IBUPROFEN DR. MAX

Package leaflet: Information for the patient

Ibuprofen Dr. Max, 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 taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet, so you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• In adults, if symptoms persist beyond 3 days of treatment for fever or 5 days for pain, or if symptoms worsen, consult a doctor. In adolescents, consult a doctor if symptoms persist beyond 3 days of treatment or if symptoms worsen.

Leaflet contents:

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

1. What Ibuprofen Dr. Max is and what it is used for

Ibuprofen Dr. Max belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs), which work by reducing pain, inflammation, and fever.
Ibuprofen Dr. Max is used for short-term symptomatic treatment of mild to moderate pain, such as headache, including migraine headache, toothache, pain due to soft tissue injuries such as bruises and sprains, menstrual pain, and fever.
Ibuprofen Dr. Max is indicated for use in adults and adolescents weighing 40 kg or more (aged 12 years and above).
Adults: Consult a doctor if symptoms persist beyond 3 days of treatment for fever or 5 days for pain, or if symptoms worsen.
Adolescents: Consult a doctor if symptoms persist beyond 3 days of treatment or if symptoms worsen.

2. Important information before using Ibuprofen Dr. Max

When not to use Ibuprofen Dr. Max

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced hypersensitivity reactions after taking pain-relieving medicines containing acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), manifested as asthma, rhinitis, itchy skin rash, or swelling of the lips, face, tongue, or throat;
• if the patient has experienced gastrointestinal bleeding or perforation related to previous use of pain-relieving and anti-inflammatory medicines (NSAIDs);
• if the patient has a peptic ulcer or gastrointestinal bleeding, or has had two or more such episodes in the past;
• if the patient has severe liver failure;
• if the patient has severe renal failure (glomerular filtration rate below 30 mL/min);
• if the patient has severe heart failure;
• if the patient is significantly dehydrated (caused by vomiting, diarrhoea, or insufficient fluid intake);
• if the patient has active bleeding (including intracranial bleeding);
• if the patient suffers from a disease of unknown origin leading to abnormal blood cell formation;
• if the patient is in the last three months of pregnancy.

Warnings and precautions
Consult a doctor or pharmacist before taking Ibuprofen Dr. Max:

• if the patient has chronic inflammatory bowel diseases, such as ulcerative colitis, Crohn's disease, a history of peptic ulcer, or other stomach or intestinal disorders;
• if the patient has asthma, as ibuprofen may increase the risk of bronchospasm (airway narrowing);
• if the patient has hay fever, nasal polyps, or chronic respiratory disease, as ibuprofen may increase the risk of allergic reactions;
• if the patient has liver, kidney, or heart problems, as ibuprofen should be used cautiously and at the lowest dose, because it may impair kidney function;
• if the patient is taking anticoagulant medicines, as ibuprofen, like other medicines in this group, may prolong bleeding time or lead to ulcer formation;
• if the patient is planning to become pregnant;
• if the patient is in the first six months of pregnancy;
• if the patient is breastfeeding;
• if the patient has an infection – see section “Infections” below.

During treatment, gastrointestinal bleeding, ulceration, or perforation may rarely occur.
Immediately inform a doctor if any unusual gastrointestinal symptoms occur.
Do not use ibuprofen together with other non-steroidal anti-inflammatory drugs or other medicines increasing the risk of stomach damage (see section “Ibuprofen Dr. Max and other medicines” below).

Effects on the heart and brain
Taking anti-inflammatory/pain-relieving medicines such as 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.
Before using Ibuprofen Dr. Max, the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart conditions such as heart failure, angina (chest pain), a history of heart attack, coronary 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 high blood pressure, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.

Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), or chest pain, have been reported during treatment.
If any of these symptoms occur, discontinue Ibuprofen Dr. Max immediately and contact a doctor or emergency medical services without delay.

Systemic Lupus Erythematosus (SLE) and mixed connective tissue disease
If the patient has systemic lupus erythematosus (SLE) or mixed connective tissue disease, consult a doctor before starting ibuprofen treatment, as there is an increased risk of developing aseptic meningitis.

Severe skin reactions
Severe skin reactions, 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), have been reported with ibuprofen use. If the patient experiences any symptoms associated with these severe skin reactions described in section 4, Ibuprofen Dr. Max should be discontinued immediately and medical help should be sought.

