Paracetamol Mylan

Package leaflet: Information for the patient

Paracetamol Mylan 500 mg tablets

paracetamol
Generic medicine
Please read all of this leaflet carefully before you take this medicine because 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 more information or advice, consult your pharmacist.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Contents of this leaflet

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

1. What Paracetamolo Mylan is 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 children aged 12 years and older ( or weighing more than 40 kg ).

2. What you need to know before taking Paracetamol Mylan

Do not take Paracetamol 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 Paracetamol Mylan:

• if you have kidney problems
• if you have liver problems, for example a condition known as Gilbert’s syndrome, severe hepatic insufficiency (Child-Pugh > 9), liver inflammation, or if you are taking medicines that affect liver function
• if you have haemolytic anaemia (a reduction in red blood cells that may cause pale yellow skin, 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 needed to maintain healthy tissues and organ function)
• if you are asthmatic and sensitive to acetylsalicylic acid (aspirin).

During treatment with Paracetamol Mylan, inform your doctor immediately if:
You suffer from serious illnesses, including severe renal 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 at regular doses for prolonged periods 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.
You should not frequently use paracetamol for long periods, as prolonged use may cause liver problems. Speak with your doctor or pharmacist if you intend to take paracetamol for a longer period.
Prolonged, high-dose, or inappropriate use of analgesics may cause headaches that should not be treated with higher doses of Paracetamol Mylan.
Do not use Paracetamol Mylan if you have alcohol dependence or liver damage, unless prescribed by your doctor, and do not take Paracetamol Mylan together with alcohol. Paracetamol 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 effectively, but may cause severe liver damage. Symptoms of liver damage typically appear a few days after overdose. It is therefore very important that you contact your doctor as soon as possible if you have taken more paracetamol than recommended.

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

Other medicines and Paracetamol Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take other products containing paracetamol.
Paracetamol Mylan may affect or be affected by other medicines. Inform your doctor or pharmacist if you are taking:

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

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

Driving and using machines
Paracetamol has no influence on the ability to drive or operate machinery; however, it may cause dizziness or drowsiness. In such cases, do not drive or operate machinery.

Paracetamol 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 Paracetamol Mylan

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

• Allow at least 4 hours between doses
• Do not take in combination with other products containing paracetamol
• Do not exceed the recommended dosage

Follow the instructions provided here, unless your doctor has given you different advice.
If you feel the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.
If you take more Paracetamol 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 treatment is started as soon as possible (preferably within 10–12 hours after overdose).
Symptoms of overdose may include: nausea (feeling unwell), vomiting, anorexia (weight loss), pallor (pale appearance), abdominal pain, and risk of hepatic injury. In such cases, the patient must go immediately to hospital.
If you forget to take Paracetamol Mylan
Do not take a double dose to make up for the missed dose.
If you have any doubts 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 everyone gets them.
If you experience any of the following serious side effects, stop taking Paracetamol Mylan and contact your doctor immediately 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 breathing difficulties (angioedema)
• severe allergic reaction or hypersensitivity reaction with fever, rash, swelling and sometimes low blood pressure
• serious skin reactions (Stevens-Johnson syndrome)
• blood disorders:
  • reduction in platelets, which may make you more prone to bruising or bleeding,
  • reduction in white blood cell count causing fever with signs of local infection such as sore throat/mouth
  • reduction in red blood cell count, which may cause anaemia, with symptoms such as fatigue and paleness.
• breathing difficulties in patients with aspirin sensitivity

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

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

Uncommon (may affect up to 1 in 100 people)

• dizziness
• drowsiness
• nervousness

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

• diarrhoea, abdominal pain (including cramps and burning sensation), 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):

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

Clinical and epidemiological data suggest that long-term use of analgesics (painkillers) may cause kidney problems.
Reporting of side effects
If you get any side effects, including ones 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 Paracetamolo Mylan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, packaging, or bottle after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Paracetamolo Mylan contains

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

Description of the appearance of Paracetamolo Mylan and the contents of the pack
Paracetamolo Mylan are white to almost white, round, flat tablets with bevelled edges and a score line on one side.
The tablet can be divided into equal doses.
Paracetamolo Mylan is available in blisters containing 10, 16, 20 and 30 tablets.
Paracetamolo Mylan is also available in blisters containing 100 tablets or in white plastic bottles closed with a white or almost white cap, containing 100 tablets. This packaging is available only by medical prescription or for administration of doses for hospital use.
It is possible that not all pack sizes are marketed.

