Ibuprofen Dr. Max

Leaflet attached to the packaging: patient information

Ibuprofen Dr. Max, 400 mg, soft capsules

Ibuprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Adults: Talk to a doctor if you do not feel better or feel worse after 4 days for pain or 3 days for fever and migraine headaches.
• Adolescents (12-18 years old): Consult a doctor if there is no improvement after 3 days or if you feel worse.

Table of contents of the leaflet

• 1. What is Ibuprofen Dr. Max and what is it used for
• 2. Important information 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 is Ibuprofen Dr. Max and what is it used for

Ibuprofen Dr. Max contains the active substance ibuprofen. It belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs relieve symptoms by changing the body's response to pain, swelling, and high temperature.
Ibuprofen Dr. Max is used to relieve mild to moderate pain, such as headaches, acute migraine with or without aura, toothaches, menstrual cramps, and pain and fever in colds.
In the case of inflammatory and degenerative joint diseases, spine, and soft tissue musculoskeletal disorders, which are accompanied by pain, redness, swelling, and stiffness of the joints, as well as neuralgia (nerve pain), the medicine can only be used with the doctor's consent.
For adults and adolescents with a body weight of 40 kg (12 years and older).

2. Important information before taking Ibuprofen Dr. Max

When not to take Ibuprofen Dr. Max:

Warnings and precautions

Before starting treatment with Ibuprofen Dr. Max, discuss it with your doctor or pharmacist:

• immediately after major surgery.
• in case of chickenpox (varicella), it is recommended to avoid taking Ibuprofen Dr. Max.

Treatment should be started with the lowest available dose, if the patient has had stomach or intestinal ulcers, is elderly, or needs to take low doses of acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal problems (see "Ibuprofen Dr. Max and other medicines"). The doctor may also prescribe protective medication for the stomach lining (e.g., misoprostol or proton pump inhibitors). You should inform your doctor if you experience any unusual stomach symptoms, especially signs of bleeding, such as vomiting blood or black stools resembling coal (see also section 4, "Possible side effects").
Patients with kidney or liver failure should consult a doctor or pharmacist before taking ibuprofen.
Medicines like Ibuprofen Dr. Max may increase the risk of heart attack ("myocardial infarction") or stroke. The risk is higher with high doses or long-term treatment. Do not exceed the recommended dose or duration of treatment (see section 3).
Before taking the medicine, the patient should discuss the treatment with a doctor or pharmacist if:
they have heart disease, such as heart failure, angina pectoris (chest pain), or have had a heart attack, coronary artery bypass grafting, if they have peripheral arterial disease (poor circulation in the legs or feet due to narrow or blocked arteries), or if they have had any type of stroke (including "mini" stroke or transient ischemic attack, transient ischemic attack "TIA") or think they are at risk of these diseases (for example, if the patient has high blood pressure, diabetes, high cholesterol, if there have been heart diseases or strokes in the patient's family, or if the patient smokes.
During ibuprofen treatment, allergic reactions to this medicine have occurred, including difficulty breathing, facial swelling, and chest pain.
If any of these symptoms are noticed, the patient should stop taking Ibuprofen Dr. Max and contact a doctor or emergency medical services immediately.
Severe skin reactions have been reported with ibuprofen, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), as well as acute generalized exanthematous pustulosis (AGEP). If the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should stop taking Ibuprofen Dr. Max and seek medical attention.
Side effects can be minimized by using the medicine in the smallest effective dose for the shortest necessary period to relieve symptoms. Elderly people are more prone to the risk of side effects.
Regular use of painkillers (several types) can lead to permanent and severe kidney damage. This risk may be increased with physical exertion, associated with salt loss and dehydration. Therefore, this should be avoided.
Long-term use of any type of painkillers for headaches can cause worsening of these headaches. If this situation occurs or is expected, the patient should stop taking the medicine and consult a doctor. In patients who experience frequent or daily headaches, despite (or due to) regular use of headache medicines, a diagnosis of medication-overuse headache should be expected.
With long-term use of Ibuprofen Dr. Max, regular monitoring of liver and kidney function tests and blood morphology is required. The doctor may recommend blood tests during treatment.

Infections

Ibuprofen Dr. Max may mask the symptoms of infection, such as fever and pain. As a result, Ibuprofen Dr. Max may delay the use of appropriate infection treatment and consequently lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.
If the patient is taking this medicine while an infection is present, and the symptoms of the infection persist or worsen, they should consult a doctor immediately.

Children and adolescents

There is a risk of kidney function disorders in dehydrated children and adolescents.
Ibuprofen Dr. Max should not be used in adolescents with a body weight below 40 kg or in children below 12 years of age.

