PACKAGE LEAFLET
Read all of this leaflet carefully, because it contains important information for you.
This medicine is available without prescription for treatment of mild illness without doctors help. However, you still need to take Toncils lozenges carefully to get the best results from it.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your pharmacist.
- You must contact a doctor if your symptoms worsen or do not improve.
- If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, or the side effect you experience (see point 4) is serious, please tell your doctor or pharmacist.
In this leaflet:
1. What Toncils lozenges are and what they are used for
2. Before you take Toncils lozenges
3. How to take Toncils lozenges
4. Possible side effects
5. How to store Toncils lozenges
6. Further information
1. WHAT TONCILS LOZENGES ARE AND WHAT THEY ARE USED FOR
Toncils lozenges are used for disinfection of mouth and throat. The active substance chlorhexidine is a broad-spectrum disinfectant, which is effective against most of the microbial species that occur in the mouth. It is effective against several bacteria, yeasts, dermatophytes and lipophilic viruses. Chlorhexidine is ineffective against bacterial spores. The other active substance benzocaine is a local anaesthetic, which onset of action is fast and which effect lasts for 5-15 minutes. Toncils lozenges are ineffective in tonsillitis caused by streptococci.
2. BEFORE YOU TAKE TONCILS LOZENGES
Do not take TONCILS lozenges
If you are allergic (hypersensitive) to chlorhexidine, benzocaine or any of the other ingredients of Toncils lozenges.
Taking other medicines
Interactions with other medicines and alcohol are not known.
Pregnancy and breast-feeding
Preparation can be used during pregnancy and breast-feeding.
Driving and using machines
Toncils lozenges do not have effect on ability to drive or to use machines
Important information about some of the ingredients of Toncils lozenges
- If your doctor has told you that you have intolerance to some sugars, contact your doctor before taking this medical product.
- Toncils lozenges contain sorbitol and xylitol, which may have laxative effect in big doses.
- Toncils lozenges contain aspartame, which is a source of phenylalanine. Aspartame may be harmful for people with phenylketonuria.
3. HOW TO TAKE TONCILS LOZENGES
Dose for adults is 1 lozenge 4-8 times per day. Dose for children 7-15 years of age is 1/2 lozenge 4-8 times per day. For children below 7 years of age only by doctor's advice.
Lozenge is dissolved slowly in the mouth.
After brushing the teeth an interval of 30 minutes is recommended before taking Toncils lozenge. If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you take more Toncils lozenges than you should
In the case of overdose, contact your doctor, hospital emergency room or Poison Information Centre (tel. 09-471 977) immediately.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Toncils lozenges can cause side effects, although not everybody gets them.
Chlorhexidine may cause staining of teeth, fillings of the dental cavity and tongue, especially during long-term use. However, the discoloration disappears when the treatment is discontinued. Transient taste disturbances and a burning sensation of tongue may occur in the initial use of Toncils. Chlorhexidine has been described to cause allergic and hypersensitive reactions, but they are rare.
Benzocaine has been described to have cause local allergic and hypersensitive reactions. Systemic adverse effects are rare. Methemoglobinemia may rarely occur especially in children with ulceration of mucous membranes.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE TONCILS LOZENGES
Keep out of the reach and sight of children.
Store below 25C. Store in the original package.
Do not use Toncils after the expiry date stated on the package.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What does Toncils lozenges contains
The active substances are Chlorhexidine dihydrochloride 5 mg and benzocaine 2 mg in one lozenge.
The common excipients for Toncils lozenges are:
Xylitol 580 mg (E 967), sorbitol 100 mg (E 420), aspartame 5 mg (E 951), microcrystalline cellulose, macrogol 6000, copovidone, carmellose sodium, magnesium oxide, magnesium stearate and anhydrous colloidal silica.
Flavouring substances for Toncils:
Anise oil, levomenthol and eucalyptus oil.
Flavouring substances for Toncils Blackcurrant:
Blackcurrant aroma, maltodextrin, sucrose 8 mg, glyceryl triacetate (E 1518), acacia gum (E 414), mono and diacetyl tartaric acid esters of mono- and diglycerides of fatty acids (E 472e), silicon dioxide (E 551), propylene glycol (E 1520), triethyl citrate (E 1505) and medium chain triglycerides
Flavouring substances for Toncils Lemon
Lemon aroma, maltodextrin, sucrose 9 mg, acacia gum (E 414), mono and diacetyl tartaric acid esters of mono- and diglycerides of fatty acids (E 472e) and silicon dioxide (E 551).
Toncils lozenges are lactose free.
Description of the medicine and the package size
Toncils lozenge: Natural white, gray spotted, round and even tablet with score. Diameter is 15 mm.
Toncils Blackcurrant and Toncils Lemon lozenges: Natural white, grey and yellow spotted, round and even tablet with score. Diameter is 15 mm.
Package size: 24 lozenges.
Marketing authorization holder and Manufacturer
Vitabalans Oy, Varastokatu 8, 13500 Hämeenlinna
Puh: 03-615 600
Fax: 03-618 3130
This leaflet was last approved on 13.11.2007
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