Active ingredients: Paracetamol
OROSOLUBLE TACHIPIRIN 250 mg granules
The package inserts of buccal tachipirina are available for pack sizes:- OROSOLUBLE TACHIPIRIN 250 mg granules
- OROSOLUBLE TACHIPIRINA 500 mg granules strawberry-vanilla flavor
- TACHIPIRINA OROSOLUBILE 500 mg granules cappuccino flavor
- TACHIPIRINA OROSOLUBILE 1000 mg granules
Why is buccal Tachipirina used? What is it for?
Paracetamol belongs to the pharmacotherapeutic class of analgesics (pain relievers) which also act simultaneously as antipyretics (fever-lowering drugs) with weak anti-inflammatory effects.
OROSOLUBLE TACHIPIRIN is used to lower fever and relieve mild to moderate pain.
Contraindications When buccal tachipirina should not be used
Do not take TACHIPIRIN OROSOLUBILE
- if you are allergic to paracetamol or any of the other ingredients of this medicine (listed in section 6)
- if you suffer from severe liver dysfunction.
Precautions for use What you need to know before taking buccal tachipirina
Talk to your doctor or pharmacist before taking TACHIPIRIN OROSOLUBILE
Take special care with TACHIPIRIN OROSOLUBILE if you suffer from severe renal or hepatic insufficiency.
The risks of overdose are greater in patients with non-cirrhotic alcoholic liver disease.
Never exceed the recommended dose:
- if you have chronic alcoholism
- if you have glucose-6-phosphate dehydrogenase deficiency
- if you suffer from haemolytic anemia
- if you have Gilbert's syndrome (familial non-haemolytic jaundice)
Prolonged or frequent use is not recommended. Patients should be advised not to take other products containing paracetamol at the same time. Taking multiple daily doses in a single administration can severely damage the liver. In this case, the patient does not lose consciousness, but the doctor should be consulted immediately. Prolonged use without medical supervision can be harmful. In children treated with 60 mg / kg per day of paracetamol, the combination with another antipyretic is not justified except in the case of ineffectiveness.
Interactions Which drugs or foods can modify the effect of buccal tachipirina
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Medicines that may alter the effects of TACHIPIRIN OROSOLUBILE:
- probenecid (a medicine used to treat gout)
- medicines that can damage the liver, for example phenobarbital (a sleeping pill), phenytoin, carbamazepine, primidone (medicines used to treat epilepsy) and rifampicin (a medicine used to treat tuberculosis). "Simultaneous use of these medicines together with paracetamol can cause liver damage
- metoclopramide and domperidone (medicines used to treat nausea). These medicines may increase the absorption and onset of action of paracetamol
- medicines that slow stomach emptying. These medicines can delay the absorption and the onset of action of paracetamol
- cholestyramine (a medicine used to reduce raised serum lipid levels). This medicine may reduce the absorption and onset of action of paracetamol. For this reason, cholestyramine should not be taken until one hour has elapsed after paracetamol administration.
- medicines used to thin the blood (oral anticoagulants, especially warfarin). Repeated intake of paracetamol for periods longer than a week increases the tendency to bleed when taking these drugs. Therefore, long-term administration of paracetamol in such cases should only take place under the supervision of the physician. Occasionally taking paracetamol in such cases. it has no significant effect on bleeding tendency.
The concomitant use of paracetamol and AZT (zidovudine, a medicine used to treat HIV infections) increases the tendency for white blood cells to decrease (neutropenia), which can compromise the immune system and increase the risk of infections. Therefore, Tachypirin OROSOLUBILE can be used simultaneously with zidovudine only on the advice of a doctor.
Effect of paracetamol intake on laboratory tests
Testing of blood sugar and blood glucose can be altered.
Warnings It is important to know that:
Care should be taken when administering paracetamol to patients with renal insufficiency (creatinine clearance ≤ 30 ml / min (see section 3 "HOW TO TAKE TACHIPIRIN OROSOLUBILE")) or hepatocellular insufficiency (mild to moderate).
The risks of overdose are greater in patients with non-cirrhotic alcoholic liver disease. Care should be taken in case of chronic alcoholism. In this case, the daily dose should not exceed 2 grams.
