What does this PIL contain?

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1 PIL Paracetamol Amsal 120 mg / 5 ml Oral solution paracetamol Please, carefully read this PIL before you start using the medicine, because it contains very important information for you. -This medicine must be consumed in accordance with this PIL, or in accordance with prescription of your doctor or your pharmacist -Keep this PIL. You may want to read it again -Ask your doctor if you need more information or advice, rergarding this product -In case of any undesirable effects, talk to your doctor or pharmacist. This includes any side effects that are not listed in this PIL. -You need to talk to your doctor if you dont feel better, or if you feel worse, after reccomended treatment. What does this PIL contain? 1. What is Paracetamol Amsal oral solution and what is it used for 2. What do you have to know before using Paracetamol Amsal oral solution 3. How to take Paracetamol Amsal oral solution 4. Possible undesirable effects 5. How to store Paracetamol Amsal oral solution 6. Additional information 1. What is Paracetamol Amsal oral solution and what is it used for Paracetamol Amsal oral solution is a medicine, available in form of oral solution, in doses of 120 mg of paracetamol per 5 ml of solution. Paracetamol Amsal oral solution contains paracetamol as active substance, characterized by analgetic and antipyretic properties. Other than efficient effect against pain and fever it also has following properties: does not affect stomach mucuos, enableing the people with digestive problems to use it. It is being used in recommended therapy doses and in short periods, does not affect the mechanism of coagulation and can be used simultanously with medicines that prevent blood coagulation (anticoagulants). On the other side, and unlike medicines with antiflammatory and antireumatic effects (salicilates), therapy doses of paracetamol do not have antiinflammatory and antireumatical effects. Paracetamol Amsal oral solution is indicated for treating of mild to moderate pain, sore throat (except tonsilitis), as well as for mild to moderate cefalgia (headache). Paracetamol Amsal oral solution is also indicated for treating of high body temperature, that do not last longer than three days, as well as for simptomatic treatment of cold and flu syndrome.

2 2. What do you have to know before using Paracetamol Amsal oral solution Do not take Paracetamol Amsal oral solution: - if you are allergic (hypersensitive) to paracetamol or any other ingredient od this medicine (see section 6.) - if you suffer from severe hepatic desease Warning and precautions: Talk to your doctor or pharmacist before taking Paracetamol Amsal oral solution. Paracetamol Amsal oral solution should be used with caution in the following situations: - Patients with severe liver or kidney disease or acute hepatitis; - Patients taking enzymatic inducers and / or drugs that affect liver function; - Patients with history of alcoholism or who usually consume 3 or more alcoholic beverages a day; - Patients with anemia, heart disease or lung (in these cases should be avoided prolonged treatment); - Patients with chronic malnutrition (the low state of glutathione), and dehydration. Paracetamol Amsal oral solution should not be used in combination with other medicines containing paracetamol or medicines that are not subject to the "prescription" dose regimen and are used to relieve pain, flu symptoms, elevated body temperature, etc.. In the treatment of pain without the supervision of a doctor or pharmacist, this medicine should not be used for more than 10 days in adults or more than 5 days in children unless it is prescribed by a physician as intense and prolonged pain may require medical assessment and treatment. This medicinal product should not be used for treating unaffected doctors and pharmacists at high temperatures (temperatures higher than 39 C), elevated body temperature that lasts longer than 3 days or repeated elevated body temperature without supervision of liver or pharmacist unless this is prescribed by doctors, because such situations may require medical assessment and treatment. Other medicines and Paracetamol Amsal oral solution Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. Talk to your doctor before taking Paracetamol Amsal Oral Solution if you are taking any of the following medicines: - Anticoagulants, such as warfarin; - Antiepileptic drugs (medicines for the treatment of epilepsy, diseases of the brain function, often associated with consciousness disorders); - Antibiotics, such as rifampicin and chloramphenicol; - Drugs used to treat inflammation and pain, such as salicylates or other nonsteroidal antiinflammatory drugs; - Medications for the treatment of HIV infection, such as AZT (zidovudine); - If you are taking holestyramine (a medicine that reduces cholesterol in your blood), you should take Paracetamol Amsal oral solution in a 1-hour interval. Taking Food, Beverage, and Alcohol with Paracetamol Amsal Oral Solution Drinking alcohol (more than 3 alcoholic drinks per day) increases the toxic effects of paracetamol on the liver.

3 Pregnancy and breastfeeding If you are pregnant or breast-feeding, think that you may be pregnant or plan to have a baby, contact your doctor or pharmacist for advice before taking this medicine. As with any other medication, if you are pregnant or breast-feeding you should ask your doctor for advice before taking paracetamol. There are epidemiological and clinical evidence of paracetamol safety during pregnancy. There was no risk of breast-feeding or breast-feeding children in human studies. Driving and using machines It has no influence on the ability to control motor vehicles and handling machines. Other warnings Paracetamol Amsal oral solution contains propylene glycol that may irritate the skin and may cause alcohol-like symptoms. Paracetamol Amsal oral solution contains parabens (methyl para-hydroxybenzoate and propyl parahydroxybenzoate). It can cause allergic reactions (possible reactions of delayed hypersensitivity). It can cause allergic reactions (possibly also reactions of delayed hypersensitivity), exceptionally bronchospasm. Paracetamol Amsal oral solution contains sorbitol. If your doctor tells you to have some sugary intolerance, talk to your doctor before you start taking this medicine. It may have a gentle laxative effect. Calorific value of 2.6 kcal / g of sorbitol. 3. How to take Paracetamol Amsal oral solution Always take Paracetamol Amsal oral solution as your docotr or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. For information purposes only and unless otherwise indicated by the physician, Paracetamol Amsal oral solution may be applied as follows: Packaging Paracetamol Amsal oral solution contains a precision cascade for precision dosing. The dosing jug is sized to measure 5 ml (120 mg paracetamol) or 2.5 ml (60 mg paracetamol) solution. Instructions for use: To open the bottle, press the cover and turn it in the opposite direction from the clock. Children: 3 months to 1 year: 2,5 ml to 5 ml (1/2 to 1 spoon ), up to 4 times a day. 1 year to 6 years : 5 ml to 10 ml ( 1 to 2 spoons ), up to 4 times a day. 6 years to 12 years : 10 ml to 20 ml (2 to 4 spoons ), up to 4 times a day. Adults: 20 ml ( 4 spoons ), up to 6 times a day. Warning: do not exceed recommended daily doses. Interval between doses should not be less than 4-6 hours. In the case of kidney or liver insufficiency, it may be necessary to reduce the dose or increase the interval between doses.

