ABFEN 600 MG EFFERVESCENT GRANULES - patient leaflet, side effects, dosage

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.

• 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 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
• 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).

Skin reactions

Serious skin reactions have been reported in association with <Brufen> treatment. You should stop taking <Brufen> and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4.

Infections

Abfen may hide signs of infections such as fever and pain. It is therefore possible that Abfen may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.

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

• – 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

• – have an infection – please see heading “Infections” above.

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.

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

This medicine contains 197 mg sodium (main component of cooking/table salt) in each sachet. This is equivalent to 9.9% of the recommended maximum daily dietary intake of sodium for an adult.

Talk to your doctor or pharmacist if you need 2 or more sachets daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.

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. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2 ).

How much to take

• 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 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 Abfen than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken. Take the medicine pack with you.

The symptoms can include: nausea, stomach pain, vomiting (may be blood streaked), headache, ringing in the ears, confusion and shaky eye movement. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling and breathing problems have been reported.

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

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

Not known (we do not know how often these happen):

• A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include:

skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).

• A red, scaly widespread rash with bumps under the skin and blisters mainly localized on the

skin folds, trunk, and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using <Brufen> if you develop these symptoms and seek medical attention immediately. See also section 2.

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

• 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

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: or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 the active substance is ibuprofen. each sachet contains 600 mg of ibuprofen.

• The other ingredients are croscarmellose sodium, malic acid, microcrystalline cellulose,

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.

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:

This leaflet was last revised in October 2020

Abfen 600 mg Effervescent Granules- PRAC update Nov 2020