Kivenul

Leaflet accompanying the packaging: information for the user

Kivenul, 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 this patient leaflet or as directed 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 this leaflet, they should tell their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Kivenul and what is it used for
• 2. Important information before taking Kivenul
• 3. How to take Kivenul
• 4. Possible side effects
• 5. How to store Kivenul
• 6. Contents of the packaging and other information

1. What is Kivenul and what is it used for

Kivenul contains two active substances (which make the medicine work in the right way). These are ibuprofen and paracetamol. Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Paracetamol works in a different way than ibuprofen, but both active substances work together to reduce pain. Kivenul is used for short-term symptomatic treatment of mild to moderate pain. It is particularly suitable for pain that has not been relieved by taking ibuprofen or paracetamol separately. Kivenul is intended for adults over 18 years of age.

2. Important information before taking Kivenul

When not to take Kivenul:

• -if the patient is allergic to ibuprofen, paracetamolor any of the other ingredients of this medicine (listed in section 6),
• -if the patient is already taking any other medicine containing paracetamol,
• -if the patient has had allergic reactions (e.g. bronchospasm, angioedema, asthma, rhinitis or urticaria) associated with the use of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs),
• -if the patient has active or recurrent peptic ulcer (e.g. stomach or duodenal ulcers) or bleeding (two or more episodes of confirmed ulceration or bleeding),
• -if the patient has had gastrointestinal bleeding or perforation in connection with previous NSAID treatment,
• -if the patient has cerebral bleeding or other active bleeding,
• -if the patient has coagulation disorders,
• -if the patient has heart, liver or kidney failure,
• -if the patient is severely dehydrated, e.g. due to vomiting, diarrhea or inadequate fluid intake,
• -if the patient is in the third trimester of pregnancy,
• -if the patient is under 18 years of age.

Warnings and precautions

Before starting treatment with Kivenul, 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 disease, hepatitis or difficulty urinating,
the patient is being treated with medications that affect liver function,
the patient is allergic to other substances,
the patient has heartburn, indigestion, stomach ulcers or any other stomach problems,
the patient has a tendency to bleed,
the patient has Gilbert's syndrome(a rare, inherited metabolic disorder that can cause symptoms such as yellowing of the skin or whites of the eyes),
the patient has systemic lupus erythematosus– an autoimmune disease that affects the connective tissue, causing joint pain, skin changes and dysfunction 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, section entitled "Infections",
the patient has a congenital deficiencyof a certain enzyme called glucose-6-phosphate dehydrogenase.,
the patient has a congenital, genetic or acquired disorder of certain enzymes that manifests with neurological complications or skin problems or sometimes both, i.e. porphyria,
the patient has hemolytic anemia,
the patient has hay fever, nasal polyps or chronic obstructive pulmonary disease,
as there may be an increased risk of allergic reactions,
the patient suffers from chronic alcoholism,
the patient is underweightor is chronically malnourished,
the patient has a complete lack of water in the body(dehydration),
the patient has recently undergone major surgery,
the patient is in the first 6 months of pregnancyor is breastfeeding,
the patient is planning a pregnancy,
You should consult a doctor if any of the above warnings apply to you currently or have applied in the past. It may be necessary to avoid taking this medicine or reduce the dose.
Side effects can be minimized by using the minimum effective dose for the shortest possible time necessary to relieve symptoms. Do not take Kivenul for more than 3 days.
Taking NSAIDs, including ibuprofen, at the same time may increase the risk of side effects (see below "Kivenul and other medicines") and should be avoided.
While taking Kivenul, you should immediately inform your doctor:
If the patient has severe diseases, including severe kidney dysfunction or sepsis (when bacteria and their toxins are circulating 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 long time or when taking paracetamol with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties, including rapid deep breathing, drowsiness, feeling sick (nausea) and vomiting.
Warning:taking higher doses than recommended does not lead to stronger pain relief, but is associated with a risk of severe liver damage. Therefore, you should not exceed the maximum daily dose of paracetamol. You should not take other medicines containing paracetamol (see also above "When not to take Kivenul"). You should consult a doctor or pharmacist before taking other medicines that also contain paracetamol. Symptoms of liver damage usually occur after several days.
Therefore, it is essential to seek medical advice immediatelyafter taking a higher dose than recommended. See also section 3 "Taking a higher dose of Kivenul than recommended".
Taking anti-inflammatory and/or pain-relieving medicines, 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. You should not exceed the recommended dose or duration of treatment.
Before starting treatment with Kivenul, you should discuss it with your doctor or pharmacist if the patient:
has heart disease, including heart failure, angina pectoris (chest pain) or has had a heart attack, coronary artery bypass grafting, peripheral arterial 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");

