PIL. ParaCet Flu 500 mg+250 mg/sachet Powder for oral solution paracetamol + ascorbic acid

Transcription

1 PIL ParaCet Flu 500 mg+250 mg/sachet Powder for oral solution paracetamol + ascorbic acid Please, carefully read this PIL before you start using the medicine. This medicine is available without prescription, but in order to achieve the best effect, it is necessary to take precaution during the consummation of ParacetFlu. Do not throw away this PIL. You may want to read it again. If you need additional information, please contact your doctor or pharmacist. What does this PIL contain? 1. What is ParacetFlu i what is it used for 2. What do you have to know before using ParacetFlu 3. How to take ParacetFlu 4. Possible side effects 5. How to store ParaCet Flu 6. Additional information 1. What is ParaCet Flu and what is it used for ParacetCet Flu is analgetic (eliminates the pain) and antipyretic (lowers increased body temperature). It's available in form of powder for oral solution, packed in sachets. Each sachet contains app 3 g of powder, which contains 500 mg of paracetamol and 250 mg ascorbic acid (vitamin C), as active substances. Besides of active substances this medicine also contains following inactive substances: Anhydrous citric acid, sodium citrate, mannitol, anhydrous colloidal silica, sodium benzoate, sodium saccharin, quinoline yellow (E104), soluble lemon flavouring and neohesperidin. At therapeutic doses, paracetamol has analgesic and antipyretic properties. Paracetamol does not have anti-inflammatory activity. The analgesic activity of paracetamol is mostly peripheral, being evident in mild to moderate pain. Paracetamol has no effect on spasmodic pain of visceral origin (heart, lungs, gastrointestinal tract, pancreas, liver, gall bladder, kidneys and urinary bladder).

2 Paracetamol lowers body temperature in cases of hyperthermia, but has no significant effect in cases of normothermia. Several studies were released, regarding the role of ascorbic acid (vitamine C) in prevention and treatment of most common colds. Formulation of the product as the powder for oral solution and singly dose packaging ensures the correct dosage and provides better safety and hygienic conditions. Each package of ParaCet Flu contains 20 sachets. 2. What do you have to know before using ParaCet Flu When not to take ParaCet Flu? Do not take ParaCet Flu if you suffer from: -Hypersensitivity to paracetamol or to any of the other ingredients of PARAMOLAN C. -Severe hepatic disease and/or renal insufficiency. -Glucose 6-phosphate dehydrogenase deficiency. -Porphyria and hepatic porphyria. Be careful with ParaCet Flu At therapeutic doses, paracetamol is relatively atoxic. However, allergic skin reactions may occur. In patients with cardiac, respiratory, hepatic or renal insufficiency, or anaemia, this product should only be administered under medical supervision, and for short periods. Paracetamol should be administered with caution in patients with a history of alcoholism, because the risk of liver damaging is higher at these patients. In self-medication of pain, this medicine should not be used for longer than 7 days in adults, or longer than 5 days in children, unless prescribed by a doctor, since intense and prolonged pain may require medical assessment and treatment. This medicine should also not be used for self-medication of high fever (temperature higher than 39ºC), fever lasting longer than 3 days, or recurring fever, unless prescribed by a doctor, since these situations require medical assessment and treatment.

3 Do not exceed the recommended doses. PARAMOLAN C contains approximately 28 mg of sodium per sachet. This should be taken into account by patients following a low-salt diet. Interaction of ParacetFlu with other medicinal products and other forms of interaction Generally speaking, Paracet Flu can be administered with other medicines. However, consult your doctor before you take Paracet Flu, if you are taking any of following: - medicines containing paracetamol, salicylates or other non-steroidal anti-inflammatory drugs; - antiepileptic agents; - rifampicin or chloramphenicol (antibiotics); -medicines containing zidovudine (antivirus); -medicines containing warfarin (anticoagulant); - Cholestyramine decreases paracetamol absorption. Therefore, an interval of 1 hour between administration of these two medicines is required to achieve the maximum analgesic effect Food and drink consummation with ParaCetFlu In case you drink more than 3 alcoholic drinks per day the risk of appearance or aggravation of hepatic lesions increases. Paracet Flu should be administered with caution in patients with a history of alcoholism. These patients should be advised to avoid regular or excessive use of paracetamol, or, alternatively, to abstain from consuming alcohol during its use. Paracet Flu administration may interfere with determination of some laboratory tests (uric acid levels in blood and glycaemia) and it is necessary for you to inform your doctor if you use (or have been recently using) Paracet Flu. Pregnancy and lactation As with any other medication, if you are pregnant or lactating, ask your doctor for advice before taking paracetamol. Epidemiological and clinical evidence of paracetamol safety during

