Package Leaflet: Information for the User

Ibuprofen Sandoz 600 mg Film-Coated Tablets EFG

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2.What you need to know before you start taking Ibuprofen Sandoz

3.How to take Ibuprofen Sandoz

4.Possible side effects

5.Storage of Ibuprofen Sandoz

6.Contents of the pack and additional information

Ibuprofeno belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

This medicine is used for the treatment of fever, the treatment of mild to moderate pain including migraine, the treatment of arthritis (inflammation of the joints, including those of the hands and feet, leading to swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder that causes cartilage damage), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

Do not take Ibuprofeno Sandoz

• if you are allergic to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, or any of the other ingredients in this medication (listed in section 6). Allergic reactions may include: skin rash with itching, facial swelling, lip or tongue swelling, nasal discharge, difficulty breathing, or asthma,
• if you have a severe liver or kidney disease,
• if you have had a stomach or duodenal ulcer or bleeding, or have suffered a perforation of the digestive tract,
• if you vomit blood,
• if you have black stools or bloody diarrhea,
• if you have bleeding or clotting disorders, or are taking anticoagulants (blood thinners). If you need to take anticoagulants, your doctor will perform blood clotting tests,
• if you have severe dehydration (caused by vomiting, diarrhea, or inadequate fluid intake),
• if you have severe heart failure,
• if you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ibuprofeno Sandoz:

• if you have edema (fluid retention),
• if you have heart disease or high blood pressure,
• if you have asthma or any other respiratory disease,
• if you have an infection; see the "Infections" section below,
• inform your doctor if you are already taking ibuprofen, as it may mask fever, an important sign of infection, making diagnosis more difficult,
• if you have kidney or liver disease, are over 60 years old, or need to take the medication for a long time (more than 1-2 weeks), your doctor may need to perform regular checks. Your doctor will tell you how often these checks should be done,
• if you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain or persistent and/or black stools, or even without previous warning symptoms,
• this risk is higher with high doses and prolonged treatment, especially in patients with a history of peptic ulcer disease and in the elderly. In these cases, your doctor may consider adding a stomach protector,
• if you are taking anticoagulants (blood thinners) or antiplatelet agents (such as aspirin), or other medications that increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors,
• if you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that often results in bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications may worsen these conditions,
• if you are taking diuretics (medications to increase urine production), as your doctor will need to monitor your kidney function,
• if you have systemic lupus erythematosus (a chronic condition that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it may cause aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria),
• if you have intermittent acute porphyria (a metabolic disorder that affects your blood and can cause symptoms such as red urine, blood in urine, or liver disease), so your doctor can assess the need for ibuprofen treatment,
• if you experience headaches after prolonged treatment, do not take higher doses of the medication,
• it is possible to experience allergic reactions with this medication,
• your doctor will perform more frequent checks if you receive ibuprofen after major surgery,
• it is recommended not to take this medication if you have chickenpox,
• allergic reactions to ibuprofen have been reported, including respiratory problems, facial and neck swelling (angioedema), and chest pain. Stop using Ibuprofeno Sandoz immediately and contact your doctor or emergency medical services if you observe any of these symptoms.

It is essential to use the smallest dose that relieves or controls pain and not to take this medication for longer than necessary to control your symptoms.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, ibuprofen may delay the appropriate treatment of the infection, increasing the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Older age

Patients over 60 years old have a higher frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.

Cardiovascular precautions

NSAIDs, such as ibuprofen, may be associated with a small increase in the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should inform your doctor or pharmacist before taking Ibuprofeno Sandoz if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease, 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 are a smoker.

Additionally, this type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Respiratory disorders

Ibuprofen should be used with caution in patients who have or have had asthma, bronchial asthma, or other respiratory allergies, as it may cause bronchospasm, urticaria, or angioedema in these patients.

Skin reactions

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular psoriasis, have been reported in association with ibuprofen treatment. Stop taking Ibuprofeno Sandoz and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Pregnancy and fertility

Due to the association of ibuprofen-type medications with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medication during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration should be limited to the minimum possible. It is believed that the risk increases with the dose and duration of treatment.

In the third trimester, the administration of ibuprofen is contraindicated:

• For women of childbearing age, it should be noted that ibuprofen-type medications have been associated with a decrease in fertility.

