Active ingredients: 2,4-dichlorobenzyl alcohol, amylmetacresol
BENAGOL 1,2 mg + 0,6 mg Ginger and Spice flavor tablets
BENAGOL 1.2 mg + 0.6 mg Honey and Lemon flavor tablets
BENAGOL 1,2 mg + 0,6 mg Cold Mint flavor tablets
BENAGOL 1,2 mg + 0,6 mg Sugar-free Lemon flavor tablets
BENAGOL 1,2 mg + 0,6 mg Sugar-free Strawberry flavor tablets
Benagol package inserts are available for pack sizes: - BENAGOL 1,2 mg + 0,6 mg Ginger and Spices taste tablets, BENAGOL 1,2 mg + 0,6 mg Honey and Lemon taste tablets, BENAGOL 1,2 mg + 0,6 mg Cold Mint taste tablets, BENAGOL 1, 2 mg + 0,6 mg Lemon flavor tablets Sugar-free, BENAGOL 1,2 mg + 0,6 mg Strawberry flavor tablets Sugar-free
- BENAGOL 1,2 mg + 0,6 mg + 74,9 mg + 33,5 mg Tablets with Vitamin C Orange flavor
- BENAGOL 1,2 mg + 0,6 mg + 8 mg Menthol-Eucalyptol flavor tablets
Why is Benagol used? What is it for?
BENAGOL contains the active ingredients 2,4-dichlorobenzyl alcohol, amylmetacresol and has an antiseptic (antibacterial) activity at the level of the oropharyngeal cavity, it is used to disinfect the mouth and throat with a prolonged effect.
BENAGOL Honey and Lemon flavor, BENAGOL Sugar Free Lemon flavor and BENAGOL Sugar Free Strawberry flavor are used in adults and children over 2 years of age.
BENAGOL Ginger and Spices flavor and BENAGOL Cold Mint flavor are used in adults and children over 12 years of age.
BENAGOL Sugar-Free Lemon flavor and BENAGOL Sugar-Free Strawberry flavor are suitable if you / your child need to control sugar intake and calories.
Talk to your doctor if you / your child do not feel better or if they feel worse after a short period of treatment.
Contraindications When Benagol should not be used
Do not take / give your child BENAGOL
- if you are allergic to 2,4-dichlorobenzyl alcohol and amylmetacresol or any of the other ingredients of this medicine (listed in section 6);
- if the child is less than 2 years old.
Do not give BENAGOL Ginger and Spices taste and BENAGOL Cold Mint taste to children under the age of 12.
Precautions for use What you need to know before taking Benagol
Talk to your doctor or pharmacist before taking / giving your child BENAGOL.
If you / your child experience allergic phenomena or irritation, stop taking this medicine and consult your doctor (see section "Possible side effects").
Children and adolescents
Do not give BENAGOL to children under 2 years of age.
Do not give BENAGOL Ginger and Spices taste and BENAGOL Cold Mint taste to children under the age of 12.
Beware of small children as swallowing the tablets whole can cause choking.
Interactions Which drugs or foods can modify the effect of Benagol
Tell your doctor or pharmacist if you / your child 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.
Only take BENAGOL if you are pregnant or breastfeeding after consulting your doctor.
Driving and using machines
BENAGOL does not affect the ability to drive or use machines.
BENAGOL taste Ginger and Spices contains sucrose and glucose
If you / your child have an intolerance to some sugars (such as sucrose and glucose), contact your doctor before taking / giving your child this medicine.
BENAGOL Ginger and Spice flavor contains aromas capable of inducing a sensation of heat in the mouth and throat when sucking the tablet.
BENAGOL Honey and Lemon flavor contains sucrose, glucose and honey (invert sugar)
If your doctor has diagnosed you / your child with intolerance to some sugars (such as sucrose, glucose and honey), contact your doctor before taking / giving your child this medicine.
BENAGOL Cold Mint flavor contains sucrose and glucose
If you / your child have an intolerance to some sugars (such as sucrose and glucose), contact your doctor before taking / giving your child this medicine.
