Axoprofen forte

Package leaflet: Information for the user

Axoprofen Forte, 40 mg/ml, oral suspension
Ibuprofenum
Please read all of this leaflet carefully before use, 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 a doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If:
  • there is no improvement after 24 hours (in children under 6 months of age)
  • there is no improvement after 3 days (in patients aged 6 months and older), or if the patient feels worse, consult a doctor.

Table of contents

1. What Axoprofen Forte is and what it is used for
2. What you need to know before taking Axoprofen Forte
3. How to take Axoprofen Forte
4. Possible side effects
5. How to store Axoprofen Forte
6. Contents of the pack and other information

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

Axoprofen Forte contains ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs work by reducing pain, inflammation, and fever.
Axoprofen Forte is used in the following conditions:

• Fever of various causes (including viral infections and post-vaccination reactions)
• Mild to moderate pain of various origins, such as:
  • Headaches, sore throat, and muscle pain, e.g. during viral infections
  • Muscle, joint, and bone pain due to musculoskeletal injuries (strains, sprains)
  • Pain due to soft tissue injuries, postoperative pain
  • Teething pain, toothache, pain following dental procedures
  • Headaches (including migraine)
  • Ear pain associated with middle ear inflammation.

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), or to other non-steroidal anti-inflammatory drugs (NSAIDs)
• if the patient has ever experienced hypersensitivity reactions such as bronchial asthma, rhinitis, itchy skin rash, or swelling of the lips, face, tongue, or throat after taking medicines containing acetylsalicylic acid (such as aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs)
• if the patient has coagulation disorders
• if the patient currently has or has had peptic ulceration of the stomach and/or duodenum, with perforation or bleeding, or if the patient has had two or more such episodes in the past
• if the patient has experienced gastrointestinal bleeding or perforation related to previous use of non-steroidal anti-inflammatory drugs (NSAIDs) (the child may vomit blood or dark particles resembling coffee grounds, or have tarry stools containing blood)
• if the patient has an increased tendency to bleed or problems producing certain blood components (such as thrombocytopenia - low platelet count)
• if the patient has severe liver, kidney, or heart failure
• if the patient is in the third trimester of pregnancy
• if the patient is dehydrated
• if the child weighs less than 5 kg and is under 3 months of age
• if the patient has a bleeding disorder.

Warnings and precautions
Before starting treatment with Axoprofen Forte, discuss this with your doctor, pharmacist, or
nurse.
This is particularly important:

• if the patient has systemic lupus erythematosus or mixed connective tissue disease
• if the patient has gastrointestinal disorders or chronic inflammatory bowel diseases such as Crohn's disease or ulcerative colitis
• if the patient has hypertension and/or heart function disorders
• if the patient has impaired kidney or liver function
• if the patient has coagulation disorders or is taking anticoagulant medicines
• if the patient suffers from or has suffered from bronchial asthma or other allergic conditions
• if the patient is dehydrated (especially in children and adolescents), as there is a risk of kidney failure
• if the patient has allergic reactions after taking acetylsalicylic acid
• if the patient has chickenpox
• if the patient has an infection - see below, section titled "Infections".

Allergic reactions to ibuprofen have included symptoms such as difficulty breathing, facial and neck swelling (angioedema), and chest pain.
If any of these symptoms occur, discontinue Axoprofen Forte immediately and contact a doctor or emergency medical services without delay.
Skin reactions
Severe skin reactions have occurred with the use of ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If the patient develops any symptoms associated with these severe skin reactions described in section 4, discontinue Axoprofen Forte immediately and seek medical help.
Infections
Like other anti-inflammatory medicines, Axoprofen Forte may mask symptoms of infection such as fever, pain, and swelling. Therefore, Axoprofen Forte may delay appropriate treatment of infection and consequently increase the 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 symptoms persist or worsen, consult a doctor immediately.
Taking pain-relieving and anti-inflammatory medicines such as Axoprofen Forte 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 (see section 3).
During long-term, high-dose painkiller treatment, headaches may occur, which should not be treated with increased doses of medication. In general, chronic use of painkillers, especially in combination with other painkillers, may cause permanent kidney damage and risk of kidney failure.
Before using Axoprofen Forte, the patient should consult a doctor or pharmacist if:

• the patient has heart conditions such as heart failure, angina (chest pain), a history of 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 ischemic attack - TIA);
• the patient has hypertension, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.

