Ibum Comfort minicaps

Leaflet accompanying the packaging: patient information

IBUM COMFORT minicaps

200 mg, soft capsules

Ibuprofen

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

This medicine should always be taken exactly as described in 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 this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact a doctor.

Table of contents of the leaflet

• 1. What is IBUM COMFORT minicaps and what is it used for
• 2. Important information before taking IBUM COMFORT minicaps
• 3. How to take IBUM COMFORT minicaps
• 4. Possible side effects
• 5. How to store IBUM COMFORT minicaps
• 6. Package contents and other information

1. What is IBUM COMFORT minicaps and what is it used for

IBUM COMFORT minicaps contains ibuprofen, a substance from the group of nonsteroidal anti-inflammatory drugs (NSAIDs), which have analgesic, antipyretic, and anti-inflammatory effects.

Indications for use

• Acute pain of various origins with mild to moderate severity:
• headaches (including migraines)
• toothaches
• muscle, joint, and bone pain
• post-traumatic pain
• neuralgia
• pain associated with colds and flu
• menstrual cramps
• ear pain occurring in middle ear inflammatory conditions
• Fever of various origins (including flu, colds, or other infectious diseases).

If there is no improvement or the patient feels worse after 3 days, they should consult a doctor.

2. Important information before taking IBUM COMFORT minicaps

When not to take IBUM COMFORT minicaps:

• if the patient is allergic to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6),
• in patients with active or past stomach and/or duodenal ulcers, perforation (hole) or bleeding, also occurring after taking NSAIDs,
• in patients who have had allergic symptoms in the past, such as rhinitis, urticaria, dyspnea, or bronchial asthma, while taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs,
• in patients with severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake),
• when taking other NSAID medicines (including COX-2 inhibitors such as celecoxib or etoricoxib),
• if there is severe liver or kidney failure,
• if the patient has severe heart failure (class IV according to NYHA),
• if there is bleeding in the brain (cerebral hemorrhage) or other bleeding,
• if there are blood clotting disorders, bleeding tendency, or blood production disorders of unknown origin,
• if the patient is in the last 3 months of pregnancy.

Warnings and precautions

Before starting IBUM COMFORT minicaps, the patient should discuss it with their doctor or pharmacist if:

• the patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, bypass surgery, or has peripheral artery disease (poor blood circulation in the legs due to narrowing or blockage of arteries) or has had any stroke (including mini-stroke or transient ischemic attack - TIA),
• the patient has high blood pressure, diabetes, high cholesterol levels, or a family history of heart disease or stroke, or smokes tobacco,
• the patient is taking other painkillers from the NSAID group or acetylsalicylic acid in a daily dose above 75 mg,
• the patient has been diagnosed with certain skin diseases (systemic lupus erythematosus, mixed connective tissue disease),
• the patient has been diagnosed with gastrointestinal diseases and chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease),
• the patient has been diagnosed with high blood pressure and/or heart function disorders,
• the patient has been diagnosed with kidney function disorders,
• the patient has been diagnosed with liver diseases,
• the patient has recently undergone major surgery,
• there is dehydration (especially in children and adolescents) due to increased risk of kidney failure,
• there are asthma, chronic rhinitis, nasal polyps, or allergic diseases (possible dyspnea),
• the patient is taking other medicines that may increase the risk of gastrointestinal side effects, such as oral corticosteroids (e.g., prednisolone), blood thinners (e.g., acenocoumarol), and selective serotonin reuptake inhibitors (antidepressants).

Long-term use of painkillers may lead to persistent serious kidney disease. Taking anti-inflammatory/painkillers, 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 and duration of treatment. During chickenpox, avoid taking IBUM COMFORT minicaps. If the patient has an infection, see below, the section entitled "Infections".

• Infections: IBUM COMFORT minicaps may mask infection symptoms, such as fever and pain. Therefore, IBUM COMFORT minicaps may delay the use of appropriate infection treatment and consequently lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine while having an infection, and the infection symptoms persist or worsen, they should consult a doctor immediately.

Skin reactions: Serious skin reactions have been reported with IBUM COMFORT minicaps. If any skin rash, mucosal lesions, blisters, or other allergic symptoms occur, the patient should stop taking IBUM COMFORT minicaps and seek medical help immediately, as these may be the first signs of a very serious skin reaction. See section 4. If any of the above conditions apply to a child, consult a doctor before taking IBUM COMFORT minicaps. There is a risk of gastrointestinal bleeding, ulceration, or perforation, which does not necessarily have to be preceded by warning symptoms or may occur in patients who have had such warning symptoms. In case of gastrointestinal bleeding or ulceration, the patient should stop taking the medicine and consult a doctor immediately. In elderly patients, there is an increased risk of adverse reactions during NSAID use, particularly those affecting the stomach and intestines. Patients who have previously experienced adverse reactions in the gastrointestinal tract, especially elderly patients, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially during the initial treatment phase.

