Hadmuliv

Leaflet accompanying the packaging: information for the user

Hadmuliv, 200 mg + 500 mg, coated tablets

Ibuprofen + Paracetamol

Read the leaflet carefully before taking 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 a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• 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 or the patient feels worse after 3 days, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Hadmuliv and what is it used for

Hadmuliv 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). Paracetamol works in a different way to ibuprofen, but both active substances work together to reduce pain. Hadmuliv is used for the short-term symptomatic treatment of mild to moderate pain. It is particularly suitable for the treatment of pain that has not responded to ibuprofen or paracetamol alone. Hadmuliv is intended for adults over 18 years of age.

2. Important information before taking Hadmuliv

When not to take Hadmuliv:

• -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 nonsteroidal 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 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 Hadmuliv, the patient should discuss with their doctor or pharmacist if they: are elderly, have or have had asthma, have kidney, heart, liver or intestinal disease, hepatitis or difficulty urinating, are being treated with medicines that affect liver function, have an allergy to other substances, have heartburn, indigestion, stomach ulcers or any other stomach problems, have a tendency to bleed, have Gilbert's syndrome (a rare, inherited metabolic disorder that may cause symptoms such as yellowing of the skin or whites of the eyes), have systemic lupus erythematosus (an autoimmune disease that affects the connective tissue, causing joint pain, skin changes and disorders of other organs) or other mixed connective tissue diseases, have gastrointestinal or chronic inflammatory bowel disease (e.g. ulcerative colitis or Crohn's disease), have an infection - see below, section "Infections", have a congenital deficiency of the enzyme glucose-6-phosphate dehydrogenase, have a congenital, genetic or acquired disorder of certain enzymes that manifests with neurological complications or skin problems or both, i.e. porphyria, have hemolytic anemia, have hay fever, nasal polyps or chronic obstructive pulmonary disease, as there may be an increased risk of allergic reactions, suffer from chronic alcoholism, are underweight or are chronically malnourished, have a lack of total body water (dehydration), have recently undergone major surgery, are pregnant or breastfeeding, or plan to become pregnant. The doctor should be consulted if any of the above warnings apply to the patient now 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. Do not take Hadmuliv for longer than 3 days. Concomitant use with NSAIDs, including selective cyclooxygenase-2 inhibitors, increases the risk of side effects (see below "Hadmuliv and other medicines") and should be avoided. While taking Hadmuliv, the patient should immediately inform their doctor: if they have severe illnesses, including severe kidney disorders or sepsis (when bacteria and their toxins are in the blood, leading to organ damage) or malnutrition, chronic alcoholism or when taking flucloxacillin (an antibiotic). A serious disease called metabolic acidosis (a blood and fluid disorder) has been reported in patients taking 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, nausea (nausea) and vomiting. Warning:taking higher doses than recommended does not lead to stronger pain relief, but is associated with a risk of serious liver damage. Therefore, the maximum daily dose of paracetamol should not be exceeded. Other medicines containing paracetamol should not be taken (see also above "When not to take Hadmuliv"). The patient should consult their 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 Hadmuliv than recommended". The use of anti-inflammatory and/or analgesic medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially if these medicines are used in high doses. The recommended dose should not be exceeded or the duration of treatment prolonged. Before starting treatment with Hadmuliv, the patient should discuss with their doctor or pharmacist if they: have heart disease, including heart failure, angina pectoris (chest pain) or have 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 have had a stroke of any kind (including "mini-stroke" or transient ischemic attack "TIA"); have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or smoke.