Other medications and Ibuprofeno Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Ibuprofeno Sandoz may affect or be affected by other medications. For example:

• other NSAIDs, such as aspirin, which may increase the risk of stomach ulcers and bleeding,
• antiplatelet agents (such as ticlopidine),
• anticoagulants (such as warfarin, ticlopidine),
• cholesterol-lowering medications (such as cholestyramine),
• selective serotonin reuptake inhibitors (used for depression),
• lithium (used for depression),
• methotrexate (used to treat cancer and inflammatory diseases),
• mifepristone (used for abortion),
• digoxin and cardiac glycosides (used to treat heart conditions),
• hydantoins (such as phenytoin, used to treat epilepsy),
• sulfonamides (such as sulfamethoxazole and cotrimoxazole, used to treat bacterial infections),
• corticosteroids (such as prednisone),
• diuretics (used to increase urine production), which may increase the risk of kidney toxicity,
• pentoxifylline (used to treat intermittent claudication),
• probenecid (used in patients with gout or with penicillin in infections),
• quinolone antibiotics (such as norfloxacin),
• sulfinpyrazone (used for gout),
• sulfonylureas (such as tolbutamide, used for diabetes), which may cause hypoglycemia,
• tacrolimus or cyclosporine (used in organ transplants to prevent rejection),
• zidovudine (used to treat HIV/AIDS),
• blood pressure-lowering medications (such as ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan),
• thrombolytics (medications that dissolve blood clots),
• aminoglycoside antibiotics (such as neomycin),
• herbal extracts: Ginkgo biloba tree extract,
• CYP2C9 inhibitors (responsible for the metabolism of many medications in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

Other medications may also affect or be affected by Ibuprofeno Sandoz treatment. Therefore, always consult your doctor or pharmacist before using Ibuprofeno Sandoz with other medications.

Ibuprofeno Sandoz may affect the following laboratory tests:

• bleeding time (may be prolonged for 1 day after stopping treatment),
• blood glucose concentration (may decrease),
• creatinine clearance (may decrease),
• hematocrit or hemoglobin (may decrease),
• serum urea nitrogen concentrations, serum creatinine, and potassium concentrations (may increase),
• liver function tests: increased transaminase values.

Inform your doctor if you are to undergo a clinical test and if you are taking or have taken ibuprofen recently.

Taking Ibuprofeno Sandoz with food, drinks, and alcohol

It is recommended to take ibuprofen with milk or food, or immediately after eating, to reduce the risk of stomach discomfort. Do not take alcohol, as it may increase gastrointestinal adverse reactions.

Pregnancy, breastfeeding, and fertility

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

This medication is not recommended for women trying to become pregnant.

Do not take ibuprofen if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your and your baby's predisposition to bleeding and delay or prolong delivery more than expected. Do not take ibuprofen during the first 6 months of pregnancy unless it is clearly necessary and as directed by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest time possible. From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in your baby's heart. If you need treatment for more than a few days, your doctor may recommend additional checks.

In breast milk, small amounts of ibuprofen and its metabolites are excreted. As there are no known adverse effects on the infant, it is usually not necessary to stop breastfeeding during short-term use at recommended doses.

Driving and operating machinery

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

Ibuprofen may delay your reaction time, which should be taken into account before engaging in activities that require increased vigilance, such as driving and operating machinery.

This applies to a greater extent when combined with alcohol.

Ibuprofeno Sandoz contains lactose, propylene glycol, and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains 0.82 mg of propylene glycol in each coated tablet.

This medication contains less than 1 mmol of sodium (23 mg) per coated tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of treatment with ibuprofen. Do not discontinue treatment beforehand, as this will not yield the expected results. Similarly, do not use this medication for a longer period than indicated by your doctor.

It is essential to use the smallest dose that relieves or controls pain and should not take ibuprofen for a longer period than necessary to control your symptoms.

The effective dose should be used for the shortest time necessary to alleviate symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults and adolescents over 14 years old:

The recommended dose for adults and adolescents over 14 years old is 600 mg every 6 to 8 hours, depending on the severity of the condition and the response to treatment.

In some cases, higher doses may be needed, but in any case, it is recommended not to exceed the maximum daily dose of 2400 mg in adults and 1600 mg in adolescents aged 14 to 18 years.

Children and adolescents under 14 years old:

This medication is not recommended for use in children or adolescents under 14 years old, as the ibuprofen dose contained is not suitable for the recommended dosage in this patient group.

Older age:

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

Kidney and/or liver diseases:

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

Administration form

This medication is administered orally.

To achieve a faster onset of action, the dose can be taken on an empty stomach. Patients with sensitive stomachs are recommended to take ibuprofen with food.

Take ibuprofen with sufficient water. Tablets should be swallowed whole, with a glass of water, without chewing, breaking, crushing, or sucking to avoid mouth discomfort and throat irritation.

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

If you take more Ibuprofeno Sandoz than you should

If you have taken more ibuprofen than you should, or if a child has ingested the medication accidentally, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested, or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

Normally, symptoms of overdose occur 4 to 6 hours after taking ibuprofen.

Overdose symptoms may include nausea, stomach pain, vomiting (which may contain blood-tinged mucus), headache, ringing in the ears, confusion, involuntary eye movement, and muscle coordination loss. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. In rare cases, cases of increased plasma acidity (metabolic acidosis), decreased body temperature, kidney function impairment, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), central and respiratory nervous system depression have been reported. Cases of cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) have also been reported.

If a severe intoxication has occurred, renal insufficiency and liver damage may occur. In these cases, the doctor will take the necessary measures.

In case of ingestion of significant amounts, activated charcoal should be administered. Gastric emptying will be considered if more than 400 mg/kg has been ingested and within 60 minutes of ingestion.

