Paracetamol/ibuprofen Sandoz Care 500 mg/200 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Paracetamol/Ibuprofen Sandoz Care 500 mg/200 mg film-coated tablets

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for use of this medicine as described in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read 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 effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 3 days. You must not take this medicine for longer than 3 days.

Contents of the leaflet

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

1. What Paracetamol/Ibuprofen Sandoz Care is and what it is used for

Paracetamol/Ibuprofen Sandoz Care contains two active substances (the components 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 substances work together to reduce pain.

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

Paracetamol/ibuprofen is used in adults over 18 years of age.

2. What you need to know before taking Paracetamol/Ibuprofen Sandoz Care

Do not take Paracetamol/Ibuprofen Sandoz Care if:

• you are allergic to ibuprofen, paracetamol, or any of the other ingredients of this medicine (listed in section 6),
• you are taking any other medicine containing paracetamol,
• you have a history of allergic reactions (e.g., bronchospasm, angioedema, asthma, rhinitis, or urticaria) associated with acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• you have active or recurrent peptic ulceration (i.e., stomach or duodenal ulcer) or bleeding (two or more distinct episodes of confirmed ulceration or bleeding),
• you have a history of gastrointestinal bleeding or perforation related to previous NSAID therapy,
• you have cerebrovascular haemorrhage or another active bleeding condition,
• you suffer from blood coagulation disorders,
• you suffer from severe heart, liver, or kidney failure,
• you are severely dehydrated, caused by vomiting, diarrhoea, or insufficient fluid intake,
• you are in the last 3 months of pregnancy,
• you are under 18 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking Paracetamol/Ibuprofen Sandoz Care if:

• you are an elderly patient,
• you have asthma or have had asthma,
• you have kidney, heart, liver, or intestinal problems, hepatitis, or difficulty urinating,
• you are being treated concomitantly with medicines affecting liver function,
• you are allergic to other substances,
• you have stomach acidity, indigestion, stomach ulcers, or any other stomach problem,
• you have a tendency to bleed,
• you have Gilbert's syndrome (a rare inherited metabolic disorder with possible signs such as yellowish discoloration of the skin or whites of the eyes),
• you have systemic lupus erythematosus (SLE), an immune system disorder affecting connective tissue and causing joint pain, skin changes, and disorders of other organs, or another mixed connective tissue disease,
• you have gastrointestinal disorders or chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease),
• you have an infection; see the section "Infections" below,
• you have an inherited deficiency of an enzyme called glucose-6-phosphate dehydrogenase,
• you have a hereditary or acquired genetic disorder of certain enzymes manifesting with neurological complications or skin problems, or occasionally both, i.e., porphyria,
• you have haemolytic anaemia,
• you have hay fever, nasal polyps, or chronic obstructive respiratory disorders, as there may be an increased risk of allergic reactions,
• you suffer from chronic alcoholism,
• you have low body weight or chronic malnutrition,
• you have total body fluid deficiency (dehydration),
• you have recently undergone major surgery,
• you are in the first 6 months of pregnancy or are breastfeeding,
• you are planning 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 medicine or require a reduced dose.

Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms. Do not take paracetamol/ibuprofen for more than 3 days.

Concomitant use with NSAIDs, including specific COX-2 inhibitors, increases the risk of adverse reactions (see below “Other medicines and Paracetamol/Ibuprofen Sandoz Care”) and should be avoided.

During treatment with paracetamol, inform your doctor immediately:

If you have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used regularly over a prolonged period or when paracetamol is taken with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Warning: Taking higher than recommended doses does not provide greater pain relief but increases the risk of severe liver damage. Therefore, the maximum daily dose of paracetamol must not be exceeded. Do not take other medicines that also contain paracetamol (see also section “Do not take Paracetamol/Ibuprofen Sandoz Care” above). Symptoms of liver damage typically appear a few days after overdose. It is therefore important to consult a doctor immediately if you have taken more than recommended. See also section 3 “If you take more Paracetamol/Ibuprofen Sandoz Care than you should”.

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.

Talk to your doctor or pharmacist about your treatment before taking this medicine if:

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

Skin reactions

Serious skin reactions have been reported with paracetamol/ibuprofen treatment. Stop taking this medicine and see a doctor immediately if you develop a skin rash, lesions of mucous membranes, blisters, or other signs of allergy, as these may be early signs of a very serious skin reaction. See section 4.

Infections

Paracetamol/ibuprofen may mask signs of infection such as fever and pain. Therefore, this medicine may delay appropriate treatment of infection, increasing the risk of complications. This has been observed in bacterial pneumonias and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor immediately.

