PARACETAMOL MYLAN PHARMACEUTICALS 500 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Paracetamol Mylan Pharmaceuticals 500mg Tablets EFG

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 5 days in adults (3 days for children from 12 years or body weight over 40 kg), or if the fever persists for more than 3 days.

Contents of the Package Leaflet

1. What is Paracetamol Mylan Pharmaceuticals and what is it used for
2. What you need to know before taking Paracetamol Mylan Pharmaceuticals
3. How to take Paracetamol Mylan Pharmaceuticals
4. Possible side effects
5. Storage of Paracetamol Mylan Pharmaceuticals
6. Package Contents and Additional Information

1. What is Paracetamol Mylan Pharmaceuticals and what is it used for

Paracetamol Mylan Pharmaceuticals is a medicine used to relieve pain and reduce fever (analgesic and antipyretic medicine).

Paracetamol Mylan Pharmaceuticals is used for the treatment of mild to moderate pain and febrile conditions in adults and children from 12 years (or body weight over 40 kg).

2. What you need to know before taking Paracetamol Mylan Pharmaceuticals

Do not take Paracetamol Mylan Pharmaceuticals

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

Warnings and Precautions

Consult your doctor or pharmacist before taking Paracetamol Mylan Pharmaceuticals:

• If you have kidney problems.
• If you have liver problems, such as a condition called 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 decrease in red blood cells that can cause yellowing of the skin and weakness or difficulty breathing).
• If you have enzyme deficiency (glucose-6-phosphate dehydrogenase deficiency).
• If you habitually consume excessive amounts of alcohol.
• If you have dehydration (your body does not have all the water or fluid it should) or severe malnutrition (your body does not have the correct amount of nutrients it needs to maintain healthy tissues and organ function).
• If you are asthmatic and sensitive to acetylsalicylic acid.

Do not use paracetamol frequently for a long period, as prolonged or frequent use may cause liver problems. Talk to your doctor or pharmacist if you intend to take paracetamol for a longer period.

Long-term use, high doses, or incorrect use of analgesics can cause headaches that should not be treated with higher doses of this medicine.

Do not use this medicine without talking to a doctor if you have a history of alcohol addiction or if you have any liver damage. Do not use this medicine with alcohol. The effect of alcohol does not increase when taking this medicine.

Never take more paracetamol than recommended in section 3 of this leaflet. A higher dose will not increase pain relief, but could cause serious liver damage. Symptoms of liver damage usually appear after a couple of days. Therefore, it is very important that you inform your doctor as soon as possible if you have taken more than the recommended dose.

Children

The use of this medicine is not recommended in children under 12 years of age or weighing less than 40 kg.

Other Medicines and Paracetamol Mylan Pharmaceuticals

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Do notuse any other medicine that contains paracetamol.

Paracetamol Mylan Pharmaceuticals may affect other medicines or vice versa. Inform your doctor or pharmacist if you are taking:

• Flucloxacillin (antibiotic), due to a serious risk of alteration of blood and fluids (metabolic acidosis with high anion gap) that must be treated urgently and may occur particularly in cases of severe renal failure, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, and if the maximum daily doses of paracetamol are used.
• Metoclopramide and domperidone (used to treat nausea or vomiting).
• Colestyramine (used to lower blood cholesterol levels). This medicine should be taken at least one hour before or after taking paracetamol.
• Chloramphenicol (used to treat infections).
• Zidovudine (used to treat AIDS).
• Warfarin and other medicines used to thin the blood, in case you need to take an analgesic daily for a long period.
• Probenecid (used to treat gout).
• Substances that include liver enzymes, such as rifampicin (used to treat infections) and medicines to treat epilepsy, such as barbiturates, phenytoin, carbamazepine.
• Propanteline (used to treat gastrointestinal ulcers).

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

If necessary, paracetamol can be used during pregnancy. You should use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Consult your doctor if the pain or fever does 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, in the recommended doses, can be used briefly during breastfeeding.

