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Gelocatil 325 Mg 12 Granulated Envelopes

Acetaminophen is effective in reducing pain and fever.

It is indicated for symptomatic relief from mild or moderate occasional pain, such as headache, dental, muscle (contractures) and fever.

Pediatric gelocatil is indicated in children between 25 and 43 kg (8 to 11 years old).

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Reference:
699453
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Description

1. What is Gelocatil pediatric and what is it used for

Paracetamol is effective in reducing pain and fever.

 

It is indicated for the symptomatic relief of occasional mild or moderate pain, such as headache, dental pain, muscle pain (contractures) and fever.

 

Gelocatil pediatric is indicated in children between 25 and 43 kg (8 to 11 years).

2. What you need to know before you take Gelocatil pediatric

Do not take Gelocatil pediatric

 

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

 

Take special care with Gelocatil pediatric

 

  • Do not take more quantity of medicine than recommended in section 3. How to take Gelocatil pediatric.
  • Simultaneous use of this medicine with other medicines containing paracetamol, for example medicines for flu and colds, should be avoided, as high doses can lead to liver damage. Do not use more than one medicine containing paracetamol without consulting your doctor.
  • They should consult their doctor before taking this medicine:
  • Patients with kidney, liver, heart or lung diseases and in patients with anemia.
  • Asthmatic patients sensitive to acetylsalicylic acid.

 

 

Use of Gelocatil pediatric with other medicines

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

 

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

 

  • Antibiotics (chloramphenicol)
  • Oral anticoagulants (acenocoumarol, warfarin)
  • Oral contraceptives and estrogen treatments
  • Antiepileptics (lamotrigine, phenytoin or other hydantoins, phenobarbital, methylphenobarbital, primidone, carbamazepine)
  • Antituberculous drugs (isoniazid, rifampicin)
  • Barbiturates (used as sleep inducers, sedatives, and anticonvulsants)
  • Activated charcoal used for diarrhea or gas treatment
  • Cholestyramine (used to lower blood cholesterol levels)
  • Medicines used to treat gout (probenecid and sulfinpyrazone)
  • Medicines used to relieve stomach, bowel, and bladder spasms or contractions (anticholinergics)
  • Medicines used for the heart (digitalis glycosides)
  • Metoclopramide and domperidone (used to prevent nausea and vomiting)
  • Propranolol used to treat high blood pressure (hypertension) and disturbances of the rhythm of the heart (cardiac arrhythmias)

 

Interference with analytical tests:

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

 

Taking Gelocatil pediatric with food and drink

Taking this medicine with food does not affect its effectiveness.

 

Pregnancy

Consult your doctor or pharmacist before taking any medicine.

If necessary, Gelocatil pediatric 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 subside or if you need to take the medicine more often.

 

Lactation

Consult your doctor or pharmacist before taking any medicine.

 

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

 

Children

Do not use in children weighing less than 25 kg (less than 6 years approximately) because it does not allow the dosage of doses lower than 1 sachet per dose (325 mg).

 

Driving and using machines

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

 

Important information about some of the ingredients of Gelocatil pediatric

  • This medicine may be harmful for people with phenylketonuria because it contains aspartame which is a source of phenylalanine.
  • Patients with low sodium diets should take into account that this medicine contains 58.5 mg of sodium per 325 mg sachet.

This medicine contains sucrose, if your doctor has told you that you have an intolerance to some sugars, contact him before taking this medicine.

3. How to take Gelocatil pediatric

Follow exactly the instructions for administration of this medicine contained in this leaflet or those indicated by your pharmacist. If in doubt, ask your doctor or pharmacist.

 

It is necessary to respect the dosages defined according to the child's weight, and therefore, choose the appropriate dosage. The approximate age based on weight is given for information purposes.

