Ibuprofen/paracetamol Milan

Leaflet accompanying the packaging: information for the user

Ibuprofen/Paracetamol Mylan, 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 used exactly as described in the 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 more information, you should speak to your pharmacist.

Do not take the medicine for longer than 3 days.

If there is no improvement or if you feel worse, you should consult a doctor. If you experience any side effects, including any possible side effects not listed in the leaflet, you should tell your doctor or pharmacist. See section 4. If after 3 days there is no improvement or if you feel worse, you should consult a doctor.

Table of contents of the leaflet

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

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

Ibuprofen/Paracetamol Mylan contains two active substances (which make the medicine work). These are ibuprofen and paracetamol. Ibuprofen belongs to a group of medicines known as nonsteroidal anti-inflammatory drugs (NSAIDs). The action of NSAIDs is to reduce pain, reduce swelling, and lower high body temperature. Paracetamol is a pain reliever that relieves pain and fever, acting differently than ibuprofen. This product is particularly useful for treating pain that requires stronger pain relief than ibuprofen or paracetamol used separately. Ibuprofen/Paracetamol Mylan is used for the short-term treatment of mild to moderate pain associated with migraine, headache, back pain, menstrual cramps, toothache, and muscle pain, symptoms of colds and flu, sore throat, and fever. Ibuprofen/Paracetamol Mylan is used in adults over 18 years of age. If after 3 days there is no improvement or if you feel worse, you should consult a doctor.

2. Important information before taking Ibuprofen/Paracetamol Mylan

When not to take the medicine Ibuprofen/Paracetamol Mylan

• -if you are taking any other medicines containing paracetamol
• -if you are taking any other painkillers, such as ibuprofen, acetylsalicylic acid in large doses(above 75 mg per day) or other nonsteroidal anti-inflammatory drugs (NSAIDs), including selective inhibitors of cyclooxygenase-2 (COX-2)

• -if you are allergic to ibuprofen, paracetamolor any of the other ingredients of this medicine (listed in section 6)
• -if you are allergic to acetylsalicylic acid or other painkillers from the NSAID group

NSAIDs

• -if you currently have or have ever had ulcers or bleeding in the stomach or duodenum(small intestine)
• -if you have blood clotting disorders
• -if you have heart, liver, or kidney failure
• -in the last 3 months of pregnancy
• -if you are under 18 years of age.

Skin reactions

Severe skin reactions have been reported with the use of ibuprofen and paracetamol. You should stop taking the medicine Ibuprofen/Paracetamol Mylan and immediately consult a doctor if you experience any rash, changes in the mucous membranes, blisters, or other signs of an allergic reaction, as these may be the first signs of a very severe skin reaction. See section 4.

Warnings and precautions

You should consult a doctor or pharmacist before taking the medicine Ibuprofen/Paracetamol Mylan

• -in elderly people
• -if there is an infection- see the heading below "Infections"
• -if you currently have or have had asthma
• -if you have kidney, heart, liveror gastrointestinal disorders
• -if you have systemic lupus erythematosus (SLE)- an autoimmune disease of the connective tissue that causes joint pain, skin changes, and disorders of other organs; or other mixed connective tissue disease
• -if you have gastrointestinal disorders or chronic non-specific enteritis(e.g. ulcerative colitis, Crohn's disease)
• -in the first 6 months of pregnancyor during breastfeeding
• -if you plan to become pregnant
• -if you have a genetic disorder called glucose-6-phosphate dehydrogenase deficiency
• -if you excessively consume alcohol(alcohol abuse/alcoholism)
• -if you are underweight, malnourished, or dehydrated
• -if you are taking other medicines that affect the liver

If you have heart disease, if you have had a strokeor if you think you may be at risk of these disorders (for example, you have high blood pressure, diabetes, high cholesterolor if you smoke), you should discuss treatment with your doctor or pharmacist. Taking anti-inflammatory 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. Do not exceed the recommended dose or duration of treatment. Before taking the medicine Ibuprofen/Paracetamol Mylan, you should discuss treatment with your doctor or pharmacist if:

• -you have heart disease, such as heart failure, angina (chest pain); you have had a heart attack or have had coronary artery bypass grafting; you have peripheral artery disease (poor blood circulation in the legs or feet due to narrowing or blockage of the arteries) or if you have had a stroke (including a mini-stroke or transient ischemic attack, TIA)
• -you have high blood pressure, diabetes, high cholesterol; there is a history of heart disease or stroke in your family; or if you smoke.

Infections
Ibuprofen/Paracetamol Mylan may mask the symptoms of infections, such as fever and pain. Therefore, it is possible that Ibuprofen/Paracetamol Mylan may delay the appropriate treatment of the infection, which may lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you are taking this medicine during an infection and the symptoms of the infection persist or worsen, you should immediately consult a doctor.