In case of high fever or signs of secondary infection or persistence of symptoms beyond 3 days, a re-evaluation of treatment should be carried out.
Paracetamol should be used with caution in cases of chronic dehydration and malnutrition. The total dose of paracetamol should not exceed 3 g per day for adults and children weighing 50 kg or more.
If your symptoms worsen or do not improve after 3 days or if you develop a high fever, you should contact your doctor.
Do not use paracetamol, unless prescribed by your doctor, if you are addicted to alcohol or liver damage. Do not use paracetamol with alcohol. Paracetamol does not enhance the effect of alcohol.
If you are taking other painkillers containing paracetamol at the same time, do not use TACHIPIRIN OROSOLUBILE without first checking with your doctor or pharmacist.
Never take more TACHIPIRIN OROSOLUBILE than advised. A higher dose does not increase the analgesic action, but can instead cause severe liver damage. Symptoms of liver damage occur after a few days. For this reason, it is very important that you contact your doctor as soon as possible if you have taken more TACHIPIRIN OROSOLUBILE. than recommended in this leaflet.
In case of prolonged misuse of painkillers in high doses, headache episodes may occur which should not be treated with higher doses of the medicine.
In general, the habitual intake of painkillers, particularly the combination of different analgesic drugs, can lead to permanent renal lesions with the risk of renal failure (analgesic nephropathy).
Suddenly stopping analgesics after a prolonged period of misuse at high doses can cause headache, fatigue, muscle pain, nervousness and autonomic symptoms. These withdrawal symptoms resolve within a few days. Until then, avoid taking any other painkillers and do not start taking them again without consulting your doctor.
You should not take BOLOSOLUBLE TACHIPIRIN for prolonged periods or in high doses without consulting your doctor or dentist.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
During pregnancy, paracetamol should not be taken for long periods, in high doses or in combination with other medicines.
Therapeutic doses of paracetamol can be used during pregnancy or breastfeeding.
Driving and using machines
The use of TACHIPIRIN BOROSOLUBILE does not influence the ability to drive or use machines.
OROSOLUBLE TACHIPIRIN contains sorbitol and sucrose
This medicine contains sorbitol and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Dosage and method of use How to use orosoluble Tachipirina: Dosage
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The dose is based on the data shown in the table below. The dose of TACHIPIRIN OROSOLUBILE depends on age and body weight. The usual dose is 10 - 15 mg paracetamol per kg body weight as a single dose, up to a total daily dose of 60 - 75 mg / kg body weight.
The time interval between individual doses depends on the symptoms and the maximum daily dose. A time interval between administrations of at least 6 hours should be maintained, ie a maximum of 4 administrations per day can be had.
If symptoms persist for more than 3 days, a doctor should be consulted.
250 mg sachets
Method / route of administration
TACHIPIRIN OROSOLUBILE 250 mg granules are for oral use only.
Do not take TACHIPIRIN BOROSOLUBILE on a full stomach.
The granulate is taken by placing it directly on the tongue and must be swallowed without water.
Special patient groups
Hepatic or renal insufficiency
In patients with hepatic or renal insufficiency, the dose should be reduced or the dosing interval extended. Ask your doctor or pharmacist for advice.
Chronic alcoholism
Chronic alcohol consumption can lower the paracetamol toxicity threshold. In these patients, the dosing interval between two doses should be at least 8 hours. 2 g of paracetamol per day should not be exceeded.
Elderly patients
No dose adjustment is required in the elderly.
If you forget to take TACHIPIRIN OROSOLUBILE
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much buccal tachipirina
In case of overdose with TACHIPIRIN OROSOLUBILE, please inform your doctor or go to the emergency room. Overdose has very serious consequences and can even lead to death.
Immediate treatment is essential, even if you feel well, due to the risk of delayed severe liver damage. Symptoms may be limited to nausea or vomiting and may not reflect the severity of the overdose or the risk of organ damage.
Side Effects What are the side effects of buccal tachipirina
Like all medicines, this medicine can cause side effects, although not everybody gets them.
