Active ingredients: Carbocysteine
LISOMUCIL adults 750 mg / 15 ml syrup with sugar
LISOMUCIL adults 750 mg / 15 ml sugar-free syrup
Lisomucil package inserts are available for pack sizes: - LISOMUCIL adults 750 mg / 15 ml syrup with sugar, LISOMUCIL adults 750 mg / 15 ml syrup without sugar
- LISOMUCIL children 100 mg / 5 ml syrup with sugar, LISOMUCIL children 100 mg / 5 ml syrup without sugar
- LISOMUCIL adults 1.5 g granules for oral suspension
- LISOMUCIL 1.5 g effervescent tablets
Why is Lisomucil used? What is it for?
What is it
Carbocysteine is a mucolytic that helps thin the bronchial mucus.
Why is it used
The product is used for the symptomatic therapy of respiratory diseases accompanied by cough and phlegm.
Contraindications When Lisomucil should not be used
Lisomucil adult syrup should not be used in case of:
- hypersensitivity (allergy) to the active substance or to any of the excipients,
- gastroduodenal ulcer,
- pregnancy and breastfeeding (see "What to do during pregnancy and" breastfeeding ").
What to do during pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine
Lisomucil adult syrup should not be used during pregnancy and lactation. Its use should also be avoided if pregnancy is suspected.
Precautions for use What you need to know before taking Lisomucil
Cough is a defense mechanism of the organism in the course of diseases of the respiratory system. If fever and / or difficulty in breathing are present, it is necessary to consult a doctor to diagnose the disease in progress and prescribe an adequate treatment. Lisomucil adults syrup with sugar
If you have diabetes or are following a low-calorie diet, keep in mind that Lisomucil adults syrup with sugar contains sucrose in an amount equal to 6 g per 15 ml (1 measuring cup or 1 tablespoon). Patients with hereditary fructose intolerance, glucose-galactose malabsorption syndrome, sucrase-isomerase enzyme deficiency should consult their doctor before taking the medicine.
Interactions Which drugs or foods can modify the effect of Lisomucil
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
At the present state of knowledge, there are no known incompatibilities between the administration of carbocysteine and the most common drugs used in the treatment of upper and lower respiratory tract diseases, or with food or laboratory tests.
Warnings It is important to know that:
The excipient Lisomucil aromatic elixir adult syrup with sugar contains ethyl alcohol in an amount equal to 200 mg for each dose of 15 ml (one measuring cup or one tablespoon). The medicinal product may be dangerous for patients suffering from alcoholism. Keep in consideration in case of pregnancy and lactation, liver disease or epilepsy
For those who carry out sporting activities, the use of medicines containing ethyl alcohol can determine positive anti-doping tests in relation to the alcohol concentration limits indicated by some sports federations.
LISOMUCIL adult syrup contains methyl parahydroxybenzoate which may cause allergic reactions (including delayed).
In the case of low sodium diets, it should be noted that the recommended dose of 15 ml of syrup contains about 100 mg of sodium.
Do not use for prolonged treatments. After a short period of treatment with no appreciable results, consult your doctor.
Lisomucil adult syrup does not affect the ability to drive or use machines.
Dosage and method of use How to use Lisomucil: Dosage
- How many
The use of Lisomucil adults 750 mg / 15 ml syrup is reserved for adults.
The recommended dose is one tablespoon or one measuring cup (15 ml of syrup equal to 750 mg of carbocysteine) three times a day, with an interval of about 8 hours between one "intake and the other".
Warning: do not exceed the indicated doses without medical advice.
- When and for how long
It can be taken regardless of meals.
If after a short period of treatment (5-10 days) the cough does not improve, it is advisable to consult a doctor.
Also consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics or if you experience fever and difficulty in breathing.
Warning: use only for short periods of treatment.
- Like
Use the product undiluted.
Overdose What to do if you have taken an overdose of Lisomucil
What to do if you have taken too much medicine
In case of accidental ingestion of an excessive dose of Lisomucil adult syrup, headache, nausea, diarrhea, gastralgia may appear. In case of accidental ingestion / intake of an excessive dose of medicine, notify your doctor immediately or go to the nearest hospital. In these cases it is useful to induce vomiting and possibly perform gastric lavage.
What to do if you have forgotten to take one or more doses
In case you have forgotten to take one or more doses of Lisomucil adult syrup, continue the treatment without taking any additional dose of medication.