Skin reactions
There have been reports of severe skin reactions associated with the use of Kivenul. If the following occur: any rash, changes in the mucous membranes, blisters or other signs of an allergic reaction, you should stop taking the medicine and seek medical help immediately, as these may be the first signs of a very severe skin reaction. See section 4.
Infections
Kivenul may mask the symptoms of an infection, such as fever and pain. As a result, Kivenul may delay the use of appropriate infection treatment, leading to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine while an infection is present, and the infection symptoms persist or worsen, they should consult their doctor immediately.
Gastrointestinal symptoms
During the use of NSAIDs, including ibuprofen, serious gastrointestinal side effects have been reported (affecting the stomach and intestines). These can occur with or without warning symptoms. The risk of these side effects is higher in patients with a history of stomach or intestinal ulcers, especially if bleeding or perforation has also occurred. The risk of gastrointestinal side effects is higher in elderly patients. You should discuss any history of gastrointestinal problems with your doctor and remain vigilant for any unusual abdominal symptoms, including nausea, vomiting, diarrhea, constipation, indigestion, abdominal pain, black stools or bloody vomit.
Long-term use of pain-relieving medicines
Long-term use of pain-relieving medicines for headaches can lead to their worsening.
If this situation occurs or is suspected, you should inform your doctor and stop the treatment.
Regular use of pain-relieving medicines, especially in combination with several pain-relieving substances, can lead to permanent kidney damage with a risk of kidney failure, a condition called analgesic nephropathy. This risk may increase with physical exertion associated with loss of salts and dehydration. Therefore, you should avoid this.
Vision problems
If you notice any vision problems after taking Kivenul, you should stop taking the medicine and consult a doctor.
Other notes
In general, habitual use of pain-relieving medicines, especially in combination with several pain-relieving substances, can lead to permanent kidney damage with a risk of kidney failure. Therefore, you should avoid this.

Children and adolescents

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

Kivenul and other medicines

You should tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Do not take Kivenul with:

• -other medicines containing paracetamol,such as some medicines used for colds and flu or pain-relieving medicines.

You should be particularly careful, as some medicines may interact with Kivenul, such as:

• -corticosteroidsin tablets,
• -antibiotics(e.g. chloramphenicol or quinolones),
• -antiemeticmedicines (e.g. metoclopramide, domperidone),
• -acetylsalicylic acid, salicylates or other NSAIDs (including COX-2 inhibitors, such as celecoxib or etoricoxib),
• -anticoagulant medicines (i.e. blood thinners/preventing blood clots, e.g. warfarin, acetylsalicylic acid, ticlopidine),
• -cardiac glycosides (e.g. digoxin), medicines that increase heart activity,
• -medicines used to treat high cholesterol(e.g. cholestyramine),
• -diureticmedicines (supporting water excretion),
• -medicines that lower high blood pressure(ACE inhibitors, such as captopril; beta-adrenergic 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),
• -phenytoin,a medicine used to prevent seizures in epilepsy
• -zidovudine, a medicine used to treat HIV infection (the virus that causes acquired immune deficiency syndrome),
• -medicines that reduce gastric emptying,
• -medicines used to treat bacterial infections called aminoglycosides,
• -medicines used to treat gout called probenecid and sulfinpyrazone,
• -antifungalmedicines that inhibit the liver enzyme CYP2C9 (e.g. voriconazole, fluconazole),
• -other substancesthat are known to affect the liver or induce liver microsomal enzymes, such as alcohol and antiepileptic medicines (e.g. carbamazepine, phenobarbital, lorazepam),
• -medicines used to treat diabetes (sulfonylurea derivatives),
• -Japanese ginseng (a herbal medicine) may increase the risk of bleeding when taking NSAIDs,
• -medicines used to treat tuberculosis (e.g. isoniazid),
• -flucloxacillin (an antibiotic), due to the serious risk of a blood and fluid disorder (called metabolic acidosis with a large anion gap), which requires emergency treatment (see section 2).

Some other medicines may also affect the action of Kivenul or be affected by it.

Therefore, before taking Kivenul with other medicines, you should consult your doctor or pharmacist.

Kivenul with food and alcohol

In order to reduce the likelihood of side effects, Kivenul should be taken with food.
You should not drink alcohol while being treated with this medicine. 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 are planning to have a baby, you should consult your doctor or pharmacist before taking this medicine.

