Package leaflet: Information for the user

IBUPROFEN LYSINE

342 mg film-coated tablets

Ibuprofen lysine

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 has 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. See section 4.

-    You must talk to a doctor if you do not feel better or if you feel worse after 3 days (for adolescents).

-    You must talk to a doctor if you do not feel better or if you feel worse after 3 days in fever and after 4 days in the treatment of pain (for adults).

What is in this leaflet

1.    What Ibuprofen Lysine tablets is and what it is used for

2.    What you need to know before you take Ibuprofen Lysine tablets

3.    How to take Ibuprofen Lysine tablets

4.    Possible side effects

5.    How to store Ibuprofen Lysine tablets

6.    Contents of the pack and other information

1.    What Ibuprofen Lysine tablets is and what it is used for

This medicine contains ibuprofen lysine which is the lysine salt of ibuprofen. Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs) which relieve pain and lower temperature when you have a fever.

Ibuprofen Lysine tablets is used for the symptomatic treatment of:

-    mild to moderate pain, such as headache, period pain and dental pain

-    fever and pain associated with common cold.

You must talk to a doctor if you do not feel better or if you feel worse after 3 days (for adolescents).

You must talk to a doctor if you do not feel better or if you feel worse after 3 days in fever and after 4 days in the treatment of pain (for adults).

2.    What you need to know before you take Ibuprofen Lysine tablets

Do not take Ibuprofen Lysine tablets:

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

-    if you have ever suffered from shortness of breath, asthma, a runny nose, swelling or hives after using acetylsalicylic acid or other similar painkillers (NSAIDs);

-    if you have (or have had two or more episodes of) a stomach or duodenal ulcer or bleeding of the stomach;

-    if you have ever had gastrointestinal bleeding or perforation related to previous use of NSAIDs ;

-    if you have severe liver, kidney or heart failure;

-    if you suffer from blood clotting disorders;

-    if you have any active bleeding (including bleeding in the brain);

-    if you suffer from a currently undiagnosed problem with your body's ability to form blood;

-    if you are severely dehydrated (caused by vomiting, diarrhoea or insufficient fluid intake);

-    if you are in the last 3 months of pregnancy;

-    if you are adolescent weighing under 40 kg or you are younger than 12 years.

Ibuprofen Lysine 342 mg film-coated tablets contains soya lecithin:

If you are allergic to peanut or soya, do not use this medicinal product.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ibuprofen Lysine tablets:

-    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 kidney or liver problems;

-    if you have or have ever had high blood pressure or heart failure;

-    if you have or have ever had stomach or bowel disorders (including ulcerative colitis or Crohn's disease);

-    if you have certain hereditary blood formation disorder (e.g. acute intermittent porphyria);

-    if you have systemic lupus erythematosus (SLE) or mixed connective tissue disease - illnesses that affect the immune system causing joint pain, skin changes and disorders of other organs;

-    if you have chicken pox (varicella) - it is advisable to avoid the use of Ibuprofen Lysine tablets;

-    if you have recently had major surgery;

-    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 Ibuprofen Lysine tablets” below) and should be avoided.

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 (3 days in adolescents or in adults 3 days in the treatment of fever and 4 days in the treatment of pain).

You should discuss your treatment with your doctor or pharmacist before taking <Product name> 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.

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

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.

The habitual use of several sorts of painkillers may cause permanent damage to the kidneys and a risk of kidney failure. This risk may be increased under physical strain associated with loss of salt and dehydration. Therefore, the habitual use of painkillers 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.

In prolonged administration of Ibuprofen Lysine tablets regular checking of your liver values, the kidney function, as well as of the blood count, is required.

NSAIDs may mask symptoms of infection and fever. Children and adolescents

There is a risk of renal impairment in dehydrated adolescents. Do not give this medicine to adolescents weighing under 40 kg or children under 12 years of age.

