Ibuprofen Catalent

Leaflet accompanying the packaging: information for the user

Ibuprofen Catalent

200 mg, soft capsules
Ibuprofenum

You should carefully read the contents of the leaflet 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 your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 3 days in the case of adolescents aged 12 to 18 years or after 3 days for fever and 4 days for pain in adults, there is no improvement or the patient feels worse, you should contact a doctor.

Table of contents of the leaflet

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

1. What is Ibuprofen Catalent and what is it used for

The active substance (which makes the medicine work) is ibuprofen.
Ibuprofen belongs to a group of medicines called "non-steroidal anti-inflammatory drugs" (NSAIDs).
The action of NSAIDs is to change the body's response to pain, swelling, and high temperature.
Ibuprofen released from the soft capsule is easily absorbed by the body and provides relief for a period of up to 8 hours.
Ibuprofen Catalent is used in adolescents with a body weight of 40 kg (from 12 years of age) and in adults for short-term, symptomatic treatment of mild to moderate pain, such as headache, toothache, menstrual pain, minor sprains and strains, fever, and pain associated with colds.

2. Important information before taking Ibuprofen Catalent

When not to take Ibuprofen Catalent:

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (see section 6), aspirin or other painkillers;
• if you have or have had a stomach ulcer, perforation or bleeding in the stomach or intestines;
• if you have experienced worsening of asthma, skin rash, itching nasal congestion or facial swelling when taking ibuprofen, aspirin or similar medicines;
• if you have had bleeding or perforation in the gastrointestinal tract when taking NSAIDs (non-steroidal anti-inflammatory drugs) before;
• if you are taking other NSAIDs (non-steroidal anti-inflammatory drugs);
• if you have severe liver, heart or kidney disease;
• if you have bleeding in the brain (cerebrovascular bleeding) or other active bleeding;
• if you have blood clotting disorders;
• if you have severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake);
• if you are in the last 3 months of pregnancy;
• if you are under 12 years of age.

Warnings and precautions

Before taking Ibuprofen Catalent, you should talk to your doctor or pharmacist if:

• you have asthma;
• you have kidney, heart, liver or intestinal disease;
• you have high cholesterol or have had a heart attack or stroke in the past;
• you have had intestinal diseases (Crohn's disease or ulcerative colitis), as this condition may worsen (see section 4, Possible side effects);
• you have systemic lupus erythematosus (an immune system disorder causing joint pain, skin changes and disorders of other organs);
• you are taking other medicines that may increase the risk of stomach or intestinal disorders, such as oral corticosteroids (e.g. prednisolone), blood thinners (e.g. warfarin), selective serotonin reuptake inhibitors (used for depression) or antiplatelet agents, such as aspirin (acetylsalicylic acid);
• you are taking ibuprofen or another NSAID (including COX-2 inhibitors, such as celecoxib or etoricoxib), as you should avoid taking these medicines at the same time;
• you are dehydrated;
• you have inherited blood disorders (such as acute intermittent porphyria);
• you have blood clotting disorders;
• you have recently undergone major surgery;
• you have an infection - see "Infections" below;
• you are pregnant or breastfeeding, may be pregnant or are planning to have a baby, you should consult a doctor or pharmacist before taking this medicine.

Other warnings

• Habitual use of painkillers can lead to permanent kidney damage with a risk of kidney failure, especially when taking several painkillers at the same time.
• NSAIDs can mask the symptoms of infection and fever.
• Long-term use of any painkillers for headaches can make them worse or increase their frequency. This is called medication overuse headache (MOH). If this occurs or is suspected, you should stop taking Ibuprofen Catalent and consult a doctor.
• During the use of all NSAIDs, at any time during treatment, in patients with warning signs or without warning signs, or in the case of previous gastrointestinal events, there is a risk of gastrointestinal bleeding, ulcers or perforation, which can be fatal.
• This risk increases with increasing doses of NSAIDs, in patients with a history of gastrointestinal ulcers, especially with bleeding and perforation (see section 2, Do not take Ibuprofen Catalent), in the elderly, and in patients taking low doses of aspirin (acetylsalicylic acid) or other medicines that may increase the risk of gastrointestinal disorders. In these patients, treatment should be started with the lowest available dose and concomitant treatment with medicines that protect against these disorders (e.g. misoprostol or proton pump inhibitors) should be considered.
• If symptoms of gastrointestinal bleeding, ulcers or perforation occur (such as severe abdominal pain, black tarry stools, vomiting blood or dark particles resembling coffee grounds), you should stop taking Ibuprofen Catalent immediately and consult a doctor.
• Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with ibuprofen. If you experience any symptoms related to these severe skin reactions described in section 4, you should stop taking Ibuprofen Catalent immediately and seek medical attention. Side effects can be minimized by using the smallest effective dose for the shortest duration necessary to relieve symptoms.

