Axoprofen forte: detailed information

Package leaflet: Information for the user

Axoprofen Forte, 400 mg, coated tablets
Ibuprofenum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the
doctor, pharmacist, or nurse.

Keep this leaflet for future reference.
If advice or further information is needed, consult a pharmacist.
If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 3 days when used for fever or after 4 days when used for pain, or if the patient feels worse, consult a doctor. In adolescents, if there is no improvement after 3 days or if the patient feels worse, consult a doctor.

Contents of the leaflet

What Axoprofen Forte is and what it is used for
Important information before taking Axoprofen Forte
How to take Axoprofen Forte
Possible side effects
How to store Axoprofen Forte
Contents of the pack and other information

1. What Axoprofen Forte is and what it is used for

Axoprofen Forte contains the active substance ibuprofen.
Ibuprofen is a medicine that reduces fever and relieves pain (non-steroidal anti-inflammatory drug - NSAID).
Axoprofen Forte is used for short-term symptomatic treatment of mild to moderate pain and (or) fever in adults and adolescents with body weight above 40 kg (aged 12 years and above).

2. Important information before using Axoprofen Forte

When not to use Axoprofen Forte:

if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6). Symptoms of hypersensitivity reactions may include: swelling of the eyelids, lips, tongue or throat;
if the patient has ever experienced a hypersensitivity reaction after taking ibuprofen, acetylsalicylic acid, or other similar pain-relieving medicines (NSAIDs), such as: bronchospasm (constriction of muscles in the lungs causing breathlessness), asthma, rhinitis, itchy nose, inflammatory nasal condition with sneezing, urticaria (itchy rash), or angioedema (subcutaneous swelling);
if the patient has unexplained disorders in the production of certain blood components;
if the patient has or has had recurrent peptic ulcer disease of the stomach and/or duodenum (peptic ulcers) or bleeding (at least two separate episodes of confirmed ulcers or bleeding);
if the patient has experienced gastrointestinal bleeding or perforation related to previous use of non-steroidal anti-inflammatory drugs (NSAIDs);
if the patient has cerebral haemorrhage (bleeding from brain vessels) or any other active bleeding;
if the patient has severe liver, kidney, or heart failure;
if the patient is severely dehydrated (e.g. due to vomiting, diarrhoea, or insufficient fluid intake);
if the patient is in the third trimester of pregnancy.

Warnings and precautions
Taking the medicine at the lowest effective dose for the shortest necessary duration
to relieve symptoms reduces the risk of adverse effects.
Before starting treatment with Axoprofen Forte, consult a doctor or pharmacist if:

the patient has systemic lupus erythematosus (SLE, sometimes known as lupus) or mixed connective tissue disease (autoimmune connective tissue disorders);
the patient has or has ever had gastrointestinal disorders (ulcerative colitis or Crohn's disease), as the patient's condition may worsen;
the patient has a certain inherited blood formation disorder (e.g. acute intermittent porphyria);
the patient has impaired kidney or liver function;
the patient has recently undergone major surgery;
the patient has a tendency towards allergies to other substances;
the patient has hay fever, nasal polyps, or chronic obstructive respiratory diseases, as such patients have an increased risk of allergic reactions; these reactions may manifest as asthma attacks (so-called analgesic-induced asthma), rapidly developing swelling (Quincke's oedema), or urticaria;
the patient is dehydrated;
the patient has an infection – see below, section titled "Infections".

Effect on the gastrointestinal tract
Avoid concomitant use of Axoprofen Forte with other non-steroidal anti-inflammatory drugs (NSAIDs), including so-called COX-2 inhibitors (selective cyclooxygenase-2 inhibitors).
Gastrointestinal bleeding, ulceration, and perforation:
Gastrointestinal bleeding, gastric and/or duodenal ulceration, and perforations resulting in death have been reported with the use of all NSAIDs. These events may occur at any time during treatment, with or without warning symptoms, and with or without prior serious gastrointestinal adverse effects.
The risk of gastrointestinal bleeding, gastric and duodenal ulceration, and perforation increases with higher NSAID doses, is greater in patients with a history of peptic ulcer disease of the stomach and/or duodenum, particularly if complicated by bleeding or perforation (see section 2 "When not to use Axoprofen Forte"), and in elderly patients. In such patients, treatment should be initiated with the lowest available dose.
In such patients and in those requiring concomitant administration of low-dose acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal disorders, the physician may consider concomitant use of gastroprotective agents (e.g. misoprostol or proton pump inhibitors).
Patients who have previously experienced gastrointestinal adverse effects, especially elderly individuals, should report any abnormal abdominal symptoms (particularly gastrointestinal bleeding), especially at the beginning of treatment.
Caution is advised in patients concurrently receiving drugs that may increase the risk of gastric and/or duodenal ulceration or bleeding, such as: oral corticosteroids, oral anticoagulants such as warfarin, selective serotonin reuptake inhibitors (used in the treatment of psychiatric disorders including depression), or antiplatelet agents such as acetylsalicylic acid (see section 2 "Axoprofen Forte and other medicines").
If gastrointestinal bleeding or gastric and/or duodenal ulceration occurs in a patient taking Axoprofen Forte, treatment should be discontinued and the patient should contact a doctor.