Skin reactions Serious skin reactions have been reported with the use of Hadmuliv. If the following occur: any skin rash, changes in the mucous membranes, blisters or other signs of allergy, the patient should stop taking the medicine and seek medical help immediately, as these may be the first signs of a very serious skin reaction. See section 4. Infections Hadmuliv may mask the symptoms of infection, such as fever and pain. As a result, Hadmuliv 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 symptoms of the infection persist or worsen, they should consult their doctor immediately. Gastrointestinal symptoms During the use of NSAIDs, including ibuprofen, serious side effects from the gastrointestinal tract (affecting the stomach and intestines) have been reported. 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. The patient should discuss any history of gastrointestinal problems with their doctor and be aware of any unusual abdominal symptoms, including nausea, vomiting, diarrhea, constipation, indigestion, abdominal pain, black stools or bloody vomiting. Long-term use of painkillers Long-term use of painkillers for headaches can lead to worsening of the headaches. If this happens or is suspected, the patient should inform their doctor and stop the treatment. Regular use of painkillers, especially in combination with several painkillers, 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, this should be avoided. Vision problems If the patient notices any vision problems after taking Hadmuliv, they should stop taking the medicine and consult their doctor. Other notes In general, habitual use of painkillers, especially in combination with several pain-relieving active substances, can lead to permanent kidney damage with a risk of kidney failure. Therefore, this should be avoided.

Children and adolescents

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

Hadmuliv and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking, or have recently taken, and any medicines they plan to take.

Do not take Hadmuliv with:

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

The patient should be particularly careful, as some medicines may interact with Hadmuliv, such as:

• -corticosteroidsin tablets,
• -antibiotics(e.g. chloramphenicol or quinolones),
• -anti-emetics(e.g. metoclopramide, domperidone),
• -acetylsalicylic acid, salicylates or other NSAIDs(including COX-2 inhibitors, such as celecoxib or etoricoxib),
• -anticoagulants(i.e. blood thinners/anti-clotting agents, e.g. warfarin, acetylsalicylic acid, ticlopidine),
• -cardiac glycosides(e.g. digoxin), medicines that increase heart activity,
• -medicines used to treat high cholesterol levels(e.g. cholestyramine),
• -diuretics(which help to remove water),
• -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,
• -zydovudine,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,
• -antifungal medicinesthat inhibit the liver enzyme CYP2C9 (e.g. voriconazole, fluconazole),
• -other substancesknown 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 milk vetch(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 Hadmuliv or be affected by it. Therefore, before starting treatment with Hadmuliv and other medicines, the patient should consult their doctor or pharmacist.

Hadmuliv with food and alcohol

To reduce the likelihood of side effects, Hadmuliv should be taken with food. The patient 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 the patient is pregnant or breastfeeding, thinks they may be pregnant or are planning to have a baby, they should consult their doctor or pharmacist before taking this medicine.

• PregnancyHadmuliv should not be taken during 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. Hadmuliv should not be taken during the first 6 months of pregnancy, unless absolutely necessary and recommended 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 Hadmuliv is used for longer 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 used in the recommended dose and for the shortest possible time.
• FertilityIbuprofen belongs to a group of medicines that may affect female fertility. Hadmuliv may make it more difficult to become pregnant. This effect is temporary and reverses after stopping the medicine.

Driving and using machines

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

3. How to take Hadmuliv

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Adults

The recommended dose is 1 tabletto be taken 1 to 3 times a day, swallowed with water. A minimum 6-hour interval should be maintained between doses. If symptoms do not improve after taking 1 tablet, a maximum of 2 tablets can be taken 1 to 3 times a day. A minimum 6-hour interval should be maintained between doses. Do 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 Hadmuliv 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 the patient, they should consult their doctor before taking Hadmuliv (see also section 2 "Warnings and precautions"). For oral use only and for short-term use only. Do not take this medicine for longer than 3 days. If symptoms persist or worsen, the patient should consult their doctor. The patient 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, the patient should consult their doctor immediately (see section 2).

