STADA Nystatin tablets, 100 tablets

Nystatin Stada 500,000 IU coated tablets. Indications: For the topical intestinal treatment of proven nystatin-sensitive yeast infections, especially following therapy with antibiotics, cytostatics, or corticosteroids.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Nystatin Stada 500,000 IU coated tablets
Active ingredient: Nystatin

Read the entire package leaflet carefully, as it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment success, Nystatin Stada must be used correctly.

• 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 14 days, you must definitely consult a doctor.
• If any of the listed side effects become serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

The package insert contains:

1. WHAT IS NYSTATIN STADA AND WHAT IS IT USED FOR?
2. WHAT DO YOU NEED TO KNOW BEFORE TAKING NYSTATIN STADA?
3. HOW SHOULD NYSTATIN STADA BE TAKED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD NYSTATIN STADA BE STORED?
6. MORE INFORMATION

1. WHAT IS NYSTATIN STADA AND WHAT IS IT USED FOR?

Nystatin Stada is a medicine for intestinal yeast infections. Nystatin Stada is used for the topical intestinal treatment of proven nystatin-sensitive yeast infections, especially following therapy with antibiotics, cytostatics, or corticosteroids.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NYSTATIN STADA?

Do not take Nystatin Stada if you are hypersensitive (allergic) to nystatin or a related active ingredient (amphotericin B, natamycin) or any of the other ingredients of Nystatin Stada.

Special care should be taken when taking Nystatin Stada:
Due to the high osmolarity of nystatin, its use in very low birth weight and premature infants is not recommended. Furthermore, Nystatin Stada coated tablets are not suitable for full-term newborns, infants, and toddlers due to possible swallowing difficulties. For this age group, other, more suitable medicinal preparations containing the active ingredient nystatin are available. Please discuss this with your doctor.

When taking Nystatin Stada with other medicines:
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. No interactions with other medicines have been reported to date.

Pregnancy and breastfeeding:
Nystatin Stada can be used during pregnancy and breastfeeding.

Driving and using machines:
No effects on the ability to drive or use machines have been reported to date.

Important information about some of the other ingredients of Nystatin Stada:
This medicine contains glucose, lactose, and sucrose. Please consult your doctor before taking Nystatin Stada if you know that you have an intolerance to some sugars.

3. HOW TO TAKE NYSTATIN STADA:

Always take Nystatin Stada exactly as described in this leaflet. Please consult your doctor or pharmacist if you are unsure.

Unless otherwise prescribed by your doctor, the usual dose is
1 tablet 3 times a day. In severe cases, you can take 2 tablets 3 times a day.

How to take:
Take the tablets after meals with plenty of liquid (e.g., a glass of water).

Duration of treatment:
Take Nystatin Stada for approximately 2 weeks. Treatment should be continued for a few days after you have completely recovered.

Please talk to your doctor or pharmacist if you feel that the effect of Nystatin Stada is too strong or too weak.

If you have taken more Nystatin Stada than you should:
Gastrointestinal disturbances such as nausea, vomiting, and diarrhea may occur. There is no known specific antidote. In cases of acute overdose, you should consult a doctor who will decide on further measures if necessary.

If you forget to take Nystatin Stada:
Do not take a double dose to make up for a forgotten dose.

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

4. POSSIBLE SIDE EFFECTS

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

Diseases of the gastrointestinal tract:

• Common: Very high doses can cause loss of appetite, diarrhea, vomiting and nausea.
• Occasionally: gastrointestinal problems.

Diseases of the skin and subcutaneous tissue:

• Occasionally: skin rash, including hives (urticaria).
• Very rare: allergic reactions.

Severe allergic reactions (Stevens-Johnson syndrome) have been observed after taking nystatin.

Reporting of side effects:
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, Germany, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE NYSTATIN STADA?

Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and label. Store tightly closed. Protect from light. Do not store above 25°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This measure helps to protect the environment.

6. FURTHER INFORMATION

What Nystatin Stada contains:
The active ingredient is: Nystatin. 1 coated tablet contains 500,000 IU (International Units) of Nystatin. The other ingredients are lactose monohydrate, microcrystalline cellulose, stearic acid (Ph. Eur.), maize starch, magnesium stearate (Ph. Eur.) [vegetable], shellac, talc, sucrose, calcium carbonate, glucose syrup, titanium dioxide (E 171), iron(III) oxide (E 172), spray-dried gum arabic, white clay, macrogol 6000, glycerol 85%, Capol 600: (bleached wax, carnauba wax, shellac), vanillin.

What Nystatin Stada looks like and contents of the pack:
Brown, round, biconvex, coated tablet. Nystatin Stada is available in packs of 20, 50, and 100 coated tablets.

Marketing Authorisation Holder:
Stada Consumer Health Deutschland GmbH, Stadastraße 2-18,
61118 Bad Vilbel, Germany
Telephone: +49 6101 603-0,
Fax: +49 6101 603-259,
Internet: www.stada.de.

Manufacturer:
Stada Arzneimittel AG,
Stadastraße 2-18,
61118 Bad Vilbel,

(Apo) Usually ship out within 3-5 business days