Effects on the kidneys
Ibuprofen may cause kidney damage, especially in patients who previously had kidney, heart, or liver problems.
Frequent use of pain-relieving medicines may lead to permanent kidney damage, and this risk increases during physical exertion – therefore, avoid strenuous physical activity during treatment.

Children and adolescents
There is a risk of impaired kidney function in dehydrated patients – including children and adolescents.

Elderly patients
Elderly patients are more susceptible to adverse effects, especially gastrointestinal bleeding and perforation, which may be fatal. There is also a risk of kidney dysfunction in dehydrated elderly patients.

Infections
Ibuprofen Dr. Max may mask objective signs of infection such as fever and pain. Therefore, Ibuprofen Dr. Max 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 ongoing infection and symptoms persist or worsen, consult a doctor immediately.
Avoid using this medicine during chickenpox infection.

Other precautions
During long-term, high-dose treatment with pain-relieving medicines, headache may occur, which should not be treated with increased doses of the medicine. In such cases, consult a doctor regarding further treatment.
Ibuprofen may transiently inhibit platelet function and prolong bleeding time.
Severe, acute hypersensitivity reactions (such as anaphylactic shock) may rarely occur. This condition requires immediate treatment.
The risk of adverse effects increases with higher doses. Therefore, treatment should be initiated at the lowest effective dose and continued for the shortest duration necessary to relieve symptoms.

Ibuprofen Dr. Max and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use, including those available without a prescription.
Adverse effects of Ibuprofen Dr. Max may be intensified by concomitant use of other medicines. Conversely, Ibuprofen Dr. Max may enhance or reduce the effects of other medicines or increase the occurrence of adverse effects of other medicines taken simultaneously with ibuprofen.
Ibuprofen Dr. Max may affect the action of other medicines, or other medicines may affect the action of Ibuprofen Dr. Max. For example:

• other NSAIDs, including selective COX-2 inhibitors, corticosteroids, and antidepressants called SSRIs (Selective Serotonin Reuptake Inhibitors), antiplatelet/anticoagulant drugs (e.g., acetylsalicylic acid, warfarin, ticlopidine), as they increase the risk of gastrointestinal adverse effects, including bleeding and peptic ulcer formation;
• methotrexate (used in the treatment of cancer and autoimmune diseases), as its elimination may be reduced;
• lithium (used in the treatment of bipolar disorder), digoxin (used in the treatment of various heart conditions), and phenytoin (used to prevent epileptic seizures), as their blood concentrations may increase;
• antihypertensive medicines – diuretics (medicines increasing fluid excretion), ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan, as ibuprofen may reduce the effectiveness of these medicines, and diuretics may increase the risk of kidney damage;
• cholestyramine (used in the treatment of high cholesterol levels), as absorption of ibuprofen in the gastrointestinal tract may be reduced;
• aminoglycoside antibiotics (antibacterial agents), as elimination from the body may be prolonged;
• cyclosporine and tacrolimus (used in the treatment of skin diseases or immunosuppression after organ transplantation), as kidney damage may occur;
• mifepristone (used for medical abortion), as the effect of mifepristone may be reduced;
• zidovudine (used in the treatment of HIV/AIDS patients), as ibuprofen use may increase the risk of bleeding into joints or bleeding leading to swelling in HIV-positive haemophiliacs;
• ritonavir, as blood concentrations of NSAIDs may increase;
• probenecid or sulfinpyrazone (used in the treatment of gout), as ibuprofen reduces the effectiveness of these medicines;
• quinolone antibiotics, as ibuprofen may increase the risk of seizures induced by these antibiotics;
• sulfonylurea derivatives (used in the treatment of type 2 diabetes), as their effect may be enhanced; rare cases of hypoglycaemia (low blood sugar) have been reported;
• bisphosphonates (used in the treatment of osteoporosis, Paget's disease, and to reduce high blood calcium levels), oxpentifylline (pentoxifylline) used in the treatment of circulatory disorders in the arteries of the arms or legs), as gastrointestinal adverse effects may be intensified;
• baclofen (a muscle relaxant), as its toxicity may be increased;
• CYP2C9 inhibitors, such as voriconazole or fluconazole (types of antifungal medicines), as they may increase sensitivity to ibuprofen;
• products containing Ginkgo biloba (herbal remedy), as there is a potential increased risk of bleeding if taken with ibuprofen.

