Ibuprofen Lysine 342mg Tablets 16s

Always take this medicine exactly as described in the 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 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.

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

• Take 1 or 2 tablets up to three times a day as required. Leave at least six hours between two doses.
• Do not chew the tablets. Take the tablets with a glass of water.
• If you have a sensitive stomach, take the tablets with food.
  Do not take more than 6 tablets in any 24 hours.

Patients with kidney or liver impairment:

• Ask your doctor before taking Ibuprofen Lysine to determine the dose and duration of treatment.

Elderly patients: 

• Elderly patients are at greater risk of developing side effects. Side effects can be minimised by taking the lowest dose for the shortest time necessary to relieve the symptoms.

Adults: Do not take for more than 5 days (3 days in case of migraine) unless your doctor tells you to. If symptoms persist or worsen, or if any new symptoms occur, consult your doctor or pharmacist.

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

• Active Ingredient: Ibuprofen 200mg (as ibuprofen lysine 342mg).
• Other Ingredients: Microcrystalline cellulose, povidone, sodium starch glycollate, colloidal anhydrous silica, magnesium stearate, the coating (contains polyvinyl alcohol-partially hydrolyzed, titanium dioxide, macrogol and talc).

Do not take Ibuprofen Lysine if you:

• Are allergic to ibuprofen or any of the other ingredients of this medicine.
• Have previously had allergic reactions (such as hives, runny nose, swelling or bronchial asthma) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• Have (or have ever had two or more episodes of) a stomach ulcer, stomach or intestinal perforation or bleeding.
• Have ever had stomach or intestinal bleeding or perforation when previously taking NSAIDs (Non-Steroidal Anti-Inflammatory Drugs).
• Have severe heart, kidney or liver failure.
• Have bleeding of the brain (cerebrovascular bleeding) or other active bleeding.
• Have bleeding predisposition (unusual tendency to bleed).
• Suffer from unclarified blood-formation disturbances.
• Are severely dehydrated (caused by vomiting, diarrhoea or insufficient fluid intake).
• Are in the last 3 months of pregnancy.

Talk to your doctor or pharmacist before taking Ibuprofen Lysine and if you have an infection - please see heading "Infections" below:

• Have Systemic Lupus Erythematosus (a condition of the immune system causing joint pain, skin changes and other organ disorders) and mixed connective tissue disease; (rare autoimmune disorder affecting connective tissue).
• Have a history of gastrointestinal disease (such as ulcerative colitis, Crohn's disease).
• Have kidney, heart, liver or bowel problems.
• Have or have ever had asthma.
• Are in the first 6 months of pregnancy.
• Have chicken pox (varicella).
• Have a hereditary blood formation disorder (acute intermittent porphyria).
• Have just undergone a major surgery.
• Have ever had allergic reactions to other medicines.
• Suffer from hay fever, nasal polyps or chronic breathing problems, as there is an increased risk of experiencing allergic reactions.
• Have problems with blood coagulation (thickening).

Infections

Ibuprofen Lysine may hide signs of infections such as fever and pain. It is therefore possible that Ibuprofen Lysine 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.

Avoid the use of Ibuprofen Lysine with other NSAIDs, including cyclooxygenase-2 selective inhibitors at the same time.

There is a risk of gastro-intestinal bleeding, ulceration or perforation, which can be fatal, with or without warning symptoms, they may also occur in patients with earlier warning symptoms. If you experience stomach or intestinal bleeding or ulceration, stop taking this medicine immediately. If you suffer from any gastrointestinal diseases, especially if you are over 65 years old, you must report any unusual gastrointestinal symptoms (especially bleeding) to your doctor, particularly at the beginning of treatment.

Skin reactions

Serious skin reactions have been reported in association with Ibuprofen Lysine treatment. You should stop taking Ibuprofen Lysine 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. 

Anti-inflammatory/pain-killer medicines such as Ibuprofen Lysine may be associated with a small increased risk of heart attack or stroke. Any risk is more likely with high doses or prolonged treatment. Do not exceed the recommended dose or duration of
treatment.

You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen Lysine if you:

• Have heart problems including heart failure, angina pectoris (chest pain) or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries) or if you have had previous stroke (including 'mini-stroke' or transient ischaemic attack "TIA").
• Might be at risk of the heart problems (for example, if you have high blood pressure, diabetes or high cholesterol, have a family history of heart disease or stroke, or if you are a smoker).

For prolonged use of Ibuprofen Lysine, regular checking of your liver values, kidney function and blood count is required.

Long term use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, talk to your doctor and stop taking this medicine.

In general, the frequent use of painkillers can lead to lasting severe kidney damage with the risk of kidney failure (analgesic
nephropathy). This risk may be increased under physical strain associated with dehydration. Do not take this medicine if you feel dehydrated.

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

Tell your doctor, even if the above warnings refer to conditions occurring in the past. Stop taking the medicine and contact your doctor immediately at the first appearance of an allergic reaction.

Children and adolescents

Ibuprofen Lysine is not intended for adolescents weighing less than 40 kg or children under 12 years of age. There is a risk of renal impairment in dehydrated adolescents.

Elderly patients

The elderly have an increased risk of side effects than the younger patients.

Other medicines and Ibuprofen Lysine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

To reduce the risk of side effects, do not take this medicine with other NSAID medicines (such as acetylsalicylic acid, ibuprofen),
including selective cyclooxygenase-2 inhibitors (nonsteroidal anti inflammatory drug (NSAID) that directly targets the enzyme
responsible for inflammation and pain, e.g. celecoxib).

Ibuprofen Lysine may affect or be affected by some other medicines.

Avoid taking this medicine with anti-inflammatory medicines (corticosteroids), herbal extracts (Ginkgo biloba) or medicines that
are prescribed:

• To treat infections (quinolone antibiotics).
• To thin your blood or prevent clotting (such as warfarin, acetylsalicylic acid, ticlopidine).
• To stimulate your heart (such as digoxin) or treat high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, angiotensin-II receptor antagonists such as losartan).
• To help you passing water (diuretics).
• For the temporary suppression of your immune system (such as methotrexate, ciclosporin, tacrolimus).
• For mania or depression (such as lithium or SSRIs).
• For pregnancy termination (such as mifepristone).
• For HIV infection treatment (such as zidovudine).
• To treat seizures (such as phenytoin).
• To treat chronic gout and gouty arthritis (such as probenecid and sulfinpyrazone).
  To treat fungal infections (voriconazole or fluconazole).
• To treat diabetes (sulfonylureas)

Ibuprofen Lysine with alcohol

Alcohol may enhance side effects of Ibuprofen Lysine, especially those affecting the central nervous system and the gastrointestinal tract. Do not drink alcohol while using Ibuprofen Lysine.

Pregnancy, breastfeeding 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.

Pregnancy: 
Do not take this medicine in the last 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby's tendency to bleed and cause labour to be later or longer than expected. You should not take ibuprofen lysine during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, ibuprofen lysine can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding:  Only small amounts of ibuprofen and its decomposition products pass into breast milk. There are no known side effects in breast-fed infants, therefore this medicine may be taken during breastfeeding if it is used at the recommended dose and for the shortest possible time.

Fertility: Ibuprofen Lysine belongs to a group of medicines which may impair fertility in women. This is reversible on stopping the medicine.

Driving and using machines

This medicine has no or negligible influence on the ability to drive and use machines when is taken according to the recommended instructions. However, at higher dosage it can cause tiredness and dizziness and the ability to react and take part actively in road traffic and to operate machines may be affected. The risk is higher when taking this medicine in combination with alcohol. If you experience these side effects, do not drive or use machines.

Ibuprofen Lysine contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.