Gastrointestinal symptoms

Serious gastrointestinal adverse effects (affecting the stomach and intestine) have been reported with the use of NSAIDs, including ibuprofen. These may occur with or without warning symptoms. The risk of such 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 discuss any history of gastrointestinal problems with your doctor and remain alert for unusual abdominal symptoms such as nausea, vomiting, diarrhoea, constipation, indigestion, abdominal pain, tar-like stools, or vomiting blood.

Prolonged use of analgesics

Prolonged use of analgesics for headaches may lead to worsening headaches. If you experience or suspect this condition, inform your doctor and discontinue treatment.

Regular use of analgesics, particularly in combination with multiple pain-relieving active ingredients, may cause permanent kidney damage with risk of kidney failure, a condition known as analgesic nephropathy. This risk may increase with physical exertion associated with salt loss and dehydration. Therefore, it should be avoided.

Vision problems

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

Other considerations

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

Children and adolescents

This medicine is contraindicated in children and adolescents under 18 years of age.

Other medicines and Paracetamol/Ibuprofen Sandoz Care

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

Do not take Paracetamol/Ibuprofen Sandoz Care with:

• other medicines containing paracetamol, such as some cold and flu or pain medicines.

Paracetamol/ibuprofen may affect or be affected by other medicines. For example:

• corticosteroid tablets,

• antibiotics (e.g., chloramphenicol or quinolones),

• antiemetic medicines (e.g., metoclopramide, domperidone),

• acetylsalicylic acid, salicylates, or other NSAIDs (including COX-2 inhibitors such as celecoxib or etoricoxib),

• anticoagulant medicines (e.g., to thin the blood/prevent clotting, e.g., warfarin, acetylsalicylic acid, ticlopidine),

• cardiac glycosides (e.g., digoxin), medicines to strengthen the heart,

• medicines for high cholesterol (e.g., cholestyramine),

• diuretics (to help urination),

• medicines to reduce high blood pressure (e.g., ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan),

• medicines to suppress the immune system (e.g., methotrexate, cyclosporine, tacrolimus),

• medicines for mania or depression (e.g., lithium or SSRIs),

• mifepristone (for termination of pregnancy),

• phenytoin, a medicine to prevent seizures in epilepsy,

• zidovudine, a medicine to treat HIV (the virus causing acquired immunodeficiency syndrome),

• medicines that decrease gastric emptying,

• medicines to treat bacterial infections called aminoglycosides,

• medicines to treat gout and gouty arthritis called probenecid and sulfinpyrazone,

• antifungal medicines that inhibit the hepatic enzyme CYP2C9 (e.g., voriconazole, fluconazole),

• other medicines known to affect the liver or that induce hepatic microsomal enzymes such as alcohol and antiepileptic medicines (e.g., carbamazepine, phenobarbital, lorazepam),

• medicines for diabetes (sulfonylureas),

• ginkgo biloba (a herbal medicine) may increase the risk of bleeding with NSAIDs,

• medicines used to treat tuberculosis (e.g., isoniazid),

• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormality (called metabolic acidosis) requiring urgent treatment (see section 2).

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

Taking Paracetamol/Ibuprofen Sandoz Care with food and alcohol

To reduce the likelihood of side effects, take Paracetamol/Ibuprofen with food.

Do not drink alcohol during treatment with this medicine. Alcohol may increase paracetamol liver toxicity.

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.

• Pregnancy
• Do not take paracetamol/ibuprofen if you are in the last 3 months of pregnancy, as it may harm the unborn baby or cause problems during delivery. It may cause kidney and heart problems in the newborn baby. It may affect your tendency to bleed and that of your baby, and may delay or prolong labour beyond expected. You should not take paracetamol/ibuprofen during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to conceive, the lowest dose for the shortest possible time should be used. If taken for more than a few days beyond 20 weeks of pregnancy, paracetamol/ibuprofen may cause kidney problems in your unborn baby, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.
• Breastfeeding

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

• Fertility

Ibuprofen belongs to a group of medicines that may affect female fertility. Paracetamol/ibuprofen may make it more difficult to become pregnant. This effect is reversible upon discontinuation of the medicine.

Driving and use of machines

Paracetamol/ibuprofen may cause dizziness, difficulty concentrating, and drowsiness.

If affected, do not drive or operate tools or machinery.

3. How to take Paracetamol/Ibuprofen Sandoz Care

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

Adults: the recommended dose is 1 tablet with water, up to 3 times a day.

Leave at least 6 hours between doses.

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

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

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

Use in elderly patients

No special dose adjustments are required. However, there is an increased risk of serious adverse reactions. The lowest possible dose for the shortest duration necessary should be used.

