Package Insert: Information for the Patient

Paracetamol/Ibuprofeno Sandoz Care 500 mg/200 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if you worsen or do not improve after 3 days. Do not take this medicine for more than 3 days.

Paracetamol/Ibuprofeno Sandoz Carecontains two active ingredients (that make the medicine work). These are ibuprofen and paracetamol.

Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). Paracetamol works differently from ibuprofen, but both active ingredients work together to reduce pain.

Paracetamol/ibuprofenis used for the occasional symptomatic treatment of mild to moderate pain.This medicineis especially indicated for pain that has not been relieved by ibuprofen or paracetamol alone.

Paracetamol/ibuprofenis used in adults aged 18 years and above.

Do not take Paracetamol/Ibuprofeno Sandoz Care if:

• You areallergic to ibuprofen, paracetamolor to any of the other components of this medication (listed in section 6),
• You are takingany other medication that contains paracetamol,
• You have a history of allergic reactions (e.g., bronchospasm, angioedema, asthma, rhinitis, or urticaria) associated with acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs),
• You have an active or recurrent peptic ulcer (i.e., stomach or duodenal ulcer) or bleeding (two or more distinct episodes of ulceration or bleeding confirmed),
• You have a history of gastrointestinal hemorrhage or perforation related to a previous treatment with NSAIDs,
• You have a cerebrovascular hemorrhage orother active hemorrhage,
• You havecoagulation disorders,
• You havesevere heart, liver, or kidney failure,
• You areseverely dehydrated, caused by vomiting, diarrhea, or inadequate fluid intake,
• You are in thelast 3 months of pregnancy,
• You are under 18 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeParacetamol/Ibuprofeno Sandoz Care if:

• You area patient of advanced age,
• You haveasthmaor have had asthma,
• You have problems with your kidneys, heart, liver, intestines, hepatitis, or difficulty urinating,
• You are being treated concomitantly with medications that affect liver function,
• You are allergic to other substances,
• You have acid reflux, indigestion, stomach ulcers, or any other stomach problem,
• You have a tendency to bleed,
• You haveGilbert's syndrome(a rare hereditary metabolic disorder with possible signs such as yellow discoloration of the skin or the white of the eyes),
• You havesystemic lupus erythematosus(SLE, for its English acronym), a disease of the immune system that affects connective tissue and causes joint pain, skin changes, and disorders of other organsor other connective tissue disease,
• You havegastrointestinal disorders or chronic inflammatory bowel disease(e.g., ulcerative colitis, Crohn's disease),
• You have aninfection;see the section "Infections" below,
• You have ahereditary deficiencyof a certain enzyme calledglucose-6-phosphate dehydrogenase,
• You have a genetic disorder or acquired disorder of certain enzymes that manifests with neurological complications or skin problems, or occasionally both, i.e.,porphyria,
• You havehemolytic anemia,
• You have hay fever, nasal polyps, or chronic obstructive respiratory disorders, as there may be a higher risk of allergic reactions,
• You suffer fromchronic alcoholism,
• You havelow weightorchronic malnutrition,
• You have atotal body water deficiency(dehydration),
• You have recently hadmajor surgery,
• You are in thefirst 6 months of pregnancyor arebreastfeeding,
• You areplanning to become pregnant.

Consult your doctor if any of the above warnings apply to you, or if you have experienced them in the past. You may need to avoid this medication or reduce the dose.

The adverse effects can be minimized by using the minimum effective dose for the shortest time necessary to control symptoms. Do not take paracetamol/ibuprofen for more than 3 days.

The concomitant use with NSAIDs, including specific COX-2 inhibitors, increases the risk of adverse reactions (see below "Other medications and Paracetamol/Ibuprofeno Sandoz Care") and should be avoided.

