Package leaflet: Information for the patient

IBUM COMFORT minicaps
200 mg, soft capsules
Ibuprofenum
Please read the entire leaflet carefully before using the 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 doctor or pharmacist.

Keep this leaflet for future reference.
If advice or further information is needed, consult a pharmacist.
If the patient experiences any adverse reactions, including those not listed in this leaflet, inform a doctor or pharmacist. See section 4.
If there is no improvement after 3 days or if the patient feels worse, consult a doctor.

Table of contents of the leaflet

What IBUM COMFORT minicaps is and what it is used for
Important information before taking IBUM COMFORT minicaps
How to take IBUM COMFORT minicaps
Possible side effects
How to store IBUM COMFORT minicaps
Contents of the pack and other information

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

IBUM COMFORT minicaps contains ibuprofen – an active substance belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs), which have analgesic, antipyretic, and anti-inflammatory properties.
Indications

Acute pain of various origins, mild to moderate in intensity:
- headaches (including migraine)
- toothache
- muscle, joint, and bone pain
- pain following injuries
- neuralgia
- pain associated with colds and flu
- painful menstruation
- ear pain occurring in middle ear inflammation
Fever of various causes (e.g. during flu, colds, or other infectious diseases).

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

2. Important information before using IBUM COMFORT minicaps

When not to use 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 previous peptic ulcer or duodenal ulcer, perforation (gastrointestinal perforation), or gastrointestinal bleeding, including cases previously occurring during treatment with NSAIDs,
in patients who have previously experienced allergic reactions such as rhinitis, urticaria, shortness of breath, or bronchial asthma during treatment with acetylsalicylic acid or other NSAIDs,
in patients with severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake),
when taking other medicines from the NSAID group (including COX-2 inhibitors such as celecoxib or etoricoxib),
in cases of severe hepatic insufficiency or severe renal insufficiency,
in patients with severe heart failure (NYHA class IV),
in cases of cerebral haemorrhage (bleeding from brain vessels) or other bleeding,
in cases of blood coagulation disorders, haemorrhagic diathesis (tendency to bleed), or blood cell production disorders of unknown origin,
if the patient is in the last 3 months of pregnancy.

Warnings and precautions
Before starting treatment with IBUM COMFORT minicaps, consult your doctor or
pharmacist if:

the patient has heart diseases such as heart failure, angina pectoris (chest pain), history of myocardial infarction, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or if the patient has ever had a stroke (including mini-stroke or transient ischaemic attack - TIA),
the patient has hypertension, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes,
the patient is taking other pain-relieving NSAIDs or acetylsalicylic acid at a daily dose exceeding 75 mg,
the patient has been diagnosed with certain skin diseases (systemic lupus erythematosus, mixed connective tissue disease),
the patient has gastrointestinal disorders or 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,
dehydration is present (especially in children and adolescents) due to increased risk of renal failure,
asthma, chronic rhinitis, nasal polyps, or allergic diseases have been diagnosed currently or in the past (shortness of breath may occur),
the patient is taking other medicines that may increase the risk of ulceration or bleeding, such as oral corticosteroids (e.g. prednisolone), anticoagulants (e.g. acenocoumarol), selective serotonin reuptake inhibitors (antidepressants), or antiplatelet drugs (such as acetylsalicylic acid).

Long-term, simultaneous use of painkillers may lead to persistent
serious kidney diseases.
Taking anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with
a small increased risk of heart attack or stroke, particularly when used at high
doses. Do not exceed the recommended dose or duration of treatment.
IBUM COMFORT minicaps should be avoided during chickenpox.
Inform your pharmacist or doctor if:

the patient has an infection - see below, section titled "Infections".

