PARACETAMOLO 500 mg/200 mg Tabletki Powlekane

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1. Paracetamolo e Ibuprofene Mylan 500 mg/200 mg film-coated tablets
   1. What is Paracetamolo e Ibuprofene Mylan and what is it used for
   2. What you need to know before taking Paracetamol and Ibuprofen Mylan
2. Paracetamol and Ibuprofen Mylan can be used during breastfeeding provided that it is
   1. How to take Paracetamolo and Ibuprofene Mylan
   2. Possible side effects
   3. How to store Paracetamolo e Ibuprofene Mylan
   4. Contents of the pack and other information

Paracetamolo e Ibuprofene Mylan 500 mg/200 mg film-coated tablets

paracetamol/ibuprofen
Generic medicine
[ Available without prescription]

Read this leaflet carefullybefore 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 told you to do.
Keep this leaflet. You may need to read it again.
If you want more information or advice, ask your pharmacist.
If any side effects occur, including those not listed in this
leaflet, tell your doctor or pharmacist. See section 4.
See a doctor if you do not feel better or if your symptoms worsen
after 3 days.

[Available only on prescription]

Read this leaflet carefullybefore taking this medicine as it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if
their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this
leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What is Paracetamolo e Ibuprofene Mylan and what it is used for
• 2. What you need to know before you take Paracetamolo e Ibuprofene Mylan
• 3. How to take Paracetamolo e Ibuprofene Mylan
• 4. Possible side effects
• 5. How to store Paracetamolo e Ibuprofene Mylan
• 6. Contents of the pack and other information

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

Paracetamolo e Ibuprofene Mylan contains two active ingredients: 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 works in a different way than ibuprofen to relieve
pain.
[ Available without prescription]
Paracetamolo e Ibuprofene Mylan is used in adults for the symptomatic short-term treatment of
mild to moderate pain, such as headache (not migraine), back pain,
menstrual pains, toothache and muscle aches, symptoms of the common cold and flu and
sore throat.
[Available only on prescription]
Paracetamolo e Ibuprofene Mylan is used in adults for the symptomatic short-term treatment of
mild to moderate pain.
This medicine is particularly suitable for pain that requires a stronger analgesic treatment than
paracetamol or ibuprofen taken alone.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after
3 days.

2. What you need to know before taking Paracetamol and Ibuprofen Mylan

Do not take Paracetamol and Ibuprofen Mylan if

• you are taking any other medicine containing paracetamol
• you are taking any other painkillerincluding ibuprofen, acetylsalicylic acidat a high dose(more than 75 mg per day) or other non-steroidal anti-inflammatory drugs(NSAIDs) including specific cyclo-oxygenase 2 (COX-2) inhibitors
• you are allergic to ibuprofen, paracetamolor to any of the other ingredients of this medicine (listed in section 6)
• you have previously had an allergic reaction, such as shortness of breath, asthma attacks, swelling of the nasal mucous membranes, skin rash and swelling (angioedema) of the face, lips, tongue or throat, or skin reactions after taking acetylsalicylic acidor other NSAID painkillers
• you have or have had in the past a ulcer or recurrent bleeding in the stomach or theduodenum(part of the small intestine) (at least two distinct episodes of confirmed bleeding or ulcer)
• you have previously experienced bleeding, ulceration or perforation of the gastrointestinal tract 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 Paracetamol and Ibuprofen Mylan if

• you are elderly
• you have an infection, see section “Infections” below
• you have asthmaor have 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 disturbance of other organs or other 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 pregnancyor are breastfeeding
• intend to become pregnant

Anti-inflammatory/pain-relieving medicines like ibuprofen can be associated with a slight
increased risk of heart attack or stroke, particularly if used at high doses. Do not
exceed the recommended dose or duration of treatment.
During treatment with Paracetamol and Ibuprofen Mylan, immediately inform your
doctor if you suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria
and their toxins circulate in the blood causing organ damage) or malnutrition, chronic alcoholism or if you are also taking flucloxacillin (an antibiotic). In patients in these
situations, a serious condition called metabolic acidosis (an abnormality of the
blood and fluids) has been reported when paracetamol is used at regular doses for a prolonged period or
when paracetamol is taken in combination with flucloxacillin. The symptoms of metabolic
acidosis may include: severe difficulty breathing with rapid, deep breathing, drowsiness, nausea and vomiting.
Before taking Paracetamol and Ibuprofen Mylan you must talk to your doctor or pharmacist
if:

• you have heart problems, including heart failure, angina pectoris (chest pain) or if you have had a heart attack, bypass surgery, peripheral occlusive arterial disease (poor circulation in the legs or feet due to narrowing or blockage of the 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 are a smoker.

