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Document: leaflet MAH GENERIC_PL 35533-0034 change

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• leaflet MAH GENERIC_PL 04917-0121
• leaflet MAH GENERIC_PL 35533-0034

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Package leaflet: Information for the user

Ibuprofen 200mg/5ml, oral suspension

For children from 10kg body weight (1 year of age), adolescents and adults

Ibuprofen

Read all of this leaflet carefully before you start using 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 Ibuprofen oral suspension is and what it is used for

2.    What you need to know before you take Ibuprofen oral suspension

3.    How to take Ibuprofen oral suspension

4.    Possible side effects

5.    How to store Ibuprofen oral suspension

6.    Contents of the pack and other information

(1) What Ibuprofen oral suspension is and what it is used for

Ibuprofen oral suspension is a medicine that reduces pain and fever (non-steroidal anti-inflammatory drug, NSAID).

Ibuprofen oral suspension is used as short-term symptomatic treatment of:

•    mild to moderate pain such as dental pain, headache.

_•    fever.

Ibuprofen oral suspension is for use in children from 10kg body weight (1 year of age), adolescents and adults.

(2 What you need to know before you take Ibuprofen oral suspension

Do not take Ibuprofen oral suspension

•    if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).

•    in a history of bronchospasm, asthma attacks, swelling of the inner lining of the nose (rhinitis), angioedema or skin reactions (urticaria) after taking acetylsalicylic acid (ASA) or other non-steroidal anti-inflammatory drugs (NSAIDs).

•    in unclarified blood-formation disturbances.

•    in a history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.

•    in active or history of recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding (two or more distinct episodes of proven ulceration or bleeding).

•    in cerebrovascular bleeding or other active bleeding.

•    in severe impairment of liver or kidney function or severe heart failure.

•    in severe dehydration (from vomiting, diarrhoea or insufficient fluid intake).

•    in the last three months of pregnancy.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ibuprofen oral suspension

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.

Safety in the gastrointestinal tract

The use of Ibuprofen oral suspension at the same time as other NSAIDs, including so-called COX-2 inhibitors (cyclooxygenase-2 selective inhibitors) should be avoided.

Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

Gastrointestinal bleeding, ulceration or perforation:

Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.

The risk of developing gastrointestinal bleeding, ulcers and perforation is higher with the increasing NSAID doses and is higher in patients with a history of ulcer, especially with complications of bleeding or perforation (see section 2: ‘Do not take Ibuprofen oral suspension’) and in elderly patients. These patients should start treatment at the lowest available dose.

For these patients, as well as patients who require additional therapy with low dose acetylsalicylic acid (ASA) or other medicines that can increase the risk of gastrointestinal disorders, combination treatment with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered.

If you have a history of side effects affecting the gastrointestinal tract, particularly if you are elderly, you should report all unusual abdominal symptoms (especially gastrointestinal bleeding), especially in the initial stages of therapy.

Caution should be advised if you are receiving at the same time medications that could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulant medicines such as warfarin, selective serotonin reuptake inhibitors (used to treat disorders including depression) or platelet aggregation inhibitors such as ASA (see section 2: ‘Other medicines and Ibuprofen oral suspension’).

Treatment must be stopped and a doctor consulted when gastrointestinal bleeding or ulceration occurs during treatment with Ibuprofen oral suspension.

NSAIDs should be used with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease), as their condition may get worse (see section 4).

Effects on the cardiovascular and cerebrovascular system

Medicines such as Ibuprofen oral suspension 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 exceed the recommended dose or duration of treatment (3 days in children; 3 days in the treatment of fever and 4 days in the treatment of pain in adolescent and adults).

If 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) you should discuss your treatment with your doctor or pharmacist.

Skin reactions

Very rarely, serious skin reactions with redness and blistering, some of them were fatal, have been reported during NSAID therapy (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis/Lyell’s syndrome; see section 4). Patients appear to be at highest risk of these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. At the first signs of skin rash, mucous membrane defects or any other signs of a hypersensitivity reaction, you should stop taking Ibuprofen oral suspension and consult your doctor immediately.