• PregnancyYou should not take Kivenul 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 unborn baby. It may affect the patient's and the baby's tendency to bleed and may cause the delivery to be later or longer than expected. You should not take Kivenul in the first 6 months of pregnancy, unless it is absolutely necessary and recommended by your doctor. If the patient requires treatment during this period or while trying to conceive, the smallest dose should be used for the shortest possible time. If Kivenul is used for more than a few days from the 20th week of pregnancy, it may cause kidney problems in the unborn baby, which can lead to a low level of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the baby's heart. If the patient requires treatment for a longer period, the doctor may recommend additional monitoring
• BreastfeedingOnly a small amount of ibuprofen and its metabolites pass into breast milk. This medicine can be taken while breastfeeding, if it is used in the recommended dose and for the shortest possible time.
• FertilityIbuprofen belongs to a group of medicines that may affect fertility in women. Kivenul may make it difficult to conceive. This effect is temporary and reverses after stopping the medicine.

Driving and using machines

Kivenul may cause dizziness, impaired concentration and drowsiness. If you experience these symptoms, you should not drive or operate machinery.

3. How to take Kivenul

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

Adults

The recommended dose is 1 tabletto 3 times a day, swallowed with water.
You should keep at least a 6-hour interval between doses.
If symptoms do not improve after taking 1 tablet, you can take up to 2 tablets 3 times a day. You should keep at least a 6-hour interval between doses.
You should not take more than 6 tablets in 24 hours(which corresponds to 1200 mg of ibuprofen and 3000 mg of paracetamol per day).
It is recommended to take Kivenul with food to reduce the risk of side effects.

Use in the elderly

No special dose adjustment is necessary. There is an increased risk of serious side effects. The lowest possible dose should be used for the shortest possible time.

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:

• -the patient has kidney problems,
• -the patient has liver problems,
• -the patient weighs less than 50 kg,
• -the patient has chronic malnutrition,
• -the patient regularly consumes alcohol (chronic alcoholism),
• -the patient is inadequately hydrated.

If any of the above points apply to you, you should consult your doctor before taking Kivenul (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 symptoms persist or worsen, you should consult your doctor.
You should use the smallest effective dose for the shortest period necessary to relieve symptoms. If the symptoms of an infection (such as fever and pain) persist or worsen, you should consult your doctor immediately (see section 2).

Taking a higher dose of Kivenul than recommended

If you have taken a higher dose of Kivenul than recommended, or if the medicine has been accidentally taken by a child, you should always contact your doctor or the nearest hospital for advice on the risk and guidance on what to do.
Symptoms may include nausea, abdominal pain, vomiting (which may contain blood), gastrointestinal bleeding, headache, ringing in the ears, confusion, or eye twitching, or less commonly dizziness, blurred vision, low blood pressure, excitement, disorientation, coma, hyperkalemia (high potassium levels in the blood), prolonged prothrombin time/INR, acute kidney failure, liver damage, respiratory failure, cyanosis, and worsening of asthma in asthmatics, drowsiness, abdominal pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, feeling cold, and breathing difficulties.

In case of overdose, you should seek medical advice immediately

even if you feel well.Taking too much paracetamol can cause delayed, severe liver damage, which can be fatal. Even if there are no symptoms of discomfort or poisoning, you may need emergency medical attention. Liver damage can become irreversible if treatment is delayed. To avoid liver damage, treatment should be started as soon as possible.

Missing a dose of Kivenul

You should not take a double dose to make up for a missed tablet. If you forget to take a dose, you should take it as soon as you remember, and the next dose should be taken after at least 6 hours.
If you have any further questions about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Regarding the following side effects, it should be taken into account that they are largely dose-dependent and vary from person to person.
The most common side effects are gastrointestinal. Gastrointestinal ulcers, perforation, or bleeding may occur, sometimes fatal, especially in the elderly. After administration, nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, black stools, and bloody vomit have been reported. Less commonly, gastritis has been observed. In particular, the risk of gastrointestinal bleeding depends on the dose and duration of treatment.
With NSAID treatment, edema, high blood pressure, and heart failure have been reported.

You should STOP TAKING Kivenul and inform your doctor if you experience:

Uncommon (may occur in less than 1 in 100 people)
symptoms of gastrointestinal bleeding (severe abdominal pain, bloody or black vomit, blood in the stool, black, tarry stools).
Rare (may occur in less than 1 in 10,000 people)
symptoms of aseptic meningitis, such as: stiffness of the neck, headache, nausea or vomiting, fever or disorientation;
severe allergic reactions. Symptoms include: swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, low blood pressure (anaphylaxis, angioedema or severe shock);
respiratory reactions, including asthma, worsening of asthma, wheezing, difficulty breathing;
severe skin reactions, such as blistering reactions, including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis;
worsening of existing severe skin infections (may cause rash, blisters, and discoloration of the skin, fever, drowsiness, diarrhea, and nausea) or worsening of other infections, including chickenpox or shingles or severe infection with tissue destruction (necrosis) and muscle damage, blisters, and peeling of the skin.
Frequency not known (frequency cannot be estimated from the available data)
severe skin reactions known as DRESS syndrome (frequency not known). Symptoms of DRESS syndrome include: skin rash, fever, swelling of the lymph nodes, and an increased number of eosinophils (a type of white blood cell)
red scaly rash with thickening of the skin and blisters, usually located in the skin folds, on the trunk, and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, you should stop taking the medicine and seek medical help immediately. See also section 2.
A serious condition that can make the blood more acidic (called metabolic acidosis), in patients with severe disease taking paracetamol (see section 2).