If any of the above conditions apply to you, talk to your doctor before using
Paracetamol and Ibuprofen Mylan.
Infections
Paracetamol and Ibuprofen Mylan may mask the signs of infection such as fever and
pain. Therefore, Paracetamol and Ibuprofen Mylan may delay appropriate treatment
of the infection, leading to an increased risk of complications. This effect
has been observed in pneumonia caused by bacteria and in bacterial skin infections related to
chickenpox. If you take this medicine while you have an infection and the symptoms of the infection
persist or worsen, consult your doctor immediately.
Skin reactions
Serious skin reactions have been reported in association with treatment with Paracetamol and Ibuprofen Mylan. Stop taking Paracetamol and Ibuprofen Mylan and consult
your doctor immediately if you develop any skin rash, mucous membrane lesions,
blisters or other signs of allergy or if you develop a widespread rash with associated fever
because these may be the first signs of a very serious skin reaction.
See section 4.

Elderly
Elderly patients have a higher risk of side effects when taking NSAIDs, in
particular effects related to the stomach and intestines.
Patients with a history of gastrointestinal toxicity, especially if elderly, should
report any unusual abdominal symptoms (especially gastrointestinal bleeding)
particularly in the early stages of treatment.

Children and adolescents
This medicine is not intended for use in children and adolescents under the age of
18 years.

Other medicines and Paracetamol and Ibuprofen Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.

Do not take Paracetamol and Ibuprofen Mylan with

• other medicines containing paracetamol
• other medicines containing NSAIDs, such as acetylsalicylic acid (at doses higher than 75 mg

per day), ibuprofen or other NSAIDs including selective cyclo-oxygenase 2 (COX-2)
inhibitors.
Particular caution is required because some medicines may interact with
Paracetamol and Ibuprofen Mylan, for example:

• corticosteroidsin tablets, used to relieve inflammation in some 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) which needs urgent treatment (see section 2)
• medicines for nausea(e.g. metoclopramide, domperidone)
• heart stimulants(e.g. glycosides)
• medicines for high cholesterol(e.g. colestyramine)
• diuretics(medicines that help eliminate excess water)
• medicines that suppress the immune system(e.g. methotrexate, cyclosporine, tacrolimus)
• medicines for mania and bipolar disorders or depression(e.g. lithium or SSRIs)
• mifepristone(for medical abortion)
• medicines for HIV(e.g. zidovudine).

Paracetamol and Ibuprofen Mylan can affect or be affected by other medicines.
For example:

• medicines anticoagulants(i.e. 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
Paracetamol and Ibuprofen Mylan. Therefore, always consult your doctor or pharmacist
before using Paracetamol and Ibuprofen Mylan together with other medicines.
Paracetamol and Ibuprofen 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, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this
medicine.
Do not take Paracetamol and Ibuprofen Mylan if you are in the last 3 months of pregnancy, because
it may cause harm to the unborn baby or problems during delivery. It can cause problems with the kidneys and
heart in the unborn baby. It can alter the mother's and baby's tendency to bleed and cause
a delay or prolongation of labour.
Take particular care if you are in the first 6 months of pregnancy. Do not take
Paracetamol and Ibuprofen Mylan during the first 6 months of pregnancy unless it is
absolutely necessary and recommended by your doctor. If you need treatment during this
period or while trying to become pregnant, you should use the lowest dose for the
shortest possible time. If it is taken for more than a few days from the
20th week of pregnancy, Paracetamol and Ibuprofen Mylan can cause kidney problems in the
unborn baby, which may 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 need treatment for more than a few days, your doctor may recommend
additional monitoring.

Paracetamol and Ibuprofen Mylan can be used during breastfeeding provided that it is

used for short-term treatment at the recommended dose.
Paracetamol and Ibuprofen Mylan may make it more difficult to become pregnant.
Ibuprofen belongs to a group of medicines that can impair female fertility.
This effect is reversible upon discontinuation of the medicine. If you are planning a
pregnancy or if you have problems starting a pregnancy, inform your doctor.

Driving and using machinery
In some people Paracetamol and Ibuprofen Mylan may cause dizziness, altered
attention, visual disturbances and drowsiness.
Take this into account in cases where a high degree of attention is required, e.g. driving vehicles. Until
you have determined the effect this medicine has on you, be careful
when driving vehicles or using machinery.

3. How to take Paracetamolo and Ibuprofene Mylan

[ Available without prescription]
Take this medicine exactly as described in this leaflet or as your doctor
or pharmacist have told you. If you have doubts, consult your doctor or pharmacist.
[ Available only on prescription]
Take this medicine always following exactly the instructions of your doctor or
pharmacist. If you have doubts, consult your doctor or pharmacist.
For short-term oral use only.
The minimum effective dose should be used for the shortest duration necessary to relieve symptoms.

