Patient leaflet - Ibuprofen Lysine 684 mg film-coated tablets
1. What Ibuprofen Lysine is and what it is used for
The active ingredient is ibuprofen. It belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
Ibuprofen Lysine is used for short-term symptomatic relief of:
- Headaches and migraine pain
Ibuprofen Lysine is indicated for use in adults, adolescents above 12 years of age and weighing at least 40 kg.
2. What you need to know before you take Ibuprofen Lysine
Do not take Ibuprofen Lysine:
- if you are allergic to ibuprofen, aspirin (acetylsalicylic acid) or other painkillers, or any of the other ingredients of this medicine (listed in section 6),
- if you have had shortness of breath, asthma, runny nose, swelling or hives after using aspirin (acetylsalicylic acid) or similar painkillers (NSAIDs),
- if you have (or have had two or more episodes of) a stomach/duodenal ulcer, or bleeding,
- if you have had gastrointestinal bleeding or perforation related to previous use of NSAIDs,
- if you have severe heart, liver or kidney failure,
- if you have unclarified blood-formation disturbances, if you have severe dehydration (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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ibuprofen Lysine if you:
- have or have had asthma or allergic disease as shortness of breath may occur,
- 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,
- have kidney, heart, liver or bowel problems,
- have a history of gastrointestinal disease (such as ulcerative colitis, Crohn’s disease),
- have certain hereditary blood formation disorder (e.g. acute intermittent porpyria),
- have Systemic Lupus Erythematosus (SLE) or mixed connetive tissue disease - conditions of the immune system causing joint pain, skin changes and other organ disorders,
- have chicken pox (varicella) – it is advisable not to take Ibuprofen Lysine as your condition might get worse,
- have an infection - please see heading “Infections” below,
- recently had major surgery,
- are dehydrated,
- are taking other NSAIDs. The use with concomitant NSAIDs, including cyclo-oxygenase-2 selective inhibitors should be avoided,
- are in the first 6 months of pregnancy.
Other warnings
- 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 Ibuprofen Lysine 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 or 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.
- Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck region (angioedema), chest pain have been reported with ibuprofen. Stop immediately Ibuprofen Lysine and contact immediately your doctor or medical emergencies if you notice any of these signs.
Serious skin reactions
Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using Ibuprofen Lysine and seek medical attention immediately, if you notice any of the symptoms related to these serious skin reactions described in 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.
Ibuprofen can temporarily inhibit blood platelet function (blood platelet aggregation). Patients with blood clotting disorders should therefore be carefully monitored. The doctor or dentist is to be asked or informed if Ibuprofen Lysine is administered before surgical procedures.
If you are taking Ibuprofen Lysine for longer than the recommended time or at higher than recommended doses you are at risk of serious harms. These include serious harms to the stomach/gut and kidneys, as well as very low levels of potassium in your blood. These can be fatal (see section 4).
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 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.
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.
Children and adolescents
Do not give this medicine to adolescents weighing under 40 kg or children under 12 years of age.
There is a risk of kidney impairment in dehydrated adolescents.
Other medicines and Ibuprofen Lysine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
- medicines that are anticoagulants (i.e. thin blood/prevent clotting e.g. aspirin (acetylsalicylic acid), warfarin, ticlopidine),
- medicines that reduce high blood pressure (ACE-Inhibitors such as captoprll, beta-blockers such as atenolol medicines, angiotensin-II receptor antagonists such as losartan),
- aspirin (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 (medicines 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,
- 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,
- 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,
- do not take Ibuprofen Lysine if you are taking more than 75 mg of aspirin (acetylsalicylic acid) a day. If you are on low-dose aspirin (acetylsalicylic acid) (up to 75 mg daily) speak to your doctor or pharmacist before you take Ibuprofen Lysine.
Some other medicines may also affect or be affected by the treatment of Ibuprofen Lysine. You should therefore always seek the advice of your doctor or pharmacist before you use Ibuprofen Lysine with other medicines.
Ibuprofen Lysine with alcohol
Some side effects, such as those affecting the gastrointestinal system or central nervous system can be more likely when alcohol is taken at the same time as Ibuprofen Lysine.
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 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 this medicine 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.
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 belongs to a group of medicines which may impair fertility in women. This effect is reversible on stopping the medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Ibuprofen Lysine
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 use only.
Package leaflet: Information for the user
Ibuprofen Lysine
684 mg film-coated tablets
Ibuprofen lysine
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).
Use in adults and adolescents weighing from 40 kg (12 years and above):
- Take 1 tablet with water, up to three times a day as required.
- Leave at least six hours between doses.
- Do not take more than three tablets (1200 mg ibuprofen) in 24 hours.