During chickenpox (varicella) it is advisable to avoid the use of Ibuprofen oral suspension.

Other information

Ibuprofen oral suspension should only be used after consulting a doctor:

•    in congenital disorder of blood formation (acute intermittent porphyria).

•    in certain disorders of the immune system (systemic lupus erythematosus or mixed connective tissue disease).

Particularly careful monitoring by a doctor is required:

•    in impairment of kidney function.

•    in impairment of liver function.

•    in dehydration.

•    directly after major surgeries.

•    in allergies (such as skin reactions to other drugs, asthma, hay fever), chronic swelling of mucous membrane of the nose or chronic obstructive airway disease - you will be at increased risk for hypersensitivity reactions.

Very rarely, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. At the first signs of a severe hypersensitivity reaction after taking Ibuprofen oral suspension, treatment must be stopped. Depending on the symptoms, any medical treatment required must be started by specialists.

Ibuprofen, the active substance of Ibuprofen oral suspension, may temporarily inhibit the blood-platelet function (thrombocyte aggregation). Patients with blood-coagulation disturbances should therefore be monitored carefully.

During prolonged use of Ibuprofen oral suspension, regular monitoring of liver enzymes, kidney function and the blood count is required.

Whilst taking Ibuprofen oral suspension, you should consult/ inform the doctor or dentist before you undergo any surgery.

If you are already taking other painkilling or fever-lowering medicines or antibiotics you can take Ibuprofen oral suspension only if told by the treating doctor.

If you suffer from a serious medical condition and/or are taking medicines on a regular basis, you should consult the treating doctor before using Ibuprofen oral suspension.

Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of medication overuse headache (MOH) should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.

The habitual use of painkillers, especially that of several painkilling drugs in combination, may quite generally lead to permanent kidney damage with the associated risk of kidney failure (analgesic nephropathy).

NSAIDs such as ibuprofen may mask the symptoms of infection and fever.

Children

Ibuprofen oral suspension is not recommended for use in children under 1 year of age or under 10kg body weight.

Other medicines and Ibuprofen oral suspension

Tell your doctor or pharmacist if you or the child to be treated are taking, have recently taken or might take any other medicines.

What should you avoid when you are taking this medicine?

Some medicines that are anticoagulants (against clotting) (e.g. acetylsalicylic acid, warfarin, ticlopidine), some medicines for high blood pressure (ACE-inhibitors e.g. captopril, beta-receptor blocking medicines, angiotensin II antagonists) and even some other medicines may affect or be affected by treatment of ibuprofen. Seek therefore always advice of a doctor before you use ibuprofen with other medicines.

Using Ibuprofen oral suspension at the same time as digoxin (used to strengthen the heart), phenytoin (used to treat seizures) or lithium (used to treat certain psychiatric disorders) can increase the concentration of these medicines in the blood. Monitoring of serum lithium levels, serum digoxin and serum phenytoin levels is generally not required if used as directed (maximum over 4 days).

Ibuprofen oral suspension can weaken the effect of water tablets (diuretics) and high blood pressure medications (antihypertensive agents) and there could be a possible increased risk for the kidney.

Ibuprofen oral suspension can weaken the effect of ACE inhibitors (used to treat heart failure and high blood pressure). Furthermore, if used at the same time, there is an increased risk that kidney dysfunction may occur.

Combined administration of Ibuprofen oral suspension and potassium sparing diuretics (certain water tablets) can lead to an increase in blood potassium levels.

The risk of gastrointestinal ulcers or bleeding is increased when Ibuprofen oral suspension is given at the same time as glucocorticoids or other anti inflammatories and painkillers of the NSAID group.

