Ibuprofen Sandoz 600 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ibuprofen Sandoz 600 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

This medicine is used to treat fever and mild to moderate pain, including migraine. It is also used in the treatment of arthritis (joint inflammation, usually affecting the hands and feet, causing swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder causing cartilage damage), ankylosing spondylitis (inflammation affecting the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

2. What you need to know before taking Ibuprofeno Sandoz

Do not take Ibuprofeno Sandoz

• if you are allergic to ibuprofen, to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs), to aspirin, or to any of the other ingredients of this medicine (listed in section 6). Signs of allergy may include itchy skin rash, swelling of the face, lips or tongue, runny nose, difficulty breathing or asthma,
• if you have severe liver or kidney disease,
• if you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the gastrointestinal tract,
• if you are vomiting blood,
• if you have black stools or bloody diarrhoea,
• if you have bleeding or blood coagulation disorders, or are taking anticoagulants (medicines used to “thin” the blood). If anticoagulants must be used concomitantly, your doctor will perform blood coagulation tests,
• if you have severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake),
• if you have severe heart failure,
• if you are in the third trimester of pregnancy.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ibuprofeno Sandoz:

• if you have oedema (fluid retention),
• if you have or have had heart problems or high blood pressure,
• if you have asthma or any other respiratory disorder,
• if you have an infection; see the section “Infections” 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 medicine long-term (more than 1–2 weeks), your doctor may need to carry out regular monitoring. Your doctor will advise you on how often these checks are needed,
• 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 or long-term treatment are used, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider prescribing a stomach-protective medicine,
• if you are taking medicines that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs),
• if you have Crohn’s disease (a chronic condition in which the immune system attacks the intestine, causing inflammation and usually bloody diarrhoea) or ulcerative colitis, as medicines like ibuprofen may worsen these conditions,
• if you are taking diuretics (medicines to increase urine production), because your doctor needs to monitor your kidney function,
• if you have systemic lupus erythematosus (a chronic disease affecting the immune system that can involve vital organs, the nervous system, blood vessels, skin and joints), as aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria) may occur,
• if you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine or liver disease), so your doctor can assess whether ibuprofen treatment is appropriate,
• if you suffer from headaches after prolonged treatment, do not take higher doses of the medicine,
• allergic reactions may occur with this medicine,
• your doctor will monitor you more closely if you receive ibuprofen after major surgery,
• it is advisable not to take this medicine if you have chickenpox,
• allergic reactions to ibuprofen, such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported. Stop taking Ibuprofeno Sandoz immediately and contact your doctor or emergency medical services right away if you notice any of these signs.

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

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 associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor without delay.

Elderly

Elderly 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 such as ibuprofen 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 Ibuprofeno Sandoz if:

• You have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary artery bypass surgery, peripheral arterial disease (circulation problems in 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.

These medicines may also cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Respiratory disorders

Ibuprofen should be used with caution in patients who have or have a history of bronchial asthma, chronic rhinitis, or allergic diseases, as ibuprofen has been reported to cause bronchospasm, urticaria, or angioedema in such patients.

Skin reactions

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 with ibuprofen treatment. Stop treatment with Ibuprofeno Sandoz and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Precautions during pregnancy and in women of childbearing potential

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

Administration of ibuprofen is contraindicated during the third trimester:

• For women of childbearing potential, it should be noted that medicines like ibuprofen have been associated with a reduced ability to conceive.

Other medicines and Ibuprofeno Sandoz

Tell your doctor or pharmacist if you are using, have recently used, or might need to 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 this may increase the risk of gastrointestinal ulcer and bleeding,
• antiplatelet agents (which prevent blood clots or thrombi in blood vessels) such as ticlopidine,
• anticoagulant medicines (e.g. for treating coagulation disorders or preventing clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine),
• cholestyramine (a medicine used to treat high cholesterol),
• selective serotonin reuptake inhibitors (used for depression),
• lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine,
• methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine,
• mifepristone (an abortion-inducing agent),
• digoxin and cardiac glycosides (used to treat heart disorders),
• hydantoins such as phenytoin (used to treat epilepsy),
• sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections),
• corticosteroids such as cortisone and prednisolone,
• diuretics (medicines used to increase urine output), as this may increase the risk of renal toxicity,
• pentoxifylline (used to treat intermittent claudication),
• probenecid (used in gout patients or together with penicillin for infections),
• quinolone antibiotics such as norfloxacin,
• sulfinpyrazone (for gout),
• sulfonylureas such as tolbutamide (for diabetes), which may cause hypoglycaemia,
• tacrolimus or cyclosporine (used in organ transplants to prevent rejection),
• zidovudine (an anti-HIV medicine),
• 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,
• CYP2C9 inhibitors (responsible for the metabolism of many drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

Ibuprofen may alter the following laboratory tests:

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

Inform your doctor if you are undergoing clinical laboratory testing and if you are currently taking or have recently taken ibuprofen.

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 possibility of stomach discomfort. 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 become pregnant, consult your doctor or pharmacist before using this medicine.

The use of this medicine is not recommended in women attempting to conceive.