Children and adolescents:
Do not give to children under 12 years of age or adolescents weighing under 40 kg.
Ibuprofen Lysine film-coated tablets have a break mark on one side. The score line is only there to help you break the tablet if you have difficulty swallowing it whole.
Treatment duration
If this medicine is required for more than 3 days or if symptoms worsen a doctor should be consulted.
If you take more Ibuprofen Lysine than you should
If you have taken more Ibuprofen Lysine 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.
The symptoms of overdose can include nausea, stomach pain, diarrhoea, ringing in the ears, headache, vomiting (may be blood streaked) blood in stools, confusion and shaky eye movement. Also, agitation, somnolence, disorientation or coma may occur. At high doses, drowsiness, excitation, chest pain, palpitation, kidney failure, liver damage, blue discolouring of the skin and mucosa (cyanosis), loss of consciousness, convulsions (mainly in children), increased bleeding tendency, weakness and dizziness, blood in urine, low levels of potassium in your blood, cold body feeling and breathing problems have been reported. Further, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Worsening of asthma in asthmatics may occur. Furthermore, there may be low blood pressure and reduced breathing.
If you forget to take Ibuprofen Lysine
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.
Some side effects may be minimised by taking the lowest dose for the shortest time necessary to relieve the symptoms. Elderly using this product are at increased risk of developing problems associated with side effects.
Medicines such as Ibuprofen Lysine may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke (see section 2, Other warnings).
Stop taking the medicine and seek immediate medical help if you develop:
- pains in your stomach, bright red faeces (stools/ motions), black tarry stools, vomiting blood or dark particles that look like coffee grounds [signs of intestinal bleeding] (uncommon).
- swelling of the face, tongue or throat, difficulty breathing, racing heart, drop in blood pressure leading to shock [signs of serious allergic reaction]. These can happen even on first use of this medicine (very rare).
- asthma attacks (possibly with drop in blood pressure), worsening of asthma, unexplained wheezing or shortness of breath [signs of serious allergic reaction] (uncommon).
- reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis] (very rare).
- widespread rash, high body temperature, enlarged lymph nodes and an increase of eosinophils (a type of white blood cells) [DRESS syndrome] (frequency cannot be estimated from the available data).
- 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 known as AGEP) (frequency cannot be estimated from the available data). See also section 2.
- severe upper stomach pain, often with nausea and vomiting [inflammation of the pancreas] (very rare).
- fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding [problems in the blood cell production] (very rare).
- 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 [signs of aseptic meningitis] (very rare);
- chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome (frequency cannot be estimated from the available data).
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(tinnitus);
- 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;
- 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 long-term use), liver failure, acute inflammation of the liver (hepatitis);
- hair loss.
Frequency unknown:
- skin becomes sensitive to light.
- decreased apetite;
- pain, burning or itching associated with urination;
- severe urinary system pain.
Ibuprofen Lysine, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood (see section 2). This is a very serious condition and will require immediate treatment. Signs and symptoms include muscle weakness and light-headedness.
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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard 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 Ibuprofen Lysine
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 after {EXP}. The expiry date refers to the last day of that month.
Store below 30ºC.
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 contains
- The active substance is ibuprofen lysine. Each film-coated tablet contains 684 mg ibuprofen lysine (equivalent to 400 mg ibuprofen).
- The other ingredients are:
Tablet core: silicified microcrystalline cellulose, copovidone, sodium starch glycolate, magnesium stearate. Film coating (Opadry 200 White 200F280000): polyvinyl alcohol part hydrolized, titanium dioxide (E171), talc, macrogol 4000, metacrylic acid-ethyl acrylate copolymer (1:1) and sodium hydrogen carbonate.
What Ibuprofen Lysine looks like and contents of the pack
Ibuprofen Lysine are oblong, biconvex, white to creamy film-coated tablets with break mark on one side. The dimensions of each tablet are approximately 20 mm x 8 mm. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
The film coated tablets are blister-packed in white PVC/ PVDC/Al foil or in alternative child-resistant white PVC/ PVDC/ Al foil fortified with PET layer.
Ibuprofen Lysine 684 mg film-coated tablets are available in blister packs containing 10, 12, 20, 24, 30 or 50 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
ALKALOID-INT d.o.o.
Šlandrova ulica 4
Ljubljana-Črnuče, 1231, Slovenia
email: info@alkaloid.si
PL 34088/0049
This medicine is authorised in the Member States of the European Economic Area and United Kingdom (Northern Ireland) under the following names:
United Kingdom
(Northern Ireland)
Ibuprofen Lysine 684 mg film-coated tablets
Germany Dolirief 400 mg Filmtabletten
Netherlands Ibuprofen Alkaloid-INT 400 mg, filmomhulde tabletten