100,000 IU / g + 100,000 IU, ointment + vaginal tablets
nystatin
What Nyvigan is and what it is used for
Nyvigan contains the active substance nystatin and is used to treat infections of the vagina and the outer parts of the abdomen, which are caused by the yeast Candida albicans or by other Candida species. Common symptoms of vaginal Candida infection are itching burning sensation and white granular discharge.
This medicine is only for adults from 18 years of age
What you need to know before using Nyvigan
Do not use Nyvigan
if you are allergic to nystatin or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Consult a physician before using this medicine if you have foul-smelling discharge, intermittent bleeding, abdominal pain, pain when vomiting, and/or fever, as these may be symptoms of a condition other than a fungal infection.
Should a hypersensitivity reaction occur, the use of the drug should be discontinued and physicians or pharmacists should be consulted for appropriate alternative treatment?
When treating fungal infections, all areas of the skin and vagina with fungal growth must be treated long enough to prevent recurrence due to untreated fungus.
To ensure a good treatment result, personal hygiene should be taken care of carefully. Furthermore, underwear should be changed every day; the most suitable are disposable panties or the use of sanitary napkins. The yellow discoloration that the drug gives to underwear disappears during normal washing.
Intercourse should be avoided during the treatment period, as infection can be transmitted to the partner. If Nyvigan ointment is used at the same time as a condom or pessary, the paraffin excipient can reduce the tear strength and thus reduce the reliability of these condoms or pessaries.
Children and young people
This medicine is not recommended for children and adolescents under 18 years of age due to lack of experience.
Other drugs and Nyvigan
It is not known that Nyvigan affects or is affected by other drugs.
Pregnancy, breastfeeding and fertility
Nystatin, the active substance in Nyvigan, is hardly absorbed through intact skin or mucous membranes.
Nyvigan can be used during pregnancy and breastfeeding.
Hands should be washed thoroughly before vaginal application to avoid upward infection during pregnancy.
Driving and using machines
Nyvigan does not affect the ability to drive and use machines.
How to use Nyvigan
Always use this medicine according to this leaflet or your doctor’s or pharmacist’s instructions. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
Component 1: Salva
For use on the skin.
The ointment should be applied with a not too thin layer twice daily on infected skin areas on the outer parts of the abdomen (at the beginning of treatment together with vaginal tablets). The ointment should be used for full healing. The duration of treatment required for this is usually up to 2 weeks.
Component 2: Vaginal tablets
For vaginal use.
Two vaginal tablets should be inserted deep into the vagina at bedtime for three consecutive days.
How do I know that the treatment is effective?
The symptoms of a vaginal Candida infection ( itching, burning sensation, and white granular discharge) should be significantly relieved within the first 3 days after starting treatment with Nyvigan. If symptoms do not improve significantly or if symptoms worsen after about a week of treatment, seek medical advice.
In case of uncertainty about the effect of the treatment, a medical examination can clarify whether the treatment has been sufficient or whether it should continue longer to achieve complete healing.
If you use more Nyvigan than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, always contact a doctor or hospital for risk assessment and advice.
No intoxication symptoms are expected in case of overdose, as the active substance (nystatin) in the ointment and the vaginal tablets are hardly absorbed into the blood when used on external parts of the genitals (ointment) or during treatment in the vagina (vaginal tablets)…
If you forget to use Nyvigan
Component 1: Salva
You can apply the missed dose on the same day you take it, as described in this leaflet.
Component 2: Vaginal tablets
You should continue treatment the next day and increase the treatment time by one day.
If you stop using Nyvigan
To achieve the desired treatment effect, follow the recommendations on treatment duration in section 3 “How to use Nyvigan”. Treatment should not be stopped until the infection has completely healed, without consulting a doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Component 1: Salva
Very rare (may affect up to 1 in 10,000 people): Hypersensitivity (rash, itching, and burning sensation.)
Component 2: Vaginal tablets
Uncommon (may affect up to 1 in 100 people): skin reactions such as burning or itching of the vagina.
If you get any side effects, talk to your doctor and talk to doctor.
How to store Nyvigan
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 and container (blister or tube). The expiration date is the last day of the specified month.
Do not store above 25 ° C.
Vaginal tablets:
Store in the original package. Sensitive to light.
Ointment
After the first opening, the ointment has a shelf life of 6 months at room temperature (15 – 25 ° C).
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
Component 1: Salva
– 1 g ointment contains 100,000 IU nystatin
– Other excipients: polyethylene, liquid paraffin, all -rac-α -Tocopherol.
Component 2: Vaginal tablets
– 1 vaginal tablet contains 100,000 IU of nystatin
– Other excipients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, maize starch.
What the medicine looks like and contents of the pack
Component 1 (ointment): Yellow ointment
Component 2 (vaginal tablets): Light yellow, oblong (18 × 10 mm), and biconvex tablets.
Pack size: combination pack with 25 g ointment and 6 vaginal tablets.
Marketing Authorization Holder and Manufacturer
Dr Pfleger Arzneimittel GmBH
Dr.-Robert-Pfleger-Str. 12
96052 Bamberg
Germany
Local representative: Avia Pharma AB, Svärdvägen 3B, 182 33 Danderyd.