0.05% mouthwash 
sodium fluoride

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

Always take this medicine exactly as described in this leaflet or as directed by your doctor/dentist, dental hygienist, or pharmacist.

  • Save this information, you may need to read it again.
  • Contact the pharmacy staff if you need more information or advice.
  • If you get any side effects, talk to a doctor/dentist, dental hygienist, or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Dentan is and what it is used for 
2. What you need to know before using Dentan 
3. How to use Dentan 
4. Possible side effects 
5. How to store Dentan 
6. Contents of the packaging and other information 

1. What Dentan is and what it is used for

Fluoride can, after the teeth appear, make the resistance to caries higher if it is added locally in the oral cavity, for example through a fluorine solution. Dentan mouthwash is a ready-to-use sodium fluoride solution intended for mouthwash.

Dentan is used as a caries prevention treatment for children over 6 years and adults. Dentan can be used for self-care in the event of an increased risk of caries, e.g. in case of dry mouth, high consumption of sweets and many snacks, partial dentures, stuck braces. A basic measure to prevent caries is the use of fluoride toothpaste.

2. What you need to know before using Dentan

Do not use Dentan

  • if you are allergic to sodium fluoride or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your dentist/pharmacist before using Dentan if you have:

  • severe kidney disease.

Other medicines and Dentan

Tell your dentist, doctor, or pharmacist if you are taking, have recently taken, or might take any other medicines. The treating dentist/physician should be aware of concomitant treatment with other drugs containing fluoride.

Pregnancy and breastfeeding

There are no risks with using Dentan during pregnancy and breast-feeding.

Driving and using machines

Dentane has no or negligible effect on the ability to drive and use machines.

Dentane contains methyl parahydroxybenzoate

Dentan contains the excipient methyl parahydroxybenzoate ( preservative E 218) which may cause an allergic reaction (possibly delayed).

3. How to use Dentan

Always take this medicine exactly as described in this leaflet or as directed by your doctor/dentist, dental hygienist, or pharmacist. If you are not sure, talk to your doctor/dentist or pharmacist.

Dosage

Children 6-12 years: Dosage according to the recommendation of dental staff.

Children over 12 years and adults with high caries risk or with a lot of caries: 

10 ml Dentan fluoride solution 1-2 times daily, as an alternative to fluoride tablets.

The liquid is taken into the mouth and allowed to strain between the teeth for 1 minute, after which the solution spits out. You should then not rinse your mouth or eat within the next half hour. The solution should not be swallowed. In case 10 ml of solution is still swallowed, the amount of fluorine is so small that there is no risk of poisoning.

If you use more Dentan than you should 

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Dentan

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Dentan and contact a doctor immediately if you get any of the following symptoms ( angioedema, very rare)

  • swelling of the face, tongue or throat
  • difficulty swallowing
  • hives and difficulty breathing

Other side effects are

Rare (may affect up to 1 in 1,000 people) : Skin rash, flushing, hives , inflammation of the mouth (may cause symptoms such as burning and stinging sensation in the mouth and tongue and swollen lips).

Has been reported (occurs in an unknown number of users) : hypersensitivity reactions (even locally in the oral cavity).

5. How to store Dentan

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. The expiration date is the last day of the specified month.

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. Contents of the packaging and other information

Content declaration

  • The active substance is sodium fluoride 0.5 mg / ml.
  • The other ingredients are methyl parahydroxybenzoate ( preservative E 218) and water.

Marketing Authorisation Holder

Meda AB

Box 906

170 09 Solna

Tel: 08-630 19 00

Muhammad Nadeem

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