Package leaflet: Information for the user

RELOGEN 40 mg/5 ml single-dose syrup, 40 mg/5 ml syrup

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 others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What RELOGEN is and what it is used for
What you need to know before taking RELOGEN
How to take RELOGEN
Possible side effects
How to store RELOGEN
Contents of the pack and other information

1. What RELOGEN is and what it is used for

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

2. What you need to know before taking RELOGEN

Do not take RELOGEN

if you are allergic (hypersensitive) to the active substance or to any of the other ingredients of RELOGEN (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 the risks associated with the accumulation of terpene derivatives in
the body, including the brain, and particularly the risk of neuropsychological disturbances.
Warnings and precautions
Talk to your doctor or pharmacist before taking RELOGEN.
Children and adolescents
The use of RELOGEN is contraindicated in children under 2 years of age. Mucolytics may induce
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 RELOGEN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Do not use RELOGEN when also taking other products (medicines or cosmetics) containing terpene derivatives (e.g. camphor, cineole, niaouli, wild thyme, 20-terpineol, terpinen, 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 breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy and/or breastfeeding, RELOGEN should be used only after consulting your doctor and evaluating with him the risk/benefit ratio in your individual case.
Driving and using machines
RELOGEN does not impair the ability to drive vehicles or operate machinery.
RELOGEN 40 mg/5 ml syrup contains maltitol, sodium, and hydroxybenzoates
RELOGEN 40 mg/5 ml syrup contains a sugar called maltitol. Patients with rare hereditary fructose intolerance (a sugar) should not take this medicine.
RELOGEN 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 RELOGEN

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 of age
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 recommended doses.
When and for how long
Warning: use only for short-term treatment.
Consult your doctor if symptoms recur repeatedly or if you have noticed any recent
change in their characteristics.
How to take
Use the markings on the dosing spoon as a reference.
If you take more RELOGEN than you should
In case of accidental ingestion/overdose of RELOGEN, contact your doctor immediately or
go to the nearest hospital.
If you forget to take RELOGEN
Do not take a double dose to make up for the missed dose.
If you stop taking RELOGEN
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 will experience them.
The side effects that may occur are mainly gastrointestinal disturbances and nausea.
Bronchial obstruction may occur with unknown frequency.
If any of the side effects worsen, or if you notice any side effects 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 may 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 RELOGEN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
The shelf life after first opening of 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. Package contents and other information

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

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

RELOGEN 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%, monobasic sodium phosphate, sodium hydroxide, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, water for injections.

Description of the appearance of RELOGEN and contents of the pack
RELOGEN 40 mg/5 ml is presented as a syrup.
Pack contents: 20 single-dose containers and one 200 ml bottle.
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)
This leaflet was last updated on