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

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

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

Patient information leaflet

Paracetamol Mylan 1000 mg tablets

paracetamol
Generic medicine
Please read this leaflet carefully before taking this medicine because 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 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

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

7. What you need to know before taking Paracetamol Mylan

Do not take Paracetamol 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 Paracetamol Mylan:

• if you have kidney problems
• if you have liver problems, for example a condition known as Gilbert's syndrome, severe hepatic insufficiency (Child-Pugh > 9), inflammation of the liver, or if you are taking medicines that affect liver function
• if you have haemolytic anaemia (a reduction in red blood cells that may cause pale yellow skin and lead to 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 necessary nutrients to maintain healthy tissues and organ function)
• if you are asthmatic and sensitive to acetylsalicylic acid (aspirin).

During treatment with Paracetamol Mylan, inform your doctor immediately if:
You suffer from serious illnesses, including severe renal impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), or if you are malnourished, suffer from chronic alcoholism, or 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 at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep, rapid breathing, drowsiness, nausea and vomiting.
You should not frequently use paracetamol for long periods, as prolonged use may cause liver problems. Speak with your doctor or pharmacist if you intend to take paracetamol for a longer period.
Prolonged, high-dose or inappropriate use of analgesics may cause headaches that should not be treated with higher doses of Paracetamol Mylan.
Do not use Paracetamol Mylan if you are dependent on alcohol or have liver damage, unless prescribed by your doctor, and do not take Paracetamol Mylan together with alcohol. Paracetamol Mylan does not enhance the effect of alcohol.
Never take more paracetamol than recommended in section 3 of this leaflet. A higher dose will not relieve pain more effectively, but may cause severe liver damage. Symptoms of liver damage usually appear a few days after overdose. It is therefore very important that you contact your doctor as soon as possible if you have taken more paracetamol than recommended.

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

Other medicines and Paracetamol Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take other products containing paracetamol.
Paracetamol Mylan may affect or be affected by other medicines. Inform your doctor or pharmacist if you are taking:

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

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

Driving and using machines
Paracetamol Mylan has no influence on the ability to drive and use machines; however, it may cause dizziness or drowsiness. In such cases, do not drive or operate machinery.

Paracetamol 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 Paracetamol Mylan

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults and adolescents aged 16 years and over (or weighing more than 50 kg):
Take from half a tablet to one tablet every 4-6 hours (3-4 times daily), but do not exceed the maximum
daily dose of 3 tablets (3,000 mg).
The tablet may be divided into equal doses. Treatment should be started with the lowest 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.

• An interval of at least 4 hours must elapse between doses
• Do not take in combination with other products containing paracetamol
• Do not exceed the recommended dosage

Follow the instructions provided here, unless your doctor has given you different advice.
If you feel the effect of this medicine is too strong or too weak, consult your doctor or
pharmacist.
If you take more Paracetamol 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 treatment is started as soon as possible (preferably within 10-12 hours after an overdose).
Symptoms may include: nausea (feeling unwell), vomiting, anorexia (weight loss), sweating and malaise. In this case, the patient must go to hospital immediately.
If you forget to take Paracetamol Mylan
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about how to use 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 Paracetamol Mylan and contact your doctor immediately 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 breathing difficulties (angioedema)
• severe allergic reaction or hypersensitivity reaction with fever, skin rash, swelling, and sometimes a drop in 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 signs of local infection such as sore throat/mouth
• reduction in red blood cells, which may cause anaemia, with symptoms such as fatigue and paleness.
• breathing difficulties in patients with aspirin sensitivity

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

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

Uncommon (may affect up to 1 in 100 people)

• dizziness
• drowsiness
• nervousness

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

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

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

• liver disorders

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 who are using paracetamol (see section 2).

Clinical and epidemiological data suggest that long-term use of analgesics (painkillers) may cause kidney problems.
Reporting of side effects
If you get any side effects, including any 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. Reporting side effects 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 stated on the blister pack, the packaging or the bottle
after Exp. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Paracetamol Mylan contains

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

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

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani 20,
20124 Milan, Italy

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

This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium Paracetamol Viatris Forte 1 g tablets
Denmark Paracetamol Viatris 1000 mg
Spain Paracetamol Mylan Pharmaceuticals 1 g tablets EFG
France Paracétamol Viatris Conseil 1000 mg tablet
Croatia Imensa 1000 mg tablets
Italy Paracetamol Mylan
Portugal Paracetamol Mylan