Ibuprofen/paracetamol sandoz

Patient Information Leaflet: Information for the User

Ibuprofen/Paracetamol Sandoz, 200 mg + 500 mg, coated tablets
Ibuprofen + Paracetamol
Please read the entire leaflet carefully before taking this medicine, as it contains important information for you.
This medicine should always be taken exactly as described in this patient 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 further information, please consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Table of contents

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

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

Ibuprofen/Paracetamol Sandoz contains two active substances (the components responsible for the medicine's action): ibuprofen and paracetamol.
Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs work by relieving pain, reducing swelling, and lowering high body temperature.
Paracetamol is an analgesic (pain-relieving) medicine that reduces pain and fever in a different way than ibuprofen. This medicine is particularly suitable for treating pain requiring stronger analgesic action than either ibuprofen or paracetamol alone.
Ibuprofen/Paracetamol Sandoz is used for the short-term treatment of mild to moderate pain associated with migraine, headache, back pain, menstrual pain, toothache, rheumatic and muscular pain, symptoms of cold and flu, sore throat, and fever.
Ibuprofen/Paracetamol Sandoz is intended for adults aged 18 years and over.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

2. Important information before using Ibuprofen/Paracetamol Sandoz

When not to use Ibuprofen/Paracetamol Sandoz:

• if the patient is already taking any other medicine containing paracetamol,
• if the patient is taking any other pain-relieving medicines, including ibuprofen, acetylsalicylic acid at high doses (>75 mg/day) or other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors,
• if the patient has hypersensitivity to ibuprofen, paracetamol or any of the other components of this medicine (listed in section 6),
• if the patient has hypersensitivity to acetylsalicylic acid or other pain-relieving medicines from the NSAID group,
• if the patient has or has ever had peptic ulcer or gastrointestinal bleeding (stomach or duodenum),
• if the patient has blood clotting disorders,
• if the patient has been diagnosed with heart, liver or kidney failure,
• if the patient is in the third trimester of pregnancy.

Warnings and precautions
Before starting treatment with Ibuprofen/Paracetamol Sandoz, consult a doctor or pharmacist if: the patient is elderly, the patient has or has had asthma, the patient has kidney, heart, liver or intestinal diseases, Gilbert's syndrome (a rare inherited metabolic disorder with possible symptoms such as jaundice of the skin or whites of the eyes), the patient has been diagnosed with systemic lupus erythematosus – an autoimmune disease affecting connective tissue, causing joint pain, skin changes and disturbances in other organ functions, or other mixed connective tissue diseases, the patient has gastrointestinal disorders or chronic inflammatory bowel disease (e.g. ulcerative colitis or Crohn's disease), the patient has an infection — see below, section titled "Infections", hereditary deficiency of an enzyme called glucose-6-phosphate dehydrogenase, chronic alcoholism, underweight or prolonged malnutrition or loss of appetite, dehydration (lack of body fluids), the patient is in the first 6 months of pregnancy or breastfeeding, the patient plans pregnancy.
If any of the above apply currently or have applied in the past, medical advice should be sought. It may be necessary to avoid using Ibuprofen/Paracetamol Sandoz or to reduce the dose.

During treatment with Ibuprofen/Paracetamol Sandoz, contact a doctor immediately if: the patient has severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, or if the patient is also taking flucloxacillin (an antibiotic).
Severe metabolic acidosis (a blood and fluid disorder) has been reported in patients taking regular doses of paracetamol over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, nausea and vomiting.

Warning: Taking higher than recommended doses does not provide better pain relief but increases the risk of severe liver damage. Therefore, the maximum daily dose of paracetamol must not be exceeded. Do not use other medicines containing paracetamol (see also section "When not to use Ibuprofen/Paracetamol Sandoz" above).
Signs of liver damage usually appear after several days. Therefore, if a dose higher than recommended has been taken, immediate medical advice must be sought. See also section 3 "If more Ibuprofen/Paracetamol Sandoz has been taken than recommended".

The use of anti-inflammatory and/or pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses.

Skin reactions
Severe skin reactions related to the use of Ibuprofen/Paracetamol Sandoz have been reported. If any skin rash, mucosal lesions, blisters or other signs of hypersensitivity occur, the medicine should be discontinued immediately and medical help sought without delay, as these may be early signs of a very serious skin reaction. See section 4.

Infections
Ibuprofen/Paracetamol Sandoz may mask symptoms of infection such as fever and pain. Therefore, Ibuprofen/Paracetamol Sandoz may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an existing infection and symptoms persist or worsen, immediate medical advice should be sought.

Before starting treatment with Ibuprofen/Paracetamol Sandoz, consult a doctor or pharmacist if the patient:

• has heart diseases, including heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including "mini-stroke" or transient ischaemic attack "TIA");
• has high blood pressure, diabetes, high cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.