Other medicines may also affect or be affected by treatment with Ibuprofen Dr. Max; therefore, always consult a doctor or pharmacist before using Ibuprofen Dr. Max with other medicines.

Ibuprofen Dr. Max and alcohol
Avoid alcohol consumption, as it may intensify adverse effects of Ibuprofen Dr. Max, especially those affecting the stomach, intestines, and brain.

Pregnancy, breastfeeding, and 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 take Ibuprofen Dr. Max during the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery.
Ibuprofen Dr. Max may cause kidney and heart dysfunction in the unborn child. It may increase the tendency to bleeding in both the mother and child and may delay or prolong labour. Do not use Ibuprofen Dr. Max during the first six months of pregnancy unless a doctor considers its use 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 the 20th week of pregnancy, Ibuprofen Dr. Max 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 a blood vessel (ductus arteriosus) in the baby's heart. If treatment longer than a few days is required, the doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk in very small amounts and usually, during short-term use, breastfeeding does not need to be interrupted. However, if longer-term treatment is anticipated, earlier weaning should be considered.

Fertility
Women who are trying to conceive should consult a doctor before taking this medicine.
Ibuprofen Dr. Max belongs to a group of medicines (NSAIDs) that may adversely affect fertility in women. Therefore, ibuprofen is not recommended for women trying to conceive or who have fertility problems. This effect is reversible after discontinuation of the medicine.

Driving and operating machinery
Ibuprofen generally does not affect the ability to drive or operate machinery. However, some patients taking ibuprofen may experience dizziness, visual disturbances, or other central nervous system (CNS) disorders. As these adverse effects may occur, patients should not perform such activities as driving or operating machinery unless they are certain that ibuprofen treatment does not affect their ability to perform these tasks. This recommendation is even more important when combined with alcohol.

Ibuprofen Dr. Max contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Ibuprofen Dr. Max

This medicine should always be taken exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult your doctor or pharmacist.
For short-term oral use only.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
If symptoms of an infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Adults: If the patient does not feel better after 3 days in case of fever or after 5 days in case of pain, or if symptoms worsen, medical advice must be sought.
Adolescents: consult a doctor after 3 days of treatment if symptoms persist or worsen.
The dose of ibuprofen depends on the patient's age and body weight. The maximum single dose for
adults and adolescents should not exceed 1 tablet (ibuprofen 400 mg). Recommended doses are:
Mild to moderate pain and fever
Adults and adolescents with body weight of 40 kg or more (over 12 years of age):
½ to 1 tablet as a single dose, or 3 to 4 times daily at intervals of 4 to 6 hours. For migraine headache, the dosing should be as follows: 1 tablet as a single dose; if necessary, 1 tablet every 4 to 6 hours.
The maximum daily dose should not exceed 3 tablets (1200 mg).
Painful menstruation
Adults and adolescents with body weight of 40 kg or more (over 12 years of age):
If needed, ½ to 1 tablet, 1 to 3 times daily at intervals of 4 to 6 hours. The maximum daily dose should not exceed 3 tablets (1200 mg).
Use in children and adolescents
Ibuprofen Dr. Max is not intended for children under 12 years of age or adolescents weighing less than 40 kg. Other dosage forms and strengths of ibuprofen are available for this group.
Elderly patients
These patients have a higher risk of adverse effects; therefore, the lowest effective dose for the shortest time necessary to achieve symptom relief should be used. In elderly patients with impaired kidney or liver function, dosing should be individually adjusted.
Impaired kidney or liver function
In patients with mild to moderate impairment of kidney or liver function, the dose should be determined by a physician. This medicine must not be used in patients with severe renal or hepatic impairment.
Method of administration
The tablet should be swallowed whole with a glass of water. Do not chew, crush, or suck the tablet. Faster onset of action may be achieved by taking the dose on an empty stomach. Patients with sensitive stomachs are advised to take ibuprofen with food.
Overdose of Ibuprofen Dr. Max
If a patient has taken more than the recommended dose of Ibuprofen Dr. Max, or if a child has accidentally ingested the medicine, always consult a doctor or go to the nearest hospital to assess potential health risks and receive advice on necessary actions.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, confusion, and involuntary eye movements. After ingestion of a large dose, 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 have occurred.
Other symptoms of overdose include drowsiness or dry mouth. In severe overdose, kidney failure and liver damage may occur.
Missed dose of Ibuprofen Dr. Max
If a dose is missed, take it as soon as possible. Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The patient can minimize the risk of adverse reactions by taking the lowest number of tablets for the shortest duration necessary to control symptoms.
If any of the following symptoms occur in the patient, ibuprofen should be discontinued immediately and medical help should be sought (see also section 2):