Effect on the circulatory system and cerebral vessels
Taking anti-inflammatory or pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment.
Before using Axoprofen Forte, the patient should discuss treatment with a doctor or pharmacist if:

the patient has heart diseases, including: heart failure, angina pectoris (chest pain), or has had a heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischaemic attack - TIA).
the patient has hypertension, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.

Skin reactions
Severe skin reactions associated with the use of Axoprofen Forte have been reported. If any skin rash, mucosal changes, blisters, or other allergy symptoms appear, discontinue taking Axoprofen Forte and seek immediate medical help, as these may be the first signs of a very serious skin reaction. See section 4.
Avoid using Axoprofen Forte during varicella virus infection.

Infections
Axoprofen Forte may mask objective signs of infection such as fever and pain. Therefore, Axoprofen Forte may delay appropriate treatment of infection and consequently lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.
If the patient takes this medicine during an existing infection and infection symptoms persist or worsen, immediate consultation with a doctor is required.

Other warnings
Very rarely, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed.
If the first symptoms of hypersensitivity occur after taking Axoprofen Forte, treatment should be discontinued and a doctor should be informed immediately. Depending on the symptoms, medical personnel must take appropriate preventive measures.
Ibuprofen may temporarily inhibit platelet function (platelet aggregation). Therefore, patients with coagulation disorders should be closely monitored.
With prolonged use of Axoprofen Forte, regular monitoring of liver function parameters, kidney function, and blood morphology with smear is necessary.
Long-term use of painkillers for headaches may lead to worsening of headaches. If this occurs or is suspected, consult a doctor and discontinue the medicine.
Generally, habitual use of painkillers, especially when taking multiple painkillers simultaneously, may lead to permanent kidney damage. This risk may increase with physical exertion associated with loss of salts and dehydration. Therefore, it should be avoided.
The risk of kidney failure is higher in dehydrated patients, elderly patients, and those taking diuretics and ACE inhibitors.
If visual disturbances occur, contact a doctor.

Elderly patients:
Elderly patients should be aware of the increased risk of adverse effects, especially gastrointestinal bleeding and perforation, which may lead to death (also refer to the warnings regarding bleeding at the beginning of section 2).

Adolescents
In dehydrated adolescents, there is a risk of impaired kidney function.

Axoprofen Forte and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Axoprofen Forte may affect other medicines, and other medicines may affect the action of this medicine.
For example:

Digoxin, phenytoin, and lithium: Concomitant use of Axoprofen Forte with digoxin (used to strengthen the heart), phenytoin (used to treat seizures/epilepsy), or lithium (used to treat, for example, depression) may increase blood levels of these drugs. Lithium levels should be monitored. Monitoring of digoxin and phenytoin levels is generally not required if used according to recommendations (for no more than 3 or 4 days).
Anticoagulants (i.e. blood thinners or clot-preventing agents, e.g. acetylsalicylic acid, warfarin, ticlopidine): NSAIDs may enhance the effects of anticoagulants such as warfarin.
Diuretics and antihypertensive medicines: Axoprofen Forte may reduce the effectiveness of medicines used to increase urine output (diuretics) and lower blood pressure (antihypertensives, i.e. ACE inhibitors, beta-blockers, and angiotensin receptor antagonists). Concomitant use of Axoprofen Forte and potassium-sparing diuretics (a certain type of diuretic) may lead to increased blood potassium levels.
Medicines lowering high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin receptor antagonists such as losartan): Axoprofen Forte may reduce the effectiveness of ACE inhibitors (used in the treatment of heart failure and high blood pressure). Additionally, during concomitant use, there may be an increased risk of impaired kidney function.
Cholestyramine (a medicine used to reduce cholesterol levels) taken simultaneously with Axoprofen Forte may reduce the absorption of Axoprofen Forte in the gastrointestinal tract. However, the clinical significance is unknown.
Other painkillers: concomitant use of Axoprofen Forte with other non-steroidal anti-inflammatory and pain-relieving medicines (NSAIDs), including COX-2 inhibitors (e.g. celecoxib), may increase the risk of gastrointestinal ulcers and bleeding.
Antiplatelet agents and certain antidepressants (selective serotonin reuptake inhibitors, SSRIs) may increase the risk of gastrointestinal bleeding.
Methotrexate: taking Axoprofen Forte within 24 hours before or after methotrexate (used in the treatment of certain cancers and rheumatism) may lead to increased methotrexate levels and intensification of its adverse effects.
Cyclosporine and tacrolimus: increased risk of kidney damage.
Probenecid and sulfinpyrazone: medicines containing probenecid or sulfinpyrazone (used in the treatment of gout) may delay the excretion of ibuprofen. This may cause accumulation of Axoprofen Forte and intensification of adverse effects.
Sulfonylurea derivatives: when Axoprofen Forte is used concomitantly with sulfonylureas (medicines used in the treatment of diabetes), blood glucose levels should be monitored.
Zidovudine: evidence indicates an increased risk of haemarthrosis (accumulation of blood in joints) and petechiae in HIV-positive patients with haemophilia taking zidovudine (an antiviral medicine used in the treatment of HIV infections) simultaneously with ibuprofen.
Quinolone antibiotics: concomitant use of antibiotics known as quinolones, such as ciprofloxacin, and ibuprofen increases the risk of seizures.
Aminoglycosides: concomitant use of Axoprofen Forte with aminoglycosides (a type of antibiotic) may inhibit the excretion of aminoglycosides.
Voriconazole and fluconazole (CYP2C9 inhibitors) used in the treatment of fungal infections, as they may increase exposure to ibuprofen. Consider reducing the ibuprofen dose, especially if ibuprofen is administered in high doses with voriconazole or fluconazole.
Ginkgo biloba (herbal medicine) used with NSAIDs may increase the risk of bleeding.
Mifepristone: concomitant use of mifepristone with other anti-inflammatory and pain-relieving NSAIDs (e.g. ibuprofen) may reduce the effectiveness of mifepristone.
Ritonavir: concomitant use with ritonavir (an antiviral medicine used in the treatment of HIV infections) may increase plasma concentrations of NSAID painkillers.
Alcohol, bisphosphonates, and oxpentifylline (pentoxifylline): concomitant use of ibuprofen with alcohol, bisphosphonates (used in osteoporosis), or pentoxifylline (used in peripheral circulatory disorders) may intensify adverse effects on the gastrointestinal tract and increase the risk of bleeding and ulcers.
Baclofen (a muscle relaxant), as it increases baclofen toxicity.
Medicines used in the treatment of inflammatory conditions (corticosteroids), as they increase the risk of gastrointestinal ulcers and bleeding.

Also, some other medicines may be affected by or may affect treatment with Axoprofen Forte. Therefore, always consult a doctor or pharmacist before using Axoprofen Forte with other medicines.

Axoprofen Forte and alcohol
Alcohol may intensify adverse effects of Axoprofen Forte, especially those affecting the central nervous system and gastrointestinal tract. Do not drink alcohol while taking Axoprofen Forte.

Pregnancy, breastfeeding, and effect on fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Do not use Axoprofen Forte during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Axoprofen Forte may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both the mother and her child and may delay or prolong labour.
During the first 6 months of pregnancy, the patient should not use this medicine unless the doctor considers its use absolutely necessary. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Axoprofen Forte may cause kidney function disorders in the unborn child if taken for longer than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk in small amounts; therefore, it is usually not necessary to interrupt breastfeeding, especially if ibuprofen is used short-term at the recommended dose for fever and pain.

Fertility
Ibuprofen belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible after discontinuation of the medicine. Inform the doctor if the patient is planning pregnancy or has difficulty conceiving.

Driving and operating machinery
Ibuprofen generally has no effect or has a negligible effect on the ability to drive and operate machinery. However, since adverse effects of central origin may occur with high doses of the medicine, such as fatigue and dizziness, the ability to react and actively participate in road traffic or operate machinery may be impaired in individual cases. This is particularly important when alcohol is consumed simultaneously.

Axoprofen Forte contains lactose
If the patient has been diagnosed with an intolerance to certain sugars, consult a doctor before using this medicine.

Axoprofen Forte contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Axoprofen Forte

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor. If in doubt, consult your doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. In case of infection, seek medical advice immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
Recommended dose:
Adults and adolescents with body weight of 40 kg or more (aged 12 years and above)
Half a 400 mg tablet (i.e. 200 mg) or one whole tablet (400 mg) as a single dose. If necessary, additional doses of half a tablet or one whole tablet may be taken.
The appropriate interval between doses should be determined according to symptoms and with regard to the maximum daily dose. This interval should not be less than 6 hours.
Do not take more than 3 tablets (1200 mg of ibuprofen) within 24 hours.
Axoprofen Forte 400 mg is not intended for use in children under 12 years of age or in adolescents with body weight below 40 kg.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to relieve symptoms.
If the patient has severe liver or kidney impairment or is elderly, the doctor will advise on the appropriate dose, which will be the lowest possible.

