Ibuprofen catalent

Package leaflet: Information for the user

Ibuprofen Catalent
200 mg, soft capsules
Ibuprofen
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 or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please contact 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 in adolescents aged 12 to 18 years, or after 3 days of treating fever and 4 days of treating pain in adults, or if you feel worse, consult your doctor.

Leaflet contents

1. What Ibuprofen Catalent is and what it is 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 pack and other information

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

The active substance (the one responsible for the effect of this medicine) is ibuprofen.
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
NSAIDs work by altering the body's response to pain, swelling, and high temperature.
Ibuprofen released from the soft capsule is readily absorbed by the body and provides relief for up to 8 hours.
Ibuprofen Catalent is used in adolescents with a body weight of at least 40 kg (aged 12 years and above) and in adults for short-term, symptomatic treatment of mild to moderate pain, such as headache, toothache, menstrual pain, minor joint pain and sprains, fever and pain associated with colds.

2. Important Information Before Taking Ibuprofen Catalent

When not to take Ibuprofen Catalent:

• if the patient is allergic to ibuprofen or any of the other ingredients of this medicine (see section 6), aspirin, or other painkillers;
• if the patient has or has previously had a stomach or intestinal ulcer, perforation, or gastrointestinal bleeding;
• if the patient has experienced worsening asthma, skin rash, runny or itchy nose, or facial swelling during previous use of ibuprofen, aspirin, or similar medicines;
• if the patient has had gastrointestinal bleeding or perforation while previously taking NSAIDs (non-steroidal anti-inflammatory drugs);
• if the patient is taking other NSAIDs (non-steroidal anti-inflammatory drugs);
• if the patient has severe liver, heart, or kidney disease;
• if the patient has brain haemorrhage (cerebrovascular haemorrhage) or any other active bleeding;
• if the patient has blood cell formation disorders;
• if the patient has severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake);
• if the patient is in the last 3 months of pregnancy;
• if the patient is under 12 years of age.

Warnings and precautions

Before starting to take Ibuprofen Catalent, speak with a doctor or pharmacist if:

• the patient suffers or has suffered from asthma;
• the patient has kidney, heart, liver, or intestinal disease;
• the patient has high cholesterol or has previously had a heart attack or stroke;
• the patient has ever had intestinal diseases (Crohn's disease or ulcerative colitis), as these conditions may worsen (see section 4, Possible side effects);
• the patient suffers from systemic lupus erythematosus (an autoimmune disorder causing joint pain, skin changes, and organ dysfunction);
• the patient is taking other medicines that may increase the risk of stomach or intestinal ulcers or bleeding, such as oral corticosteroids (e.g. prednisolone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (used for depression), or antiplatelet drugs such as aspirin (acetylsalicylic acid);
• the patient is already taking ibuprofen or another NSAID (including COX-2 inhibitors such as celecoxib or etoricoxib), as concurrent use of these medicines should be avoided;
• the patient is dehydrated;
• the patient has a hereditary blood formation disorder (such as acute intermittent porphyria);
• the patient has blood clotting disorders;
• the patient has recently undergone major surgery;
• the patient has an infection – see section "Infections" below;
• the patient is in the first 6 months of pregnancy, unless otherwise advised by a doctor.

If Ibuprofen Catalent is used long-term, regular blood tests are required to monitor blood counts, liver, and kidney function.

Anti-inflammatory and pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), or chest pain, have been reported. If any of these symptoms occur, discontinue Ibuprofen Catalent immediately and contact a doctor or emergency medical services without delay.

Before starting to take Ibuprofen Catalent, discuss treatment with a doctor or pharmacist if:

• the patient has or has had heart disease, including heart failure, angina (chest pain), heart attack, coronary artery bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or has had any stroke (including "mini-stroke" or transient ischaemic attack, TIA);
• the patient has high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or is a smoker.

Other warnings

• Regular use of painkillers may lead to permanent kidney damage and risk of kidney failure, particularly when multiple painkillers are used simultaneously.
• NSAIDs may mask symptoms of infection and fever.
• Long-term use of any painkillers for headaches may worsen or increase their frequency. This is known as medication-overuse headache (MOH). If such headache occurs or is suspected, discontinue Ibuprofen Catalent and consult a doctor.
• When using any NSAID, at any point during treatment, there is a risk of gastrointestinal bleeding, ulceration, or perforation – with or without warning symptoms – which may be fatal.
• This risk increases with higher NSAID doses, in patients with a history of peptic ulcer disease (especially with bleeding or perforation – see section 2, Do not take Ibuprofen Catalent), in elderly patients, and in patients taking low-dose aspirin (acetylsalicylic acid) or other drugs that may increase gastrointestinal risks. In such patients, treatment should start with the lowest available dose, and concomitant gastroprotective therapy (e.g. misoprostol or proton pump inhibitors) should be considered.
• If any symptoms of gastrointestinal bleeding, ulceration, or perforation occur (such as severe upper abdominal pain, black tarry stools, vomiting blood or dark particles resembling coffee grounds), immediately stop taking Ibuprofen Catalent and consult a doctor.
• Serious skin reactions have been reported with ibuprofen use, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP). If any of the symptoms associated with these serious skin reactions described in section 4 occur, discontinue Ibuprofen Catalent immediately and seek medical help.