4 If you have taken more Paracetamol Amsal oral solution than you should Paracetamol is a medicine that, if given at high doses, can cause serious liver damage, therefore taking too much a dose of this medicine can cause serious situations and may even lead to death. However, in adults and adolescents, liver poisoning is rarely reported after taking doses below 10 g. Liver injury rates occur in adult patients taking paracetamol at a dose of 10 g or more. Deaths are rare (less than 3 to 4% in untreated cases) and little is mentioned overdose with less than 15 g. In children, acute overdose of less than 150 mg / kg is not associated with toxic effects on the liver. In the first 24 hours, the first symptoms occurring after overdose of potentially liver toxic to paracetamol may be: bluntness, nausea, vomiting, anorexia, and abdominal pain. Treatment: Adequate control of overdose with paracetamol requires urgent intervention. So, even in the absence of early symptoms, the patient needs to go to emergency, fot emergency treatment. According to the degree of intoxication, the patient will be given appropriate treatment and take appropriate measures. If you have forgotten to take Paracetamol Amsal oral solution Since the need to take a medicine results from pain-induced or elevated body temperature, you are unlikely to have forgotten to take the medicine. However, if this happens, do not take a double dose to make up for the dose you have forgotten to take. If it is almost time for the next dose, wait until then and take the usual dose at normal time with the onset of treatment as usual. If you have any concerns or concerns regarding the use of this medicine, contact your doctor or pharmacist. 4. Possible unwanted effects Like all medicines, Paracetamol Amsal oral solution can cause undesirable effects, although not all individuals should be exposed. The effects listed below are divided by the following frequency frequencies: very common ( 1 / 10); Common ( 1 / 100, <1/10); Unusual ( 1 / 1000, <1/100); Rare ( 1 / 10000, <1/1000); Very rare (<1/10000); Unknown (can not be estimated from available data). Blood and lymphatic system disorders: Very rare: blood disorders such as neutropenia (reduction of white blood cells - blood neutrophils), thrombocytopenia (decrease in blood platelet counts), and pancytopenia (reduction of all blood components - white blood cells, red blood cells and platelets ), Bleeding, hemolytic anemia (red blood cell anemia), leukopenia (reduction of white blood cells - blood leukocytes), methaemoglobinemia (increased blood methaemoglobin levels), which refers to prolonged administration of high doses of the medicine. Skin and subcutaneous tissue disorders: Rarely: hypersensitivity reactions (urticaria and itching: itching of the skin) and edema (swelling). Rash is usually type of erythema or urticaria, although in some cases elevated body temperature and mucosal damage may occur. These allergic reactions occur more frequently in patients with history of hypersensitivity to salicylates. Treatment should be discontinued if an allergic reaction occurs.

5 Gastrointestinal disorders: Often: nausea, vomiting. Occasionally: diarrhea, abdominal pain. Renal and urinary disorders: Unknown: Difficulty or pain in the urination (painful urination), urination less often than usual (urine volume is lower than usual), traces of urinary blood. Metabolic and nutritional disorders: Unknown: hypoglycemia (low blood sugar level). Liver and bile disorders: Unknown: jaundice (yellow color of skin and eyes), liver insufficiency. General disorders: Unknown: elevated body temperature. Reporting suspicion of unwanted drug effects In the event of any unwanted reactions after the administration of the drug, you should inform your doctor or pharmacist. This implies all possible undesirable reactions not listed in this guidance on the medicine as well as those that are. 5. How to store Paracetamol Amsal oral solution Store at temperatures up to 25 C. Keep this medicine out of sight and reach of children. Do not use this medicine after the expiry date stated on the pack. Do not dispose of any medicines through wastewater or household waste. Ask your pharmacist how to dispose of medicines that you no longer use. These measures will help protect the environment. 6. Package contents and other information on the medicine The active substance is paracetamol. 5 ml syrup contains 120 mg paracetamol. The other ingredients are: macrogol type 400, sorbitol 70% solution, propylene glycol (E1520), methylparaben, propylparaben, sodium saccharin (E954), apricot aroma, nougat aroma, concentrate of currant syrup and purified water. How Paracetamol Amsal oral solution looks like and contents of the pack Paracetamol Amsal oral solution is available in dark glass, class III, with safety stopper and 200 ml. Name and address of the holder of a marketing authorization Amsal Pharmaceuticals d.o.o. Sarajevo Igmanska Vogošća Bosnia and Herzegovina Name and address of the drug manufacturer (administrative headquarters) Amsal Pharmaceuticals d.o.o. Sarajevo

6 Igmanska Vogošća Bosnia and Herzegovina Medication regime The drug is sold without a prescription, in the pharmacy. The number and date of the decision on the license for putting the finished medicinal product on market: /16 dated