Children and adolescents

In dehydrated children and adolescents, there is a risk of kidney function disorder.

IBUM COMFORT minicaps and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take:

• corticosteroids (e.g., prednisolone), as they may increase the risk of stomach or intestinal ulcers or bleeding,
• other NSAID medicines (including COX-2 inhibitors such as celecoxib or etoricoxib),
• antiplatelet agents (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (antidepressants), as they increase the risk of gastrointestinal side effects,
• blood pressure medicines and diuretics, as NSAIDs may weaken their effect and increase the risk of kidney damage; in such cases, it is essential for the patient to drink plenty of fluids during the day,
• lithium (a medicine used in depression), as lithium levels may increase,
• methotrexate (a medicine used in cancer or rheumatic diseases), as methotrexate levels may increase,
• tacrolimus (an immunosuppressive medicine), as the risk of kidney toxicity may increase,
• cyclosporin (an immunosuppressive medicine), as there is limited data on increased risk of kidney toxicity,
• zydovudine (a medicine used in AIDS treatment), as taking IBUM COMFORT minicaps may increase the risk of joint or bleeding, leading to swelling (in patients with hemophilia and a positive HIV antibody test).

IBUM COMFORT minicaps may interact with other medicines or other medicines may interact with IBUM COMFORT minicaps. For example:

• anticoagulant medicines (i.e., blood thinners or anti-clotting agents, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine),
• blood pressure-lowering medicines (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan).

Also, some other medicines may be affected by or affect the treatment with IBUM COMFORT minicaps. Therefore, before taking IBUM COMFORT minicaps with other medicines, the patient should always consult a doctor or pharmacist.

Taking IBUM COMFORT minicaps with food and drink

Food reduces the absorption of ibuprofen from the gastrointestinal tract. When taking ibuprofen in high doses and consuming alcohol at the same time, symptoms such as fatigue and headaches may occur.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult a doctor or pharmacist before taking this medicine. Pregnancy: Do not take IBUM COMFORT minicaps if the patient is in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. It may cause kidney and heart problems in the unborn baby. It may increase the risk of bleeding in the patient and their baby and cause delayed or prolonged labor. During the first 6 months of pregnancy, do not take the medicine unless absolutely necessary and prescribed by a doctor. If treatment is necessary during this period or when trying to conceive, the smallest effective dose should be used for the shortest possible time. From the 20th week of pregnancy, IBUM COMFORT minicaps may cause kidney function disorders in the unborn baby if taken for more than a few days. This may lead to a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring. Breastfeeding: Ibuprofen passes into breast milk in small amounts. With short-term use of ibuprofen in recommended doses, harmful effects on breastfed babies seem unlikely. Fertility: Ibuprofen may make it more difficult to conceive. If the patient is planning a pregnancy or is having trouble conceiving, they should inform their doctor.

Driving and using machines

Short-term use of the medicine has no effect or a negligible effect on the ability to drive and use machines. If the patient experiences blurred vision, fatigue, dizziness, or other nervous system side effects, they should not drive or operate machinery.

IBUM COMFORT minicaps contains sorbitol

The medicine contains 62.5 mg of sorbitol in each capsule. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, in which the patient's body does not break down fructose, they should consult a doctor before taking the medicine.

3. How to take IBUM COMFORT minicaps

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist. The medicine is taken orally. The capsules should be swallowed whole with a glass of water. The capsules should not be chewed, sucked, or crushed. In patients with sensitive stomachs, it is recommended to take IBUM COMFORT minicaps with meals. The medicine should not be taken in patients with a body weight below 20 kg. The recommended dose is: Children - the maximum daily dose of ibuprofen is 20-30 mg/kg body weight, divided into 3 to 4 single doses. Children aged 6 to 9 years (body weight 20-29 kg): initial dose 1 capsule. Then, if necessary, 1 capsule every 8 hours. The maximum daily dose is 3 capsules (600 mg ibuprofen). Children aged 10 to 12 years (body weight 30-39 kg): initial dose 1 capsule. Then, if necessary, 1 capsule every 6 hours. The maximum daily dose is 4 capsules (800 mg ibuprofen). Adults and adolescents over 12 years (body weight over 40 kg): initial dose 1 to 2 capsules. Then, if necessary, 1 (200 mg) to 2 (400 mg) capsules every 4 (for a dose of 200 mg) to 6 hours (for a dose of 400 mg). The maximum daily dose is 6 capsules (1200 mg ibuprofen). The minimum interval between doses is 4-6 hours. Do not exceed the maximum daily dose. 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 while taking this medicine, consult a doctor immediately (see section 2). The medicine is intended for short-term use, so if symptoms worsen or do not improve after 3 days, or if new symptoms occur, consult a doctor. In patients with mild and moderate kidney and/or liver function disorders, there is no need to reduce the dose. In elderly patients, caution should be exercised when taking IBUM COMFORT minicaps (see "Warnings and precautions").