Adverse effects can be minimized by using the lowest effective dose for the shortest duration needed to control symptoms.

Infections

Ibuprofen Catalent may mask symptoms of infection such as fever and pain. Therefore, Ibuprofen Catalent may delay appropriate treatment of infection, potentially increasing 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 infection and symptoms persist or worsen, medical advice should be sought immediately.

Elderly patients

In elderly patients, the risk of adverse effects from NSAIDs, particularly gastrointestinal effects, is increased. See section 4, Possible side effects.

Children and adolescents

Dehydrated children and adolescents may be at risk of impaired kidney function. This medicine must not be given to adolescents with body weight below 40 kg or under 12 years of age.

Ibuprofen Catalent and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

If any of the above events occur, consult a doctor or pharmacist. If the patient is unsure about which types of medicines they are taking, they should show the medicine to a doctor or pharmacist.

Use of Ibuprofen Catalent with alcohol
Do not drink alcohol while taking Ibuprofen Catalent. Taking alcohol together with Ibuprofen Catalent may increase the likelihood of certain adverse effects, for example, those affecting the gastrointestinal tract or the central nervous system.

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

Pregnancy
If a patient becomes pregnant while taking ibuprofen, she should inform her doctor.
Do not use this medicine during the last three months of pregnancy. It may cause kidney and heart problems in the unborn child. It may affect the tendency to bleed in both mother and child and may cause delivery to occur later than expected or to last longer than expected. Avoid using this medicine during the first six months of pregnancy unless otherwise advised by a doctor. If used for longer than a few days from week 20 of pregnancy, Ibuprofen Catalent may cause kidney problems in the unborn child, which may lead to low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If treatment lasting longer than a few days is required, the doctor may recommend additional monitoring.

Breastfeeding
Only small amounts of ibuprofen and its breakdown products pass into breast milk.
Ibuprofen Catalent may be used during breastfeeding at the recommended dose and for the shortest possible duration.

Fertility
Ibuprofen Catalent belongs to a group of medicines (NSAIDs) which may impair fertility in women. This effect is reversible upon discontinuation of the medicine.

Driving and operating machinery
When used short-term, this medicine has little or no influence on the ability to drive or operate machinery. However, at higher doses, adverse effects such as fatigue, dizziness or visual disturbances may occur, which may affect the ability to react while driving or operating machinery. These effects are more likely when the medicine is taken together with alcohol.

Important information about certain 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 information leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Ibuprofen Catalent is intended for oral use.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If the patient has an infection and symptoms (such as fever and pain) persist or worsen (see section 2), contact your doctor immediately.

Dosage
Adults, elderly patients, and adolescents aged 12 years and older with a body weight of at least 40 kg:
Depending on need, take 1 to 2 capsules up to three times daily.
Swallow the capsules whole with a glass of water. Leave at least 4 hours 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
In adolescents with body weight of at least 40 kg, aged 12 to 18 years: if treatment longer than 3 days is needed or if symptoms worsen, consult a doctor.
In adults: if the product is required for more than 3 days for fever or more than 4 days for pain, or if symptoms worsen, consult a doctor.

If you take more Ibuprofen Catalent than you should, or if children accidentally ingest the medicine, contact your doctor or nearest hospital immediately for advice on potential risks and necessary actions.
Symptoms of overdose may include nausea, epigastric pain, vomiting (possibly with blood), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, confusion, and nystagmus. Excitement, drowsiness, confusion, or coma may also occur. Seizures have been reported rarely. After large overdoses, 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 may be reported. Additionally, prothrombin time (INR) may be prolonged, likely due to impaired blood clotting factor function. Acute kidney failure and liver damage may occur. In patients with asthma, worsening of asthma symptoms may occur.
Additionally, low blood pressure and breathing difficulties may occur.