Axoprofen Forte may cause visual disturbances (scotoma, color vision disturbances). In such cases, discontinue the medicine and undergo an ophthalmological examination.
Axoprofen Forte and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
This is particularly important if the patient is taking:

• other medicines containing ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs), including those available without prescription
• acetylsalicylic acid (aspirin) used to prevent heart attacks and strokes – the protective effect may be reduced after taking ibuprofen
• anticoagulants (e.g., warfarin)
• antiplatelet agents (e.g., dipyridamole, clopidogrel)
• mifepristone (used for medical termination of pregnancy)
• zidovudine (used in HIV treatment)
• sulfonylurea derivatives such as glibenclamide (used in diabetes treatment)
• methotrexate (used in psoriasis, arthritis, and certain types of cancer)
• cardiac glycosides (e.g., digoxin used in treating certain heart conditions)
• phenytoin (an anticonvulsant), as ibuprofen may increase serum levels of this medicine
• diuretics
• antihypertensive medicines (e.g., captopril, atenolol, losartan)
• corticosteroids (anti-inflammatory medicines)
• SSRIs (antidepressants used in depression)
• aminoglycoside antibiotics (used in infections)
• lithium (used in mood disorders)
• cyclosporine or tacrolimus (used to prevent transplant rejection)
• cholestyramine (used to lower cholesterol)
• voriconazole or fluconazole (types of antifungal medicines)
• probenecid and sulfinpyrazone (used in gout treatment)
• baclofen (a muscle relaxant)
• ritonavir (a medicine used in HIV treatment)
• products containing Ginkgo biloba, as they may increase the risk of bleeding.

If in doubt whether any of the above situations apply, consult a doctor or pharmacist before use.
If the patient or caregiver is unsure about which medicines are being taken, show the medicines to a doctor or pharmacist.
Axoprofen Forte may affect the action of other medicines, or other medicines may affect the action of Axoprofen Forte. For example:

• anticoagulant medicines (i.e., blood thinners, preventing clot formation, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine),
• blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, angiotensin II receptor antagonists such as losartan).

Also, some other medicines may be affected by or may influence treatment with Axoprofen Forte. Therefore, always consult a doctor or pharmacist before using Axoprofen Forte with other medicines.
Axoprofen Forte with food, drink, and alcohol
The medicine should preferably be taken after food.
Avoid consuming alcohol while taking Axoprofen Forte, as this may worsen adverse effects.
Pregnancy, breastfeeding, and effects 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 3 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 the child and may delay or prolong labor.
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 required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible duration.
From the 20th week of pregnancy, Axoprofen Forte may cause kidney dysfunction 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 the blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is required, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk in small amounts and is unlikely to adversely affect the infant, especially if used for a short duration.
Fertility
Ibuprofen belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible upon discontinuation of the medicine. It is unlikely that this medicine, when used occasionally, will affect the ability to conceive; however, inform the doctor before use if the patient has difficulty conceiving.
Driving and operating machinery
There is no data available on the effect of Axoprofen Forte on the ability to drive or operate machinery.
Axoprofen Forte contains sorbitol 70%
The medicine contains 40 mg of 70% sorbitol in each 1 ml of oral suspension.
Sorbitol is a source of fructose. If fructose intolerance has previously been diagnosed in an adult or child, or if hereditary fructose intolerance (a rare genetic disorder in which the patient's body cannot break down fructose) has been diagnosed, consult a doctor before taking the medicine or giving it to a child.
Axoprofen Forte contains propylene glycol
The medicine contains 10 mg of propylene glycol in each 1 ml of oral suspension.
Axoprofen Forte contains sodium benzoate (E 211)
The medicine contains 2 mg of sodium benzoate (E 211) in each 1 ml of oral suspension.
Axoprofen Forte contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Axoprofen Forte

This medicine should always be used exactly as described in this patient information leaflet or as advised by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
This medicine is intended for short-term use only.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If symptoms of infection (such as fever and pain) persist or worsen, medical advice should be sought immediately (see section 2).
The dosage of this medicine may vary depending on the patient, age, and condition being treated.
Each 5 ml of suspension contains 200 mg of ibuprofen.
This medicine does not contain sugar and therefore may be taken by patients with diabetes.
Shake the bottle well before use.

