Label: information for the patient

Expectym, 110 mg/ml, syrup

Liquid extract of thyme

Read this label carefully before starting to take this medication, as it contains important information for you.

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

1. What isExpectymand what it is used for

2. What you need to know before starting to takeExpectym

3. How to takeExpectym

4. Possible adverse effects

5. Storage ofExpectym6. Contents of the container and additional information

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

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

Do not take Expectym:

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

Warnings and precautions

Take special precautions and consult your doctor or pharmacist:

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

Consult your doctor or pharmacist before taking this medication.

Children

Do not administer to children under 4 years.

Expectym with other medications

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

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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

Breastfeeding

Do not take Expectym during breastfeeding. As a general precaution and due to the lack of clinical information, this medication should not be taken during breastfeeding.

Fertility

No data are available regarding fertility.

Driving and operating machinery

No data indicate that this medication may affect concentration or the ability to respond while driving.

Expectym contains:

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

Follow exactly the medication administration instructions contained in this leaflet or those indicated 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 appropriate dose. There are not enough 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 adverse effects occur that are not listed in the leaflet.

If you take more Expectym than you should

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

If you forgot to take Expectym

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Expectym

Not applicable.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use (www.notificaRAM.es). By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

• Keep this medication out of the sight and reach of children.
• Store in its original packaging.
• Once opened, the conservation period of this medication is 28 days.
• Do not use this medication after the expiration date that appears on the box and the bottle after CAD. The expiration date is the last day of the month indicated.
• Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

Composition of Expectym:

The active principle 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).

Solvents for extraction: 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 packaging

Expectym is a transparent, brown syrup with the characteristic odor of thyme. It is available in an amber-colored 200 ml 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.

Holder of the marketing authorization and responsible manufacturer

Conforma NV

Zenderstraat 10

9070 Destelbergen

Belgium

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

This medicine is authorized in the member states of the European Economic Area with 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 review of this leaflet: 03/2018.

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