Ibuprofen/Paracetamol Sandoz and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use.

Do not use Ibuprofen/Paracetamol Sandoz with:

• other medicines containing paracetamol, such as some cold and flu remedies or painkillers,
• other medicines containing NSAIDs, such as acetylsalicylic acid, ibuprofen, used to treat pain, inflammation or fever.

Exercise particular caution, as some medicines may interact with Ibuprofen/Paracetamol Sandoz, for example:

• corticosteroids in tablet form,
• flucloxacillin (an antibiotic), due to a serious risk of blood and body fluid disorder (called high anion gap metabolic acidosis), which requires urgent treatment (see section 2),
• antibiotics (e.g. chloramphenicol or quinolones),
• anti-emetic medicines (e.g. metoclopramide, domperidone),
• medicines used to thin the blood or prevent blood clots (e.g. warfarin, acetylsalicylic acid, ticlopidine),
• medicines stimulating heart function (e.g. cardiac glycosides),
• medicines used to treat high cholesterol (e.g. cholestyramine),
• diuretics (promoting water excretion),
• medicines lowering high blood pressure (e.g. ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists, e.g. losartan),
• medicines suppressing immune system function (e.g. methotrexate, cyclosporine, tacrolimus),
• medicines used in the treatment of mania or depression (e.g. lithium or selective serotonin reuptake inhibitors, SSRI),
• mifepristone (used to terminate pregnancy),
• medicines used in HIV infection (e.g. zidovudine),
• probenecid (a medicine used to treat high uric acid levels in blood and gout),
• other medicines known to affect the liver.

Some other medicines may also affect the action of Ibuprofen/Paracetamol Sandoz or be affected by it. Therefore, before starting treatment with Ibuprofen/Paracetamol Sandoz together with other medicines, the patient should consult a doctor or pharmacist.

Ibuprofen/Paracetamol Sandoz and food
To reduce the likelihood of adverse effects, Ibuprofen/Paracetamol Sandoz should be taken with food.

Pregnancy, breastfeeding and fertility

If a woman is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

• Pregnancy Do not take Ibuprofen/Paracetamol Sandoz during the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. It may cause kidney and heart problems in the unborn child. It may affect the tendency to bleed in both the mother and the child and may result in delayed or prolonged labour. Do not take Ibuprofen/Paracetamol Sandoz during the first 6 months of pregnancy unless absolutely necessary and recommended by a doctor. If treatment is required during this period or when trying to conceive, the lowest effective dose should be used for the shortest possible duration. If Ibuprofen/Paracetamol Sandoz is used for longer than a few days beyond week 20 of pregnancy, it may cause kidney problems in the unborn child, 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 is required for longer than a few days, the doctor may recommend additional monitoring.
• Breastfeeding Only small amounts of ibuprofen and its metabolites pass into breast milk. It may be used during breastfeeding if taken at the recommended dose and for the shortest possible duration.
• Fertility Ibuprofen belongs to a group of medicines that may impair fertility in women. Ibuprofen/Paracetamol Sandoz may make it more difficult to become pregnant. This effect is reversible after stopping the medicine.

Driving and operating machinery
Ibuprofen/Paracetamol Sandoz may cause dizziness, concentration disturbances and drowsiness. If these symptoms occur, the patient should not drive or operate machinery.

3. How to use Ibuprofen/Paracetamol Sandoz

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
For oral use only and for short-term use only.
Adults
The recommended dose is 1 tablet up to 3 times daily, taken with food and accompanied by water.
At least a 6-hour interval must be maintained between consecutive doses.
If symptoms do not improve after taking 1 tablet, a maximum of 2 tablets may be taken up to 3 times daily.
Do not take more than 6 tablets within 24 hours (corresponding to 1200 mg of ibuprofen and 3000 mg of paracetamol per day).
Use in children and adolescents
Do not use in children and adolescents under 18 years of age.
A dose reduction to a maximum of 4 tablets per day may be necessary if:

• there are kidney problems,
• there are liver problems,
• the patient weighs less than 50 kg,
• the patient is chronically undernourished,
• the patient regularly consumes alcohol (chronic alcoholism),
• the patient is insufficiently hydrated.

If any of the above situations apply, consult a doctor before taking Ibuprofen/Paracetamol Sandoz (see also section 2 "Warnings and precautions").

Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If symptoms of an infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Do not use Ibuprofen/Paracetamol Sandoz for longer than 3 days. If symptoms worsen or persist, consult a doctor.
Taking more than the recommended dose of Ibuprofen/Paracetamol Sandoz
If a patient takes more than the recommended dose of Ibuprofen/Paracetamol Sandoz or if the medicine is accidentally taken by a child, always contact a doctor or the nearest hospital for advice on potential risks and necessary actions.
Symptoms of overdose may include nausea, abdominal pain, vomiting (possibly with blood traces), gastrointestinal bleeding (see section 4), diarrhoea, headache, tinnitus, confusion and nystagmus. Excitation, drowsiness, disorientation or coma may also occur.
Seizures may occur rarely in patients. After large doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), peripheral and central dizziness and weakness, cold sensation, and breathing difficulties may be observed. Additionally, prothrombin time/INR may be prolonged, likely due to impaired coagulation factor function in circulation. Acute renal failure and liver damage may occur. In patients with asthma, worsening of asthma is possible.
Additionally, low blood pressure, shallow breathing, and blue-red discoloration of the skin and mucous membranes (cyanosis) may occur.
In case of taking a dose higher than recommended, seek immediate medical advice even if the patient feels well. An excessive dose of paracetamol may cause delayed, severe liver damage. Delayed intervention may lead to irreversible liver damage.
Missed dose of Ibuprofen/Paracetamol Sandoz
Do not take a double dose to make up for a missed tablet. If a patient forgets to take a dose, they should take it as soon as they remember, and the next dose should be taken no sooner than 6 hours after the missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
STOP USING the medicine and inform your doctor if the patient experiences:
heartburn, indigestion,
symptoms of gastrointestinal bleeding (severe abdominal pain, vomiting blood or material resembling coffee grounds,
blood in stools, black tarry stools),
symptoms of meningitis, such as: neck stiffness, headache, nausea or
vomiting, fever or feeling disoriented,
symptoms of a severe allergic reaction (swelling of the face, tongue or throat, difficulty breathing,
worsening of asthma),
severe skin reactions known as DRESS syndrome (frequency unknown). Symptoms of
DRESS syndrome include: skin rash, fever, swollen lymph nodes and increased eosinophil count (a type of white blood cell),
severe skin reactions such as blisters (occurring not very frequently),
Frequency unknown (cannot be estimated based on available data):
A serious condition that may cause the blood to become more acidic (so-called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).
Other possible adverse reactions:
Common (may occur in less than 1 in 10 people):
abdominal pain or discomfort, nausea or vomiting, diarrhoea,
increased liver enzyme activity (detected in blood tests),
excessive sweating.
Uncommon (may occur in less than 1 in 100 people)
headaches and dizziness, flatulence and constipation, skin rashes, itching, facial swelling,
reduced number of red blood cells or increased number of platelets (blood cells involved in clotting).
Very rare (may occur in less than 1 in 10,000 people)
reduction in blood cells (leading to sore throat, mouth ulcers, flu-like symptoms, significant fatigue, unexplained bleeding, bruising and nosebleeds),
visual disturbances, tinnitus, sensation of spinning,
confusion, depression, hallucinations,
fatigue, general malaise,
severe skin reactions such as blistering,
high blood pressure, fluid retention,
liver function disorders (leading to yellowing of the skin and whites of the eyes),
kidney function disorders (leading to increased or decreased urine output, swelling of legs),
heart failure (leading to breathlessness), swelling of hands, arms, feet and legs.
Frequency unknown (frequency cannot be estimated based on available data)
Red, scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, discontinue taking Ibuprofen/Paracetamol Sandoz and seek immediate medical attention.
See also section 2;
skin becomes sensitive to light.
Use of medicines such as Ibuprofen/Paracetamol Sandoz may be associated with a small increased risk of heart attack (myocardial infarction) or stroke (see section 2).
Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301/fax: + 48 22 49 21 309/website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Ibuprofen/Paracetamol Sandoz

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister pack after EXP. The expiry date refers to the last day of the specified month.
Store in the original packaging to protect from light.
No special temperature storage conditions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Ibuprofen/Paracetamol Sandoz contains

• The active substances are ibuprofen and paracetamol. Each coated tablet contains 200 mg of ibuprofen and 500 mg of paracetamol.
• The other ingredients are: maize starch, crospovidone (type A), colloidal anhydrous silica, povidone K-30, pregelatinised maize starch, talc and stearic acid (50). Coating: polyvinyl alcohol, talc, macrogol 3350, titanium dioxide (E 171).

What Ibuprofen/Paracetamol Sandoz looks like and contents of the pack
Ibuprofen/Paracetamol Sandoz is a white or almost white, oval coated tablet measuring 19.7 mm x 9.2 mm.
The coated tablets are packed in blisters made of Aluminium/PVC/PVDC foil and placed in a cardboard box.
Pack sizes:
Blisters: 10 coated tablets.
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Lek Pharmaceuticals d.d.
Verovškova ulica 57
1526 Ljubljana
Slovenia
Rontis Hellas Medical and Pharmaceutical Products S.A.
Larissa Industrial Area, P.O. Box 3012
41 500 Larissa
Greece
For further information about the medicine and its names in the European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00