PARACETAMOLO 500 mg Tabletka

Treść ulotki

1. Paracetamolo Mylan 500 mg tablets
   1. What is Paracetamolo Mylan and what is it used for
   2. What you need to know before you take Paracetamolo Mylan
   3. How to take Paracetamolo Mylan
   4. Possible side effects
   5. How to store Paracetamolo Mylan
   6. Contents of the pack and other information
2. Paracetamolo Mylan 1000 mg tablets
   1. What is Paracetamolo Mylan and what it is used for
   2. What you need to know before you take Paracetamolo Mylan
   3. How to take Paracetamolo Mylan
   4. Possible side effects
   5. How to store Paracetamolo Mylan
   6. Contents of the pack and other information

Paracetamolo Mylan 500 mg tablets

paracetamol

Generic medicine

Read this 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 told you.
Keep this leaflet. You may need to read it again.

• 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 get worse after 3 days.

Contents of this leaflet

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

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

Paracetamol is a medicine that relieves pain and reduces fever (analgesic and antipyretic).
Paracetamolo Mylan is used to relieve mild to moderate pain and/or fever in adults and children aged 12 years and over (or weighing more than 40 kg).

2. What you need to know before you take Paracetamolo Mylan

Do not take Paracetamolo Mylan

• If you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6).

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

• if you have kidney problems
• if you have liver problems, such as a condition known as Gilbert's syndrome, severe liver failure (Child-Pugh > 9), liver inflammation or if you are taking medicines that affect liver function
• if you have hemolytic anemia (a reduction in red blood cells that can make the skin pale yellow and cause weakness or shortness of breath)
• if you have an enzymatic deficiency (glucose-6-phosphate dehydrogenase deficiency)
• if you regularly consume excessive amounts of alcohol
• if you are dehydrated (your body does not have enough water or fluids) or severely malnourished (your body does not have the right amount of nutrients it needs to keep tissues and organ function healthy)
• if you have asthma and are sensitive to acetylsalicylic acid (aspirin).

During treatment with Paracetamolo Mylan, immediately inform your doctor if:
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. Symptoms of metabolic acidosis may include: severe difficulty breathing with rapid deep breathing, drowsiness, nausea and vomiting.
Do not frequently use paracetamol for long periods as prolonged use can cause liver problems. Talk to your doctor or pharmacist if you intend to take paracetamol for a longer period.
Prolonged, high-dose or incorrect use of pain relievers can cause headaches that should not be treated with higher doses of Paracetamolo Mylan.
Do not use Paracetamolo Mylan if you suffer from alcohol dependence or liver damage, unless prescribed by your doctor, and do not use Paracetamolo Mylan with alcohol. Paracetamolo Mylan does not enhance the effect of alcohol.
Never take more paracetamol than recommended in section 3 of this leaflet. A higher dose does not relieve pain more, while it can cause serious liver damage. Symptoms of liver damage usually occur for the first time after a few days. Therefore, it is very important that you contact your doctor as soon as possible if you have taken more paracetamol than recommended.

Children
Paracetamolo Mylan is not recommended for children under 12 years of age or weighing less than 40 kg.

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

Do nottake other products containing paracetamol.
Paracetamolo Mylan can affect or be affected by other medicines. Tell your doctor or pharmacist if you are taking:

• flucloxacillin (antibiotic), due to a serious risk of changes in blood and fluids (called metabolic acidosis) that needs to be treated urgently (see section 2)
• metoclopramide or domperidone (used to treat nausea (feeling sick) or vomiting)
• cholestyramine (used to lower cholesterol in the blood). This medicine must be taken at least one hour before or after taking paracetamol
• chloramphenicol (for the treatment of infections)
• zidovudine (for the treatment of AIDS)
• warfarin and other medicines used to thin the blood, if you need to take a medicine to relieve pain every day for a long period
• probenecid (for the treatment of gout)
• substances that induce liver enzymes e.g. rifampicin (used to treat infections) and medicines for the treatment of epilepsy such as barbiturates, phenytoin, carbamazepine
• propantheline (used for the treatment of gastrointestinal ulcers).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If necessary, paracetamol can be used during pregnancy. It is advisable to use the lowest possible dose that relieves pain and/or fever and take it for the shortest possible time. Contact your doctor if the pain and/or fever does not decrease or if you have to take the medicine more often.
Although paracetamol is excreted in breast milk in small amounts, no adverse effects have been reported in breastfed infants. Paracetamol at recommended doses can be used for short periods during breastfeeding.

