Gelocatil 1 g oral solution

Package leaflet: Information for the user

Introduction

GELOCATIL 1 g Oral Solution

Paracetamol

Contents of the leaflet:

1. What Gelocatil 1 g Oral Solution is and what it is used for.
2. Before taking Gelocatil 1 g Oral Solution.
3. How to take Gelocatil 1 g Oral Solution.
4. Possible side effects.
5. Storage of Gelocatil 1 g Oral Solution.
6. Further information.

1. What Gelocatil 1 g Oral Solution is and what it is used for

Paracetamol is effective in reducing pain and fever.

It is indicated for the symptomatic relief of mild to moderate occasional pain, such as headache, dental pain, muscular pain (muscle strains), or back pain (lumbago), and in febrile conditions.

Gelocatil is indicated for adults.

2. Before taking Gelocatil

Do not take Gelocatil if:

• you are allergic (hypersensitive) to paracetamol or to any of the other ingredients of Gelocatil.

Take special care with Gelocatil:

• Do not take more medicine than the recommended dose stated in section 3, How to take Gelocatil.
• The simultaneous use of this medicine with other medicines containing paracetamol, such as cold and flu remedies, should be avoided, as high doses may cause liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
• Chronic alcoholics should take care not to exceed 2 grams of paracetamol in 24 hours.
• Patients with kidney, liver, heart, or lung disease, or those with anemia, should consult their doctor before taking this medicine.
• If you are being treated with medication for epilepsy, consult your doctor before taking this medicine, because when used together, the efficacy is reduced and the hepatotoxicity of paracetamol is increased, especially with high-dose paracetamol treatment.
• Patients with asthma who are sensitive to acetylsalicylic acid should consult their doctor before taking this medicine.
• During treatment with Gelocatil, inform your doctor immediately if:

You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients in these situations when paracetamol is used at regular doses over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe difficulty breathing with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

Use of other medicines:

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

In particular, if you are using any of the following medicines, the dose of some of them may need to be adjusted or treatment may need to be interrupted:

• 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)
• Medicines to lower blood cholesterol levels: (cholestyramine)
• Medicines used to increase urine elimination (loop diuretics such as those in the furosemide group)
• Medicines used to treat gout (probenecid and sulfinpyrazone)
• Medicines used to prevent nausea and vomiting: Metoclopramide and domperidone
• Medicines used to treat high blood pressure (hypertension) and heart rhythm disorders (cardiac arrhythmias): Propranolol
• Flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) requiring urgent treatment (see section 2)

Interference with laboratory tests:

If you are due to have any laboratory tests (including blood and urine tests, etc.), inform your doctor that you are taking/using this medicine, as it may alter the results.

Taking Gelocatil with food and drink

Taking this medicine with food does not affect its efficacy.

Use in children

Do not use in individuals under 18 years of age.

Pregnancy

Consult your doctor or pharmacist before using any medicine.

If necessary, Gelocatil may be used during pregnancy. Use the lowest dose possible to relieve pain or fever and use it for the shortest possible duration. Contact your doctor if pain or fever do not improve or if you need to take the medicine more frequently.

Breast-feeding

Consult your doctor or pharmacist before using any medicine.

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

Driving and using machines:

The influence of paracetamol on the ability to drive and use machines is none or negligible.

Gelocatil contains propylene glycol, sorbitol, methyl p-hydroxybenzoate (E-218), propyl p-hydroxybenzoate (E-216) and sodium:

This medicine contains 2000 mg of propylene glycol in each sachet.

If you are pregnant or breast-feeding, do not take this medicine unless recommended by your doctor. Your doctor may carry out additional check-ups while you are taking this medicine.

If you have hepatic or renal impairment, do not take this medicine unless recommended by your doctor. Your doctor may carry out additional check-ups while you are taking this medicine.

This medicine contains 2000 mg of sorbitol in each sachet.

Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor (or your child’s doctor) before taking this medicine.

May cause allergic reactions (possibly delayed) because it contains methyl p-hydroxybenzoate (E-218) and propyl p-hydroxybenzoate (E-216).

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

3. How to take Gelocatil

Follow these instructions unless your doctor has given you different advice. Consult your doctor or pharmacist if you have any doubts.

The usual dose is:

Adults:

Take 1 sachet every 6–8 hours as needed. Do not take more than 3 grams (3 sachets) in 24 hours.

Patients with liver disease: must consult their doctor before taking this medicine.

They should take the amount prescribed by their doctor, with a minimum interval of 8 hours between doses.

They should not take more than 2 paracetamol sachets in 24 hours, divided into 2 doses.

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

Take a maximum of 500 milligrams per dose.

Due to the dosage (1 gram of paracetamol), this medicine is not indicated for this patient group.

This medicine is taken orally.

The contents of the sachet may be taken diluted in a liquid, preferably water, or taken directly. Once the sachet is opened, the entire contents should be consumed.

Always use the lowest effective dose.

The prolonged use of high daily doses of paracetamol should be avoided, as this increases the risk of adverse effects such as liver damage.

Administration of this medicine should only occur when pain or fever is present. As these symptoms subside, treatment should be discontinued.

If pain persists for more than 5 days, fever for more than 3 days, or if pain or fever worsen or new symptoms appear, treatment should be stopped and a doctor consulted.

If you take more Gelocatil than you should:

You must consult your doctor or pharmacist immediately.

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

If you have ingested an overdose, you must go immediately to a medical center even if you do not have symptoms, as symptoms often do not appear until 3 days after the overdose has been ingested, even in cases of severe poisoning.

Treatment for overdose is most effective if started within 4 hours of taking the medicine.

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, go immediately to a medical center or call the Toxicology Information Service (telephone 91 562 04 20), stating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, Gelocatil may have adverse effects, although not everyone experiences them.

• Rare adverse effects (occurring in 1 to 10 out of 10,000 people) include: malaise, low blood pressure (hypotension), and increased blood transaminase levels.
• Very rare adverse effects (occurring in less than 1 out of 10,000 people) include: kidney disorders, cloudy urine, allergic dermatitis (skin rash), jaundice (yellowing of the skin), blood disorders (agranulocytosis, leucopenia, neutropenia, haemolytic anaemia), and hypoglycaemia (low blood sugar). Very rarely, severe skin reactions have been reported.

Paracetamol may cause liver damage when taken at high doses or during prolonged treatment.

• Adverse effects with frequency not known (cannot be estimated from available data): A serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who use paracetamol (see section 2).

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Gelocatil 1 g Oral Solution

Keep out of the reach and sight of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional information

Composition of Gelocatil:

Each sachet contains 1 gram of paracetamol as the active substance.

The other components (excipients) are sodium saccharin, propylene glycol, macrogol, sorbitol (E-420), methyl p-hydroxybenzoate and propyl p-hydroxybenzoate (E-218 and E-216), povidone K12, neohesperidin DC, sulphite ammonia caramel (E-150-d), raspberry flavour, strawberry flavour, ascorbic acid or sodium hydroxide, and purified water.

Appearance of the product and contents of the container:

Gelocatil is a clear oral solution with a slight amber tint, supplied in single-dose sachets.

Pack sizes are 4 and 10 sachets.

Marketing Authorization Holder:

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 – Barcelona (Spain)

Manufacturer:

Ferrer Internacional, S.A.

Joan XXIII, 10

08950 – Esplugues de Llobregat (Barcelona)

or

Ferrer Internacional, S.A.

Joan Buscallá, 1-9

08173 – Sant Cugat del Vallès (Barcelona)

Local Representative:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 – Barcelona (Spain)

Date of the most recent review of this leaflet: February 2025

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