"Rare" frequency means an effect that affects 1 to 10 users in 10,000.
"Very rare" frequency means an effect that affects less than 1 user in 10,000.
The following rare side effects may occur:
- non-haemolytic anemia and bone marrow depression
- anemia
- thrombocytopenia
- edema
- diseases of the exocrine pancreas: acute and chronic pancreatitis
- gastrointestinal bleeding, abdominal pain, diarrhea, nausea, vomiting
- liver failure, liver necrosis, jaundice
- allergic conditions, anaphylactic reactions, drug or food allergies
- hives, itching, rash, sweating, purpura, angioedema
- nephropathies and tubular disorders
Very rare cases of severe skin reactions have been reported.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the sachet and carton after EXP. The expiry date refers to the last day of the month.
Do not store above 30 ° C.
Store in the original package to protect from light and moisture.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Deadline "> Other information
What TACHIPIRINA OROSOLUBILE 250 mg granules contains
The active ingredient is: paracetamol
1 sachet contains 250 mg of paracetamol
The other ingredients are: Sorbitol, Talc, Butyl methacrylate basic copolymer, Magnesium oxide light, Carmellose sodium, Sucralose, Magnesium stearate (Ph.Eur), Hypromellose, Stearic acid, Sodium laurilsulfate, Titanium dioxide (E 171), Simethicone, Aroma of strawberry (contains maltodextrin, gum arabic (E414), natural flavoring substances and / or identical to natural ones, propylene glycol (E1520), Triacetin (E1518), Maltol (E636)), Vanilla flavor (contains Maltodextrin, natural flavoring substances and / or identical to natural ones, propylene glycol (E1520), sucrose)
Description of the appearance of OROSOLUBLE TACHIPIRIN and contents of the pack
Aluminum sachet with white or almost white granulate. OROSOLUBLE TACHIPIRIN is available in packs of 10 or 20 sachets.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
TACHIPIRINA OROSOLUBILE 250 MG GRANULATE
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
One sachet contains 250 mg of paracetamol.
Excipients with known effects:
One sachet contains 600 mg sorbitol (E420) and 0.1 mg sucrose.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM -
Granulated
White or almost white granules.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
OROSOLUBLE TACHIPIRIN is indicated for the symptomatic treatment of mild to moderate pain and fever.
04.2 Posology and method of administration -
Doses depend on body weight and age. A single dose ranges from 10 to 15 mg / kg of body weight up to a maximum of 60 - 75 mg / kg for the total daily dose.
The time interval between individual doses depends on the symptoms and the maximum daily dose. In any case, it should not be less than 4 hours.
OROSOLUBLE TACHIPIRIN should not be used for more than three days without consulting your doctor.
250 mg sachets
Method of administration
For oral use only. The granulate is taken by placing it directly on the tongue and must be swallowed without water. TACHIPIRIN OROSOLUBILE should not be taken on a full stomach.
Special populations
Hepatic or renal insufficiency
In patients with hepatic or renal insufficiency or Gilbert's syndrome, the dose should be reduced or the time interval between administrations extended.
Patients with renal insufficiency
In patients with severe renal insufficiency (creatinine clearance
Chronic alcoholism
Chronic alcohol consumption can lower the paracetamol toxicity threshold. In these patients, the time interval between two doses should be at least 8 hours. The dose of 2 g of paracetamol per day should not be exceeded.
Elderly patients
No dose adjustment is required in the elderly.
For all indications:
Adults, the elderly and children over 12 years of age: the usual dose is 500 - 1000 mg every 4 - 6 hours up to a maximum of 3 g per day.
The dose should not be repeated for four hours.
Kidney failure
The dose should be reduced in case of renal insufficiency.
The effective daily dose should be considered, without exceeding 60 mg / kg / day (without exceeding 3 g / day), in the following situations:
Adults weighing less than 50 kg
Hepatocellular insufficiency (mild to moderate)
Chronic alcoholism
Dehydration
Chronic malnutrition
Hepatic or renal insufficiency
In patients with hepatic or renal insufficiency or Gilbert's syndrome, the dose should be reduced or the dosing interval extended.
The sachet formulation is not recommended for children under 4 years of age. Older children (4 - 12 years) can be given 250 - 500 mg every 4 - 6 hours up to a maximum of 4 doses over a 24 hour period.
04.3 Contraindications -
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Patients with severe hepatic dysfunction (Child-Pugh> 9).
• severe renal or hepatic insufficiency (Child-Pugh> 9)
• acute hepatitis
• concomitant treatment with medicinal products that affect liver function
• glucose-6-phosphate dehydrogenase deficiency
• haemolytic anemia
• alcohol abuse
• severe haemolytic anemia
04.4 Special warnings and appropriate precautions for use -
To avoid the risk of overdose, it is necessary to check that any other drugs taken concomitantly do not contain paracetamol.
Paracetamol should be administered with particular caution in the following cases:
• hepatocellular insufficiency (Child-Pugh
• chronic alcohol abuse
• severe renal insufficiency (creatinine clearance
• Gilbert's syndrome (familial non-haemolytic jaundice).
If you have a high fever or signs of secondary infection, or if symptoms persist for more than 3 days, you should see your doctor.
In general, medicines containing paracetamol can only be taken for a few days and in low doses without consulting your doctor or dentist.
In case of prolonged misuse of analgesics in high doses, headache episodes may occur which should not be treated with higher doses of the drug.
In general, the habitual intake of analgesics, especially a combination of several analgesic substances, can lead to permanent kidney damage with the risk of renal failure (analgesic nephropathy).
Prolonged or frequent use is not recommended. Patients should be warned not to take other products containing paracetamol at the same time. Taking multiple daily doses in a single administration can severely damage the liver. In this case, the patient does not lose consciousness, but a doctor should be consulted immediately. Prolonged use without medical supervision can be harmful. In children treated with 60 mg / kg per day of paracetamol, the combination with another antipyretic is not justified except in the case of ineffectiveness.
Suddenly stopping analgesics after a prolonged period of misuse, at high doses, can cause headache, fatigue, muscle pain, nervousness and autonomic symptoms. These withdrawal symptoms resolve within a few days. Until then, further analgesics should be avoided and should not be resumed without consulting your doctor.
Care should be taken when taking paracetamol in combination with inducers of cytochrome CYP3A4 or when using substances that induce liver enzymes such as rifampicin, cimetidine and antiepileptics such as glutethimide, phenobarbital and carbamazepine.
Care should be taken when administering paracetamol to patients with renal insufficiency (creatinine clearance? 30 ml / min, see section 4.2) or hepatocellular insufficiency (mild to moderate).
Alcohol consumption should be avoided during treatment with paracetamol.
The risks of overdose are greater in patients with non-cirrhotic alcoholic liver disease. Care should be taken in case of chronic alcoholism. In patients with alcohol abuse the dose should be reduced (see section 4.2). In this case, the daily dose should not exceed 2 grams.
This medicine contains sorbitol and sucrose. Patients with rare hereditary problems such as fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should avoid taking this medicine.
In the presence of high fever or signs of secondary infection or persistence of symptoms beyond 3 days, a re-evaluation of treatment should be carried out.
Doses higher than recommended involve the risk of very serious liver injury. Treatment with the antidote should be given as soon as possible (see section 4.9).
Paracetamol should be used with caution in cases of chronic dehydration and malnutrition.
04.5 Interactions with other medicinal products and other forms of interaction -
Intake of probenecid inhibits the binding of paracetamol to glucuronic acid, resulting in an approximately two-fold reduction in paracetamol clearance. In patients taking probenecid concomitantly, the dose of paracetamol should be reduced.
The metabolism of paracetamol is increased in patients taking medicinal products that induce enzymes, such as rifampicin and some antiepileptics (carbamazepine, phenytoin, phenobarbital, primidone). Some isolated reports describe unexpected hepatotoxicity in patients taking enzyme-inducing medicinal products.
Concomitant administration of paracetamol and AZT (zidovudine) increases the tendency to neutropenia. Therefore, co-administration of this drug with AZT should only be done on the advice of a physician.
