Ibuprofen (als lysine) Mylan OTC 400 mg, filmomhulde tabletten

1. What is and what it is used for

<INVENTED NAME> contains the active substance ibuprofen. It belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body’s response to pain and high temperature.

[200mg only]

<INVENTED NAME> tablets are used for the symptomatic treatment of mild to moderate pain, such as headache, dental pain, period pain and fever and pain as the result of a cold.

[400 mg only]

<INVENTED NAME> tablets are used for the symptomatic treatment of mild to moderate pain, such as headache, acute migraine headache with or without aura, dental pain, period pain and fever and pain as the result of a cold.

2. What do you need to know before you take

Do not take <INVENTED NAME>:

• if you are allergic to ibuprofen or any other ingredients of this medicine (listed in section 6)
• if you have had an allergic reaction such as asthma, difficulty in breathing, swelling of the face, tongue or throat nettle rash, itchy runny nose to acetylsalicylic acid (ASA) or other NSAIDs
• if you have (or have had two or more episodes of) a stomach ulceror bleeding
• if you have had gastrointestinal perforation or bleeding when taking NSAIDs
• if you are suffering from cerebrovascular or other active bleeding
• if you are suffering from unclarified blood-formation disturbances
• if you have severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)
• if you have severe liver, kidney or heart failure
• if you are in the last 3 months of pregnancy.

[200 mg only]

<INVENTED NAME> contraindicated in children under 6 years (less than 20 kg body weight).

[400 mg only]

<INVENTED NAME> is contraindicated in adolescents under 40 kg body weight or children under 12 years.

Warnings and precautions:

Talk to your doctor or pharmacist before taking <INVENTED NAME>:

• if you have recently had major surgery
• if you have or have had asthma or allergic disease as shortness of breath may occur
• if you suffer from hayfever, nasal polyps or chronic obstructive respiratory disorders as an increased risk of allergic reactions exists. The allergic reactions may present as asthma attacks (so-called analgesic asthma), Quincke’s oedema or urticaria
• if you have heart problems
• if you have a history of gastrointestinal disease (such as ulcerative colitis, Crohn’s disease)
• if you have systemic lupus erythematosus or mixed connective tissue disease (a disease affecting the skin, joints and kidneys)
• if you have certain hereditary blood formation disorders (e.g. acute intermittent porphyria)
• if you have a blood clotting disorder
• if you are taking other NSAIDs. The use with concomitant NSAIDs, including cyclo-oxygenase-2 specific inhibitors, increases the risk of adverse reactions (see section “Other medicines and <INVENTED NAME>” below) and should be avoided
• if you have chicken pox (varicella) it is advisable to avoid use of <INVENTED NAME>
• if you are elderly.

Patients with kidney or liver problems should first consult a doctor before taking ibuprofen tablets.

Medicines such as <INVENTED NAME> may be associated with a small increased risk of heart attack

(“myocardial infarction”) or stroke. Any risk is more likely with high doses or prolonged treatment. Do not exceed the recommended dose or duration of treatment (see section 3).

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.

Very rare reports of potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of ibuprofen. Patients are at higher risk of such reactions during the first month of therapy. Stop taking <INVENTED NAME> and talk to your doctor or pharmacist if you notice a skin rash, mucosal lesions, or any other signs of allergic reactions (see section 4).

Undesirable effects may be minimised by using the minimum effective dose for the shortest period of time. The elderly are at increased risk of side effects.

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 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.

NSAIDs may mask symptoms of infection and fever.

In prolonged administration of <INVENTED NAME> regular checking of your liver values, the kidney function, as well as the blood count, is required. Your doctor may ask you to have blood tests during treatment.