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 unborn baby. It may affect your and your baby’s tendency to bleed and delay or prolong labour more than expected. You should not take ibuprofen during the last 3 months of pregnancy. 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 conceive, you should take the lowest possible 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, leading 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 more than a few days is needed, your doctor may recommend additional monitoring.

Minimal amounts of ibuprofen and its metabolites are excreted in breast milk. As no adverse effects in infants are known, breastfeeding usually does not need to be interrupted during short-term use at recommended doses.

Driving and using machines

If you experience dizziness, vertigo, visual 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, special precautions are generally not required.

Ibuprofen may delay your reaction time, which should be considered before engaging in activities requiring high alertness, such as driving and operating machinery.

This is particularly relevant when combined with alcohol.

Ibuprofeno Sandoz contains lactose, propylene glycol and sodium

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 0.82 mg of propylene glycol per film-coated tablet.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; i.e., essentially “sodium-free”.

3. How to take Ibuprofen Sandoz

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate how long you should take ibuprofen. Do not stop treatment earlier, as otherwise the expected results will not be achieved. Likewise, do not use this medicine for longer than indicated by your doctor.

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

The lowest effective dose should be used for the shortest duration 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 for adults and adolescents over 14 years is 600 mg every 6 to 8 hours, depending on the severity of symptoms and response to treatment.

In some conditions, higher doses may be required, 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:

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

Advanced age:

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.

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

This medicine is administered orally.

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

Take ibuprofen with sufficient water. The 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 think that the effect of ibuprofen is too strong or too weak, inform your doctor or pharmacist.

If you take more Ibuprofen Sandoz than you should

If you have taken more ibuprofen than you should, or if a child has accidentally ingested the medicine, consult your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount ingested, or go to the nearest hospital to learn about the risks and obtain advice on the measures to be taken.

It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

Symptoms of overdose usually occur 4 to 6 hours after taking ibuprofen.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, involuntary eye movements, and lack of muscle coordination. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported. Rarely, cases of increased blood plasma acidity (metabolic acidosis), decreased body temperature, impaired kidney function, bleeding from the stomach and intestine, coma, transient loss of breathing (apnea), depression of the central nervous and respiratory systems have occurred. Cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) has also been reported.

In cases of severe poisoning, renal failure and liver damage may occur. In such cases, the doctor will take the necessary measures.

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

If you forget to take Ibuprofen Sandoz

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

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

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

4. Possible adverse effects

Like all medicines, this medicine 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 treatments and when the daily dose is below the recommended maximum dose.

Frequent 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 stools.
• Vomiting blood.

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

• Gastritis.
• Duodenal ulcers, gastric ulcers.
• Skin redness, itching or tingling of the skin, skin rash.
• Urticaria.
• Purpura (purple spots on the skin).
• Skin reactions due to light exposure, hypersensitivity.
• Paresthesia (numbness, tingling, "pins and needles" sensation, more frequent in hands, feet, arms or legs).
• Drowsiness, fatigue.
• Headache.
• Dizziness or feeling of instability.
• Irritability.
• Insomnia.
• Anxiety.
• Hearing disturbances.
• Vision disturbances.
• Rhinitis (inflammation of the nasal mucosa).
• Inflammation of the oral mucosa with ulcer formation (mouth ulcers).
• Gastrointestinal perforations.
• Hepatitis (inflammation of the liver), abnormalities in liver function 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, usually resulting in bloody diarrhea).

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

• Depression.
• Psychotic reaction.
• Tinnitus (ringing or noises in the ear).
• Edema (swelling caused by fluid accumulation in tissues).
• Optic neuritis.
• Aplastic anemia.
• Neuropathy.
• Renal 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.
• Prolongation of bleeding time, anemia.
• Lupus erythematosus (joint pain and fever), severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes, and purplish lesions, typically on the trunk) and toxic epidermal necrolysis (erosions of mucous membranes and painful lesions with necrosis and detachment 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 associated with infections has been observed coinciding with the use of NSAIDs. If signs of infection appear or worsen during ibuprofen use, it is recommended to seek medical advice promptly.

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 mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofeno Sandoz if you experience these symptoms and seek immediate medical attention. See also section 2.
• Skin rash, such as recurrent reddish or dark spots appearing in the same area after taking ibuprofen, possibly accompanied by itching or burning (drug-induced fixed eruption).
• Skin becomes sensitive to light.

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

• Non-elevated reddish spots, target-shaped or circular lesions 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 and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis),
• Allergic reactions such as skin rashes, facial swelling, wheezing in the chest or difficulty breathing,
• Vomiting blood or material resembling coffee grounds,
• Blood in stools or diarrhea with blood,
• 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 arms or legs,
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Sandoz

Keep this medicine out of sight and reach of children.

Store below 30°C.

Do not use this medicine after the expiry date stated on the packaging after "CAD/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 properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of Ibuprofeno Sandoz 600 mg film-coated tablets EFG

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

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

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

Appearance of the product and contents of the container

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

It is available in packs containing 40 tablets 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. Podlipie 16,
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

Date of the most recent review of this leaflet: January 2026

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