Driving and using machines
Paracetamol has no influence on the ability to drive and use machines, however, it can cause dizziness or drowsiness. In this case, do not drive vehicles and do not use machines.

Paracetamolo Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Paracetamolo Mylan

Take this medicine following the instructions provided in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Treatment should be started with the lowest effective dose.
The recommended dose is:
Adults and adolescents from 16 years of age (or weighing more than 50 kg):
Take 1 or 2 tablets every 4-6 hours (3-4 times a day) but do not exceed the maximum daily dose of
6 tablets (3000 mg).
Children 12 years of age or older (or weighing more than 40 kg):
Take 1 500 mg tablet up to 4 times a day.
The maximum daily dose should not exceed 4 tablets (2000 mg).
This medicine is not recommended for children under 12 years of age.

• An interval of at least 4 hours must be respected between two administrations
• Do not take in association with other products containing paracetamol
• Do not exceed the indicated dosage

Follow the instructions given here, unless your doctor has provided you with other advice.
If you feel that the effect of this medicine is too strong or too weak, consult your doctor or
pharmacist.

If you take more Paracetamolo Mylan than you should
If you have taken more paracetamol than you should, contact your doctor or pharmacist immediately. There is a
risk of liver damage, even if you feel well. To prevent liver damage, it is important that the doctor
can start treatment as soon as possible (preferably within 10-12 hours of an overdose).
Symptoms of overdose may include: nausea (feeling unwell), vomiting (feeling sick), anorexia
(weight loss), pale complexion (pallor), abdominal pain and risk of liver damage. In this case, the
patient should go to hospital immediately.

If you forget to take Paracetamolo Mylan
Do not take a double dose to make up for a missed dose.
If you have any questions about using 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.

If you experience any of the following serious side effects, stop taking Paracetamolo
Mylan and seek immediate medical attention or go to the nearest hospital:
Very rare(may affect up to 1 in 10,000 people)

• swelling of the face, tongue or throat, difficulty swallowing, hives and difficulty breathing (angioedema)
• severe allergic reaction or hypersensitivity reaction with fever, rash, swelling and sometimes low blood pressure
• severe skin reactions (Stevens-Johnson syndrome)
• blood disorders:
• reduction in platelets, which may make you more prone to bruising or bleeding,
• reduction in the number of white blood cells causing fever with symptoms of local infection such as sore throat/mouth
• reduction in the number of red blood cells, which can cause anemia, with symptoms such as fatigue and paleness.
• difficulty breathing in patients with sensitivity to aspirin

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

• nausea (feeling unwell)
• vomiting (feeling unwell)
• mild drowsiness (drowsiness)

Uncommon(may affect up to 1 in 100 people)

• dizziness (vertigo)
• drowsiness
• nervousness

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

• diarrhea, abdominal pain (including cramps and burning), constipation
• erythema (redness of the skin)
• burning sensation in the throat

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

• liver disorders

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

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

Clinical and epidemiological data seem to indicate that long-term use of analgesics
(pain relievers) may cause kidney problems.

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 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 Paracetamolo 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 blister, the carton or the bottle
after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Paracetamolo Mylan contains

• The active ingredient is paracetamol.
• The other excipients are sodium starch glycolate, povidone, pregelatinized maize starch, stearic acid

Description of the appearance of Paracetamolo Mylan and contents of the pack
Paracetamolo Mylan are tablets of colour from white to off-white, round, flat, with a bevelled edge
with an incision line on one side.
The tablet can be divided into equal doses.
Paracetamolo Mylan is available in blisters of 10, 16, 20 and 30 tablets.
Paracetamolo Mylan is also available in blisters of 100 tablets or in white plastic bottles closed by
a stopper from white to off-white containing 100 tablets. This pack is only available on
prescription or for the administration of doses for hospital use.
Not all pack sizes may be marketed.

