IBUPROFEN DR. MAX PHARMA

Package leaflet: Information for the patient

Ibuprofen Dr. Max Pharma, 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 used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet, so that you can read it again when necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days of treatment for fever or after 5 days for pain in adults, or after 3 days of treatment in adolescents, or if you feel worse, you should consult a doctor.

Table of contents

1. What Ibuprofen Dr. Max Pharma is and what it is 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 pack and other information

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

Ibuprofen Dr. Max Pharma belongs to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs), which have antipyretic (fever-reducing), analgesic (pain-relieving), and anti-inflammatory effects.
Ibuprofen Dr. Max Pharma is used for short-term symptomatic relief of mild to moderate pain such as headache, including migraine headache, back pain, toothache, menstrual pain, postoperative pain, muscle and joint pain associated with influenza, and for symptomatic treatment of soft tissue injuries such as sprains and muscle strains, as well as in cases of fever.
Ibuprofen Dr. Max Pharma is intended for use in adults and adolescents with body weight of 40 kg or more (aged over 12 years).
If there is no improvement after 3 days of treatment for fever or after 5 days for pain in adults, or after 3 days of treatment in adolescents, or if you feel worse, you should consult a doctor.

2. Information before using Ibuprofen Dr. Max Pharma

When not to use Ibuprofen Dr. Max Pharma:

• if the patient is allergic 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 painkillers and anti-inflammatory drugs (NSAIDs),
• if the patient has experienced perforation or bleeding of the stomach or small intestine (duodenum) related to previous use of painkillers and anti-inflammatory drugs (NSAIDs),
• if the patient currently has a stomach or duodenal ulcer or gastrointestinal bleeding, or if the patient has had two or more such episodes in the past,
• if the patient has severe impairment of liver, kidney, or heart function,
• if the patient is in the last 3 months of pregnancy,
• if the patient has severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake),
• if the patient has active bleeding (including in the brain).

Warnings and precautions
Before using Ibuprofen Dr. Max Pharma, consult a doctor:

• if the patient has chronic inflammatory bowel diseases such as ulcerative colitis or gastrointestinal inflammation (Crohn's disease), as these conditions may worsen. If the patient suffers from gastrointestinal disorders, the medicine should be used with caution, as it may increase the risk of gastrointestinal bleeding and other complications. Patients with gastric or duodenal ulcers are at increased risk of gastrointestinal bleeding.
• if the patient has asthma, the risk of bronchospasm (constriction of the airways) may increase.
• if the patient is taking medicines affecting blood clotting, Ibuprofen Dr. Max Pharma or other drugs in this group may prolong bleeding time or lead to ulceration.
• if the patient has hay fever, nasal polyps, or chronic respiratory disease, the risk of allergic reactions may increase.
• if the patient has kidney disease, Ibuprofen Dr. Max Pharma should be used with caution and always at the lowest effective dose, as drugs in this group may impair kidney function. The same precautions apply to liver disease.
• if the patient has an infection – see section “Infections” below.

The risk of adverse effects increases with higher doses and in elderly patients. Therefore, treatment should start with the lowest possible dose and continue for the shortest duration necessary to relieve symptoms.

Ulcers, perforations, and gastrointestinal bleeding
Occasionally, gastrointestinal bleeding, ulceration, or perforation may occur during treatment. If any unusual gastrointestinal problems are observed, contact a doctor immediately.

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

Effects on the heart and brain
Anti-inflammatory and/or pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment.
Before using Ibuprofen Dr. Max Pharma, discuss this with a doctor or pharmacist if:

• the patient has heart problems, including heart failure, angina (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any stroke (including "mini-stroke" or transient ischaemic attack (TIA)).
• the patient has high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if the patient smokes.

Allergic reactions to ibuprofen, including difficulty breathing, swelling of the face and neck (angioedema), and chest pain, have been reported during treatment. If any of these symptoms occur, Ibuprofen Dr. Max Pharma should be stopped immediately and medical help should be sought without delay.

Aseptic meningitis (inflammation of the meninges without bacterial infection)
Aseptic meningitis has been rarely reported in patients treated with ibuprofen. However, this condition occurs more frequently in patients with connective tissue diseases, such as systemic lupus erythematosus (SLE).

Infections
Ibuprofen Dr. Max Pharma may mask symptoms of infection such as fever and pain. Therefore, it may delay appropriate treatment of infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an infection and symptoms persist or worsen, medical advice should be sought immediately.
The use of Ibuprofen Dr. Max Pharma is not recommended during chickenpox.