BENAGOL Sugar-Free Lemon flavor and BENAGOL Sugar-Free Strawberry flavor contain maltitol
If your doctor has diagnosed you / your child with intolerance to some sugars (such as maltose derivatives), contact your doctor before taking / giving your child these medicines.
Dose, Method and Time of Administration How to use Benagol: Posology
Always take / give your child this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults and adolescents
The recommended dose is 1 tablet every 2-3 hours. Warning: do not exceed the recommended doses without consulting your doctor.
For BENAGOL Cold Mint flavor, do not exceed the daily maximum of 8 tablets.
You can take / give your child BENAGOL at any time of the day, slowly dissolving each tablet in the mouth.
Warning: use this medicine only for short periods of treatment.
Consult your doctor if the disorder occurs repeatedly or if you notice any recent changes in its characteristics.
Children
Do not give BENAGOL to children under 2 years of age.
Do not give BENAGOL Ginger and Spices taste and BENAGOL Cold Mint taste to children under the age of 12.
In children over 2 years of age, consult your doctor who will indicate the appropriate dose for the child.
Beware of small children as swallowing the tablets whole can cause choking.
Overdose What to do if you have taken too much Benagol
If you take / give your child more BENAGOL than they should
In case of accidental ingestion / intake of an excessive dose of BENAGOL, notify your doctor immediately or go to the nearest hospital.
Accidental ingestion of an excessive dose of this medicine can cause stomach and intestinal disorders.
If you forget to take / give your child BENAGOL
Do not take / give your child a double dose to make up for a forgotten tablet.
If you stop taking BENAGOL
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 Benagol
Like all medicines, this medicine can cause side effects, although not everybody gets them.
With the use of Benagol the following side effects may rarely occur, if so
STOP taking this medicine and consult your doctor immediately:
- local allergic phenomena
- irritation of the tongue.
- disorders of the stomach and intestines.
Reporting of side effects
If you / your child 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 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
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 carton after EXP.
The expiry date refers to the last day of that month.
Use BENAGOL Honey and Lemon flavor tablets in the tube pack within 3 months from the date of first opening.
Do not store 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 BENAGOL contains
BENAGOL Ginger and Spice flavored tablets
- the active ingredients are: 2,4-dichlorobenzyl alcohol 1,2 mg; amylmetacresol 0.6 mg
- the other ingredients are: sucrose, liquid glucose (see paragraph "BENAGOL flavor Ginger and Spices contains sucrose and glucose"), tartaric acid, anthocyanins (E163), plum flavor, cream flavor, spice flavor, ginger flavor, medium chain triglycerides.
BENAGOL Honey and Lemon flavored tablets
- the active ingredients are: 2,4-dichlorobenzyl alcohol 1,2 mg; amylmetacresol 0.6 mg
- the other ingredients are: sucrose, liquid glucose, honey (invert sugar) (see paragraph "BENAGOL Honey and Lemon flavor contains sucrose, glucose and honey (invert sugar)"), mint essence, lemon essence, tartaric acid.
BENAGOL Cold Mint tablets
- the active ingredients are: 2,4-dichlorobenzyl alcohol 1,2 mg; amylmetacresol 0.6 mg
- the other ingredients are: liquid sucrose, liquid glucose (see paragraph "BENAGOL Cold Mint flavor contains sucrose and glucose"), xylitol, menthol, mint flavor, eucalyptus oil.
BENAGOL Sugar-free Lemon flavor tablets
- the active ingredients are: 2,4-dichlorobenzyl alcohol 1,2 mg; amylmetacresol 0.6 mg
- the other components are: lemon flavor, sodium saccharinate, tartaric acid, maltitol syrup (see paragraph "BENAGOL Lemon flavor without sugar and BENAGOL strawberry flavor without sugar contain maltitol"), isomaltose.
BENAGOL Strawberry flavored tablets without sugar
- the active ingredients are: 2,4-dichlorobenzyl alcohol 1,2 mg; amylmetacresol 0.6 mg
- the other components are: strawberry flavor, anthocyanins (E163), sodium saccharinate, tartaric acid, maltitol syrup (see paragraph "BENAGOL Sugar Free Lemon flavor and BENAGOL Sugar Free Strawberry flavor contain maltitol"), isomaltose.
Description of what BENAGOL looks like and contents of the pack
BENAGOL 1.2 mg + 0.6 mg Cold Mint flavor tablets, BENAGOL 1.2 mg + 0.6 mg Ginger and Spice flavor tablets are presented in tablets packed in blister packs of 16 tablets.
BENAGOL 1,2 mg + 0,6 mg Sugar-free lemon flavor tablets, BENAGOL 1,2 mg + 0,6 mg Sugar-free strawberry flavor tablets are presented in tablets packed in blisters of 16, 24 tablets.
BENAGOL Honey and Lemon flavor tablets comes in tablets packed in blisters of 16, 24, 36 tablets and in tubes of 10 and 20 tablets.
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
BENAGOL PADS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
BENAGOL Ginger and Spice flavored tablets, Honey and Lemon flavored tablets, Sugar-free Lemon flavored tablets, Sugar-free Strawberry flavored tablets and Cold Mint flavored tablets:
One tablet contains: Active ingredients: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg.
BENAGOL Menthol-Eucalyptol flavor tablets:
One tablet contains: Active ingredients: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg; menthol 8.0 mg.
BENAGOL Tablets with Vitamin C Orange flavor:
One tablet contains: Active ingredients: 2,4-dichlorobenzyl alcohol 1.2 mg; amylmetacresol 0.6 mg; sodium ascorbate 74.9 mg; ascorbic acid 33.5 mg.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Pads.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Antiseptic of the oral cavity.
04.2 Posology and method of administration
Let one tablet dissolve slowly in the mouth every 2 or 3 hours. In children over 2 years of age, consult your doctor for an appropriate dosage.
Do not exceed the recommended doses and in particular, for BENAGOL with Vitamin C Orange flavor and BENAGOL Cold Mint flavor, do not exceed the daily maximum of 8 tablets.
Administer BENAGOL with Cold Mint flavor and BENAGOL with Ginger and Spices flavor to adults and children over 12 years of age.
BENAGOL taste Menthol-Eucalyptol is contraindicated in children up to 30 months of age (see section 4.3).
The duration of treatment with BENAGOL Menthol-Eucalyptol flavor should not exceed 3 days.
BENAGOL Sugar-Free Lemon flavor and BENAGOL Sugar-Free Strawberry flavor are suitable for those patients who need to control their sugar and calorie intake.
Beware of small children as if the tablets are swallowed whole they can cause choking.
04.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients.
Do not administer to children under 2 years of age.
BENAGOL Menthol-Eucalyptol taste is contraindicated in children up to 30 months of age.
BENAGOL Menthol-Eucalyptol taste is contraindicated in children with a history of epilepsy or febrile convulsions.
Do not give BENAGOL Cold Mint flavor and BENAGOL Ginger and Spice flavor to children under the age of 12.
04.4 Special warnings and appropriate precautions for use
In case of sensitization or irritation phenomena it is necessary to interrupt the administration and consult the doctor to institute suitable treatment.
Do not give the product to children under 2 years of age.
After a few days of treatment without appreciable results, consult your doctor.
BENAGOL taste Menthol-Eucalyptol contains terpene derivatives which, in excessive doses, can cause neurological disorders such as convulsions in infants and children.
Treatment with BENAGOL Menthol-Eucalyptol taste should not be prolonged for more than 3 days due to the risks associated with the accumulation of terpene derivatives, such as example camphor, cineole, niaouli, wild thyme, terpineol, terpine, citral, menthol and essential oils of pine needles, eucalyptus and turpentine (due to their lipophilic properties the rate of metabolism and disposal is not known) in tissues and in the brain, in particular neuropsychological disorders.
A higher dose than recommended should not be used to avoid an increased risk of adverse drug reactions and disorders associated with overdose (see section 4.9).
