Serra Paracetamol 500 mg 10 tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. This medicine is available without a prescription. However, for best results, it should be used with care.

- Keep this leaflet as you may need to read it again.

- If you need advice or more information, ask your pharmacist.

- If symptoms worsen or if fever persists for more than 3 days or pain for more than 5 days, you should consult your doctor.

- If you think that any of the side effects you are experiencing are serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

Contents of the package leaflet:

1. What Paracetamol MABO-Serra is and what it is used for.

2. What you need to know before you start taking Paracetamol MABO-Serra

3. How to take Paracetamol MABO-Serra

4. Possible side effects.

5. Storage of Paracetamol MABO-Serra

6. Contents of the pack and additional information

Paracetamol is effective in reducing pain and fever.

It is indicated for the symptomatic relief of occasional mild to moderate pain, such as headache, dental pain, muscle pain (contractures) or back pain (lumbago), as well as in febrile states in adults and children from 10 years of age (weighing more than 33 kg).

Do not take Paracetamol MABO-Serra

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

Warnings and precautions

Consult your doctor or pharmacist before you start taking Paracetamol MABO-Serra.

- Do not take more of the medicinal product than recommended in section 3.

- Concomitant use of this medicine with other medicines containing paracetamol, e.g. cold and flu medicines, should be avoided as high doses may result in liver damage. Do not use more than one medicine containing paracetamol without consulting a doctor.

- Chronic alcoholics should be careful not to take more than 2 g/in 24 hours of paracetamol.

- Patients with kidney, liver, heart or lung disease and patients with anaemia should consult a doctor before taking this medicine.

When being treated with a medicine to treat epilepsy, a doctor should be consulted before taking this medicine, because when they are used at the same time, the efficacy is reduced and the hepatotoxicity of paracetamol is enhanced, especially in treatments with high doses of paracetamol.

- Asthmatic patients sensitive to acetylsalicylic acid should consult a doctor before taking this medicinal product.

Interference with laboratory tests

If you are going to have any analytical test (including blood tests, urine tests, etc...) tell your doctor that you are taking/using this medicine, as it may alter the results.

Use of Paracetamol MABO-Serra with other medicines

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

In particular, if you are using any of the following medicines, as it may be necessary to change the dose of some of them or discontinue treatment:

- Medicines to prevent blood clots: oral anticoagulants ( acenocoumarol, warfarin).

- Medicines to treat epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine).

- Medicines to treat tuberculosis (isoniazid, rifampicin).

- Medicines to treat depression and seizures: Barbiturates (used as hypnotics, sedatives and anticonvulsants).

- Drugs used to lower blood cholesterol levels: (cholestyramine)

- Medicines used to increase urine output (loop diuretics such as those in the furosemide group).

- Medicines used for the treatment of gout (probenecid and sulfinpyrazone).

- Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone

- Medicines used in the treatment of high blood pressure (hypertension) and heart rhythm disturbances (cardiac arrhythmias): Propranolol.

Taking paracetamol MABO-Serra with food, drinks and alcohol

The use of paracetamol in patients who regularly consume alcohol (3 or more alcoholic drinks, beer, wine, liquor, etc. per day) may cause liver damage.

Taking this medicine with food does not affect its effectiveness.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

IMPORTANT FOR WOMEN

If you are pregnant or think you may be pregnant, consult your doctor before taking this medicine. The use of medicines during pregnancy may be dangerous to the embryo or foetus and should be monitored by your doctor.

Paracetamol passes into breast milk, so breast-feeding women should consult their doctor or pharmacist before taking this medicine.

Driving and use of machines

Paracetamol has no or negligible influence on the ability to drive and use machines.

Paracetamol MABO-Serra contains sodium

This medicine contains less than 23 mg sodium (1 mmol) per tablet, i.e. essentially "sodium-free".

Follow the instructions for taking this medicine exactly as directed by your doctor or pharmacist. If you are in any doubt, ask your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents over 15 years of age:

Take 1 tablet (500 mg paracetamol) every 4-6 hours, as needed.

If necessary, 1 gram (2 tablets) may be taken every 8 hours, 3 times a day.

