Ibum femina

Package leaflet: Information for the patient

IBUM FEMINA
200 mg, soft capsules
Ibuprofenum
Please read all of this leaflet carefully before taking this medicine, because 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 or pharmacist.

• Keep this leaflet so that you can read it again if 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, or if you feel worse, consult your doctor.

Contents of the leaflet

1. What I F is and what it is used for
2. Important information before taking I F
3. How to take I F
4. Possible side effects
5. How to store I F
6. Contents of the pack and other information

1. What I F is and what it is used for

I F contains ibuprofen – a substance belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs), which have analgesic, antipyretic and anti-inflammatory properties.
Indications

• Acute mild to moderate pain of various origins:
  • Painful menstruation
  • Headaches (including migraines)
  • Toothaches
  • Musculoskeletal and bone pain
  • Pain following injuries
  • Neuralgic pain
  • Pain associated with colds and influenza
  • Ear pain occurring in inflammatory conditions of the middle ear
• Fever of various origins (e.g. during influenza, colds or other infectious diseases).

If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before using Ibum Femina

When not to use Ibum Femina:

• if the patient is allergic to ibuprofen, other non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other ingredients of this medicine (listed in section 6),
• in patients with active or previous peptic ulceration or perforation (of the stomach and/or duodenum), gastrointestinal bleeding, or a history thereof, including cases occurring during treatment with NSAIDs,
• in patients who previously experienced allergic symptoms such as rhinitis, urticaria, dyspnoea, 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 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 conditions,
• in patients with coagulation disorders, haemorrhagic diathesis (tendency to bleed), or blood formation disorders of unknown origin,
• if the patient is in the last 3 months of pregnancy.

Warnings and precautions
Before starting treatment with Ibum Femina, consult a 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 has previously suffered a stroke (including mini-stroke or transient ischaemic attack - TIA),
• the patient suffers from hypertension, diabetes, elevated cholesterol levels, has a family history of heart disease or stroke, or is a smoker,
• the patient is taking other painkillers from the NSAID group 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 conditions are currently present or have occurred in the past (dyspnoea 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 agents (such as acetylsalicylic acid).

During treatment with ibuprofen, allergic reactions to this medicine have occurred, including breathing difficulties, facial and neck swelling (angioedema), and chest pain.
If any of these symptoms occur, stop taking Ibum Femina immediately and contact a doctor or emergency medical services without delay.
Concurrent, long-term use of painkillers may lead to persistent, serious kidney diseases.
Taking anti-inflammatory/analgesic 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.
Avoid using Ibum Femina during chickenpox.
Inform your pharmacist or doctor if:

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

Infections
Ibum Femina may mask symptoms of infection such as fever and pain. Therefore, Ibum Femina 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 infection symptoms persist or worsen, medical advice should be sought immediately.

Skin reactions
Severe skin reactions associated with the use of Ibum Femina have been reported.
If any skin rash, mucosal changes, blisters, or other allergic symptoms appear, discontinue taking Ibum Femina and seek immediate medical help, as these may be the first signs of a very serious skin reaction. See section 4.
Serious 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 occurred with ibuprofen use. If the patient experiences any of the symptoms related to these severe skin reactions described in section 4, Ibum Femina should be discontinued immediately and medical help should be sought.

If any of the above conditions apply to a child, consult a doctor before using Ibum Femina.
There is a risk of gastrointestinal haemorrhage, ulceration, or perforation, which may occur without warning symptoms or in patients who previously experienced such warning signs. If gastrointestinal bleeding or ulceration occurs, discontinue the medicine immediately and contact a doctor.
Elderly patients have an increased risk of adverse effects during treatment with NSAIDs, particularly those affecting the stomach and intestines.
Patients who 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 Femina with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use:

• 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 agents (such as acetylsalicylic acid) and selective serotonin reuptake inhibitors (antidepressants), as they increase the risk of gastrointestinal adverse effects,
• antihypertensive medicines and diuretics, as NSAIDs may reduce the effectiveness of these medicines and increase the 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 ibuprofen may increase lithium levels,
• methotrexate (used in cancer or rheumatic disease treatment), as ibuprofen may increase methotrexate levels,
• tacrolimus (an immunosuppressive medicine), as there is an increased risk of nephrotoxicity,
• cyclosporine (an immunosuppressive medicine), as limited data suggest an increased risk of nephrotoxicity,
• zidovudine (used in AIDS treatment), as using Ibum Femina may increase the 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 (used in gout treatment): may delay ibuprofen excretion,
• digoxin, phenytoin, and lithium: ibuprofen may increase plasma concentrations of these medicines,
• quinolone antibiotics: may increase the risk of seizures,
• cholestyramine: may delay and reduce 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 (used in HIV therapy): ritonavir may increase plasma concentrations of NSAIDs,
• aminoglycosides (a class of antibiotics): NSAIDs may reduce aminoglycoside excretion,
• mifepristone: NSAIDs should not be used within 8–12 days after mifepristone administration, as they may reduce its effectiveness,
• calcium channel antagonists: 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.

Using ibuprofen with herbal products such as ginkgo (Ginkgo biloba) and meadowsweet (Filipendula ulmaria) may increase the risk of bleeding due to additive antiplatelet effects. Concurrent use of ibuprofen and products containing ma huang (Ephedra sinica) may increase the risk of gastrointestinal mucosal damage.

