IBUPROFEN SANDOZ 600 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ibuprofen Sandoz 600 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Ibuprofen Sandoz and what is it used for
2. What you need to know before you take Ibuprofen Sandoz
3. How to take Ibuprofen Sandoz
4. Possible side effects
5. Storage of Ibuprofeno Sandoz
6. Contents of the pack and other information

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

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

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

2. What you need to know before you take Ibuprofen Sandoz

Do not take Ibuprofen Sandoz

• if you are allergic to ibuprofen, to other medicines of the non-steroidal anti-inflammatory drug (NSAID) group, to aspirin, or to any of the other ingredients of this medicine (listed in section 6). Allergic reactions may include: skin rash with itching, swelling of the face, lips or tongue, nasal discharge, difficulty breathing, or asthma,
• if you have severe liver or kidney disease,
• if you have had a stomach or duodenal ulcer 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 disorders or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If you need to take anticoagulant medicines at the same time, your doctor will perform blood coagulation tests,
• if you have severe dehydration (caused by vomiting, diarrhea, or insufficient 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 Ibuprofen Sandoz:

• if you have edema (fluid retention),
• if you have or have had heart disorders or have high blood pressure,
• if you have asthma or any other respiratory disorder,
• if you have an infection; see the "Infections" section below,
• tell your doctor if you are already taking ibuprofen, as it may mask fever, which is 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 medicine for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks,
• if you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by severe abdominal pain or persistent pain and/or black stools, or even without previous warning symptoms,
• this risk is higher when high doses are used and treatments are prolonged, in patients with a history of peptic ulcer and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protective medicine,
• if you are taking medicines that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the aspirin type. You should also discuss the use of other medicines that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors,
• if you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea) or ulcerative colitis, as ibuprofen-type medicines may worsen these conditions,
• if you are being treated with diuretics (medicines used to increase urine production), as your doctor should monitor your kidney function,
• if you have systemic lupus erythematosus (a chronic disease 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 that protect the brain and spinal cord, not caused by bacteria),
• if you have acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that your doctor can assess the convenience or not of treatment with ibuprofen,
• if you experience headaches after prolonged treatment, do not take higher doses of the medicine,
• allergic reactions may occur with this medicine,
• your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery,
• it is advisable not to take this medicine if you have chickenpox,
• with ibuprofen, signs of allergic reaction to this medicine have been reported, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using Ibuprofeno Sandoz immediately and contact your doctor or the emergency medical service immediately if you notice any of these signs.

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

Infections

Ibuprofen may hide the signs of an infection, such as fever and pain. Consequently, ibuprofen may delay the appropriate treatment of the infection, which may increase 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 the symptoms of the infection persist or worsen, consult a doctor without delay.

Older adults

Older patients have a higher frequency of adverse reactions to NSAIDs (non-steroidal anti-inflammatory drugs), especially gastrointestinal bleeding and perforation, which can be fatal.

Cardiovascular precautions

Anti-inflammatory/analgesic medicines like ibuprofen may be associated with a small increased risk of having a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

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

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

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

Respiratory disorders

Ibuprofen should be used with caution when administered to patients who have or have had bronchial asthma, chronic rhinitis, or allergic diseases, as ibuprofen has been reported to 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 syndrome), acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue Ibuprofeno Sandoz and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Precautions during pregnancy and in women of childbearing age

Because the administration of ibuprofen-type medicines has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless it is strictly necessary. In these cases, the dose and duration will 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 taken into account that ibuprofen-type medicines have been associated with a decrease in fertility.

Other medicines and Ibuprofeno Sandoz

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

• other non-steroidal anti-inflammatory drugs, such as aspirin, as it may increase the risk of stomach ulcers and bleeding,
• antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels) such as ticlopidine,
• anticoagulant medicines (e.g., for the treatment of coagulation problems/prevention of coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine),
• cholestyramine (a medicine used to treat high cholesterol),
• selective serotonin reuptake inhibitors (used in depression),
• lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine,
• methotrexate (for the treatment of cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine,
• mifepristone (abortion inducer),
• digoxin and cardiac glycosides (used in the treatment of heart disorders),
• hydantoins such as phenytoin (used in the treatment of epilepsy),
• sulfonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections),
• corticosteroids such as cortisone and prednisolone,
• diuretics (medicines used to increase urine production), as it may increase the risk of kidney toxicity,
• pentoxifylline (for the treatment of intermittent claudication),
• probenecid (used in patients with gout or with penicillin in infections),
• quinolone antibiotics such as norfloxacin,
• sulfinpyrazone (for gout),
• sulfonylureas such as tolbutamide (for diabetes), as it may cause hypoglycemia,
• tacrolimus or cyclosporin (used in organ transplants to prevent rejection),
• zidovudine (a medicine against the AIDS virus),
• medicines that lower high blood pressure (ACE inhibitors such as captopril, beta blockers such as atenolol, and angiotensin II receptor antagonists such as losartan),
• thrombolytics (medicines that dissolve blood clots),
• aminoglycoside antibiotics such as neomycin,
• herbal extracts: Ginkgo biloba tree,
• CYP2C9 inhibitors (responsible for the metabolism of numerous medicines in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

Lab tests that may be affected by ibuprofen:

• 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),
• blood concentrations of urea nitrogen and serum creatinine and potassium (may increase),
• liver function tests: increased transaminase values.

Tell your doctor if you are going to have a clinical analysis and if you are taking or have recently taken ibuprofen.

