Ibuprofen Kern Pharma 600 mg effervescent granules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ibuprofen Kern Pharma 600 mg effervescent granules EFG

Read this 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, consult 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 you, because it could be harmful to them.
• If you experience any side effects, talk to your doctor or pharmacist, even if the side effects are 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 side 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:

• Rheumatoid arthritis (inflammation of the joints, usually affecting the hands and feet, causing swelling and pain), juvenile rheumatoid arthritis, ankylosing spondylitis (inflammation affecting the joints of the spine), osteoarthritis, and other acute or chronic rheumatic conditions.
• Soft tissue injuries such as sprains and strains.
• Mild to moderate pain such as dental pain, postoperative pain, headache, and menstrual pain.
• Fever of various causes.

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

It is important that you use the lowest 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 had a gastrointestinal perforation while taking a non-steroidal anti-inflammatory drug.
• If you currently have or have had more than once a stomach or duodenal ulcer or gastrointestinal 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 diarrhea.
• If you have bleeding or blood coagulation disorders, or if you are taking anticoagulants (medications used to "thin" the blood). If concomitant use of anticoagulant medications is necessary, your doctor will perform blood coagulation tests.
• If you have worsening of ulcerative colitis or Crohn's disease.
• If you are allergic to acetylsalicylic acid or other NSAIDs. Such reactions could include skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, breathing difficulties, or asthma.
• If you are pregnant (see section “Pregnancy and breastfeeding”).

Warnings and precautions

Allergic reactions to ibuprofen, including respiratory problems, swelling of the face and neck region (angioedema), and chest pain, have been reported. Stop using Ibuprofeno Kern Pharma 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, 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 these cases, your doctor may consider adding a stomach-protective medication.
• If you have had kidney or liver disease.
• If you have edema (fluid retention).
• If you have heart disease or high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you have an infection; see the “Infections” section below.
• If 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 monitoring. Your doctor will advise you on the frequency of these checks.

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 medications 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 medications like ibuprofen may worsen these conditions.

Skin reactions

Use special caution with Ibuprofeno Kern Pharma:

Serious skin reactions, 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), have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofeno Kern Pharma 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 (NSAIDs) 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.

Discuss your treatment with your doctor or pharmacist before taking Ibuprofeno Kern Pharma if:

• You have heart problems, including heart failure, angina (chest pain), a previous heart attack, coronary 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 ischemic 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 administration of NSAIDs like ibuprofen has been associated with an increased risk of congenital abnormalities and miscarriage, it 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.

Administration of ibuprofen is contraindicated during the third trimester of pregnancy.

For women of childbearing age, it should be noted that NSAIDs like ibuprofen may reduce fertility.

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

Infections

Ibuprofeno may mask signs of infection, such as fever and pain. Therefore, Ibuprofeno may delay appropriate treatment of an 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 infection symptoms persist or worsen, consult a doctor immediately.

Use of Ibuprofeno Kern Pharma with other medicines

Inform your doctor or pharmacist if you are 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 clotting disorders 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, 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).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat 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, 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 labor. 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, the lowest possible dose should be taken 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 is needed for longer than a few days, your doctor may recommend additional monitoring.

Although only small amounts of the medicine pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during breastfeeding.

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

Driving and use of 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 use it for a short period, no special precautions are usually 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 with him before taking this medicine.

This medicine contains 162.5 mg (7 mmol) of sodium (a main component of table/cooking salt) per sachet. This corresponds to 8.2% of the maximum daily recommended sodium intake for an adult.

Consult your doctor or pharmacist if you need to take 2 or more sachets daily for a prolonged period, especially if you have been advised to follow a low-sodium diet.

3. How to take Ibuprofen Kern Pharma

Follow exactly the administration instructions for Ibuprofen Kern Pharma as indicated 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 early, as otherwise the expected results may not be achieved. Likewise, do not take ibuprofen for longer than indicated by your doctor.

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).

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

Dosage

Adults:

The dosage should be adjusted according to the severity of the condition and the patient's symptoms.

Generally, the recommended daily dose is 1,200 mg of ibuprofen (2 sachets), divided into 2 doses.

In some conditions, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 2,400 mg of ibuprofen (4 sachets).

Paediatric population:

The use of this medicine is not recommended in children under 14 years of age, as the dose of ibuprofen it contains is not suitable for the recommended dosage in these children.

Elderly population:

If you are over 60 years old, your doctor may prescribe a lower than usual dose. If so, 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 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.

Method of administration

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 pack, contact your doctor or pharmacist immediately, the Toxicology Information Service, telephone: 91 562 04 20, or go to the nearest hospital to find out about the risks and obtain advice on the measures to be taken, indicating the medicine and the amount ingested. It is recommended to bring the medicine pack and the package leaflet to the healthcare professional.

Symptoms of overdose may include: stomach pain, nausea, vomiting (which may contain blood-stained sputum), apathy, 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 and dizziness, blood in the urine, low blood potassium levels, 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 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 the usual time.

4. Possible adverse effects

Like all medicines, Ibuprofeno Kern Pharma can cause adverse effects, although not everyone will experience 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 recommended maximum dose.

The 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 every 100 patients)

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

Rare (affects between 1 and 10 in every 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, diarrhoea, flatulence, constipation, heartburn, abdominal pain, blood in stools, oral 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:

• Flat, red, target-shaped or circular spots 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 enlarged 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 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 very serious blistering reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

Drug reaction with eosinophilia and systemic symptoms: A serious 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 located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Discontinue 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 difficulty.

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 frequent in patients with autoimmune diseases).

Central nervous system disorders:

Common: fatigue or drowsiness, headache, dizziness or feeling of instability.

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, nervousness, 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 difficulty breathing 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), hypertension, and heart failure have also been observed in association with treatment with medicines of the ibuprofen type.

Renal and urinary disorders:

Kidney function abnormalities.

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 difficulty, asthma, palpitations, hypotension (decrease in blood pressure), or shock.

If any of the following adverse effects occur, stop treatment immediately and consult your doctor without delay:

• Allergic reactions such as skin rashes, swelling of the face, wheezing or breathing difficulty.
• Vomiting blood or material resembling coffee grounds.
• Blood in stools or bloody diarrhoea.
• 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 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 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 or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and their containers. This helps protect the environment.

6. Contents of the package and other information

Composition of Ibuprofeno Kern Pharma 600 mg effervescent granules EFG

• The active substance is ibuprofen. Each sachet contains 600 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, and orange flavour.

Appearance of the medicine and contents of the pack

Ibuprofeno Kern Pharma 600 mg is presented as white effervescent granules. Each pack contains 20 or 40 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 leaflet: November 2024

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