Infections
IBUM COMFORT minicaps may mask symptoms of infection, such as fever and pain. Therefore, IBUM COMFORT minicaps 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 existing infection and infection symptoms persist
or worsen, medical advice should be sought immediately.
Skin reactions
Severe skin reactions associated with the use of IBUM COMFORT minicaps have been reported. If any skin rash, mucosal changes, blisters, or other allergic symptoms appear, stop taking IBUM COMFORT minicaps immediately and seek medical help without delay, 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, contact a doctor before using IBUM COMFORT minicaps.
There is a risk of gastrointestinal bleeding, ulceration, or perforation, which may occur without warning symptoms or may occur in patients who have previously experienced such warning symptoms. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately and contact your doctor.
Elderly patients have an increased risk of adverse effects during treatment with NSAIDs, particularly those affecting the stomach and intestines.
Patients who have previously experienced adverse effects in the gastrointestinal tract, especially elderly patients, should report any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially during the initial phase of treatment.
Children and adolescents
In dehydrated children and adolescents, there is a risk of impaired kidney function.
IBUM COMFORT minicaps and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take:

corticosteroids (e.g. prednisolone), as they may increase the risk of gastrointestinal ulceration or bleeding,
other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib),
antiplatelet drugs (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (antidepressants), as they increase the risk of gastrointestinal adverse effects,
antihypertensive drugs and diuretics, as NSAIDs may reduce the effectiveness of these medicines and there is a possibility of increased risk of kidney damage; in such cases, it is important that the patient drinks plenty of fluids throughout the day,
lithium (a medicine used in depression), as the effect of lithium may increase,
methotrexate (a medicine used in cancer or rheumatic diseases), as the effect of methotrexate may increase,
tacrolimus (an immunosuppressive medicine), as there is an increased risk of nephrotoxicity,
cyclosporine (an immunosuppressive medicine), as there are limited data on increased risk of nephrotoxicity,
zidovudine (a medicine used in the treatment of AIDS), as using IBUM COMFORT minicaps may lead to an increased risk of joint bleeding or bleeding
leading to swelling (in patients with haemophilia and a positive HIV antibody test),
sulfonylurea derivatives (antidiabetic medicines): clinical interactions between these medicines and NSAIDs may occur; monitoring of blood glucose levels is recommended,
probenecid and sulfinpyrazone (medicines used in the treatment of gout): may delay the elimination of ibuprofen,
digoxin, phenytoin, and lithium: ibuprofen may increase the plasma concentration of these medicines,
quinolone antibiotics: may increase the risk of seizures,
cholestyramine: may delay and reduce the absorption of NSAIDs,
voriconazole and fluconazole (antifungal medicines): may increase exposure to NSAIDs,
baclofen (a muscle relaxant): toxic effects of baclofen may occur after starting ibuprofen,
ritonavir (a medicine used in HIV therapy): ritonavir may increase plasma concentrations of NSAIDs,
aminoglycosides (a type of antibiotic): NSAIDs may reduce aminoglycoside excretion,
mifepristone: do not use NSAIDs within 8–12 days after mifepristone administration, as they may reduce the effectiveness of mifepristone,
calcium channel blockers: reduced antihypertensive efficacy and increased risk of gastrointestinal bleeding,
desipramine: increased desipramine toxicity, typical of tricyclic antidepressants,
levofloxacin and ofloxacin: increased risk of serious central nervous system effects,
thienopyridine derivatives: increased risk of bleeding due to additive antiplatelet and anticoagulant effects,
bisphosphonates: increased risk of gastrointestinal adverse effects.

The use of ibuprofen with herbal preparations such as Ginkgo biloba and
Filipendula ulmaria may increase the risk of bleeding due to additive antiplatelet effects. Concurrent use of ibuprofen and products containing Ephedra sinica may cause an increased risk of gastrointestinal mucosal damage.
IBUM COMFORT minicaps may affect the action of other medicines or other medicines may
affect the action of IBUM COMFORT minicaps. For example:

anticoagulant medicines (i.e. blood thinners or those preventing clot formation, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine),
blood pressure-lowering medicines (ACE inhibitors such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan).

