ASPECTON

ASPECTON cough syrup

Important notes (mandatory information)

Aspecton cough syrup. Active ingredient: thyme herb thick extract. Areas of application: for improving symptoms of colds of the respiratory tract with viscous mucus, for improving symptoms of acute bronchitis.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Aspecton cough syrup, liquid for oral use for adults and children aged 1 year and over
Active ingredient: thyme herb thick extract

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or even worse after 7 days, contact your doctor.

What this package leaflet contains

1. WHAT IS ASPECTON COUGH SYRUP AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ASPECTON COUGH SYRUP?
3. HOW TO TAKE ASPECTON COUGH SYRUP?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE ASPECTON COUGH SYRUP?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS ASPECTON COUGH SYRUP AND WHAT IS IT USED FOR?

Aspecton cough syrup is a herbal medicine for colds of the respiratory tract. Aspecton cough syrup is used to improve symptoms of colds of the respiratory tract with viscous mucus, to improve symptoms of acute bronchitis. If you do not feel better or even worse after 7 days, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ASPECTON COUGH SYRUP?

Aspecton cough syrup must not be taken if you are allergic to thyme or other Lamiaceae (Labiatae), birch, mugwort, celery or any of the other ingredients of this medicine listed in section 6. There are no sufficient studies on the use of this medicine in children under 1 year of age. It should therefore not be used in children under 1 year of age.

Warnings and precautions

If symptoms persist for more than a week or if shortness of breath, fever, or purulent or bloody sputum occur, a doctor must be consulted.

This medicine contains sorbitol

Please only take Aspecton cough syrup after consulting your doctor if you are known to suffer from an intolerance to certain sugars. The calorific value is 2.6 kcal/g sorbitol. Sorbitol can have a mild laxative effect. 10 ml contains 3.9 g sorbitol (a source of 0.98 g fructose) corresponding to approx. 0.33 bread units (BE).

Macrogolglycerol hydroxystearate can cause stomach upset and diarrhea.

Taking Aspecton cough syrup with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used, or plan to take/use any other medicines. No interactions with other medicines are known to date. Studies with Aspecton cough syrup on possible interactions with other medicines administered at the same time are not available.

Taking Aspecton cough syrup with food and drink

There are no special precautions to be taken.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Aspecton cough syrup should not be used during pregnancy and breast-feeding due to insufficient studies.

Driving and using machines

There are no special precautions to be taken.

3. HOW TO TAKE ASPECTON COUGH SYRUP?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

• Adults and children aged 12 years and over: 10 ml 3 — 4 times a day
• Children aged 11 — 12 years: 5 ml 3 times a day
• Children aged 5 — 10 years: 2.5 ml 3 — 4 times a day
• Children aged 1 — 4 years: 2.5 ml twice a day

A measuring cup is included in the package of Aspecton cough syrup.

Method of administration

For oral use. Aspecton cough syrup should be taken with sufficient liquid (preferably water). It can be taken with or without meals.

Duration of use

The duration of treatment depends on the course of the disease and may be determined by the doctor if necessary. However, please always observe the precautions listed in section 2 and the information under "Side effects". Please talk to your doctor or pharmacist if you have the impression that the effect of Aspecton cough syrup is too strong or too weak.

If you have taken more Aspecton cough syrup than you should

Poisoning with Aspecton cough syrup has not been reported to date. If too much Aspecton cough syrup is taken, the symptoms described under "Side effects" may possibly occur more frequently. In this case, please notify a doctor. He can decide on any necessary measures.

If you forget to take Aspecton cough syrup

Do not take twice the amount if you have forgotten to take the previous dose.

If you stop taking Aspecton cough syrup

Interrupting or prematurely ending treatment is generally harmless. If in doubt, ask your doctor.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them. Hypersensitivity reactions such as shortness of breath, skin rashes, hives, and swelling of the face, mouth and/or throat may occur. Stomach upset such as cramps, nausea, vomiting may also occur. The frequency of side effects is not known. If side effects occur, the preparation should be discontinued and a doctor should be consulted. He can decide on the severity and any further measures that may be necessary. Aspecton cough syrup must not be taken again at the first signs of a hypersensitivity reaction.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW TO STORE ASPECTON COUGH SYRUP?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and label after "Use by:". The expiry date refers to the last day of the month indicated. Storage conditions: No special storage conditions are required for this medicine. Note on shelf life after opening: Aspecton cough syrup has a shelf life of 6 months after opening.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Aspecton cough syrup contains

100 ml of liquid contains: Thick extract of thyme herb (1.7-2.5:1) 6.69 g. Extraction agent: 10% (m/m) ammonia solution, 85% (m/m) glycerol, 90% (V/V) ethanol, water (1:20:70:109). The other ingredients are: glycerol, 85% glycerol, propylene glycol, 70% sorbitol solution (non-crystallizing), macrogolglycerol hydroxystearate, purified water, bitter fennel oil. Note: Aspecton cough syrup contains no alcohol (ethanol).

What Aspecton cough syrup looks like and contents of the pack

Aspecton cough syrup is a brown, slightly cloudy liquid. Aspecton cough syrup is available in packs of 100 ml (N1) and 200 ml (N2). Each pack contains a measuring cup (marking of the medical device: CE 0123).

Further information

Aspecton cough syrup is sugar-free and therefore suitable for diabetics (0.33 BE per 10 ml). Aspecton cough syrup is alcohol-free (ethanol) and therefore also suitable for patients who must avoid alcohol (ethanol). Due to the content of plant extraction agents, Aspecton cough syrup may occasionally become cloudy and/or a slight sediment may form; however, this does not affect the effect of the medicine.

Pharmaceutical entrepreneur and manufacturer

Krewel Meuselbach GmbH
Krewelstraße 2
53783 Eitorf
Phone: 02243 / 87-0
Fax: 02243 / 87-175
E-Mail: Info@krewel-meuselbach.de

This package leaflet was last revised in April 2015.

Source: Information from the package leaflet
Status: 12/2017
Active ingredient: thyme herb thick extract. Areas of application: for improving symptoms of colds of the respiratory tract with viscous mucus, for improving symptoms of acute bronchitis.