OTOVOWEN

OTOVOWEN mixture

Important notes (mandatory information)

Otovowen mixture. Areas of application: The areas of application are derived from the homeopathic medicinal product images. These include: Improvement of symptoms in otitis media, rhinitis. Warning: Contains 53% alcohol by volume!

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Otovowen mixture for oral use
Active ingredients: Aconitum napellus Dil. D6; Capsicum annuum Dil. D4; Chamomilla recutita Ø; Echinacea purpurea Ø; Hydrargyrum bicyanatum Dil. D6; Hydrastis canadensis Dil. D4; Iodum Dil. D4; Natrium tetraboracicum Dil. D4; Sambucus nigra Ø; Sanguinaria canadensis Ø.
Homeopathic medicine for otitis media

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Otovowen must be taken as directed in order to be effective.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 2 days, you should definitely see a doctor.
• If any of the side effects listed occur or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This package leaflet contains

1. WHAT IS OTOVOWEN AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO CONSIDER BEFORE TAKING OTOVOWEN?
3. HOW TO TAKE OTOVOWEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE OTOVOWEN?
6. FURTHER INFORMATION

1. WHAT IS OTOVOWEN AND WHAT IS IT USED FOR?

Otovowen is a homeopathic medicine for otitis media. Areas of application: The areas of application are derived from the homeopathic medicinal product images. These include: Improvement of symptoms in otitis media, rhinitis.

2. WHAT DO YOU NEED TO CONSIDER BEFORE TAKING OTOVOWEN?

Otovowen must not be taken if you are hypersensitive to any of the active or inactive ingredients or to Compositae. For fundamental reasons, Otovowen must not be used in progressive systemic diseases such as tuberculosis, leukemia and leukemia-like diseases, inflammatory diseases of the connective tissue (collagenoses), autoimmune diseases, multiple sclerosis, AIDS, HIV infection or other chronic viral diseases.

Special care must be taken when taking Otovowen:

• in case of fever, severe pain, headache or neck pain, discharge from the ear and if symptoms persist for more than 2 days. In these cases, a doctor should be consulted.
• in children under 2 years of age. The medicine should not be used in children under 2 years of age without medical advice and does not replace other medicines prescribed by the doctor.

When taking Otovowen with other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Interactions with other medicines are not known.

When taking Otovowen with food and drink

The effect of a homeopathic medicine can be adversely affected by generally harmful factors in the lifestyle and by stimulants and luxury foods.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking/using any medicine. There is insufficient documented experience with the use of Otovowen during pregnancy and breast-feeding. It should therefore only be used during pregnancy and breast-feeding after consulting a doctor.

Driving and using machines

No special precautions are required.

Important information about certain other ingredients of Otovowen

This medicine contains 53% alcohol by volume.

3. HOW TO TAKE OTOVOWEN?

Always take Otovowen exactly as described in this leaflet. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is:

In acute conditions, every half to whole hour, maximum 12 times a day, in chronic conditions, take the following single doses 1 - 3 times a day:

• Adults 12 – 15 drops,
• Children between 6 and 12 years 5 – 10 drops,
• Toddlers up to 6 years of age 4 – 7 drops,
• Infants up to 1 year of age 2 – 4 drops after seeking medical advice.

A single dose of 5 drops contains approximately 90 mg of alcohol. Infections in the nose and throat can easily spread to the middle ear, especially in children. Otovowen should therefore be taken early on at the first signs of an upper respiratory tract infection. Therapy should be continued until all symptoms have subsided.

Duration of use

Otovowen should not be taken for longer than 8 weeks.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

Possible side effects

In individual cases, hypersensitivity reactions may occur. Skin rash, itching, rarely facial swelling, shortness of breath, dizziness and a drop in blood pressure have been observed for medicines containing echinacea preparations. In this case, you should stop taking the medicine and consult your doctor. Note: When using a homeopathic medicine, existing symptoms may temporarily worsen (initial aggravation). In this case, you should stop taking the medicine and consult your doctor.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Department 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 OTOVOWEN?

Keep out of reach of children! Do not use the medicine after the expiry date which is stated on the label/carton. The expiry date refers to the last day of the month. Storage conditions: No special storage conditions are required for this medicine. Shelf life after opening: 6 months.

6. FURTHER INFORMATION

What Otovowen contains

The active ingredients are: 10 ml contains: Aconitum napellus Dil. D6 0.075 ml; Capsicum annuum Dil. D4 0.075 ml; Chamomilla recutita Ø 0.225 ml; Echinacea purpurea Ø 0.75 ml; Hydrargyrum bicyanatum Dil. D6 0.075 ml; Hydrastis canadensis Dil. D4 0.075 ml; Iodum Dil. D4 0.075 ml; Natrium tetraboracicum Dil. D4 0.075 ml; Sambucus nigra Ø 0.225 ml; Sanguinaria canadensis Ø 0.075 ml. The other ingredient is: Ethanol 43% (m/m). 1 ml corresponds to 27 drops.

What Otovowen looks like and contents of the pack

Otovowen is a clear, yellow liquid. Pack sizes: 30 ml and 50 ml mixture.

Pharmaceutical entrepreneur and manufacturer

WEBER & WEBER GMBH & Co. KG
Herrschinger Str. 33
82266 Inning/Ammersee
Phone: 0 81 43 / 927-0
Fax: 0 81 43 / 70 84
www.weber-weber.de
information@weber-weber.net

This leaflet was last revised in June 2016.

Source: Package leaflet information
Status: 12/2017
Areas of application: The areas of application are derived from the homeopathic medicinal product images. These include: Improvement of symptoms in otitis media, rhinitis. Warning: Contains 53% alcohol by volume!