Other medicines and <INVENTED NAME>

Some medicines that are anti-coagulants (against clotting) (e.g. acetylsalicylic acid, warfarin, ticlopidin), some medicines against high blood pressure (ACE-inhibitors e.g. captopril, betareceptor blocking medicines, angiotensin II antagonists), and even some other medicines may effect or be effected by the treatment of ibuprofen. Therefore always seek advice of a doctor before you use ibuprofen with other medicines.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. In particular, tell them if you are taking:



• Acetylsalicylic acid, or other NSAIDs (anti-inflammatories and analgesics)
• Digoxin (for heart insufficiency)
• Glucocorticoids (medicinal products containing cortisone or cortisone-like substances)
• Anti-platelet agents
• Acetylsalicylic acid (low dose)
• Medicines for thinning the blood (such as warfarin)
• Phenytoin (for epilepsy)
• Selective serotonin reuptake inhibitors (medicines used for depression)
• Lithium (a medicine for manic depressive illness and depression)
• Probenecid and Sulfinpyrazones (medicines for treating gout)
• Medicines for high blood pressure and water tablets
• Potassium sparing diuretics
• Methotrexate (a medicine for cancer or rheumatism)
• Tacrolimus and cyclosporin (immunosuppressive medicines)
• Zidovudine: (a medicine for treating HIV/AIDS)

Since this may increase the risk of gastrointestinal ulcers or bleeding

Since the effect of digoxin may be enhanced

Since this may increase the risk of gastrointestinal ulcers or bleeding

Since this may increase the risk of bleeding

Since the blood-thinning effect may be impaired

Since ibuprofen may enhance the effects of these medicines

Since the effect of phenytoin may be enhanced

As these may increase the risk of gastrointestinal bleeding

Since the effect of lithium may be enhanced

Since the excretion of ibuprofen may be delayed

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

Since this may lead to hyperkalaemia (high potassium levels in the blood)

Since the effect of methotrexate may be enhanced

Since kidney damage may occur

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

• Sulfonylureas (antidiabetic medicines)
• Quinolone antibiotics
• Mifepristone (medicine prescribed for pregnancy termination)
• Bisphosphonates (medicines prescribed to treat osteoporosis)
• Oxpentifylline (pentoxyfilline) (medicine prescribed to increase the blood flow to arms and legs)
• Baclofen, a muscle relaxant

Interactions may be possible

Since the risk for convulsions may be increased

Since ibuprofen may reduce the effect of this medicine

Since these may increase the risk of gastrointestinal ulcers or bleeding

Since this may increase the risk of gastrointestinal bleeding

Since the toxicity of baclofen may be enhanced

Low dose ASA

Do not take this medicine if you are taking ASA at doses of above 75 mg daily. If you are on low-dose ASA (up to 75 mg daily) speak to your doctor or pharmacist before you take <INVENTED NAME>.

<INVENTED NAME> with alcohol

Consumption of alcohol should be avoided while taking <INVENTED NAME> as it may intensify possible side effects.

Pregnancy, breast-feeding and fertility

Do not take <INVENTED NAME> in the last 3 months of pregnancy.

If you are in the first 6 months of pregnancy, 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.

<INVENTED NAME> tablets belong to a group of medicines which may impair fertility in woman. This effect is reversible on stopping the medicine. It is unlikely that <INVENTED NAME>, 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

For short-term use and at normal dosage this medicine has no or negligible influence on the ability to drive and use machines. If side-effects such as tiredness, dizziness, drowsiness and visual disturbances occur, do not drive or operate machines. Alcohol consumption increases the risk of these side effects.

3. How to take

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 product is intended for short term use only. You should take the lowest effective dose for the shortest time necessary to relieve your symptoms.

You should not take <INVENTED NAME> for longer than 3 days in the case of migraine or fever, or 4 days for the treatment of pain unless your doctor tells you to.

If symptoms persist or worsen consult your doctor.

[200 mg only]

Adults and adolescents over 40 kg body weight(12 years of age and above):

The recommended dose is 200 mg to 400 mg (1 or 2 tablets), up to three times a day as required. Leave at least four hours between 200 mg (1 tablet) doses and at least six hours between 400 mg (2 tablets) doses. Do not take more than 1200 mg (6 tablets) in 24 hours.