Platelet aggregation inhibitors acid and certain antidepressants (selective serotonin reuptake inhibitors/SSRIs) can increase the risk of gastrointestinal bleeding.

Administration of Ibuprofen oral suspension within 24 hours before or after dosing with methotrexate can lead to higher methotrexate concentrations and an increase in its undesirable effects.

Ciclosporin (used to prevent transplant rejections, as well as in rheumatism treatment) is more likely to cause kidney damage if certain non steroidal anti inflammatory drugs are given at the same time. Similarly, this effect cannot be ruled out for any ciclosporin/ibuprofen combination.

Medicines containing probenecid or sulphinpyrazone (used to treat gout) may delay the elimination of ibuprofen. This can cause ibuprofen to accumulate in the body and increase its undesirable effects.

NSAIDs may enhance the effects of anti-coagulants such as warfarin. Monitoring of the blood clotting status is recommended when combining these treatments.

Clinical studies have shown interactions between NSAIDs and sulphonylureas (used to lower blood sugar). Although no interactions between ibuprofen and sulphonylureas have been described to date, monitoring of blood sugar levels is recommended as a precaution during combined use.

Tacrolimus: The risk of kidney damage is increased when both medications are given at the same time.

Zidovudine: In HIV positive patients with haemophilia (‘bleeders’), there is evidence of a higher risk of haemarthrosis (bleeding into joints) and haematoma when zidovudine and ibuprofen are taken at the same time.

Quinolone antibiotics: May increase the risk of convulsions when both medications are taken at the same time.

CYP2C9 Inhibitors: Concomitant administration of ibuprofen with CYP2C9 inhibitors may increase the exposure to ibuprofen (CYP2C9 substrate). In a study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased S(+)-ibuprofen exposure by approximately 80 to 100% has been shown. Reduction of the ibuprofen dose should be considered when potent CYP2C9 inhibitors are administered concomitantly, particularly when high-dose ibuprofen is administered with either voriconazole or fluconazole.

Taking Ibuprofen Oral Suspension with alcohol

You should avoid alcohol while taking Ibuprofen oral suspension.

Pregnancy, breast-feeding and fertility

Pregnancy

Tell your doctor if you become pregnant during intake of Ibuprofen oral suspension. Do not take this medicine in the last 3 months of pregnancy. Avoid the use of this medicine in the first 6 months of pregnancy unless your doctor advises otherwise.

Breast-feeding

Only small amounts of ibuprofen and its decomposition products pass into the breast milk. As no harmful effects to infants are known to date, it is not usually necessary to interrupt breast-feeding during short-term use of ibuprofen at the recommended doses.

Fertility

This medicine belongs to a group of medicines (NSAIDs) which may impair the fertility in women. This effect is reversible on stopping the medicine.

Driving and using machines

Central nervous side effects, such as tiredness and dizziness, can occur when using Ibuprofen oral suspension. As a result, the ability to react may be altered in individual cases and the

ability to take part actively in road traffic and use machines may be impaired. This particularly applies in interaction with alcohol. You may no longer be able to react quickly and appropriately enough to unexpected and sudden events. If affected, do not drive your car or any other vehicles; do not use machines or perform any dangerous tasks.

Ibuprofen oral suspension contains maltitol liquid and sodium

If you have been told by your doctor that you or the child to be treated have an intolerance to some sugars, contact your doctor before taking this medicinal product.

This medicinal product contains 1.74mmol (39.90mg) sodium per highest single dose of 7.5 ml. To be taken into consideration by patients on a controlled sodium diet.

(3) How to take Ibuprofen Oral Suspension

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

In children and adolescents Ibuprofen oral suspension is dosed depending on body weight (BW), as a rule with 7 to 10mg/kg BW as a single dose to a maximum of 30mg/kg BW as the total daily dose.

The interval between the doses should be at least 6 hours.

Do not exceed the recommended dose.

Not recommended for use in children under 1 year of age or under 10kg body weight.

Oral use.

