Sallevia

PATIENT INFORMATION LEAFLET

Leaflet included in the packaging: patient information

Sallevia

110 mg/ml, syrup
Thymi extractum fluidum
(Liquid extract of thyme herb)

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

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 5 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Sallevia and what is it used for
• 2. Important information before taking Sallevia
• 3. How to take Sallevia
• 4. Possible side effects
• 5. How to store Sallevia
• 6. Package contents and other information

1. What is Sallevia and what is it used for

Sallevia relieves productive (wet) cough associated with a cold.
Sallevia is a traditional herbal medicinal product containing a liquid extract of thyme herb (Thymus vulgarisL. and/or Thymus zygisL.), for use in specific indications resulting from its long-term use.
If after 5 days there is no improvement or the patient feels worse, they should contact their doctor.

2. Important information before taking Sallevia

When not to take Sallevia:

If the patient is allergic (hypersensitive) to the active substance, thyme, other plants of the Lamiaceae family (formerly Labiatae, lip-shaped flowers) or to any other ingredients of this medicinal product (listed in section 6).

Warnings and precautions

Consult a doctor or pharmacist before taking this medicinal product.
In case of shortness of breath, fever, or purulent sputum (respiratory secretions) or if symptoms persist for more than 5 days or worsen, consult a doctor or pharmacist.

Children

Do not use in children under 4 years of age.

Sallevia and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
No systematic studies on interactions have been conducted.

Sallevia with food, drink, and alcohol

No interactions with food, drink, or alcohol have been found.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Sallevia should not be used during pregnancy.
Breastfeeding
Sallevia should not be used during breastfeeding.
Fertility
There are no data on the effect of the medicine on fertility.

Driving and using machines

There are no data suggesting that the medicine may affect concentration or cause drowsiness.

Sallevia contains:

• 3.1% (V/V) ethanol(alcohol), i.e., up to 500 mg of alcohol per 20 ml dose (or 125 mg per 5 ml dose), equivalent to 12.5 ml of beer and 5.1 ml of wine per 20 ml dose. Harmful to individuals with alcoholism. Consideration should be given when used in pregnant or breastfeeding women, children, and individuals at high risk, such as patients with liver disease or epilepsy.
• 380 mg/ml sorbitol(E 420). Sorbitol may have a mild laxative effect. Energy value: 2.6 kcal/g sorbitol. Patients with previously diagnosed intolerance to some sugars should consult their doctor before taking the medicine.

3. How to take Sallevia

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose:
Age
Dose
Maximum daily dose
60 ml
(6.6 g of liquid extract of thyme herb)
Adults and adolescents over 12 years
10-20 ml, 3 times a day
Thymus vulgarisL. and/or thyme herb
Thymus zygisL.
25 ml
(2.75 g of liquid extract of thyme herb)
Children from 4 to 12 years
5 ml, 5 times a day
Thymus vulgarisL. and/or thyme herb
Thymus zygisL.
Children under 4 years
Not recommended
Not recommended
Sallevia should be taken orally. The packaging includes a measuring cup to measure the correct dose. There are no sufficient data on special dosing recommendations in liver or kidney function disorders.
If symptoms do not improve within 5 days or if side effects not described in the leaflet occur, consult a doctor or pharmacist.

Taking a higher dose of Sallevia than recommended

No cases of overdose have been reported. If a higher dose of the medicine is taken than recommended, consult a doctor or pharmacist immediately, who may decide on the need for appropriate corrective measures. It is possible to intensify side effects (gastrointestinal disorders).

Missing a dose of Sallevia

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

Stopping Sallevia treatment

Not applicable.
If you have any further questions on the use of 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.
The following side effects have been reported:

• Gastrointestinal disorders The frequency of this side effect is not known.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sallevia

• Keep the medicine out of the sight and reach of children.
• Store in the original packaging.
• After first opening, the shelf life of the medicinal product is 28 days.
• Do not use this medicine after the expiry date stated on the carton or bottle. The month and year are stated on the packaging. The expiry date refers to the last day of the stated 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. Package contents and other information

What Sallevia contains:

The active substance is:
Liquid extract of thyme herb (Thymi extractum Fluidum).
1 ml of syrup (corresponding to 1.1 g) contains 110 mg (0.11 ml) of liquid extract of Thymus vulgarisL. and/or Thymus zygisL. (1:2-2.5).
Extraction solvent: ammonium hydroxide 10% (m/m) / glycerol 85% (m/m) / ethanol 90% (V/V) / purified water (1/20/70/109).
Other ingredients are:
sorbitol (E 420), benzoic acid (E 210), xanthan gum, and purified water.

What Sallevia looks like and what the package contains

Sallevia is a brown syrup with a characteristic thyme odor. Available in a 200 ml brown glass bottle with a child-resistant plastic closure. A measuring cup is included in the packaging.

Marketing authorization holder and manufacturer

Conforma NV
Zenderstraat 10
9070 Destelbergen
Belgium
To obtain further information on this medicinal product, 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
Spain: Expectym, 110 mg/ml, syrup
France: Timifit, 110 mg/ml, syrup

Date of last revision of the leaflet:

03/2018