Sandoz Care Paracetamol/Ibuprofen 500 Mg/200 Mg , 16 coated tablets

Over 18 years of age.

Adults: the recommended dose is 1 tablet with water, three tablets daily every 8 hours, leaving at least six hours between doses.

Do not take more than six tablets in a 24-hour period.

The active substances are ibuprofen and paracetamol. Each tablet contains 200 mg ibuprofen and 500 mg paracetamol.
Excipients:
Tablet core: maize starch, crospovidone (type A) (E1202), colloidal anhydrous silica (E551), povidone K (E1201), pregelatinised maize starch, talc (E553b), stearic acid (50).
Coating: poly(vinyl alcohol) (E1203), talc (E553b), macrogol 3350 (E1521), titanium dioxide (E171).

Contraindications

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 medicines containing paracetamol,
- have a history of allergic reactions (e.g. bronchospasm, angioedema, asthma, rhinitis or urticaria) associated with aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs),
- have an active or recurrent peptic ulcer (i.e., stomach or duodenal ulcer) or bleeding (two or more distinct episodes of proven ulceration or bleeding),
- have a history of gastrointestinal bleeding or perforation related to previous NSAID treatment,
- have cerebrovascular or other active bleeding,
- have blood clotting disorders,
- has severe heart, liver or kidney failure,
- are severely dehydrated, caused by vomiting, diarrhoea or insufficient fluid intake,
- are in the last 3 months of pregnancy,
- are under 18 years of age.

Side effects

The most frequently observed side effects are gastrointestinal in nature. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, may occur, especially in elderly patients. Nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, tarry stools, bloody vomiting, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported after administration. Gastritis has been observed less frequently. In particular, the risk of gastrointestinal bleeding depends on the dose range and duration of use.
Oedema, high blood pressure and heart failure have been reported in association with NSAID treatment.

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

- symptoms of aseptic meningitis, inflammation of the lining of the brain such as: stiff neck, 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 experience rash, blistering and discolouration of the skin, fever, drowsiness, diarrhoea and nausea), orworsening of other infections, such as chickenpox or shingles or severe infection with destruction (necrosis) of subcutaneous skin, tissue and muscle, blistering and peeling of the skin.

- a severe skin reaction known as DRESS syndrome (frequency not known). Symptoms of DRESS include: rash, fever, swollen lymph nodes and an increase in eosinophils (a type of white blood cell),
- red, scaly, widespread rash with bumps under the skin and blisters located mainly in the skin folds, trunk and upper extremities, accompanied by fever at the start of treatment (acute generalised exanthematous pustulosis).

- gastrointestinal complaints such as stomach pain, heartburn, indigestion, nausea, vomiting, gas and constipation, diarrhoea, mild gastrointestinal blood loss which may cause anaemia in rare cases,
- elevated alanine aminotransferase, elevated gamma-glutamyltransferase and abnormal liver function tests with paracetamol,
- swelling and fluid retention, swelling of ankles or legs (oedema); fluid retention usually responds quickly to discontinuation of the combination,
- increased levels of creatinine and urea in the blood.
- central nervous system disturbances such as headache, dizziness, insomnia, agitation, irritability or tiredness,
- hives, itching,
- inability to empty the bladder completely (urinary retention),
- thick mucus in the airways,
- various types of rash,
- gastrointestinal ulcers, potentially with bleeding and perforation or gastrointestinal bleeding, worsening of inflammation of the colon (colitis) and digestive tract (Crohn's disease), ulcerative stomatitis, gastritis,
- decreased haemoglobin and haematocrit, increased aspartate aminotransferase, increased blood alkaline phosphatase, increased blood creatine phosphokinase, increased platelet (blood clotting cells) count
- abnormal dreams,
- kidney tissue damage (particularly in long-term use),
- high level of uric acid in the blood (hyperuricaemia),
- abnormal skin sensation (tingling, pins and needles).
- Blood formation disorders (agranulocytosis, anaemia, aplastix anaemia, haemolytic anaemia, leucopenia, neutropenia, pancytopenia and thrombocytopenia). Early signs are fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding, bruising and nosebleeds,
- optic neuritis and drowsiness, aseptic meningitis in patients with existing disorders (such as systemic lupus erythematosus and mixed connective tissue disease), symptoms include neck stiffness, headache, nausea, vomiting, fever or loss of consciousness,
- visual disturbances; in this case, you should stop using this medicine and consult a doctor,
- hearing loss, ringing in the ears, spinning sensation (vertigo), confusion, psychotic reactions, hallucinations, depression,
- fatigue, general malaise,
- increased sweating, sensitivity to light, exfoliative dermatoses,
- rash with red patches on the skin (purpura),
- hair loss,
- high blood pressure, vasculitis,
- inflammation of the oesophagus, inflammation of the pancreas, formation of diaphragm-like intestinal structures,
- liver problems, liver dysfunction, liver damage (particularly in long-term use), liver failure, acute hepatitis, yellowing of the skin and/or liver, liver damage (particularly in long-term use), liver failure, acute hepatitis, liver damage (particularly in long-term use), liver failure, acute hepatitis, yellowing of the skin and/or liver.In overdose of paracetamol can cause acute liver failure, liver failure, liver necrosis and liver damage,
- nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome and acute and chronic renal failure,
- rapid or irregular heartbeat, also called palpitations, tachycardia, arrhythmia and other cardiac arrhythmias, heart failure (causing shortness of breath, swelling), myocardial infarction. Your pharmacist's opinion

if you suffer from any type of pain and after taking ibuprofen or paracetamol it is not relieved, this combination of the two may be indicated, as both active ingredients work together to reduce pain, do not take for more than three days.
Read the package leaflet included with this medicine carefully. If you have any questions, you can consult our team of pharmaceutical experts.

If you have any questions, you can consult our team of pharmacists.