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

Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate
Hal Far, Birzebbugia
BBG3000
Malta

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Belgium Paracetamol Viatris 500 mg tablets
Denmark Paracetamol Viatris 500 mg
Spain Paracetamolo Mylan Pharmaceuticals 500 mg comprimidos EFG
France Paracétamol Viatris Conseil 500 mg comprimé
Croatia Imensa 500 mg tablets
Italy Paracetamolo Mylan
Portugal Paracetamol Mylan

Paracetamolo Mylan 1000 mg tablets

paracetamol

Generic medicine

Read this 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 7. What is Paracetamolo Mylan and what it is used for
• 8. What you need to know before you take Paracetamolo Mylan
• 9. How to take Paracetamolo Mylan
• 10. Possible side effects
• 11. How to store Paracetamolo Mylan
• 12. Contents of the pack and other information

6. What is Paracetamolo Mylan and what it is used for

Paracetamol is a medicine that relieves pain and reduces fever (analgesic and antipyretic).
Paracetamolo Mylan is used to relieve mild to moderate pain and/or fever in adults and in
children aged 16 years and over ( or weighing more than 50 kg).

7. What you need to know before you take Paracetamolo Mylan

Do not take Paracetamolo Mylan

• if you are allergic to paracetamol or to any of the other ingredients of this medicine (listed in section 6).

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

• if you have kidney problems
• if you have liver problems, such as a condition known as Gilbert's syndrome, severe liver failure (Child-Pugh > 9), liver inflammation or if you are taking medicines that affect liver function
• if you have hemolytic anemia (a reduction in red blood cells that can make the skin pale yellow and cause weakness or shortness of breath)
• if you have an enzyme deficiency (glucose-6-phosphate dehydrogenase deficiency)
• if you regularly consume excessive amounts of alcohol
• if you are dehydrated (your body does not have enough water or fluids) or severely malnourished (your body does not have the right amount of nutrients it needs to keep tissues and organ function healthy)
• if you have asthma and are sensitive to acetylsalicylic acid (aspirin).

During treatment with Paracetamolo Mylan, immediately inform your doctor if:
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. Symptoms of metabolic acidosis may include: severe difficulty breathing with rapid deep breathing, drowsiness, nausea and vomiting.
Do not use paracetamol frequently for long periods as prolonged use can cause
liver problems. Talk to your doctor or pharmacist if you intend to take paracetamol for a
longer period.
Prolonged, high-dose or incorrect use of analgesics can cause headaches that should not be
treated with higher doses of Paracetamolo Mylan.
Do not use Paracetamolo Mylan if you suffer from alcohol dependence or liver damage, unless it has been
prescribed by your doctor and you do not use Paracetamolo Mylan with alcohol. Paracetamolo Mylan does not enhance
the effect of alcohol.
Never take more paracetamol than recommended in section 3 of this leaflet. A higher dose does not relieve pain more, while it can cause serious liver damage. Symptoms of liver damage usually occur for the first time after a few days. Therefore, it is very important that
you contact your doctor as soon as possible if you have taken more paracetamol than recommended.

Children
Paracetamolo Mylan is not recommended for children under 16 years of age or weighing less than 50 kg.

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

Do nottake other products containing paracetamol.
Paracetamolo Mylan can affect or be affected by other medicines. Tell your doctor or
pharmacist if you are taking:

• flucloxacillin (antibiotic), due to a serious risk of changes in blood and fluids (called metabolic acidosis) that needs to be treated urgently (see section 2)
• metoclopramide or domperidone (used to treat nausea (feeling sick) or vomiting (feeling unwell))
• cholestyramine (used to lower cholesterol in the blood). Paracetamol must be taken at least one hour before or four hours after taking this medicine
• chloramphenicol (for the treatment of infections)
• zidovudine (for the treatment of AIDS)
• warfarin and other medicines used to thin the blood, if you need to take a medicine to relieve pain every day for a long period
• probenecid (for the treatment of gout)
• substances that induce liver enzymes e.g. rifampicin (used to treat infections) and medicines for the treatment of epilepsy such as barbiturates, phenytoin, carbamazepine
• propantheline (used to treat gastrointestinal ulcers).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
If necessary, paracetamol can be used during pregnancy. It is advisable to use the lowest possible dose
that relieves pain and/or fever and take it for the shortest possible time. Contact your doctor if the pain
and/or fever does not decrease or if you need to take the medicine more often.
Although paracetamol is excreted in breast milk in small amounts, no adverse effects have been
reported in breastfed infants. Paracetamol at recommended doses can be used during
breastfeeding.