For treatment of migraine headache the recommended dose is 2 tablets of 200 mg as a single dose. If necessary, take 400 mg (2 tablets) dose with intervals of 4 to 6 hours. Do not take more than 1200 mg (6 tablets) in any 24 hours.

Use in children over 6 years (20 kg – 40 kg body weight):

The recommended daily dose is 20 mg to 30 mg of ibuprofen per kg body weight divided into three or four separate doses as shown in the table below. Leave at least six to eight hours between doses.

Body weight		Single dose	Maximum daily dose
20 kg – 29 kg	one 200 mg tablet (equals 200 mg	three 200 mg tablets (equals 600
	ibuprofen)		mg ibuprofen)
30 kg – 39 kg	one 200 mg tablet (equals 200 mg	four 200 mg tablets (equals 800
	ibuprofen)		mg ibuprofen)

Use in children under 6 years (less than 20 kg body weight):

<INVENTED NAME> is contraindicated for use in children under 6 years (less than 20 kg body weight).

[400 mg only]

Adults and adolescents from 40 kg body weight (12 years of age and above)

The recommended dose is 400 mg (1 tablet), up to three times a day as required. Leave at least six hours between 400 mg (1 tablet) doses. Do not take more than 1200 mg (3 tablets) in 24 hours.

For treatment of migraine headache the recommended dose is 1 tablet of 400 mg as a single dose. If necessary, take 400 mg (1 tablet) dose with intervals of 4 to 6 hours. Do not take more than 1200 mg (3 tablets) in any 24 hours.

Use in adolescents under 40 kg body weight or in children under 12 years of age:

<INVENTED NAME> is contraindicated for use in adolescents under 40 kg body weight or in children under 12 years.

Method of administration

<INVENTED NAME> tablets are swallowed whole with plenty of water. Do not chew the tablets.

Patients with a sensitive stomach should take the tablets during a meal. Taking the tablets after a meal may delay the onset of pain or fever relief. Do not exceed the recommended dose or take more frequently than recommended.

If you take more <INVENTED NAME> than you should

You may experience nausea, stomach ache, headache, vomiting, diarrhoea, ringing in the ears, vomiting blood and blood in stools. More serious poisoning can lead to dizziness, drowsiness, excitation, disorientation, low blood pressure, reduced breathing (respiratory depression), blue discolouring of the skin and mucosa (cyanosis), loss of consciousness, convulsions and coma. You should seek immediate medical advice in the event of an overdose, even if you feel well.

If you forget to take <INVENTED NAME>

Simply refer to the directions above on how to take the medicine and do not take more than is advised.

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.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects may be minimised by taking the lowest dose for the shortest time necessary to relieve the symptoms. Elderly people using this product are at increased risk of developing problems associated with side effects.

Medicines such as <INVENTED NAME> may be associated with a small increased risk of heart attack

(“myocardial infarction”) or stroke.

Some of the undermentioned undesirable effects are less frequent when the maximum daily dose is 1200 mg compared to high-dose therapy in rheumatism patients.

If you think you have any of the following side effects or symptoms, stop taking this medicine and seek immediate help:

• stomach and intestinal ulcers, sometimes with bleeding and perforation, vomiting blood or have black tar-like stools (common: may affect up to 1 in 10 people)
• kidney disease with blood in the urine which can be associated with renal failure (uncommon: may affect up to 1 in 100 people)
• severe allergic reactions (very rare: may affect up to 1 in 10,000 people) such as:
  • difficulties in breathing or unexplained wheezing
  • dizziness or faster heartbeat
  • drop in blood pressure leading to shock
  • swelling of your face, tongue or throat
• potentially life-threatening skin rashes with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals (Steven-Johnson syndrome) or serious skin reactions which starts with painful red areas, then large blisters and ends with peeling of layers of skin. This is accompanied by fever and chills, aching muscles and generally feeling unwell (toxic epidermal necrolysis) (very rare: may affect up to 1 in 10,000 people)
• severe condition of the skin that may affect the mouth and other parts of the body with symptoms including: red, often itchy spots, similar to the rash of measles, which starts on the limbs and sometimes on the face and the rest of the body. The spots may blister or may progress to form raised, red, pale-centred marks. Those affected may have fever, sore throat, headache and/or diarrhoea (very rare: may affect up to 1 in 10,000 people)
• severe flaking or peeling of the skin (very rare: may affect up to 1 in 10,000 people)
• inflammation of the pancreas with severe upper stomach pain, often with nausea and vomiting (very rare: may affect up to 1 in 10,000 people)
• nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, light coloured bowel motions, dark coloured urine which may be signs of hepatitis or liver failure (very rare: may affect up to 1 in 10,000 people)
• disease of the heart with shortness of breath and swelling of the feet or legs due to fluid build-up (heart failure) (very rare: may affect up to 1 in 10,000 people)
• aseptic meningitis (infection around the brain or spinal cord with symptoms including fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light and clouding of the mental state and thus not being fully in contact with the environment) (very rare: may affect up to 1 in 10,000 people)
• heart attack (“myocardial infarction”, very rare: may affect up to 1 in 10,000 people) or stroke (not known: frequency cannot be estimated from the available data)
• severe kidney damage (papillary necrosis), particularly in long term use (rare: may affect up to 1 in 1,000 people)
• worsening of infection-related inflammations (e.g. development of flesh eating bacteria syndrom) particulalry if using other NSAIDs (very rare: may affect up to 1 in 10,000 people)

Stop taking the medicine and tell your doctor if you experience:

Very common (may affect more than 1 in 10 people)

• indigestion or heartburn

• abdominal pain (pains in your stomach) or other abnormal stomach Uncommon (may affect up to 1 in 100 people):
• Visual disturbances

Tell your doctor if you experience any of the below side effects: Very common (may affect more than 1 in 10 people)

 nausea, wind, diarrhoea, constipation, vomiting

Common (may affect up to 1 in 10 people):

• headache, sleepiness, dizziness, spinning sensation tiredness, agitation, inability to sleep, irritability
• stomach and intestinal ulcers, sometimes with bleeding and perforation; hidden blood loss which may lead to a condition in which there is a decreased number of red blood cells (symptoms include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), black tar-like stools, vomiting blood, mouth ulcers and cold sores, inflammation of the colon (symptoms include diarrhoea, usually with blood and mucus, stomach pain, fever), worsening of inflammatory bowel disease, inflammation of bowel wall

Uncommon (may affect up to 1 in 100 people):

• hives, itching, unusual bleeding or bruising under the skin, skin rash, asthma attacks (sometimes with hypotension)
• runny or blocked nose, sneezing, facial pressure or pain, difficulty in breathing
• inflammation of the stomach (symptoms include pain, nausea, vomiting, vomiting blood, blood in the bowel motions)
• increased sensitivity of the skin to sun
• swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, sometime with high blood pressure
• fluid build-up in the body's tissues especially in patients with high blood pressure or kidney problems

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

• a disease affecting the skin, joints and kidneys (lupus erythematosus syndrome)
• depression, confusion, hallucinations, mental illness with strange or disturbing thoughts or moods
• buzzing, hissing, whistling, ringing or other persistent noise in the ears
• increase of blood urea nitrogen, serum transaminases and alkaline phosphatase, decrease in haemoglobin and haematocrit values, inhibition of platelet aggregation, prolonged bleeding time, decrease of serum calcium, increase in serum uric acid, all seen on a blood test
• loss of vision

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

• fast or irregular heart beats (palpitations)
• fluid build-up in the body's tissues
• high blood pressure
• inflammation of the food pipe, narrowing of intestines
• liver disease, liver damage (especially in long-term use), liver failure, yellowing of the skin and/or eyes, also called jaundice
• unusual hair loss or thinning
• severe skin infections with soft tissue complications may occur if you have chicken pox
• menstrual period disorders
• build-up of fluid in the lungs, symptoms include breathlessness, which may be very severe and usually worsens on lying down.