Use in children and adolescents
Axoprofen Forte is not recommended for children under 3 months of age or weighing less than 5 kg due to insufficient data on use in this age group.
Children under 6 months of age should only be given this medicine after consultation with a doctor.
Do not use in children aged 3 to 6 months for longer than 24 hours.
If symptoms worsen or do not improve within 24 hours of treatment, consult a doctor.
Do not use in children over 6 months of age for longer than 3 days.
If symptoms worsen or do not improve within 3 days of treatment, consult a doctor.
Do not exceed the recommended dose.

The recommended daily dose is 20 to 30 mg/kg body weight, divided into 3 or 4 doses. At least 6 hours should elapse between doses.

• Infants aged 3 to 6 months (weighing over 5 kg): 1.25 ml (50 mg ibuprofen) - 3 times daily.
• Infants aged 6 to 12 months (weighing 7 kg–9 kg): 1.25 ml (50 mg ibuprofen) - 3 to 4 times daily.
• Children aged 1 to 3 years (weighing 10 kg–15 kg): 2.5 ml (100 mg ibuprofen) - 3 times daily.
• Children aged 4 to 6 years (weighing 16 kg–20 kg): 3.75 ml (150 mg ibuprofen) - 3 times daily.
• Children aged 7 to 9 years (weighing 21 kg–29 kg): 5 ml (200 mg ibuprofen) - 3 times daily.
• Children aged 10 to 12 years (weighing 30 kg–40 kg): 7.5 ml (300 mg ibuprofen) - 3 times daily.
• Adolescents over 12 years of age (weighing over 40 kg): 7.5 ml (300 mg ibuprofen) - 3 to 4 times daily.

Use in adult patients
For adult patients, other pharmaceutical forms of ibuprofen at doses of 200 mg, 400 mg, or 600 mg are recommended. However, in cases of swallowing difficulties, the suspension form may be administered at 7.5 ml (equivalent to 300 mg ibuprofen) 4 times daily.
The maximum recommended daily dose for adults and adolescents is 1200 mg.
If treatment needs to continue for more than 3 days for fever reduction or more than 4 days for pain relief, or if the patient's condition worsens, medical advice should be sought.
Elderly patients
Dosage adjustment is not required, except in cases of renal or hepatic impairment. In such cases, the dose should be individually determined.
If symptoms persist or worsen, consult a doctor.
Use the lowest effective dose for the shortest possible duration necessary to relieve symptoms.
Do not exceed the recommended dose.
A measuring spoon or an oral syringe dosing device with a 5 ml capacity and markings to aid dosing is supplied with the packaging.

Overdose of Axoprofen Forte
If a patient takes more than the recommended dose of Axoprofen Forte, or if a child accidentally ingests the medicine, always contact a doctor or go to the nearest hospital for assessment of potential health risks and advice on necessary actions.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding (see section 4 below), diarrhoea, headache, tinnitus, confusion, and nystagmus. Excitement, drowsiness, disorientation, or coma may also occur. Seizures may occur rarely. After ingestion of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing difficulties may occur. The prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute renal failure and liver damage may also occur. In asthmatic patients, asthma may worsen. Additionally, low blood pressure and breathing difficulties may occur.

Missed dose of Axoprofen Forte
Do not take a double dose to make up for a missed dose.
If a dose is missed, the next dose should be given as needed, provided that at least 4 hours have passed since the last dose.
If you have any questions or doubts about using this medicine, contact your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Medicines such as Axoprofen Forte may cause a small increased risk of heart attack (myocardial infarction) or stroke.
Fluid retention (oedema), increased blood pressure, and heart failure have been observed in connection with the use of NSAIDs.

If the patient experiences any of the serious adverse reactions listed below, treatment must be discontinued and medical advice sought immediately:

• Red, flat, target-like or circular skin rashes on the trunk, often with blisters in the centre, peeling of the skin, and ulcers in the mouth, throat, nose, genital organs, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

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

• Presence of blood in stool or black, tarry stools;
• Vomiting blood or material resembling coffee grounds;
• Severe allergic reactions presenting as: swelling of the face, tongue, neck, or throat, difficulty breathing, rapid heartbeat, fainting, dizziness, or collapse;
• Wheezing (asthma), worsening of asthma attacks, breathing difficulties;
• Symptoms of meningitis, such as: neck stiffness, fever, disorientation, headache, nausea, vomiting. The risk of meningitis is increased in patients with pre-existing autoimmune diseases such as systemic lupus erythematosus or mixed connective tissue disease;
• Severe skin allergic reactions which may include peeling, blistering, and skin damage;
• Worsening of pre-existing severe skin infections;
• Infections associated with conditions for which non-steroidal anti-inflammatory drugs are used (e.g. necrotizing fasciitis). If signs of infection appear or worsen during ibuprofen treatment, the patient should seek medical advice immediately;
• Gastric and/or duodenal ulcers and gastrointestinal bleeding;
• Kidney disorders which may lead to kidney failure (the patient may pass more or less urine, blood in urine or cloudy urine may occur, shortness of breath, fatigue, loss of appetite, swollen ankles);
• Hypertension, heart failure (the patient may be excessively tired, have difficulty breathing, or leg oedema).

