Ibuprofen/paracetamol mylan

Package leaflet: Information for the user

Ibuprofen/Paracetamol Mylan, 200 mg + 500 mg, film-coated tablets
ibuprofen + paracetamol
Please read the entire leaflet carefully before taking this 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.
Keep this leaflet for future reference.
If you need advice or further information, please consult your pharmacist.
Do not take this medicine for longer than 3 days.
If there is no improvement or if the patient feels worse, consult a doctor.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days or if the patient feels worse, consult a doctor.

Contents of the leaflet

1. What Ibuprofen/Paracetamol Mylan is and what it is 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 pack and other information

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

Ibuprofen/Paracetamol Mylan contains two active substances (the components responsible for the medicine's action):
ibuprofen and paracetamol.
Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs work by reducing pain, inflammation, and high body temperature.
Paracetamol is an analgesic that relieves pain and fever, acting differently from ibuprofen.
This product is particularly useful in the treatment of pain requiring stronger analgesic action than ibuprofen or paracetamol taken separately.
Ibuprofen/Paracetamol Mylan is used for the short-term relief of mild to moderate pain associated with migraine, headache, backache, menstrual pain, toothache, muscle pain, symptoms of cold and flu, sore throat, and fever.
Ibuprofen/Paracetamol Mylan is intended for use in adults aged 18 years and older.
If there is no improvement after 3 days or if the patient feels worse, consult a doctor.

2. Important information before using Ibuprofen/Paracetamol Mylan

When not to use Ibuprofen/Paracetamol Mylan

• if the patient is taking any other medicines containing paracetamol
• if the patient is taking any other pain-relieving medicines, such as ibuprofen, acetylsalicylic acid in high doses (above 75 mg per day) or other medicines from the group of non-steroidal anti-inflammatory drugs (NSAIDs), including selective inhibitors of cyclooxygenase-2 (COX-2)
• if the patient is allergic to ibuprofen, paracetamol or any of the other ingredients of this medicine (listed in section 6)
• if the patient is allergic to acetylsalicylic acid or other pain-relieving medicines from the NSAID group
• if the patient currently has or has ever had ulcers or bleeding in the stomach or duodenum (small intestine)
• if the patient has blood clotting disorders
• if the patient has heart, liver or kidney failure
• during the last 3 months of pregnancy
• if the patient is under 18 years of age

Skin reactions
Severe skin reactions have been reported in connection with the use of ibuprofen and paracetamol. You should stop taking Ibuprofen/Paracetamol Mylan and contact a doctor immediately if any rash, mucosal lesions, blisters or other signs of allergy appear, as these may be the first symptoms of a very serious skin reaction. See section 4.
Warnings and precautions
Consult a doctor or pharmacist before using Ibuprofen/Paracetamol Mylan

• in elderly patients
• if there is an infection – see the section below titled “Infections”
• if the patient has been diagnosed with asthma, currently or in the past
• if the patient has impaired function of the kidneys, heart, liver or intestinal disorders
• if the patient has systemic lupus erythematosus (SLE) – an autoimmune connective tissue disease causing joint pain, skin lesions and organ dysfunction; or other mixed connective tissue disease
• if the patient has gastrointestinal disorders or chronic inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease)
• during the first 6 months of pregnancy or during breastfeeding
• if the patient plans to become pregnant
• • has a genetic disorder called glucose-6-phosphate dehydrogenase deficiency
• • consumes excessive alcohol (alcohol abuse/alcoholism)
• • is underweight, malnourished or dehydrated
• • is taking other medicines affecting the liver

If the patient has heart disease, has previously suffered a stroke, or believes they may be at risk of these conditions (for example, has high blood pressure, diabetes or high cholesterol, or smokes), they should discuss treatment with their 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 using Ibuprofen/Paracetamol Mylan, discuss treatment with a doctor or pharmacist if:

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

Infections
Ibuprofen/Paracetamol Mylan may mask symptoms of infection such as fever and pain. Therefore, it may delay appropriate treatment of infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an infection and symptoms persist or worsen, they should seek immediate medical advice.
Ibuprofen/Paracetamol Mylan and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned for use.
When not to use Ibuprofen/Paracetamol Mylan

• with other medicines containing paracetamol
• with flucloxacillin (an antibiotic), due to a serious risk of blood and fluid disorders (metabolic acidosis with high anion gap), which require urgent treatment and may occur particularly in cases of severe renal failure, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism, or when maximum daily doses of paracetamol are used
• with other medicines from the NSAID group, such as acetylsalicylic acid, ibuprofen.

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

• corticosteroids in tablet form
• antibiotics (e.g. chloramphenicol or quinolones)
• anti-emetics (e.g. metoclopramide, domperidone)
• medicines that thin the blood or prevent clotting (e.g. warfarin, acetylsalicylic acid, ticlopidine)
• medicines stimulating heart function (e.g. glycosides)
• medicines used for high cholesterol (e.g. cholestyramine)
• diuretics (helping eliminate excess water)
• medicines used for high blood pressure (e.g. ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan)
• medicines suppressing immune system function (e.g. methotrexate, cyclosporine, tacrolimus)
• medicines used in the treatment of mania or depression (e.g. lithium or SSRIs – selective serotonin reuptake inhibitors)
• mifepristone (a medicine causing pharmacological termination of pregnancy)
• medicines used in HIV infection (e.g. zidovudine).

Ibuprofen/Paracetamol Mylan may also affect the action of certain other medicines or be affected by them. Therefore, always consult a doctor or pharmacist before using Ibuprofen/Paracetamol Mylan with other medicines.
Ibuprofen/Paracetamol Mylan and food
To reduce the likelihood of adverse effects, take Ibuprofen/Paracetamol Mylan during a meal.
Pregnancy, breastfeeding and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not take this medicine during 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 problems in the unborn child. It may affect bleeding tendencies in both mother and child and may delay or prolong labour. Do not take this medicine during the first 6 months of pregnancy unless absolutely necessary and recommended by a doctor. If use is necessary during this period or when trying to conceive, take the lowest possible dose for the shortest possible time. If taken for more than a few days starting from week 20 of pregnancy, Ibuprofen/Paracetamol Mylan may cause kidney problems in the unborn child, which may lead to reduced amniotic fluid volume surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If longer-term treatment is required, the treating doctor may recommend additional monitoring.
Breastfeeding
Ibuprofen and its metabolites pass into breast milk only in small amounts. The medicine may be used during breastfeeding if taken at the recommended dose and for the shortest possible duration.
Female fertility
Ibuprofen/Paracetamol Mylan may cause difficulty in becoming pregnant.
Ibuprofen: Ibuprofen belongs to a group of medicines that may adversely affect female fertility. This effect is reversible upon discontinuation of the medicine. Inform your doctor if you are planning to become pregnant or if you experience problems conceiving.
Driving and operating machinery
Ibuprofen/Paracetamol Mylan may cause dizziness, reduced concentration and drowsiness. If these symptoms occur, do not drive or operate any tools or machinery.

3. How to take Ibuprofen/Paracetamol Mylan

This medicine should always be taken exactly as described in the patient leaflet, or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Take orally only for a short period (no longer than 3 days).
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. Do not
take Ibuprofen/Paracetamol Mylan for longer than 3 days. If symptoms worsen or do not improve, especially if the patient has an infection with symptoms such as fever and pain, or if prolonged use of the medicine beyond 3 days is required, consult a doctor.

Adults:
The recommended dose is 1 tablet with food, taken with water , up to 3 times daily.
There should be an interval of at least 6 hours between doses .
If symptoms do not subside after taking 1 tablet, up to 2 tablets may be taken, up to three times daily.
Do not take more than 6 tablets in 24 hours (corresponding to a daily dose of 1200 mg ibuprofen and 3000 mg paracetamol).

Use in children and adolescents
Do not use in children and adolescents under 18 years of age.

Patients with impaired kidney or liver function
In patients with impaired kidney or liver function, and in patients with Gilbert's syndrome, the dose should be reduced or the interval between doses extended. In patients with severe kidney impairment, the interval between doses should be at least 6 hours. Consult a doctor or pharmacist.

