Package leaflet: information for the patient

Synosept APTEO MED, 1.2 mg + 0.6 mg, hard pastilles
Alcohol 2,4-dichlorobenzylicus + Amylmetacresolum
Please read this 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 patient leaflet or as directed by the
physician, pharmacist, or nurse.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any not listed in this leaflet, inform your physician, pharmacist, or nurse. See section 4.
If symptoms do not improve after three days or if you feel worse, consult your physician.

Leaflet contents

What Synosept APTEO MED is and what it is used for
Important information before using Synosept APTEO MED
How to use Synosept APTEO MED
Possible side effects
How to store Synosept APTEO MED
Contents of the pack and other information

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

Synosept APTEO MED pastilles contain amylmetacresol and 2,4-dichlorobenzyl alcohol as active ingredients. Both substances are antiseptics.
Synosept APTEO MED is indicated for the relief of sore throat symptoms. Sucking the pastille allows the active ingredients to act locally in the throat where discomfort occurs, helping to soothe throat irritation. This helps 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 amylometacresol, 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

If the patient experiences any other throat problems, consult a doctor or pharmacist.
Prolonged use of this medicine is not recommended.
Contact a doctor if symptoms persist for more than 3 days, worsen, or if other symptoms occur such as high fever, headache, nausea or vomiting, or skin rash, as this may indicate a bacterial infection (e.g. tonsillitis or pharyngitis) which requires different treatment as determined by a physician.

Children
Due to the size of the tablets, there is a risk of choking with Synosept APTEO MED in young children.
This medicine must not be given to children under 6 years of age.

Synosept APTEO MED with other medicines
There are no clinically significant interactions with other medicines known.
Tell your doctor if the patient is taking, has recently taken or might take any other medicines, including those obtained without a prescription.

Pregnancy, breastfeeding and fertility
There are insufficient data on the use of amylometacresol and 2,4-dichlorobenzyl alcohol in pregnant women. The safety of Synosept APTEO MED during pregnancy has not been established. If the patient is pregnant or suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
It is not known whether 2,4-dichlorobenzyl alcohol, amylometacresol and their metabolites pass into human breast milk. Risk to newborns and/or infants cannot be excluded. If the patient is breastfeeding, she should consult a doctor or pharmacist before using this medicine.
There are no available data on the effect of amylometacresol and 2,4-dichlorobenzyl alcohol on fertility.

Driving and operating machinery
The effect of this medicine on the ability to drive or operate machinery is unknown.

Synosept APTEO MED contains liquid maltitol (E 965) and isomalt (E 953)
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a 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 liquid maltitol.
Energy value: 2.3 kcal/g of maltitol/isomalt.

Synosept APTEO MED contains sunset yellow (E 110)
This medicine may cause allergic reactions.

Synosept APTEO MED contains a flavouring substance containing 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 patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Synosept APTEO MED is intended for use in adults and children over 6 years of age.

Adults: One tablet every 2 or 3 hours, as needed. Maximum dose is 8 tablets per day.

Children over 6 years of age: maximum of 4 tablets per day, with at least a 2-hour interval between doses.

For use on the oral mucosa. The tablet should be sucked slowly until completely dissolved.

Use the lowest effective dose of Synosept APTEO MED for the shortest duration necessary to relieve symptoms, not longer than 3 days. If symptoms persist after 3 days, worsen, or if new symptoms occur such as high fever, headache, nausea or vomiting, or skin rash, consult a doctor.

Use of more than the recommended dose of Synosept APTEO MED

If an overdose of Synosept APTEO MED is taken, gastrointestinal disturbances may occur. Do not take further doses of the medicine.

Consult a doctor or pharmacist.

Missed 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If allergic reactions to the medicine occur, its use should be discontinued and medical advice should be sought
from a doctor or pharmacist. If any of the adverse symptoms worsen or if any adverse reactions not listed
in this leaflet occur, the doctor or pharmacist should be informed.

Adverse reactions that may occur:
Frequency unknown (frequency cannot be determined from the available data)

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, they should be reported
to a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw,
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Synosept APTEO MED

There are no special requirements for storage conditions of this medicinal product.
The medicine should be stored out of 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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask a pharmacist
how to dispose of medicines no longer required. Such measures will help protect
the environment.

6. Contents of the pack and other information

What Synosept APTEO MED contains

The active substances in this medicine are 2,4-dichlorobenzyl alcohol and amylometacresol. Each hard pastille contains 1.2 mg of 2,4-dichlorobenzyl alcohol and 0.6 mg of amylometacresol.
The other ingredients are: Peppermint essential oil, Quinoline Yellow (E 104), Sodium saccharin (E 954), Tartaric acid (E 334), Isomalt (E 953), Maltitol liquid 75% (E 965), Sunset Yellow (E 110), Lemon flavour (lemon oil and terpenes, natural citral), Honey flavour (propylene glycol, phenylacetic acid and others).

What Synosept APTEO MED looks like and contents of the pack
Synosept APTEO MED 1.2 mg + 0.6 mg, hard pastilles are yellow, round, biconvex hard pastilles with a diameter of 19 mm, with a honey and lemon flavour.
The hard pastilles are available in PVC/PVDC/Aluminium blisters contained in a cardboard box.
The pack contains 8, 12 or 24 hard pastilles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
tel. 607 696 231
e-mail: [email protected]
Manufacturer:
LOZY’S PHARMACEUTICALS, S.L.
Campus Empresarial no. 1
Lekaroz, 31795 Navarra
Spain