Taking Ibuprofeno Sandoz with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The use of this medicine is not recommended in women who are 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 ability to bleed and delay or prolong labor more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless it is clearly necessary and as indicated 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 possible time. From the 20th week of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may cause low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Ibuprofen and its degradation products are excreted in breast milk in minimal amounts. As no adverse effects are known in the breastfed infant, it is not usually necessary to interrupt breastfeeding during short-term use at recommended doses.

Driving and using machines

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medicine, do not drive or use hazardous machinery. If you only take one dose of ibuprofen or for a short period, it is not necessary to take special precautions.

Ibuprofen may delay your reaction time, which should be taken into account before performing activities that require greater vigilance, such as driving and using machinery.

This applies to a greater extent to the combination with alcohol.

Ibuprofeno Sandoz contains lactose, propylene glycol, and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

This medicine contains 0.82 mg of propylene glycol in each tablet.

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

3. How to take Ibuprofeno Sandoz

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

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

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

The lowest effective dose should be used for the shortest time necessary to relieve 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:

The recommended dose in adults and adolescents over 14 years is 600 mg every 6 to 8 hours, depending on the intensity of the condition and 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 from 14 to 18 years.

Children and adolescents under 14 years:

The use of this medication is not recommended in children and adolescents under 14 years, as the dose of ibuprofen it contains is not suitable for the recommended dosage in this group of patients.

Advanced 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 checked that you tolerate the medication well.

Kidney and/or liver disease:

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

Method of administration

This medication is administered orally.

To achieve a faster onset of action, the dose can be taken on an empty stomach. It is recommended that patients with sensitive stomachs take ibuprofeno with food.

Take ibuprofeno with sufficient water. The tablets should be swallowed whole, with a glass of water, without chewing, breaking, crushing, or sucking to avoid discomfort in the mouth and throat irritation.

If you think the effect of ibuprofeno 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 ibuprofeno than you should, or if a child has accidentally ingested the medication, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested, or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken.

It is recommended to take the packaging and the prospectus of the medication to the healthcare professional.

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

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), headache, ringing in the ears, confusion, involuntary eye movement, and lack of muscle coordination. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties have been reported. In rare cases, there have been cases of increased blood plasma acidity (metabolic acidosis), decreased body temperature, altered kidney function, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), central nervous system depression, and respiratory system. There have also been cases of cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate).

If a severe poisoning has occurred, kidney failure 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 lavage 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 make up for forgotten doses.

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

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not all people experience them.

Adverse effects of medications like ibuprofeno are more common in people over 65 years old.

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

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

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

Uncommon adverse effects(may affect up to 1 in 100 patients)

• Gastritis.
• Duodenal ulcers, gastric ulcers.
• Redness of the skin, itching or tingling of the skin, rash.
• Urticaria.
• Purpura (purple spots on the skin).
• Reactions to light, hypersensitivity.
• Paresthesia (sensation of numbness, tingling, burning, etc., more frequent in hands, feet, arms, or legs).
• Drowsiness, fatigue.
• Headache.
• Dizziness or feeling of instability.
• Irritability.
• Insomnia.
• Anxiety.
• Auditory disturbances.
• Visual disturbances.
• Rhinitis (inflammation of the nasal mucosa).
• Inflammation of the oral mucosa with ulcer formation (oral aphthae).
• 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 (chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea).

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

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

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

• Edema
• Pancreatitis
• Esophagitis
• Prolonged bleeding time, anemia.
• Lupus erythematosus (joint pain and fever), severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and at least two mucous membranes and lesions of purple color, preferably on the trunk) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and shedding of the epidermis), erythema multiforme (skin lesion), erythema multiforme. Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox.
• Heart failure, myocardial infarction, hypertension.
• Exacerbation of inflammation related to infections has been observed with the use of NSAIDs. If signs of infection or worsening occur during the use of ibuprofeno, it is recommended to consult a doctor as soon as possible.

Frequency not known(cannot be estimated from available data).

• Asthma, bronchospasm, dyspnea (difficulty breathing).
• Generalized red scaly rash, with bumps under the skin and blisters located mainly in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofeno Sandoz if you experience these symptoms and seek medical attention immediately. See also section 2.
• Skin becomes sensitive to light.

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

• red spots, not raised, in a target or circular shape on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis),
• generalized rash, elevated body temperature, and hypertrophic lymph nodes (DRESS syndrome),
• generalized red scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis),
• allergic reactions such as skin rashes, facial swelling, chest tightness, or difficulty breathing,
• vomiting blood or coffee-ground-like material,
• blood in stool or bloody diarrhea,
• severe stomach pain,
• severe or persistent headache,
• yellowing of the skin (jaundice),
• signs of severe hypersensitivity (allergy) (see above in this section),
• swelling of the limbs or fluid accumulation in the arms or legs,
• chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome.

Reporting adverse effects

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

5. Conservation of Ibuprofeno Sandoz

Keep this medication out of sight and reach of children.

Store below 30°C.

Do not use this medication after the expiration date shown on the packaging after "CAD/EXP". The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and unused medications in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Ibuprofeno Sandoz 600 mg film-coated tablets EFG

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

Core of the tablet: sodium croscarmellose, hypromellose, lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, anhydrous colloidal silica, magnesium stearate.

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

Appearance of the product and package contents

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

They are presented in packages with 40 tablets packaged in aluminum-PVC/PVDC blisters.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A. Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

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 Varsovia

Poland

or

SAG Manufacturing S.L.U.

Ctra. N-I, Km 36,

28750 San Agustín de Guadalaix

Madrid

Spain

Date of the last revision of this prospectus:March 2025

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/