IBUPROFEN 400 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Ibuprofen Dr. Max Pharma, 400 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Ibuprofen Dr. Max Pharma and what is it used for
4. Important information before taking Ibuprofen Dr. Max Pharma
   1. When not to take Ibuprofen Dr. Max Pharma:
   2. Warnings and precautions
   3. Children and adolescents
   4. Ibuprofen Dr. Max Pharma and other medicines
   5. Ibuprofen Dr. Max Pharma and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Ibuprofen Dr. Max Pharma contains lactose
   9. Ibuprofen Dr. Max Pharma contains sodium
5. How to take Ibuprofen Dr. Max Pharma
   1. Adults and adolescents with a body weight of 40 kg or more (over 12 years of age)
   2. Use in children and adolescents
   3. Taking a higher dose of Ibuprofen Dr. Max Pharma than recommended
   4. Missing a dose of Ibuprofen Dr. Max Pharma
6. Possible side effects
   1. Reporting side effects
7. How to store Ibuprofen Dr. Max Pharma
8. Contents of the packaging and other information
   1. What Ibuprofen Dr. Max Pharma contains
   2. What Ibuprofen Dr. Max Pharma looks like and contents of the pack
   3. Marketing authorization holder and manufacturer/importer
   4. Marketing authorization holder:
   5. Manufacturer/Importer:
   6. This medicine is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet: 12/2024

Leaflet accompanying the packaging: patient information

Ibuprofen Dr. Max Pharma, 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.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 days in the case of fever or after 5 days in the case of pain in adults, and after 3 days of treatment in adolescents, no improvement occurs or the patient feels worse, they should contact a doctor.

Table of contents of the leaflet

• 1. What is Ibuprofen Dr. Max Pharma and what is it used for
• 2. Important information before taking Ibuprofen Dr. Max Pharma
• 3. How to take Ibuprofen Dr. Max Pharma
• 4. Possible side effects
• 5. How to store Ibuprofen Dr. Max Pharma
• 6. Contents of the packaging and other information

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

Ibuprofen Dr. Max Pharma belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs), which have a fever-reducing (antipyretic), pain-relieving (analgesic), and anti-inflammatory effect. Ibuprofen Dr. Max Pharma is used for the short-term symptomatic treatment of mild to moderate pain such as headache, including migraine headache, back pain, toothache, menstrual pain, post-operative pain, and muscle and joint pain accompanying the flu, as well as for the symptomatic treatment of soft tissue injuries, such as sprains and muscle strains, and in case of fever. Ibuprofen Dr. Max Pharma is intended for the treatment of adults and adolescents with a body weight of 40 kg or more (over 12 years of age). If after 3 days in the case of fever and after 5 days in the case of pain in adults, and after 3 days of treatment in adolescents, no improvement occurs or the patient feels worse, they should contact a doctor.

2. Important information before taking Ibuprofen Dr. Max Pharma

When not to take Ibuprofen Dr. Max Pharma:

• if the patient is hypersensitive to ibuprofen or any of the other ingredients of this medicine (listed in section 6),
• if the patient has experienced allergic reactions, such as asthma, rhinitis, urticaria, or swelling of the lips, face, tongue, or throat after taking medicines containing acetylsalicylic acid or other anti-inflammatory and analgesic medicines (NSAIDs),
• if the patient has had a perforation or bleeding in the stomach or small intestine (duodenum) related to previous use of anti-inflammatory and analgesic medicines (NSAIDs),
• if the patient has an ulcer or bleeding in the stomach or small intestine (duodenum) or if the patient has had two or more such episodes in the past,
• if the patient has severe liver, kidney, or heart disorders,
• if the patient is in the last 3 months of pregnancy,
• if the patient has severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake),
• if the patient has active bleeding (including in the brain).

Warnings and precautions

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

• if the patient has chronic inflammatory bowel diseases, such as ulcerative colitis (ulcerative colitis) or Crohn's disease, as these conditions may worsen. If the patient suffers from gastrointestinal diseases, the medicine should be used with caution, as it may increase the risk of bleeding and other gastrointestinal complications. Patients with stomach or duodenal ulcers are at increased risk of gastrointestinal bleeding.
• if the patient has asthma, the risk of bronchospasm (convulsive bronchoconstriction) may increase.
• if the patient is taking medicines that affect blood clotting, Ibuprofen Dr. Max Pharma or other medicines from this group may prolong bleeding time or lead to ulcers.
• if the patient has hay fever, nasal polyps, or chronic respiratory disease, the risk of an allergic reaction may increase.
• if the patient has kidney disease, Ibuprofen Dr. Max Pharma should be used with caution and always in the smallest effective dose, as medicines from this group may impair kidney function. The same precautions apply in the case of liver diseases.
• if the patient has an infection - see "Infections" below.