Other medicines and Ibuprofen Lysine tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Ibuprofen Lysine tablets may affect or be affected by some other medicines. For example:

-    acetylsalicylic acid, or other NSAIDs - since they may increase the risk of gastrointestinal ulcers or bleeding;

-    digoxin (for heart insufficiency) - since the effect of digoxin may be enhanced;

-    glucocorticoids (medicinal products containing cortisone or cortisone-like substances) - since this may increase the risk of gastrointestinal ulcers or bleeding;

-    anti-platelet agents - since this may increase the risk of gastrointestinal bleeding;

-    acetylsalicylic acid (low dose) - since the blood-thinning effect may be impaired;

-    medicines that are anti-coagulants, (i.e thin blood/ prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine) - since ibuprofen may enhance the effects of these medicines;

-    phenytoin (for epilepsy) - since the effect of phenytoin may be enhanced;

-    selective serotonin reuptake inhibitors (medicines used for depression) - since this may increase the risk of gastrointestinal bleeding;

-    lithium (a medicine for manic depressive illness and depression) - since the effect of lithium may be enhanced;

-    probenecid and sulfinpyrazones (medicines for gout) -since the excretion of ibuprofen may be delayed;

-    medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan) and water tablets (diuretics) - since ibuprofen may diminish the effects of these medicines and there could be a possible increased risk for the kidney;

-    potassium spearing diuretics - since this may lead to high potassium levels in the blood;

-    methotrexate (a medicine for cancer or rheumatism) -since the effect of methotrexate may be enhanced;

-    tacrolimus and cyclosporine (immunosuppressive medicines) - since kidney damage may occur;

-    mifepristone (for pregnancy termination) - since the effect of mifepristone may be reduced;

-    zidovudine (a medicine for treating HIV/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;

-    sulfonylureas (antidiabetic medicines) - interactions may be possible;

-    quinolone antibiotics - since the risk for convulsions may be increased;

-    medicines that inhibit CYP2C9 enzyme such as the antifungals voriconazole or fluconazole - since exposure to ibuprofen may be increased;

-    a herbal remedy called ginkgo biloba - there is a chance that you may bleed more easily if you are taking ibuprofen and ginkgo biloba at the same time.

Some other medicines may also affect or be affected by the treatment of Ibuprofen Lysine tablets. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen Lysine tablets with other medicines.

Ibuprofen Lysine tablets with food, drink and alcohol

It is recommended that patients with sensitive stomachs take Ibuprofen Lysine tablets with food.

Some side effects, such as those affecting the gastrointestinal system can be more likely when alcohol is taken at the same time as Ibuprofen Lysine tablets.

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 in the last 3 months of pregnancy. Avoid the use of this medicine in the first 6 months of pregnancy unless the doctor advises otherwise.

Only small amounts of ibuprofen and its decomposition products pass into breast milk. This medicine may be taken during breast-feeding if it is used at the recommended dose and for the shortest possible time.

Ibuprofen Lysine tablets 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 Lysine tablets, 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 the recommended dosage, this medicine has little or no 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.

Ibuprofen Lysine 342 mg film-coated tablets contains colour Sunset yellow aluminium lake (E110) and colour Ponceau 4R aluminium lake (E124)

This medicine contains colours (E110 and E124), which may cause allergic reactions.

Ibuprofen Lysine 342 mg film-coated tablets contains glucose

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

3. How to take Ibuprofen Lysine tablets

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.

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

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

Take 1 or 2 tablets with water, up to three times a day as required. Leave at least 6 hours between doses. Do not take more than 6 tablets in any 24 hour period.

If you are an adult and need to take Ibuprofen Lysine tablets for more than 3 days if you have fever or for more than 4 days for the treatment of pain or if your symptoms worsen consult your doctor.

Use in children and adolescents

Do not give to adolescents weighing under 40 kg or children under 12 years.

If in adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.

The film-coated tablets should be swallowed whole with water.

The score line is only there to help you break the tablet if you have difficulty swallowing it whole.

It is recommended that patients with sensitive stomachs take Ibuprofen Lysine tablets with food.

If you take more Ibuprofen Lysine tablets than you should

You may experience, nausea, stomach ache or headache, vomiting, diarrhoea, ringing in the ears, dizziness, vomiting blood and blood in stools. More serious poisoning can lead to drowsiness, excitation, disorientation, low blood pressure, kidney failure, liver damage, reduced breathing

(respiratory depression), blue discolouring of the skin and mucosa (cyanosis), loss of consciousness, coma, convulsions, myoclonic cramps in children, metabolic acidosis and increased bleeding tendency. Worsening of asthma in asthmatics may occur.

You should seek immediate medical advice in the event of an overdose, even if you feel well.

If you forget to take Ibuprofen Lysine tablets

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.

