Leaflet: information for the user

Paracetamol Pharma Combix 650 mg tablets EFG

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

- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What Paracetamol Pharma Combix is and what it is used for

2. What you need to know before you start taking Paracetamol Pharma Combix

3. How to take Paracetamol Pharma Combix

4. Possible side effects

5. Storage of Paracetamol Pharma Combix

6. Contents of the pack and additional information

Paracetamol belongs to a group of medicines called analgesics and antipyretics.

It is indicated for the treatment of symptoms of mild to moderate pain and fever.Consult a doctor if the pain worsens or does not improve after 5 days, or the fever after 3 days.

Do not take Paracetamol Pharma Combix:

-If you are allergic (hypersensitive) to paracetamol, chlorpropamide or to any of the other components of this medication (listed in section 6).

Warnings and precautions:

-Consult your doctor, pharmacist or nurse before starting to take paracetamol.

-Do not take more than the recommended dose in the section 3. How to take Paracetamol Pharma Combix.

-In patients with asthma sensitive to acetylsalicylic acid, consult your doctor before taking this medication.

-If you have any kidney, liver, heart or lung disease or have anemia (decrease in hemoglobin levels in the blood, due or not due to a decrease in red blood cells), consult your doctor before taking this medication.

-When undergoing treatment with any medication for epilepsy, consult your doctor before taking this medication, as when used together, it decreases the effectiveness and increases the hepatotoxicity of paracetamol, especially in high-dose paracetamol treatments.

-In chronic alcoholics, be careful not to take more than 3 tablets of 650 mg of paracetamol in 24 hours.

-If the pain persists for more than 5 days, fever for more than 3 days, or if the pain or fever worsen or other symptoms appear, consult your doctor and reevaluate the clinical situation.

Children and adolescents:

-In children and adolescents under 15 years, consult your doctor or pharmacist as there are other presentations with doses adapted to this group of patients.

Other medications and Paracetamol Pharma Combix:

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.

Paracetamol may interact with the following medications:

-Blood clotting medication: Oral anticoagulants (acenocoumarol, warfarin)

-Medications for treating epilepsy: Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)

-Medications for treating tuberculosis: (isoniazid, rifampicin)

-Medications for treating depression and seizures: Barbiturates (used as hypnotics, sedatives and anticonvulsants)

-Medications used to lower cholesterol levels in the blood: (colestiramine)

-Medications used to increase urine elimination (diuretics such as furosemide)

-Medications used to treat gout (probencid and sulfinpyrazone)

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

-Medications used to treat high blood pressure (hypertension) and heart rhythm disorders (arrhythmias): Propranolol

Do not use with other analgesics (pain-relieving medications) without consulting your doctor.

As a general rule for any medication, it is recommended to inform your doctor or pharmacist if you are taking another medication. In the case of oral anticoagulants, this medication can be administered occasionally as the preferred analgesic.

Interference with analytical tests:

If you are to undergo any analytical test (including blood, urine, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results of these tests.

Paracetamol Pharma Combix with food, drinks and alcohol:

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

The taking of this medication with food does not affect its efficacy.

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before using any medication.

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor before taking this medication.

In case of need, Paracetamol Pharma Combix can be used during pregnancy. Use the lowest possible dose that reduces pain or fever and use it for the shortest possible time. Contact your doctor if the pain or fever do not decrease or if you need to take the medication more frequently.

The consumption of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Small amounts of paracetamol may appear in breast milk, therefore, consult your doctor or pharmacist before taking this medication.

Driving and operating machinery:

The influence of paracetamol on the ability to drive and operate machinery is negligible or insignificant.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Paracetamol must be taken orally.

The recommended dose is:

Adults and adolescents over 15 years:The usual dose is 1 tablet (650 mg of paracetamol) every 4-6 hours. Doses should be spaced at least 4 hours apart. No more than 6 tablets should be taken in 24 hours.

Patients with liver disease:Before taking this medication, they must consult their doctor. They should take the amount of medication prescribed by their doctor with a minimum interval of 8 hours between each dose.

They should not take more than 3 tablets of 650 mg of paracetamol in 24 hours.

Patients with kidney disease:Before taking this medication, they must consult their doctor. Take a maximum of 500 milligrams per dose.

Due to the dose, 650 mg of paracetamol, it is not indicated for this group of patients.

Older patients:They should consult their doctor.

Use in children and adolescents:Not to be used in children under 15 years.

If it is estimated that the action of Paracetamol is too strong or too weak, inform your doctor or pharmacist. When requiring the administration of doses lower than

650 milligrams of paracetamol per dose, other presentations of paracetamol should be used that adapt to the required dosage.

If you take more Paracetamol Pharma Combixthan you should:

You should consult your doctor or pharmacist immediately.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowish discoloration of the skin and eyes (jaundice) and abdominal pain.

If you have ingested an overdose, you should go immediately to a medical center, even if you do not notice the symptoms, as they often do not appear until 3 days after ingestion of the overdose, even in cases of severe poisoning. The treatment of the overdose is more effective if it is initiated within 4 hours of ingestion of the medication.

Patients undergoing treatment with barbiturates or chronic alcoholics may be more susceptible to the toxicity of a paracetamol overdose.

In case of overdose or accidental ingestion, consult your doctor or call the Toxicological Information Service (phone 91 562 04 20), indicating the medication and the amount ingested.

If you forgot to take Paracetamol Pharma Combix

Do not take a double dose to compensate for the missed doses, simply take the missed dose when you remember, taking the next doses with the indicated spacing between doses (at least 4 hours).

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Rare adverse effects that may occur (in up to 1 in 1,000 people) are: discomfort, low blood pressure (hypotension), and increased levels of transaminases in the blood.

Very rare adverse effects that may occur (in up to 1 in 10,000 people) are: kidney diseases, cloudy urine, allergic dermatitis (skin rash), jaundice (yellow discoloration of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar). Rarely, severe skin reactions have been reported.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Composition of Paracetamol Pharma Combix:

Each tablet contains 650 mg of paracetamol as the active ingredient.

The other components (excipients) are potato starch sodium carboxymethyl (Type A), pregelatinized cornstarch, povidone K30 (E-1201), stearic acid (E-570), and crospovidone (E-1202).

Appearance of the product and content of the packaging:

Paracetamol Pharma Combix is presented in oral tablets for administration.

The tablets are oblong, biconvex, white in color, with a notch on one face and marked with PB on the other face.

Available in packaging of 20 and 40 tablets and a clinical pack of 500 tablets, conditioned in PVC/PVdC/Aluminum blisters.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

SAG Manufacturing S.L.U

Crta.N-I, Km 36,

San Agustín de Guadalix,

28750 Madrid

Spain

or

Galenicum Health, S.L.

Avda. Cornellá 144, 7º-1ª, Edificio Lekla

Esplugues de Llobregat

08950 Barcelona

Spain

Last review date of this leaflet:March 2021

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