The concomitant intake of drugs that accelerate gastric emptying, such as metoclopramide, accelerates the absorption and onset of action of paracetamol.
The concomitant intake of drugs that slow gastric emptying can delay the absorption and the onset of action of paracetamol.
Cholestyramine reduces the absorption of paracetamol and, therefore, cannot be administered until one hour has elapsed after paracetamol administration.
Repeated intake of paracetamol for periods longer than a week increases the effect of anticoagulants, particularly warfarin. Therefore, long-term administration of paracetamol in patients treated with anticoagulants should only take place under the supervision of the physician. Occasional paracetamol intake has no significant effect on bleeding tendency.
Effects on laboratory tests
Paracetamol can interfere with the determinations of uricaemia using phosphotungstic acid and with those of blood glucose using the glucose-oxidase-peroxidase reaction. Probenecid causes an almost two-fold reduction in the clearance of paracetamol by inhibiting its conjugation with glucuronic acid. A reduction in paracetamol should be considered in case of concomitant treatment with probenecid.
Paracetamol increases plasma levels of acetylsalicylic acid and chloramphenicol.
04.6 Pregnancy and breastfeeding -
Pregnancy
Epidemiological data from the use of oral therapeutic doses of paracetamol do not indicate any undesirable effects on pregnancy or on the health of the fetus or newborn. Prospective data on pregnancies exposed to overdoses did not show an increased risk of malformation. Reproductive studies with oral administration they did not show any malformation or foetotoxic effect.
Consequently, under normal conditions of use, paracetamol can be used for the entire duration of pregnancy, after having performed a benefit and risk assessment.
During pregnancy, paracetamol should not be taken for long periods, in high doses or in combination with other drugs since the safety of use in these cases is not established.
Feeding time
After oral intake, paracetamol is excreted in breast milk in small quantities. No undesirable effects have been reported in breastfed infants. Therapeutic doses of this medicine can be used during breastfeeding.
04.7 Effects on ability to drive and use machines -
TACHIPIRIN OROSOLUBILE does not affect the ability to drive or use machines. No studies on the ability to drive and use machines have been performed.
04.8 Undesirable effects -
The MedDRA system / organ classification is used with the following frequencies: very common (≥ 1/10), common (≥ 1/100,
Very rare cases of severe skin reactions have been reported.
Nephrotoxic effects are infrequent and have not been reported in association with therapeutic doses, except after prolonged administration.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address www.agenziafarmaco.gov.it/it/responsabili
04.9 Overdose -
There is a risk of poisoning, especially in the elderly, young children, patients with liver disease, chronic alcoholism and patients with chronic malnutrition. Overdose can be fatal in these cases.
Symptoms usually appear within the first 24 hours and include: nausea, vomiting, anorexia, paleness, and abdominal pain.
Overdose, i.e. administration of 10 g of paracetamol or more in a single dose in adults or administration of 150 mg / kg body weight in a single dose in children, causes liver cell necrosis which can lead to complete necrosis and irreversible, resulting in hepatocellular insufficiency, metabolic acidosis and encephalopathy which can lead to coma and death. At the same time, increased levels of hepatic transaminases (AST, ALT), lactate dehydrogenase and bilirubin are observed, together with the increase in prothrombin levels which may appear 12 - 48 hours after administration.
Emergency procedure:
Immediate hospitalization
Collection of blood samples to determine the initial plasma concentration of paracetamol
Gastric lavage
IV (or oral if possible) administration of the N-acetylcysteine antidote as soon as possible and before 10 hours have elapsed since the overdose
Implement symptomatic treatment.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: other analgesics and antipyretics, anilides, ATC code: N02BE01
The mechanism of analgesic action has not been fully determined. Paracetamol may act mainly by inhibiting the synthesis of prostaglandins in the central nervous system (CNS) and, to a lesser extent, by peripheral action by blocking the generation of painful impulses. The peripheral action could also be due to the inhibition of prostaglandin synthesis or to the inhibition of the synthesis and actions of other substances that sensitize the pain receptors to mechanical or chemical stimulation.
