause great difficulty in swallowing
and breathing (angioedema)
Rare (may affect up to 1 in 1,000 people):

rapid heartbeat, severe fall in blood pressure or life threatening shock

Abfen 600 mg Effervescent Granules– COA Mylan and CCDS 2014

Very rare (may affect up to 1 in 10,000 people):

severe rash, peeling, blistering or flaking skin

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 straight away if you notice any of the side effects
above.
Stop taking this medicine and tell your doctor if you notice any of the following:
Common (may affect up to 1 in 10 people):

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):
• rash
• feeling dizzy or tired
• 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 drowsy
• feeling anxious
• feeling a tingling sensation or ‘pins and needles’
• difficulty sleeping
• hives, itching
• skin becomes sensitive to light
• visual disturbances, hearing problems
• ringing in ears (tinnitus)
• sensation of feeling dizzy or spinning (vertigo)
• hepatitis, yellowing of your skin or eyes, reduced liver function
• reduced kidney function, inflammation of the kidneys, kidney failure
• sneezing, blocked, itchy or runny nose (rhinitis)
• stomach or gut ulcer, hole in the wall of the digestive tract
• 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
• 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
• reduction in blood cells (anaemia)
Rare (may affect up to 1 in 1,000 people):
• feeling depressed or confused
• fluid retention (oedema)
• a brain infection called ‘non-bacterial meningitis’
• loss of vision
• liver damage

Abfen 600 mg Effervescent Granules– COA Mylan and CCDS 2014

Very rare (may affect up to 1 in 10,000 people):
• heart failure, heart attack, high blood pressure
• liver failure
• inflammation of the pancreas
• 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
• worsening of ulcers in the large intestine (colitis) or Crohn’s Disease (bowel 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)
• a small increased risk of heart attack 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 Abfen

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 this medicine after the expiry date which is stated on the outer carton and sachet. 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 protect the environment.

6.

Contents of the pack and other information

What Abfen contains
• The active substance is ibuprofen. Each sachet contains 600 mg of ibuprofen.
• 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 Abfen looks like and contents of the pack
Abfen 600 mg Effervescent Granules are a white powder with an orange flavour.
Your medicine will be in a sachet.
After reconstitution, the suspension has a white, translucent appearance, free from foreign substances,
with an orange odour.
Each pack contains 10, 20, 30, 40 or 50 sachets.

Abfen 600 mg Effervescent Granules– COA Mylan and CCDS 2014

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Mylan Products Ltd, 20 Station Close, Potters Bar , Herts, EN6 1TL, UK
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
Estonia
Hungary
Ireland
Latvia
Lithuania
Romania
Slovenia

Abfen 600 mg Effervescent Granules
Brufen
Brufen 600 mg Pezsgőgranulátum
Brufen 600 mg Effervescent Granules
Brufen 600 mg putojošās granulas
Brufen 600 mg šnypščiosios granulės
BRUFEN 600 mg granule efervescente
BRUFEN 600 mg šumeča zrnca

This leaflet was last revised inNovember 2016

Abfen 600 mg Effervescent Granules– COA Mylan and CCDS 2014

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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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