Ibuprofen/Paracetamol Mylan and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as about the medicines you plan to take.

When not to take the medicine Ibuprofen/Paracetamol Mylan

• -with other medicines containing paracetamol
• - flucloxacillin(an antibiotic), due to the serious risk of blood and fluid disorders (metabolic acidosis with a large anion gap), which require emergency treatment and which may occur especially in the case of severe kidney failure, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), malnutrition, chronic alcoholism, and when taking the maximum daily doses of paracetamol
• -with other NSAIDs, such as acetylsalicylic acid, ibuprofen.

You should be particularly careful, as some medicines may interact with the medicine Ibuprofen/Paracetamol Mylan, for example:

• - corticosteroidsin tablets
• - antibiotics(e.g. chloramphenicol or quinolones)
• - anti-emetic medicines(e.g. metoclopramide, domperidone)
• -medicines that thin the blood or prevent blood clots(e.g. warfarin, acetylsalicylic acid, ticlopidine)
• - heart medicines(e.g. glycosides)
• -medicines used for high cholesterol(e.g. cholestyramine)
• - diuretic medicines(which facilitate the excretion of excess water)
• -medicines taken for high blood pressure(e.g. ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan)
• - immunosuppressive medicines(e.g. methotrexate, cyclosporine, tacrolimus)
• -medicines used to treat mania or depression(e.g. lithium or SSRI - selective serotonin reuptake inhibitors
• - mifepristone(a medicine that causes pharmacological abortion)
• - medicines used to treat HIV infection(e.g. zidovudine).

The medicine Ibuprofen/Paracetamol Mylan may also affect the action of some other medicines or be affected by them. Therefore, before taking the medicine Ibuprofen/Paracetamol Mylan with other medicines, you should always consult a doctor or pharmacist.

Taking the medicine Ibuprofen/Paracetamol Mylan with food

In order to reduce the likelihood of side effects, you should take the medicine Ibuprofen/Paracetamol Mylan during meals.

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 a doctor or pharmacist before taking this medicine.
Pregnancy
You should not take this medicine in the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. The medicine may cause kidney and heart disorders in the unborn child. It may affect the tendency to bleed in the mother and child and may cause a delay or prolongation of labor. You should not take this medicine in the first 6 months of pregnancy, unless it is absolutely necessary and recommended by a doctor. If the use of the medicine is necessary during this period or when trying to become pregnant, you should take the smallest effective dose for the shortest possible time. If you take the medicine for more than a few days starting from the 20th week of pregnancy, Ibuprofen/Paracetamol Mylan may cause kidney disorders in the unborn child, which may lead to a decrease in the amount of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If you need to take the medicine for a longer period, your doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen and its metabolites pass into breast milk in small amounts. The medicine can be taken during breastfeeding, if it is used in the recommended dose and for the shortest possible time.
Fertility in women
The medicine Ibuprofen/Paracetamol Mylan may cause difficulties in becoming pregnant.
Ibuprofen:Ibuprofen belongs to a group of medicines that may have a negative effect on female fertility. This effect is reversible after stopping the medicine. You should inform your doctor if you are planning to become pregnant or if you are having problems becoming pregnant.

Driving and using machines

Ibuprofen/Paracetamol Mylan may cause dizziness, impaired concentration, and drowsiness. If you experience these symptoms, you should not drive or operate any tools or machines.

3. How to take Ibuprofen/Paracetamol Mylan

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist. In case of doubt, you should consult a doctor or pharmacist. Take orally only for a short time (no longer than 3 days). Use the smallest effective dose for the shortest time necessary to relieve the symptoms. Do nottake the medicine Ibuprofen/Paracetamol Mylan for longer than 3 days.If the symptoms worsen or do not improve, especially if you have an infection with symptoms such as fever and pain, or if you need to take the medicine for longer than 3 days, you should consult a doctor.

Adults:

The recommended dose is1 tablet with food, washed down with water, up to 3 times a day. You should keep an interval of at least 6 hours between doses. If the symptoms do not improve after taking 1 tablet, you can take up to 2 tablets up to three times a day. Do not take more than 6 tablets in 24 hours(which corresponds to a dose of 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.

Patients with kidney or liver disorders

In patients with kidney or liver disorders and in patients with Gilbert's syndrome, the dose should be reduced or the interval between doses prolonged. In patients with severe kidney disorders, the interval between doses should be at least 6 hours. You should consult a doctor or pharmacist.