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 Ibuprofen Lysine tablets may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

If you suffer from any of the following at any time during your treatment stop taking the medicine and seek immediate medical help:

-    Pass blood in your faeces (stools/motions)

-    Pass black tarry stools

-    Vomit any blood or dark particles that look like coffee grounds.

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

-    Indigestion or heartburn

-    Abdominal pain (pains in your stomach) or other abnormal stomach symptoms.

If any of the following occurs, stop taking this medicine and consult your doctor immediately or go to the emergency department of the nearest hospital:

-    signs of very rare (may affect up to 1 in 10,000 people) but serious allergic reaction such as, swelling of the face, tongue or throat, difficulty breathing, racing heart, drop in blood pressure leading to shock. These can happen even on first use of this medicine.

-    signs of uncommon (may affect up to 1 in 100 people) but serious allergic reaction such as asthma attacks (possibly with drop in blood pressure), worsening of asthma, unexplained wheezing or shortness of breath.

-    severe very rare skin reactions (may affect up to 1 in 10,000 people) such as rashes covering the whole body, peeling, blistering or flaking skin (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).

-    inflammation of the pancreas with severe upper stomach pain, often with nausea and vomiting, which occurs very rarely (may affect up to 1 in 10,000 people).

-    problems in the blood cell production (first signs are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding) which occur very rarely (may affect up to 1 in 10,000 people).

Tell your doctor if you experience any of the below side effects:

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

-    gastrointestinal complaints, such as heart burn, abdominal pain, feeling sick, being sick, wind (flatulence), diarrhoea, constipation and slight blood losses in stomach and/or bowel 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), inflammation of the stomach (gastritis), worsening of colitis and Crohn's disease;

-    central nervous system disturbances such as headache, dizziness, sleeplessness, agitation, irritability or tiredness;

-    visual disturbances;

-    allergic reactions, such as skin rashes and itching;

-    various skin rashes.

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

-    ringing in the ears;

-    kidney damage (papillary necrosis) and elevated uric acid concentrations in the blood.

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

-    inflammation of the oesophagus, narrowing of intestines;

-    severe skin infections and soft tissue complications may occur if you have chicken pox;

-    fluid build-up in the body's tissues especially in patients with high blood pressure or kidney problems, swelling and foamy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis) that may lead to acute kidney failure;

-    psychotic reactions, depression;

-    worsening of infection-related inflammations (e.g. development of flesh eating bacteria syndrome -necrotizing fasciitis) associated with use of certain painkillers (NSAIDs) has been described. If signs of an infection occur or get worse during use of ibuprofen, you must go to a doctor without delay. It is to be investigated whether there is an indication for an anti-infective/ antibiotic therapy;

-    high blood pressure, inflammation of blood vessels, palpitations, heart failure, heart attack;

-    liver dysfunction, liver damage (especially in longterm use), liver failure, acute inflammation of the liver (hepatitis);

-    aseptic meningitis (inflammation of the linings of the brain with symptoms including neck stiffness, headache, feeling sick, being sick, fever or clouding of the mental state). Patients with autoimmune disorders (SLE, mixed connective-tissue disease) may be more likely to be affected;

-    hair loss.

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 Ibuprofen Lysine tablets

Keep this medicine out of the sight and reach of children. Store below 25° C.

Do not use this medicine after the expiry date which is stated on the carton after {EXP}. 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 Ibuprofen Lysine tablets contains

The active substance is ibuprofen lysine. Each tablet contains 342 mg ibuprofen lysine equivalent to 200 mg ibuprofen.

The other ingredients are:

Tablet core: silicified microcrystalline cellulose (contains: Cellulose, microcrystalline and Silica, colloidal anhydrous); copovidone; croscarmellose sodium (E468); silica colloidal anhydrous; magnesium stearate (E470b); talc (E553b). Film coating: hypromellose (E464), titanium dioxide (E171), polydextrose, talc (E553b), maltodextrin, medium chain triglycerides, colour ponceau 4R aluminium lake (E124), color Sunset yellow aluminium lake (E110), colour Indigo carmine aluminium lake (E132), carmellose sodium (E466), glucose monohydrate, mica-based pearlescent pigment (Mica/Titanium dioxide) (E555/E171), soya lecithin (E322).

What Ibuprofen Lysine tablets looks like and contents of the pack

Ibuprofen Lysine_UK_mock-up_ verzija 4.indd 2 14-Oct-15 10:52:02 AM