EXPECTYM 110 mg/mL SYRUP

Introduction

Package Leaflet: Information for the Patient

Expectym, 110 mg/ml, syrup

Thyme liquid extract

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 5 days.

Contents of the Package Leaflet

1. What is Expectym and what is it used for
2. What you need to know before taking Expectym
3. How to take Expectym
4. Possible side effects
5. Storage of Expectym
6. Contents of the pack and further information

1. What is Expectym and what is it used for

Expectym is a traditional herbal medicinal product used to relieve productive cough associated with colds, based exclusively on its traditional use. Expectym is a medicine for adults, adolescents, and children over 4 years old. Expectym contains thyme liquid extract (Thymus vulgarisL., herbaor Thymus zygisL., herba).

You should consult a doctor if it worsens or does not improve after 5 days.

2. What you need to know before taking Expectym

Do not take Expectym:

If you are allergic (hypersensitive) to thyme (Thymus vulgarisL., herbaor Thymus zygisL., herba), to other components of the Lamiaceae family, or to any of the ingredients of this medicine (see section 6).

Warnings and precautions

Be particularly cautious and consult your doctor or pharmacist:

• If you experience breathing difficulties, fever, or purulent secretions
• If symptoms persist for more than 5 days

Consult your doctor or pharmacist before taking this medicine.

Children

Do not administer to children under 4 years old.

Taking Expectym with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking Expectym with food, drinks, and alcohol

No interactions with food, drinks, or alcohol have been described.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

It is not recommended to take Expectym during pregnancy. As a general precaution and due to the lack of clinical data, this medicine should not be taken during pregnancy.

Breastfeeding

It is not recommended to take Expectym during breastfeeding. As a general precaution and due to the lack of clinical data, this medicine should not be taken during breastfeeding.

Fertility

There are no data related to fertility.

Driving and using machines

There are no data indicating that this medicine may affect concentration or response to drive.

Expectym contains:

• ethanolat 3.1 vol% (alcohol), i.e., up to 500 mg per 20 ml dose (or 125 mg per 5 ml dose), equivalent to 12.5 ml of beer, 5.1 ml of wine per 20 ml dose. It is harmful to people suffering from alcoholism. The alcohol content should be taken into account in the case of pregnant or breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy.
• 380 mg/ml sorbitol(E420). Sorbitol may have a mild laxative effect. Caloric value 2.6 kcal/g sorbitol. If your doctor has told you that you have an intolerance to sorbitol or some sugars, consult with them before taking this medicine.

3. How to take Expectym

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Expectym is taken orally. The package includes a measuring device to measure the correct dose. There are no sufficient data to recommend a specific dose for cases of renal or hepatic insufficiency.

Consult your doctor or pharmacist if symptoms persist after five days of treatment or if side effects occur that are not listed in the package leaflet.

If you take more Expectym than you should

No cases of overdose have been reported. Immediately contact your doctor or pharmacist if you take more Expectym than you should. They will decide on the appropriate measures. It is possible that the side effects listed below in section 4 (gastrointestinal disorders) may be intensified.

If you forget to take Expectym

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

If you stop taking Expectym

Not applicable.

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.

Adverse reactions mainly consist of gastrointestinal problems and, in people with hypersensitivity, anaphylactic shock or allergic reactions may occur. The frequency of these side effects is unknown.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines (www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Expectym

• Keep this medicine out of the sight and reach of children.
• Store in the original package.
• Once opened, the shelf life of this medicine is 28 days.
• Do not use this medicine after the expiry date stated on the carton and bottle after EXP. The expiry date is the last day of the month indicated.
• 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 further information

Composition of Expectym:

The active substance is:

Thyme liquid extract (Thymus vulgarisL., herbaor Thymus zygisL., herba). 1 ml of syrup (equivalent to 1.1 g) contains 110 mg (0.11 ml) of thyme liquid extract (Thymus vulgarisL., herbaor Thymus zygisL., herba) (1:2-2.5).

Extraction solvents: 10% (m/m) ammonia solution / 85% (m/m) glycerin / 90% (V/V) ethanol / purified water (1/20/70/109).

The other ingredients are:

sorbitol (E420), benzoic acid (E210), xanthan gum, and purified water.

Appearance and packaging of the product

Expectym is a clear, brown syrup with the characteristic smell of thyme. It is available in a 200 ml amber glass bottle with a child-resistant plastic cap and a dosing device.

The dosing device has markings for 2.5 ml, 5 ml, 10 ml, 15 ml, and 20 ml.

Marketing authorization holder and manufacturer

Conforma NV

Zenderstraat 10

9070 Destelbergen

Belgium

For more information about this medicine, contact the local representative of the marketing authorization holder:

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium, Netherlands, Luxembourg, Germany, Portugal, Austria: Pulmocap Thymus, 110 mg/ml, syrup

Italy: Timo Conforma, 110 mg/ml, syrup

France: Timifit, 110 mg/ml, syrup

Poland: Sallevia

Date of the last revision of this package leaflet:03/2018.

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”