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

• Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include widespread skin rash, high fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell);
• Red, scaly rash with subcutaneous nodules and blisters, predominantly located in skin folds, trunk, and upper limbs, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, treatment with Axoprofen Forte must be discontinued and immediate medical assistance sought. See also section 2;
• Severe skin and soft tissue infections as complications during chickenpox;
• Skin becomes sensitive to light.

Furthermore, if the patient experiences any of the following serious adverse reactions, treatment must be discontinued and medical advice sought immediately:
Uncommon (occurring in 1 to 10 in 1,000 patients)

• Skin allergic reactions such as itching, urticaria (red rash);
• Visual disturbances;
• Abdominal pain, indigestion, nausea.

Rare (occurring in 1 to 10 in 10,000 patients)

• Dizziness, insomnia, restlessness, irritability, feeling of fatigue;
• Optic nerve damage;
• Vomiting.

Very rare (occurring in less than 1 in 10,000 patients)

• Yellowing of the skin or eyes, pale stools, or upper abdominal pain (these symptoms may be caused by liver function disorders);
• Fatigue, unusual bruising or unexplained bleeding, sore throat, mouth ulcers, flu-like symptoms including fever. These may be due to changes in blood count.

Other possible adverse reactions:
Common (affecting 1 to 10 in 100 patients)

• Feeling of fatigue.

Uncommon (affecting 1 to 10 in 1,000 patients)

• Headache.

Rare (affecting 1 to 10 in 10,000 patients)

• Oedema, diarrhoea, bloating, constipation. Medical advice should be sought if bloating persists for more than a few days and is troublesome.

Very rare (affecting less than 1 in 10,000 patients)

• Exacerbation of ulcerative colitis and Crohn's disease;
• Swelling or ulceration of the oral mucosa.

Frequency unknown (frequency cannot be estimated from available data)

• Fluid retention, which may cause limb oedema;
• Hypertension;
• Increased risk of heart attack or stroke (may be due to long-term use of high-dose ibuprofen). At the dose administered to children, the likelihood of these adverse reactions is low;
• Chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions 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.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Axoprofen Forte

Do not store above 25°C. Keep in the original packaging to protect from light.
Keep the medicine out of the sight and reach of children.
Shake well before use.
After first opening the bottle, the medicine should be used within 3 months.
Do not use this medicine after the expiry date stated on the label of the bottle and the cardboard
pack after EXP. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer required. Such measures help protect the environment.

6. Package contents and other information

What Axoprofen Forte contains

• The active substance is ibuprofen. Each 5 ml of oral suspension contains 200 mg of ibuprofen.
• Other ingredients are: propylene glycol, anhydrous citric acid, sodium benzoate (E 211), sodium saccharin, sodium citrate, 70% sorbitol, glycerol, xanthan gum, polysorbate 80, orange flavour, purified water.

What Axoprofen Forte looks like and contents of the pack
Axoprofen Forte is a white or almost white, homogeneous suspension with an orange flavour.
Pack:
A 100 ml or 200 ml amber glass bottle (Type III), with a child-resistant closure made of polyethylene and polypropylene (HDPE/PPH/LDPE), with an attached 5 ml measuring spoon made of polypropylene (PP) marked in 1.25 ml increments, or an oral dosing syringe made of polypropylene/polyethylene (HDPE) with markings every 0.25 ml, all contained in a cardboard box.
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa 30 Street
02-867 Warsaw
Tel: +48 22 855 40 93
Manufacturer
Laboratórios Basi – Indústria Farmacêutica, S.A.
Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16
3450-232 Mortágua
Portugal

Patient Information Leaflet

Axoprofen Forte, 40 mg/ml, oral suspension
Ibuprofen
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Always take this medicine exactly as described in this patient leaflet or as directed by your
doctor, pharmacist, or nurse.

