SOGENEX

Package leaflet: Information for the user

SOGENEX 40 mg/5 ml oral solution single dose, 40 mg/5 ml oral solution

Sobrerol
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What SOGENEX is and what it is used for
2. What you need to know before taking SOGENEX
3. How to take SOGENEX
4. Possible side effects
5. How to store SOGENEX
6. Contents of the pack and other information

1. What SOGENEX is and what it is used for

SOGENEX contains the active substance sobrerol. Sobrerol belongs to a group of medicines called mucolytics. These medicines work by liquefying and facilitating the elimination of thick mucus hypersecretions (phlegm).
SOGENEX is indicated to help remove excess mucus in acute and chronic respiratory tract disorders.
Consult your doctor if you do not notice improvement or if you notice a worsening of symptoms.

2. What you need to know before taking SOGENEX

Do not take SOGENEX

• if you are allergic (hypersensitive) to the active substance or to any of the other components of SOGENEX (listed in section 6).
• in children under 2 years of age.
• in children with a history of epilepsy or febrile seizures.

Take special care:
This medicinal product contains sobrerol which, in excessive doses, may cause neurological disorders such as
seizures in newborns and children.
Do not extend treatment beyond 3 days due to risks associated with the accumulation of terpene derivatives in
the body, including the brain, and particularly due to the risk of neuropsychological disturbances.
Warnings and precautions
Talk to your doctor or pharmacist before taking SOGENEX.
Children and adolescents
The use of SOGENEX is contraindicated in children under 2 years of age. Mucolytics may cause bronchial occlusion (the ability to clear bronchial mucus in children under 2 years is limited
due to the characteristics of their respiratory tract).
Other medicines and SOGENEX
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Do not use SOGENEX when also taking other products (medicinal or cosmetic) containing terpene derivatives
(e.g. camphor, cineole, niaouli, wild thyme, α-terpineol, terpin, citral, menthol, and essential oils
of pine needles, eucalyptus, and turpentine), regardless of the route of administration (oral, rectal,
cutaneous, or pulmonary).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
During pregnancy and/or breastfeeding, SOGENEX should be used only after consulting your doctor and
evaluating with him the risk/benefit ratio in your individual case.
Driving and using machines
SOGENEX does not impair the ability to drive vehicles or operate machinery.
SOGENEX 40 mg/5 ml syrup contains maltitol, sodium, and hydroxybenzoates
SOGENEX 40 mg/5 ml syrup contains a sugar called maltitol; patients with rare hereditary
fructose intolerance (a sugar) should not take this medicine.
SOGENEX contains sodium (0.29 mmol of sodium in 5 ml, i.e. more than 1 mmol of sodium per 20 ml), which should be taken into account in individuals on a low-sodium diet.
The multidose syrup also contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate, which may
cause allergic reactions (including delayed-type reactions).

3. How to take SOGENEX

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Use in children over 2 years
The recommended dose is: 10 ml twice daily.
Use in adults
The recommended dose is: 10–20 ml twice daily.
Warning: Do not exceed the indicated doses.
When and for how long
Warning: Use only for short-term treatment periods.
Consult your doctor if symptoms recur frequently or if you have noticed any recent changes
in their characteristics.
How to use
Use the markings on the dosing cup as a reference.
If you take more SOGENEX than you should
In case of accidental ingestion/overdose of SOGENEX, contact your doctor immediately or go to the nearest hospital.
If you forget to take SOGENEX
Do not take a double dose to make up for a forgotten dose.
If you stop treatment with SOGENEX
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects that may occur are mainly gastrointestinal disorders and nausea.
Bronchial obstruction may occur with unknown frequency.
If any of the side effects worsen, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects 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.

5. How to store SOGENEX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp". The expiry date refers to the last day of that month.
The shelf life after first opening the bottle is 28 days (record the date of first opening in the designated space on the carton).
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What SOGENEX contains
SOGENEX 40 mg/5 ml syrup single-dose
One single-dose container:

• the active substance is: sobrerol 40 mg;
• the other components are: maltisorb (maltitol 75%), glycerol 98%, monosodium phosphate, sodium hydroxide, water for injections.

SOGENEX 40 mg/5 ml syrup 200 ml
5 ml:

• the active substance is: sobrerol 40 mg;
• the other components are: maltisorb (maltitol 75%), glycerol 98%, monosodium phosphate, sodium hydroxide, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, water for injections.

Description of the appearance of SOGENEX and contents of the pack
SOGENEX 40 mg/5 ml is a syrup.
Pack contents: 20 single-dose containers and 1 bottle of 200 ml.
Marketing Authorization Holder
Genetic S.p.A., Via G. Della Monica n. 26, Castel San Giorgio (SA)
Manufacturer:
Genetic S.p.A., Contrada Canfora, Fisciano (SA)
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