NOTICE
ANSM - Updated: 14/03/2019
Name of the drug
TERPINE GONNON 0.5 PERCENT, oral solution
terpin
framed
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
You should always take this medicine exactly as described in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Talk to your pharmacist for any advice or information.
· If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects that are not mentioned in this leaflet. See section 4.
· You should talk to your doctor if you do not feel better or if you feel worse.
What does this booklet contain ?
1. What is TERPINE GONNON 0.5 PERCENT, oral solution and in what cases is it used?
2. What information do you need to know before taking TERPINE GONNON 0.5 PERCENT, oral solution?
3. How to take TERPINE GONNON 0.5 PERCENT, oral solution?
4. What are the possible side effects?
5. How to store TERPINE GONNON 0.5 PERCENT, oral solution?
6. Contents of the package and other information.
1. WHAT IS TERPINE GONON 0.5 PERCENT, oral solution AND WHAT IT IS USED FOR?
Pharmacotherapeutic group - ATC code: EXPECTORANT (R: Respiratory System), R05CA.
This medicine is a modifier of bronchial secretions.
It is recommended in cases of recent respiratory disease with difficulty of expectoration (difficulties to reject spitting bronchial secretions) in adults.
You should talk to your doctor if you do not feel better or if you feel worse.
2. WHAT INFORMATION IS NECESSARY BEFORE YOU TAKE AROUND GONON 0.5 PERCENT, oral solution?
Do not take TERPINE GONNON 0.5 PERCENT, oral solution:
· if you are allergic to terpine or any of the other ingredients of this medicine, listed in section 6,
· if you are treated with any of the following medications and unless directed by your doctor:
o drugs causing an antabuse reaction with alcohol,
o CNS depressants,
o non-selective MAOIs,
o insulin,
o metformin,
o hypoglycemic sulfonamides.
Warnings and precautions
Talk to your doctor or pharmacist before taking TERPINE GONNON 0.5 PERCENT, oral solution .
This medicine contains 31.6% ethanol (alcohol) theft, i.e. up to 3700 mg per dose, which equals 94.8 ml of beer, 39.5 ml of wine per dose. Dangerous when used in alcoholic subjects. To be taken into account in pregnant or lactating women, children and high-risk groups such as hepatic insufficiency or epileptics. The amount of alcohol in this medicine can alter the effects of other drugs.
If your doctor tells you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The use of this drug is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency (rare hereditary diseases).
Medical advice is needed:
· in case of oily or purulent expectoration,
· if you have a chronic (long-term) lung and bronchial disease.
This treatment must always be accompanied by voluntary coughing for sputum; the simultaneous intake of a medication to calm cough is therefore illogical.
Do not take medicine that will dry up bronchial secretions during the treatment period with this medicine.
In case of diabetes or low carbohydrate diet, consider the sucrose content (3 g per tablespoon).
Children and adolescents
This medicine is only for adults. Because of the alcohol content (3.7 g per tablespoon), do not administer this oral solution in children.
Other medicines and TERPINE GONNON 0.5 PERCENT, oral solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines (disulfiram, certain antibacterials, some antifungals) that cause an antabuse reaction with alcohol (heat, redness, vomiting, palpitations), central nervous system depressants (antidepressants, antihistamines, anxiolytics, neuroleptics, opioids, certain antihypertensives), drugs for the treatment of diabetes (chlorpropamide, glibenclamide, glipizide, insulin, metformin, sulphonylureas).
The amount of alcohol in this medicine can alter the effects of other drugs.
TERPINE GONNON 0.5 PERCENT, oral solution with food, drinks and alcohol
Because of the alcohol content (3.7 g per tablespoon), avoid taking alcoholic beverages.
Pregnancy and lactation and fertility
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.
It is best not to administer this medicine during pregnancy. However, no adverse effects have been reported during pregnancy.
As a precaution, avoid administration of this drug while breastfeeding.
Driving and using machines
The amount of alcohol in this medication can affect your ability to drive and use machines.
TERPINE GONON 0.5 PERCENT, oral solution contains sucrose and ethanol.
3. HOW TO TAKE AROUND GONON 0.5 PERCENT, oral solution?
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.
RESERVED FOR THE ADULT.
The recommended dose is 1 tbsp, 4 times a day.
Oral way.
The solution can be swallowed pure or diluted in a little water.
Do not exceed 8 to 10 days of treatment without medical advice.
If you take more TERPINE GONON 0.5 PERCENT, oral solution than you should
Not applicable.
If you forget to take TERPINE GONNON 0.5 PERCENT, oral solution
Not applicable.
If you stop taking TERPINE GONNON 0.5 PERCENT, oral solution
Not applicable.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
· possibility of digestive disorders (nausea, vomiting, abdominal pain).
Declaration of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effects that are not mentioned in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Internal site t: www.signalement-sante.gouv.fr
By reporting side effects, you can help provide more information on the safety of the medicine.
5. HOW TO STORE TERPINE GONON 0.5 PERCENT, oral solution?
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 bottle. The expiry date refers to the last day of this month.
Do not dispose of any medication in the sewage system or garbage. Ask your pharmacist to eliminate medications you no longer use. These measures will help protect the environment .
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What TERPINE GONNON contains 0.5 PERCENT, oral solution
· The active substance is:
Terpine ................................................. .................................................. .......................... 0,5 g
For 100 ml.
· The other components are:
Ethanol (1) , glycerol, sucrose (2) , concentrate for syrup of tolu balm, caramel (3) , aroma bitter almond (4) , ethylvanillin, purified water.
(1) The content of the ethanol solution includes the amount of alcohol in the tolu balm syrup concentrate.
(2) The content of the sucrose solution includes the amount of sucrose in the tolu balm syrup concentrate.
(3) Caramel composition: sucrose, water.
(4) Composition of bitter almond aroma: essential oil of almond or apricot kernels.
1 tablespoon contains 75 mg of terpine, 3 g of sucrose and 3.7 g of absolute alcohol
Alcoholic title = 31.6% V / V
What TERPINE GONNON 0.5 PERCENT, oral solution and contents of the pack
This medication is in the form of an oral solution; bottle of 200 ml and 250 ml.
Marketing Authorization Holder
MERCK FAMILY MEDICATION SAS
37, SAINT ROMAIN STREET
69379 LYON CEDEX 08
Operator of the marketing authorization
MERCK FAMILY MEDICATION
18 C, BOULEVARD WINSTON CHURCHILL
21000 DIJON
Maker
LAPHAL INDUSTRY
AVENUE OF PROVENCE
13190 ALLAUCH
Or
H2 PHARMA
21 JACQUES TATI STREET
ZAC LA CROIX BONNET
78390 CRAY WOOD
Names of the medicine in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
[to be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).