If you miss a dose of Ibuprofen Catalent
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
The risk of adverse effects can be reduced by taking the lowest effective dose
for the shortest duration necessary to relieve symptoms.
In any of the following cases, STOP TAKING THE MEDICINE
and seek immediate medical help:

• Symptoms of gastrointestinal bleeding, such as: severe upper abdominal pain, black tarry stools, vomiting blood or dark particles resembling coffee grounds.
• Symptoms of a rare but severe allergic reaction, such as worsening asthma, unexplained wheezing or shortness of breath, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, drop in blood pressure leading to shock. These may occur even after the first dose of this medicine. If any of these symptoms occur, contact a doctor immediately.
• Red, flat, target-like or circular spots on the trunk, often with blisters in the center, peeling skin, mouth ulcers, and lesions in the throat, nose, genital organs and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Extensive rash, high fever, and swollen 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). If any of the following adverse effects occur, worsen, or if any unlisted adverse effects occur, YOU SHOULD INFORM YOUR DOCTOR.
  Common (may affect up to 1 in 10 people)
• Gastrointestinal disturbances such as abdominal pain, nausea, indigestion, diarrhoea, bloating (wind) and constipation, heartburn, vomiting, and minor gastrointestinal bleeding which, in rare cases, may lead to anaemia.
  Uncommon (may affect up to 1 in 100 people)
• Gastric and intestinal ulcers, perforation or bleeding, mouth ulcers, exacerbation of active inflammatory bowel disease (colitis or Crohn's disease), inflammation of the stomach (gastritis, inflammation of the gastric mucosa).
• Headache, dizziness, insomnia, restlessness, irritability 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 elevated blood uric acid levels (pain in the sides and/or upper abdomen, blood in the urine and fever may be symptoms of kidney damage).
• Decreased haemoglobin levels, resulting in anaemia.
  Very rare (may affect up to 1 in 10,000 people)
• Pancreatitis or oesophagitis (gastrointestinal tract), formation of diaphragm-like strictures in the small and large intestine.
• Heart failure, heart attack, and facial or hand swelling (oedema).
• Reduced urine output and oedema (especially in patients with high blood pressure or impaired kidney function), oedema and cloudy urine; inflammatory kidney disease which may lead to acute kidney failure. If any of these symptoms or general malaise occur, stop taking Ibuprofen Catalent immediately and consult a doctor without delay, as these may be the first signs of kidney damage or kidney failure.
• Hair loss (alopecia).
• Psychotic reactions, depression.
• High blood pressure, vasculitis causing red or purple skin spots.
• Palpitations.
• Liver function disorders, liver damage (early signs may include skin discolouration), especially during prolonged treatment, liver failure, acute hepatitis.
• Problems with blood cell production – early symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nose and skin bleeding, and unexplained bruising. In such cases, the medicine must be discontinued immediately and medical advice sought. Do not attempt self-treatment with painkillers or antipyretics.
• Worsening of inflammation associated with infection. If signs of infection appear or worsen, seek medical advice immediately, as treatment with antibiotics or other therapies may be necessary.
• During ibuprofen use, symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever or altered consciousness have been observed. Patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease) may be at higher risk of developing these symptoms. If these symptoms occur, contact a doctor immediately.
  Frequency not known:
• Respiratory system reactions such as asthma, difficulty breathing or laboured breathing.
• A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and increased numbers of a specific type of white blood cells.
• Skin becomes sensitive to light.
• Red, scaly, widespread rash with subcutaneous vesicles and blisters mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). If such symptoms occur, discontinue use of Ibuprofen Catalent immediately and contact a doctor without delay.
• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome. NSAIDs such as this medicine may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke. See section 2, Warnings and precautions.
  Reporting of adverse effects
  If any adverse effects occur in the patient, including any possible adverse effects not listed in this leaflet, inform a 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 to provide more information on the safety of the medicine.

5. How to store Ibuprofen Catalent

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box following "EXP". The expiry date refers to the last day of the specified month.
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Doing so helps protect the environment.

6. Contents of the pack and other information

What Ibuprofen Catalent contains
The active substance 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), carmine red (E124), white ink (propylene glycol (E1520), titanium dioxide (E171), poly(vinyl)phthalate, macrogol 400, ammonium hydroxide 28% (E527)), 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 coating, printed with a logo in white ink, containing a clear liquid filling.
Approximate length: from 12.9 mm to 13.5 mm; approximate diameter: from 7.8 mm to 8.4 mm.
Ibuprofen Catalent is available in blisters made of PVC/PVDC/Aluminum or PVC/PE/PVDC/Aluminum, containing 10, 12, 16, 18, 20, 24, 28, 30, 32, 36, 48, or 96 soft capsules.
The PVC layer may be transparent or opaque. Blister strips are packed in cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorisation 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 and 2
73614 Schorndorf
GERMANY

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