Also, some other medicines may be affected by or may affect treatment with IBUM COMFORT
minicaps. Therefore, always consult a doctor or pharmacist before using IBUM COMFORT minicaps with other medicines.
Use of IBUM COMFORT minicaps with food and drink
Food reduces the absorption of ibuprofen from the gastrointestinal tract.
When using ibuprofen at high doses and consuming alcohol simultaneously, symptoms such as fatigue and headache may occur.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant, 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 IBUM COMFORT minicaps if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both the mother and her child and may delay or prolong labour. The medicine should not be used during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From week 20 of pregnancy, IBUM COMFORT minicaps may cause kidney function disorders in the unborn child if taken for longer than a few days. This may lead to reduced amniotic fluid volume surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is necessary, the doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen passes into breast milk in small amounts. After short-term use of ibuprofen at recommended doses, harmful effects on infants seem unlikely.
Fertility
Ibuprofen may impair fertility. If the patient is planning pregnancy or has difficulty conceiving, she should inform her doctor.
Driving and operating machinery
Short-term use of the medicine has no effect or has negligible effect on the ability to drive and operate machinery. If visual disturbances, fatigue, dizziness, or other adverse effects from the nervous system occur, driving and operating machinery are not recommended.
IBUM COMFORT minicaps contains sorbitol
The medicine contains 62.5 mg of sorbitol per capsule. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the patient's body cannot break down fructose, the patient should contact a doctor before taking this medicine.

3. How to use IBUM COMFORT minicaps

This medicine should always be taken exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for oral use. The capsules should be swallowed whole with a glass of water. Do not chew, suck or break the capsules. In patients with a sensitive stomach, it is recommended to take IBUM COMFORT minicaps during meals.
This medicine should not be used in patients with body weight below 20 kg.
Recommended dosage:
Children – maximum daily dose of ibuprofen is 20–30 mg per kg body weight, divided into 3 to 4 single doses.
Children aged 6 to 9 years (body weight 20–29 kg): initial dose of 1 capsule. Then, if needed, 1 capsule every 8 hours. Maximum daily dose is 3 capsules (600 mg of ibuprofen).
Children aged 10 to 12 years (body weight 30–39 kg): initial dose of 1 capsule. Then, if needed, 1 capsule every 6 hours. Maximum daily dose is 4 capsules (800 mg of ibuprofen).
Adults and adolescents over 12 years of age (body weight over 40 kg): initial dose of 1 to 2 capsules. Then, if needed, 1 (200 mg) to 2 (400 mg) capsules every 4 hours (for 200 mg dose) to every 6 hours (for 400 mg dose). Maximum daily dose is 6 capsules (1200 mg of ibuprofen).
The minimum interval between doses should be 4 to 6 hours. Do not exceed the maximum daily dose.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
This medicine is intended for short-term and immediate use only. If symptoms worsen or do not improve within 3 days, or if new symptoms occur, consult a doctor.
In patients with mild to moderate renal or (and) hepatic impairment, dose reduction is not required.
In elderly patients, caution should be exercised when using IBUM COMFORT minicaps (see "Warnings and precautions").
Use of a higher than recommended dose of IBUM COMFORT minicaps
If a patient has taken more than the recommended dose of IBUM COMFORT minicaps, or if a child has accidentally ingested the medicine, seek medical advice immediately from a doctor or go to the nearest hospital to assess possible health risks and receive guidance on necessary actions.
Symptoms may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, confusion and nystagmus. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness and dizziness, blood in urine, feeling cold and breathing difficulties may occur.
Missed dose of IBUM COMFORT minicaps
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.
The risk of adverse effects can be reduced by using the lowest effective dose for the shortest duration necessary to relieve symptoms.
If any adverse effects occur, or if you have any doubts, stop taking the medicine and consult your doctor as soon as possible.
Elderly patients taking this medicine belong to a group at increased risk of experiencing problems related to adverse effects.