Taking a higher dose of the medicine Ibuprofen/Paracetamol Mylan than recommended

If you have taken a higher dose of the medicine Ibuprofen/Paracetamol Mylan than recommended or if a child has taken this medicine by accident, you should always consult a doctor or go to the nearest hospital to find out what the risk to your health is and what actions you should take. Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, disorientation, and nystagmus. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, as well as blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties have been reported. If you have taken too much of the medicine, you should immediately tell your doctor, even if you feel well. Taking too much paracetamol can cause delayed, serious liver damage.

Missing a dose of the medicine Ibuprofen/Paracetamol Mylan

You should not take a double dose to make up for a missed dose. If you forget to take a dose, you should take it as soon as you remember, and the next dose at least 6 hours later.

4. Possible side effects

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

You should STOP TAKINGthe medicine and inform your doctor if you experience:

• -heartburn, indigestion
• -symptoms of gastrointestinal bleeding(severe stomach pain, bloody vomiting or vomiting resembling coffee grounds, blood in the stool, black tarry stools)
• -symptoms of meningitis, such as stiffness of the neck, headaches, nausea or vomiting, fever, or a feeling of disorientation
• -symptoms of a severe allergic reaction(swelling of the face, tongue, or throat, difficulty breathing, or worsening of asthma)
• -severe skin reactionsknown as DRESS syndrome (frequency not known). The symptoms of DRESS syndrome include: skin rash, fever, lymph node enlargement, and an increased number of eosinophils (a type of white blood cell).
• -severe skin reaction, such as blistering(frequency of occurrence not known).

Other possible side effects

Common(may occur in up to 1 in 10 people)

• -stomach pain or discomfort, nausea or vomiting, diarrhea
• -increased liver enzyme activity (shown in blood tests)
• -excessive sweating
• -swelling.

Uncommon(may occur in up to 1 in 100 people)

• -pain and dizziness, gas and constipation, rash, facial swelling, and itching
• -decreased red blood cell count or increased platelet count (blood cells involved in blood clotting)
• -oral ulcers
• -stomach or duodenal ulcers (peptic ulcers)
• -worsening of ulcerative colitis (causing ulcers and bleeding)
• -Crohn's disease (inflammatory bowel disease)
• -gastritis (inflammation of the stomach lining)
• -pancreatitis (inflammation of the pancreas) causing severe stomach pain radiating to the back.

Rare(may occur in up to 1 in 1,000 people)

• -feeling of tingling, numbness, or itching

Very rare(may occur in up to 1 in 10,000 people)

• -decreased blood cell count (with sore throat, oral ulcers, flu-like symptoms, severe fatigue, bleeding, and nosebleeds of unknown cause)
• -vision disorders, ringing in the ears, feeling of spinning
• -disorientation, depression, hallucinations
• -fatigue, general malaise
• -severe skin reactions, such as blistering
• -high blood pressure, fluid retention
• -liver disorders (causing yellowing of the skin and whites of the eyes)
• -kidney disorders (causing increased or decreased urination, swelling of the legs)
• -heart failure (causing shortness of breath)
• -cases of abnormal changes in blood and fluids (metabolic acidosis with a large anion gap) occurring after an increase in acidic blood pH, when paracetamol is used with flucloxacillin (an antibiotic used to treat certain infections), usually in the presence of risk factors (see section 2).

Frequency not known(frequency cannot be estimated from the available data)

• -a red, flaking, widespread rash with nodular eruptions and blisters, mainly in skin folds, on the torso, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). If you experience these symptoms, you should stop taking the medicine Ibuprofen/Paracetamol Mylan and immediately consult a doctor. See also section 2.
• -increased sensitivity of the skin to light

Taking medicines like Ibuprofen/Paracetamol Mylan 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 the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 4921 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 Mylan

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 "Expiry date (EXP)". The expiry date refers to the last day of the month.
Store in the original packaging to protect from light. This medicine does not require special storage conditions in terms of temperature.
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 does the medicine Ibuprofen/Paracetamol Mylan contain

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:
Core: corn starch, crospovidone (type A), colloidal anhydrous silica, povidone K-30, corn starch paste, talc, stearic acid (50).
Coating: polyvinyl alcohol, talc, macrogol 3350, titanium dioxide (E 171).

What does the medicine Ibuprofen/Paracetamol Mylan look like and what does the packaging contain

Ibuprofen/Paracetamol Mylan is a white to almost white, oval, coated tablet with dimensions of 19.7 mm x 9.2 mm.
The coated tablets are available in blisters in cardboard boxes containing 10, 12, 16, or 20 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Mylan Ireland Limited
Unit 35/36 Grange Parade
Baldoyle Industrial Estate, Dublin 13
Ireland

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larisa Industrial Area
41004 Larisa
Greece
To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, you should contact the local representative of the marketing authorization holder:
Mylan Healthcare Sp. z o.o.
Tel: +48 22 54 66 400
Date of last revision of the leaflet:March 2025