Inimur Complex

Package leaflet: information for the patient

Inimur Complex 10 g / 4,000,000 I.U. vaginal cream, 500 mg / 200,000 I.U. soft vaginal capsules

nifuratel / nystatin
Please read this leaflet carefully before using this medicine as it contains
important 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, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Inimur Complex is and what it is used for
2. What you need to know before using Inimur Complex
3. How to use Inimur Complex
4. Possible side effects
5. How to store Inimur Complex
6. Contents of the pack and other information

1. What Inimur Complex is and what it is used for

This medicinal product contains:

• nifuratel, a substance with antifungal properties (acts by inhibiting the growth of fungal organisms) and antiprotozoal activity (acts against parasitic infections);
• nistatin, a substance with strong antifungal action.

Inimur Complex is therefore used to combat pathogenic microorganisms (fungi such as Candida, protozoa such as Trichomonas, and bacteria) in conditions affecting the lower portion of the female genital organs (vulvovaginal area).
Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Inimur Complex

Do not use Inimur Complex
if you are allergic to nifuratel, nystatin, or any of the other ingredients of this
medicinal product (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before using Inimur Complex.
During treatment with this medicinal product, you must NOT have sexual intercourse.
Other medicines and Inimur Complex
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding
with breast milk, consult your doctor or pharmacist before using this medicinal product.
During pregnancy and breastfeeding, the product should be administered only
when necessary and under medical supervision.
No studies on fertility in humans have been conducted.
Driving and using machines
This medicinal product does not affect the ability to drive vehicles or operate machinery.
Inimur Complex vaginal cream contains

• methyl parahydroxybenzoate and propyl parahydroxybenzoate, which
  can cause allergic reactions (including delayed reactions);
• propylene glycol: this medicinal product contains 50 mg of propylene glycol per gram; Inimur Complex soft vaginal capsules contain:
• sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which
  can cause allergic reactions (including delayed reactions).

3. How to use Inimur Complex

Use this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Inimur Complex 10 g / 4,000,000 I.U. vaginal cream
The recommended dose is 2.5 g of vaginal cream, once or twice daily, or as otherwise prescribed by your doctor, to be administered intravaginally in the evening and/or morning.
The cream must be applied using the provided dosing syringe.
Instructions for using the syringe

1. Screw the dosing syringe onto the tube of vaginal cream,

and press the tube to fill the syringe with the required amount of vaginal cream (according to the markings corresponding to grams of cream).

2. Unscrew the syringe from the tube and insert it into the vagina, then push the plunger.
3. If necessary, remove the cannula from the plunger and screw it onto the opposite end of the syringe before vaginal insertion.

A plastic applicator is included in the package. After use, the applicator must be thoroughly washed and prepared for subsequent use.
Inimur Complex 500 mg / 200,000 I.U. soft vaginal capsules
The recommended dose is 1 vaginal capsule daily, or as otherwise prescribed by your doctor, to be inserted deeply into the vagina.
It is important to remember that, for optimal therapeutic effect, you should use your finger to guide the capsule into the deepest part of the vagina.
If you forget to use Inimur Complex
Do not use a double dose to make up for the missed dose.
If you stop treatment with Inimur Complex
Consult your doctor if you wish to discontinue treatment early.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Very rare (may affect up to 1 in 10,000 people):

• dermatitis
• urticaria
• vaginal burning
• vaginal itching

Prolonged use of this medicine may lead to sensitization phenomena (this occurs when a given dose of a substance produces a greater effect than that observed after the first administration).
Stop treatment immediately and consult your doctor if symptoms of an allergic reaction occur, such as skin rashes.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly through the national reporting system at the following website: http://www.aifa.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Inimur Complex

Store below 25°C.
Do not use Inimur Complex 10 g / 4,000,000 I.U. vaginal cream more than 12 days after opening.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after
"Expiry". The expiry date refers to the last day of that month.
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 Inimur Complex contains
Inimur Complex 10 g / 4,000,000 I.U. vaginal cream

• The active substances are nifuratel and nystatin. Each 100 g of vaginal cream contains 10 g of nifuratel and 4,000,000 I.U. of nystatin.
• The other components are xalifin 15, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, glycerol, non-crystallizable liquid sorbitol, propylene glycol, carbomers, triethanolamine, purified water.

Inimur Complex 500 mg / 200,000 I.U. soft vaginal capsules

• Active substances: nifuratel and nystatin. Each capsule contains 500 mg of nifuratel and 200,000 I.U. of nystatin.
• Other components inside the capsule: dimethicone.
• Capsule shell components: gelatin, glycerol, sodium ethyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate, titanium dioxide, yellow iron oxide (E 172).

Description of the appearance of Inimur Complex and contents of the pack
Inimur Complex 10 g / 4,000,000 I.U. vaginal cream is supplied in a box containing a 30 g tube of cream and a dosing syringe with a dedicated cannula.
Inimur Complex 500 mg / 200,000 I.U. soft vaginal capsules is supplied in a box containing a blister pack of 6 or 12 soft vaginal capsules.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Polichem S.r.l. - Via G. Marcora, 11 - 20121 Milan, Italy

Manufacturer:
Inimur Complex 10 g / 4,000,000 I.U. vaginal cream
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1, 29016 Cortemaggiore (PC), Italy
Inimur Complex 500 mg / 200,000 I.U. soft vaginal capsules
Doppel Farmaceutici S.r.l. - Via Volturno, 48, Quinto de’ Stampi, 20089 Rozzano (MI), Italy
or
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1, 29016 Cortemaggiore (PC), Italy