BENAGOL taste Menthol-Eucalyptol is flammable, it must not be approached to flames.
Important information about some of the ingredients
The BENAGOL line, except BENAGOL Lemon flavor Sugar Free and BENAGOL Strawberry flavor Sugar Free, contains sucrose: this should be taken into account in case of diabetes or low calorie diets (see point 4.2).
All the tablets (except BENAGOL lemon flavor without sugar and BENAGOL strawberry flavor without sugar) contain glucose and are therefore not suitable for patients with glucose / galactose malabsorption syndrome; they also contain sucrose so they are not suitable for patients with hereditary fructose intolerance and sucrase-isomaltase deficiency.
Benagol Ginger and Spice flavor contains excipients capable of inducing a sensation of heat in the mouth and throat when sucking the tablet.
04.5 Interactions with other medicinal products and other forms of interaction
There are no known interactions with other drugs.
BENAGOL taste Menthol-Eucalyptol should not be used concomitantly with other products (medicinal or cosmetic) containing terpene derivatives, regardless of the route of administration (oral, rectal, cutaneous, nasal or inhalation).
04.6 Pregnancy and lactation
In pregnant and breastfeeding women, the product should be administered only in case of real need, under the direct supervision of the doctor.
BENAGOL Menthol flavor - Eucalyptol:
Pregnancy
There are no or limited amount of data on the use of menthol in pregnant women.
BENAGOL taste Menthol - Eucalyptol is not recommended during pregnancy and in women of childbearing age who do not use contraceptive measures.
Feeding time
There is insufficient information on the excretion of menthol in breast milk.
BENAGOL taste Menthol - Eucalyptol should not be used during breastfeeding.
04.7 Effects on ability to drive and use machines
No effects on ability to drive or use machines have been reported.
04.8 Undesirable effects
Gastrointestinal disorders, hypersensitivity phenomena, irritation of the tongue can rarely occur.
BENAGOL taste Menthol - Eucalyptol: due to the presence of menthol and in case of non-observance of the recommended doses, there may be a risk of convulsions in children and infants.
04.9 Overdose
Any overdose could only cause gastrointestinal disturbances, for which appropriate symptomatic treatments must be adopted.
BENAGOL taste Menthol - Eucalyptol: in case of accidental oral intake or incorrect administration in infants and children there may be a risk of neurological disorders.
If necessary, administer appropriate symptomatic treatment in specialized treatment centers.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: antiseptic.
ATC code: R02AA03
The active ingredients 2,4-dichlorobenzyl alcohol and amylmetacresol have broad-spectrum local antibacterial activity on gram-positive and gram-negative pathogens, and on fungi present in the oropharyngeal cavity. Menthol has a balsamic action. Ascorbic acid has antioxidant and capillary-protective properties. It is a useful adjuvant in the treatment of colds.
Terpene derivatives can lower the epileptogenic threshold.
05.2 Pharmacokinetic properties
A bioavailability study conducted with BENAGOL tablets demonstrated a rapid release of 2,4-dichlorobenzyl alcohol and amylmetacresol in saliva with peaks reached within 3-4 minutes from the start of sucking.
The amount of 2,4-dichlorobenzyl alcohol and amylmetacresol found in saliva after 120 minutes is approximately 50% of the administered amount.
05.3 Preclinical safety data
No secondary effects attributable to the use of the product have been observed in clinical trials and in large-scale use in many countries.
Toxicological tests on various animal species have shown that the product is well tolerated even after prolonged administration.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
BENAGOL Ginger and Spice flavored tablets:
One tablet contains: sucrose, liquid glucose, tartaric acid, anthocyanins (E163), plum flavor, cream flavor, spice flavor, ginger flavor, medium chain triglycerides.
BENAGOL Honey and Lemon flavored tablets:
One tablet contains: mint essence, lemon essence, tartaric acid, honey, liquid glucose, sucrose.
BENAGOL Menthol-Eucalyptol flavor tablets:
One tablet contains: indigo carmine (E 132), eucalyptol essence, tartaric acid, liquid sucrose, liquid glucose.