The risk of side effects increases with increasing dose and in the elderly. Therefore, it is necessary to start treatment with the lowest possible dose and continue treatment for the shortest time necessary to relieve symptoms. Ulcers, perforations, and gastrointestinal bleeding
Rarely, during treatment, gastrointestinal bleeding, ulcers, or perforation may occur. If any unusual gastrointestinal problems are observed, the patient should immediately contact a doctor. Skin reactions
Severe skin reactions, such as 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. If the patient experiences any symptoms associated with these severe skin reactions described in section 4, they should immediately discontinue Ibuprofen Dr. Max Pharma and seek medical attention. Effect on the heart and brain
Anti-inflammatory and analgesic medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. The patient should not exceed the recommended dose or duration of treatment. Before taking Ibuprofen Dr. Max Pharma, the patient should discuss this with their doctor or pharmacist if they have:

• heart disorders, including heart failure, angina pectoris (chest pain), or a history of heart attack, bypass surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrow or blocked arteries), or any stroke (including "mini-stroke" or transient ischemic attack, TIA).
• high blood pressure, diabetes, high cholesterol, or a family history of heart disease or stroke, or if the patient is a smoker.

During ibuprofen treatment, symptoms of an allergic reaction to this medicine, including difficulty breathing, swelling around the face and neck (angioedema), and chest pain, have been reported. If the patient experiences any of these symptoms, they should immediately discontinue Ibuprofen Dr. Max Pharma and contact their doctor or emergency services. Aseptic meningitis (meningitis without bacterial infection)
Rarely, "aseptic" meningitis has been reported in patients treated with ibuprofen. However, this disease occurs more frequently in patients with connective tissue diseases, belonging to the so-called "collagenoses", such as systemic lupus erythematosus. Infections
Ibuprofen Dr. Max Pharma may mask the symptoms of infection, such as fever and pain. Therefore, it is possible that Ibuprofen Dr. Max Pharma may delay the use of appropriate infection treatment, which may lead to an increased risk of complications. This has been observed in the course of pneumonia caused by bacteria and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an infection and the symptoms of the infection persist or worsen, they should immediately consult a doctor. It is not recommended to take Ibuprofen Dr. Max Pharma during chickenpox. Other precautions
Long-term use of painkillers for headaches can worsen them. If this occurs or is suspected, the patient should stop taking Ibuprofen Dr. Max Pharma and consult a doctor. Ibuprofen may temporarily inhibit platelet function.

Children and adolescents

Dehydrated children and adolescents are at risk of kidney disorders. Due to the high amount of active substance, Ibuprofen Dr. Max Pharma is not intended for children under 12 years of age and adolescents with a body weight below 40 kg.

Ibuprofen Dr. Max Pharma and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Ibuprofen Dr. Max Pharma may affect the action of some other medicines or other medicines may affect its action. For example:

• acetylsalicylic acid - may increase the risk of side effects
• other NSAIDs (including COX-2 inhibitors) - may increase the risk of gastrointestinal bleeding and ulcers
• anticoagulant medicines (e.g., warfarin) - ibuprofen may enhance their effect
• methotrexate (used in the treatment of cancer and autoimmune diseases) - ibuprofen may affect its elimination
• lithium (used in the treatment of depression and mania) and phenytoin (used in the prevention of epileptic seizures) - ibuprofen may increase their blood levels
• cardiac glycosides (e.g., digoxin) - ibuprofen may increase their blood levels and exacerbate heart failure
• diuretics (diuretic medicines) - may enhance the side effects of ibuprofen; ibuprofen may reduce the effect of these medicines
• medicines for high blood pressure (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan) - ibuprofen may reduce their effect
• cholestyramine (used in the treatment of high cholesterol) - concomitant use with ibuprofen may reduce the absorption of ibuprofen in the gastrointestinal tract
• aminoglycosides (medicines against certain types of bacteria) - the elimination of aminoglycosides may be prolonged, and ibuprofen may increase their toxicity
• antiplatelet medicines (used to prevent blood clotting, e.g., acetylsalicylic acid, ticlopidine) and SSRIs (antidepressant medicines), such as paroxetine, sertraline, citalopram - may increase the risk of gastrointestinal bleeding
• cyclosporine and tacrolimus (used in immunosuppression after organ transplantation) - ibuprofen may increase the risk of nephrotoxicity
• zidovudine (used in the treatment of HIV patients) - ibuprofen may increase the risk of side effects
• mifepristone (used to terminate pregnancy) - ibuprofen may reduce its effectiveness
• probenecid or sulfinpyrazone (used in the treatment of gout) - ibuprofen may reduce the effect of these medicines
• quinolone antibiotics (medicines against certain types of bacteria) - the risk of seizures may be increased
• sulfonylurea derivatives (used in the treatment of type 2 diabetes) - ibuprofen may enhance their effect. When used concomitantly with these medicines, rare cases of hypoglycemia (low blood sugar) have been reported.
• corticosteroids (medicines used in inflammatory conditions) - may increase the risk of gastrointestinal side effects (ulcers or gastrointestinal bleeding)
• voriconazole and fluconazole (types of antifungal medicines) - concomitant use may increase exposure to ibuprofen
• Ginkgo biloba herbal medicine - may increase the risk of bleeding.

