IBUPROFEN DR. MAX

Package leaflet: Information for the patient

Ibuprofen Dr. Max, 400 mg, soft capsules
Ibuprofenum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• Adults: Consult your doctor if you do not feel better or feel worse after 4 days in case of pain or after 3 days in case of fever and migraine headaches.
• Adolescents (aged 12–18 years): Consult your doctor if there is no improvement after 3 days or if you feel worse.

Table of contents of the leaflet

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

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

Ibuprofen Dr. Max contains the active substance ibuprofen. It belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs relieve symptoms by altering 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, toothache, menstrual pain, and pain and fever associated with colds.
In inflammatory and degenerative diseases of the joints, spine, and soft tissues of the musculoskeletal system associated with pain, redness, swelling, and joint stiffness, as well as neuralgia (nerve pain), this medicine should only be used on the advice of a doctor.
For adults and adolescents with a body weight of at least 40 kg (12 years of age and older).

2. Important information before using Ibuprofen Dr. Max

When not to use Ibuprofen Dr. Max:

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• if the patient has had an allergic reaction such as asthma, difficulty breathing, swelling of the face, tongue or throat, urticaria, itching or runny nose, allergic reaction to aspirin or another medicine from the NSAID group.
• if the patient has gastric or duodenal ulcer or gastrointestinal bleeding (or if there have been two or more such episodes in the past).
• if the patient has previously experienced gastrointestinal bleeding or perforation while taking NSAIDs.
• if the patient has cerebral haemorrhage or any other active bleeding.
• if the patient has unexplained disorders of the blood-forming system.
• if the patient has severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).
• if the patient has severe liver, kidney or heart failure.
• if the patient is in the last 3 months of pregnancy.

Warnings and precautions
Before starting treatment with Ibuprofen Dr. Max, consult your doctor or pharmacist:

• immediately after major surgery.
• if the patient has or has ever had asthma or allergic disease, as shortness of breath may occur.
• if the patient suffers from hay fever, nasal polyps or chronic obstructive pulmonary disease, as there is an increased risk of allergic reactions. Allergic reactions may manifest as asthma attacks (so-called analgesic-induced asthma), Quincke's oedema (angioedema) or urticaria.
• if the patient has heart disease.
• if the patient has ever had gastrointestinal ulcers (see also section "When not to use Ibuprofen Dr. Max").
• if the patient has gastrointestinal disorders (such as ulcerative colitis, Crohn's disease).
• if the patient has systemic lupus erythematosus or mixed connective tissue disease (affecting skin, joints and kidneys).
• if hereditary blood-forming disorders (acute intermittent porphyria) have been diagnosed.
• if the patient has blood coagulation disorders.
• if the patient is taking other NSAIDs. Concomitant use with other NSAIDs, including selective COX-2 inhibitors, should be avoided due to increased risk of adverse effects (see section "Ibuprofen Dr. Max with other medicines" below).
• in case of chickenpox (varicella), use of Ibuprofen Dr. Max is not recommended.
• if the patient is elderly.
• if the patient has an infection – see below, section titled "Infections".

Treatment should be initiated at the lowest available dose if the patient has ever had gastrointestinal ulcers, is elderly, or requires concomitant low-dose acetylsalicylic acid or other medicines that may increase gastrointestinal risk (see "Ibuprofen Dr. Max with other medicines"). The doctor may also add gastroprotective treatment (e.g. misoprostol or proton pump inhibitors). Inform your doctor if any unusual gastrointestinal symptoms occur, especially signs of bleeding such as vomiting blood or black, tarry stools (see also section 4. "Possible side effects").
Patients with kidney or liver impairment should consult a doctor or pharmacist before using ibuprofen.
Medicines such as 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 using this medicine, the patient should discuss treatment with a doctor or pharmacist if:
heart disease is present, such as heart failure, angina pectoris (chest pain), or if the patient has had a heart attack, peripheral artery bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including "mini" stroke or transient ischaemic attack "TIA"), or if the patient believes they are at risk of such conditions (for example, if 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 this medicine, including difficulty breathing, facial and neck swelling (angioedema), or chest pain, have occurred during ibuprofen use.
If any of these symptoms occur, discontinue Ibuprofen Dr. Max immediately and contact a doctor or emergency medical services without delay.
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 generalised exanthematous pustulosis (AGEP) have been reported with ibuprofen use. If the patient develops any symptoms related to these severe skin reactions described in section 4, Ibuprofen Dr. Max should be discontinued immediately and medical help sought.
Adverse effects can be minimised by using the lowest effective dose for the shortest duration necessary to relieve symptoms. Elderly patients are more susceptible to adverse effects.
Generally, frequent use (of several types) of painkillers may lead to permanent, severe kidney dysfunction. This risk may be increased during physical exertion associated with salt loss and dehydration. Therefore, this should be avoided.
Long-term use of any type of painkillers for headaches may worsen headache symptoms. If this occurs or is expected, discontinue the medicine and consult a doctor. In patients with frequent or daily headaches, despite (or because of) regular use of headache medications, a diagnosis of medication-overuse headache should be considered.
Regular monitoring of liver and kidney function tests and blood counts is required during long-term treatment with Ibuprofen Dr. Max. The doctor may recommend blood tests during treatment.