Infections

Ibuprofen Catalent may mask the symptoms of infection, such as fever and pain. Therefore, Ibuprofen Catalent may delay the use of appropriate infection treatment, which can lead to increased risk of complications. This has been observed in the course of pneumonia caused by bacteria and bacterial skin infections associated with chickenpox. If you are taking this medicine during an infection and the symptoms of the infection persist or worsen, you should consult a doctor immediately.

Elderly

In the elderly, the risk of side effects, especially those related to the stomach and intestines, is increased when using NSAIDs. See section 4, Possible side effects.

Children and adolescents

In dehydrated children and adolescents, there is a risk of kidney function disorders. This medicine should not be given to adolescents with a body weight below 40 kg or under 12 years of age.

Ibuprofen Catalent and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.

If you experience any of the above interactions, you should consult a doctor or pharmacist. If you are not sure what types of medicines you are taking, you should show the medicine to your doctor or pharmacist.

Taking Ibuprofen Catalent with alcohol

You should not drink alcohol while taking Ibuprofen Catalent. Taking alcohol with Ibuprofen Catalent may increase the likelihood of certain side effects, such as those related to the gastrointestinal tract or central nervous system.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should consult a doctor or pharmacist before taking this medicine.
Pregnancy
If you become pregnant while taking ibuprofen, you should inform your doctor.
You should not take this medicine in the last 3 months of pregnancy. It may cause problems with the kidneys and heart of the unborn child. It may affect the tendency to bleed in the mother and child and may cause the delivery to be later or longer than expected. You should avoid taking this medicine in the first 6 months of pregnancy, unless your doctor advises otherwise. If you are taking this medicine for more than a few days from the 20th week of pregnancy, Ibuprofen Catalent may cause problems with the kidneys of the unborn child, which may lead to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Only small amounts of ibuprofen and its breakdown products pass into breast milk.
Ibuprofen Catalent can be used during breastfeeding at the recommended dose and for as short a time as possible.
Fertility
Ibuprofen Catalent belongs to a group of medicines (NSAIDs) that may impair fertility in women. This effect is reversible after stopping the medicine.

Driving and using machines

In the case of short-term use, this medicine has a minor or no effect on the ability to drive and use machines. However, after higher doses, side effects such as fatigue, dizziness or vision disturbances may occur, which affect the ability to react in traffic and operate machinery. These effects are more likely when taking the medicine with alcohol.

Important information about some of the ingredients of this medicine:

This medicine contains:

• Carmoisine (E124), which may cause allergic reactions.
• Sorbitol (E420) - this medicine contains 59.3 mg of sorbitol, liquid, partially dehydrated in each capsule.

3. How to take Ibuprofen Catalent

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult a doctor or pharmacist.
Ibuprofen Catalent is for oral use.
You should use the smallest effective dose for the shortest duration necessary to relieve symptoms. If you have an infection and the symptoms of the infection persist or worsen (see section 2), you should consult a doctor immediately.

Dosage

Adults, elderly, and adolescents with a body weight of 40 kg from 12 years of age:

Take 1 to 2 capsules up to three times a day as needed.
Swallow the capsules whole with a glass of water. There should be at least a 4-hour interval between doses.
Do not take more than 6 capsules of Ibuprofen Catalent (1200 mg) in 24 hours.
Do not give this medicine to children under 12 years of age.

Duration of treatment

For adolescents with a body weight of 40 kg, from 12 to 18 years of age:if it is necessary to use the medicine for more than 3 days or if the symptoms worsen, you should consult a doctor.
For adults:if it is necessary to use the product for more than 3 days for fever or more than 4 days for pain, or if the symptoms worsen, you should consult a doctor.
If you have taken more Ibuprofen Catalent than you should, or if a child has taken this medicine by mistake, you should always contact a doctor or the nearest hospital for advice on the risk and the actions to be taken.
Symptoms of overdose may include nausea, abdominal pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4 below), diarrhea, headache, ringing in the ears, confusion, and convulsions. You may also experience agitation, sleepiness, confusion, or coma. Rarely, patients have experienced seizures. After taking large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Additionally, the prothrombin time (INR) may be prolonged, probably due to the disruption of blood clotting factors. Acute kidney failure and liver damage may occur. In patients with asthma, worsening of asthma symptoms may occur. Additionally, low blood pressure and difficulty breathing may occur.

Missing a dose of Ibuprofen Catalent

You should not take a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The risk of side effects can be minimized by taking the smallest effective dose for the shortest duration necessary to relieve symptoms.

In any of the following cases, you should STOP TAKINGthe medicine and seek medical attention immediately:

• Symptoms of gastrointestinal bleeding, such as severe abdominal pain, black tarry stools, vomiting blood or dark particles resembling coffee grounds.
• Symptoms of a rare but serious allergic reaction, such as worsening of asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, low blood pressure leading to shock. These may occur even after the first use of this medicine. If you experience any of these symptoms, you should contact a doctor immediately.
• Red, non-raised, target-like or circular patches on the trunk, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).
• Red, scaly, widespread rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

If you experience any of the following side effects, their worsening, or side effects not listed below, you should INFORM YOUR DOCTOR.