If you have any questions about the use of Lisomucil Adult Syrup, ask your doctor or pharmacist
Side Effects What are the side effects of Lisomucil
Like all medicines, Lisomucil Adult Syrup can cause side effects, although not everybody gets them.
The following may occur: dizziness. In such cases it is recommended to reduce the dosage.
Undesirable effects are listed according to the following frequency classification:
Very common (≥1 / 10); common (≥1 / 100,
Immune system disorders:
frequency not known: anaphylactic reaction;
Gastrointestinal disorders:
very common: diarrhea, nausea and upper abdominal pain
Frequency not known: vomiting.
Skin and subcutaneous tissue disorders:
frequency not known: Steven-Johnson syndrome; Erythema multiforme; Toxic skin rash; drug rash; rash. In such cases, stop the treatment and consult your doctor to establish a suitable therapy.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. These side effects are usually transient.
However, when they occur, it is advisable to consult your doctor or pharmacist.
Request and fill in the undesirable effects report form available at the pharmacy (form B).
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. Undesirable effects can also be reported directly through the national reporting system at "https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse". By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Lisomucil adults syrup with sugar: Keep at a temperature not exceeding 25 ° C. 3
Lisomucil adult sugar-free syrup: No special storage precautions.
Expiry: see the expiry date indicated on the package.
Warning: do not use the medicine after the expiry date indicated on the package. The expiry date indicated refers to the product in intact packaging, correctly stored.
Do not use if package shows visible signs of deterioration.
Keep this medicine out of the reach and sight of children.
It is important to always have information on the medicine available; therefore keep both the box and the package leaflet.
Composition
Active principle:
1 ml of syrup contains: active ingredient: carbocysteine 50 mg
Excipients:
Lisomucil adults syrup with sugar:
sucrose, methyl parahydroxybenzoate, caramel powder, aromatic elixir (82% ethanol), cinnamon essence, sodium hydroxide and purified water.
Lisomucil adults sugar-free syrup:
glycerol, hydroxyethylcellulose, sodium saccharin, sodium methyl parahydroxybenzoate, caramel powder, flavoring, sodium hydroxide and purified water.
How it looks
Adult Lisomucil with Sugar and Adult Lisomucil Sugar Free come in syrup form.
The contents of the package are a 200 ml bottle with a measuring cup.
The bottle is equipped with a child resistant closure which requires a rational movement for opening. To open, press the cap and unscrew. To close, screw again.
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
LISOMUCIL ADULTS 750 MG / 15 MG SYRUP WITH SUGAR
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of syrup contains:
Active principle:
carbocysteine 50 mg
Excipients:
Syrup with sugar: sucrose, methyl parahydroxybenzoate, aromatic elixir (ethanol 82%), sodium hydroxide;
Sugar-free syrup: methyl parahydroxybenzoate, sodium hydroxide.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Syrup.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Symptomatic therapy of respiratory diseases accompanied by cough and phlegm.
04.2 Posology and method of administration
The use of LISOMUCIL adults 750 mg / 15 ml syrup is reserved for adults.
The recommended posology is as follows:
1 measuring cup or 1 tablespoon (15 ml of product equal to 750 mg of carbocysteine)
3 times a day with an interval of 8 hours between one "intake and the other".
Do not exceed the recommended dose.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Gastroduodenal ulcer. Pregnancy and breastfeeding.
04.4 Special warnings and appropriate precautions for use
LISOMUCIL adult syrup with sugar contains sucrose (6 g for each 15 ml dose of syrup): this should be taken into account in case of diabetes or low-calorie diets. Patients with hereditary fructose intolerance, glucose-galactose malabsorption syndrome, sucrase-isomerase enzyme deficiency should not take this medicine.
The excipient Lisomucil aromatic elixir adult syrup with sugar contains ethyl alcohol in an amount equal to 200 mg per 15 ml dose (one measuring cup or one tablespoon). The medicinal product may be dangerous for patients suffering from alcoholism. in case of pregnancy and lactation, liver disease or epilepsy.
For those who carry out sporting activities, the use of medicines containing ethyl alcohol can determine positive anti-doping tests in relation to the alcohol concentration limits indicated by some sports federations.
LISOMUCIL adult syrup contains methyl parahydroxybenzoate which may cause allergic reactions (including delayed).
In case of a low sodium diet, it should be borne in mind that the recommended dose of 15 ml of syrup contains about 100 mg of sodium.
04.5 Interactions with other medicinal products and other forms of interaction
At the present state of knowledge, there are no known incompatibilities between the administration of carbocysteine and the most common drugs used in the treatment of upper and lower respiratory tract diseases, or with food or laboratory tests.