Infections
Ibuprofen Dr. Max may mask objective signs of infection such as fever and pain. Therefore, Ibuprofen Dr. Max may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.
If the patient takes this medicine during an ongoing infection and symptoms persist or worsen, immediate consultation with a doctor is necessary.

Children and adolescents
There is a risk of kidney dysfunction in dehydrated children and adolescents.
Use of Ibuprofen Dr. Max is not recommended in adolescents with body weight below 40 kg or in children under 12 years of age.

Ibuprofen Dr. Max and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Ibuprofen Dr. Max may affect the action of other medicines or other medicines may affect the action of Ibuprofen Dr. Max, for example:

• anticoagulant medicines (i.e. blood thinners/preventing blood clots, e.g. acetylsalicylic acid, warfarin, ticlopidine).
• medicines lowering high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan).

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

• Acetylsalicylic acid or other NSAIDs (anti-inflammatory and pain-relieving medicines): because this may increase the risk of gastrointestinal ulcers or bleeding.
• Digoxin (in heart failure): because digoxin's effect may be enhanced.
• Glucocorticoids (medicines containing cortisone or cortisone-like substances): because this may increase the risk of gastrointestinal ulcers or bleeding.
• Antiplatelet medicines: because this may increase the risk of bleeding.
• Phenytoin (used in epilepsy treatment): because phenytoin's effect may be enhanced.
• Selective serotonin reuptake inhibitors (medicines used in depression): they may increase the risk of gastrointestinal bleeding.
• Lithium (a medicine used in bipolar disorder and depression): because lithium's effect may be enhanced.
• Probenecid and sulfinpyrazone (medicines used in gout treatment): because excretion of ibuprofen may be delayed.
• Medicines used for hypertension and diuretics: because ibuprofen may reduce the effectiveness of these medicines and there may be increased risk to kidneys.
• Potassium-sparing diuretics: because this may lead to hyperkalaemia (high blood potassium levels).
• Methotrexate (a medicine used in cancer or rheumatoid arthritis treatment): because methotrexate's effect may be enhanced.
• Tacrolimus and cyclosporine (immunosuppressive medicines): because kidney damage may occur.
• Zidovudine (a medicine used in HIV/AIDS treatment): because ibuprofen use may increase the risk of joint bleeding or bleeding leading to swelling in haemophilic patients with HIV.
• Sulfonylureas (antidiabetic medicines): interactions may occur.
• Quinolone antibiotics: because the risk of seizures may be increased.
• Aminoglycosides (antibiotics): because excretion of aminoglycosides may be prolonged.
• Mifepristone (a medicine prescribed to terminate pregnancy): because ibuprofen may reduce the effectiveness of this medicine.
• Bisphosphonates (medicines prescribed for osteoporosis treatment): because they may increase the risk of gastrointestinal ulcers or bleeding.
• Oxpentifylline (pentoxifylline) (a medicine recommended to improve blood flow to hands and feet): because this may increase the risk of gastrointestinal bleeding.
• Baclofen, a muscle relaxant: because baclofen toxicity may be increased.
• Voriconazole or fluconazole (medicines prescribed for fungal infections): because sensitivity to ibuprofen may be increased.