If you forget to take Ibuprofeno Sandoz

Do not take a double dose to compensate for the missed doses.

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The side effects of medicines such as ibuprofen are more common in people over 65 years old.

The incidence of side effects is lower in short-term treatments and if the daily dose is below the maximum recommended dose.

Common side effects(may affect up to 1 in 10 patients)

• Gastrointestinal bleeding, especially in elderly patients.
• Nausea.
• Vomiting
• Diarrea.
• Flatulence.
• Dyspepsia (gastrointestinal secretion or motility disorder).
• Constipation.
• Heartburn.
• Abdominal pain.
• Blood in stool.
• Vomiting with blood.

Rare side effects(may affect up to 1 in 100 patients)

• Gastritis.
• Ulcers of the duodenum, gastric ulcers.
• Redness of the skin, itching, or tingling in the skin, skin rash.
• Urticaria.
• Purpura (purple spots on the skin).
• Photoreactions in the skin, hypersensitivity.
• Paresthesia (numbness, tingling, or aching, etc. more common in hands, feet, arms, or legs).
• Drowsiness, fatigue.
• Headache.
• Dizziness or feeling of instability.
• Irritability.
• Insomnia.
• Anxiety.
• Auditory disturbances.
• Vision disturbances.
• Rhinitis (inflammation of the nasal mucosa).
• Inflammation of the oral mucosa with the formation of ulcers (oral ulcers).
• Gastrointestinal perforations.
• Hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes).
• Exacerbation of colitis and Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea).

Rare side effects(may affect up to 1 in 1,000 patients)

• Depression.
• Psychotic reaction.
• Tinnitus (ringing or sounds in the ear).
• Edema (swelling caused by the accumulation of fluid in tissues).
• Optic neuritis.
• Aplastic anemia.
• Neuropathy.
• Renal tissue damage (papillary necrosis), increased serum uric acid concentration.

Very rare side effects(may affect up to 1 in 10,000 patients)

• Edema
• Pancreatitis
• Esofagitis
• Prolonged bleeding time, anemia.
• Lupus erythematosus (joint pain and fever), severe skin reactions including Stevens-Johnson syndrome (widespread skin and mucous membrane lesions and purpura, usually on the trunk) and toxic epidermal necrolysis (widespread skin lesions with necrosis and detachment of the epidermis), erythema multiforme (skin lesions), erythema multiforme.Exceptionally, severe skin infections and soft tissue complications may occur during varicella.
• Heart failure, myocardial infarction, hypertension.
• Exacerbation of inflammation related to infections coinciding with the use of NSAIDs. If signs of infection or worsening of these symptoms occur during ibuprofen use, consult a doctor as soon as possible.

Unknown frequency(cannot be estimated from available data).

• Asthma, bronchospasm, dyspnea (difficulty breathing).
• Eruption of red scaly skin, with bumps under the skin and localized blisters, mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute pustular exanthema). Stop taking Ibuprofeno Sandoz if you experience these symptoms and seek medical attention immediately. See section 2.
• The skin becomes sensitive to light.

If any of the following side effects occur, discontinue treatment and seek immediate medical attention:

• Flat, non-elevated, circular, or target-like red spots on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and symptoms similar to the flu (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis),
• Generalized skin rash, elevated body temperature, and hypertrophied lymph nodes (DRESS syndrome),
• Generalized, red, and scaly rash, with protuberances under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema),
• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing,
• Vomiting blood or coffee-ground-like material,
• Blood in stool or diarrhea with blood,
• Severe stomach pain,
• Severe headache or persistent headache,
• Yellowing of the skin (jaundice),
• Signs of severe hypersensitivity (allergy) (see above in this same section),
• Swelling of the limbs or accumulation of fluid in the arms or legs,
• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store below 30°C.

Do not use this medication after the expiration date that appears on the packaging after “CAD/EXP”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the packaging and unused medicines if you are unsure. By doing so, you will help protect the environment.

Composition of Ibuprofeno Sandoz 600 mg film-coated tablets

• The active ingredient is ibuprofen. Each tablet contains 600 mg of ibuprofen.
• The other components are:

Tablet core: sodium croscarmellose, hypromellose, lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, anhydrous colloidal silica, magnesium stearate.

Coating: titanium dioxide (E-171), hypromellose, talc, and propylene glycol.

Appearance of the product and contents of the packaging

Ibuprofeno Sandoz are film-coated, oval, biconvex, and white tablets.

They are presented in aluminum-PVC/PVDC blisters containing 40 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Laboratorios Cinfa, S.A.

Olaz-Chipi, 10.Polig. Area (Huarte-Pamplona) – 31620

Spain

or

Lek SA.

Ul. Podlipie16,

95 010 Strykow

Poland

or

Lek SA.

Ul Domaniewska 50 C

02-6702 Warsaw

Poland

or

SAG Manufacturing S.L.U.

Ctra. N-I, Km 36,

28750 San Agustín de Guadalaix

Madrid

Spain

Last review date of this leaflet:March 2025

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/