Method of administration
Axoprofen Forte is intended for oral use.
Tablets should be swallowed whole with a glass of water.
To avoid irritation of the stomach or throat, do not crush, chew or suck the tablets. The tablet may be divided into equal doses.
Patients with sensitive stomachs are advised to take Axoprofen Forte during meals.
This medicine is intended for short-term use only.

Adult patients
If it is necessary to use this medicine for longer than 3 days for fever reduction or longer than 4 days for pain relief, or if symptoms worsen, consult a doctor.

Adolescents
If it is necessary to use this medicine for longer than 3 days or if symptoms worsen, consult a doctor.

Overdose of Axoprofen Forte
If a patient takes more than the recommended dose of Axoprofen Forte or if a child accidentally ingests this medicine, always consult a doctor or go to the nearest hospital for assessment of potential health risks and advice on appropriate actions.
Symptoms may include: nausea, stomach pain, vomiting (possibly with blood), or less commonly diarrhoea. Additionally, headache, gastrointestinal bleeding, visual disturbances, tinnitus, disorientation and nystagmus may occur, as well as worsening of asthma in asthmatic patients. After ingestion of a large dose, drowsiness, excitement, disorientation, chest pain, palpitations, loss of consciousness, seizures (mainly in children), vestibular vertigo, weakness and dizziness, blood in urine, low blood pressure, increased blood potassium levels, prolonged prothrombin time/INR, acute kidney failure, liver damage, respiratory depression, cyanosis, cold sensation and breathing difficulties have been reported.

Missed dose of Axoprofen Forte
Do not take a double dose to make up for a missed dose.
If you have any questions or doubts about using this medicine, contact your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
The most commonly observed adverse effects involve the gastrointestinal tract. Gastric and (or) duodenal ulcers, perforation or bleeding may occur, sometimes leading to death, especially in elderly patients (see section 2: "Warnings and precautions").
After administration of the medicine, the following have been reported: nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, tarry stools, vomiting blood, mouth and throat sores (ulcerative stomatitis), exacerbation of colitis and Crohn's disease (see section 2: "Warnings and precautions"). Gastritis has been observed rarely.
The risk of gastrointestinal bleeding particularly depends on the dose and duration of treatment.
Due to the use of NSAIDs, fluid retention (oedema), increased blood pressure and heart failure have been observed.

Serious adverse effects

Treatment with Axoprofen Forte must be discontinued and immediate medical advice sought if the patient develops symptoms of very rare (may affect 1 in 10,000 people), but serious allergic reactions such as:
swelling of the face, tongue or throat (laryngeal oedema with airway obstruction),
difficulty breathing,
rapid heartbeat,
drop in blood pressure leading to life-threatening shock.
Immediate medical advice should be sought if the patient experiences symptoms such as fever and significant worsening of general health or fever with local symptoms such as: sore throat or larynx, or mouth, or problems with urination. Axoprofen Forte may cause a reduction in white blood cells (agranulocytosis, very rare adverse effect (may affect no more than 1 in 10,000 patients)) with decreased immunity to infections. It is important to inform the physician about taking this medicine.
Severe skin and mucosal lesions (blisters), such as Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome) and (or) erythema multiforme, have been reported. Additionally, a severe skin reaction called DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling and increased eosinophil count (a type of white blood cell) [frequency unknown (frequency cannot be estimated from available data)]. Treatment with Axoprofen Forte should be discontinued and medical advice sought immediately if the patient develops a rash or mucosal changes. Severe rashes may include blisters on the skin, especially on legs, arms, hands and feet, and may also affect the face and lips. This may become even more serious if blisters enlarge and spread and the skin begins to peel off partially (toxic epidermal necrolysis).
Treatment with Axoprofen Forte must be discontinued and immediate medical advice sought if the patient experiences relatively severe upper abdominal pain, vomiting blood, bloody stools and (or) tarry stools.
Fluid accumulation in tissues (oedema), particularly in patients with high blood pressure (hypertension) or kidney dysfunction, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute renal failure (kidney failure) [very rare adverse effect (may affect no more than 1 in 10,000 people)]. Reduced urine output, fluid accumulation in the body (oedema) and malaise may be symptoms of kidney disease or even kidney failure.