Other precautions
Long-term use of painkillers for headache may worsen headaches. If this occurs or is suspected, stop taking Ibuprofen Dr. Max Pharma and consult a doctor.
Ibuprofen may temporarily inhibit platelet function.

Children and adolescents
In dehydrated children and adolescents, there is a risk of impaired kidney function.
Due to the high amount of active substance, Ibuprofen Dr. Max Pharma is not intended for children under 12 years of age or adolescents weighing less than 40 kg.

Ibuprofen Dr. Max Pharma and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use.
Ibuprofen Dr. Max Pharma may affect the action of certain other medicines, or other medicines may affect its action. For example:

• acetylsalicylic acid – may increase the risk of adverse effects
• other NSAIDs (including COX-2 inhibitors) – may increase the risk of gastrointestinal bleeding and ulcers
• anticoagulants (e.g. warfarin) – ibuprofen may enhance the effect of these medicines
• methotrexate (used in cancer and autoimmune disease treatment) – ibuprofen may affect its elimination
• lithium (used in depression and mania treatment) and phenytoin (used to prevent epileptic seizures) – ibuprofen may increase their blood concentration
• cardiac glycosides (e.g. digoxin) – ibuprofen may increase their blood concentration and worsen heart failure
• diuretics – may increase adverse effects of ibuprofen; ibuprofen may reduce the effectiveness of diuretics
• antihypertensive medicines (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan) – ibuprofen may reduce their effectiveness
• cholestyramine (used to treat high cholesterol) – concomitant use with ibuprofen may reduce ibuprofen absorption in the gastrointestinal tract
• aminoglycosides (antibiotics against certain bacteria) – excretion 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 (antidepressants) 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 HIV treatment) – ibuprofen may increase the risk of adverse effects
• mifepristone (used to terminate pregnancy) – ibuprofen may reduce its effectiveness
• probenecid or sulfinpyrazone (used in gout treatment) – ibuprofen may reduce their effectiveness
• quinolone antibiotics (used against certain bacteria) – risk of seizures may be increased
• sulfonylurea derivatives (used in type 2 diabetes treatment) – ibuprofen may enhance their effect. Hypoglycaemia (low blood sugar) has been rarely reported with concomitant use.
• corticosteroids (used in inflammatory conditions) – may increase the risk of gastrointestinal adverse effects (ulceration or gastrointestinal bleeding)
• voriconazole and fluconazole (antifungal agents) – concomitant use may increase exposure to ibuprofen
• herbal remedy Ginkgo biloba – may increase the risk of bleeding.

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

Ibuprofen Dr. Max Pharma and alcohol
Avoid alcohol consumption, as it may worsen possible adverse effects of ibuprofen, especially those affecting the stomach, intestines, or central nervous system.

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 use Ibuprofen Dr. Max Pharma 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 problems in the unborn child. It may affect bleeding tendency in both the mother and child and may delay or prolong labour. During the first 6 months of pregnancy, Ibuprofen Dr. Max Pharma should not be used unless a doctor considers its use absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Ibuprofen Dr. Max Pharma may cause kidney dysfunction in the unborn child if used for longer than a few days – this may lead to low levels of amniotic fluid (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is required, the doctor may recommend additional monitoring.

Breastfeeding
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 interrupt breastfeeding if ibuprofen is used at the recommended dose and for the shortest possible duration.

Fertility
Ibuprofen Dr. Max Pharma belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible after discontinuation of the medicine.

Driving and operating machinery
Ibuprofen Dr. Max Pharma has no effect or negligible effect on the ability to drive or operate machinery. However, if dizziness, drowsiness, fatigue, visual disturbances, or other central nervous system effects occur during treatment, the patient should not drive or operate machinery. This is particularly important when combined with alcohol.

Ibuprofen Dr. Max Pharma contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

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

3. How to use Ibuprofen Dr. Max Pharma

This medicine should always be taken exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
For short-term use only.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. In case of infection, seek immediate medical advice if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults and adolescents with body weight of 40 kg or more (aged over 12 years)
The recommended dose for the treatment of acute pain or fever is 1 tablet (400 mg) as a single dose or up to 3 times daily, if necessary, with intervals of 4 to 6 hours between doses.
The maximum daily dose should not exceed 3 tablets (1200 mg).
Dose adjustment is not required in elderly patients (over 65 years of age).
If adults require treatment with this medicine for more than 3 days due to fever or more than 5 days due to pain, or if symptoms worsen, medical advice should be sought.
If adolescents require treatment with this medicine for more than 3 days or if symptoms worsen, medical advice should be sought.

