DORITHRICIN

DORITHRICIN throat lozenges wild berry

Important notes (mandatory information)

Dorithricin Halstabletten Waldbeere, lozenges. Areas of application: for symptomatic treatment of infections of the oral and pharyngeal cavity with sore throats and difficulty swallowing.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Dorithricin Halstabletten Waldbeere 0.5 mg/1.0 mg/1.5 mg, lozenges
Active ingredients: Tyrothricin/Benzalkonium chloride/Benzocaine

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always use 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 notice any side effects, contact 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 if you feel worse after 2 days, contact your doctor.

What this package leaflet contains

1. WHAT ARE DORITHRICIN HALSTABLETTEN WALDBEERE AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING DORITHRICIN HALSTABLETTEN WALDBEERE?
3. HOW TO TAKE DORITHRICIN HALSTABLETTEN WALDBEERE?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE DORITHRICIN HALSTABLETTEN WALDBEERE?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE DORITHRICIN HALSTABLETTEN WALDBEERE AND WHAT ARE THEY USED FOR?

Dorithricin Halstabletten Waldbeere are an oral and pharyngeal therapeutic. Area of application: for symptomatic treatment of infections of the oral and pharyngeal cavity with sore throats and difficulty swallowing.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING DORITHRICIN HALSTABLETTEN WALDBEERE?

Dorithricin Halstabletten Waldbeere must not be taken if you are allergic to tyrothricin, benzalkonium chloride, benzocaine or any of the other ingredients of Dorithricin Halstabletten Waldbeere listed in section 6.

Warnings and precautions

In the case of severe sore throats or sore throats accompanied by high fever, headaches, nausea or vomiting, you should seek the advice of a doctor. In particular, in the case of purulent tonsillitis with fever, your doctor will decide whether you can use Dorithricin Halstabletten Waldbeere in addition to other treatment measures, such as taking antibiotics. Dorithricin Halstabletten Waldbeere should not be used on fresh wounds in the oral and pharyngeal cavity. Patients with a tendency to hypersensitivity reactions of the skin (allergic contact eczema) should avoid taking Dorithricin Halstabletten Waldbeere, as hypersensitivity reactions are possible.

Children

Since the proper method of use (sucking) is not guaranteed in infants and toddlers, Dorithricin Halstabletten Waldbeere are not suitable for infants and toddlers under 24 months. When used in children, care should be taken to ensure that they have already acquired the ability to suck in a controlled manner.

Taking Dorithricin Halstabletten Waldbeere together with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. No interactions with other medicines have been reported to date when used as directed.

Pregnancy and breastfeeding

To date, there have been no indications of any harmful effects on the foetus from Dorithricin Halstabletten Waldbeere. Nevertheless, as a precaution, it should only be taken during pregnancy and breastfeeding after consulting your doctor or pharmacist.

Dorithricin Halstabletten Waldbeere contain sorbitol

Please only take Dorithricin Halstabletten Waldbeere after consulting your doctor if you know that you suffer from an intolerance to certain sugars. Patients with the rare hereditary fructose intolerance should not take Dorithricin Halstabletten Waldbeere.

Note for diabetics

The sugar substitute sorbitol contained in 1 lozenge corresponds to approx. 0.07 bread units (BE). Sorbitol can have a slightly laxative effect.

3. HOW TO TAKE DORITHRICIN HALSTABLETTEN WALDBEERE?

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: Allow 1 - 2 lozenges to dissolve slowly in the mouth several times a day, every 2 - 3 hours, as needed. Treatment should be continued for one day after symptoms have subsided.

If you have taken more Dorithricin Halstabletten Waldbeere than you should

Poisoning with Dorithricin Halstabletten Waldbeere can be ruled out when used as directed and has not been reported to date. After taking a very large number of tablets, gastrointestinal complaints and, especially in children, an increased level of methaemoglobin in the blood may occur. Possible signs are shortness of breath and bluish discolouration of the lips and fingers. If you suspect a significant overdose, please contact a doctor. As countermeasures, the doctor will recommend giving plenty of water and charcoal tablets and, if necessary, appropriate measures against methaemoglobinaemia.

If you forget to take Dorithricin Halstabletten Waldbeere

Do not take double the amount if you have forgotten to take the previous dose. Suck 1 Dorithricin Halstablette Waldbeere immediately and then continue taking it in the usual dosage.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Possible side effects

Rare

In rare cases, hypersensitivity reactions may occur, especially to a breakdown product of benzocaine (aminobenzoic acid ester). In external use, especially in children and when applied to larger wound areas, an increased level of methaemoglobin in the blood has occurred. Possible signs of this are shortness of breath and bluish discolouration of the lips and fingers.

Frequency not known

In sensitive patients, allergic reactions can also be caused by substances that are chemically related to benzocaine, such as penicillins, sulphonamides, sunscreens, p-aminosalicylic acid (paraphenylenediamine sensitisation).

Reporting of side effects

If you notice any side effects, contact 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 DORITHRICIN HALSTABLETTEN WALDBEERE?

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 container after "Use by:". The expiry date refers to the last day of the month indicated. Storage conditions: Do not store above 25°C. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Dorithricin Halstabletten Waldbeere contain

The active ingredients are: 1 lozenge contains: Tyrothricin 0.5 mg, Benzalkonium chloride 1.0 mg, Benzocaine 1.5 mg. The other ingredients are: Sorbitol (Ph. Eur.), talc, sucrose stearate type III, saccharin sodium 2H20, flavouring, povidone (K 25), carmellose sodium (Ph. Eur.).

What Dorithricin Halstabletten Waldbeere look like and contents of the pack

Pink round tablets Packs of 20 lozenges and 40 lozenges.

Marketing Authorisation Holder

MEDICE Pharma GmbH & Co. KG
Kuhloweg 37
58638 Iserlohn
Telephone: (02371) 152790
Telefax: (02371)937-329
e-mail: info@medice-pharma.de

Manufacturer and co-distributor

MEDICE Arzneimittel Pütter GmbH & Co. KG
Kuhloweg 37
58638 Iserlohn
Telephone: (02371) 937-0
Telefax: (02371)937-329
e-mail: info@medice.de
www.medice.de

This package leaflet was last revised in May 2014.

Source: Information from the package leaflet
Status: 01/2018
Areas of application: for symptomatic treatment of infections of the oral and pharyngeal cavity with sore throats and difficulty swallowing.