Probably, paracetamol produces the antipyretic action by acting centrally on the hypothalamic thermoregulation center to produce peripheral vasodilation, which causes an increase in blood flow through the skin, sweating and heat loss. The central action probably implies the "inhibition of prostaglandin synthesis in the hypothalamus."
05.2 "Pharmacokinetic properties -
Absorption
Absorption of oral paracetamol is rapid and complete. Maximum plasma concentrations are reached 30 - 60 minutes after ingestion.
Distribution
Paracetamol is rapidly distributed in all tissues. Concentrations in blood, saliva and plasma are comparable. Protein binding is poor. Time for maximum concentration, 0.5 - 2 hours; maximum plasma concentrations, 5 - 20 mcg (mcg) / ml (with doses up to 50 mg); time to maximum effect, 1 - 3 hours; duration of action, 3 - 4 hours.
Biotransformation
Paracetamol is metabolized mainly in the liver following two important metabolic pathways: conjugation with glucuronic acid and conjugation with sulfuric acid. The second route is rapidly saturable at doses higher than therapeutic doses. A minor pathway, catalyzed by cytochrome P450, leads to the formation of an intermediate reagent (N-acetyl-p-benzoquinonimin) which, under normal conditions of use, is rapidly detoxified from glutathione and eliminated in the urine, after conjugation with the cysteine and mercapturic acid. Conversely, in case of severe intoxication, the amount of this toxic metabolite increases.
Elimination
Elimination is essentially urinary. 90% of the ingested dose is eliminated by the kidneys within 24 hours, mainly in glucuroconjugated (60 to 80%) and sulfur conjugated (20 to 30%) forms. Less than 5% is eliminated unchanged. The elimination half-life is approximately 2 hours.
Pathophysiological changes
Renal insufficiency: in case of severe renal insufficiency (creatinine clearance less than 10 ml / min.), The elimination of paracetamol and related metabolites is delayed.
Elderly subjects: the ability to conjugate remains unchanged.
05.3 Preclinical safety data -
In animal experiments related to acute, subchronic and chronic toxicity of paracetamol in rats and mice, gastrointestinal lesions, changes in blood counts, degeneration of the liver and renal parenchyma and necrosis were observed. The causes of these alterations have been attributed on the one hand to the mechanism of action and on the other to the metabolism of paracetamol.
Extensive studies have not revealed a significant genotoxic risk of paracetamol at therapeutic, ie non-toxic, doses.
Long-term studies in rats and mice have shown no evidence of significant oncogenic effects at non-hepatotoxic doses of paracetamol.
Paracetamol crosses the placenta.
Animal studies have not produced evidence of reproductive toxicity.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Sorbitol
Talc
Basic butyl methacrylate copolymer
Light magnesium oxide
Carmellose sodium
Sucralose
Magnesium stearate (Ph.Eur.)
Hypromellose
Stearic acid
Sodium lauryl sulfate
Titanium dioxide (E 171)
Simethicone
Strawberry flavor (contains maltodextrin, gum arabic (E414), natural flavoring substances and / or identical to natural ones, propylene glycol (E1520), triacetin (E1518), maltol (E636))
Vanilla flavor (contains maltodextrin, natural and / or natural flavoring substances, propylene glycol (E1520), sucrose)
06.2 Incompatibility "-
Not relevant.
06.3 Period of validity "-
3 years
06.4 Special precautions for storage -
Do not store above 30 ° C. Store in the original package to protect from light and moisture.
06.5 Nature of the immediate packaging and contents of the package -
Aluminum sachets. Packs of 10 or 20 sachets.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling -
Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Joint Chemical Companies Angelini Francesco - ACRAF SpA - Viale Amelia 70, 00181 Rome (Italy)
08.0 MARKETING AUTHORIZATION NUMBER -
OROSOLUBLE TACHIPIRIN 250 mg granules, 10 sachets AIC n. 040313013
OROSOLUBLE TACHIPIRIN 250 mg granules, 20 sachets AIC n. 040313025
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
Date of first authorization: 28/04/2011
Date of renewal of the Authorization: 21/09/2015
10.0 DATE OF REVISION OF THE TEXT -
AIFA determination of 16/12/2015