Some other medicines may also affect treatment with Ibuprofen Dr. Max Pharma or other medicines may have an effect on Ibuprofen Dr. Max Pharma. Therefore, before taking Ibuprofen Dr. Max Pharma with other medicines, the patient should always consult their doctor or pharmacist.

Ibuprofen Dr. Max Pharma and alcohol

The patient should avoid consuming alcohol, as it may increase the possible side effects of ibuprofen, especially those affecting the stomach, intestines, or central nervous system.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Ibuprofen Dr. Max Pharma should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Ibuprofen Dr. Max Pharma may cause kidney and heart disorders in the unborn child. It may affect the patient's and their child's tendency to bleed and may cause delayed or prolonged labor. During the first 6 months of pregnancy, Ibuprofen Dr. Max Pharma should not be taken unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest dose of the medicine should be used for the shortest time possible. From the 20th week of pregnancy, Ibuprofen Dr. Max Pharma 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 baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.
Breastfeeding
Long-term treatment is not recommended for breastfeeding mothers. Ibuprofen and its metabolites pass into breast milk in very small amounts, and usually, there is no need to stop breastfeeding if ibuprofen is used in the recommended dose and for the shortest possible time.
Fertility
Ibuprofen Dr. Max Pharma belongs to a group of medicines (NSAIDs) that may affect fertility in women. This effect is reversible after stopping the medicine.

Driving and using machines

Ibuprofen Dr. Max Pharma has no or negligible influence on the ability to drive and use machines. However, if during treatment, the patient experiences dizziness, drowsiness, fatigue, changes in vision, or other symptoms from the central nervous system, they should not drive vehicles or operate machines. This is especially true when combined with alcohol.

Ibuprofen Dr. Max Pharma contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

Ibuprofen Dr. Max Pharma contains sodium

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

3. How to take Ibuprofen Dr. Max Pharma

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
For short-term use only.
The patient should use the smallest effective dose for the shortest time necessary to relieve symptoms. In case of infection, they should immediately contact a doctor if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults and adolescents with a body weight of 40 kg or more (over 12 years of age)

The recommended dose for the treatment of acute pain or fever is 1 tablet (400 mg) given as a single dose or up to 3 times a day, as needed, with an interval of 4 to 6 hours between doses.
The maximum daily dose should not exceed 3 tablets (1200 mg).
There is no need to adjust the dose in elderly patients (over 65 years of age).
If it is necessary to use this medicine in adults for more than 3 days in the case of fever or 5 days in the case of pain, or if symptoms worsen, the patient should consult a doctor.
If it is necessary to use this medicine in adolescents for more than 3 days or if symptoms worsen, the patient should consult a doctor.

Use in children and adolescents

Ibuprofen Dr. Max Pharma is not intended for children under 12 years of age and adolescents with a body weight below 40 kg. Other forms and strengths of ibuprofen are available for this group.
Method of administration
Ibuprofen Dr. Max Pharma tablets should be swallowed whole with a large amount of water. The tablets should not be chewed, divided, or crushed to avoid discomfort in the mouth or throat irritation.
A faster onset of action can be achieved by taking the dose on an empty stomach. Patients with sensitive stomachs should take Ibuprofen Dr. Max Pharma with food.

Taking a higher dose of Ibuprofen Dr. Max Pharma than recommended

In case of taking a larger amount of Ibuprofen Dr. Max Pharma than recommended or accidental ingestion by children, the patient should always contact a doctor or the nearest hospital to get an opinion on the risk and advice on what actions to take.
Symptoms of overdose may include nausea, abdominal pain, vomiting (which may be bloody), headache, ringing in the ears, confusion, and trembling of the eyeballs. In case of large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Other symptoms of overdose include lethargy or dry mouth. In case of severe overdose, kidney failure and liver damage may occur.