The package includes a 5 ml oral syringe (graduated in 0.25ml steps).

Shake the bottle vigorously before use.

The oral suspension can be taken without regard to meals. People with a sensitive stomach are recommended to take Ibuprofen oral suspension during meals.

Please talk to your doctor or pharmacist if you feel that the effect of Ibuprofen oral suspension is too strong or too weak.

Duration of treatment

For short-term use only.

If in children symptoms worsen or persist for more than 3 days, a doctor should be consulted.

If in adolescents and adults symptoms worsen or if this product is required for more than 3 days in the case of fever or for more than 4 days for the treatment of pain, a doctor should be consulted.

If you take more Ibuprofen oral suspension than you should

Stop ibuprofen and see a doctor if you experience any overdose symptoms such as headache, dizziness, light-headedness, unconsciousness (also seizures in children), abdominal pain, nausea and vomiting, bleeding in the gastrointestinal tract, liver and kidney dysfunction, drop in blood pressure, reduced breathing (respiratory depression) or cyanosis (bluish discoloration of the lips or the skin).

There is no specific antidote.

If an overdose with Ibuprofen oral suspension is suspected, notify a doctor at once. According to the severity of the poisoning, they can decide about the measures that might be required.

If you forget to take Ibuprofen oral suspension

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.

The listing of undesirable effects below comprises all side effects reported during treatment with ibuprofen, including those reported during high-dose long-term therapy in patients with rheumatism.

Reported frequencies beyond very rare reports refer to short-term use of daily doses up to a maximum of 1200mg ibuprofen (= 30ml Ibuprofen oral suspension, maximum daily dose for adults and adolescents from 12 years of age) for oral formulations and a maximum of 1800mg ibuprofen for suppositories.

Regarding the following adverse drug reactions, it must be taken into account that they are mainly dose dependent and vary from patient to patient.

The most commonly observed side effects are gastrointestinal in nature.

Stomach/duodenal ulcers (peptic ulcers), perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur (see section 2: ‘Warnings and precautions’).

Nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, tarry stool, vomiting blood, ulcerative stomatitis (inflammation of the mucous membrane of the mouth with ulceration), worsening of the intestinal disorders colitis and Crohn’s disease (see section 2: ‘Take special care with’) have been reported following use.

Less frequently, inflammation of the mucous membrane of the stomach (gastritis) has been observed.

Medicines such as Ibuprofen oral suspension may be associated with a small increased risk of heart attack (‘myocardial infarction’) or stroke.

Oedema, high blood pressure and heart failure have been reported in association with NSAID treatment.

Common (may affect up to 1 in 10 people)

•    Gastrointestinal symptoms such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation and minor gastrointestinal blood losses that may cause anaemia in exceptional cases.

Uncommon (may affect up to 1 in 100 people)

•    Stomach or intestinal ulcers, sometimes with bleeding and perforation. Inflammation of the lining of the mouth with ulceration (ulcerative stomatitis), worsening of colitis or Crohn’s disease, inflammation of the lining of the stomach (gastritis).

In the case of significant pain in the upper belly, vomiting blood, seeing blood in the stool or black stool, you must stop Ibuprofen oral suspension and inform the doctor straight away.

•    Central nervous disturbances such as headache, dizziness, sleeplessness, agitation, irritability or tiredness.

•    Visual disturbances. A doctor is to be informed in this case, and Ibuprofen oral suspension must no longer be taken.

•    Hypersensitivity reactions with skin rash and itching, as well as asthma attacks (possibly with drop in blood pressure). In this case, you must consult your doctor immediately and stop taking/administering Ibuprofen oral suspension.

•    Various skin rashes.

Rare (may affect up to 1 in 1,000 people)

•    Kidney tissue damage (papillary necrosis), particularly in long-term therapy, increased uric acid concentration in the blood.

•    Ringing in the ears (tinnitus).

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

•    Palpitations, heart failure, heart attack (myocardial infarction).