4 pregnancy is available. Paracetamol is excreted in human milk, but not in clinically significant amounts. Effects on ability to drive and use machines This medicine has no influence on the ability to drive and use machines. 3. Administration of ParaCet Flu Paracet Flu is intended for oral administration following dissolution of sachet contents in water. Paracetamol is intended for oral usage immediately after dissolution of sachet content in water. Unless it is indicated otherwise by doctor, ParaCet Flu can be administered as follows: Adults and children older than 12 years: Pour the contents of one or two sachets in a cup of cold or hot water, 4 times daily. Sugar may be added to the solution. The evening dose may be prepared as a sweetened hot drink. Maximum dose: Adults - 4 g of paracetamol, i.e., 8 sachets daily Children older than 12 years - 3 g of paracetamol, i.e., 6 sachets daily Warning: Do not exceed recommended daily doses In case of renal insufficiency, dose reduction or longer intervals between doses may be required. Overdosing with ParaCetFlu The symptoms of paracetamol overdose in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Hepatic lesions are likely to occur in adult patients taking paracetamol doses equal or higher than 10 g. Treatment: Despite the absence of early symptoms, patients should be taken to hospital emergency services, for immediate treatment. In case of acute intoxication, gastric emptying should be performed, by induction or aspiration. Forced diuresis may be required following correction of acidaemia through sodium bicarbonate infusion. Basic measures may include blood and dextrose infusion. Gastric emptying should be considered, through aspiration or gastric lavage; administration of vegetable charcoal should be considered as an early treatment.

5 In case you forgot to take ParaCetFlu Considering the fact, that the administration of this medicine arises from state of pain or fever, it is less likely that you forgot to take the medicine. However, if that happens, take the medicine as soon as you remember to, but do not take a double dose to compensate the forgotten dose. If it's around time for following dose, wait for it and take the regular dose, at the regular time. In case of any doubts or questions, regarding administration of ParacetFlu, please contact your doctor or pharmacist. 4. Possible undesirable effects As well as any other medicine, ParaCet Flu also can lead to some undesirable effects. Common recommended doses of paracetmol are usually well tolerated. However, skin rash and other hypersensitivity reactions (urticaria, pruritus and oedema) may occur occasionally. These allergic reactions occur more frequently in patients with a history of hypersensitivity to salicylates. Treatment should be discontinued if allergic reactions occur. Blood disorders may occur very rarely, in case of administration of larger amounts. Other undesirable effects reported include the following: Nausea, vomiting, diarrhoea and abdominal pain. Dysuria, oliguria, haemoglobinuria. Fever, hypoglycaemia, jaundice, hepatic insufficiency. Cases of Lyell's syndrome and Stevens-Johnson syndrome have also been reported, a severe allergic reaction infecting skin and mucous membranes, and manifests as decay of upper skin layers. The presence of mannitol in the formulation may be responsible for a mild laxative effect. In case of any mentioned or some unmentioned side effects, please inform your doctor or your pharmacist. Reporting suspicion of undesirable effects In case of any undesirable effects after taking the medicine, it is necessary to inform your doctor or pharmacist. This includes all possible undesirable side effects that are not stated in this PIL, as well as those that are stated above. 5. ParaCet Flu storage precautions ParaCet Flu must be kept out of reach of children. Do not store above 25º C. Protect from humidity and light. Before taking ParaCet Flu, check the expiry date, printed on the package. ParaCet Flu cannot be used after expiry date. 6. Additional information 1 sachet of ParaCetFlu contains: Active substances: Paracetamol 500 mg

6 Ascorbic acid 250 mg List of excipients: Anhydrous citric acid, sodium citrate, mannitol, anhydrous colloidal silica, sodium benzoate, sodium saccharin, quinoline yellow (E104), soluble lemon flavouring and neohesperidin. ParaCet Flu appearance and content Paper sachets coated with aluminum, containing acc 3 g of powder for oral solution. Each box contains 20 sachets. Authorisation holder Amsal Pharmaceuticals d.o.o. Sarajevo Igmanska Vogošća BiH Manufacturer (administrative headquarter) Amsal Pharmaceuticals d.o.o. Sarajevo Igmanska Vogošća BiH Issuing regime: No prescription needed. Number and date of marketing authorisation: /16 od