Not known (frequency cannot be estimated from available data)

• worsening of an inflammatory disease that can affect any part of the gastrointestinal tract (symptoms include pain, fever, diarrhoea and loss of weight), worsening of inflammation of the colon ( symptoms diarrhoea, usually with blood and mucus, stomach pain, fever)

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 national reporting system listed in Appendix V* [to be completed nationally]. 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 use <INVENTED NAME> after the expiry date which is stated on the blister, carton or bottle after

‘EXP’. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Bottles: Use within 60 days of opening. Once open, keep bottle tightly closed.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What <INVENTED NAME> contains:

The active substance is ibuprofen (as lysine).

Each 200 mg tablet contains 200 mg of ibuprofen (as lysine).

Each 400 mg tablet contains 400 mg of ibuprofen (as lysine).

The other ingredients of a tablet are cellulose, microcrystalline; silica, colloidal anhydrous; crospovidone; povidone; magnesium stearate; talc (E553b). The tablet coating contains polyvinyl alcohol, hydrolysed; titanium dioxide (E171); macrogol (E1521); talc (E553b). The printing ink contains shellac; iron oxide black (E172); ammonium hydroxide (E527).

What <INVENTED NAME> looks like and contents of the pack

200 mg strength comes as a white to off-white, film-coated, round, biconvex, bevelled edge tablet imprinted with “M” over “IL1” in black ink on one side of the tablet and blank on the other side.

400 mg strength comes as a white to off-white, film-coated, oval, biconvex, bevelled edge tablet imprinted with “M IL2” in black ink on one side of the tablet and blank on the other side.

<INVENTED NAME> is available in blister packs of 2, 4, 6, 10, 12, 16, 20, 24, 30, 48, 50, 100, 200 tablets and bottles of 48, 100, 200 (dispensing pack) tablets. Each bottle also contains silica gel (desiccant) which helps to protect your tablets against moisture.

Not all pack sizes may be marketed.

Houder van de vergunning voor het in de handel brengen

Mylan B.V

Dieselweg 25

3752 LB Bunschoten

Nederland

Fabrikant

Gerard Laboratories

35/36 Baldoyle Industrial Estate

Grange Road

Dublin 13

Ierland

Generics [UK] Limited

Potters Bar

Hertfordshire

EN6 1TL

Verenigd Koninkrijk

Mylan Hungary Kft

H-2900 Komarom

Mylan street 1

Hongarije

This medicinal product is authorised in the Member States of the EEA under the following names:

Belgium	Ibuprofen Lysine Mylan Pharma 200 mg filmomhulde
	tabletten
	Ibuprofen Lysine Mylan Pharma 400 mg filmomhulde
	tabletten
Germany	Ibuprofen Mylan 400 mg Filmtabletten
Ireland	Ibuprofen 200 mg film-coated tablets
	Ibuprofen 400 mg film-coated tablets
Italy	Ibuprofene Mylan
Luxembourg	Ibuprofen Lysine Mylan Pharma 200 mg comprimés
	pelliculés
	Ibuprofen Lysine Mylan Pharma 400 mg comprimés
	pelliculés
Poland	Myibuprofen
	Myibuprofen Forte
The Netherlands	Ibuprofen (als lysine) Mylan OTC 200 mg, filmomhulde
(RMS)	tabletten
	Ibuprofen (als lysine) Mylan OTC 400 mg,filmomhulde
	tabletten

Deze bijsluiter is voor het laatst goedgekeurd in september 2013.