• Keep this leaflet. You may need to read it again.
• If you need advice or more information, ask your pharmacist.
• If you get any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If:
• symptoms do not improve within 24 hours (in children under 6 months of age)
• symptoms do not improve within 3 days (in patients over 6 months of age) or if the patient feels worse, contact your doctor.

Contents of the leaflet

1. What Axoprofen Forte is and what it is used for
2. What you need to know before taking Axoprofen Forte
3. How to take Axoprofen Forte
4. Possible side effects
5. How to store Axoprofen Forte
6. Contents of the pack and other information

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

Axoprofen Forte contains ibuprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These work by reducing pain, inflammation, and fever.
Axoprofen Forte is used in the following cases:

• Fever of various causes (including viral infections and post-vaccination reactions)
• Mild to moderate pain of various origins, such as:
  • Headache, sore throat, and muscle pain, e.g. during viral infections
  • Muscle, joint, and bone pain due to musculoskeletal injuries (strains, sprains)
  • Soft tissue injuries, postoperative pain
  • Teething pain, toothache, pain after dental procedures
  • Headache (including migraine)
  • Ear pain associated with middle ear inflammation.

2. What you need to know before taking Axoprofen Forte

Do not take Axoprofen Forte:

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6), or to other non-steroidal anti-inflammatory drugs (NSAIDs)
• if you have ever experienced hypersensitivity reactions such as bronchial asthma, rhinitis, itchy rash, or swelling of the lips, face, tongue, or throat after taking medicines containing acetylsalicylic acid (such as aspirin) or other NSAIDs
• if you have bleeding disorders
• if you have or have had a stomach or duodenal ulcer with perforation or bleeding, or if you have had two or more such episodes in the past
• if you have experienced gastrointestinal bleeding or perforation related to previous use of NSAIDs (the child may vomit blood or dark particles resembling coffee grounds, or have tarry stools containing blood)
• if you have an increased tendency to bleed or problems with blood component production (such as thrombocytopenia - low platelet count)
• if you have severe liver, kidney, or heart failure
• if you are in the third trimester of pregnancy
• if you are dehydrated
• if the child weighs less than 5 kg and is under 3 months of age
• if you have a bleeding tendency.

Warnings and precautions
Before starting treatment with Axoprofen Forte, discuss it with your doctor, pharmacist, or nurse.
This is particularly important:

• if you have systemic lupus erythematosus or mixed connective tissue disease
• if you have gastrointestinal disorders or chronic inflammatory bowel diseases such as Crohn's disease or ulcerative colitis
• if you have hypertension and/or heart function disorders
• if you have impaired kidney or liver function
• if you have coagulation disorders or are taking anticoagulant medicines
• if you have bronchial asthma or other allergic diseases
• if you are dehydrated (especially in children and adolescents), as there is a risk of kidney failure
• if you have allergic reactions after taking acetylsalicylic acid
• if you have chickenpox
• if you have an infection - see below under "Infections".

Allergic reactions to ibuprofen have been reported, including difficulty breathing, facial and neck swelling (angioedema), and chest pain. If any of these symptoms occur, discontinue Axoprofen Forte immediately and contact your doctor or emergency medical services without delay.
Skin reactions
Severe skin reactions have been reported with ibuprofen use, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If you experience any of the symptoms associated with these serious skin reactions described in section 4, stop taking Axoprofen Forte immediately and seek medical help.
Infections
Like other anti-inflammatory medicines, Axoprofen Forte may mask symptoms of infection such as fever, pain, and swelling. Therefore, Axoprofen Forte may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you are taking this medicine during an existing infection and symptoms persist or worsen, consult your doctor immediately.
Taking pain-relieving and anti-inflammatory medicines such as Axoprofen Forte may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment (see section 3).
With long-term, high-dose treatment with pain-relieving medicines, headaches may occur that should not be treated with increased doses of medicine. In general, chronic use of pain-relieving medicines, especially in combination with other painkillers, may lead to permanent kidney damage and risk of kidney failure.
Before taking Axoprofen Forte, you should consult your doctor or pharmacist if:

• you have heart diseases such as heart failure, angina (chest pain), history of heart attack, coronary artery bypass surgery, peripheral artery disease (poor blood circulation in legs due to narrowed or blocked arteries), or if you have had any stroke (including mini-stroke or transient ischemic attack - TIA);
• you have hypertension, diabetes, high cholesterol levels, a family history of heart disease or stroke, or if you smoke.