Driving and using machines
Paracetamolo Mylan has no effect on the ability to drive and use machines, however, it may
cause dizziness or drowsiness. If this happens, do not drive vehicles and do not use machines.

Paracetamolo Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

8. How to take Paracetamolo Mylan

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults and adolescents starting from 16 years of age (or weighing more than 50 kg):
Take from half a tablet to one tablet every 4-6 hours (3-4 times a day) but do not exceed the
maximum daily dose of 3 tablets (3,000 mg).
The tablet can be divided into equal doses. Treatment should be started with the lowest possible effective
dose (half a tablet). Do not take more than 1 tablet at a time.
This medicine is not recommended for children under 16 years of age.

• Between two administrations, an interval of at least 4 hours must be respected
• Do not take in association with other products containing paracetamol
• Do not exceed the indicated dosage

Follow the instructions given here, unless your doctor has provided you with other advice.
If you feel that the effect of this medicine is too strong or too weak, consult your doctor or
pharmacist.

If you take more Paracetamolo Mylan than you should
If you have taken more paracetamol than you should, contact your doctor or pharmacist immediately. There is a
risk of liver damage, even if you feel well. To prevent liver damage, it is important that your doctor
can start treatment as soon as possible (preferably within 10-12 hours after an overdose).
Symptoms may include: nausea (feeling unwell), vomiting (feeling unwell), anorexia (weight loss),
sweating and malaise. In this case, the patient should go to hospital immediately.

If you forget to take Paracetamolo Mylan
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

9. Possible side effects

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

If you experience any of the following serious side effects, stop taking Paracetamolo
Mylan and seek immediate medical attention or go to the nearest hospital:
Very rare(may affect up to 1 in 10,000 people)

• swelling of the face, tongue or throat, difficulty swallowing, hives and difficulty breathing (angioedema)
• severe allergic reaction or hypersensitivity reaction with fever, rash, swelling and sometimes low blood pressure
• severe skin reactions (Stevens-Johnson syndrome)
• blood disorders:
• reduction in platelets, which may make you more prone to bruising or bleeding,
• reduction in white blood cells causing fever with symptoms of local infection such as sore throat/mouth
• reduction in red blood cells, which can cause anemia, with symptoms such as fatigue and paleness.
• difficulty breathing in patients sensitive to aspirin

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

• nausea (feeling unwell)
• vomiting (feeling unwell)
• mild drowsiness (torpor)

Uncommon(may affect up to 1 in 100 people)

• dizziness (vertigo)
• drowsiness
• nervousness

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

• diarrhea, abdominal pain (including cramps and burning), constipation
• erythema (redness of the skin)
• burning sensation in the pharynx

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

• liver disorders

Not known(frequency cannot be estimated from available data)

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

Clinical and epidemiological data seem to indicate that long-term use of analgesics
(pain relievers) may cause kidney problems.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly through 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.

10. How to store Paracetamolo Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the blister, on the box or on the bottle
after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of the
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Paracetamolo Mylan contains

• The active ingredient is paracetamol.
• The other excipients are sodium starch glycolate, povidone, pregelatinized maize starch, stearic acid

Description of the appearance of Paracetamolo Mylan and contents of the pack
Paracetamolo Mylan are tablets of colour from white to off-white, biconvex, oblong, uncoated
with a score line on both sides.
The tablet can be divided into equal doses.
Paracetamolo Mylan is available in blisters of 8 and 10 tablets.
Paracetamolo Mylan is also available in blisters of 16, 20, 30 and 40 tablets or in plastic bottles
white closed by a stopper from white or off-white containing 100 tablets. These packs are
available only on medical prescription or for the administration of doses for hospital use.
Not all pack sizes may be marketed.

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

Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate
Hal Far, Birzebbugia
BBG3000
Malta

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Belgium Paracetamol Viatris Forte 1 g tablets
Denmark Paracetamolo Viatris 1000 mg
Spain Paracetamolo Mylan Pharmaceuticals 1 g EFG tablets
France Paracétamol Viatris Conseil 1000 mg divisible tablet
Croatia Imensa 1000 mg tablets
Italy Paracetamolo Mylan
Portugal Paracetamol Mylan