Ibuprofen Dr. Max and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Ibuprofen Dr. Max may affect the action of other medicines or other medicines may affect the action of Ibuprofen Dr. Max, for example:

• blood-thinning medicines (such as acetylsalicylic acid, warfarin, ticlopidine).
• medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-adrenergic receptor blockers such as atenolol, angiotensin II receptor antagonists such as losartan).

Additionally, some other medicines may be affected or may affect the action of Ibuprofen Dr. Max. Therefore, before taking Ibuprofen Dr. Max with other medicines, the patient should always consult a doctor or pharmacist.
In particular, the doctor or pharmacist should be informed if the patient is taking any of the following medicines:

• Acetylsalicylic acid or other NSAIDs (anti-inflammatory and pain-relieving medicines): As this may increase the risk of stomach ulcers or bleeding.
• Digoxin (in case of heart failure): As the action of digoxin may be enhanced.
• Corticosteroids (medicines containing cortisone or substances similar to cortisone): As this may increase the risk of stomach ulcers or bleeding.
• Antiplatelet agents: As this may increase the risk of bleeding.
• Phenytoin (used to treat epilepsy): As the action of phenytoin may be enhanced.
• Selective serotonin reuptake inhibitors (medicines used to treat depression): They may increase the risk of gastrointestinal bleeding.
• Lithium (a medicine used to treat manic-depressive illness and depression): As the action of lithium may be enhanced.
• Probenecid and sulfinpyrazone (medicines used to treat gout): As the excretion of ibuprofen may be delayed.
• Medicines used to treat high blood pressure and diuretics: As ibuprofen may weaken the action of these medicines and there may be a risk to the kidneys.
• Potassium-sparing diuretics: As this may lead to hyperkalemia (high potassium levels in the blood).
• Methotrexate (a medicine used to treat cancer or rheumatism): As the action of methotrexate may be enhanced.
• Tacrolimus and cyclosporin (immunosuppressive medicines): As kidney damage may occur.
• Zidovudine (a medicine used to treat HIV/AIDS): As taking ibuprofen may increase the risk of bleeding into the joint or bleeding that leads to swelling in patients with hemophilia who have HIV.
• Sulfonylurea (an antidiabetic medicine): Interactions may occur.
• Quinolone antibiotics: As the risk of seizures may be increased.
• Aminoglycosides (antibiotics): As the excretion of aminoglycosides may be prolonged.
• Mifepristone (a medicine prescribed to terminate pregnancy): As ibuprofen may weaken the action of this medicine.
• Bisphosphonates (medicines prescribed for osteoporosis): As they may increase the risk of stomach ulcers or bleeding.
• Oxpentifylline (pentoxifylline) (a medicine recommended to increase blood flow to the hands and feet): As this may increase the risk of gastrointestinal bleeding.
• Baclofen, a muscle relaxant: As the toxicity of baclofen may be increased.
• Voriconazole or fluconazole (medicines prescribed for fungal infections): As sensitivity to ibuprofen may be increased.

Taking Ibuprofen Dr. Max with products containing Japanese pagoda tree may increase the risk of bleeding.

Low dose of acetylsalicylic acid

Do not take this medicine if you are taking acetylsalicylic acid in doses above 75 mg per day. If you are taking acetylsalicylic acid in a low dose (up to 75 mg per day), you should tell your doctor or pharmacist before taking Ibuprofen Dr. Max.

Ibuprofen Dr. Max with alcohol

While taking Ibuprofen Dr. Max, you should avoid consuming alcohol, as it may increase the possible side effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take Ibuprofen Dr. Max if you are in the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery.
It may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in the mother and child and cause delayed or prolonged labor. During the first 6 months of pregnancy, Ibuprofen Dr. Max should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest dose should be used for the shortest possible time. From the 20th week of pregnancy, Ibuprofen Dr. Max may cause kidney function disorders in the unborn child if taken for more than a few days. This may lead to a low level of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart. If treatment is required for a period longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding

Ibuprofen appears in breast milk in very small amounts, and breastfeeding usually does not need to be interrupted during short-term use. However, if long-term treatment is recommended, it is advisable to consider weaning.

Fertility

Ibuprofen Dr. Max belongs to a group of medicines (NSAIDs) that may impair female fertility. This effect is reversible after stopping the medicine. It is unlikely that occasional use of Ibuprofen Dr. Max will affect the chances of becoming pregnant; however, you should tell your doctor before taking the medicine if you have problems becoming pregnant.

