Ibuprofen/paracetamol Sandoz

Leaflet attached to the packaging: information for the user

Ibuprofen/Paracetamol Sandoz, 200 mg + 500 mg, coated tablets

Ibuprofen + Paracetamol

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

Ibuprofen/Paracetamol Sandoz contains two active substances (which make the medicine work). These are ibuprofen and paracetamol.
Ibuprofen belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
The action of NSAIDs is to relieve pain, reduce swelling, and lower high body temperature.
Paracetamol is a pain reliever that reduces pain and fever in a different way than ibuprofen. This medicine is particularly suitable for treating pain that requires stronger pain relief than 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 and over.
If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before taking Ibuprofen/Paracetamol Sandoz

When not to take Ibuprofen/Paracetamol Sandoz:

• -if the patient is already taking any other medicine containing paracetamol,
• -if the patient is taking any other pain relievers, including ibuprofen, acetylsalicylic acid in high doses(>75 mg/day) or other NSAIDs(including selective COX-2 inhibitors),
• -if the patient is allergic to ibuprofen, paracetamolor any of the other ingredients of this medicine (listed in section 6),
• -if the patient is allergic to acetylsalicylic acid or other pain relievers from the NSAID group

NSAIDs,

• -if the patient has or has ever had stomach ulcers or bleeding from the stomach or duodenum(small intestine),
• -if the patient has blood clotting disorders,
• -if the patient has heart, liver, or kidney failure,
• -if the patient is in the third trimester of pregnancy.

Warnings and precautions

Before starting to take Ibuprofen/Paracetamol Sandoz, you should discuss it with your doctor or pharmacist if:
the patient is elderly,
the patient has or has had asthma,
the patient has kidney, heart, liver, or intestinal diseases,
the patient has Gilbert's syndrome (a rare inherited metabolic disorder with possible symptoms such as yellowing of the skin or whites of the eyes),
the patient has been diagnosed with systemic lupus erythematosus- an autoimmune disease that affects connective tissue, causing joint pain, skin changes, and disorders of other organs 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, the section entitled "Infections".
hereditary deficiency of the enzyme called glucose-6-phosphate dehydrogenase
chronic alcoholism,
malnutrition or prolonged malnutrition or loss of appetite,
fluid deficiency in the body (dehydration),
the patient is in the first 6 months of pregnancyor breastfeeding,
the patient is planning to become pregnant.
If any of the above applies to the patient currently or in the past, they should consult their doctor. It may be necessary to avoid taking Ibuprofen/Paracetamol Sandoz or reduce its dose.
While taking Ibuprofen/Paracetamol Sandoz, you should immediately inform your doctor:
If the patient has severe illnesses, including severe kidney disorders or sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) or malnutrition,
chronic alcoholism or when the patient is also taking flucloxacillin (an antibiotic).
There have been reports of a severe disease called metabolic acidosis (a blood and fluid disorder) in patients who take paracetamol in regular doses for a longer period or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling of nausea (nausea) and vomiting.
Warning: Taking higher doses than recommended does not provide better pain relief, but increases the risk of severe liver damage. Therefore, you should not exceed the maximum daily dose of paracetamol. Do not take other medicines containing paracetamol (see also the section "When not to take Ibuprofen/Paracetamol Sandoz" above).
Symptoms of liver damage usually appear after a few days. Therefore, if the patient has taken a higher dose than recommended, they should immediatelycontact their doctor. See also section 3 "Taking a higher dose of Ibuprofen/Paracetamol Sandoz than recommended".
Taking anti-inflammatory and/or pain relievers, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially if these medicines are taken in high doses.
Skin reactions
There have been reports of severe skin reactions associated with the use of Ibuprofen/Paracetamol Sandoz. If the following occur: any skin rash, changes in the mucous membranes, blisters, or other symptoms of an allergic reaction, the patient should stop taking the medicine and seek medical help immediately, as these may be the first symptoms of a very severe skin reaction. See section 4.
Infections
Ibuprofen/Paracetamol Sandoz may mask the symptoms of an infection, such as fever and pain. As a result, Ibuprofen/Paracetamol Sandoz may delay the use of appropriate infection treatment and consequently lead to an increased risk of complications. This has been observed in the course of bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine while an infection is present, and the symptoms of the infection persist or worsen, they should immediately consult their doctor
Before starting to take Ibuprofen/Paracetamol Sandoz, the patient should discuss it with their doctor or pharmacist if they:

• -have heart disease, including heart failure, angina pectoris (chest pain), or if the patient has had a heart attack, coronary artery bypass grafting, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries), or stroke of any kind (including "mini-stroke" or transient ischemic attack "TIA");
• -have high blood pressure, diabetes, high cholesterol, if there is a history of heart disease or stroke in the patient's family, or if the patient smokes.