During treatment with paracetamol, report immediately to your doctor if:

If you have severe diseases, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (a blood and fluid anomaly) has been reported in patients in these situations when using paracetamol at regular doses for a prolonged period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe respiratory distress with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Warning: taking higher doses than the recommended doses does not provide greater pain relief, but it increases the risk of severe liver damage. Therefore, do not exceed the maximum daily dose of paracetamol. Do not take other medications that also contain paracetamol (see also the section "Do not take Paracetamol/Ibuprofeno Sandoz Care" above). Symptoms of liver damage usually occur for the first time after a couple of days. Therefore, it is essential to consult a doctorimmediatelyif you have taken more than recommended. See also section 3 "If you take more Paracetamol/Ibuprofeno Sandoz Care than you should."

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increase in the risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or treatment duration.

You should discuss your treatment with your doctor or pharmacist before takingthis medicationif:

• You have heart problems, such as heart failure, angina (chest pain), or if you have had a heart attack, coronary bypass surgery, peripheral artery disease (poor circulation in the legs and feet due to narrowed or blocked arteries) or any type of stroke (including '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 are a smoker.

Skin reactions

Severe skin reactions associated with treatment withparacetamol/ibuprofenhave been reported. Stop takingthis medicationand see your doctor immediately if you develop skin rash, membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Infections

Paracetamol/ibuprofenmay mask signs of an infection, such as fever and pain. Therefore, it is possible thatthis medicationmay delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor immediately.

Gastrointestinal symptoms

Severe gastrointestinal adverse effects (affecting the stomach and intestines) have been reported with the use of NSAIDs, including ibuprofen. These may occur with or without warning symptoms. The risk of these side effects is higher in patients with a history of stomach or intestinal ulcers, particularly if there was bleeding or perforation. Elderly patients have a higher risk of gastrointestinal adverse effects. You should analyze any history of gastrointestinal problems with your doctor and remain alert to any unusual abdominal symptoms, such as nausea, vomiting, diarrhea, constipation, indigestion, abdominal pain, stool with a tar-like appearance, or vomiting with blood.

Prolonged use of analgesics

The prolonged use of analgesics for headaches may even worsen them. If you experience or suspect this situation, you should inform your doctor and interrupt treatment.

The regular use of analgesics, particularly in combination with several pain-relieving medications, may cause permanent kidney damage with a risk of kidney failure, a condition called analgesic nephropathy. This risk may increase under physical exertion associated with salt loss and dehydration. Therefore, it should be avoided.

Eye problems

If you notice any problems with your vision after usingparacetamol/ibuprofen, stop using the medication and consult a doctor.

Other considerations

In general, the habitual intake of analgesics, particularly in combination with several active analgesic principles, may lead to permanent kidney damage with a risk of kidney failure. Therefore, it should be avoided.

Children and adolescents

This medication is contraindicated in children and adolescents under 18 years old.

Other medications and Paracetamol/Ibuprofeno Sandoz Care

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not take Paracetamol/Ibuprofeno Sandoz Care with:

• Othermedications that contain paracetamol, such as e.g., some cold and flu medications or pain relievers.

Paracetamol/ibuprofenmay affect or be affected by other medications. For example:

• Tablets ofcorticosteroids,
• antibiotics(e.g., cloranfenicol or quinolones),
• Medicationsantiemetic(e.g., metoclopramide, domperidone),
• Acetylsalicylic acid, salicylates, or other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib),
• Anticoagulant medications (e.g., to dilute the blood/prevent coagulation e.g., warfarin, acetylsalicylic acid, ticlopidine),
• Cardiac glycosides (e.g., digoxin), heart-strengthening medications,
• Medications forhigh cholesterol(e.g., cholestyramine),
• diuretics(to help urinate),
• Medications that reducehigh blood pressure(e.g., ACE inhibitors such as captopril, beta blockers such as atenolol, angiotensin II receptor antagonists such as losartan),
• Medications forimmunosuppression(e.g., methotrexate, cyclosporine, tacrolimus),
• Medications formania or depression(e.g., lithium or SSRIs),
• mifepristone(for abortion),
• phenytoin, a medication for preventing seizures in epilepsy,
• zidovudine, a medication for treating HIV (the virus that causes acquired immunodeficiency syndrome),
• Medications that decreasegastric emptying,
• Medications for treating bacterial infections calledaminoglycosides,