Taking a higher dose of Hadmuliv than recommended

If the patient has taken a higher dose of Hadmuliv than recommended, or if the medicine has been accidentally taken by a child, they should always contact a 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 and nystagmus, or less commonly diarrhea. Additionally, after high doses, dizziness, blurred vision, low blood pressure, excitement, disorientation, coma, hyperkalemia (elevated potassium levels in the blood), prolonged prothrombin time/INR, acute kidney failure, liver damage, respiratory failure, cyanosis and worsening of asthma in asthmatics, drowsiness, chest 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, the patient should seek medical advice immediately

even if they feel well.An overdose of paracetamol may cause delayed, serious liver damage, which can be fatal. Even if there are no symptoms of discomfort or poisoning, the patient may need urgent 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 Hadmuliv

The patient should not take a double dose to make up for a missed tablet. If they forget 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. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Hadmuliv can cause side effects, although not everybody gets them. The following side effects are largely dose-dependent and vary from patient to patient. The most common side effects are gastrointestinal in nature. Gastrointestinal ulcers, perforation or bleeding may occur, sometimes fatally, especially in elderly patients. After administration, nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, black stools and bloody vomiting have been reported. Less commonly, stomatitis 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.

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

Uncommon (may affect up to 1 in 100 people) symptoms of gastrointestinal bleeding (severe abdominal pain, bloody or black vomiting, blood in the stool, black tarry stools). Rare (may affect up to 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, asthma worsening, wheezing, breathing difficulties; 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 skin discoloration, fever, drowsiness, diarrhea and nausea) or worsening of other infections, including chickenpox or shingles or severe infection with tissue destruction (necrosis) and skin peeling. 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, swollen lymph nodes and increased eosinophil count (a type of white blood cell); red scaly rash with thickening under the skin and blisters, mainly in skin folds, on the trunk and upper limbs, with fever at the start of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the patient 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 illness taking paracetamol (see section 2).

Other possible side effects:

Common(may affect up to 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, swelling of the ankles or feet (edema); increased creatinine and urea levels in the blood; Uncommon(may affect up to 1 in 100 people) central nervous system disorders, such as headache, dizziness, insomnia, excitement, irritability or fatigue; urticaria, pruritus; urinary retention; thickening of respiratory tract secretions; various types of rash; gastrointestinal ulcers, potentially with bleeding and perforation or gastrointestinal bleeding, worsening of inflammatory bowel disease (colitis) and Crohn's disease, stomatitis, 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 affect up to 1 in 1,000 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 affect up to 1 in 10,000 people) blood disorders, such as agranulocytosis, anemia, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia and thrombocytopenia. The first symptoms are: fever, sore throat, superficial mouth 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; visual disturbances; in this case, the patient should stop taking Hadmuliv and consult their doctor; hearing loss, ringing in the ears, feeling of spinning (vertigo), confusion, psychotic reactions, hallucinations, depression; fatigue, general malaise; increased sweating, sensitivity to light, exfoliative dermatoses; red scaly rash with thickening under the skin and blisters, mainly in skin folds, on the trunk and upper limbs, with fever at the start of treatment (acute generalized exanthematous pustulosis); hair loss; high blood pressure, vasculitis; esophagitis, pancreatitis, formation of diaphragmatic strictures in the intestines; liver problems, dysfunction, damage (especially with long-term use), liver failure, acute hepatitis, jaundice (yellowing of the skin and/or whites of the eyes); 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 (leading to shortness of breath, swelling), myocardial infarction. Frequency not known(frequency cannot be estimated from the available data) increased sensitivity of the skin to light. The use of medicines such as Hadmuliv may be associated with a small increased 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 this leaflet, they should consult their 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, more information can be gathered on the safety of this medicine.

5. How to store Hadmuliv

The medicine should be stored out of 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 stated. Store in the original packaging to protect from light. There are no special storage temperature recommendations for this 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 packaging and other information

What Hadmuliv contains

• The active substances of Hadmuliv 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), anhydrous colloidal silica, povidone K-30, cornstarch, talc and stearic acid (50). Coating: polyvinyl alcohol, talc, macrogol 3350, titanium dioxide (E 171).

What Hadmuliv looks like and contents of the pack

Hadmuliv is a white or almost white, oval, coated tablet, 19.7 mm x 9.2 mm in size. 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, PO Box 3012, 41 500 Larissa, 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 Hadmuliv, Hungary Ibuprofen/Paracetamol Sandoz 200 mg/500 mg filmtabletta

For more information about this medicine, the patient should contact their local representative of the marketing authorization holder:

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