Active ingredients: Sobrerol
Sobrepin 300 mg granules
Why is Sobrepin used? What is it for?
The active ingredient in Sobrepin is sobrerol, a mucolytic. This medicine is used as a thinner of bronchial secretions in the treatment of respiratory diseases characterized by thick and viscous hypersecretion.
Contact your doctor if you do not notice any improvement or if you notice worsening of your symptoms.
Contraindications When Sobrepin should not be used
Do not take Sobrepin:
- if you are allergic to sobrerol or any of the other ingredients of this medicine (listed in section 6).
- in children under 2 years of age
Precautions for use What you need to know before you take Sobrepin
Talk to your doctor or pharmacist before taking Sobrepin.
Children
Do not use Sobrepin in children under 2 years of age, as mucolytics can induce occlusion of the bronchi (the ability to clear bronchial mucus in children under 2 years of age is limited due to the characteristics of their airways).
Interactions Which drugs or foods may change the effect of Sobrepin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Warnings It is important to know that:
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. Take Sobrepin only in cases of real need under the direct supervision of your doctor.
Driving and using machines
Sobrepin does not affect the ability to drive or use machines.
Sobrepin contains aspartame, sorbitol and E110 dye
The aspartame in this medicine is a source of phenylalanine. It may be harmful if you have phenylketonuria (a rare disease characterized by the inability to metabolise the amino acid phenylalanine).
This medicine contains sorbitol: if you have been told by your doctor that you have "intolerance to some sugars, contact your doctor before taking this medicine.
The dye E110, present in the granules, can cause you allergic reactions.
Dose, Method and Time of Administration How to use Sobrepin: Posology
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 recommended dose is:
Adults: 2 sachets per day
Dissolve the contents of one sachet in half a glass of water.
Warning: do not exceed the indicated doses.
Take only for short periods of treatment.
Consult your doctor if the disorder occurs repeatedly or if you notice any recent changes in its characteristics.
Overdose What to do if you have taken too much Sobrepin
No cases of overdose have been reported.
In case of accidental ingestion / intake of an overdose of Sobrepin, notify your doctor immediately or go to the nearest hospital.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Sobrepin
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Undesirable effects with frequency not known (frequency cannot be estimated from the available data):
- bronchial obstruction (temporary narrowing of the upper respiratory tract),
- gastric (stomach) discomfort,
- nausea.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
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, http://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 package. The expiry date refers to the last day of that month. The expiry date refers to the product in intact packaging, correctly stored.
Do not store the medicine above 25 ° C.
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.
Composition and pharmaceutical form
What Sobrepin contains:
- The active ingredient is: sobrerol 300 mg. One sachet of 3 g of granules contains 300 mg of sobrerol.
- The other ingredients are: mandarin flavor, lemon flavor, orange flavor, citric acid, sodium saccharin, aspartame, polysorbate 20, E110, sorbitol.
What Sobrepin looks like and contents of the pack
Sobrepin 300 mg granules are presented in the form of granules for oral solution.
The contents of the packs are 24 and 60 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
SOBREPIN
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sobrepin 40 mg / 5 ml syrup:
100 ml of syrup contain:
Active principle:
sobrerol 0.8 g.
Excipients:
sucrose 30 g;
methyl p-hydroxybenzoate 0.1 g;
propyl p-hydroxybenzoate 0.03 g;
ethanol 5 g.
For the full list of excipients, see section 6.1.
Sobrepin 300 mg granules:
A 3 g sachet contains:
Active principle:
sobrerol 300 mg.
Excipients:
aspartame 10 mg;
sorbitol 2304 mg;
E110 1 mg.
For the full list of excipients, see 6.1.
03.0 PHARMACEUTICAL FORM
• Syrup.
• Granulate.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Sobrepin is used for the treatment of respiratory conditions characterized by thick and viscous hypersecretion.
04.2 Posology and method of administration
40 mg / 5 ml syrup: use the marks on the measuring cup as a reference.
children over 2 years: 10 ml twice a day.
adults: 10-20 ml twice a day.
Due to the presence of ethanol in the syrup, the use of other pharmaceutical forms in children under the age of 6 is recommended (see also 4.4 Special warnings and appropriate precautions for use).
300 mg granules:
adults: 2 sachets per day; dissolve the contents of one sachet in half a glass of water.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
The drug is contraindicated in children under 2 years of age.
04.4 Special warnings and appropriate precautions for use
Mucolytics can induce bronchial obstruction in children under 2 years of age. In fact, the drainage capacity of the bronchial mucus is limited in this age group, due to the physiological characteristics of the respiratory tract.
They should not be used in children less than 2 years of age (see section 4.3).
Warnings related to some of the ingredients of Sobrepin
Granulated
The aspartame in this medicine is a source of phenylalanine. It can be harmful to people with phenylketonuria.
Due to the sorbitol present in the formulation, individuals with rare hereditary forms of fructose intolerance should not take this medicine.
The dye E110, present in the granules for oral solution, can cause allergic reactions.
Syrup
Due to the sucrose present in the formulation, subjects with rare hereditary forms of fructose intolerance, glucose / galactose malabsorption and sucrase / isomaltase insufficiency should not take this medicine.
Also to be taken into consideration in people with diabetes mellitus.
The syrup contains 5% ethanol (ethyl alcohol), equivalent to 500 mg (dose for children over 2 years), 500 mg - 1 g (adult dose). Harmful for those suffering from alcoholism. To be taken into account in pregnant or breastfeeding patients, children and the population at risk, such as patients with liver disease or epilepsy.
The syrup also contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate which can cause allergic reactions (including delayed type).
For those who carry out sporting activities: the "use of medicines containing ethyl alcohol can" determine positivity to doping tests in relation to the alcohol concentration limits indicated by some sports federations.
04.5 Interactions with other medicinal products and other forms of interaction
There are no known interactions of sobrerol with other drugs.
04.6 Pregnancy and lactation
In pregnancy and breastfeeding, the safety of sobrerol is not sufficiently demonstrated; therefore Sobrepin should only be administered when, in the judgment of the physician, the potential benefits outweigh the possible risks.
04.7 Effects on ability to drive and use machines
Sobrepin does not affect the ability to drive or use machines.
04.8 Undesirable effects
Bronchial obstruction: frequency unknown
Gastric upset and nausea can occur.
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
No cases of overdose have been reported.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: mucolytic.
ATC code: R05CB07.
Sobrerol, through a hydration mechanism, increases the volume of bronchial secretions thus acting as a fluidifying agent.
It also modifies the biochemical and cellular component of mucus and increases the speed of the ciliary beat. These actions, together, favor the airway purification mechanisms which are reflected in an improvement in respiratory function.
05.2 Pharmacokinetic properties
Sobrerol is rapidly absorbed by the first tracts of the "gastrointestinal tract. Maximum at 60". Sobrerol is rapidly distributed. The rapid distribution is confirmed by elevated sobrerol levels found in bronchial mucus as early as one hour after administration.
In humans, the plasma half-life of sobrerol is 2.39 hours and 2.98 hours in bronchial mucus.
The biotransformation of sobrerol in humans has two types of reaction: that in phase I in which the passage of sobrerol to carvone takes place. The one in phase II constituted by conjugation with glucuronic acid.
A total of 9 metabolites have been identified in humans and animals.
In humans, sobrerol is eliminated almost exclusively via the kidneys in the form of free sobrerol, glucurono-conjugated sobrerol, carvone.
05.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, reproductive toxicity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Sobrepin 40 mg / 5 ml syrup:
sucrose, glycerin, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, monobasic sodium phosphate, saccharin, sodium hydroxide, ethyl alcohol, caramel (E150), raspberry flavor, crème caramel flavor, cherry brandy flavor, purified water.
Sobrepin 300 mg granules:
mandarin aroma, lemon aroma, orange aroma, citric acid, sodium saccharin, aspartame, polysorbate 20, E110, sorbitol.
06.2 Incompatibility
None known.
06.3 Period of validity
Granules and syrup
5 years.
Syrup: after first opening: 6 months.
06.4 Special precautions for storage
Store at a temperature not exceeding 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
Sobrepin 40 mg / 5 ml syrup
Type III yellow glass bottle with polypropylene child resistant closure fitted with an internal polyethylene seal. Polypropylene measuring cup with 2,5 - 5 - 7,5 - 10 ml notches.
Sobrepin 300 mg granules
Bags in coupled paper / aluminum / polythene.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Bayer S.p.A - Viale Certosa 130 - 20156 - Milan
08.0 MARKETING AUTHORIZATION NUMBER
"Sobrepin 40 mg / 5 ml syrup" 1 bottle of 200 ml AIC n ° 021481256
"Sobrepin 300 mg granules" 24 sachets of 3 g AIC n ° 021481320
"Sobrepin 300 mg granules" 60 sachets of 3 g AIC n ° 021481282
Not all pack sizes may be marketed.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Renewal: June 2010
10.0 DATE OF REVISION OF THE TEXT
JULY 2015