•    Inflammation of the gullet (oesophagitis) or of the pancreas (pancreatitis), formation of membrane-like narrowing in the small and large intestines (intestinal, diaphragm-like strictures).

•    Reduced urinary output and accumulation of fluid in the body (oedema), particularly in patients with high blood pressure or impaired kidney function. Nephrotic syndrome (fluid accumulation in the body [oedemas] and pronounced protein excretion in the urine), inflammatory kidney disease (interstitial nephritis), which may be accompanied by acute kidney dysfunction.

Should these symptoms occur or get worse, you must stop Ibuprofen oral suspension and contact your doctor straight away.

•    Liver dysfunction, liver damage, especially during long-term treatment, liver failure, acute inflammation of the liver (hepatitis).

•    Problems with blood formation (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis).

Early signs may include: fever, sore throat, superficial wounds in the mouth, flu-like symptoms, pronounced fatigue, nosebleeds and skin bleeding. If any of these problems occur, stop this medicine immediately and see a doctor. You should not self-medicate with painkillers or fever lowering medicines.

•    Severe skin reactions such as skin rash with redness and blistering (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis/Lyell’s syndrome), hair loss (alopecia).

In exceptional cases, severe skin infections and soft-tissue complications may occur during a chickenpox (varicella) infection (see also ‘Infections and infestations’).

•    A worsening of infection-related inflammations (e.g. development of necrotising fasciitis) coinciding with the use of certain anti-inflammatory medicines (non-steroidal anti-inflammatory drugs, to which Ibuprofen oral suspension also belongs) has been described.

If signs of an infection (e.g. reddening, swelling, overheating, pain, fever) occur or get worse during use of Ibuprofen oral suspension, ask a doctor for advice without delay.

•    High blood pressure (arterial hypertension).

•    Signs of aseptic meningitis such as severe headache, nausea, vomiting, fever, stiff neck or clouding of consciousness. Patients with certain immune system disorders (systemic lupus erythematosus or mixed connective tissue disease) appear to be at increased risk.

•    Severe general hypersensitivity reactions. Signs may include: swelling of the face, tongue and inner larynx with airway narrowing, breathlessness, fast heart beat, blood pressure drop to the point of life-threatening shock.

If you experience any of the above symptoms, which you may even when using this medicine for the very first time, you need immediate medical assistance.

•    Psychotic reactions, depression.

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 (website: 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 Ibuprofen Oral Suspension

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and bottle. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Once opened, this medicine is stable at room temperature for 6 months.

(6) Contents of the pack and other information

What Ibuprofen oral suspension contains

The active substance is ibuprofen.

1ml oral suspension contains 40mg ibuprofen.

The other ingredients are:

Sodium benzoate (E211), citric acid anhydrous, sodium citrate, saccharin sodium, sodium chloride, hypromellose, xanthan gum, maltitol liquid, glycerol (E422), thaumatin (E957), strawberry flavour (natural flavouring preparations, maize maltodextrin, triethyl citrate (E-1505), propylene glycol (E-1520) and benzyl alcohol), purified water.

What Ibuprofen oral suspension looks like and contents of the pack

Ibuprofen oral suspension is a white or off-white viscous suspension.

Ibuprofen oral suspension 200mg/5ml oral suspension is available in bottles of 30ml, 100ml, 150ml and 200ml with a child-resistant closure.

Not all pack-sizes may be marketed.

For accurate dosing a polypropylene oral syringe for oral administration, graduated in 0.25 ml steps up to 5 ml, is included in the pack.

Marketing Authorisation Holder

Aspire Pharma Ltd Bellamy House Winton Road Petersfield Hampshire GU323HA United Kingdom

Manufacturer

Farmasierra Manufacturing, SL

Carretera de Irun, km 26.200

28700 San Sebsatian de los Reyes (Madrid)

Spain

This leaflet was last revised in 10/2014

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