Sinosept Apteo Med

Package Leaflet: Information for the Patient

Synosept APTEO MED, 1.2 mg + 0.6 mg, hard tablets
Alcohol 2,4-dichlorobenzylicus + Amylmetacresolum

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient, or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after three days there is no improvement or you feel worse, contact a doctor.

Table of Contents of the Leaflet

• 1. What is Synosept APTEO MED and what is it used for
• 2. Important information before using Synosept APTEO MED
• 3. How to use Synosept APTEO MED
• 4. Possible side effects
• 5. How to store Synosept APTEO MED
• 6. Contents of the pack and other information

1. What is Synosept APTEO MED and what is it used for

Synosept APTEO MED hard tablets contain amylmetacresol and 2,4-dichlorobenzyl alcohol. Both ingredients are antiseptics.
Synosept APTEO MED is indicated for the relief of sore throat symptoms. Sucking on the tablet allows the active substances to act on the throat where discomfort occurs, and also soothes throat irritations. This helps to relieve pain and discomfort in the mouth and throat.

2. Important information before using Synosept APTEO MED

When not to use Synosept APTEO MED:

• If the patient is allergic (hypersensitive) to amylmetacresol, 2,4-dichlorobenzyl alcohol, or any of the other ingredients of this medicine (listed in section 6);
• In children under 6 years of age.

Warnings and precautions

In case of other throat problems, consult a doctor or pharmacist.
Long-term use of this medicine is not recommended.
Consult a doctor if symptoms persist for more than 3 days, worsen, or if other symptoms occur, such as high fever, headache, nausea, or vomiting, and skin rash, as this may indicate a bacterial infection (e.g., tonsillitis or pharyngitis) that requires different treatment, to be decided by a doctor.

Children

Due to the size of the tablets, there is a risk of choking on Synosept APTEO MED in small children.
The medicine should not be given to children under 6 years of age.

Synosept APTEO MED and other medicines

No clinically significant interactions with other medicines are known.
Tell your doctor about all medicines you are taking now or have recently taken, as well as medicines you plan to take, even those that are available without a prescription.

Pregnancy, breastfeeding, and fertility

There are insufficient data on the use of amylmetacresol and 2,4-dichlorobenzyl alcohol in pregnant women. The safety of Synosept APTEO MED during pregnancy has not been established. If you are pregnant or think you may be pregnant, or are planning to have a baby, consult a doctor or pharmacist before using this medicine.
It is not known whether 2,4-dichlorobenzyl alcohol, amylmetacresol, and their metabolites pass into breast milk. The risk to newborns and (or) infants cannot be excluded. If you are breastfeeding, consult a doctor or pharmacist before using this medicine.
There are no available data on the effect of amylmetacresol and 2,4-dichlorobenzyl alcohol on fertility.

Driving and using machines

The effect of the medicine on the ability to drive and use machines is not known.

Synosept APTEO MED contains maltitol liquid (E 965) and isomalt (E 953)

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The medicine may have a mild laxative effect, as each tablet contains 1.830 g of isomalt and 457.6 mg of maltitol liquid.
Caloric value: 2.3 kcal/g maltitol/isomalt.

Synosept APTEO MED contains orange yellow (E 110)

The medicine may cause allergic reactions.

Synosept APTEO MED contains a fragrant substance with citral

Citral may cause allergic reactions.

3. How to use Synosept APTEO MED

Synosept APTEO MED should always be used exactly as described in this package leaflet for the patient, or as directed by a doctor or pharmacist. If you have any doubts, consult a doctor or pharmacist.
Synosept APTEO MED is intended for adults and children over 6 years of age.
Adults:One tablet every 2 or 3 hours, as needed. The maximum dose is 8 tablets per day.
Children over 6 years of age:a maximum of 4 tablets in 24 hours, with at least a 2-hour interval between tablets.
For use on the mucous membrane of the mouth. The tablet should be sucked slowly until it is completely dissolved.
Use the smallest effective dose of Synosept APTEO MED for the shortest duration necessary to relieve symptoms, not longer than 3 days. If after 3 days the symptoms do not improve, worsen, or if other symptoms occur, such as high fever, headache, nausea, or vomiting, and skin rash, consult a doctor.

Using more than the recommended dose of Synosept APTEO MED

In case of using more than the recommended dose of Synosept APTEO MED, gastrointestinal disorders may occur. Do not take additional doses of the medicine.
Consult a doctor or pharmacist.

Missing a dose of Synosept APTEO MED

Do not take a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience an allergic reaction to the medicine, stop using it and consult a doctor or pharmacist. If any of the side effects get worse, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Side effects that may occur:

Frequency not known(frequency cannot be estimated from the available data)

• allergic reactions [may manifest as rash, angioedema (skin and mucous membrane swelling), urticaria, bronchospasm, and hypotension with fainting],
• abdominal pain, nausea, discomfort in the mouth [may manifest as throat irritation, paresthesia in the mouth (abnormal sensations in the mouth such as warmth, burning, tingling, numbness, etc.), mouth swelling, and glossodynia (burning in the mouth)], tongue pain,
• skin rash.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Synosept APTEO MED

There are no special precautions for storage.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after:
“EXP”. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Synosept APTEO MED contains

• The active substances of the medicine are 2,4-dichlorobenzyl alcohol and amylmetacresol. One hard tablet contains 1.2 mg of 2,4-dichlorobenzyl alcohol and 0.6 mg of amylmetacresol.
• The other ingredients of the medicine are: peppermint oil, quinoline yellow (E 104), sodium saccharin (E 954), tartaric acid (E 334), isomalt (E 953), maltitol liquid 75% (E 965), orange yellow (E 110), lemon flavor (lemon oil and terpene, natural citral), honey flavor (propylene glycol, benzoic acid, and others).

What Synosept APTEO MED looks like and contents of the pack

Synosept APTEO MED, 1.2 mg + 0.6 mg, hard tablets are yellow, round, biconvex hard tablets with a diameter of 19 mm, with a honey and lemon flavor.
The hard tablets are available in PVC/PVDC/Aluminum blisters in a cardboard box.
The pack contains 8, 12, or 24 hard tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
phone: 607 696 231
e-mail: [email protected]

Manufacturer:

LOZY’S PHARMACEUTICALS, S.L.
Campus Empresarial no. 1
Lekaroz, 31795 Navarra
Spain

Date of last revision of the leaflet: