Paracetamol and ibuprofen Mylan: detailed information

PACKAGE LEAFLET

Package leaflet: information for the user

Paracetamol and Ibuprofen Mylan 500 mg/200 mg film-coated tablets

paracetamol/ibuprofen
Generic medicine
[ Available without prescription ]
Please read this entire leaflet carefully before taking this medicine, as it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.
Keep this leaflet. You may need to read it again.
If you need further information or advice, consult your pharmacist.
If you experience any side effects, including any not listed in this
leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen
after 3 days.
[Available only on prescription]
Please read this entire leaflet carefully before taking this medicine, as it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if
their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this
leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet

What Paracetamol and Ibuprofen Mylan is and what it is used for
What you need to know before taking Paracetamol and Ibuprofen Mylan
How to take Paracetamol and Ibuprofen Mylan
Possible side effects
How to store Paracetamol and Ibuprofen Mylan
Package contents and other information

1. What Paracetamolo e Ibuprofene Mylan is and what it is used for

Paracetamolo e Ibuprofene Mylan contains two active substances: paracetamol and ibuprofen.
Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
NSAIDs work by reducing pain and swelling.
Paracetamol is an analgesic that acts differently from ibuprofen to relieve pain.
[ Available without prescription]
Paracetamolo e Ibuprofene Mylan is used in adults for the short-term symptomatic treatment of mild to moderate pain, such as headache (not migraine), backache, menstrual pain, toothache, muscle pain, symptoms of cold and flu, and sore throat.
[Available only on prescription]
Paracetamolo e Ibuprofene Mylan is used in adults for the short-term symptomatic treatment of mild to moderate pain.
This medicine is particularly suitable for pain requiring stronger analgesic treatment than paracetamol or ibuprofen taken alone.
Consult your doctor if you do not notice any improvement or if you notice worsening of symptoms after 3 days.

2. What you need to know before taking Paracetamolo e Ibuprofene Mylan

Do not take Paracetamolo e Ibuprofene Mylan if

you are taking any other medicine containing paracetamol
you are taking any other painkiller, including ibuprofen, acetylsalicylic acid at high dose (more than 75 mg per day), or other non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclo-oxygenase-2 (COX-2) inhibitors
you are allergic to ibuprofen, paracetamol, or to any of the other ingredients of this medicine (listed in section 6)
you have previously experienced an allergic reaction, such as shortness of breath, asthma attacks, swelling of nasal mucosa, skin rash, or swelling (angioedema) of the face, lips, tongue, or throat, or skin reactions after taking acetylsalicylic acid or other NSAID painkillers
you have or have previously had recurrent stomach or duodenal ulcers or bleeding (at least two distinct episodes of confirmed bleeding or ulceration)
you have previously had gastrointestinal bleeding, ulceration, or perforation caused by treatment with an NSAID
you have a blood clotting disorder
you suffer from severe heart failure, severe liver or kidney impairment
you are in the last 3 months of pregnancy

Warnings and precautions
Talk to your doctor or pharmacist before taking Paracetamolo e Ibuprofene Mylan if:

you are elderly
you have an infection – see section “Infections” below
you have asthma or have previously suffered from asthma
you have problems with your kidneys, heart, liver, or intestines
you have systemic lupus erythematosus (SLE), a condition in which the immune system damages connective tissue, causing joint pain, skin changes, and organ dysfunction, or another mixed connective tissue disease
you have gastrointestinal disorders or chronic inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease)
you are in the first 6 months of pregnancy or are breastfeeding
you intend to become pregnant

Anti-inflammatory/painkillers such as ibuprofen may be associated with a slight increase in the risk of heart attack or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
During treatment with Paracetamolo e Ibuprofene Mylan, inform your doctor immediately if you have serious conditions such as severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported when paracetamol is used regularly over a prolonged period or when paracetamol is taken concomitantly with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep, rapid breathing, drowsiness, nausea, and vomiting.
Before taking Paracetamolo e Ibuprofene Mylan, speak with your doctor or pharmacist if:

you have heart problems, including heart failure, angina pectoris (chest pain), or have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or any type of stroke (including ‘mini-stroke’ or transient ischaemic attack ‘TIA’)
you have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

If any of the above conditions apply to you, consult your doctor before using Paracetamolo e Ibuprofene Mylan.
Infections
Paracetamolo e Ibuprofene Mylan may mask signs of infection such as fever and pain. Therefore, Paracetamolo e Ibuprofene Mylan could delay appropriate treatment of the infection, increasing the risk of complications. This effect has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult your doctor immediately.
Skin reactions
Serious skin reactions have been reported with Paracetamolo e Ibuprofene Mylan treatment. Stop taking Paracetamolo e Ibuprofene Mylan and contact your doctor immediately if you develop any skin rash, mucosal lesions, blisters, or other signs of allergy, or if you develop widespread redness with fever and pustules, as these may be early signs of a very serious skin reaction. See section 4.
Elderly
Elderly patients have a higher risk of adverse effects when taking NSAIDs, particularly gastrointestinal effects.
Patients with a history of gastrointestinal toxicity, especially if elderly, should report any unusual abdominal symptoms (particularly gastrointestinal bleeding), especially during the initial stages of treatment.
Children and adolescents
This medicine is not intended for use in children and adolescents under 18 years of age.
Other medicines and Paracetamolo e Ibuprofene Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Paracetamolo e Ibuprofene Mylan with

other medicines containing paracetamol
other medicines containing NSAIDs, such as acetylsalicylic acid (at doses above 75 mg per day), ibuprofen, or other NSAIDs, including selective cyclo-oxygenase-2 (COX-2) inhibitors.
Special caution is required because some medicines may interact with Paracetamolo e Ibuprofene Mylan, for example:
corticosteroids in tablet form, used to reduce inflammation in certain areas of the body (e.g. cortisone, prednisone)
antibiotics (e.g. chloramphenicol or quinolones)
antibiotics (flucloxacillin), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2)
anti-nausea medicines (e.g. metoclopramide, domperidone)
cardiac stimulants (e.g. glycosides)
medicines for high cholesterol (e.g. cholestyramine)
diuretics (medicines that help eliminate excess water)
medicines that suppress the immune system (e.g. methotrexate, cyclosporine, tacrolimus)
medicines for mania, bipolar disorders, or depression (e.g. lithium or SSRIs)
mifepristone (for termination of pregnancy)
HIV medicines (e.g. zidovudine)

Paracetamolo e Ibuprofene Mylan may affect or be affected by other medicines. For example:

anticoagulants (i.e. medicines that thin the blood/prevent clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine)
medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan)

Other medicines may also affect or be affected by treatment with Paracetamolo e Ibuprofene Mylan. Always consult your doctor or pharmacist before using Paracetamolo e Ibuprofene Mylan with other medicines.
Paracetamolo e Ibuprofene Mylan with food and alcohol
Do not drink alcohol during treatment, as it may increase the risk of liver damage.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Paracetamolo e Ibuprofene Mylan during the last 3 months of pregnancy, as it may cause harm to the unborn baby or complications during delivery. It may cause kidney and heart problems in the unborn child. It may affect the tendency of both mother and baby to bleed and may delay or prolong labour.
Exercise particular caution if you are in the first 6 months of pregnancy. Do not take Paracetamolo e Ibuprofene Mylan during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to conceive, use the lowest effective dose for the shortest possible duration. If taken for more than a few days starting from week 20 of pregnancy, Paracetamolo e Ibuprofene Mylan may cause kidney problems in the unborn child, which could lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If you require treatment for more than a few days, your doctor may recommend additional monitoring.
Paracetamolo e Ibuprofene Mylan may be used during breastfeeding provided it is used for short-term treatment at the recommended dose.
Paracetamolo e Ibuprofene Mylan may make it more difficult to become pregnant.
Ibuprofen belongs to a group of medicines that may impair female fertility. This effect is reversible upon discontinuation of the medicine. If you are planning a pregnancy or have difficulty conceiving, inform your doctor.
Driving and using machines
In some people, Paracetamolo e Ibuprofene Mylan may cause dizziness, reduced attention, visual disturbances, and drowsiness.
Take this into account when high concentration is required, for example when driving vehicles or operating machinery. Until you know how this medicine affects you, be cautious when driving or using machines.

3. How to take Paracetamol and Ibuprofen Mylan

[ Available without prescription ]
Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.
[ Available only by prescription ]
Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
For short-term oral use only.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms.
Do not take Paracetamol and Ibuprofen Mylan for more than 3 days. If symptoms worsen or persist, especially if you have an infection with symptoms such as fever and pain, consult your doctor immediately.
Adults: The recommended dose is one tablet with water and food, up to 3 times a day.
Allow at least 6 hours between doses.
If one tablet does not control symptoms, up to two tablets may be taken, no more than 3 times a day. Due to the presence of paracetamol, the single dose of two tablets is intended for patients weighing 60 kg or more.
Do not take more than six tablets in any 24-hour period (equivalent to 3,000 mg of paracetamol and 1,200 mg of ibuprofen per day).
If you have mild to moderate liver or kidney impairment, or if you are elderly, your doctor will advise you on the correct dose equivalent to the lowest possible. Do not take this medicine if you have severe liver or kidney impairment.
Use in children and adolescents
Not intended for use in children and adolescents under 18 years of age.
Method of administration
Take the tablets with a glass of water.
To reduce the likelihood of adverse effects, take Paracetamol and Ibuprofen Mylan with food.
If you take more Paracetamol and Ibuprofen Mylan than you should
If you have taken more Paracetamol and Ibuprofen Mylan than you should, or if children have accidentally taken it, contact your doctor or the nearest hospital immediately for advice on the risk and necessary actions.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), headache, ringing in the ears, confusion, and eye tremors. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (particularly in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing difficulties have been reported.
If you take an excessive amount of this medicine, seek immediate medical attention, even if you feel well. Too much paracetamol can cause severe, delayed liver damage.
If you forget to take Paracetamol and Ibuprofen Mylan
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember, then take the next dose at least 6 hours later.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking this medicine and contact your doctor immediately if you experience:

signs of intestinal bleeding (severe stomach pain, vomiting blood or material that looks like coffee grounds, blood in stools, black tarry stools) (uncommon).
signs of inflammation of the lining of the brain such as: neck stiffness, headache, nausea or vomiting, fever or feeling confused (very rare).
signs of a severe allergic reaction. Symptoms include swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, low blood pressure (very rare).
asthma, wheezing, shortness of breath (very rare).
serious skin reactions with blistering such as erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare).
a serious skin reaction known as DRESS syndrome. Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells) (frequency not known).
a serious skin reaction known as PEAG (generalized exanthematic pustulosis). Widespread red rash with peeling, blisters under the skin and vesicles mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (very rare).

Other possible side effects
Common (may affect up to 1 in 10 people)

stomach pain or discomfort, indigestion, nausea or vomiting, diarrhoea
increased levels of liver enzymes (detected in blood tests)
excessive sweating
fluid retention with swelling of the ankles or legs (oedema)

Uncommon (may affect up to 1 in 100 people)

headache and dizziness
flatulence and constipation
reduction in red blood cells or increase in platelets (blood cells that help clotting), causing unexplained bleeding, bruising and nosebleeds
abnormal laboratory test results (blood test results and liver and kidney enzyme levels)
worsening of colitis and Crohn’s disease
dyspepsia (gastritis)
inflammation of the pancreas accompanied by severe pain in the upper abdomen spreading to the back and vomiting (pancreatitis)
skin rashes, itching
mouth ulcers

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

tingling in the hands and feet

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

reduction in blood cells (causing sore throat, mouth ulcers, flu-like symptoms, severe fatigue, unexplained bleeding, bruising and nosebleeds)
vision disorders, tinnitus, dizziness
confusion, depression, hallucinations
fatigue, general feeling of being unwell
skin sensitivity to light
high blood pressure
liver problems (causing yellowing of the skin and whites of the eyes)
kidney problems (causing increased or decreased urine output, leg swelling)
heart failure (causing shortness of breath, swelling)
optic neuritis and somnolence

Not known (frequency cannot be estimated from the available data)

severe condition that may make the blood more acidic (called metabolic acidosis), in patients with a serious illness using paracetamol (see section 2)

Medicines such as Paracetamol and Ibuprofene Mylan may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke (see section 2).
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Paracetamol and Ibuprofen Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and blister, after 'Exp'. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Paracetamol and Ibuprofen Mylan contains
The active substances are paracetamol and ibuprofen. Each film-coated tablet contains
500 mg of paracetamol and 200 mg of ibuprofen.
The other components are:
Tablet core: maize starch, crospovidone (type A) (E1202), anhydrous colloidal silica
(E551), povidone K-30 (E1201), pregelatinized starch, talc (E553b), stearic acid (50).
Film coating: polyvinyl alcohol (E1203), talc (E553b), macrogol 3350 (E1521),
titanium dioxide (E171).
Description of the appearance of Paracetamol and Ibuprofen Mylan and package contents
Paracetamol and Ibuprofen Mylan 500 mg/200 mg tablets are film-coated, white to off-white, oval-shaped tablets measuring 19.7 mm x 9.2 mm.
They are available in blisters packed in boxes containing 10, 12, 16 or 20 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Mylan S.p.A., via Vittor Pisani 20 – 20124 Milan, Italy
Manufacturer
Rontis Hellas Medical And Pharmaceutical Products S.A.
Larissa Industrial Area, P.O. Box 3012
Larissa
41 500
Greece
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Czech Republic: Brufen Combi
Denmark: Paracetamol/Ibuprofen Viatris
Italy: Paracetamol e Ibuprofene Mylan
Norway: Ibuprofen/Paracetamol Viatris
Slovakia: Brufen Combi
Spain: Dalsydol DUO