Trachyhelp 5 mg/1,5 mg (20 lozenges)

Keep in a dry place out of reach of children.

TRACHIHELP pastilles 5 mg / 1.5 mg * 20 SOPHARMA

Package leaflet: User Information

Trachihelp® 5 mg /1.5 mg compressed lozenges

Chlorhexidine dihydrochloride/Benzocaine

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, pharmacist or nurse has told you.

• Keep this leaflet. You may have to read it again.
• If you need additional information or advice, ask your pharmacist.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See n. 4.
• If after 5 days you do not feel better or your condition worsens, you should seek medical attention.

What is in this leaflet:

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

1. What Trachyhelp is and what it is used for

Trachyhelp-pressed lozenges are intended for topical use in order to reduce the number of microorganisms in inflammatory diseases of the oral cavity (stomatitis, gingivitis, aphthae) and throat (tonsillitis, pharyngitis, laryngitis)

2. What you need to know before you use Trachihelp

Do not use Trachyhelp:

• if you are allergic to chlorhexidine, benzocaine or any of the other ingredients of this medicine (listed in section 6);
• if you have wounds and ulcers in the oral cavity and throat;
• if you have been found to have low plasma levels of the enzyme cholinesterase;
• in children under 4 years of age.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Trachyhelp.

It is necessary to know that:
Trachyhelp pressed lozenges should be applied with caution and only under medical supervision if you have wounds and ulcerations of the mucous membrane of the mouth and throat.
Long-term use (more than one week) of medicinal products containing chlorhexidine may lead to reversible staining of the tongue and teeth.

Children and adolescents

This medicine is not intended for use in children under 4 years of age.

Other medicines and Trachyhelp

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor or pharmacist if you are taking or have recently taken medicines belonging to the sulphonamide or aminosalicylates group. Benzocaine reduces the effect of these drugs.

Trachyhelp with food, drink and alcohol

Do not eat or drink fluids within 30 minutes of taking the medicine.

Pregnancy, breast-feeding 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. To date, there are no known contraindications to the use of this medicinal product during pregnancy and lactation.

Driving and using machines

There is no evidence that the ability to drive or use machines has been shown.

Due
to the content of aspartame, the product should not be used by people suffering from phenylketonuria (an inherited disease associated with disorders in the metabolism of the important amino acid phenylalanine, leading to its accumulation in the body).

3. How to use Trachyhelp

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults and children over 12 years of age:
Several times a day 1 lozenge. If necessary, one tablet can be sucked every 1-2 hours up to a maximum dose of 8 tablets per day.

Use in children and adolescents

Children from 4 to 12 years of age:
Up to 4 lozenges per day, taken every few hours.

Children under 4 years of age:
Should not be used in this age group.

Treatment should be started as soon as possible at the onset of the first symptoms and continue for 1-2 days after their resolution.

Method of administration:

For oromucosal use.
Sucking tablets are kept in the mouth until dissolved. They are not swallowed!
It is desirable after taking the tablet for 30 minutes not to consume food and drink. The last tablet is taken at bedtime and at least 30 minutes after brushing your teeth.

If you take more Trachyhelp than you should

When applying the product according to the recommendations, the probability of overdose is minimal.
There is a possibility of manifestations of overdose only in case of ingestion of a large amount of the drug.
In this case, it is necessary to contact your doctor for advice.

If you forget to take Trachyhelp

Do not take a double dose to make up for a forgotten dose.
If you forget to take one dose, do so during the next regular dose.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

With prolonged use, a transient change in taste and a burning sensation and stiffness of the tongue may occur.

Prolonged use (more than one week) of medicinal products containing chlorhexidine may lead to staining of the teeth, which can be cleaned with toothpaste.
Reversible coloring of the tongue is also possible.

Rarely manifestations of local irritant effect and contact allergy are observed. In very rare cases, general hypersensitivity reactions to anaphylactic shock (life-threatening allergic reaction) are also possible.

When applying benzocaine, blood disorders have been observed in young children (methaemoglobinaemia – the formation of pathological hemoglobin).

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information about the safety of this medicine.

5. How to store Trachyhelp

Keep out of the reach of children.
Store below 25°C.

Do not use this medicine after the expiry date which is stated on the carton after the abbreviation EXP. 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 to protect the environment.

6. Contents of the pack and other information

What Trachyhelp contains

• The active substances in 1 tablet are: chlorhexidine dihydrochloride 5 mg and benzocaine 1.5 mg.
• Excipients: isomalt; macrogol 6000; peppermint aroma (menthol, menthon, peppermint essential oil, maltodextrin, sodium starch octenyl succinate E 1450); aspartame (E 951); magnesium stearate.

What Trachyhelp looks like and contents of the pack

White or off-white, round, flat pressed lozenges with mint flavor.

The pack contains 9 or 10 lozenges in a PVC/AL foil blister.
1,2 or 3 blisters x 9 tablets with a leaflet in a cardboard box. 1 or 2 blisters x 10 tablets with a leaflet in a cardboard box.

Marketing authorisation holder and manufacturer:

“Adipharm” EAD, Bulgaria

Made for:

Sopharma AD, Bulgaria