ASPECTON

ASPECTON cough drops

Important notes (mandatory information)

Aspecton cough drops. 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 drops, oral solution for adults and children aged 2 and over
Active ingredient: thyme herb thick extract

Read the entire package leaflet carefully before you start taking this medicine, as 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 ARE ASPECTON COUGH DROPS AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ASPECTON COUGH DROPS?
3. HOW TO TAKE ASPECTON COUGH DROPS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE ASPECTON COUGH DROPS?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE ASPECTON COUGH DROPS AND WHAT ARE THEY USED FOR?

Aspecton cough drops are a herbal medicine for colds of the respiratory tract. Aspecton cough drops are 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 DROPS?

Aspecton cough drops must not be taken if you are allergic to thyme or other Lamiaceae (Labiatae), birch, mugwort, celery, menthol or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

If symptoms persist for more than 1 week or if shortness of breath, fever, purulent or bloody sputum occur, a doctor must be consulted. There are no sufficient studies on the use of this medicine in children under 2 years of age. It should therefore not be used in children under 2 years of age.

Taking Aspecton cough drops with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. No interactions with other medicines are known to date. There are no studies with Aspecton cough drops on possible interactions with other medicines administered at the same time.

Taking Aspecton cough drops with food and drink

There are no special instructions.

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 drops should not be used during pregnancy and breast-feeding due to insufficient studies.

Driving and using machines

There are no special instructions.

3. HOW TO TAKE ASPECTON COUGH DROPS?

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 and over: 3 — 4 times a day 31 to a maximum of 61 drops.
• Children aged 11 — 12: 3 times a day 15 drops.
• Children aged 5 — 10: 3 — 4 times a day 10 drops.
• Children aged 2 — 4: 2 times a day 10 drops.

Method of administration

For oral use. Aspecton cough drops can be taken undiluted or in water. They 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 drops is too strong or too weak.

If you have taken more Aspecton cough drops than you should

Poisoning with Aspecton cough drops has not been reported to date. If too much Aspecton cough drops are taken, the symptoms described under "Side effects" may be more severe. In this case, please notify a doctor. He/she can decide on any necessary measures.

If you forget to take Aspecton cough drops

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

If you stop taking Aspecton cough drops

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 problems such as cramps, nausea and 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/she can decide on the severity and any further measures that may be necessary. Aspecton cough drops must not be taken again at the first signs of a hypersensitivity reaction. In appropriately sensitised patients, menthol can trigger hypersensitivity reactions (including shortness of breath).

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 on the safety of this medicine.

5. HOW TO STORE ASPECTON COUGH DROPS?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the folding box and the 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 drops have a shelf life of 6 months after opening.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Aspecton cough drops contain

10 ml of liquid (1 ml corresponds to 27 drops) contain: 4.23 g of thick extract of thyme herb (1.7-2.5:1). Extraction agent: 10% (m/m) ammonia solution, 85% (m/m) glycerol, 90% (V/V) ethanol: water (1:20:70:109). The other ingredients are: 85% glycerol, propylene glycol, star anise oil, eucalyptus oil, levomenthol. Note: Aspecton cough drops do not contain any alcohol (ethanol).

What Aspecton cough drops look like and contents of the pack

Aspecton cough drops are a brown to dark brown, cloudy solution. Aspecton cough drops are available in packs of 30 ml (N1) and 50 ml (N2).

Further information

Aspecton cough drops are sugar-free and therefore suitable for diabetics (< 0.01 BE per dose). Aspecton cough drops are alcohol-free (ethanol) and are therefore also suitable for patients who must avoid alcohol (ethanol). Due to the content of plant extracts, Aspecton cough drops may occasionally become cloudy and/or form a slight sediment; however, this does not affect the efficacy of the medicine.

Pharmaceutical entrepreneur and manufacturer

Krewel Meuselbach GmbH
Krewelstraße 2
53783 Eitorf
Telephone: 02243 / 87-0
Telefax: 02243 / 87-175
E-mail: Info@krewel-meuselbach.de

This package leaflet was last revised in June 2014.

Source: Information from the package leaflet
Status: 11/2017
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.