Driving and using machines

With short-term use and at normal doses, this medicine does not affect or has negligible effects on the ability to drive and use machines. If side effects such as fatigue, dizziness, drowsiness, and vision disturbances occur, do not drive or operate machinery. Consuming alcohol increases the risk of these side effects.

Ibuprofen Dr. Max contains sorbitol

The medicine contains 50 mg of sorbitol in each capsule.

3. How to take Ibuprofen Dr. Max

This medicine should always be taken exactly as advised by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Use the smallest effective dose for the shortest necessary period to relieve symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).

Adults and adolescents with a body weight of 40 kg (12 years and older)

The recommended dose is 400 mg (1 capsule), if necessary, up to 3 times a day. Maintain an interval of at least 6 hours between 400 mg (1 capsule) doses. Do not take more than 1200 mg (3 capsules) in 24 hours.
For the treatment of migraine headache, the recommended dose is 1 capsule of 400 mg in a single dose. If necessary, take a 400 mg (1 capsule) dose at intervals of 4 to 6 hours. Do not take more than 1200 mg (3 capsules) in 24 hours.
If adults take the medicine for more than 3 days for migraine headache or fever or more than 4 days for pain, or if symptoms worsen, consult a doctor. If adolescents (12 years and older) take the medicine for more than 3 days or if symptoms worsen, consult a doctor.

Use in children and adolescents

Ibuprofen Dr. Max should not be used in adolescents with a body weight below 40 kg or in children below 12 years of age.

Method of administration

Ibuprofen Dr. Max capsules should be swallowed whole with a large amount of water. Do not chew the capsules.
Patients with sensitive stomachs should take the capsules during meals. Taking the capsules after meals may delay the action of the medicine in relieving pain or fever. Do not exceed the recommended dose or take it more frequently than recommended.

Taking a higher dose of Ibuprofen Dr. Max than recommended

In case of taking a higher dose of Ibuprofen Dr. Max than recommended or accidental ingestion by children, always consult a doctor or the nearest hospital for advice on the risk and actions to be taken. Symptoms of overdose may include nausea, abdominal pain, vomiting (which may contain blood), headache, ringing in the ears, confusion, and trembling eye movements. After taking large doses, drowsiness, chest pain, rapid heartbeat, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties have been reported. In severe poisoning, prolonged bleeding, acute kidney failure, liver damage, and worsening of asthma in asthmatics may occur.

Missing a dose of Ibuprofen Dr. Max

Read the instructions on how to take the medicine and do not take more than recommended.
Do not take a double dose to make up for a missed dose.
In case of further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Ibuprofen Dr. Max can cause side effects, although not everybody gets them.
Side effects can be minimized by using the medicine in the smallest effective dose for the shortest necessary period to relieve symptoms. Elderly people taking this medicine are more prone to the risk of side effects.
Taking medicines like Ibuprofen Dr. Max may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Some of the side effects listed below occur less frequently when the maximum daily dose is 1200 mg compared to therapy with high doses in patients with rheumatism.

If you experience any of the following symptoms or side effects, stop taking the medicine and consult a doctor immediately:

• stomach or intestinal ulcers, which may be accompanied by bleeding and perforation, vomiting blood or black stools (frequent: may occur in 1 in 10 patients);
• kidney disease with blood in the urine, which may be associated with kidney failure (uncommon: may occur in 1 in 100 patients);
• severe allergic reaction (rare: may occur in 1 in 10,000 patients), with symptoms such as:
• difficulty breathing or unexplained wheezing,
• dizziness or rapid heartbeat,
• low blood pressure leading to shock,
• swelling of the face, lips, or throat.
• red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling skin, ulcers in the mouth, throat, nose, genitals, 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) (rare: may occur in 1 in 10,000 patients);
• a red, scaly rash with bumps under the skin and blisters mainly on the skin folds, torso, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). See also section 2 (frequency not known: frequency cannot be estimated from the available data);
• a severe skin reaction that may appear around the mouth or other parts of the body with symptoms such as: red, often itchy, rash-like measles, which appears on the limbs and sometimes on the face and other parts of the body. The rash may change into blisters or develop into large, red spots with a pale center. The skin reaction is accompanied by fever, sore throat, headache, and (or) diarrhea (very rare: may occur in 1 in 10,000 patients);
• severe peeling or "shedding" of the skin (very rare: may occur in 1 in 10,000 patients);
• pancreatitis with severe abdominal pain, often with nausea and vomiting (very rare: may occur in 1 in 10,000 patients);
• nausea, vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and whites of the eyes, pale stools, dark urine, which may be signs of liver or kidney failure (very rare: may occur in 1 in 10,000 patients);
• heart disease with shortness of breath and swelling of the feet and ankles due to fluid accumulation (heart failure) (very rare: may occur in 1 in 10,000 patients);
• aseptic meningitis (inflammation of the brain or spinal cord membranes, with symptoms such as fever, nausea, vomiting, headache, stiff neck, and extreme sensitivity to light and disturbances of consciousness) (very rare: may occur in 1 in 10,000 patients);
• heart attack (very rare: may occur in 1 in 10,000 patients) or stroke (frequency not known: frequency cannot be estimated from the available data);
• acute kidney failure (renal necrosis) especially after long-term use of the medicine (rare: may occur in 1 in 1,000 patients);
• worsening of inflammatory conditions caused by infection (e.g., necrotizing fasciitis) especially when taking other NSAIDs at the same time (very rare: may occur in 1 in 10,000 patients);
• problems with blood cell production - the first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding (very rare: may occur in 1 in 10,000 patients);
• may occur a severe skin reaction called DRESS syndrome. DRESS symptoms include: skin rash, fever, swollen lymph nodes, and an increase in the number of eosinophils (a type of white blood cell) (frequency not known: frequency cannot be estimated from the available data).