Do not take Paracetamolo and Ibuprofene Mylan for more than 3 days.If symptoms worsen
or persist, especially if you have an infection with symptoms such as fever and pain, seek
immediate medical attention.

Adults: the recommended dose isone tablet with water and food, up to 3 times a day.
Allow at least 6 hours between doses.
If one tablet does not control the symptoms, you can take a maximum of two tablets for
no more than 3 times a day. Due to the presence of paracetamol, the single dose of two tablets
is intended for patients with a body weight of 60 kg or more.

Do not take more than six tablets in a 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 tell you what the correct dose is equivalent to the minimum 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.
Route of administration
You must take the tablets with a glass of water.
To reduce the likelihood of side effects, take Paracetamolo and Ibuprofene Mylan with
food.

If you take more Paracetamolo and Ibuprofene Mylan than you should
If you have taken more Paracetamolo and Ibuprofene Mylan than you should or if children have
accidentally taken Paracetamolo and Ibuprofene Mylan, always contact your doctor or
the nearest hospital for advice on the risk and guidance on what to do.
Symptoms of overdose may include nausea, stomach pain, vomiting (with traces of
blood), headache, ringing in the ears, confusion and eye twitching. At high doses
drowsiness, chest pain, palpitations, loss of consciousness, seizures
(mainly in children), weakness and dizziness, blood in the urine, low potassium
levels in the blood, feeling cold to the body and breathing problems 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 serious delayed liver damage.
If you forget to take Paracetamolo and Ibuprofene Mylan
Do not take a double dose to make up for a missed 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 using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

STOP taking this medicine and contact your doctor if you experience:

• signs of intestinal bleeding(severe stomach pain, vomiting blood or vomit that looks like coffee grounds, blood in the stool, black tarry stools) (uncommon).
• signs of inflammation of the lining of the brainsuch as: stiff neck, headache, nausea or vomiting, fever or feeling disoriented (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).
• severe skin reactionswith blister formationsuch as erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare).
• severe skin reaction known as DRESS syndrome. Symptoms of DRESS syndrome include: rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells) (frequency not known).
• severe skin reaction known as PEAG (acute generalized exanthematous pustulosis). Red and widespread rash with scaling, blisters under the skin and blisters located predominantly on 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, diarrhea
• increased levels of liver enzymes (detected with blood tests)
• excessive sweating
• fluid retention with swelling of the ankles or legs (edema)

Uncommon(may affect up to 1 in 100 people)

• headache and dizziness
• flatulence and constipation
• reduction in the number of red blood cells or increase in the number of platelets (cells that clot blood), causing unexplained bleeding, bruising and nosebleeds
• abnormal laboratory test results (blood tests and liver and kidney enzyme results)
• worsening of colitis and Crohn's disease
• dyspepsia (gastritis)
• inflammation of the pancreas accompanied by severe pain in the upper abdomen that spreads 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 disturbances, ringing in the ears, dizziness
• confusion, depression, hallucinations
• fatigue, general feeling of unwellness
• 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, swelling of the legs)
• heart failure (causing shortness of breath, swelling)
• inflammation of the optic nerve and drowsiness

Not known(frequency cannot be estimated from available data)

• severe condition that can make the blood more acidic (called metabolic acidosis), in patients with a serious illness who are using paracetamol (see paragraph 2)

Medicines like Paracetamol and Ibuprofene Mylan may be associated with a modest
increased risk of heart attack (“myocardial infarction”) or stroke (see paragraph 2).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system 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 Paracetamolo e Ibuprofene Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is 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 any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Paracetamolo e Ibuprofene Mylan contains
The active ingredients are paracetamol and ibuprofen. Each film-coated tablet contains
500 mg of paracetamol and 200 mg of ibuprofen.
The other ingredients are:
Tablet core: corn 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 Paracetamolo e Ibuprofene Mylan and contents of the pack
Paracetamolo e Ibuprofene Mylan 500 mg/200 mg tablets are film-coated
tablets, from white to off-white in colour, oval in shape, with dimensions of 19.7 mm x 9.2 mm.
They are available in blisters in packs of 10, 12, 16 or 20 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A., via Vittor Pisani 20 – 20124 Milano

Manufacturer
Rontis Hellas Medical And Pharmaceutical Products S.A.
Larissa Industrial Area, P.O. Box 3012
Larissa
41 500
Greece

This medicinal product is authorised in the Member States of the European Economic Area with
the following denominations:
Czech Republic: Brufen Combi
Denmark: Paracetamol/Ibuprofen Viatris
Italy: Paracetamolo e Ibuprofene Mylan
Norway: Ibuprofen/Paracetamol Viatris
Slovakia: Brufen Combi
Spain: Dalsydol DUO