Use in children and adolescents
Ibuprofen Dr. Max Pharma is not intended for children under 12 years of age or adolescents with body weight below 40 kg. Other formulations 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. Do not chew, divide or crush the tablets to avoid discomfort in the mouth or throat irritation.
A faster onset of action may be achieved by taking the dose on an empty stomach. Patients with a sensitive stomach should take Ibuprofen Dr. Max Pharma with food.

Accidental overdose of Ibuprofen Dr. Max Pharma
If you take more Ibuprofen Dr. Max Pharma than recommended, or if the medicine is accidentally taken by children, you should always contact your doctor or the nearest hospital for advice on potential risks and necessary actions.
Symptoms of overdose may include nausea, abdominal pain, vomiting (which may be bloody), headache, tinnitus, confusion, and nystagmus. With large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, low blood potassium levels, feeling cold, and breathing difficulties have been reported. Other symptoms of overdose include lethargy or dryness of the mouth. In severe overdose, kidney failure and liver damage may occur.

Missed dose of Ibuprofen Dr. Max Pharma
Do not take a double dose to make up for a missed dose.
If you have any further questions 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.
Adverse reactions associated with the use of Ibuprofen Dr. Max Pharma are the same as those
observed with other non-steroidal anti-inflammatory drugs.
If any of the following symptoms occur in a patient, Ibuprofen Dr. Max Pharma should be discontinued immediately and medical help should be sought (see section 2):

• red, flat, target-like or circular spots 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 occur in 1 out of 10,000 patients),
• red, scaly widespread 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),
• a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling, and increased eosinophil count (a type of white blood cell), frequency unknown (frequency cannot be estimated from available data).

The following adverse reactions may occur during ibuprofen use, listed in order from most frequent:

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 or tiredness
• headache
• skin rash

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

• various forms of kidney disorders, such as nephritis, nephrotic syndrome (a set of symptoms indicating kidney disease), and kidney failure
• catarrh (nasal inflammation)
• gastritis
• stomach or intestinal ulcer, perforation of the gastrointestinal tract wall
• oral mucosal ulcers
• hepatitis, jaundice, liver function abnormalities
• shortness of breath, bronchial asthma, bronchospasm
• tingling sensation
• difficulty falling asleep
• drowsiness
• restlessness
• urticaria, itching, purpura (purplish skin spots due to bleeding under the skin)
• angioedema (swelling 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)
• photosensitivity
• blurred or disturbed vision (visual impairment)
• hearing disturbances, tinnitus (ringing in the ears)
• balance disorders

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

• aseptic meningitis (inflammation of the protective membrane covering the brain)
• feelings of depression or disorientation
• optic neuritis, toxic optic neuropathy (damage to the optic nerve)
• oedema

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

• pancreatitis
• liver failure
• heart failure
• heart attack
• high blood pressure
• severe kidney damage (renal papillary necrosis), particularly with long-term use
• severe forms of skin reactions
• severe allergic reaction causing facial, tongue or throat swelling, breathing difficulties, tachycardia, hypotension (anaphylaxis or severe shock)
• blood count abnormalities – initial symptoms include: fever, sore throat, oral mucosal ulcers, flu-like symptoms, extreme fatigue, nosebleeds, and bruising

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

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

In case of more severe reactions such as facial swelling or breathing difficulties, vision disturbances, or black stools, the medicine should be discontinued immediately and a doctor should be contacted without delay.
Medicines such as Ibuprofen Dr. Max Pharma 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 not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Ibuprofen Dr. Max Pharma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following: EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Ibuprofen Dr. Max Pharma contains

• The active substance is ibuprofen. Each coated tablet contains 400 mg of ibuprofen.
• The other ingredients are:
  Tablet core: microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, anhydrous colloidal silicon dioxide, 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, capsule-shaped, film-coated tablets, smooth on both sides, approximately 16.7 x 7.8 mm, in a cardboard box.
Pack sizes: 10, 12, 20, 24, 30, 36, 48 and 50 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation 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.
Průmyslová 961/16
747 23 Bolatice
Czech Republic
Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

This medicinal product is authorised in 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 filmom obalené tablety
Romania: Ibuprofen Dr. Max 400 mg comprimate filmate
Italy: Binofenum