Patient leaflet - Otoplex oral drops
what it is used for
Other medicines and Otoplex Oral Drops
Do not use this medicine if you are taking any immunosuppressant medications such as ciclosporin, methotrexate, azathioprine, sirolimus, tacrolimus, canakinumab, basiliximab, belimumab,
mycophenolate mofetil and belatacept.
Otoplex Oral Drops is a homeopathic medicinal product used within the homeopathic tradition for the relief of minor earache.
2. What you need to know before you take Otoplex Oral Drops
Do not take Otoplex Oral Drops
if you
Before taking this medicine, tell your doctor or pharmacist if you are taking a medicine that contains alcohol (ethanol), or if you are taking, have recently taken or might take any other medicines, including any bought without a prescription.
Pregnancy and breastfeeding
This product should not be taken during pregnancy and/or breastfeeding.
- are allergic to any of the active ingredients (listed in section 6), Echinacea, Chamomile or to other plants of the Asteraceae/Compositae family, or sources of capsaicinoids (e.g. pepper plants or chilli) or to ethanol
are taking any medicines known to interact with alcohol e.g. metronidazole, disulfiram
- are under 12 years old
- are pregnant or breastfeeding
- have discharge from your ear or something is stuck in your ear
- are taking any of the medicines listed under the section “Other medicines and Otoplex Oral Drops”
or if you suffer from
- the infection called tuberculosis
- frequent allergic reactions such as hives (urticaria), eczema, asthma
- connective tissue disease with formation of clumps of cells (sarcoidosis) mainly occurring in the lymph nodes, lungs and liver
- autoimmune diseases such as inflammation of the connective tissue (collagenoses), or multiple sclerosis
- conditions which decrease your resistance to infection (e.g. HIV or AIDS)
blood disorders involving the white blood count system such as low white blood cell count due to
Driving and using machines
No studies on the effects on driving or operating machines have been performed. This product contains small amounts of alcohol (see below).
If affected do not drive or use machines.
Otoplex Oral Drops contains alcohol
This medicine contains 53 vol.-% alcohol. Each dose (15 drops) contains 270 mg of alcohol (ethanol).
The amount of alcohol in each dose is equivalent to 7 ml beer or 3 ml wine.
The small amount of alcohol in this medicine is not expected to have any noticeable effects if taken as recommended in this leaflet or by your doctor.
Drinking alcohol whilst taking this product should be avoided, because the effects of alcohol may be increased. Tell your doctor before taking this medicine if you are taking any other medicines containing ethanol (alcohol).
3. How to take Otoplex Oral Drops
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
For oral use only.
Adults, the elderly and children over 12 years of age
Take 12 - 15 drops, approximately every 90 minutes, up to 12 times a day, in a glass of water.
Maximum daily dose = 12 x 15 drops (180 drops).
Do not take more than the label/leaflet tells you to.
This product is not recommended for use in children under 12 years of age.
If symptoms worsen during the use of Otoplex Oral Drops, or persist after 2 days of using Otoplex Oral Drops, or fever, worsening or severe ear pain, headache or neck ache, or discharge from the ear occurs, please consult a doctor or qualified healthcare practitioner.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
If you take too many drops, consult your doctor or pharmacist.
If you miss a dose, take the next dose when it's due. Do not take a double dose to make up for the missed dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Echinacea can trigger allergic reactions in patients who are prone to allergic reactions. Chamomile preparations can also cause hypersensivity reactions including severe allergic reactions following mucosal contact.
If any of the following serious allergic reactions occur, you should stop taking this medicine and seek medical advice immediately:
- Anaphylactic reaction - severe and potentially life threatening reaction with symptoms that may include feeling lightheaded or faint, breathing difficulties or wheezing, a fast heartbeat, skin rash, confusion, anxiety or loss of consciousness.
- Swelling or blistering of the skin, such as the face, lips, tongue, mouth or throat
- Difficulty breathing including shortness of breath
- Asthma or worsening of asthma symptoms If other allergic skin reactions such as skin rash, urticaria (red bumps) or itching occur, medical advice should be sought as soon as possible.
Association with autoimmune diseases has been reported for Echinacea such as:
- Inflammation of the brain and spinal chord (multiple sclerosis)
- Painful lumps on the shins (erythema nodosum)
- Low blood platelet count (immunothrombocytopenia)
- Destruction of blood cells by antibodies (Evans Syndrome)
- Dryness in the mouth and eye with kidney tubular dysfunction (Sjögren Syndrome).
A decrease in white blood cells (leukopenia) may occur in longer term use.
The frequency of these effects occuring is not known.
If you experience any of the above side effects you should consult your doctor, pharmacist or qualified healthcare practitioner.
Reporting of side effects
If you get any side effects, talk to your doctor, pharma-cist or qualified healthcare practitioner. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Otoplex Oral Drops
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label/carton. The expiry date refers to the last day of that month.
Storage conditions
This medicinal product does not require any special storage conditions. Store in the original container.
Do not use this product 6 months after first opening.
Ask your pharmacist how to throw away medicines you no longer use.
6. Contents of the pack and other
information
What Otoplex Oral Drops contains
Each ml (27 drops) of oral drops contains:
- Aconitum napellus 12X
- Capsicum annuum 4X
- Chamomilla recutita Ø
- Echinacea purpurea Ø
- Hydrargyrum bicyanatum 6X
- Hydrastis canadensis 4X
- Iodum 4X
- Natrium tetraboracicum 4X
- Sambucus nigra Ø
- Sanguinaria canadensis Ø
The other ingredients are purified water and ethanol.
What Otoplex Oral Drops looks like and contents of the pack
Otoplex Oral Drops is a clear, yellow liquid.
Pack sizes: 30 ml and 50 ml oral drops, solution. Not all pack sizes are marketed.
National Rules Authorization Holder and Manufacturer
Weber & Weber GmbH
Herrschinger Str. 33
82266 Inning/Ammersee
Germany
Phone +49 (0)8143 9270
Fax +49 (0)8143 927 270
information@weber-weber.net
This leaflet was last revised in September 2023.
Upon request the package leaflet will be available in a larger print or audio version for the blind and partially sighted.
Call this number: +49 (0)8143 9270