• Medications for treating gout and gouty arthritis calledprobencid and sulfinpyrazone,
• antimycoticsthat inhibit the CYP2C9 liver enzyme (e.g., voriconazole, fluconazole),
• Othermedications thatare known toaffect the liverorinduce hepatic microsomal enzymessuch as alcohol and antiepileptic medications (e.g., carbamazepine, phenobarbital, lorazepam),
• Medications for treating diabetes (sulfonilureas),
• ginkgo biloba(a herbal medication) may increase the risk of bleeding with NSAIDs,
• Medications used to treat tuberculosis (e.g.,isoniazid),
• flucloxacillin(antibiotic), due to a severe risk of blood anomaly and fluidity (called metabolic acidosis) that must receive urgent treatment (see section 2).

Other medications may also affect or be affected by paracetamol/ibuprofen treatment. Therefore, you should always seek the advice of your doctor or pharmacist before using paracetamol/ibuprofen with other medications.

Taking Paracetamol/Ibuprofeno Sandoz Care with food and alcohol

To reduce the risk of side effects, take Paracetamol/Ibuprofeno with food.

Do not drink alcohol during treatment with this medication. Alcohol may increase the toxicity of paracetamol in the liver.

Pregnancy, breastfeeding, and fertility

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

• Pregnancy
• Do not take paracetamol/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 the baby at birth. It may affect your tendency to bleed and that of your baby and make delivery delayed or prolonged beyond what is expected. Do not take paracetamol/ibuprofen during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while trying to become pregnant, use the lowest dose for the shortest time possible. If taken for more than a few days from 20 weeks of pregnancy, paracetamol/ibuprofen may cause kidney problems in your baby at birth that may lead to low amniotic fluid levels 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.
• Lactation

Only small amounts of ibuprofen and its metabolites pass into breast milk. This medication can be taken during breastfeeding if used at the recommended dose and for the shortest time possible.

• Fertility

Ibuprofen belongs to a group of medications that may affect female fertility. Paracetamol/ibuprofen may make it difficult to become pregnant. This is reversible by stopping the medication.

Driving and operating machinery

Paracetamol/ibuprofen may cause dizziness, concentration problems, and drowsiness.

If affected, do not drive or use tools or machines.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should be taken exactly as directed.Consult your doctor or pharmacist again if you are unsure.

Adults: the recommended dose is 1 tabletwithwater, up to 3 times a day.

Leave at least6 hours between doses.

If one tablet does not control symptoms, up to a maximum of 2 tablets may be taken up to 3 times a day. Leave at least 6 hours between doses.

Do not take more than six tablets in a 24-hour period(equivalent to 1,200 mg of ibuprofen and 3,000 mg of paracetamol per day).

To reduce the risk of adverse effects, it is recommended to take paracetamol/ibuprofen with food.

Use in the elderly

No special dose adjustments are required. There is a higher risk of severe adverse reactions. The lowest effective dose should be used for the shortest duration possible.

Use in children and adolescents

Not suitable for use in children and adolescents under 18 years old.

It may be necessary to reduce your dose to a maximum of 4 tablets per day if:

• You have kidney problems,
• You have liver problems,
• You weigh less than 50 kg,
• You suffer from chronic malnutrition,
• You regularly drink alcohol (chronic alcoholism),
• You are not sufficiently hydrated.

If any of the above applies to you, speak with your doctor before taking paracetamol/ibuprofen (see also section 2 “Warnings and precautions”).

Only for oral use and for short-term use.

Do not take this medication for more than 3 days.