Axoprofen Forte may cause visual disturbances (e.g. blurred vision, colour vision disturbances). In such cases, discontinue the medicine and undergo an ophthalmological examination.
Axoprofen Forte with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
This is particularly important if you are taking:

• other medicines containing ibuprofen or other NSAIDs, including those available without prescription
• acetylsalicylic acid (aspirin) used to prevent heart attacks and strokes – protection may be reduced after taking ibuprofen
• anticoagulant medicines (e.g. warfarin)
• antiplatelet medicines (e.g. dipyridamole, clopidogrel)
• mifepristone (used for medical termination of pregnancy)
• zidovudine (used in HIV treatment)
• sulfonylurea derivatives such as glibenclamide (used in diabetes treatment)
• methotrexate (used in psoriasis, arthritis, and some types of cancer)
• cardiac glycosides (e.g. digoxin used in certain heart conditions)
• phenytoin (an antiepileptic medicine), as ibuprofen may increase its serum concentration
• diuretics (water tablets)
• antihypertensive medicines (e.g. captopril, atenolol, losartan)
• corticosteroids (anti-inflammatory medicines)
• SSRIs (antidepressants used in depression)
• aminoglycoside antibiotics (used in infections)
• lithium (used in mood disorders)
• cyclosporine or tacrolimus (used to prevent transplant rejection)
• cholestyramine (used to lower cholesterol levels)
• voriconazole or fluconazole (antifungal medicines)
• probenecid and sulfinpyrazone (used in gout treatment)
• baclofen (a muscle relaxant)
• ritonavir (used in HIV treatment)
• products containing Ginkgo biloba (Ginkgo biloba), as they may increase the risk of bleeding.

If you are unsure whether any of the above situations apply, consult your doctor or pharmacist before taking this medicine.
Axoprofen Forte may affect the action of other medicines, or other medicines may affect the action of Axoprofen Forte. For example:

• anticoagulant medicines (i.e. blood thinners, preventing clot formation, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine),
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan).

Also, some other medicines may be affected by or may affect treatment with Axoprofen Forte. Therefore, always consult your doctor or pharmacist before taking Axoprofen Forte with other medicines.
Axoprofen Forte with food, drink, and alcohol
Take the medicine preferably after meals.
Avoid alcohol while taking Axoprofen Forte, as it may increase the risk of adverse effects.
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.
Pregnancy
DO NOT take Axoprofen Forte during the last 3 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 mother and child and may delay or prolong labour.
During the first 6 months of pregnancy, you should not take this medicine unless your doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Axoprofen Forte may cause kidney problems 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 the blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk in small amounts and is unlikely to have a negative effect on the infant, especially if used for a short time.
Fertility
Ibuprofen belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible after stopping the medicine. It is unlikely that occasional use of this medicine will affect the ability to conceive, but inform your doctor if you have difficulty conceiving.
Driving and operating machinery
There is no data on the effect of Axoprofen Forte on the ability to drive or operate machinery.
Axoprofen Forte contains 70% sorbitol
This medicine contains 40 mg of 70% sorbitol in each 1 ml of oral suspension.
Sorbitol is a source of fructose. If fructose intolerance has been previously diagnosed in an adult or child, or if hereditary fructose intolerance (a rare genetic disorder in which the body cannot break down fructose) has been diagnosed, consult your doctor before taking or giving this medicine to a child.
Axoprofen Forte contains propylene glycol
This medicine contains 10 mg of propylene glycol in each 1 ml of oral suspension.
Axoprofen Forte contains sodium benzoate (E 211)
This medicine contains 2 mg of sodium benzoate (E 211) in each 1 ml of oral suspension.
Axoprofen Forte contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to take Axoprofen Forte

Always take this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
This medicine is intended for short-term use only.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).
Dosage may vary depending on the patient, age, and condition.
Each 5 ml of suspension contains 200 mg of ibuprofen.
This medicine does not contain sugar and may therefore be taken by patients with diabetes.
Shake the bottle well before use.
Use in children and adolescents
Axoprofen Forte is not recommended for children under 3 months of age or weighing less than 5 kg due to insufficient data on use in this age group.
Children under 6 months of age should only be given this medicine after consulting a doctor.
Do not use in children aged 3 to 6 months for longer than 24 hours.
If symptoms worsen or do not improve after 24 hours of treatment, consult your doctor.
Do not use in children over 6 months of age for longer than 3 days.
If symptoms worsen or do not improve after 3 days of treatment, consult your doctor.
Do not exceed the recommended dose.
The recommended daily dose is 20 to 30 mg/kg body weight, given in 3 or 4 divided doses. Allow at least 6 hours between doses.

