Expectym 110 mg/ml syrup

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Expectym, 110 mg/ml, syrup

Liquid thyme extract

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of the leaflet

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

1. What Expectym is and what it is used for

Expectym is a traditional herbal medicinal product that helps relieve productive cough associated with the common cold, based exclusively on its traditional use. Expectym is a medicine for adults, adolescents, and children over 4 years of age. Expectym contains liquid extract of thyme (Thymus vulgaris L., herba or Thymus zygis L., herba).

You should consult a doctor if symptoms worsen or do not improve after 5 days.

2. What you need to know before starting to take Expectym

Do not take Expectym:

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

Warnings and precautions

Exercise special caution 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 of age.

Taking Expectym with other medicines

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

Taking Expectym with food, drinks, and alcohol

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

Pregnancy and breastfeeding

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

Pregnancy

Taking Expectym during pregnancy is not recommended. As a general precaution and due to the lack of clinical information, this medication should not be taken during pregnancy.

Breastfeeding

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

Fertility

There are no data available regarding fertility.

Driving and use of machines

There are no data indicating that this medicine may affect concentration or the ability to respond while driving.

Expectym contains:

• Ethanol at 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 or 5.1 ml of wine per 20 ml dose. This is harmful for individuals suffering from alcoholism. The alcohol content should be taken into account in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.
• 380 mg/ml sorbitol (E420). Sorbitol may produce a mild laxative effect. Calorific value: 2.6 kcal/g sorbitol. If your doctor has informed you that you have sorbitol intolerance or intolerance to certain sugars, consult with your doctor before taking this medicine.

3. How to take Expectym

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in 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 insufficient data to recommend a specific dose for cases of renal or hepatic impairment.

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

If you take more Expectym than you should

No overdose cases have been reported. Contact your doctor or pharmacist immediately 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 become more pronounced.

If you forget to take Expectym

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

If you stop taking Expectym

Not applicable.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products (www.notificaRAM.es). By reporting adverse 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 packaging.
• After opening, 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 and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Expectym:

The active substance is:

Liquid extract of thyme (Thymus vulgaris L., herba or Thymus zygis L., herba). 1 ml of syrup (equivalent to 1.1 g) contains 110 mg (0.11 ml) of liquid extract of Thymus vulgaris L., herba or Thymus zygis L., 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 components are:

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

Appearance of the product and contents of the container

Expectym is a transparent, brown syrup with the characteristic odour 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 further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

This medicinal product 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 most recent revision of this leaflet: 03/2018.

“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”