• Red, flat, target-like or circular skin lesions on the trunk, often with blisters in the center, skin peeling, mucosal ulcers in the mouth, throat, nose, genital organs and eyes. 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 (may affect up to 1 in 10 people),
• Skin rash, fever, swollen lymph nodes and increased eosinophil count, a type of white blood cells (DRESS syndrome), frequency unknown (frequency cannot be estimated from available data),
• 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 generalized exanthematous pustulosis), frequency unknown (frequency cannot be estimated from available data),
• Facial swelling or shortness of breath, skin blisters, vision disturbances, black stools or vomiting blood.

Common (may affect up to 1 in 10 people)

• nausea
• vomiting
• diarrhoea
• constipation
• bloating
• indigestion
• abdominal pain
• gastrointestinal bleeding (black stools or vomiting blood)
• dizziness
• feeling of fatigue
• headache
• rash

Uncommon (may affect up to 1 in 100 people)

• drowsiness
• feeling of anxiety
• tingling or pricking sensation
• difficulty falling asleep
• photosensitivity
• various types of kidney function disorders, such as nephritis, nephrotic syndrome (a group of symptoms in kidney disease) and kidney failure
• rhinitis (inflammation of the nasal mucosa)
• gastric or intestinal ulcers
• perforation of the gastrointestinal tract wall
• gastritis
• oral mucosal ulceration
• hepatitis
• jaundice
• liver function abnormalities
• bronchial asthma
• bronchoconstriction (bronchospasm)
• breathing difficulties
• ringing in the ears (tinnitus)
• feeling of dizziness or vertigo
• visual disturbances
• hearing disturbances
• urticaria
• itching
• purpura (petechial skin bleeding)
• hypersensitivity reactions
• angioedema (swelling in various body parts, such as subcutaneous tissue of the face, mucous membranes of the respiratory and gastrointestinal tract, causing problems depending on the affected area)

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

• feeling of depression or disorientation
• aseptic meningitis (inflammation of the meninges without bacterial infection)
• optic neuritis
• toxic optic neuropathy (damage to the optic nerve)
• edema

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

• liver failure
• heart failure
• heart attack
• pancreatitis
• high blood pressure
• severe forms of skin reactions
• changes in blood cell counts (red and white blood cells, platelets)
• papillary necrosis (particularly with long-term treatment)
• anaphylactic reaction – severe hypersensitivity reaction, symptoms of which may include: facial, tongue and laryngeal swelling, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema or severe shock)

Frequency not known (frequency cannot be estimated from available data):

• worsening of ulcerative colitis or Crohn's disease (colitis)
• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Medicines such as Ibuprofen Dr. Max may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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.: +48 22 49 21 301, fax: +48 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 provide more information on the safety of the medicine.

5. How to store Ibuprofen Dr. Max

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box,
blister pack, or container after: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must 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. Contents of the package and other information

What the medicine Ibuprofen Dr. Max contains

• The active substance is ibuprofen. Each coated tablet contains 400 mg of ibuprofen.
• The other ingredients are: Tablet core: microcrystalline cellulose, colloidal anhydrous silica, hydroxypropylcellulose, sodium lauryl sulfate, sodium croscarmellose, talc. Tablet coating (Opadry (white) 06B28499): hypromellose, macrogol 400, titanium dioxide (E 171).

What the medicine Ibuprofen Dr. Max looks like and contents of the pack
White, oval, biconvex coated tablets with a division line on one side. The tablet can be divided into equal doses.
Pack sizes:
Blister packs: 6, 10, 12, 20, 24, 30, 36, 40, 48, 50, 60 and 100 coated tablets.
Containers: 10, 20, 30, 36, 40, 50, 60 and 100 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
110 00 Prague
Czech Republic
tel.: (+420) 516 770 199
Manufacturer:
Medis International a.s.
Průmyslová 961/16
747 23 Bolatice
Czech Republic
This medicine is authorised in the European Economic Area countries under the following names:
Czech Republic: Ibuprofen Dr. Max
Poland: Ibuprofen Dr. Max
Slovakia: Ibuprofen Dr. Max 400 mg film-coated tablets