Package leaflet: Information for the patient

NIZACOL

500 mg tablets
miconazole
Please read this leaflet carefully before taking this medicine because it contains impor-
tant information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it could be dangerous.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What NIZACOL is and what it is used for
What you need to know before taking NIZACOL
How to take NIZACOL
Possible side effects
How to store NIZACOL
Contents of the pack and other information

1. What NIZACOL is and what it is used for

NIZACOL contains the active substance miconazole and is used to treat fungal infections (candidiasis) of the mouth and throat (stomatitis, thrush) and of the gastrointestinal tract.

2. What you should know before taking NIZACOL

Do not take NIZACOL

if you are allergic to the active substance, to other similar antifungal medicines, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking NIZACOL.
Children and adolescents
In very early infancy, NIZACOL should be administered only when strictly necessary and under direct medical supervision.
Other medicines and NIZACOL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
NIZACOL may enhance the anticoagulant effect of coumarin drugs. If NIZACOL is used concomitantly with coumarin drugs, your doctor may adjust the dose of the coumarin drug.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
If you are pregnant, use this medicine only if clearly needed and under direct medical supervision.
Driving and operating machinery
NIZACOL does not impair the ability to drive or operate machinery.
NIZACOL contains Lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take NIZACOL

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 500–1000 mg daily (1–2 tablets); your doctor will determine the exact dose.
Continue treatment for at least one week after symptoms have disappeared.
In oral candidiasis, allow the tablets to dissolve slowly in the mouth.

If you take more NIZACOL than you should
If you have taken more NIZACOL than you should, stop taking it and contact your doctor immediately.

If you forget to take NIZACOL
Do not take a double dose to make up for the missed tablet.

If you stop taking NIZACOL
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you experience any of the following side effects, stop taking NIZACOL and contact your doctor:

swelling of the face, tongue or throat; difficulty swallowing; hives and breathing difficulties (angioedema, anaphylactic reaction);
a skin allergic reaction, which may include round or oval patches with redness and swelling of the skin, skin rash with blisters, and itching sensation (fixed drug eruption). Darkening of the skin in the affected areas may also occur, which could persist after healing. A fixed drug eruption usually recurs at the same site (or sites) if the medicine is taken again (frequency not known).

Inform your doctor or pharmacist if you notice any of the following side effects:

skin rash with pustules/blisters filled with pus (acute generalized exanthematous pustulosis) (frequency not known).

Nausea, headache (cephalalgia), skin rashes, and diarrhoea may occur during prolonged treatment.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NIZACOL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What NIZACOL contains
The active substance is miconazole.
The other ingredients are lactose, microcrystalline cellulose, corn starch, saccharin, polyvinylpyrrolidone, magnesium stearate, colloidal silicon dioxide.

Description of the appearance of NIZACOL and contents of the pack
A carton containing one blister with 10 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
NEW RESEARCH srl
Via Tiburtina, 1143
00156 Rome
Italy

Manufacturer
SPECIAL PRODUCT’S LINE S.r.l.
Strada Paduni n° 240
03012 Anagni (FR)
Italy