 

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

 

  • Children between 25 and 43 kg (approximately 8 to 11 years old) : 1 sachet of 325 mg every 4-6 hours as needed. Depending on weight, children weighing less than 33 kg should not exceed 5 sachets in 24 hours and those weighing over 33 kg up to 6 sachets in 24 hours.

 

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

 

Gelocatil Pediatric is taken by mouth.

Open the envelope and pour the contents directly into your mouth. The granules are immediately dispersed in the saliva and then swallowed.

 

It can be taken both with and without food.

Always use the lowest dose that is effective.

 

The use of high daily doses of paracetamol for prolonged periods of time should be avoided as the risk of suffering adverse effects such as liver damage is increased.

 

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

 

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

 

 

If your child takes more Gelocatil Pediatric than he should

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested .

 

If an overdose has been ingested, go quickly to a medical center even if there are no symptoms, since these often do not appear until 3 days after the ingestion of the overdose, even in cases of severe poisoning.

 

Overdose symptoms may be: dizziness, vomiting, loss of appetite, yellowing of the skin and eyes (jaundice), and abdominal pain.

 

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

 

Patients taking barbiturates or chronic alcoholics may be more susceptible to toxicity from a paracetamol overdose.

 

If you forget to take Gelocatil pediatric

Do not give the child a double dose to make up for the forgotten dose, just give the forgotten dose when you remember, taking the next doses with the interval between doses indicated in each case (4-6 hours).

4. Possible side effects

Like all medicines, Gelocatil pediatric can have side effects, although not everyone gets them.

 

Rare side effects that may occur (up to 1 in 1,000 patients) are: malaise, drop in blood pressure (hypotension), and increased levels of transaminases 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, leukopenia, neutropenia, hemolytic anemia) and hypoglycemia (low blood sugar). Very rare cases of serious skin reactions have been reported.

 

Paracetamol can damage the liver when taken in high doses or in long-term treatments.

 

Communication of adverse effects

If you experience any kind of side effect, consult your doctor or pharmacist, even if it is about possible side effects that are not listed in this leaflet. You can also communicate them directly through the Spanish Pharmacovigilance System for medicines for Human Use: https://www.notificaram.es . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Gelocatil pediatric

Keep out of the sight and reach of children.

 

No special storage conditions are required.

 

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

 

Medicines must not be disposed of via wastewater or household waste. Deposit the containers and medicines that you do not need at the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of medicines no longer required. This way you will help to protect the environment.

6. Package contents and additional information

Composition of Gelocatil pediatric

 

The active substance is paracetamol. Each sachet contains 325 mg of paracetamol.

 

The other ingredients (excipients) are calcium carbonate, sodium hydrogen carbonate, anhydrous citric acid, anhydrous sodium citrate, aspartame (E-951), mask it (composed of natural flavorings, flavoring substances identical to the natural ones, maltodextrin, sucrose, aspartame (E-951) and acesulfame potassium (E-950)), Mannitol (E-421), lemon flavor, amorphous silica, glycerol (E-422) type 1 distearate, croscarmellose sodium, sodium carboxymethyl starch (starch type A potato), ethyl cellulose, hydroxypropyl methyl cellulose, polyethylene glycol 400.

 

Product appearance and pack size

 

Pediatric Gelocatil is a white, lemon-scented granule that comes in sachets for oral administration.

Packed in boxes of 12 and 20 envelopes.

 

Holder of the marketing authorization and responsible for manufacturing

 

Headline

Ferrer Internacional, SA

Gran Vía Carlos III, 94

08028 Barcelona

Spain

 

Responsible for manufacturing

 

Farmalider, SA

C / Aragoneses, 2

28108 Madrid

 

or

 

Biofabri, SL

A relva, S / n,

Or Porriño

36400 Pontevedra

 

or

 

Edefarm, SL

Polígono Industrial Enchilagar del Rullo, 117

46191 Villamarchante,

Valencia

 

Date of the last revision of this leaflet: October 2019

 

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

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Product Details
699453
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