Concomitant use of Ibuprofen Dr. Max with products containing Japanese pagoda tree (Sophora japonica) may increase the risk of bleeding.

Low-dose acetylsalicylic acid
Do not take this medicine if the patient is taking acetylsalicylic acid in doses exceeding 75 mg per day. If the patient is taking low-dose acetylsalicylic acid (up to 75 mg per day), inform the doctor or pharmacist before taking Ibuprofen Dr. Max.

Ibuprofen Dr. Max and alcohol
Avoid alcohol while taking Ibuprofen Dr. Max, as it may worsen possible adverse effects.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

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

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

Fertility
Ibuprofen Dr. Max belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible after discontinuation of the medicine. It is unlikely that occasional use of Ibuprofen Dr. Max would affect chances of becoming pregnant, but the doctor should be informed before taking the medicine if the patient has difficulty conceiving.

Driving and using machines
When used short-term and at normal doses, this medicine has no effect or negligible effect on the ability to drive or operate machinery. However, if adverse effects such as fatigue, dizziness, drowsiness or visual disturbances occur, the patient should not drive or operate machinery. Alcohol consumption increases the risk of these adverse effects.

Ibuprofen Dr. Max contains sorbitol
The medicine contains 50 mg of sorbitol per capsule.

3. How to take Ibuprofen Dr. Max

This medicine should always be taken according to the recommendations of a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of an infection
(such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).

Adults and adolescents with body weight of 40 kg or more (12 years of age and older)
The recommended dose is 400 mg (1 capsule), if necessary, up to 3 times daily. There should be an interval of at least
6 hours between 400 mg (1 capsule) doses. Do not take more than 1200 mg (3 capsules) within 24 hours.

For the treatment of migraine headache, the recommended dose is a single dose of 1 capsule (400 mg). If needed, take
400 mg (1 capsule) every 4 to 6 hours. Do not take more than 1200 mg (3 capsules) within 24 hours.

If adults use this medicine for more than 3 days for migraine headache or fever, or for more than 4 days for pain relief,
or if symptoms worsen, consult a doctor. If adolescents (aged 12 years and older) use this medicine for more than 3 days
or if symptoms worsen, consult a doctor.

Use in children and adolescents
Ibuprofen Dr. Max is not recommended for use in adolescents weighing less than 40 kg or in children under 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 a sensitive stomach should take the capsules during a meal. Taking the capsules after a meal may delay
the medicine's effect in relieving pain or reducing fever. Do not exceed the recommended dose or take it more frequently
than recommended.

If you take more Ibuprofen Dr. Max than you should
If you take more than the recommended dose of Ibuprofen Dr. Max or if the medicine is accidentally ingested by children,
contact a doctor or the nearest hospital immediately for advice on the risks and actions to be taken. Symptoms of overdose
may include nausea, abdominal pain, vomiting (which may contain blood), headache, tinnitus, confusion, and nystagmus.
After ingestion of 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.
In severe poisoning, prolonged bleeding, acute kidney failure, liver damage, and worsening of asthma in asthmatics may occur.

If you miss a dose of Ibuprofen Dr. Max
Follow 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.

If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects can be minimised by using the lowest effective dose for the shortest duration necessary to relieve symptoms. Elderly patients taking this medicine are at higher risk of experiencing adverse effects.
Taking medicines such as Ibuprofen Dr. Max may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Some of the adverse effects listed below occur less frequently when the maximum daily dose is 1200 mg compared to high-dose therapy in patients with rheumatic conditions.

If the patient experiences any of the following symptoms or adverse effects, they should stop taking the medicine and seek immediate medical advice:

• Gastric or intestinal ulcers, which may sometimes be accompanied by bleeding and perforation, vomiting blood or tarry stools (common: may occur in 1 in 10 patients);
• Kidney disease manifested by blood in the urine, which may be associated with kidney failure (uncommon: may occur in 1 in 100 patients);
• Severe allergic reaction (very rare: may occur in 1 in 10,000 people), 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, flat, target-like or circular skin lesions, often with blisters in the centre, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin reactions 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, scaly rash with subcutaneous nodules and blisters located mainly in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). See also section 2 (frequency unknown: frequency cannot be estimated from available data);
• Severe skin reaction, which may appear around the mouth or other body parts, with symptoms such as: red, often itchy blisters, similar to the rash seen in measles, appearing on limbs and sometimes on the face and other body parts. Blisters may evolve into larger blisters or develop into large red spots with a pale centre. The skin reaction is accompanied by fever, sore throat, headache and (or) diarrhoea (very rare: may occur in 1 in 10,000 patients);
• Severe skin peeling or "sloughing off" of the skin (very rare: may occur in 1 in 10,000 patients);
• Pancreatitis with severe upper abdominal pain, often accompanied by 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-coloured urine, which may indicate liver or kidney failure (very rare: may occur in 1 in 10,000 patients);
• Heart problems, accompanied by shortness of breath and swelling of the feet and legs due to fluid accumulation (heart failure) (very rare: may occur in 1 in 10,000 patients);
• Aseptic meningitis (inflammation of the membranes surrounding the brain or spinal cord), accompanied by symptoms such as fever, nausea, vomiting, headache, stiff neck, extreme sensitivity to bright light, and altered 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 unknown: frequency cannot be determined from available data);
• Acute kidney failure (renal papillary necrosis), especially after prolonged use of the medicine (rare: may occur in 1 in 1,000 patients);
• Worsening of infection-related inflammatory conditions (e.g. necrotising fasciitis), particularly when used concomitantly with other NSAIDs (very rare: may occur in 1 in 10,000 patients);
• Problems with blood cell production – early signs include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding (very rare: may occur in 1 in 10,000 people);
• A severe skin reaction called DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell) (unknown frequency: frequency cannot be estimated from available data).

Other adverse effects:
Very common (may occur in 1 in 10 patients):

• Nausea, heartburn, flatulence, diarrhoea, constipation, vomiting, abdominal pain.

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

• Headache, drowsiness, dizziness, fatigue, restlessness, difficulty sleeping, irritability;
• Occult blood loss, which may lead to a condition characterised by reduced red blood cell count (symptoms include fatigue, headaches, difficulty breathing during exercise, dizziness and pale skin), mouth ulcers and cold sores, colitis (symptoms include diarrhoea, usually with blood and mucus, abdominal pain, fever), exacerbation of inflammatory bowel disease, mucositis.

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

• Urticaria, itching, petechiae or bruising under the skin, skin rash, asthma attacks (sometimes with hypotension);
• Runny or stuffy nose, sneezing, pressure or pain in the face, difficulty breathing;
• Gastritis (symptoms include pain, nausea, vomiting, vomiting blood, blood in stool);
• Increased skin sensitivity to sunlight;
• Fluid accumulation in body tissues, especially in patients with high blood pressure or impaired kidney function;
• Visual disturbances.

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

• Skin, joint and kidney disorders (systemic lupus erythematosus);
• Depression, disorientation, hallucinations, psychiatric disorders with unusual or disturbing thoughts and mood;
• Tinnitus (ringing, buzzing, whistling, or other persistent noises in the ears);
• Increased blood urea nitrogen, serum aminotransferases and alkaline phosphatase, decreased haemoglobin and haematocrit values, inhibition of platelet aggregation, prolonged bleeding time, decreased serum calcium concentration, increased serum uric acid concentration, detectable 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 body tissues;
• High blood pressure;
• Oesophagitis, intestinal stricture;
• Hair loss or thinning;
• Severe skin infections with complications involving soft tissues; these may occur during herpes zoster;
• Menstrual disorders.

Frequency unknown (cannot be determined from available data):

• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Ibuprofen Dr. Max

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated 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 package 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 monooleate (E 494), povidone K30, potassium hydroxide (E 525). Capsule shell composition: gelatin (E 441), macrogol 400 (E 1521), sorbitol liquid (E 420), medium-chain triglycerides. Coating composition: isopropyl alcohol.

What Ibuprofen Dr. Max looks like and contents of the pack
Transparent, oval, soft gelatin capsule containing a colourless to pale yellow,
transparent, sticky liquid, packed in transparent PVC/PVDC/Aluminium 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 Authorisation Holder and Manufacturer
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.
Prumyslova 961/16
747 23 Bolatice
Czech Republic

This medicinal product is authorised 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