Other possible side effects:

Common(may occur in less than 1 in 10 people):
gastrointestinal disorders, such as abdominal pain, heartburn, indigestion, nausea, vomiting, bloating, and constipation, diarrhea, minor gastrointestinal bleeding, which in exceptional cases may cause anemia;
increased alanine aminotransferase activity, increased gamma-glutamyltransferase activity, and abnormal liver function test results after paracetamol administration; edema and fluid retention, ankle or foot swelling (edema); fluid retention usually responds quickly to discontinuation of concomitant treatment;
increased creatinine and urea levels in the blood;
increased sweating.
Uncommon(may occur in less than 1 in 100 people)
central nervous system disorders, such as headache, dizziness, insomnia, agitation, irritability, or fatigue;
urticaria, itching;
inability to completely empty the bladder (urinary retention);
thickening of the respiratory tract mucus;
rash of various types;
gastrointestinal ulcers, potentially with bleeding and perforation or gastrointestinal bleeding, worsening of inflammatory bowel disease (inflammatory bowel disease) and gastrointestinal disease (Crohn's disease), oral ulceration, gastritis;
decreased hemoglobin and hematocrit levels, increased aspartate aminotransferase activity, increased alkaline phosphatase activity in the blood, increased creatine phosphokinase activity in the blood, increased platelet count (blood clotting cells).
Rare(may occur in less than 1 in 1000 people)
sleep disorders;
kidney tissue damage (especially with long-term use);
high uric acid levels in the blood (hyperuricemia);
abnormal skin sensation (tingling, tingling, and prickling).
Very rare(may occur in less than 1 in 10,000 people)
blood disorders (agranulocytosis, anemia, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, and thrombocytopenia).
The first symptoms are: fever, sore throat, superficial oral ulcers, flu-like symptoms, severe fatigue, unexplained bleeding, bruising, and nosebleeds;
optic neuritis and drowsiness, aseptic meningitis in patients with existing diseases (such as systemic lupus erythematosus and mixed connective tissue disease), symptoms include stiffness of the neck, headache, nausea, vomiting, fever, or disorientation;
vision disorders; in such cases, you should stop taking Kivenul and consult a doctor;
hearing loss, ringing in the ears, feeling of spinning (vertigo), confusion, psychotic reactions, hallucinations, depression;
fatigue, general malaise;
sensitivity to light, exfoliative dermatitis;
red scaly rash (exfoliative dermatitis);
hair loss;
high blood pressure, vasculitis;
esophagitis, pancreatitis, formation of diaphragmatic strictures;
liver problems, dysfunction, liver damage (especially with long-term use), liver failure, acute hepatitis, jaundice (yellowing of the skin and/or whites of the eyes); in paracetamol overdose, acute liver failure can occur, liver dysfunction, liver necrosis, and liver damage;
nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome, and acute and chronic kidney failure;
rapid or irregular heartbeat, also known as palpitations, tachycardia, arrhythmia, and other heart rhythm disorders, heart failure (causing shortness of breath, swelling), myocardial infarction.
Frequency not known(frequency cannot be estimated from the available data)
photosensitivity of the skin.
Taking medicines like Kivenul may be associated with a small increased risk of heart attack (myocardial infarction) or stroke (see section 2).

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, you should consult your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 Kivenul

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 packaging to protect from light.
There are no special storage temperature instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Kivenul contains

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

What Kivenul looks like and contents of the pack

Kivenul is white or almost white, oval, coated tablets with dimensions of 19.7 mm x 9.2 mm.
The coated tablets are packaged in PVC/PVDC/Aluminum blisters and placed in a cardboard box.
Pack sizes:
Blisters: 20 coated tablets.
Single-dose blisters: 20 x 1 coated tablet.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.
Larissa Industrial Area,
P.O. Box 3012
Larissa, 41 500
Greece
Lek d.d.
Verovškova Ulica 57
1526 Ljubljana
Slovenia

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland
Kivenul
Portugal
Ibuprofeno + Paracetamol Sandoz

For further information about this medicine, you should contact your local representative of the marketing authorization holder:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00
Date of last revision of the leaflet:01/2025