GELOCATIL 500 mg GRANULES

Introduction

Package Leaflet: Information for the User

Gelocatil 500 mg Granules

Paracetamol

Contents of the Package Leaflet:

1. What is Gelocatil and what is it used for
2. What you need to know before you start taking Gelocatil
3. How to take Gelocatil
4. Possible side effects
5. Storage of Gelocatil
6. Contents of the pack and further information.

1. What is Gelocatil and what is it used for

Paracetamol is effective for reducing pain and fever.

It is indicated for the symptomatic relief of occasional mild or moderate pain, such as headache, dental, muscular (cramps) or back (lumbago) pain and fever.

Gelocatil is indicated in adults and adolescents over 44 kg (from 12 years old).

2. What you need to know before you start taking Gelocatil

Do not takeGelocatil

• 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 starting to take Gelocatil.
• Do not take more medicine than recommended in section 3. How to take Gelocatil.
• The simultaneous use of this medicine with other medicines containing paracetamol, such as flu and cold medicines, should be avoided, as high doses can lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• Chronic alcoholics should not take more than 2 g (4 sachets) of paracetamol in 24 hours, divided into several doses.
• The following patients should consult their doctor before taking this medicine:

• Patients with kidney, liver, heart, or lung disease, and patients with anemia.
• Patients with asthma who are sensitive to acetylsalicylic acid.

• During treatment with Gelocatil, inform your doctor immediately if:

If you have severe illnesses, such as severe kidney failure or sepsis (when bacteria and their toxins circulate in the blood, causing damage to organs), or if you have malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A severe disease called metabolic acidosis (an anomaly in blood and fluids) has been reported in patients in these situations when paracetamol is used at regular doses for a prolonged period or when paracetamol is taken with flucloxacillin. The symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea) and vomiting.

Using Gelocatil with other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicine, including those obtained without a prescription.

In particular, if you are using medicines that contain any of the following active ingredients, as it may be necessary to reduce the dose of some of them or interrupt treatment:

• Antibiotics (chloramphenicol)
• Oral anticoagulants (acenocoumarol, warfarin)
• Oral contraceptives and estrogen treatments
• Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
• Antituberculars (isoniazid, rifampicin)
• Barbiturates (used as sleep inducers, sedatives, and anticonvulsants)
• Activated charcoal used for diarrhea or gas treatment
• Cholestyramine (used to decrease blood cholesterol levels)
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid anomaly (called metabolic acidosis) that requires urgent treatment (see section 2).
• Medicines used to treat gout (probenecid and sulfinpyrazone)
• Medicines used to relieve stomach, intestine, and bladder spasms or contractions (anticholinergics)
• Medicines used for heart conditions (digitalis glycosides)
• Metoclopramide and domperidone (used to prevent nausea and vomiting)
• Propranolol used in the treatment of high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias)

Interference with analytical tests:

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

Taking Gelocatil with food, drinks, and alcohol

The use of paracetamol in patients who habitually consume alcohol (3 or more alcoholic beverages per day) may cause liver damage.

Taking this medicine with food does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

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.

In case of need, Gelocatil 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. Contact your doctor if the pain or fever does not decrease or if you need to take the medicine more frequently.

Breastfeeding

Paracetamol is excreted in breast milk, so breastfeeding women should consult their doctor or pharmacist before using this medicine.

Children

Do not use in children with a weight of less than 44 kg (under 12 years old) because it does not allow for dosing of doses less than 1 sachet (500 mg) per dose.

Driving and using machines

The influence of paracetamol on the ability to drive and use machines is zero or insignificant.

Gelocatil contains aspartame, sodium, sucrose, and glucose

• This medicine contains 23.82 mg of aspartame in each sachet. Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.
• This medicine contains 107.92 mg of sodium (main component of table salt/cooking salt) in each sachet. This is equivalent to 5.4% of the maximum daily sodium intake recommended for an adult. Consult your doctor or pharmacist if you need 4 or more sachets per day for a prolonged period, especially if you have been advised to follow a low-salt diet (sodium).
• This medicine contains sucrose; if your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.
• It may cause cavities.

.

3. How to take Gelocatil

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

The recommended dose is:

• Adults: the recommended dose is 1 sachet (500 mg paracetamol) every 4-6 hours as needed. If necessary, 2 sachets of 500 mg can be taken every 6-8 hours, not exceeding 6 sachets in 24 hours. Do not take more than 3 grams (6 sachets) in 24 hours.

• Adolescents over 44 kg (from 12 years old): the recommended dose is 1 sachet (500 mg paracetamol) every 4-6 hours as needed, not exceeding 5 sachets in 24 hours.

Patients with liver or kidney disease: should consult their doctor before taking this medicine. If your doctor prescribes this medicine, you should wait at least 8 hours between two doses.

Gelocatil is taken orally.

Open the sachet and pour the contents directly into the mouth. The granules disperse immediately in saliva and then swallow.

It can be taken with or without food.

Always use the lowest effective dose.

High daily doses of paracetamol should be avoided during prolonged periods, as the risk of side effects such as liver damage increases.

The administration of this medicine is subject to the appearance of pain or fever. As they disappear, this medication should be discontinued.

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

If you take more Gelocatil than you should

In case of overdose or accidental ingestion, 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 have ingested an overdose, go quickly to a medical center, even if you have no symptoms, as they often do not appear until 3 days after ingestion, even in cases of severe poisoning.

The symptoms of overdose may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), abdominal pain, and pancreas inflammation (pancreatitis).

Treatment of overdose is more effective if started within 4 hours of ingestion of the medicine.

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

If you forget to take Gelocatil

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

4. Possible side effects

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

Rare side effects that may occur (up to 1 in 1,000 patients) are: discomfort, low blood pressure (hypotension), and increased transaminase levels in the blood.

• Very rare side effects that may occur (up to 1 in 10,000 patients) are: kidney disease, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, hemolytic anemia), and hypoglycemia (low blood sugar). Very rare cases of severe skin reactions have been reported.

• Paracetamol may damage the liver when taken in high doses or in prolonged treatments.

Side effects of unknown frequency (cannot be estimated from the available data): a severe disease that can make the blood more acidic (called metabolic acidosis) in patients with severe disease using paracetamol (see section 2).

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects 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 Gelocatil

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

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

6. Contents of the pack and further information

Composition of Gelocatil

The active ingredient is paracetamol. Each sachet contains 500 mg of paracetamol.

The other ingredients (excipients) are calcium carbonate, sodium hydrogen carbonate, anhydrous citric acid, anhydrous sodium citrate, aspartame (E-951), flavoring (contains potato maltodextrin, sucrose, and aspartame (E-951)), mannitol (E-421), lemon flavor (contains corn maltodextrin), amorphous silica, glycerol (E-422) diester type 1, sodium croscarmellose, sodium carboxymethyl starch (type A potato starch), ethyl cellulose, hydroxypropyl methylcellulose, polyethylene glycol 400.

Appearance of the product and pack size

Gelocatil is a white granule with a lemon odor, presented in sachets for oral administration.

Packaged in boxes of 12 and 20 sachets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Farmalider, S.A.

C/Aragoneses, 2

28108 Madrid

or

Edefarm, S.L.

Polígono Industrial Enchilagar del Rullo, 117

46191 Villamarchante

Valencia

Date of the last revision of this leaflet:February 2025

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