Common (may affect up to 1 in 10 people)

• Gastrointestinal disorders, such as abdominal pain and nausea, indigestion, diarrhea, bloating (gas) and constipation, heartburn, vomiting, and minor bleeding in the stomach and/or intestines, which in rare cases may lead to anemia.

Uncommon (may affect up to 1 in 100 people)

• Stomach and intestinal ulcers, perforation or bleeding, mouth ulcers, worsening of active intestinal disease (ulcerative colitis or Crohn's disease), gastritis (inflammation of the stomach lining).
• Headache, dizziness, insomnia, restlessness, or fatigue.
• Visual disturbances.
• Skin rashes and other skin reactions, such as itching.

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

• Ringing in the ears (tinnitus), hearing loss.
• Kidney damage and increased uric acid levels in the blood (pain in the sides and/or abdomen and fever may be signs of kidney damage).
• Decreased hemoglobin levels, leading to anemia.

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

• Pancreatitis or esophageal inflammation (inflammation of the digestive tract), formation of diaphragm-like constrictions in the small and large intestines.
• Heart failure, heart attack, and swelling of the face or hands (edema).
• Decreased urine output and swelling (especially in patients with high blood pressure or reduced kidney function), swelling, and cloudy urine; kidney inflammation, which can lead to acute kidney failure. If you experience any of these symptoms or general malaise, you should stop taking Ibuprofen Catalent and consult a doctor immediately, as they may be the first signs of kidney damage or failure.
• Hair loss (alopecia).
• Psychotic reactions, depression.
• High blood pressure, vasculitis (inflammation of blood vessels) causing red or purple spots on the skin.
• Palpitations.
• Liver function disorders, liver damage (the first symptoms may be skin discoloration), especially during long-term treatment, liver failure, acute liver inflammation.
• Blood disorders - the first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and unexplained bruising. In such cases, you should stop taking the medicine and consult a doctor immediately. You should not try to treat yourself with painkillers or antipyretics.
• Worsening of infection-related inflammation. If infection symptoms occur or worsen, you should consult a doctor immediately, as antibiotic or other treatment may be necessary.
• During the use of ibuprofen, symptoms of aseptic meningitis have been observed, with stiffness in the neck, headache, nausea, vomiting, fever, or changes in consciousness. Patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease) may be more prone to these symptoms. If you experience these symptoms, you should contact a doctor immediately.

Frequency not known:

• Respiratory system reactions, such as asthma, difficulty breathing, or shortness of breath.
• A severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and an increase in the number of white blood cells of a specific type.
• The skin becomes sensitive to light.
• A red, scaly, widespread rash with blisters under the skin and blisters, mainly in skin folds, on the trunk and upper limbs, which is accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). If you experience such symptoms, you should stop taking Ibuprofen Catalent and consult a doctor immediately.
• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome. Medicines in the NSAID group, such as this one, may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke. See section 2, Warnings and precautions.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your 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, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +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, you can help provide more information on the safety of this medicine.

5. How to store Ibuprofen Catalent

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ibuprofen Catalent contains

The active substance of the medicine is ibuprofen.
Each capsule contains 200 mg of ibuprofen.
The other ingredients are: macrogol 600, potassium hydroxide (E525), purified water, gelatin, sorbitol, liquid, partially dehydrated (E420), carmoisine (E124), white ink (propylene glycol (E1520), titanium dioxide (E171), poly(vinyl) acetate phthalate, medium-chain triglycerides, lecithin (E322) (derived from soy).

What Ibuprofen Catalent looks like and contents of the pack

Oval capsule with a transparent red gelatin shell, with a logo printed in white ink, containing a transparent liquid filling.
Approximate length: 12.9 mm to 13.5 mm; approximate diameter: 7.8 mm to 8.4 mm.
Ibuprofen Catalent is available in blisters of PVC/PVDC/Aluminum or PVC/PE/PVDC/Aluminum foil, containing 10, 12, 16, 18, 20, 24, 28, 30, 32, 36, 48, 96 soft capsules.
The PVC layer may be transparent or opaque. The blister strips are packaged in a carton box.
Not all pack sizes may be marketed.

Marketing authorization holder

Catalent Germany Eberbach GmbH, Gammelsbacher Str. 2, 69412 Eberbach, GERMANY

Manufacturer

Catalent Germany Eberbach GmbH, Gammelsbacher Str. 2, 69412 Eberbach, GERMANY or Catalent Germany Schorndorf GmbH, Steinbeisstr. 1 und 2, 73614 Schorndorf, GERMANY

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: 27.02.2025