Use in children and adolescents

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

Your dose may need to be reduced 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 drink alcohol regularly (chronic alcoholism),
• you are not adequately hydrated.

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

For oral use only and for short-term use only.

Do not take this medicine for more than 3 days.

If your symptoms worsen or persist, consult your doctor.

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

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/Ibuprofen Sandoz Care than you should

If you have taken more paracetamol/ibuprofen than you should, or if a child has accidentally ingested the medicine, contact your doctor or pharmacist immediately or go to the nearest hospital for advice on the risks and the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see section 4), diarrhoea, headache, tinnitus, confusion, tremulous eye movements (nystagmus), blurred vision. Agitation, drowsiness, disorientation or coma may also occur. Occasionally, patients may develop seizures. At high doses, cases of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness and vertigo, blood in the urine, low blood potassium levels, feeling cold, and breathing difficulties may occur. Prothrombin time/INR may be prolonged, probably due to interference with circulating coagulation factors. Acute renal failure and liver damage may occur. Asthma may worsen in asthmatic individuals. In addition, hypotension, reduced breathing, and blue-red discoloration of the skin and mucous membranes (cyanosis) may occur.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

Contact a doctor immediately if you have taken too much medicine, even if you feel well. This is because excessive amounts of paracetamol may cause delayed, severe liver damage, which can be fatal. Even if there are no signs of discomfort or poisoning, urgent medical attention may be required. Liver damage may become irreversible if treatment is delayed. To prevent liver damage, it is essential to obtain medical treatment as soon as possible.

If you forget to take Paracetamol/Ibuprofen Sandoz Care

Do not take a double dose to make up for 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 after the previous one.

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.

With regard to the following adverse effects, it should be noted that they largely depend on the dose and may vary from patient to patient.

The most frequently observed adverse effects are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation, or gastrointestinal bleeding, sometimes fatal, may occur, especially in elderly patients. After administration, nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, tarry stools, vomiting blood, ulcerative stomatitis, and exacerbation of colitis and Crohn’s disease have been reported. Gastritis has been observed less frequently. 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 treatment with NSAIDs.

STOP taking the medicine and inform your doctor if you experience:

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

• signs of intestinal bleeding (severe stomach pain, vomiting blood or material resembling coffee grounds, blood in stools, black tarry stools).

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

• symptoms of aseptic meningitis, inflammation of the lining of the brain, 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 heartbeat, low blood pressure (anaphylaxis, angioedema, or severe shock),
• respiratory reactivity including asthma, worsening of asthma, wheezing, difficulty breathing,
• severe forms of skin reactions, such as blistering reactions, including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis,
• worsening of existing 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, muscle, blisters, and skin peeling.

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

• a serious skin reaction known as DRESS syndrome (frequency not known). Symptoms of DRESS include: skin rash, fever, swollen lymph nodes, and increased eosinophils (a type of white blood cell),
• widespread 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 this medicine if you develop these symptoms and seek immediate medical attention. See also section 2.
• A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with serious illness who use paracetamol (see section 2).

Other possible adverse effects

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

• gastrointestinal discomfort such as stomach pain, heartburn, indigestion, nausea, vomiting, gas, and constipation, diarrhea, minor gastrointestinal blood loss which may exceptionally lead to anemia,
• elevated alanine aminotransferase, elevated gamma-glutamyltransferase, and abnormal liver function tests with paracetamol,
• swelling and fluid retention, swelling of ankles or legs (edema); fluid retention usually responds rapidly to discontinuation of the combination,
• increased levels of creatinine and urea in blood.

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

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

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

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

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

• blood formation disorders (agranulocytosis, anemia, aplastic anemia, hemolytic an游戏副本

5. Storage of Paracetamol/Ibuprofen Sandoz Care

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

Do not use this medicine after the expiry date which is stated on the carton and blister after CAD/EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from light.

This medicine does not require any special storage temperature conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Paracetamol/Ibuprofen Sandoz Care

• The active substances are ibuprofen and paracetamol. Each tablet contains 200 mg of ibuprofen and 500 mg of paracetamol.
• Other components are:

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

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

Appearance of Paracetamol/Ibuprofen Sandoz Care and contents of the container

Film-coated tablets, white to off-white in colour, oval-shaped, with dimensions of 19.7 mm x 9.2 mm.

The tablets are packed in aluminium-PVC/PVDC blisters.

Pack sizes:

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova, 57

SLO-1526 Ljubljana

Slovenia

or

Rontis Hellas S.A., Medical and Pharmaceutical Products

Larissa Industrial Area, P.O. Box 3012,

Larissa, 41 500

Greece

Date of the most recent revision of this information: January 2026.

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