Other side effects:

Very common (may occur in 1 in 10 patients):

• nausea, heartburn, gas, diarrhea, constipation, vomiting, abdominal pain.

Common (may occur in less than 1 in 10 patients):

• headache, drowsiness, dizziness, fatigue, excitement, difficulty sleeping, irritability;
• hidden blood loss, which can lead to a condition with reduced red blood cell count (symptoms are fatigue, headaches, difficulty breathing during exercise, dizziness, and pale skin), mouth ulcers, and herpes simplex, colitis (symptoms are diarrhea, usually with blood and mucus, abdominal pain, fever), worsening of inflammatory bowel disease, gastritis.

Uncommon (may occur in less than 1 in 100 patients):

• hives, itching, bruising or bleeding under the skin, skin rash, asthma attacks (sometimes with low blood pressure);
• runny nose or stuffy nose, sneezing, facial pressure or pain, difficulty breathing;
• gastritis (symptoms are pain, nausea, vomiting, bloody vomiting, bloody stools);
• increased sensitivity of the skin to sunlight;
• fluid accumulation in the body's tissues, especially in patients with high blood pressure or kidney function disorders;
• vision disturbances.

Rare (may occur in less than 1 in 1,000 patients):

• skin, joint, and kidney diseases (systemic lupus erythematosus);
• depression, disorientation, hallucinations, mental disorders with strange or disturbing thoughts and moods;
• ringing, buzzing, whistling, or other persistent noises in the ears;
• increased urea nitrogen in the blood, aminotransferases, and alkaline phosphatase in serum, decreased hemoglobin and hematocrit values, inhibition of platelet aggregation, prolonged bleeding time, decreased calcium levels in serum, increased uric acid levels in serum, visible in blood tests;
• vision loss.

Very rare (may occur in less than 1 in 10,000 patients):

• rapid or irregular heartbeat (palpitations);
• fluid accumulation in the body's tissues;
• high blood pressure;
• esophagitis, intestinal narrowing;
• hair loss or thinning of hair;
• severe skin infections with soft tissue complications; they may occur during chickenpox;
• menstrual disorders.

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

• chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ibuprofen Dr. Max

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the month.
Do not store above 30°C.
Medicines should 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 Ibuprofen Dr. Max contains

• The active substance is ibuprofen. Each capsule contains 400 mg of ibuprofen.
• The other ingredients are: macrogol 400 (E 1521), sorbitan oleate (E 494), povidone K30, potassium hydroxide (E 525). Capsule composition: gelatin (E 441), macrogol 400 (E 1521), sorbitol, liquid (E 420), medium-chain triglycerides. Glaze composition: isopropyl alcohol.

What Ibuprofen Dr. Max looks like and contents of the pack

Transparent, oval, soft gelatin capsule containing a colorless to light yellow, clear, viscous liquid, packaged in transparent PVC/Aluminum blisters.
Dimensions: 15.25 mm x 10 mm.
Pack sizes: 10, 12, 20, 24, 30, 48, and 50 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic
tel.: (+420) 516 770 199

Manufacturer/Importer:

Medis International a.s.
Prumyslova 961/16
747 23 Bolatice
Czech Republic

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:
Ibuprofen Dr. Max
Poland:
Ibuprofen Dr. Max
Slovakia:
Ibuprofen Dr. Max 400 mg
Romania:
Ibuprofen Dr. Max 400 mg capsule moi
Italy:
Ibuprofene Dr. Max

Date of last revision of the leaflet: 10/2024