Indications of Paralyoc Paracetamol PARALYOC is an oral lyophilisate (a tablet which dissolves in the mouth). This drug contains paracetamol. For the relief of pain and/or fever such as headache, flu, toothache, stiffness, period pains. Suitable for adults and children over 27kg (or approximately from the age of 8 years old). Carefully read the label before using. For children weighing less than 27kg, there are other paracetamol drugs: consult your doctor or pharmacy for more information. How to take this drug This medication is taken orally. Leave the lyophilisate to dissolve in the mouth (do not crunch) or drink immediately after dissolving it in a small quantity of liquid (water, milk, fruit juice). If your child has a fever with a temperature higher than 38.5°C you can improve the efficiency of the treatment in the following ways: · Undress your child · Make them drink, · Do not leave your child in a place that is too hot. Dosage Suitable for adults and children over 27kg (or approximately from the age of 8 years old). The dose of paracetamol is dependent upon the weight of the child; the age is mentioned for information purposes. If you do not know the child’s weight you must weigh them so that you give them the appropriate dose. Paracetamol has many dosages; this allows the treatment to be adapted to each child's weight. The recommended daily dose of paracetamol depends on the weight of the child: approximately 60mg/kg per day, to be taken 4-6 times, either 15mg/kg every 6 hours or 10mg/kg every 4 hours. For children weighing between 27-40kg (approximately 8-13 years old) the dosage is 1 lyophilisate every 6 hours. Do not take more than 4 lyophilisates in any 24 hours. For children weighing between 41-50kg (approximately 12-15 years old) the dosage is 1 lyophilisate every 4 hours. Do not take more than 6 lyophilisates in any 24 hours. For adults and children weighing more than 50kg (approximately from the age of 15 years old): The usual dosage is 1-2 lyophilisates each time, and depending on the level of pain they can be taken minimum every 4 hours. It is not recommended to take more than 3g of paracetamol a day, roughly 6 lyophilisates per day. However in the case of severe pain and from your doctors recommendation, the total dose can be increased up to 4g per day, roughly 8 tablets per day. However: · Doses of paracetamol higher than 3g need a doctors note. · NEVER TAKE MORE THAN 4 GRAMS OF PARACETAMOL PER DAY (taking into account all drugs that contain paracetamol). Do not take more often than every 4 hours. In the case of severe kidney disease (severe renal impairment), tablets must be taken at least 8 hours apart and the total dose must not exceed 6 500mg tablets per day (3g). The maximum daily dosage must not exceed 60mg/kg per day (not exceeding 3g per day) in the following cases: · Adults weighing less than 50kg, · Severe liver disease, · Chronic alcoholism, · Chronic malnutrition, · Dehydration. IF IN DOUBT CONSULT YOUR DOCTOR OR PHARMACIST. If you think that the effect of this medication is too strong or too weak, consult your doctor or pharmacist. Frequency of dose Regular doses avoid pain and fever fluctuations. For children, doses need to be spaced out, including during the night, preferably every 6 hours, and no less than 4 hours. For adults doses need to be spaced out at a minimum of 4 hours. In the case of severe kidney disease (severe renal impairment), tablets must be taken at least 8 hours apart. Composition Active Ingredient: Micro encapsulated paracetamol: 500 mg By oral lyophilisate. Other ingredients: Aspartame, polysorbate 60, Xanthan gum, dextran 70, orange flavouring, mono hydrous lactose. Format This drug is in the form of an oral lyophilisate. Box of 16. Precautions for use If the pain persists for more than 5 days or the fever for more than 3 days, or in the case of insufficient effectiveness or new symptoms occur, do not continue treatment without permission of your doctor. Before starting this treatment, check that you are not taking other drugs which contain paracetamol, Inform your doctor if you have liver or kidney disease, or alcohol abuse. Inform your doctor if you take other drugs containing paracetamol, In case of nutrition (malnutrition) or dehydration problems, PARALYOC must be taken with caution. · This drug contains lactose. This drug is not recommended for patients with a galactose intolerance, a Lapp lactose intolerance or glucose-galactose malabsorption (rare hereditary illnesses). IF IN DOUBT DO NOT HESITATE TO CONSULT YOUR DOCTOR OR PHARMACIST FOR ADVICE. Special warnings In case of an overdose or if you have taken too much of a dose, consult your doctor immediately. This drug contains paracetamol. Other drugs contain this. Do not mix with other drugs so as not to exceed the recommended daily dose see section on Dosage). Contraindications Do not take PARALYOC 500mg oral lyophilisate in the following cases: · known allergy to paracetamol, or one of its components, · severe liver disease, · if you suffer from phenylketonuria (a hereditary disease discovered at birth) due to the aspartame content. IF IN DOUBT IT IS ADVISABLE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE. Interactions with other drugs If your doctor takes a blood test to check the level of uric acid, inform the laboratory that you have taken this medication. Talk to your doctor or pharmacist if you take or have recently taken any other drug, including any non-prescription drugs. Pregnancy and breast feeding Paracetamol, if used responsibly, can be taken during pregnancy as well as during breast feeding. Consult your doctor or pharmacist before taking any drugs. Side effects Like all drugs PARALYOC 500mg oral lyophilisate can cause side effects (this will not affect everyone): · In rare cases an outbreak of skin redness or an allergic reaction can occur followed by a swelling of the face and neck or a sudden fall in blood pressure. You must immediately stop the treatment, alert your doctor and stop taking drugs which contain paracetamol. · As an exception biological changes will need a blood test: liver functioning problems, abnormally low levels of certain white blood cells or blood cells such as platelets that can result in nosebleeds or bleeding of the gums. In this case consult your doctor. If you notice side effects that are not mentioned here, or if certain side effects become more severe, please consult your doctor or pharmacist. Instructions in case of overdose In case of an overdose or accidental poisoning, inform your doctor immediately. Storage conditions No specific storage precautions.