04.6 Pregnancy and lactation
The product is contraindicated in case of pregnancy and lactation.
04.7 Effects on ability to drive and use machines
Since carbocysteine does not affect normal alertness, there are no known adverse effects of the drug on the ability to drive and use machines.
04.8 Undesirable effects
Undesirable effects are listed according to the following frequency classification:
Very common (≥1 / 10); common (≥1 / 100,
Immune system disorders:
frequency not known: anaphylactic reaction;
Gastrointestinal disorders:
very common: diarrhea, nausea and upper abdominal pain
Skin and subcutaneous tissue disorders:
frequency not known: Steven-Johnson syndrome; Erythema multiforme; Toxic skin rash; drug rash; rash. In such cases, stop the treatment and consult your doctor to establish a suitable therapy.
The following may occur: dizziness. In such cases it is recommended to reduce the dosage.
04.9 Overdose
Symptoms due to overdose include: headache, nausea, diarrhea, stomach pain. Induce vomiting and possibly perform gastric lavage.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: respiratory system, mucolytics;
ATC code: R05CB03
From a chemical point of view, the carbocysteine molecule is characterized by the presence of blocked sulfur and therefore by the absence of the labile sulfhydryl group characteristic of cysteine derivatives with direct mucolytic activity.
It carries out its pharmacological action through a mucolytic and mucoregulatory process.
The study of the pharmacological characteristics of carbocysteine, in animals and humans, has shown that it has the property of increasing the synthesis of sialomucins, fundamental constituents of bronchial mucus, on which its rheological properties depend. In man, the administration of carbocysteine induces the qualitative and quantitative modification of the mucus typical of chronic obstructive pulmonary disease, rich in neutral mucins and poor in sialomucins, significantly increasing the share of the latter. It is also shown that carbocysteine favors the reduction of the inflammatory process and of the hyperplasia and hypertrophy of the mucosecerning structures of the mucosa. This is possible thanks to the inhibitory action on bradykinins carried out by sialic acid, a fundamental constituent of sialomucins.
05.2 Pharmacokinetic properties
Carbocysteine is rapidly and completely absorbed orally, reaching its blood peak within 2 hours of its administration. It is fixed in an elective way at the pulmonary level, where its concentration is six times that of the plasma and remains so from the 3rd to the 24th hour following administration. Carbocysteine is eliminated by the kidney for the most part unchanged, and in part as thiodiglycolic acid, a metabolite with complementary pharmacological activity.
05.3 Preclinical safety data
Acute toxicity studies and chronic toxicity studies conducted for 6 months did not show evidence of toxicity at the recommended therapeutic dosages in treated animals. Similarly, teratogenic research conducted on three animal species (mice, rats and rabbits) did not reveal any formation anomalies.
Peri- and postnatal toxicity studies in rats have shown that carbocysteine does not interfere with either embryofetal or postnatal development.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
LISOMUCIL adults syrup with sugar:
sucrose, methyl parahydroxybenzoate, caramel powder, aromatic elixir (82% ethanol), cinnamon essence, sodium hydroxide, purified water.
LISOMUCIL adults syrup unsweetened:
glycerol, hydroxyethylcellulose, sodium saccharin, sodium methyl parahydroxybenzoate, caramel powder, flavoring, sodium hydroxide, purified water.
06.2 Incompatibility
None known.
06.3 Period of validity
LISOMUCIL adult syrup with sugar: 3 years.
LISOMUCIL adults sugar-free syrup: 3 years.
06.4 Special precautions for storage
LISOMUCIL adults syrup with sugar: Keep at a temperature not exceeding 25 ° C.
LISOMUCIL adult sugar-free syrup: No special storage precautions.
06.5 Nature of the immediate packaging and contents of the package
Lithographed cardboard box containing a 200 ml glass bottle with child resistant closure, package leaflet and measuring cup.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
sanofi-aventis S.p.A. - Viale L. Bodio, 37 / b - IT-20158 Milan
08.0 MARKETING AUTHORIZATION NUMBER
LISOMUCIL adults syrup with sugar: AIC 023185059
LISOMUCIL adults syrup without sugar: AIC 023185097
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
LISOMUCIL adults syrup with sugar: 13 March 1975/1 June 2010
LISOMUCIL adults syrup without sugar: 12 May 1999/1 June 2010
10.0 DATE OF REVISION OF THE TEXT
May 2013
