Nyodex 75 mg / ml concentrate for gargle water povidone, iodinated
What Nyodex Is And What It Is Used For
Nyodex is used for topical treatment of mild cold symptoms in the oral cavity and throat.
Nyodex contains povidone-iodine, which has a killing effect on bacteria, viruses, and fungi found in the oral cavity.
What You Need To Know Before Using Nyodex
Do Not Use Nyodex
- If you are allergic to iodine, povidone or any of the other ingredients of this medicine (listed in section 6)
- If you have disorders of thyroid function
- within 2 weeks before or after:
- An examination of the thyroid gland called radioiodine scintigraphy
- Radioiodine treatment for thyroid cancer
- To children younger than 1 year.
Products containing mercury should not be used at the same time as a substance may be formed which may damage the skin.
Warnings And Cautions
Talk to your doctor or pharmacist before using this medicine.
Stop using Nyodex and contact a doctor immediately if you experience
- Swelling of the face, tongue, and/or throat
- Shortness of breath
- Difficulty swallowing.
Stop taking it if you get a rash.
Be careful when gargling with Nyodex so that you do not accidentally get the medicine down into the airways as this can cause inflammation in the lungs ( pneumonitis ).
Discoloration can occur if you have a denture, braces, or the like. If possible, it is therefore recommended to remove the denture, braces, or the like before treatment with this medicine.
Use For Children
Nyodex should not be used in children under 1 year of age and is not recommended for children under 12 years of age.
Other Medicines And Nyodex
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is especially important if:
- You have a planned iodine treatment of the thyroid gland within 2 weeks (so-called radioiodine treatment). See section “Do not use Nyodex”
- You are treated with lithium, as this medicine can affect lithium treatment.
Talk to a doctor or nurse before undergoing an examination or leaving a laboratory sample:
- Nyodex must not be used within 2 weeks before or after examinations based on body iodine uptake. Namely, the body’s uptake of iodine from products containing povidone iodine (such as Nyodex) can affect these examinations ( scintigraphy of the thyroid gland, determination of protein-bound iodine (PBI) and radioiodine diagnostics). See section “Do not use it”.
- Nyodex can affect the results of certain laboratory tests e.g. measurement of hemoglobin or glucose in faeces or urine.
Pregnancy, Breastfeeding And Fertility
As this medicine may affect the baby, it should not be used during pregnancy or breastfeeding, unless your doctor decides otherwise.
Driving And Using Machines
Nyodex has no or negligible effect on the ability to drive and use machines.
How To Use Nyodex
- Always take this medicine exactly as described in this leaflet or as your doctor advised. Ask your doctor or pharmacist if you are unsure.
- Only for local treatment in the oral cavity and throat.
- Nyodex should be diluted before use.
- Adults and children over 12 years of age: Mix 1 part Nyodex (approx. 5 ml or 1 teaspoon) with 4 parts water. Gargle or rinse 3-4 times a day (preferably after a meal) for at least 30 seconds up to 2 minutes. Do not swallow.
- Nyodex should be diluted before use.
- The treatment should not last more than 14 days per treatment session.
- Not recommended for children under 12 years.
If You Use More Nyodex Than You Should Do
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Symptoms of overdose can include
- Impaired kidney function (decreased urine production)
- Rapid heartbeat
- Rapid fall in blood pressure (so-called circulatory collapse)
- Difficulty breathing
- Cramps
- Fever
- Stomach problems
- Effects on thyroid function
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Nyodex Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Medicines can cause allergic reactions, although severe allergic reactions are rare. In very rare cases, it may cause severe allergic reactions such as
- Anaphylactic shock
- Angioedema
Stop using this medicine and contact a doctor immediately if you experience sudden
- Wheezing
- Difficulty breathing
- Swelling of the eyelids, face or lips, rash or itching, especially if it involves the whole body.
The following side effects have been reported in patients using it:
Rare Nyodex side effects (may affect up to 1 in 1,000 people)
- Allergy (hypersensitivity)
- Contact dermatitis (with symptoms such as redness of the skin, small blisters and itchy skin)
Very rare (may affect up to 1 in 10,000 people)
- Angioedema and anaphylactic shock (see above)
Has been reported (occurs in an unknown number of users)
How to store Nyodex
- Do not store above 25 ° C.
- 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 carton. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents Of The Pack And Other Information
Content Declaration
- The active substance is iodinated povidone.
- The other ingredients are:
- Purified water
- Ethanol (96%)
- Glycerol
- Anhydrous disodium phosphate
- Methyl salicylate
- Saccharin sodium
- Anhydrous citric acid
- Sodium hydroxide
- Menthol
What The Medicine Looks Like And Contents Of The Pack
- Clear, reddish to a brown solution.
- Nyodex is available in plastic bottles containing 120 ml.
Marketing Authorization Holder And Manufacturer
Mundipharma AB
Mölndalsvägen 30 B
412 63 Gothenburg
Manufacturer
Fidelio Healthcare Limburg GmbH
Mundipharmastrasse 2
65549 Limburg
Germany