If your symptoms worsen or persist, consult 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 take more Paracetamol/Ibuprofeno Sandoz Care than you should

If you have taken more paracetamol/ibuprofen than you should, or if a child has ingested the medication accidentally, consult your doctor or pharmacist immediately or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

Symptoms may include nausea, stomach pain, vomiting (which may be streaked with blood), gastrointestinal bleeding, headache, ringing in the ears, confusion, and nystagmus (trembling eye movement) or, less frequently, diarrhea. Additionally, at high doses, dizziness, blurred vision, low blood pressure, excitement, disorientation, coma, hyperkalemia (elevated potassium levels in the blood), increased prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, and exacerbation of asthma in asthmatics, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, feeling cold in the body, and respiratory problems.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Talk to a doctor immediately if you have taken too much medication, even if you feel well.The reason is that an excessive amount of paracetamol can cause severe late liver damage, which can be fatal. Even if there are no signs of discomfort or poisoning, you may need urgent medical attention. Liver damage can become irreversible in case of late intervention. To avoid liver damage, it is essential to receive medical treatment as soon as possible.

If you forgot to take Paracetamol/Ibuprofeno Sandoz Care

Do not take a double dose to compensate for the missed doses. If you forget to take a dose, take it as soon as you remember and then take the next dose at least 6 hours later.

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.

Regarding the following side effects, it should be noted that they depend to a great extent on the dose and vary from one patient to another.

The most frequently observed side effects are of a gastrointestinal nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, may occur, especially in elderly patients. After administration, nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, black stools, vomiting with blood, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported. Less frequently, gastritis has been observed. In particular, the risk of gastrointestinal bleeding depends on the dose range and duration of use.

Cases of edema, high blood pressure and heart failure have been reported in association with AINE treatment.

STOP TAKING THE MEDICINE and inform your doctor if you experience:

Rare (may affect up to 1 in 100 people):

• signs of intestinal bleeding (severe stomach pain, vomiting with blood or liquid that looks like coffee grounds, blood in the stool, black stools).

Very rare(may affect up to 1 in 10,000 people):

• symptoms of aseptic meningitis, inflammation of the brain lining such as: neck stiffness, headache, nausea or vomiting, fever or loss of consciousness,
• severe allergic reactions. Symptoms may include: swelling of the face, tongue or larynx, difficulty breathing, rapid heart rate, low blood pressure (anaphylaxis, angioedema or severe shock),
• respiratory reactivity including asthma, worsening of asthma, wheezing, difficulty breathing,
• severe skin reactions, such as bullous reactions, including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis,
• worsening of severe skin infections (you may notice rash, blisters and skin discoloration, fever, drowsiness, diarrhea and nausea), or worsening of other infections, such as chickenpox or shingles or severe infection with destruction (necrosis) of subcutaneous tissue, skin and muscle, blisters and skin peeling.

Unknown frequency (cannot be estimated from available data):

• a severe skin reaction known as DRESS (unknown frequency). DRESS symptoms include: skin rash, fever, lymph node inflammation and an increase in eosinophils (a type of white blood cell),
• a red, scaly, generalized rash with protuberances under the skin and localized blisters mainly on the skin folds, trunk and upper limbs, accompanied by fever at the start of treatment (acute generalized pustular exanthema). Stop taking this medicine if you develop these symptoms and seek medical attention immediately. See also section 2.
• a severe disease that can make the blood more acidic (metabolic acidosis) in patients with severe disease who use paracetamol (see section 2).

Other possible side effects

Frequent(may affect up to 1 in 10 people):

• gastrointestinal discomfort such as stomach pain, heartburn, indigestion, nausea, vomiting, gas and constipation, diarrhea, mild gastrointestinal bleeding that may cause anemia in exceptional cases,
• increased alanine aminotransferase, increased gamma-glutamyltransferase and abnormal liver function tests with paracetamol,
• swelling and fluid retention, swelling of the ankles or legs (edema); fluid retention usually responds quickly to discontinuation of the combination,
• increased levels of creatinine and urea in the blood.

Rare(may affect up to 1 in 1,000 people):

• central nervous system alterations such as headache, dizziness, insomnia, agitation, irritability or fatigue,
• urticaria, itching,
• inability to completely empty the bladder (urinary retention),
• thick mucus in the respiratory tract,
• various types of rash,
• gastrointestinal ulcers, potentially with bleeding and perforation or gastrointestinal bleeding, worsening of colon inflammation (colitis) and digestive tract inflammation (Crohn's disease), ulcerative stomatitis, gastritis,
• decreased hemoglobin and hematocrit, increased aspartate aminotransferase, increased alkaline phosphatase in the blood, increased creatine phosphokinase in the blood, increased platelet count (blood clotting cells).