BENAGOL Tablets with Vitamin C Orange flavor:
One tablet contains: sucrose, liquid glucose, tartaric acid, orange flavor, menthol, propylene glycol.
BENAGOL Sugar-free Lemon flavor tablets:
One tablet contains: lemon flavor, sodium saccharinate, tartaric acid, maltitol syrup, isomaltose.
BENAGOL Strawberry flavored tablets without sugar:
One tablet contains: strawberry flavor, anthocyanins (E163), sodium saccharinate, tartaric acid, maltitol syrup, isomaltose.
BENAGOL Cold Mint tablets:
One tablet contains: xylitol, menthol, mint flavor, eucalyptus oil, liquid sucrose, liquid glucose.
06.2 Incompatibility
There are no known incompatibilities with other substances.
06.3 Period of validity
3 years
24 months BENAGOL Ginger and Spice flavored tablets and BENAGOL Strawberry flavored tablets without sugar.
18 months BENAGOL Honey and Lemon flavor tablets in tubes of 10 and 20 tablets.
BENAGOL Honey and Lemon flavor tablets in tubes of 10 and 20 tablets: use the product within 3 months from the date of first opening the package.
06.4 Special precautions for storage
Do not store above 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
PVC / PVDC and heat-sealed aluminum blisters.
BENAGOL Honey and Lemon flavor tablets in tubes of 10 and 20 tablets: PP tube with PE cap with desiccant.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Reckitt Benckiser Healthcare International Ltd - 103-105 Bath Road, Slough, Berkshire, SL1 3UH (UK)
Representative for Italy:
Reckitt Benckiser Healthcare (Italy) S.p.A. - via G. Spadolini, 7 - 20141 Milan
08.0 MARKETING AUTHORIZATION NUMBER
BENAGOL Ginger and Spice flavor tablets - 16 tablets - AIC n. 016242226
BENAGOL Honey and Lemon flavor tablets - tube of 10 tablets - AIC n. 016242176
BENAGOL Honey and Lemon flavor tablets - tube of 20 tablets - AIC n. 016242202
BENAGOL Honey and Lemon flavor tablets - 16 tablets - AIC n. 016242240
BENAGOL Honey and Lemon flavor tablets - 24 tablets - AIC n. 016242063
BENAGOL Honey and Lemon flavor tablets - 36 tablets - AIC n. 016242149
BENAGOL Tablets with Vitamin C Orange flavor - 16 tablets - AIC n. 016242238
BENAGOL Tablets with Vitamin C Orange flavor - 24 tablets - AIC n. 016242075
BENAGOL Tablets with Vitamin C Orange flavor - 36 tablets - AIC n. 016242152
BENAGOL Menthol-Eucalyptol flavor tablets - 16 tablets - AIC n. 016242188
BENAGOL Menthol-Eucalyptol flavor tablets - 24 tablets - AIC n. 016242048
BENAGOL Sugar-free Lemon flavor tablets - 16 tablets - AIC n. 016242214
BENAGOL Sugar-free Lemon flavor tablets - 24 tablets - AIC n. 016242087
BENAGOL Sugar-free Strawberry flavor tablets - 16 tablets - AIC n. 016242190
BENAGOL Sugar-free Strawberry flavor tablets - 24 tablets - AIC n. 016242137
BENAGOL Cold Mint flavor tablets - 16 tablets - AIC n. 016242164
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
BENAGOL Honey and Lemon flavored tablets - first marketing date: November 1981
BENAGOL Tablets with Vitamin C Orange flavor - first marketing date: March 1988
BENAGOL Menthol-Eucalyptol flavor tablets - first marketing date: July 1991
BENAGOL Sugar-free Lemon flavor tablets - first commercialization date: November 1998
BENAGOL Sugar-free Strawberry flavored tablets - first marketing date: September 2006
BENAGOL Cold Mint tablets - first commercialization date: April 2010
BENAGOL Ginger and Spice flavored tablets - first release date: September 2011
10.0 DATE OF REVISION OF THE TEXT
17 July 2012