If any of the listed symptoms appear or worsen, treatment with Axoprofen Forte must be discontinued and immediate medical advice sought.

Other adverse effects
Common (affects no more than 1 in 10 patients):

gastrointestinal symptoms such as: heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhoea, constipation, indigestion and minor gastrointestinal bleeding, which in individual cases may lead to deficiency of red blood cells (anaemia).

Uncommon (affects no more than 1 in 100 patients)

central nervous system disorders such as: headache, dizziness, insomnia, excessive excitation, irritability or fatigue;
visual disturbances. In such cases, ibuprofen should be discontinued and medical advice sought;
peptic ulcer disease of the stomach and (or) duodenum (peptic ulcers), sometimes with bleeding and perforation (defects in the gastrointestinal wall), sometimes fatal, may occur especially in elderly patients, ulcerative stomatitis (inflammation of the lip line with ulceration), exacerbation of colitis and Crohn's disease, gastric mucosal inflammation (colitis);
gastritis;
hypersensitivity reactions such as: skin rash and itching, and asthma attacks (possibly accompanied by sudden drop in blood pressure).

If such symptoms occur, medical advice must be sought immediately and Axoprofen Forte discontinued.

Rare (affects no more than 1 in 1,000 patients)

tinnitus (ringing in the ears)
hearing loss
kidney tissue damage (papillary necrosis), elevated uric acid levels in blood, elevated blood urea levels.

Very rare (affects no more than 1 in 10,000 patients)

blood cell formation disorders such as reduced number of red blood cells or haemoglobin concentration (anaemia), white blood cell count (leukopenia) or platelets (thrombocytopenia) and other blood disorders (pancytopenia, agranulocytosis, eosinophilia, coagulopathy, neutropenia, aplastic anaemia or haemolytic anaemia). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding.
due to the use of non-steroidal anti-inflammatory drugs (including Axoprofen Forte), cases of worsening inflammatory conditions caused by infections (e.g. necrotizing fasciitis) have been described. If symptoms of infection (e.g. redness, swelling, warmth, pain, fever) appear or worsen during treatment with Axoprofen Forte, the patient should immediately consult a physician. The physician will determine whether antibiotic therapy is indicated.
during ibuprofen use, symptoms of aseptic meningitis (inflammation of the meninges not caused by infection) such as severe headache, nausea, vomiting, fever, neck stiffness or altered consciousness have been observed. The risk appears to be higher in patients with certain autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease).
low blood sugar levels (hypoglycaemia);
low sodium levels in blood (hyponatraemia);
palpitations, heart failure, myocardial infarction;
hypertension;
vasculitis;
oesophagitis or pancreatitis, formation of diaphragm-like strictures in the intestine;
psychotic reactions, hallucinations, confusion, depression, anxiety;
asthma, breathing difficulties (dyspnoea), bronchospasm;
yellowing of the eye whites and (or) skin (jaundice), liver function disorders, liver damage, especially during long-term treatment, liver failure, acute hepatitis;
severe skin reactions such as: skin rash with redness and blisters (e.g. Stevens-Johnson syndrome), erythema multiforme, hair loss (alopecia), red or purple discoloured spots on the skin (purpura) or photosensitivity reactions (sunlight-induced);
in exceptional cases during chickenpox, severe skin and soft tissue infections may occur.

Frequency unknown (frequency cannot be estimated from available data):

nasal mucosal inflammation (rhinitis);
tingling and prickling sensation (paraesthesia) and optic neuritis;
abnormal kidney function;
red, scaly rash with subcutaneous nodules and blisters located mainly in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). If such symptoms develop, treatment must be discontinued and immediate medical advice sought. See also section 2.

Medicines such as Axoprofen Forte may slightly increase the risk of heart attack (myocardial infarction) or stroke.

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Axoprofen Forte

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister pack after EXP. The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Axoprofen Forte contains

The active substance is ibuprofen. Each coated tablet contains 400 mg of ibuprofen.
The other ingredients are:
Tablet core: hypromellose, sodium croscarmellose, monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, colloidal anhydrous silica, sodium lauryl sulfate, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E 171), talc, propylene glycol.

What Axoprofen Forte looks like and contents of the pack
White or almost white, round coated tablets, with a score line on one side, 12 mm in diameter.
The tablet can be divided into equal doses.
Pack contains 20 or 50 coated tablets.

Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
ul. Baletowa 30
02-867 Warsaw
Poland

Manufacturer
Aristo Pharma GmbH
Wallenroder Str. 8-10
13435 Berlin
Germany

For more detailed information about this medicine and its trade names in the countries of the European Economic Area, please contact the Marketing Authorisation Holder.