Taking a higher dose of IBUM COMFORT minicaps than recommended

If the patient has taken a higher dose of IBUM COMFORT minicaps than recommended or if a child has accidentally taken the medicine, 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 may include nausea, stomach pain, vomiting (which may contain blood), headaches, ringing in the ears, disorientation, and nystagmus. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have occurred, as well as blood in the urine, feeling cold, and breathing difficulties.

Missing a dose of IBUM COMFORT minicaps

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

4. Possible side effects

Like all medicines, IBUM COMFORT minicaps can cause side effects, although not everybody gets them. The risk of side effects can be minimized by using the smallest effective dose for the shortest time necessary to relieve symptoms. If side effects occur or if in doubt, the patient should stop taking the medicine and talk to a doctor as soon as possible. Elderly patients taking this medicine are at increased risk of side effects. The patient should stop taking the medicine and consult a doctor immediately if they experience:

• symptoms of gastrointestinal bleeding, such as severe stomach pain, black stools, bloody vomiting, or coffee-ground-like particles,
• symptoms of rare but serious allergic reactions, such as worsening of asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, and drop in blood pressure leading to shock. These symptoms may occur even after the first use of the medicine. If any of these symptoms occur, the patient should contact a doctor immediately,
• severe skin reactions, such as a rash covering the whole body, peeling, blistering, and shedding of the skin.

Frequent(occurring in 1 to 10 patients in 100):

• heartburn, stomach pain, nausea, vomiting, bloating with gas, diarrhea, constipation.

Uncommon(occurring in 1 to 10 patients in 1,000):

• gastritis, colitis, and worsening of Crohn's disease (inflammatory bowel disease),
• headaches, dizziness, insomnia, agitation, irritability, or fatigue,
• visual disturbances,
• stomach ulcers, which may bleed or perforate,
• mouth ulcers and/or swelling and irritation of the mouth,
• allergic reactions with rash and itching, asthma attacks (with possible drop in blood pressure).

Rare(occurring in 1 to 10 patients in 10,000):

• tinnitus (ringing in the ears).

Very rare(occurring in less than 1 patient in 10,000):

• esophagitis or pancreatitis, intestinal obstruction,
• severe skin reactions, including rash with redness and blisters, which may peel and be accompanied by fever, chills, and muscle pain, poor general condition, and Stevens-Johnson syndrome. In exceptional cases, severe skin infections have occurred during chickenpox (chickenpox),
• reduced urine output and swelling (possible acute kidney failure or kidney inflammation). Kidney damage or increased urea levels in the blood (first symptoms are reduced urine output, cloudy urine, blood in the urine, back pain, possible swelling of the legs, and general poor condition),
• blood disorders (first symptoms are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and unexplained or unusual bruising),
• psychotic reactions and depression,
• worsening of inflammatory conditions due to infection. If infection symptoms occur or worsen while taking IBUM COMFORT minicaps, consult a doctor,
• swelling, high blood pressure, rapid heartbeat, heart failure, heart attack,
• liver function disorders or hepatitis. Liver failure or damage, especially during long-term use, manifested by yellowing of the skin and eyes or pale stools and dark urine,
• very rarely, during ibuprofen use, symptoms of aseptic meningitis have been observed, including stiff neck, headache, poor general condition, fever, or changes in consciousness. Patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) are more prone to side effects. If these symptoms occur, the patient should contact a doctor immediately.

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

• severe skin reactions known as DRESS syndrome. DRESS syndrome symptoms include skin rash, fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell),
• red scaly rash with thickening under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the patient should stop taking IBUM COMFORT minicaps and seek medical help immediately. See also section 2,
• skin becomes sensitive to light. Taking such medicines as IBUM COMFORT minicaps 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 the leaflet, they should tell 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: Aleje 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, more information can be collected on the safety of the medicine.

5. How to store IBUM COMFORT minicaps

Keep the medicine out of the sight and reach of children. Store in a temperature below 25°C. Store in the original packaging to protect from moisture. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What IBUM COMFORT minicaps contains

• The active substance of the medicine is ibuprofen. 1 capsule contains 200 mg of ibuprofen.
• Other ingredients (excipients) are: macrogol 400, potassium hydroxide 50%, and the capsule shell contains: gelatin, liquid sorbitol, partially dehydrated.

What IBUM COMFORT minicaps looks like and package contents

IBUM COMFORT minicaps are oval, transparent, light yellow capsules, tightly filled with a solution, with a smooth, shiny surface. One package of the medicine contains 2, 4, 6, 8, 10, or 15 soft capsules in PVC/PVDC/Aluminum blisters in a cardboard box.

Marketing authorization holder and manufacturer

Hasco-Lek Pharmaceutical Company S.A., 51-131 Wrocław, ul. Żmigrodzka 242 E

Medicine information

phone: 22 742 00 22, e-mail: [email protected]

Date of last leaflet update: