Ibuprofen Kern Pharma 200 mg effervescent granules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ibuprofen Kern Pharma 200 mg effervescent granules EFG

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 must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Ibuprofeno Kern Pharma is and what it is used for

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

Ibuprofeno Kern Pharma is indicated for the treatment of symptoms of:

• Juvenile rheumatoid arthritis (inflammation of the joints, usually including those of the hands and feet, leading to swelling and pain appearing at an early age).
• Mild to moderate painful conditions.
• Fever of various causes.

2. What you need to know before starting to take Ibuprofeno Kern Pharma

It is important that you use the smallest dose that relieves/controls your pain and that you do not take Ibuprofeno Kern Pharma for longer than necessary to control your symptoms.

Do not take Ibuprofeno Kern Pharma

• If you are allergic (hypersensitive) to ibuprofen, to other drugs in the group of non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the other ingredients of Ibuprofeno Kern Pharma.
• If you have previously experienced stomach or duodenal bleeding or have suffered a perforation of the digestive tract while taking a non-steroidal anti-inflammatory drug.
• If you currently have or have had more than one episode of stomach or duodenal ulcer or bleeding.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy (see section “Pregnancy and breastfeeding”).
• If you have severe liver or kidney disease.
• If you are vomiting blood.
• If you have black stools or bloody diarrhoea.
• If you have bleeding or blood coagulation disorders, or if you are taking anticoagulants (medications used to “thin” the blood). If it is necessary to use anticoagulants simultaneously, your doctor will perform blood coagulation tests.
• If you have a worsening of ulcerative colitis or Crohn’s disease.
• If you are allergic to acetylsalicylic acid or other NSAIDs. Such reactions could include itchy skin rash, facial, lip or tongue swelling, runny nose, breathing difficulties, or asthma.
• If you are pregnant (see section “Pregnancy and breastfeeding”).

Warnings and precautions

Allergic reactions to ibuprofen, including respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using Ibuprofeno Kern Pharma immediately and contact your doctor or emergency medical services right away 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 are used or treatment is prolonged, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider prescribing a stomach-protective medication.
• If you have had kidney or liver disease.
• If you have oedema (fluid retention).
• If you have or have had heart disease or high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you have an infection; see the section “Infections” below.
• If you have heart, kidney, or liver disease, are over 60 years old, or need to take the medicine long-term (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 occur.

Inform your doctor

• If you are taking medications 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 bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• If you have Crohn’s disease or ulcerative colitis, as medicines like ibuprofen may worsen these conditions.

Skin reactions

Take special care with Ibuprofeno Kern Pharma:

Severe skin reactions have been reported with ibuprofen, including 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). Discontinue treatment with Ibuprofeno Kern Pharma and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Cardiovascular precautions

Medicines such as ibuprofen (non-steroidal anti-inflammatory/analgesic drugs) 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.

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 artery 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 ischaemic attack “TIA”).
• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

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

Precautions during pregnancy and in women of childbearing age

Because the use of medicines like ibuprofen has been associated with an increased risk of congenital malformations or miscarriage, administration during the first and second trimesters of pregnancy is not recommended unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

Administration of ibuprofen is contraindicated during the third trimester.

For women of childbearing age, it should be noted that medicines like ibuprofen have been associated with reduced fertility.

Inform your doctor if you have started treatment with ibuprofen before your appointment, as ibuprofen may mask symptoms of a possible infection, making diagnosis more difficult.

Infections

Ibuprofen may mask signs of infection, such as fever and pain. Therefore, ibuprofen may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor immediately.

Taking Ibuprofeno Kern Pharma with other medicines

Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines, including those obtained without a prescription, as it may be necessary to interrupt treatment or adjust the dose of one or more of them.

Ibuprofeno Kern Pharma may interact with or be affected by other medicines. For example:

• Other non-steroidal anti-inflammatory drugs (NSAIDs).
• Anticoagulant medicines (e.g. used to treat coagulation problems or prevent clotting, such as 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). Your doctor may adjust the dose of this medicine.
• Methotrexate. Your doctor may adjust the dose of this medicine.
• Mifepristone.
• Digoxin and cardiac glycosides (used in the treatment of heart failure).
• Hydantoins such as phenytoin (used in the treatment of epilepsy).
• Sulphonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics.
• Fluconazole.
• Pentoxifylline.
• Probenecid.
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone.
• Sulfonylureas such as tolbutamide.
• Tacrolimus.
• Zidovudine.

Other medicines may also interact with or be affected by treatment with Ibuprofeno Kern Pharma. Therefore, you should always consult your doctor or pharmacist before using Ibuprofeno Kern Pharma with other medicines.

Taking Ibuprofeno Kern Pharma with food and drinks

It is recommended to take ibuprofen during or immediately after meals to reduce the possibility of stomach discomfort.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Ibuprofen should not be taken during pregnancy, especially during the third trimester. It may cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and may delay or prolong labour 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 effective dose for the shortest possible time. From week 20 of pregnancy, ibuprofen may cause kidney problems in your unborn baby 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.

Although only small amounts of the medicine pass into breast milk, prolonged use of ibuprofen during breastfeeding is not recommended.

Therefore, if you become pregnant or are breastfeeding, consult your doctor.

Driving and using machines

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medicine, you should not drive or operate dangerous machinery.

If you take only a single dose of ibuprofen, or take it for a short period, no special precautions are necessary.

Ibuprofeno Kern Pharma contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine. It may cause tooth decay.

This medicine contains 53.8 mg of sodium (a main component of table/cooking salt) per sachet. This corresponds to 2.7% of the maximum daily sodium intake recommended for an adult.

Consult your doctor or pharmacist if you need to take this medicine for a prolonged period, especially if you have been advised to follow a low-salt (sodium) diet.

3. How to take Ibuprofen Kern Pharma

Follow exactly the administration instructions for Ibuprofen Kern Pharma provided by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medicine.

Your doctor will determine the duration of your treatment with ibuprofen. Do not stop the treatment earlier, as otherwise the expected results will not be achieved. Likewise, do not take ibuprofen for longer than indicated by your doctor.

The lowest effective dose for the shortest necessary duration should be used 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).

If you feel that the effect of ibuprofen is too strong or too weak, inform your doctor or pharmacist.

Dosing

Pediatric population:

• Children and adolescents weighing 25 to 40 kg: The recommended daily dose is 600 mg – 800 mg of ibuprofen, divided into 3 or 4 doses (1 sachet 3 or 4 times daily), with a maximum recommended daily dose of 800 mg.
• Children and adolescents weighing over 40 kg: The recommended daily dose is 1,200 mg – 1,600 mg of ibuprofen per day, divided into 3 or 4 doses (2 sachets 3 or 4 times daily), with a maximum recommended daily dose of 1,600 mg.

Higher doses may be required for the treatment of juvenile rheumatoid arthritis, although it is recommended not to exceed 40 mg/kg/day of ibuprofen.

The interval between doses will depend on the progression of symptoms, but should never be less than 4 hours. This medicine is not recommended for children under six months of age.

Adults:

The recommended daily dose is 1,200 mg – 1,800 mg of ibuprofen per day, divided into 3 or 4 doses (2 or 3 sachets 3 or 4 times daily), with a maximum recommended daily dose of 2,400 mg.

Elderly population:

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

Patients with kidney and/or liver disease:

If you suffer from kidney and/or liver disease, your doctor may prescribe a lower than usual dose. In such case, take exactly the dose prescribed by your doctor.

Administration method

Ibuprofen Kern Pharma is administered orally. Take after dissolving the contents of the sachet in approximately half a glass of water.

If you take more Ibuprofen Kern Pharma than you should

If you have taken more Ibuprofen Kern Pharma than you should, or if a child has accidentally ingested the contents of the package, contact your doctor or pharmacist immediately, call the Toxicology Information Service at telephone: 91 562 04 20, or go to the nearest hospital to assess the risk and receive advice on the measures to be taken, indicating the medicine and the amount ingested. It is recommended to bring the medicine’s 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.

More severe symptoms may occur, such as gastrointestinal bleeding, low blood pressure, seizures, and respiratory disturbances. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties have been reported.

If you forget to take Ibuprofen Kern Pharma

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

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 the usual time.

4. Possible adverse effects

Like all medicines, Ibuprofeno Kern Pharma can cause adverse effects, although not everyone experiences them.

Adverse effects of medicines such as ibuprofen are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the maximum recommended dose.

Possible adverse effects are classified by frequency of occurrence:

Very common (affects more than 1 in 10 patients)

Common (affects between 1 and 10 in 100 patients)

Uncommon (affects between 1 and 10 in 1,000 patients)

Rare (affects between 1 and 10 in 10,000 patients)

Very rare (affects fewer than 1 in 10,000 patients)

The following adverse effects have been observed:

Gastrointestinal disorders:

The most common adverse effects associated with medicines such as ibuprofen 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, worsening of ulcerative colitis and Crohn's disease have also been observed. Gastritis has been observed less frequently.

Skin and subcutaneous tissue disorders:

Stop treatment with Ibuprofeno Kern Pharma and seek immediate medical attention if you notice 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 rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized, 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: urticaria, itching, appearance of bruises.

Very rare: sudden onset of intense skin itching or blisters on the skin, joint pain and fever (lupus erythematosus), hair loss, skin reactions due to light exposure.

Medicines such as ibuprofen may, very rarely, be associated with severe blistering reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

Drug reaction with eosinophilia and systemic symptoms: 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: generalized 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 Ibuprofeno Kern Pharma immediately if you experience these symptoms and seek medical attention immediately. See also section 2.

Immune system disorders:

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: joint pain and fever (lupus erythematosus), aseptic meningitis (inflammation of the membranes covering the brain and spinal cord caused by certain viruses, more common in patients with autoimmune diseases).

Central nervous system disorders:

Common: fatigue or drowsiness, headache, dizziness or feeling unsteady.

Rare: tingling sensation.

Very rare: aseptic meningitis (inflammation of the membranes covering the brain and spinal cord caused by certain viruses, see immune system disorders).

Psychiatric disorders:

Uncommon: difficulty sleeping, anxiety.

Rare: psychotic reaction, restlessness, irritability, depression, confusion.

Ear and labyrinth disorders:

Common: vertigo.

Uncommon: sensation of pulsations or ringing in the ear.

Rare: ear disorders.

Eye disorders:

Uncommon: visual disturbances.

Rare: reversible decrease in visual acuity.

Blood and lymphatic system disorders:

Very rare: prolonged bleeding time, decreased white blood cells (may present as frequent infections with fever, chills or sore throat), decreased red blood cells (may present as shortness of breath and pale skin).

Cardiac and vascular disorders:

Swelling of the limbs or fluid accumulation in the arms or legs (more likely in individuals with high blood pressure or kidney disorders). Heart failure (the amount of blood pumped by the heart is insufficient to meet the body's needs) or high blood pressure (hypertension), especially in elderly patients.

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

Medicines such as ibuprofen may be associated with a moderately increased risk of heart attack ("myocardial infarction") or stroke.

Edema (fluid retention), arterial hypertension, and heart failure have also been observed in association with treatment with medicines of the ibuprofen type.

Renal and urinary disorders:

Kidney disorders.

Hepatobiliary disorders:

Medicines such as ibuprofen may, rarely, be associated with liver damage.

Hepatitis (inflammation of the liver) and jaundice (yellowing of the skin).

General disorders:

Worsening of inflammation during infectious processes.

To date, no severe allergic reactions have been reported with ibuprofen, although they cannot be ruled out. Manifestations of such effects could include fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, swelling of the face, tongue and throat, breathing difficulties, asthma, palpitations, hypotension (low blood pressure), or shock.

If any of the following adverse effects occur, stop treatment immediately and consult your doctor:

• Allergic reactions such as skin rashes, swelling of the face, wheezing or breathing difficulties.
• Vomiting blood or material resembling coffee grounds.
• Blood in stools or bloody diarrhea.
• Severe stomach pain.
• Blisters or significant skin peeling.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects 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 Ibuprofen Kern Pharma

Keep out of the sight and reach of children.

Do not store above 25°C.

Do not use Ibuprofen Kern Pharma 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 drains or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofeno Kern Pharma 200 mg effervescent granules EFG

• The active substance is ibuprofen. Each sachet contains 200 mg of ibuprofen.
• The other components (excipients) are: anhydrous citric acid, sodium lauryl sulfate, povidone, sodium saccharin, anhydrous sodium carbonate, sodium hydrogen carbonate, anhydrous colloidal silica, anhydrous lactose, orange flavor, and sucrose.

Appearance of the medicinal product and contents of the container

Ibuprofeno Kern Pharma 200 mg is presented as effervescent granules of white colour. Each pack contains 10 or 20 sachets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

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

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