Driving and Using Machines

This medicine does not have effects that modify the ability to drive and use machines, however, it may cause dizziness or drowsiness. If this happens, do not drive or use machines.

Paracetamol Mylan Pharmaceuticals contains Sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to take Paracetamol Mylan Pharmaceuticals

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Treatment should be started with the lowest effective dose.

The recommended dose is:

Adults and adolescents from 16 years (or body weight over 50 kg):

Take one or two tablets every 4-6 hours (3-4 times a day), but do not exceed the maximum daily dose of 6 tablets (3000 mg).

Children from 12 years (or body weight over 40 kg):

Take one 500 mg tablet up to 4 times a day.

The maximum daily dose should not exceed 4 tablets (2000 mg).

The use of this medicine is not recommended in children under 12 years.

• Doses should be spaced at least 4 hours apart.
• Do not use this medicine in combination with other medicines that contain paracetamol.
• Do not exceed the indicated dose.

Follow the instructions provided in this leaflet, unless your doctor has given you other instructions.

Tell your doctor if this medicine is too strong or too weak for you.

If you take more Paracetamol Mylan Pharmaceuticals than you should

If you have used more paracetamol than you should, consult 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 starts treatment as soon as possible (preferably within 10-12 hours of taking the overdose).

Symptoms of overdose may be: nausea (feeling of discomfort), vomiting, anorexia (weight loss), pallor, abdominal pain, and risk of liver damage. In this case, the patient should go to the hospital immediately.

In case of overdose, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Paracetamol Mylan Pharmaceuticals

Do not take a double dose to make up for forgotten doses.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking Paracetamol Mylan Pharmaceuticals and contact a doctor or go to the nearest hospital immediately if you experience any of these serious side effects

Very rare(affect less than 1 user in 10,000)

• 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 a drop in blood pressure
• Severe skin reactions (Stevens-Johnson syndrome)
• Blood disorders:

• Decrease in the number of platelets, which can make you more prone to bruising or bleeding
• Decrease in the number of white blood cells, which can cause fever with symptoms of local infection, such as throat or mouth irritation
• Decrease in red blood cells, which can cause anemia, with symptoms such as fatigue and pallor

• Breathing difficulties in patients with sensitivity to acetylsalicylic acid

Other side effects

Common(may affect up to 1 in 10 people)

• Nausea (feeling of discomfort)
• Vomiting
• Mild drowsiness (drowsiness)

Uncommon(may affect up to 1 in 100 people)

• Dizziness (dizziness)
• Drowsiness (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(affect less than 1 user in 10,000)

• Liver disorders

Clinical and epidemiological data seem to indicate that long-term administration of analgesics may cause kidney problems.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Paracetamol Mylan Pharmaceuticals

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister, carton, or bottle after EXP. The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Paracetamol Mylan Pharmaceuticals

• The active ingredient is paracetamol.
• The other ingredients and excipients are sodium starch glycolate (type A), povidone K30, pregelatinized corn starch, stearic acid.

Appearance of the product and package contents

Paracetamol Mylan Pharmaceuticals is presented in the form of bisected, flat, round, and white to off-white tablets, scored on one side.

The tablet can be divided into equal doses.

Paracetamol Mylan Pharmaceuticals is available in blisters containing 10, 16, 20, or 30 tablets.

Paracetamol Mylan Pharmaceuticals is also available in blisters of 100 tablets or in white plastic bottles sealed with a white to off-white pad containing 100 tablets. This pack size is only available with a prescription or for hospital use.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Mylan Pharmaceuticals, S.L.

C/ Plom, 2-4, 5th floor

08038 - Barcelona

Spain

Manufacturer

APL Swift Services Ltd

HF26, Hal Far Industrial Estate

Hal Far, Birzebbugia

BBG3000

Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

You can request more information about this medicine from the local representative of the Marketing Authorization Holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 - Barcelona

Spain

Date of the last revision of this leaflet:May 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) https://www.aemps.gob.es/.