IBUPROFEN 400 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Ibuprofen Dr. Max, 400 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
3. What is Ibuprofen Dr. Max and what is it used for
4. Important information before taking Ibuprofen Dr. Max
   1. When not to take Ibuprofen Dr. Max
   2. Warnings and precautions
   3. Children and adolescents
   4. Elderly
   5. Ibuprofen Dr. Max and other medications
   6. Ibuprofen Dr. Max and alcohol
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
   9. Ibuprofen Dr. Max contains sodium
5. How to take Ibuprofen Dr. Max
   1. Use in children and adolescents
   2. Elderly
   3. Taking a higher than recommended dose of Ibuprofen Dr. Max
   4. Missing a dose of Ibuprofen Dr. Max
6. Possible side effects
   1. Reporting side effects
7. How to store Ibuprofen Dr. Max
8. Contents of the packaging and other information
   1. What Ibuprofen Dr. Max contains
   2. What Ibuprofen Dr. Max looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet: 10/2024

Leaflet accompanying the packaging: patient information

Ibuprofen Dr. Max, 400 mg, coated tablets

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 this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If symptoms persist in adults after 3 days of treatment for fever or after 5 days for pain or worsening symptoms, consult a doctor. In adolescents, consult a doctor if symptoms persist after 3 days of treatment or worsen.

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 packaging and other information

1. What is Ibuprofen Dr. Max and what is it 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 caused by soft tissue injury, such as bruises and sprains, menstrual cramps, and fever. Ibuprofen Dr. Max is indicated for use in adults and adolescents with a body weight of 40 kg (from 12 years of age). Adults: Consult a doctor if symptoms persist after 3 days of treatment for fever or after 5 days for pain or worsening symptoms. Adolescents: Consult a doctor if symptoms persist after 3 days of treatment or worsen.

2. Important information before taking Ibuprofen Dr. Max

When not to take Ibuprofen Dr. Max

• if the patient is hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has had hypersensitivity reactions after taking painkillers containing acetylsalicylic acid or other painkillers and anti-inflammatory drugs (NSAIDs) with symptoms such as asthma, runny nose, itchy skin rash, or swelling of the lips, face, tongue, or throat;
• if the patient has had gastrointestinal bleeding or perforation related to previous use of painkillers and anti-inflammatory drugs (NSAIDs);
• if the patient has active peptic ulcer or has had two or more episodes of this condition in the past;
• if the patient has severe liver failure;
• if the patient has severe kidney failure (glomerular filtration rate below 30 mL/min);
• if the patient has severe heart failure;
• if the patient has significant dehydration (caused by vomiting, diarrhea, or insufficient fluid intake);
• if the patient has active bleeding (including cerebral hemorrhage);
• if the patient has a disease of unknown origin, resulting in the formation of abnormal blood cells;
• if the patient is in the last 3 months of pregnancy.

Warnings and precautions

Before taking Ibuprofen Dr. Max, the patient should consult a doctor or pharmacist:

• if the patient has chronic inflammatory bowel diseases, such as ulcerative colitis (ulcerative colitis) or Crohn's disease, or a history of stomach or intestinal disease;
• if the patient has asthma, ibuprofen may increase the risk of bronchospasm (bronchial constriction);
• if the patient has hay fever, nasal polyps, or chronic respiratory disease, ibuprofen may increase the risk of an allergic reaction;
• if the patient has liver, kidney, or heart problems, ibuprofen should be used with caution and in the smallest dose, as it may impair kidney function;
• if the patient is taking medications that affect blood clotting, ibuprofen, like other medications in this group, may prolong bleeding time or lead to the formation of stomach ulcers;
• 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 "Infections" below.

During treatment, gastrointestinal bleeding, ulcers, or perforation may occur. The patient should immediately inform their doctor if they experience any unusual gastrointestinal problems. Ibuprofen should not be taken with other non-steroidal anti-inflammatory drugs or other medications that increase the risk of stomach damage (see "Ibuprofen Dr. Max and other medications" below). The effect on the heart and brain Taking anti-inflammatory/painkillers, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses. The patient should not exceed the recommended dose and duration of treatment. Before taking Ibuprofen Dr. Max, the patient should discuss their treatment with a doctor or pharmacist if:

• they have heart disease, such as heart failure, angina pectoris (chest pain), if they have had a heart attack, bypass surgery, or have peripheral arterial disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or if they have had any stroke (including mini-stroke or transient ischemic attack - TIA).

If the patient has high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or smokes, they should consult their doctor before taking Ibuprofen Dr. Max.

Children and adolescents

There is a risk of worsening kidney function in dehydrated patients - children and adolescents.

Elderly

Elderly patients are more prone to side effects, especially gastrointestinal bleeding and perforation, which can be fatal. There is a risk of kidney function disorders in dehydrated elderly patients. Infections Ibuprofen Dr. Max may mask the symptoms of infection, such as fever and pain. Therefore, 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 related to chickenpox. If the patient is taking this medication during an infection and the symptoms of the infection persist or worsen, they should immediately consult a doctor. The patient should avoid taking this medication during a chickenpox infection. Other precautions During long-term treatment with high doses of painkillers, the patient may experience headaches, which should not be treated with increased doses of the medication. In such cases, the patient should consult a doctor about further treatment. Ibuprofen may temporarily inhibit platelet function and prolong bleeding time. Rarely, severe, acute hypersensitivity reactions (such as anaphylactic shock) may occur. This condition requires immediate treatment. The risk of side effects increases with the dose. Therefore, the patient should start treatment with the smallest possible dose and continue treatment for the shortest time necessary to control the symptoms.

Ibuprofen Dr. Max and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take, including those available without a prescription. The side effects of Ibuprofen Dr. Max may be exacerbated by concomitant use of other medications. On the other hand, Ibuprofen Dr. Max may enhance or reduce the effect of other medications or increase the risk of side effects of other medications taken concomitantly with ibuprofen. Ibuprofen Dr. Max may affect the action of other medications or other medications may affect the action of Ibuprofen Dr. Max. For example:

• other NSAIDs, including selective COX-2 inhibitors, corticosteroidsand medications used to treat depression, known as SSRIs (Selective Serotonin Reuptake Inhibitors) (selective serotonin reuptake inhibitors), antiplatelet/anticoagulant medications(e.g., acetylsalicylic acid, warfarin, ticlopidine), as they increase the risk of gastrointestinal side effects, including bleeding and stomach ulcers
• methotrexate(used to treat cancer and autoimmune diseases), as its elimination may be reduced
• lithium(used to treat manic-depressive illnesses), digoxin(used to treat various heart conditions) and phenytoin(used to prevent seizures), as their blood levels may increase
• medications that lower high blood pressure - diuretics(medications that increase urine production), ACE inhibitors, such as captopril, beta-blockers, such as atenolol, medications that are angiotensin II receptor antagonists, such as losartan,as ibuprofen may reduce the effect of these medications, diuretics may increase the risk of kidney damage
• cholestyramine(used to treat high cholesterol), as the absorption of ibuprofen in the gastrointestinal tract may be reduced
• aminoglycoside antibiotics(antibacterial medications), as their elimination from the body may be prolonged
• cyclosporineand tacrolimus(used to treat skin diseases or immunosuppression after organ transplantation), as kidney damage may occur
• mifepristone(used for abortion), as the effect of mifepristone may be reduced
• zidovudine(used to treat HIV/AIDS patients), as the use of ibuprofen may increase the risk of bleeding into the joint or bleeding leading to swelling in people with HIV-related hemophilia
• ritonavir, as the level of NSAIDs in the blood may increase
• probenecidor sulfinpyrazone(used to treat gout), as ibuprofen weakens the effect of these medications
• quinolone antibiotics, as ibuprofen may increase the risk of seizures caused by these antibiotics
• sulfonylurea derivatives(used to treat type 2 diabetes), as the effect of these medications may be enhanced; rare cases of hypoglycemia (low blood sugar) have been reported
• bisphosphonates(used to treat osteoporosis, Paget's disease, and to reduce high calcium levels in the blood), pentoxifylline(used to treat circulatory disorders in the legs or arms), as gastrointestinal side effects may be enhanced
• baclofen(a muscle relaxant), as its toxicity may be increased
• CYP2C9 inhibitors, such as voriconazole or fluconazole (a type of antifungal medication), as they may increase sensitivity to ibuprofen
• products containing Ginkgo biloba(a herbal remedy), as there is a likelihood of increased bleeding risk if taken with ibuprofen.

Also, some other medications may be affected or have an effect on treatment with Ibuprofen Dr. Max, so the patient should always consult a doctor or pharmacist before taking Ibuprofen Dr. Max with other medications.

Ibuprofen Dr. Max and alcohol

The patient should avoid consuming alcohol, as it may enhance the side effects of Ibuprofen Dr. Max, especially those affecting the stomach, intestines, and brain.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to become pregnant, they should consult a doctor or pharmacist before taking this medication. Pregnancy The patient should not take Ibuprofen Dr. Max if they are in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Ibuprofen Dr. Max may cause kidney and heart disorders in the unborn child. It may also increase the risk of bleeding in the patient and child and cause delayed or prolonged labor. During the first 6 months of pregnancy, the patient should not take Ibuprofen Dr. Max unless their doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the patient should use the smallest possible dose for the shortest time necessary to control symptoms. From the 20th week of pregnancy, Ibuprofen Dr. Max may cause kidney disorders in the unborn child if taken for more than a few days. This may lead to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct (ductal constriction) in the child's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring. Breastfeeding Ibuprofen passes into breast milk in very small amounts, and usually, during short-term use of the medication, breastfeeding does not need to be interrupted. However, if long-term treatment is planned, the patient should consider stopping breastfeeding. Fertility Women who want to become pregnant should consult their doctor about taking this medication. Ibuprofen Dr. Max belongs to a group of medications (NSAIDs) that may adversely affect female fertility. Therefore, ibuprofen is not recommended for women who are trying to conceive or have difficulty conceiving. This effect is reversible after stopping the medication.

Driving and using machines

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

Ibuprofen Dr. Max contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per tablet, which means the medication is considered "sodium-free".

3. How to take Ibuprofen Dr. Max

This medication should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult a doctor or pharmacist. For short-term oral use only. The patient should use the smallest effective dose for the shortest time necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should immediately consult a doctor (see section 2). Adults: If the patient does not feel better after 3 days for fever or after 5 days for pain or if the symptoms worsen, they should consult a doctor. Adolescents: The patient should consult a doctor after 3 days of treatment if the symptoms persist or worsen. The dose of ibuprofen depends on the patient's age and weight. The maximum single dose for adults and adolescents should not exceed 1 tablet (ibuprofen 400 mg). The recommended dose is:

Mild to moderate pain and fever

Adults and adolescents with a body weight of 40 kg (from 12 years of age):

½ to 1 tablet given as a single dose or 3 to 4 times a day at 4 to 6 hour intervals. The dosage for migraine headache should be as follows: 1 tablet given as a single dose, if necessary 1 tablet given at 4 to 6 hour intervals. The maximum daily dose should not exceed 3 tablets (1200 mg).

Painful menstruation

Adults and adolescents with a body weight of 40 kg (from 12 years of age):

If necessary, ½ to 1 tablet, 1 to 3 times a day, at 4 to 6 hour intervals. 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 and adolescents with a body weight below 40 kg. Other dosage forms and strengths of ibuprofen are available for this group.

Elderly

In these patients, there is a higher risk of side effects, so the smallest effective dose should be used for the shortest time necessary to relieve symptoms. In elderly patients with kidney or liver function disorders, the dose should be determined individually. Kidney or liver function disorders In patients with mild to moderate kidney or liver function disorders, the doctor should determine the dose. The medication should not be used in patients with severe kidney or liver failure. Method of administration The tablet should be swallowed with a glass of water. It should be taken without chewing, crushing, or sucking. Faster action can be achieved by taking the dose on an empty stomach. Patients with sensitive stomachs are advised to take ibuprofen with food.

Taking a higher than recommended dose of Ibuprofen Dr. Max

If the patient has taken a higher dose of Ibuprofen Dr. Max than recommended or if a child has accidentally taken the medication, they should always consult a doctor or go to the nearest hospital to get an opinion on possible health risks and advice on what to do. Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, disorientation, and involuntary eye movements. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness may occur. Other symptoms of overdose include drowsiness or dry mouth. In cases of severe overdose, kidney failure and liver damage may occur.

Missing a dose of Ibuprofen Dr. Max

If a dose is missed, it should be taken as soon as possible. The patient should not take a double dose to make up for the missed dose. If the patient has any further doubts about taking this medication, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Ibuprofen Dr. Max can cause side effects, although not everybody gets them. The patient can minimize the risk of side effects by taking the smallest number of tablets for the shortest time necessary to control symptoms. If the patient experiences any of the following symptoms, they should stop taking ibuprofen and seek medical attention (see also section 2):

• red, non-raised, target-like or circular spots 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), very rare (may affect up to 1 in 10 people),
• skin rash, fever, swollen lymph nodes, and increased eosinophils, a type of white blood cell (DRESS syndrome), frequency not known (frequency cannot be estimated from available data),
• red, peeling rash with bumps under the skin and blisters located mainly on skin folds, torso, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis), frequency not known (frequency cannot be estimated from available data),
• swelling of the face or difficulty breathing, blisters on the skin, vision disturbances, black stools, or vomiting blood.

Frequent(may affect up to 1 in 10 people)

• nausea
• vomiting
• diarrhea
• constipation
• bloating
• indigestion
• stomach pain
• gastrointestinal bleeding (black stools or bloody vomiting)
• dizziness
• fatigue
• headache
• rash

Uncommon(may affect up to 1 in 100 people)

• drowsiness
• restlessness
• tingling or prickling sensation
• difficulty sleeping
• skin sensitivity to light
• various kidney function disorders, such as kidney inflammation, nephrotic syndrome (a set of symptoms in kidney disease), and kidney failure
• runny nose (rhinitis)
• stomach or intestinal ulcers
• hole in the wall of the gastrointestinal tract
• stomach inflammation
• mouth ulcers
• liver inflammation
• jaundice
• liver function disorders
• asthma
• bronchial constriction (bronchospasm)
• breathing difficulties
• ringing in the ears (tinnitus)
• vertigo or dizziness
• vision disturbances
• hearing disturbances
• hives
• itching
• purpura (patchy bleeding into the skin)
• allergic reactions
• angioedema (swelling occurring in various parts of the body, such as subcutaneous tissue of the face, mucous membranes of the respiratory and gastrointestinal tracts, and causing problems depending on the affected area)

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

• depression or disorientation
• aseptic meningitis (meningitis without bacterial infection)
• optic neuritis (inflammation of the optic nerve)
• 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 skin reactions
• changes in blood cell counts (red and white blood cells, platelets)
• tab necrosis (especially with long-term treatment)
• anaphylactic reaction - a severe allergic reaction, whose symptoms may include: swelling of the face, tongue, and larynx, difficulty breathing, 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 (inflammatory bowel disease)
• chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.

Medications like Ibuprofen Dr. Max may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting side effects

If side effects occur, including those not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medication.

5. How to store Ibuprofen Dr. Max

Keep out of the sight and reach of children. Do not use this medication after the expiry date stated on the carton, blister, or container after: EXP. The expiry date refers to the last day of the month stated. There are no special precautions for storage. Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Ibuprofen Dr. Max contains

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

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

White, oval, biconvex coated tablets with a dividing line on one side. The tablet can be divided into equal doses. Package 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 authorization holder and manufacturer

Marketing authorization 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 medicinal product 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 film-coated tablets

Date of last revision of the leaflet: 10/2024