Do not take more than 3 g of paracetamol in 24 hours (6 tablets).

High daily doses of paracetamol should be avoided for prolonged periods of time as this increases the risk of adverse effects such as liver damage.

Patients with liver disease: Before taking this medicine you should consult your doctor.

They should take the amount of medicine prescribed by their doctor with a minimum interval of 8 hours between each dose.

They should not take more than 2 grams of paracetamol in 24 hours, spread over several doses.

Patients with kidney disease: consult your doctor before taking this medicine.

Take a maximum of 500 milligrams per dose.

Depending on your illness, your doctor will tell you whether you should take your medicine at least 6 or 8 hours apart.

You should not take more than 2 grams in 24 hours spread over several doses, and in no case should you take more than 500 milligrams per dose.

Use in children and adolescents

Children: It is necessary to respect the dosages defined according to weight. The age of the child according to weight is given for information only.

The recommended daily dose of paracetamol is approximately 60 mg/kg/day, divided into 4 or 6 daily doses, i.e. 15 mg/kg every 6 hours or 10 mg/kg every 4 hours.

- Children weighing 33-40 kg (10-12 years): 1 tablet per dose according to weight/age, every 6 hours, up to a maximum of 4 tablets per day.

- Children weighing between 41 and 50 kg (12 to 15 years): 1 tablet per dose, every 6 or 4 hours, up to a maximum of 5 tablets per day.

This medicine is taken orally.

The tablets should be taken with a glass of liquid, preferably water.

Always take the lowest effective dose.

Taking this medicine is dependent on the onset of pain or fever. As soon as the pain or fever disappears, treatment should be stopped.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or other symptoms appear, you should stop treatment and consult your doctor.

If you take more Paracetamol MABO-Serra than you should

You should consult your doctor or pharmacist immediately.

Symptoms of overdose may include: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice) and abdominal pain.

If you have taken an overdose, you should go to a medical centre immediately even if you do not notice symptoms, as symptoms often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning.

Treatment of overdose is most effective if started within 4 hours of ingestion.

Patients on barbiturates or chronic alcoholics may be more susceptible to toxicity from an overdose of paracetamol.

In case of overdose or accidental ingestion, seek immediate medical attention or call the Poisons Information Service (telephone 91 562 04 20), indicating the medicinal product and the quantity taken.

Like all medicines, Paracetamol MABO-Serra may cause side effects, although not everybody gets them.

Rare side effects that may affect up to 1 in 1,000 people include: malaise, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare side effects that may affect up to 1 in 10,000 people are: Kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin).(yellowing of the skin), blood disorders (agranulocytosis, leukopenia, neutropenia, haemolytic anaemia) and hypoglycaemia (low blood sugar).

Serious skin reactions have been reported very rarely.

Paracetamol can damage the liver when taken in high doses or in prolonged treatment.

Reporting side effects

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

Keep out of the sight and reach of children.

No special storage conditions are necessary.

Do not use this medicine after the expiry date which is stated on the carton after EXP.

The expiry date is the last day of the month indicated.

Medicines should not be flushed down the drain or thrown away. Please dispose of unneeded medicines and containers at the SIGRE Point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unneeded medicine containers and medicines. In this way, you will help to protect the environment.

Composition of Paracetamol MABO-Serra

The active substance is paracetamol. Each tablet contains 500 mg paracetamol.

The other ingredients (excipients) are: Saccharin sodium, hydroxypropyl cellulose, magnesium stearate, talc, sodium carboxymethyl potato starch, silicon dioxide, orange flavouring.

Appearance of the product and contents of the package

The tablets are round, white and grooved.

The pack contains 10 or 20 tablets in aluminium/PVC blister packs.

Marketing Authorisation Holder

MABO-FARMA S.A.

Calle Rejas 2, planta 1

28821 Coslada (Madrid)

Spain

Responsible for manufacturing

LABORATORIOS ALCALA FARMA S.L.

Avda. de Madrid, 82

28802 ALCALÁ DE HENARES (Madrid)

Date of last review of this package leaflet: February 2022

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Health Products (AEMPS) http://www.aemps.gob.es/