Patient Information Leaflet

Paracetamol Mylan Pharmaceuticals 1g tablets EFG

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

Follow exactly the administration instructions contained in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any 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 you worsen or do not improve after 5 days in adults (3 days for children aged 12 years or more and/or weighing more than 40 kg), or if the fever persists for more than 3 days.

1.What Paracetamol Mylan Pharmaceuticals is and what it is 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.Contents of the pack and additional information

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

Paracetamol Mylan Pharmaceuticals is used for the treatment of mild to moderate pain and febrile states in adults and children 16 years of age or older (or with a body weight of 50 kg or more).

Do not take Paracetamol Mylan Pharmaceuticals

• If you are allergic to paracetamol or any of the other components of this medication (listed in section6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Paracetamol Mylan Pharmaceuticals:

• If you have kidney problems.
• If you have liver problems, for example, a condition called Gilbert's syndrome, severe liver insufficiency (Child-Pugh > 9), liver inflammation, or if you use medications that affect liver function.
• If you have hemolytic anemia (a decrease in red blood cells that can cause yellow skin discoloration and weakness or difficulty breathing).
• If you have enzyme deficiency (glucose-6-phosphate dehydrogenase deficiency).
• If you regularly consume excessive amounts of alcohol.
• If you have dehydration (your body does not have enough water or fluid) or severe malnutrition (your body does not have the correct amount of nutrients needed 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 of time, as prolonged or frequent use can cause liver problems. Talk to your doctor or pharmacist if you plan to take paracetamol for a longer period.

Prolonged use, high doses, or incorrect use of analgesics can cause headaches that should not be treated with higher doses of this medication.

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

Never take more paracetamol than recommended in section3 of this prospectus. A higher dose will not increase pain relief, but could cause severe liver damage. Liver damage symptoms usually appear within a couple of days. It is very important to inform your doctor as soon as possible if you have taken more doses than recommended.

Children

The use of this medication is not recommended in children under 16years of age or weighing less than 50kg.

Other medications and Paracetamol Mylan Pharmaceuticals

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do notuse any other medication that contains paracetamol.

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

• Flucloxacillin (antibiotic), due to a severe risk of blood and fluid disorder (metabolic acidosis with high anion gap) that must be treated urgently and may occur particularly in cases of severe renal insufficiency, sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, and if maximum daily doses of paracetamol are used.
• Metoclopramide and domperidone (used for the treatment of nausea or vomiting).
• Colestiramine (used to reduce blood cholesterol levels). Paracetamol should be taken at least one hour before or four hours after using this medication.
• Chloramphenicol (used for the treatment of infections).
• Zidovudine (used for the treatment of AIDS).
• Warfarin and other medications used to thin the blood, in case you need to take a painkiller daily for a long period.
• Probenecid (used to treat gout).
• Substances that include liver enzymes, for example, rifampicin (used for the treatment of infections) and medications for treating epilepsy, such as barbiturates, phenytoin, carbamazepine.
• Propantelina (used for the treatment of gastrointestinal ulcers).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Paracetamol may be used during pregnancy. You should use the lowest possible dose that reduces pain or fever and use it for the shortest time possible. Consult your doctor if pain or fever do not improve or if you need to take the medication more frequently.

Although paracetamol is excreted in breast milk in small amounts, no adverse effects have been reported in breastfed infants. Paracetamol, in recommended doses, can be used during breastfeeding.

Driving and operating machinery

This medication does not have effects that modify the ability to drive and operate machinery, however, it may cause dizziness or numbness. If this happens, do not drive or operate machinery.

Paracetamol Mylan Pharmaceuticals contains sodium

This medication contains less than 23mg of sodium (1mmol) per tablet; this is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents 16 years or older (or weight greater than 50 kg):

Take half a tablet or 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 start with the lowest effective dose (half a tablet). Do not take more than one tablet at a time.

This medication is not recommended for use in children under 16 years.

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

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

Inform your doctor if this medication is too potent or too weak for you.

If you take more Paracetamol Mylan Pharmaceuticals than you should

If you have taken 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 essential that your doctor starts treatment as soon as possible (preferably within 10–12 hours of the overdose).

Symptoms may include: nausea (feeling unwell), vomiting, anorexia (weight loss), sweating, and indisposition. In this case, the patient should go to the hospital immediately.

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

If you forgot to take Paracetamol Mylan Pharmaceuticals

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

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

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

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

Very rare(affects 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, in some cases, a drop in blood pressure
• Severe skin reactions (Stevens-Johnson syndrome)
• Blood disorders:

• Decrease in platelet count, which may make you more prone to bruising or bleeding
• Decrease in white blood cell count, which causes fever with symptoms of local infection, such as throat or mouth irritation
• Decrease in red blood cells, which may cause anemia, with symptoms such as fatigue and paleness

• Difficulty breathing in patients with sensitivity to acetylsalicylic acid

Other side effects

Frequent(may affect up to 1 in 10 people)

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

Occasional(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 (skin redness)
• Sensation of burning in the pharynx

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

• Liver disorders

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the blister pack, box, or bottle after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Paracetamol Mylan Pharmaceuticals

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

Appearance of the product and contents of the package

Paracetamol Mylan Pharmaceuticals is presented in the form of non-coated, oblong, biconvex, white to off-white tablets, scored on both sides.

The tablet can be divided into equal doses.

Paracetamol Mylan Pharmaceuticals is available in blisters containing 8 or 10tablets.

Paracetamol Mylan Pharmaceuticals is also available in blisters of 16, 20, 30 or 40tablets or in white plastic bottles sealed with a white to off-white cap containing 100tablets. These package sizes are only available by prescription or for hospital dose dispensing.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Mylan Pharmaceuticals, S.L.

C/ Plom, 2-4, 5th floor

08038 – Barcelona

Spain

Responsible manufacturer

Aurex BV

Baarnsche Dijk1

3741LN Baarn

Netherlands

or

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 with the following names:

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 - Barcelona

Spain

Last review date of this leaflet:May 2022

The detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/.