Gelocatil 650 mg oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
GELOCATIL 650 mg Oral Solution
Paracetamol
Read the entire leaflet carefully because it contains important information for you.
This medicine can be purchased without a prescription. However, to obtain the best results, it must be used carefully.
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Keep this leaflet, as you may need to read it again.
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If you need advice or further information, consult your pharmacist.
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If symptoms worsen or if fever persists for more than 3 days or pain for more than 5 days, you should consult a doctor.
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If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet contents:
- What Gelocatil 650 mg Oral Solution is and what it is used for.
- Before taking Gelocatil 650 mg Oral Solution.
- How to take Gelocatil 650 mg Oral Solution.
- Possible side effects.
- How to store Gelocatil 650 mg Oral Solution.
- Further information.
1. What Gelocatil 650 mg 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, muscle pain (muscle spasms), or back pain (lumbago), as well as in febrile conditions.
Gelocatil is indicated for adults and adolescents over 14 years of age.
2. Before taking Gelocatil
Do not take Gelocatil if:
- you are allergic (hypersensitive) to paracetamol or to any of the other components 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 take more than 2 grams of paracetamol in 24 hours.
- Patients with kidney, liver, heart, or lung disease, and patients with anaemia, should consult their doctor before taking this medicine.
- If you are being treated with medication for epilepsy, you should consult your doctor before taking this medicine, as when used together, the effectiveness may be reduced and the hepatotoxicity of paracetamol may be increased, especially with high-dose paracetamol regimens.
- Asthmatic patients 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 for prolonged periods 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:
Inform 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, as it may be necessary to adjust the dose 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)
- Medicines to lower blood cholesterol levels: (cholestyramine)
- Medicines used to increase urine elimination (loop diuretics such as furosemide)
- 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 or urine tests, etc.), inform your doctor that you are taking/using this medicine, as it may alter test results.
Taking Gelocatil with food and drink:
The use of paracetamol in patients who regularly consume alcohol (3 or more alcoholic drinks: beer, wine, spirits, etc., per day) may cause liver damage.
Taking this medicine with food does not affect its efficacy.
Use in children:
- Not to be used in adolescents under 14 years of age.
Pregnancy:
Consult your doctor or pharmacist before using any medicine.
IMPORTANT FOR WOMEN:
If you are pregnant or think you may be pregnant, consult your doctor before taking this medicine. Taking medicines during pregnancy may be dangerous for the embryo or fetus and should be monitored by your doctor.
If necessary, Gelocatil may be used during pregnancy. Use the lowest possible dose that relieves pain or fever, and use it for the shortest possible time. 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, so women who are breast-feeding should consult their doctor or pharmacist before taking this medicine.
Driving and using machines:
The effect 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 1300 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 insufficiency, 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 the child is under 5 years of age, consult your doctor or pharmacist, especially if other medicines containing propylene glycol or alcohol have been administered.
This medicine contains 1300 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 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 and adolescents over 14 years of age (weight 64-65 kg): Take 1 sachet every 4-6 hours as needed. Do not take more than 3 grams (4 sachets) in 24 hours.
Patients with liver disease: must consult their doctor before taking this medicine.
They should take the amount of medicine prescribed by their doctor, with a minimum interval of 8 hours between doses.
They should not take more than 3 sachets of paracetamol in 24 hours, divided into 3 doses.
Patients with kidney disease: must consult their doctor before taking this medicine.
Take a maximum of 500 milligrams of paracetamol per dose.
Due to the dosage of 650 milligrams 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, consume all of its contents.
Always use the lowest effective dose.
The use of high daily doses of paracetamol over prolonged periods should be avoided, as this increases the risk of adverse effects such as liver damage.
Administration of this medicine should be based on the presence of pain or fever. 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 should contact 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 taken 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, even in cases of severe poisoning.
Treatment of 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), indicating 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 between 1 and 10 out of every 10,000 people) include: malaise, low blood pressure (hypotension), and increased blood transaminase levels.
- Very rare adverse effects (occurring in fewer than 1 out of every 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 rare cases of severe skin reactions have also been reported.
Paracetamol can damage the liver when taken at high doses or during prolonged treatment.
- Adverse effects of unknown frequency (cannot be estimated from available data): A serious condition causing increased acidity of the blood (called metabolic acidosis) in critically ill patients using 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 can 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 650 mg Oral Solution
Keep out of the reach and sight of children.
No special storage conditions are required.
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 must 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 are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Additional Information
Composition of Gelocatil:
Each sachet contains 650 milligrams of paracetamol.
The other components 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, ammonium sulfite caramel (E-150-d), raspberry flavour, strawberry flavour, ascorbic acid or sodium hydroxide, and purified water.
Appearance of the product and contents of the pack:
Gelocatil is a clear oral solution with a slight amber tint, supplied in single-dose sachets.
Packs contain 4 or 12 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 revision of this leaflet: February 2025
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/