Ibuprofen/Paracetamol Sandoz and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take.

Do not take Ibuprofen/Paracetamol Sandoz with:

• -other medicines containing paracetamol, such as some medicines used for colds and flu or for pain relief.
• -other NSAID medicines, such as acetylsalicylic acid, ibuprofen, used for pain, inflammation, or fever.

The patient should be cautious, as some medicines may interact with Ibuprofen/Paracetamol Sandoz, such as:

• - corticosteroidsin tablets,
• - flucloxacillin(an antibiotic), due to the serious risk of a disorder affecting blood and body fluids (called metabolic acidosis with a large anion gap), which requires emergency 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 that stimulate the heart(e.g. glycosides),
• -medicines used to treat high cholesterol(e.g. colestyramine),
• -diuretic medicines(which help to remove excess water),
• -medicines that lower high blood pressure(e.g. ACE inhibitors, such as captopril, beta blockers, such as atenolol, angiotensin II receptor antagonists, e.g. losartan),
• -medicines that suppress the immune system(e.g. methotrexate, cyclosporine, tacrolimus),
• -medicines used to treat mania or depression(e.g. lithium or selective serotonin reuptake inhibitors, SSRIs),
• - mifepristone(used to terminate pregnancy),
• - medicines used to treat HIV infection(e.g. zidovudine),
• -probenecid (a medicine used to treat high levels of uric acid in the 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 taking Ibuprofen/Paracetamol Sandoz with other medicines, the patient should consult their doctor or pharmacist.

Ibuprofen/Paracetamol Sandoz with food

In order to reduce the likelihood of side effects, Ibuprofen/Paracetamol Sandoz should be taken with food.

Pregnancy, breastfeeding, and fertility

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

• Pregnancy You should not take Ibuprofen/Paracetamol Sandoz in the last 3 months of pregnancy, as it may harm the unborn baby or cause problems during delivery. It may cause problems with the baby's kidneys and heart. It may affect the patient's tendency to bleed and the baby's tendency to bleed and may cause the delivery to be later or longer than expected. You should not take Ibuprofen/Paracetamol Sandoz in the first 6 months of pregnancy, unless it is absolutely necessary and advised by a doctor. If the patient requires treatment during this period or while trying to conceive, the lowest dose should be used for the shortest possible time. If Ibuprofen/Paracetamol Sandoz is used for more than a few days from the 20th week of pregnancy, it may cause problems with the baby's kidneys, which may lead to a low level of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If the patient requires treatment for a longer period, the doctor may recommend additional monitoring
• Breastfeeding Only small amounts of ibuprofen and its metabolites pass into breast milk. It can be taken while breastfeeding, if used in the recommended dose and for the shortest possible time.
• Fertility Ibuprofen belongs to a group of medicines that may affect fertility in women. Ibuprofen/Paracetamol Sandoz may make it more difficult to become pregnant. This effect is temporary and reverses after stopping the medicine.

Driving and using machines

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

3. How to take Ibuprofen/Paracetamol Sandoz

This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.
For oral use only and for short-term use.

Adults

Recommended doseis 1 tablet up to 3 times a day, taken with food and water.
A minimum 6-hour intervalshould be maintained between doses.
If symptoms do not improve after taking 1 tablet, up to 2 tablets may be taken up to 3 times a day.
Do not take more than 6 tablets in 24 hours(which corresponds 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.

