Paramolan

The active substance is paracetamol.
Tablet: White round tablet.
Each tablet contains 500 mg of Paracetamol.
Oral solution: Each ml contains 24 mg paracetamol.
Suppository: Each Paramolan suppository 125 mg contains Paracetamol 125 mg.
Each Paramolan suppository 250 mg contains Paracetamol 250 mg.
Excipients/Inactive Ingredients: Tablet: Pregelatinized starch, povidone and stearic acid.
Oral solution: Macrogol type 400, liquid sorbitol, propylene glycol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, saccharin sodium, apricot aroma, nougat aroma, currant syrup concentrate and purified water.
Suppository: Glycerides of fatty acids.

Tablet: Paramolan tablet is a medicinal product available in the form of tablets for oral administration.
Paramolan tablet is indicated for the treatment of fever and mild to moderate pain such as headache, migraine and relief of acute low back pain.
Oral solution: Paramolan oral solution contains paracetamol, belongs to a group of medicines called analgesics and antipyretics.
It is used for mild to moderate pain including headache, migraine, nerve pain, toothache, sore throat, period pains and general aches and pains.
It is also used to relieve the symptoms of cold and flu.
It is also used to help reduce a fever (high temperature).
Suppository: Paramolan suppositories contain as active ingredient paracetamol, which is characterized by its analgesic and antipyretic properties used to treat pain and high temperature (fever) in children.

Patients must be advised to always take Paramolan exactly as prescribed. Patients must be advised to check with the doctor or pharmacist if they are not sure.
Tablet: For information purposes only, and unless otherwise indicated by a doctor, Paramolan tablet may be administered as follows: The usual dose for adults and children over 12 years: 1-2 tablets every 4-6 hours as required. Do not exceed the maximum daily dose of 8 tablets (4 g) in 24 hours.
For children 6-12 years: ½-1 tablet every 4 to 6 hours when necessary up to a maximum of 4 doses and do not exceed 4 tablets in 24 hours.
The tablets may be swallowed whole or dissolved in water.
Forgotten intake of Paramolan Tablet: If this happens, do not administer a double dose to replace for the forgotten dose, wait until the next dose at the usual time.
If the patient has any further questions about using this medicine, they must be advised to ask the doctor or pharmacist.
Oral solution: Paramolan oral solution may be administered as the tables as follows: This medicine contains 120 mg of paracetamol in one 5 ml spoonful.
Patients must be advised to take this medicine by mouth only.
Never give more medicine than shown in table.
Shake well before use.
Always use the measuring spoon supplied for a more accurate administration of the dose.
Do not give this medicine with any other paracetamol-containing product.
How much to take: See Tables 1, 2 and 3.

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

Forgotten intake of this medicine: The next dose should be taken at the usual time, resuming treatment as usual. A double dose should not be taken to make up for a forgotten dose.
Suppository: How to give Paramolan Suppositories to children: In general, except advice by doctors or pharmacists, Paramolan suppositories can be administered as follows: 125 mg: 3 to 12 months: 1 suppository every 4 to 6 hours, up to a maximum of 4 doses in 24 hours.
1 to 5 years: 1-2 suppositories every 4 to 6 hours, up to a maximum of 4 doses in 24 hours.
250 mg: 6 to 12 years: 1 suppository (250 mg) to 2 suppositories (500 mg) each time.
Caution: Do not exceed 4 times daily.
Not recommended to use in children under 3 months.
The interval between doses should not be less than 4 hours.
In case of renal or hepatic impairment, may require a dose reduction or an enlargement of the interval between administrations.
Forgotten administration of Paramolan Suppositories to children: Do not administer a double dose and give the usual dose as soon as remembered. However, if it is almost time for the next dose, skip the missed dose.
If the patient/guardian/caregiver has any further questions on the use of this product, they must be advised to ask the doctor or pharmacist.

Tablet: Paramolan tablet contains paracetamol, which is a drug that, if administered in overdoses (ingested 12 g or more of Paracetamol in total) can cause serious damage to the liver.
Common signs of paracetamol overdose may be nausea and vomiting. Abdominal pain may be the first indication of liver damage.
Hepatic failure may occur.
Acute renal failure with acute tubular necrosis may develop.
Treatment for Paracetamol overdose: Immediate and appropriate treatment in hospital should be given as soon as overdose is known.
Oral solution: Immediate medical advice should be sought in the event of an overdose, even if the child seems well, because of the risk of delayed, serious liver damage. Patients/guardians/caregivers must be advised to phone the doctor or go to the nearest accident and emergency department straight away.
There may be no symptoms during the first 24 hours although paleness, nausea (feeling sick), vomiting (being sick) and abdominal pain may occur.
Suppository: Paracetamol is a drug that if administered in large doses can cause serious damage to the liver.
Adequate control of an overdose of paracetamol requires immediate treatment, so despite the absence of early symptoms, the patient should be taken to the emergency hospital for immediate treatment. As the degree of intoxication, the children will be given the appropriate measures of treatment and support.