Very rare(may affect up to 1 in 10,000 people):

• abnormal dreams,
• renal tissue damage (particularly with long-term use),
• high levels of uric acid in the blood (hyperuricemia),
• abnormal skin sensation (tingling, numbness).

Very rare(may affect up to 1 in 10,000 people):

• blood formation disorders (agranulocytosis, anemia, aplastic anemia, hemolytic anemia, leucopenia, neutropenia, pancitopenia and thrombocytopenia). The first signs are: fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe fatigue, unexplained bleeding, hematomas and nasal bleeding,
• optic neuritis and somnolence, aseptic meningitis in patients with existing conditions (such as systemic lupus erythematosus and mixed connective tissue disease), symptoms include: neck stiffness, headache, nausea, vomiting, fever or loss of consciousness,
• visual alterations; in this case, you should stop using this medicine and consult a doctor,

• hearing loss, ringing in the ears, dizziness, confusion, psychotic reactions, hallucinations, depression,
• fatigue, general malaise,
• increased sweating, sensitivity to light, exfoliative dermatosis,
• rash with red spots on the skin (purpura),
• hair loss,
• high blood pressure, vasculitis,
• inflammation of the esophagus, inflammation of the pancreas, formation of intestinal structures similar to a diaphragm,
• liver problems, dysfunction, liver damage (particularly with long-term use), liver failure, acute hepatitis, yellowing of the skin and/or the white of the eyes, also known as jaundice; in paracetamol overdose it can cause acute liver failure, liver failure, liver necrosis and liver damage,
• renal toxicity in various forms, including interstitial nephritis, nephrotic syndrome and acute and chronic renal failure,
• rapid or irregular heartbeats, also known as palpitations, tachycardia, arrhythmia and other cardiac arrhythmias, heart failure (which causes difficulty breathing, swelling), myocardial infarction.

Unknown(cannot be estimated from available data):

• the skin becomes sensitive to light.

Medicines like paracetamol/ibuprofen may be associated with a small increase in the risk of heart attack ("myocardial infarction") or stroke (see section 2).

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 theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box and blisterpack after CAD/EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from light.

This medication does not require any special storage temperature.

Medicines should not be disposed of through drains or trash. Dispose of containers and unused medications at the SIGRE pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of Paracetamol/Ibuprofeno Sandoz Care

• The active principles are ibuprofen and paracetamol. Eachtabletcontains200 mg of ibuprofen and 500 mg of paracetamol.
• The other components are:

Tablet core: maize starch, crospovidone (type A) (E 1202), anhydrous colloidal silica (E 551), povidone K-30 (E 1201), pregelatinized maize starch, talc (E 553b), stearic acid (50).

Covering: poly(vinyl alcohol) (E 1203), talc (E 553b), macrogol 3350 (E 1521), titanium dioxide (E171).

Appearance of the product and contents of the packaging

Paracetamol/Ibuprofeno Sandoz Care 500 mg/200 mg are film-coated white to off-white oval-shaped tablets, with dimensions of 19.7 mm x 9.2 mm.

The film-coated tablets are packaged in aluminium-PVC/PVDC blisters.

Packaging sizes:

Blister packs: 10, 16 or 20 film-coated tablets.

Unit dose blister packs: 10x1, 16x1 or 20x1 film-coated tablets

Only some packaging sizes may be commercially available.

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

Lek Pharmaceuticals d.d.

Verovškova, 57

SLO-1526Ljubljana

Slovenia

or

Rontis Hellas S.A., Medical and Pharmaceutical Products

Larissa Industrial Area, P.O. Box 3012,

Larissa, 41 500

Greece

Revision date of thisleaflet:March 2025.

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