The dose may need to be reduced to a maximum of 4 tablets per day if:

• there are kidney problems,
• there are liver problems,
• the patient weighs less than 50 kg,
• the patient is malnourished for a long time,
• the patient regularly consumes alcohol (chronic alcoholism),
• the patient is not sufficiently hydrated. If any of the above applies to the patient, they should talk to their doctor before taking Ibuprofen/Paracetamol Sandoz (see also section 2 "Warnings and precautions").

The patient should use the lowest effective dose for the shortest period necessary to relieve the symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, the patient should immediately consult their doctor (see section 2).
Do not take Ibuprofen/Paracetamol Sandoz for more than 3 days. If the symptoms worsen or persist, the patient should consult their doctor.

Taking a higher dose of Ibuprofen/Paracetamol Sandoz than recommended

If the patient has taken a higher dose of Ibuprofen/Paracetamol Sandoz than recommended or the medicine has been accidentally taken by a child, they should always contact their doctor or the nearest hospital for advice on what to do.
Symptoms may include nausea, abdominal pain, vomiting (which may contain blood), headache, ringing in the ears, confusion, and nystagmus. After high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been observed.

In case of taking a higher dose than recommended, the patient should seek medical advice

even if they feel well.Taking too much paracetamol can cause delayed, severe liver damage. If treatment is delayed, liver damage may become irreversible.

Missing a dose of Ibuprofen/Paracetamol Sandoz

The patient should not take a double dose to make up for a missed tablet. If the patient forgets to take a dose, they should take it as soon as they remember, and the next dose should be taken after at least 6 hours.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The patient should STOP TAKING the medicine and inform their doctor if they experience:

heartburn, indigestion,
symptoms of gastrointestinal bleeding(severe abdominal pain, bloody or black vomit, presence of blood in stool, black, tarry stools,
symptoms of meningitis, such as: stiffness of the neck, headache, nausea or vomiting, fever or feeling disoriented,
symptoms of a severe allergic reaction(swelling of the face, tongue, or throat, difficulty breathing,
severe skin reactionsknown as DRESS syndrome (frequency not known). Symptoms of DRESS syndrome include: skin rash, fever, swelling of lymph nodes, and increased number of eosinophils (a type of white blood cell),
severe skin reactions, such as blistering(not very common),
Frequency not known(cannot be estimated from the available data):
A serious condition that can make the blood more acidic (called metabolic acidosis), in patients with severe illness taking paracetamol (see section 2).

Other possible side effects:

Common(may affect up to 1 in 10 people):
abdominal pain or discomfort, nausea or vomiting, diarrhea,
increased liver enzyme activity (detected in blood tests),
excessive sweating.
Uncommon(may affect up to 1 in 100 people)
headache and dizziness, gas and constipation, skin rash, itching, facial swelling,
decrease in red blood cell count or increase in platelet count (cells involved in blood clotting).
Rare(may affect up to 1 in 1,000 people)
decrease in blood cell count (leading to sore throat, mouth ulcers, flu-like symptoms, significant fatigue, unexplained bleeding, bruising, and nosebleeds),
vision disturbances, ringing in the ears, feeling 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 the legs),
heart failure (leading to shortness of breath), swelling of the hands, feet, and ankles.
Frequency not known(frequency cannot be estimated from the available data)
A red scaly rash with thickening of the skin and blisters, usually on the folds of the skin, on the torso, and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the patient should stop taking Ibuprofen/Paracetamol Sandoz and seek medical help immediately. See also section 2;
the skin becomes sensitive to light.
Taking medicines like Ibuprofen/Paracetamol Sandoz may be associated with a small increase in the risk of heart attack (myocardial infarction) or stroke (see section 2).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should consult their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ibuprofen/Paracetamol Sandoz

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
Store in the original package to protect from light.
There are no special storage instructions for the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ibuprofen/Paracetamol Sandoz contains

• The active substances of the medicine are ibuprofen and paracetamol. Each coated tablet contains 200 mg of ibuprofen and 500 mg of paracetamol.
• The other ingredients are: corn starch, crospovidone (type A), colloidal anhydrous silica, povidone K-30, corn 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 with dimensions of 19.7 mm x 9.2 mm.
The coated tablets are packaged in blisters of aluminum/PVC/PVDC and placed in a cardboard box.
Pack sizes:
Blisters: 10 coated tablets.

Marketing authorization 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