Ibum Femina may affect the action of other medicines, or other medicines may affect the action of Ibum Femina. 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).

Other medicines may also be affected by or influence treatment with Ibum Femina. Therefore, always consult a doctor or pharmacist before using Ibum Femina with other medicines.

Using Ibum Femina with food and drink
Food reduces the absorption of ibuprofen from the gastrointestinal tract.
When taking ibuprofen at high doses and consuming alcohol simultaneously, symptoms such as fatigue and headache may occur.

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 Ibum Femina if you are in the last 3 months of pregnancy, as it may harm the unborn child or cause delivery complications. 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. Do not use this medicine 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, use the lowest possible dose for the shortest possible time. From the 20th week of pregnancy, Ibum Femina may cause kidney problems in the unborn child; if taken for longer than a few days, it 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 is required for longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding
Ibuprofen passes into breast milk in small amounts. When used short-term at recommended doses, harmful effects on infants appear 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 this medicine has no effect or negligible effect on the ability to drive or operate machinery. However, if visual disturbances, fatigue, dizziness, or other nervous system-related adverse effects occur, driving and operating machinery are not recommended.

Ibum Femina contains sorbitol
This 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 consult a doctor before taking this medicine or giving it to a child.

3. How to use I F

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 should be taken orally. The capsules should be swallowed whole with a glass of water. Do not chew, suck or crush the capsules. For patients with a sensitive stomach, it is recommended to take I F during meals.
I F should not be used in patients weighing less than 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 necessary, 1 capsule every 8 hours. Maximum daily dose is 3 capsules (600 mg ibuprofen).
Children aged 10 to 12 years (body weight 30–39 kg): initial dose of 1 capsule. Then, if necessary, 1 capsule every 6 hours. Maximum daily dose is 4 capsules (800 mg ibuprofen).
Adults and adolescents over 12 years of age (body weight over 40 kg): initial dose of 1 to 2 capsules. Then, if necessary, 1 (200 mg) to 2 (400 mg) capsules every 4 hours (for 200 mg dose) to 6 hours (for 400 mg dose). 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 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 immediate and short-term use. 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 and/or hepatic impairment, dose reduction is not required.
In elderly patients, caution should be exercised when using IBUM FEMINA (see "Warnings and precautions").

Overdose of I F
If a patient has taken more than the recommended dose of I F, or if a child has accidentally ingested the medicine, always consult a doctor or go to the nearest hospital for advice on possible health risks and actions to take.
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, convulsions (mainly in children), weakness and dizziness, blood in urine, feeling cold and breathing difficulties may occur.

Missed dose of I F
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 adverse effects occur or if there is any doubt, treatment should be discontinued and medical advice should be sought as soon as possible.
Elderly patients taking this medicine belong to a group at increased risk of problems related to adverse effects.
THE MEDICINE SHOULD BE DISCONTINUED AND IMMEDIATE MEDICAL ADVICE SOUGHT IF 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, drop in blood pressure leading to shock. Symptoms may occur even after the first dose. If any of these symptoms occur, immediate medical advice must be sought,
• symptoms of severe skin reactions, such as:
  • red, flat, target-like or circular rashes on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • widespread rash, high fever and enlarged lymph nodes (DRESS syndrome).
  • red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Other possible adverse effects include:
Common (occur in 1 to 10 patients out of 100):

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

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

• gastritis, colitis and exacerbation of Crohn's disease (inflammatory bowel disease),
• headache, dizziness, insomnia, restlessness, irritability or fatigue,
• visual disturbances,
• gastric ulcers which may bleed or perforate,
• oral ulcers and (or) swelling and irritation of the mouth,
• hypersensitivity reactions with rash and itching, asthma attacks (possibly with 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, accompanied by fever, chills, muscle pain, malaise, Stevens-Johnson syndrome. In exceptional cases, severe skin infections during chickenpox (varicella) have been reported,
• passing less urine than usual and swelling (possible acute kidney failure or inflammation). Kidney damage or increased blood urea levels (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 ulcers, 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 I F, medical advice should be sought,
• 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 or dark urine,
• very rarely, during ibuprofen use, symptoms of aseptic meningitis with neck stiffness, headache, malaise, fever or altered consciousness have been observed. Patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) are more susceptible to adverse effects. Immediate medical advice should be sought if these occur.

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

• chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome,
• severe skin reactions known as DRESS syndrome. Symptoms of DRESS syndrome include skin rash, fever, swollen lymph nodes 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 generalized exanthematous pustulosis). If such symptoms occur, treatment with I F should be discontinued and immediate medical help sought. See also section 2,
• skin becomes sensitive to light.

Taking medicines such as I F 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, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine I F

Keep the medicine out of the sight and reach of children.
Store below 25°C. Keep 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 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 pack and other information

What Ibum Femina contains

• The active substance is ibuprofen. Each capsule contains 200 mg of ibuprofen.
• The other ingredients (excipients) are: macrogol 400, potassium hydroxide 50%, and capsule shell composed of: gelatin, sorbitol liquid partially dehydrated, patent blue (E 131), quinoline yellow (E 104).

What Ibum Femina looks like and contents of the pack
Ibum Femina is in the form of oval, transparent green capsules, tightly filled with solution, having a smooth, glossy surface.
One pack contains 2, 4, 6, 7, 10, 15, 30, 45 or 60 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]