Ibukern 600 mg oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibukern 600 mg oral suspension

Ibuprofen

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Ibukern is and what it is used for
2. What you need to know before taking Ibukern
3. How to take Ibukern
4. Possible adverse effects
5. How to store Ibukern
6. Contents of the pack and other information

1. What Ibukern is and what it is used for

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is indicated for the treatment of fever and mild to moderate pain associated with conditions such as dental pain, postoperative pain, headache including migraine, and for the symptomatic relief of pain, fever, and inflammation accompanying conditions such as pharyngitis (inflammation of the upper part of the throat), tonsillitis (inflammation of the tonsils), and otitis (inflammation of certain structures of the middle ear), among others. It is also indicated for the treatment of arthritis or joint inflammation (rheumatoid, psoriatic, gouty, etc.), osteoarthritis (cartilage inflammation of the joints), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation (bursitis, synovitis, capsulitis, or other types of traumatic or sports-related inflammatory injuries), and primary dysmenorrhea (painful menstruation).

2. What you need to know before taking Ibukern

It is important that you use the lowest dose that relieves/controls your pain and that you do not take this medicine for longer than necessary to control your symptoms.

Do not take Ibukern if:

• You are allergic to ibuprofen or to any of the other components of this medicine (listed in section 6).
• You have previously experienced a stomach or duodenal bleed or have suffered a perforation of the digestive tract while taking a non-steroidal anti-inflammatory drug (NSAID).
• You currently have or have had on more than one occasion: a stomach or duodenal ulcer or bleeding.
• You have severe heart failure.
• You are in the third trimester of pregnancy.
• You have a serious disease of the liver or kidneys.
• You have bleeding disorders or blood coagulation disorders, or you are taking anticoagulants (medicines used to "thin" the blood).
• You have an exacerbation of ulcerative colitis or Crohn's disease.
• After taking acetylsalicylic acid or other NSAIDs, you have experienced skin rash with itching, swelling of the face, lips or tongue, nasal discharge, breathing difficulties or asthma.

Warnings and precautions

Allergic reactions to ibuprofen, such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported. Stop using Ibukern immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Consult your doctor, pharmacist, or nurse before starting to take this medicine if:

• You have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms.
• This risk is higher when high doses and prolonged treatments are used, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor may consider prescribing a stomach-protective medicine.
• You are taking medicines that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• You have Crohn's disease or ulcerative colitis, as medicines of this type may worsen these conditions.
• You have previously had kidney or liver disease.
• You have edema (fluid retention).
• You suffer from asthma or any other respiratory disorder.
• You have an infection; see the "Infections" section below.
• You have heart, kidney, or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (more than 1–2 weeks), your doctor may need to perform regular check-ups. Your doctor will advise you on how often these checks should be carried out.

Skin reactions

Take special care with Ibukern:

Serious skin reactions have been reported with ibuprofen treatment, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP). Stop treatment with Ibukern and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Cardiovascular precautions

Medicines such as ibuprofen, which are anti-inflammatory/analgesic, may be associated with a small increased risk of having a heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking ibuprofen if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, bypass surgery, peripheral arterial disease (circulation problems in the legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").
• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Also, these types of medicines may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Consult your doctor or pharmacist before starting to take Ibukern.

Infections

Ibukern may mask signs of infection, such as fever and pain. Therefore, this medicine may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Children:

Do not administer to children under 12 years of age without consulting a doctor.

Taking Ibukern with other medicines:

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

Ibukern may interact with or be affected by other medicines. For example:

• Other non-steroidal anti-inflammatory drugs (NSAIDs): as this may increase the risk of adverse effects.
• Anticoagulant medicines (e.g., to treat or prevent blood clotting, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, and angiotensin II receptor antagonists such as losartan).
• Lithium (a medicine used to treat depression): as this may increase blood levels of lithium and the risk of adverse effects. If you need to take lithium and ibuprofen, your doctor may need to adjust your lithium dose.
• Methotrexate: if you take methotrexate and ibuprofen simultaneously (within a 24-hour interval), blood levels of methotrexate and the risk of toxicity may increase. Your doctor may advise you not to take ibuprofen if you are receiving high-dose methotrexate treatment.
• Hydantoins such as phenytoin (for the treatment of epilepsy).
• Sulfonamides: as they may increase their toxic effects.

Other interactions requiring caution:

• Corticosteroids such as cortisone and prednisolone, diuretics, fluconazole, pentoxifylline, probenecid, quinolones (such as norfloxacin), sulfinpyrazone, sulfonylureas (such as tolbutamide), tacrolimus, cyclosporine, zidovudine, as they may increase the risk of gastrointestinal ulcer or bleeding.
• Selective serotonin reuptake inhibitor (SSRI) antidepressants may also increase the risk of gastrointestinal bleeding.

Other medicines may also affect or be affected by treatment with Ibukern. Therefore, you should always consult your doctor or pharmacist before using Ibukern with other medicines.

Taking Ibukern with food and drinks:

You may take it alone or with food. In general, it is recommended to take it with meals to reduce the possibility of stomach discomfort.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy:

Precautions during pregnancy and in women of childbearing age

Because the use of this type of medicine has been associated with an increased risk of congenital abnormalities or miscarriage, its use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

During the third trimester, administration of this medicine is contraindicated.

It may cause kidney and heart problems in your fetus. It may affect your and your baby's tendency to bleed and may delay or prolong labor more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may lead to low levels of amniotic fluid 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 needed, your doctor may recommend additional monitoring.

For women of childbearing age, it should be noted that these types of medicines have been associated with a reduced ability to conceive.

Breastfeeding:

Although drug levels in breast milk are negligible, it is recommended to consult your doctor during long-term treatment or when using high doses while breastfeeding.

Driving and using machines

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medicine, you should not drive or operate machinery. If you only take a single dose of ibuprofen or take it for a short period, no special precautions are necessary.

Ibukern contains sodium, sodium benzoate (E-211), and maltitol liquid (E-965)

This medicine contains 87 mg of sodium (main component of table/cooking salt) per sachet. This corresponds to 4.35% of the maximum daily sodium intake recommended for an adult.

This medicine contains 15 mg of sodium benzoate (E-211) per sachet.

This medicine contains liquid maltitol. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine. It may produce a mild laxative effect because it contains 7.5 g of liquid maltitol per sachet.

Calorific value: 2.3 kcal/g of maltitol/isomalt.

3. How to take Ibukern

Follow exactly the administration instructions for this medicine as provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults:

The recommended dose for adults and adolescents is one sachet (600 mg) every 6 to 8 hours, depending on the severity of symptoms and response to treatment. In adults, the recommended maximum daily dose is 2400 mg, whereas in adolescents it is 1600 mg.

Do not administer this medicine to children under 12 years of age without consulting a doctor.

If you have kidney and/or liver disease, your doctor may prescribe a lower-than-usual dose. If so, take exactly the dose prescribed by your doctor.

Elderly patients:

If you are over 60 years of age, your doctor may prescribe a lower-than-usual dose. In such cases, the dose may only be increased once your doctor has confirmed that you tolerate the medicine well.

Always use the lowest effective dose. The duration of treatment will be determined by your doctor; do not discontinue treatment prematurely.

This medicine is administered orally.

This product is a suspension. It should be homogenized before use by pressing with your fingers on the top and bottom parts of the sachet several times. It can be taken directly from the sachet or diluted in water.

If gastrointestinal discomfort occurs, it is recommended to take the medicine with food.

Remember to take your medicine as prescribed. If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.

If you take more Ibukern than you should

If you have taken more Ibukern than you should, or if a child has accidentally ingested the contents of the package, contact your doctor or pharmacist immediately, the Toxicology Information Service at telephone number: 91 562 04 20, or go to the nearest hospital to learn about the risks and receive advice on the measures to be taken, indicating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

Symptoms of overdose may include: stomach pain, nausea, vomiting (which may contain blood-stained sputum), indifference, drowsiness, headache, involuntary eye movements, tinnitus, confusion, and lack of muscle coordination. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported.

If you forget to take Ibukern

Do not take a double dose to make up for missed doses.

If you forget to take your scheduled dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at your usual time.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Ibukern may cause adverse effects, although not everyone experiences them.

The frequencies are defined as follows: very common (may affect more than 1 in 10 people), common (may affect up to 1 in 10 people), uncommon (may affect up to 1 in 100 people), rare (may affect up to 1 in 1,000 people), very rare (may affect up to 1 in 10,000 people), and not known frequency (cannot be estimated from available data).

The following adverse effects have been observed:

Gastrointestinal:

The most common adverse effects associated with medicines containing this active ingredient are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stools, mouth ulcers, and worsening of ulcerative colitis and Crohn's disease have also been observed. Less frequently, gastritis has been reported.

Common: nausea, vomiting, abdominal pain, heartburn, flatulence, and constipation.

Uncommon: gastrointestinal bleeding, stomach or duodenal ulcers.

Rare: gastric or intestinal perforation, inflammation of the esophagus, and ulcers or inflammation of the intestine.

Dermatological:

Discontinue treatment with Ibukern and seek immediate medical attention if you experience any of the following symptoms:

• Red, non-elevated spots, target-shaped or circular rashes on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• Widespread, red, scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Common: skin rash.

Uncommon: skin redness, itching or swelling of the skin, swelling of the lips, face, or tongue, increased nasal discharge, and breathing difficulties.

Rare: severe allergic reactions (anaphylactic shock).

Very rare: sudden onset of intense skin itching or skin blisters, joint pain, and fever (systemic lupus erythematosus), hair loss, photosensitivity skin reactions. Medicines containing this active ingredient may, very rarely, be associated with severe blistering reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and allergic vasculitis.

Aseptic meningitis (inflammation of the membranes covering the brain and spinal cord), mostly occurring in patients with autoimmune disorders such as systemic lupus erythematosus.

Severe allergic reaction that may present with nausea, vomiting, swelling of the face, tongue, and throat, breathing difficulties, asthma, palpitations, hypotension, or shock.

Drug reaction with eosinophilia and systemic symptoms (DRESS): A severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell).

Frequency not known: Widespread, red, scaly rash with bumps under the skin and blisters, mainly affecting skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Ibukern immediately if you experience these symptoms and seek medical attention right away. See also section 2.

Central Nervous System:

Common: headache.

Uncommon: fatigue or drowsiness.

Very rare: aseptic meningitis.

Psychiatric:

Common: feeling of instability and nervousness.

Uncommon: anxiety.

Rare: disorientation or confusion, depression.

Auditory:

Uncommon: tinnitus (ringing or buzzing in the ears).

Rare: hearing impairment.

Ocular:

Uncommon: visual disturbances.

Rare: abnormal or blurred vision.

Hematological:

Very rare: prolonged bleeding time, blood cell disorders (early symptoms may include: fever, sore throat, mouth ulcers, flu-like symptoms, excessive fatigue, nosebleeds, and skin bleeding).

Cardiovascular:

These medicines may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke.

Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Edema (fluid retention), high blood pressure, and heart failure have also been observed in association with treatment using medicines of this type.

Renal:

Kidney disease.

Hepatic:

Rare: hepatitis (liver inflammation) and jaundice (yellowing of the skin). These medicines may, in rare cases, be associated with liver injury.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibukern

Keep this medicine out of sight and reach of children.

Store in the original packaging.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Ibukern

• The active substance is ibuprofen. Each sachet contains 600 mg of ibuprofen.
• The other components (excipients) are: Sodium benzoate (E-211), anhydrous citric acid, sodium citrate, sodium saccharin, sodium chloride, hypromellose, xanthan gum, liquid maltitol, thaumatin (E-957), strawberry flavour, glycerol and purified water.

Appearance of the product and contents of the pack

Ibukern 600 mg is presented as an oral suspension. Heat-sealed sachets made from an aluminium complex (polyester, aluminium, polyethylene, polyester and polyethylene). Each pack contains 20 or 40 sachets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent revision of this leaflet: November 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/