Taking more than the recommended dose of Ibuprofen/Paracetamol Mylan
If a patient takes more than the recommended dose of Ibuprofen/Paracetamol Mylan, or if a child accidentally ingests this medicine, always contact a doctor or go to the nearest hospital to determine the health risk and appropriate actions.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, confusion, and nystagmus. After a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, presence of blood in urine, low blood potassium levels, feeling cold, and breathing difficulties have been reported.
If an excessive dose of the medicine is taken, the patient should immediately inform a doctor, even if feeling well. An excessive dose of paracetamol may cause delayed, serious liver damage.

Missed dose of Ibuprofen/Paracetamol Mylan
Do not take a double dose to make up for a missed dose. If a patient forgets to take a dose, they should take it as soon as they remember, and then take the next dose at least 6 hours later.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You should STOP TAKING the medicine and contact a doctor immediately if the patient experiences:

• heartburn, indigestion
• symptoms of gastrointestinal bleeding (severe stomach pain, vomiting blood or coffee-ground-like vomit, blood in stool, black tarry stools)
• symptoms of meningitis, such as neck stiffness, headache, nausea or vomiting, fever, or feeling disoriented
• symptoms of a severe allergic reaction (swelling of the face, tongue or throat, difficulty breathing or worsening asthma)
• severe skin reactions known as DRESS syndrome (frequency unknown). Symptoms of DRESS syndrome include skin rash, fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell).
• severe skin reaction such as blisters (frequency unknown).

Other possible adverse reactions
Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• headache and dizziness, gas and constipation, rash, facial swelling, and itching
• decreased number of red blood cells or increased number of platelets (blood cells involved in blood clotting)
• oral mucosal ulceration (open sores in the mouth)
• stomach or duodenal ulceration (peptic ulcer)
• exacerbation of inflammatory bowel disease leading to ulceration and bleeding (exacerbation of ulcerative colitis)
• inflammatory bowel disease (Crohn’s disease)
• inflammation of the gastric mucosa (gastritis)
• pancreatitis causing severe abdominal pain radiating to the back.

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

• tingling, numbness, or itching sensations

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

• reduction in blood cell count (with sore throat, oral mucosal ulceration, flu-like symptoms, severe exhaustion, bleeding and bruising, and unexplained nosebleeds)
• visual disturbances, tinnitus, sensation 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 urine output, leg swelling)
• heart failure (causing shortness of breath)
• cases of abnormal blood and fluid changes (metabolic acidosis with high anion gap) occurring after increased plasma acidity when paracetamol is used concomitantly 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 available data)

• red, scaly widespread rash with subcutaneous nodules and blisters occurring mainly in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). If these symptoms occur, treatment with Ibuprofen/Paracetamol Mylan should be discontinued immediately and a doctor should be consulted without delay. See also section 2.
• skin photosensitivity

Use of medicines such as Ibuprofen/Paracetamol Mylan may be associated with a small increased risk of myocardial infarction (heart attack) or stroke (see section 2).
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921 301, fax: +48 22 4921 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Ibuprofen/Paracetamol Mylan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following “Expiry (EXP)”. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light. This medicine does not require special storage conditions regarding temperature.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Ibuprofen/Paracetamol Mylan contains
The active substances in this medicine are ibuprofen and paracetamol. Each coated tablet contains 200 mg of ibuprofen and 500 mg of paracetamol.
The other ingredients are:
Tablet core: corn starch, crospovidone (type A), colloidal anhydrous silica, povidone K-30, pregelatinized corn starch, talc, stearic acid (50).
Coating of the tablet: polyvinyl alcohol, talc, macrogol 3350, titanium dioxide (E 171).
What Ibuprofen/Paracetamol Mylan looks like and contents of the pack
Ibuprofen/Paracetamol Mylan is a white to almost white, oval coated tablet measuring 19.7 mm x 9.2 mm.
The coated tablets are available in blisters packed in cardboard boxes containing 10, 12, 16 or 20 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation 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
For further information about this medicine and its brand names in the European Economic Area countries, please contact the local representative of the marketing authorisation holder:
Mylan Healthcare Sp. z o.o.
Tel: +48 22 54 66 400