DECATYLEN NATURAL SPRAY 20ML

Code: R02AA02 

Vendor, principal: Teva. 

DECATYLEN 0.25MG/+0.03MG N20

Package leaflet: Information for the user

Decatylen, 0.25 mg/0.03 mg lozenges

Dequalinium chloride/cinchocaine hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

What is in this leaflet

1.   What Decatylen is and what it is used for
2.   What you need to know before you use Decatylen
3.   How to use Decatylen
4.   Possible side effects
5.   How to store Decatylen
6.   Contents of the pack and other information

1. What Decatylen is and what it is used for

Decatylen lozenges eliminate bacteria and viruses that can cause throat pain and mouth inflammation. The lozenges also contain an analgesic agent.
Decatylen lozenges are generally well-tolerated and do not cause mucous membrane irritation. Decatylen does not cause dental caries and it can be used by diabetic patients. Decatylen is used for the antiseptic treatment of the mouth and pharynx, as well as for relieving pain caused by bacterial and fungal infections.
You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

2. What you need to know before you use Decatylen Do not use Decatylen

-   if you are allergic to dequalinium chloride, cinchocaine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
-   if you are allergic to certain substances known as quaternary ammonium compounds (e.g. benzalkonium chloride).
Do not use Decatylen if you have any of the allergies listed above.

Warnings and precautions

Talk to your doctor or pharmacist before using Decatylen.
Talk to your doctor
-   if you have a high fever,
-   if your symptoms are not alleviated in one week.

Other medicines and Decatylen

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Toothpaste: the anionic tensides found in regular toothpaste reduce the efficiency of Decatylen. As a result, you should wait for at least half an hour after brushing your teeth before you use Decatylen.

Pregnancy and breast-feeding

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. Dequalinium/cinchocaine can be used during pregnancy and breast-feeding.

Driving and using machines

Even though no corresponding studies have been conducted, it is extremely unlikely that Decatylen affects the ability to drive or use machines.

Decatylen contains sorbitol

The sweetener used in Decatylen lozenges is sorbitol (E420) that does not cause tooth decay (caries).
The lozenges are also suitable for diabetic patients.
If you have been told by your doctor that you have intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to use Decatylen

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Unless prescribed otherwise by your doctor, the regular dose is:
Adults and adolescents over 12 years of age:
Allow one lozenge to dissolve in your mouth every 2 hours. After the symptoms of inflammation recede, take 1 lozenge every 4 hours.
Children over 4 years of age:
Allow one lozenge to dissolve in your mouth every 3 hours. After the symptoms of inflammation recede, take 1 lozenge every 4 hours.
You must talk to a doctor if your symptoms worsen and do not improve after 7 days.
If you feel that the effect of the medicine is too weak or too strong, talk to your doctor or pharmacist.

If you use more Decatylen than you should

Dequalinium/cinchocaine is generally well-tolerated. Nevertheless, overdosing can cause dizziness, vomiting, and symptoms of oesophagal irritation.
Treatment of an overdose is symptomatic. Alleviating measures can be used if necessary; vomiting and gastric lavage should be avoided.

If you forget to use Decatylen

Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Allergic reactions accompanied by rash and pruritus have occurred in very rare cases.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, talk to your doctor or pharmacist.
The incidence of side effects is defined as follows: very common ≥ 1/10), common ≥ 1/100 to < 1/10), uncommon ≥ 1/1,000 to < 1/100), rare ≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), unknown (cannot be estimated from available data).
Immune system disorders
Rare: hypersensitivity reactions
Respiratory, chest, and mediastinal disorders Uknown: dyspnoea

Reporting of side effects

If you 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 www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5.   How to store Decatylen

Keep this medicine out of the sight and reach of children.
Do not store at a temperature higher than 25°C.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.   Contents of the pack and other information What Decatylen contains

-   The active substances are dequalinium chloride and cinchocaine hydrochloride. Each lozenge contains 0.25 mg of dequalinium chloride (Dequalini chloridi) and 0.03 mg of cinchocaine hydrochloride (Cinchocaini hydrochloridi).
-   The other ingredients are sorbitol (E420), talc, magnesium stearate, colloidal silica, peppermint aroma, peppermint oil.

What Decatylene looks like and contents of the pack

White round lozenges with a flat edge and a score line on one side and the marking “D” on the other side.
The tablets are packaged in a PVC/Aclar-aluminium blister package.
The pack contains 20, 30 or 40 lozenges.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Mepha Lda.
Lagoas Park,
2740-298 Porto Salvo,
Portugal
Manufacturers
Merckle GmbH Ludwig-Merckle-Strasse 3 89143 Blaubeuren Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
UAB Sicor Biotech Estonian branch
Lootsa 8
11415 Tallinn
Republic of Estonia
Phone: +372 6610801

This leaflet was last revised in March 2017