• Infants 3 to 6 months (body weight over 5 kg): 1.25 ml (50 mg ibuprofen) - 3 times daily.
• Infants 6 to 12 months (body weight 7 kg-9 kg): 1.25 ml (50 mg ibuprofen) - 3 to 4 times daily.
• Children 1 to 3 years (body weight 10 kg-15 kg): 2.5 ml (100 mg ibuprofen) - 3 times daily.
• Children 4 to 6 years (body weight 16 kg-20 kg): 3.75 ml (150 mg ibuprofen) - 3 times daily.
• Children 7 to 9 years (body weight 21 kg-29 kg): 5 ml (200 mg ibuprofen) - 3 times daily.
• Children 10 to 12 years (body weight 30 kg-40 kg): 7.5 ml (300 mg ibuprofen) - 3 times daily.
• Adolescents over 12 years (body weight over 40 kg): 7.5 ml (300 mg ibuprofen) - 3 to 4 times daily.

Use in adult patients
For adult patients, other pharmaceutical forms of ibuprofen at doses of 200 mg, 400 mg, or 600 mg are recommended. However, in cases of swallowing difficulties, the suspension form may be administered 4 times daily at 7.5 ml (equivalent to 300 mg ibuprofen).
The maximum recommended daily dose for adults and adolescents is 1200 mg.
If treatment is required for longer than 3 days for fever reduction or longer than 4 days for pain relief, or if the patient's condition worsens, consult your doctor.
Elderly patients
No dose adjustment is necessary except in cases of kidney or liver impairment. In such cases, the dose should be individually determined.
If symptoms do not improve or worsen, contact your doctor.
Use the lowest effective dose for the shortest possible time needed to relieve symptoms.
Do not exceed the recommended dose.
The pack includes a measuring spoon or an oral dosing syringe with a 5 ml capacity and markings to facilitate dosing.
Instructions for using Axoprofen Forte with an oral dosing syringe:

1. Shake the bottle vigorously before use to mix the contents.
2. Unscrew the bottle cap (press down and turn counterclockwise – as shown on the cap).
3. Firmly insert the syringe into the neck of the bottle.
4. To fill the syringe, turn the bottle upside down, then slowly pull the plunger down to draw the suspension up to the desired mark on the syringe scale.
5. Return the bottle to its upright position and carefully remove the syringe.
6. Place the tip of the syringe in the patient's mouth, then slowly press the plunger to carefully empty the syringe contents.
7. If the dose exceeds 5 ml, repeat steps 2 to 6 to administer the correct amount of medicine.
8. After use, close the bottle by screwing on the cap, and wash and dry the syringe.

Taking more Axoprofen Forte than recommended
If you take more than the recommended dose of Axoprofen Forte or if a child accidentally takes the medicine, always contact your doctor or go to the nearest hospital for advice on possible health risks and what actions to take.
Symptoms of overdose may include nausea, stomach pain, vomiting (blood may be present), gastrointestinal bleeding (see section 4 below), diarrhoea, headache, ringing in the ears, confusion, and nystagmus. Excitement, drowsiness, confusion, or coma may also occur. Seizures may rarely occur. After large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing difficulties may occur. Prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute kidney failure and liver damage may occur. In asthmatics, asthma may worsen.
Additionally, low blood pressure and breathing difficulties may occur.
If you miss a dose of Axoprofen Forte
Do not take a double dose to make up for a missed dose.
If you miss a dose, take the next dose when needed, provided that the last dose was taken at least 4 hours earlier.
If you have any questions or doubts about using this medicine, contact your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Medicines such as Axoprofen Forte may cause a small increased risk of heart attack or stroke.
Fluid retention (oedema), increased blood pressure, and heart failure have been observed with NSAID use.
If you experience any of the following serious side effects, stop taking the medicine and contact your doctor immediately:

• Red, flat, target-like or circular spots on the trunk, often with blisters in the centre, skin peeling, mouth, throat, nose, genital, or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