STOP TAKING THE MEDICINE AND CONTACT YOUR DOCTOR IMMEDIATELY IF
ANY OF THE FOLLOWING OCCUR:

symptoms of gastrointestinal bleeding, such as severe abdominal pain, black stools, vomiting blood or dark particles resembling coffee grounds,
symptoms of rare but serious allergic reactions, such as worsening asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, palpitations, or a drop in blood pressure leading to shock. These symptoms may occur even after the first dose. If any of these symptoms occur, contact your doctor immediately,
severe skin reactions, such as rash affecting the whole body, peeling, formation of blisters and shedding of skin sheets.

Common (occur in 1 to 10 patients out of 100):

heartburn, abdominal pain, nausea, vomiting, bloating with gas release, diarrhoea, constipation.

Uncommon (occur in 1 to 10 patients out of 1,000):

inflammation of the stomach or large intestine, and exacerbation of Crohn's disease (inflammatory bowel disease),
headache, dizziness, insomnia, restlessness, irritability or fatigue,
visual disturbances,
stomach ulcers, which may bleed or perforate,
oral ulceration and (or) swelling and irritation of the mouth,
hypersensitivity reactions with rash and itching, asthma attacks (possibly with a drop in blood pressure).

Rare (occur in 1 to 10 patients out of 10,000):

tinnitus (ringing in the ears).

Very rare (occur in less than 1 patient out of 10,000):

oesophagitis or pancreatitis, intestinal obstruction,
severe skin reactions, including rash with redness and blisters, which may peel and are accompanied by fever, chills, muscle pain, malaise, Stevens-Johnson syndrome. In exceptional cases, severe skin infections have occurred during chickenpox (varicella),
reduced urine output compared to usual and swelling (possible acute kidney failure or inflammation). Kidney damage or increased blood urea concentration (early signs include reduced urine output, cloudy urine, blood in urine, back pain, possible leg swelling and general malaise),
problems with blood cell production (early symptoms include fever, sore throat, superficial oral ulceration, flu-like symptoms, severe fatigue, nosebleeds and skin bleeding, unexplained or unusual bruising),
psychotic reactions and depression,
worsening of inflammatory condition due to infection. If signs of infection occur or worsen during treatment with IBUM COMFORT minicaps, consult your doctor,
swelling, high blood pressure, palpitations, heart failure, heart attack,
liver function disorders or hepatitis. Liver failure or damage, especially during long-term use, manifesting as yellowing of the skin and eyes, pale stools and dark urine,
very rarely, during ibuprofen use, symptoms of aseptic meningitis have been observed, including neck stiffness, headache, malaise, fever or disturbances of consciousness. Patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) are at higher risk of adverse effects. Contact your doctor immediately if any of these symptoms occur.

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

severe skin reactions known as DRESS syndrome. Symptoms of DRESS syndrome include skin rash, fever, lymph node swelling and increased eosinophil count (a type of white blood cell),
red scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk and upper limbs, with fever occurring at the beginning of treatment (acute generalised exanthematous pustulosis). If such symptoms occur, discontinue taking IBUM COMFORT minicaps and seek medical help immediately. See also section 2,
skin becomes sensitive to light. Taking medicines such as IBUM COMFORT minicaps may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

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:
Aleje 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 to provide more information on the safety of this medicine.

5. How to store IBUM COMFORT minicaps

Keep this medicine out of sight and reach of children.
Store 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 stated month.
Medicines must not be disposed of via sewage systems or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Ibum COMFORT minicaps contains

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

What Ibum COMFORT minicaps looks like and contents of the pack
Ibum COMFORT minicaps is in the form of oval, transparent, light yellow soft capsules,
hermetically filled with a solution, having a smooth, glossy surface.
One package contains 2, 4, 6, 8, 10 or 15 soft capsules in PVC/PVDC/Aluminium blisters,
packed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
„PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicinal product information
tel.: 22 742 00 22
e-mail: [email protected]