Missing a dose of Ibuprofen Dr. Max Pharma

The patient should not take a double dose to make up for a missed dose.
If the patient has further questions about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ibuprofen Dr. Max Pharma can cause side effects, although not everybody gets them.
The side effects of Ibuprofen Dr. Max Pharma are the same as those of other non-steroidal anti-inflammatory medicines.
If the patient experiences any of the following symptoms, they should immediately stop taking Ibuprofen Dr. Max Pharma and seek medical attention (see section 2):

• red, non-raised, target-like, or round patches on the torso, often with blisters in the center, peeling of the 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 occur in 1 in 10,000 patients),
• red, peeling, widespread rash with nodules under the skin and blisters located mainly on the skin folds, torso, and upper limbs with accompanying fever at the beginning of treatment (acute generalized exanthematous pustulosis), frequency not known (frequency cannot be estimated from the available data),
• a severe skin reaction known as DRESS syndrome. The symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and an increased number of eosinophils (a type of white blood cell), frequency not known (frequency cannot be estimated from the available data).

The following side effects may occur during ibuprofen treatment, in order of frequency:

• Frequent(may affect up to 1 in 10 patients):
• nausea, vomiting, diarrhea, constipation, bloating, indigestion, abdominal pain, gastrointestinal bleeding (black stools or bloody vomiting)
• dizziness or fatigue
• headache
• skin rash

Uncommon(may affect up to 1 in 100 patients):

• various forms of kidney disorders, such as kidney inflammation, nephrotic syndrome (a set of symptoms of kidney disease), and kidney failure
• rhinitis (runny nose)
• gastritis
• stomach or intestinal ulcers, holes in the wall of the gastrointestinal tract
• mouth ulcers
• liver inflammation, jaundice, liver function disorders
• shortness of breath, asthma, bronchospasm
• tingling sensation
• sleep disturbances
• drowsiness
• restlessness
• hives, itching, purpura (patchy bleeding into the skin)
• angioedema (swelling that occurs in various parts of the body, such as subcutaneous tissue of the face, mucous membranes of the respiratory and gastrointestinal tracts, causing problems in the affected area)
• sensitivity to light
• blurred or disturbed vision (amblyopia)
• hearing disorders, ringing in the ears (tinnitus)
• balance disorders

Rare(may affect up to 1 in 1,000 patients):

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

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

• pancreatitis
• liver failure
• heart failure
• heart attack
• high blood pressure
• severe kidney damage (renal papillary necrosis), especially with long-term use
• severe skin reactions
• severe allergic reaction causing swelling of the face, tongue, or throat, shortness of breath, tachycardia, hypotension (anaphylaxis or severe shock)
• blood count changes - the first symptoms are: fever, sore throat, mouth ulcers, flu-like symptoms, feeling very tired, nosebleeds, and bruising

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

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

In case of more severe reactions, such as swelling of the face or shortness of breath, vision disturbances, or black stools, the patient should stop taking the medicine and immediately contact a doctor.
Medicines like Ibuprofen Dr. Max Pharma may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they 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, phone: +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, it is possible to gather more information on the safety of the medicine.

5. How to store Ibuprofen Dr. Max Pharma

The medicine should be stored out of 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 stated.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Ibuprofen Dr. Max Pharma contains

• The active substance of the medicine is ibuprofen. Each coated tablet contains 400 mg of ibuprofen.
• Other ingredients are: Tablet core:microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, colloidal anhydrous silica, povidone, corn starch, sodium lauryl sulfate, magnesium stearate (E 470). Tablet coating:hydroxypropylcellulose (E 463), hypromellose 2910/3 (E 464), hypromellose 2910/6 (E 464), macrogol 400, titanium dioxide (E 171).

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

White coated tablets in the shape of a capsule, smooth on both sides, approximately 16.7 x 7.8 mm in size, in a cardboard box.
Package sizes: 10, 12, 20, 24, 30, 36, 48, and 50 coated tablets.
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer/importer

Marketing authorization holder:

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

Manufacturer/Importer:

Medis International a.s.
Průmyslová 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 Pharma
Poland:
Ibuprofen Dr. Max Pharma
Slovakia:
Ibuprofen Dr. Max Pharma 400 mg film-coated tablets
Romania:
Ibuprofen Dr. Max 400 mg film-coated tablets

Date of last revision of the leaflet: 12/2024