Paramolan should not be taken/given: if the patient is allergic (hypersensitive) to the active substance paracetamol or to any of the other excipients/ingredients of Paramolan listed in Description (an allergic reaction can include a rash, itching or shortness of breath); if the patient suffers from severe liver disease/disorder.
Patients/guardians/caregivers must be advised to speak to the doctor or pharmacist if any of these apply to the patient.

Paramolan should be administered with caution in the following situations: patients with impaired liver function or renal disease, acute hepatitis; patients taking enzymatic inducers and/or drugs that affect liver function; patients with a history of alcoholism (liver problems, including those due to drinking too much alcohol).
Patients/guardians/caregivers must be advised not to take/give Paramolan with any other drug containing Paracetamol unless advised by a doctor or pharmacist.
Patients may be more at risk of the side effects of paracetamol. Patients/guardians/caregivers must be advised to speak to the doctor or pharmacist if any of these apply to the patient.
Patients/guardians/caregivers must be advised that this medicine should not be used for self-medication of high fever, fever lasting for a few days, or recurring fever, unless prescribed by a doctor.
Driving and using machines: This medicine should not affect the ability to drive or use machines.
Use in Children: Tablet: The administration of tablets for children under 12 years shall take consideration to the risk of suffocation.
Suppository: Patients with anemia, heart or lung disease (in these cases should be avoided long-term treatment).

Tablet: The patient must always be advised by the doctor or pharmacist before taking any medicine if she is pregnant or breast-feeding.
Paracetamol is generally considered to be the analgesic of choice in pregnant patients.
The amount of paracetamol distributed into breast milk is too small to be harmful to a breast-fed infant.
Oral solution: If the patient is pregnant, planning to become pregnant or is breast-feeding, she must be advised to talk to the doctor or pharmacist before taking this medicine.

Like all medicines, Paramolan can cause side effects, although not everybody gets them.
If any of the side effects get serious, or if any side effects not listed in this monograph are noticed, patients/guardians/caregivers must be advised to inform the doctor or pharmacist.
Tablet: Neutropenia; thrombocytopenia; pancytopenia; leukopenia; agranulocytosis; skin rash; urticaria; dyspnoea; angioedema; nausea; vomiting; abdominal pain; hepatic insufficiency; asthma; hypotension.
Oral solution: The following side effects may sometimes happen.
If the patient has an allergic reaction to this medicine, they must be advised to see a doctor straight away.
An allergic reaction may include: skin rash, flaking skin, boils, sore lips and mouth, swelling of the face, fever; sudden wheezing, fluttering or tightness of the chest or collapse.
If the patient gets any of the following side effects, they must be advised to stop taking this medicine and to see the doctor as soon as possible: bruising more easily, sore throat or other signs of infection (these may be signs of a blood disorder); severe pain in the abdomen and back, with fever (high temperature), loss of appetite, nausea and vomiting (these may be signs of pancreas inflammation); very rare cases of serious skin reactions have been reported.
Patients must be advised to inform the doctor if they get any of these side effects: Skin rash.
If paracetamol is taken for a long time, it may lead to liver and kidney problems but if the right amount is taken over a short period of time there should be no problems.
Suppository: These side effects of paracetamol should be noted: Allergic reactions; Skin problem (rash or itching); Liver problem.

Patients/guardians/caregivers must be advised to inform the doctor or pharmacist if the patient is taking or has recently taken any other medicines, including medicines obtained without a prescription.
Tablet: Patients must be advised to talk to the doctor before taking Paramolan tablet if they are taking any of the following medicines: anticoagulants, such as warfarin; anti-epileptic drugs; antibiotics, such as rifampicin and chloramphenicol; medicines to treat HIV infections, such as AZT (zidovudine); if the patient is taking cholestyramine (a drug that reduces blood cholesterol), the patient should make a 1-hour interval between taking this medicine and Paramolan tablet.
Oral solution: The patient must not take any other medicines that contain paracetamol while taking this medicine.
Patients must be advised to inform the doctor if the patient is taking any of these medicines: barbiturates (sleeping tablets); tricyclic antidepressants (such as amitriptyline); colestyramine (used to treat high cholesterol); warfarin (used to thin the blood and prevent clotting); zidovudine (used in HIV infections and AIDS); domperidone and metoclopramide (used to treat nausea and vomiting); anticonvulsants (medicines used to treat epilepsy or fits); oral contraceptives "the pill".
Suppository: Paramolan suppositories should not be used at the same time with other medicines that contain paracetamol.
In the case of taking the following medicines, guardians/caregivers must be advised to consult the doctor before giving Paramolan suppositories to children: Anticoagulants such as warfarin; Anti-epileptic drugs.
Alcohol or any medicines containing alcohol should not be given to the child while they are being given these suppositories.

Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Store below 25°C. Do not store above 25°C.
Oral solution: Protect from light.
Patients must be advised not to use the solution if they notice anything wrong with the medicine. They must be advised to talk to the pharmacist.
Suppository: Store in original container.

Analgesics (Non-Opioid) & Antipyretics

N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve pain and fever.

P₂