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

• Blood in stool or black, tarry stools;
• Vomiting blood or material resembling coffee grounds;
• Severe allergic reactions including: swelling of the face, tongue, neck, or throat, difficulty breathing, rapid heartbeat, fainting, dizziness, or collapse;
• Wheezing (asthma), worsening asthma attacks, breathing difficulties;
• Symptoms of meningitis such as: neck stiffness, fever, confusion, headache, nausea, vomiting. The risk of meningitis is increased in patients with existing autoimmune diseases such as systemic lupus erythematosus or mixed connective tissue disease;
• Severe skin allergic reactions including skin peeling, blisters, and skin damage;
• Worsening of existing severe skin infections;
• Infections associated with conditions for which NSAIDs are used (e.g. necrotizing fasciitis). If signs of infection appear or worsen during ibuprofen use, the patient should seek immediate medical attention;
• Stomach and/or duodenal ulcers and gastrointestinal bleeding;
• Kidney disorders that may lead to kidney failure (the patient may pass more or less urine, blood in urine or cloudy urine may occur, the patient may have shortness of breath, feel weak and tired, have no appetite, or have swollen ankles);
• Hypertension, heart failure (the patient may feel excessively tired, have breathing difficulties, or leg swelling).

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

• Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS include widespread skin rash, high fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell);
• Red, scaly rash with subcutaneous nodules and blisters, mainly in skin folds, trunk, and upper limbs, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, discontinue Axoprofen Forte and seek immediate medical help. See also section 2;
• Severe skin and soft tissue infections as complications of chickenpox;
• Skin becomes sensitive to light.

Additionally, if you experience any of the following serious side effects, stop taking the medicine and contact your doctor immediately:
Not common (occur in 1 to 10 out of 1,000 patients)

• Skin allergic reactions such as itching, urticaria (red rash);
• Visual disturbances;
• Abdominal pain, indigestion, nausea.

Rare (occur in 1 to 10 out of 10,000 patients)

• Dizziness, insomnia, excitement, irritability, feeling of fatigue;
• Optic nerve damage;
• Vomiting.

Very rare (occur in less than 1 out of 10,000 patients)

• Yellowing of the skin or eyes, pale stools, or upper abdominal pain (these may be due to liver function disorders);
• Fatigue, unusual bruising or unexplained bleeding, sore throat, mouth ulcers, flu-like symptoms including fever. These may be due to changes in blood counts.

Other possible side effects:
Common (affect 1 to 10 out of 100 patients)

• Feeling of fatigue.

Not common (affect 1 to 10 out of 1,000 patients)

• Headache.

Rare (affect 1 to 10 out of 10,000 patients)

• Swelling, diarrhoea, bloating, constipation. Consult your doctor if bloating persists for more than a few days and is bothersome.

Very rare (affect less than 1 out of 10,000 patients)

• Worsening of ulcerative colitis and Crohn's disease;
• Swelling or ulcers of the oral mucosa.

Frequency unknown (frequency cannot be determined from available data)

• Fluid retention, which may cause limb swelling;
• Hypertension;
• Increased risk of heart attack or stroke (may result from long-term, high-dose ibuprofen use). At the dose given to children, the likelihood of these adverse effects is low
• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side 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.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the Marketing Authorisation Holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Axoprofen Forte

Do not store above 25°C. Keep in the original packaging to protect from light.
Keep out of sight and reach of children.
Shake well before use.
After first opening, use within 3 months.
Do not use this medicine after the expiry date stated on the bottle and carton label after EXP. The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the pack and other information

What Axoprofen Forte contains

• The active substance is ibuprofen. Each 5 ml of oral suspension contains 200 mg of ibuprofen.
• Other ingredients are: propylene glycol, anhydrous citric acid, sodium benzoate (E 211), sodium saccharin, sodium citrate, 70% sorbitol, glycerol, xanthan gum, polysorbate 80, orange flavour, purified water.

What Axoprofen Forte looks like and contents of the pack
Axoprofen Forte is a white or almost white, homogeneous suspension with an orange flavour.
Pack:
A 100 ml or 200 ml amber glass bottle (Type III), with a child-resistant closure made of polypropylene (PP) with a polyethylene (LDPE) connector, with an attached 5 ml oral dosing syringe made of polypropylene/polyethylene (HDPE) marked every 0.25 ml, all contained in a cardboard box.
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa 30 Street
02-867 Warsaw
Tel: +48 22 855 40 93
Manufacturer
Laboratórios Basi – Indústria Farmacêutica, S.A.
Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16
3450-232 Mortágua
Portugal