Inimur

Package leaflet: information for the patient

Inimur 250 mg vaginal tablets, 200 mg coated tablets, 10% vaginal cream

nifuratel
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult 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 reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Inimur 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 properties (acts against parasitic infections).
Inimur is therefore used to counteract pathogenic microorganisms (germs, protozoa such as Trichomonas, fungi and yeasts like monilia) in the following conditions:

• disorders affecting the lower portion of the female genital tract (vulvovaginal area);
• leucorrhoea (abundant vaginal discharge, more or less sticky, whitish-transparent in color);
• treatment of urinary tract infections.

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Inimur

Do not use Inimur

• if you are allergic to nifuratel or to any of the other ingredients of this medicine (listed in section 6);
• during pregnancy, unless your doctor considers it strictly necessary;
• if you are breastfeeding;
• in very early infancy, unless the paediatrician considers it strictly necessary.

Warnings and precautions
Talk to your doctor or pharmacist before using Inimur.
During treatment with this medicine, you MUST NOT have sexual intercourse.
Your doctor may also treat your partner with Inimur (200 mg coated tablets)
to prevent the risk of reinfection.
Children
In very early infancy, this product should be administered only when clearly necessary and if considered strictly necessary by the paediatrician.
Other medicines and Inimur
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inimur has not shown interactions with other medicines in clinical use.
Inimur and alcohol
During treatment with Inimur, you must avoid drinking alcoholic beverages, as you may experience discomfort and nausea; these symptoms resolve spontaneously.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, this 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 medicine does not impair the ability to drive or operate machinery.
Inimur 200 mg coated tablets contain

• sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

Inimur 10% vaginal cream contains

• methyl parahydroxybenzoate and propyl parahydroxybenzoate: may cause allergic reactions (including delayed reactions);
• propylene glycol: this medicine contains 50 mg of propylene glycol per gram;

3. How to use Inimur

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Treatment of vulvovaginal disorders and leucorrhoea

The recommended dose varies depending on which formulation you are using:

Inimur 250 mg vaginal tablets

The recommended dose is 1 vaginal tablet to be inserted deeply into the vagina at bedtime, for 10 days.

It is important to remember that for optimal therapeutic effect, you should use your finger to guide the tablet into the deepest part of the vagina.

Inimur 10% vaginal cream

The recommended dose in adult patients is 2–3 g of vaginal cream to be inserted deeply into the vagina at bedtime, for 10 days.

The cream should be applied using the provided dosing syringe, optionally connected to the dedicated cannula.

The recommended dose in children is 1–2 g of vaginal cream to be inserted into the vagina at bedtime, for 10 days. The cream should be applied using the dosing syringe connected to the dedicated cannula.

Instructions for using the dosing syringe

1. Screw the dosing syringe onto the cream tube and press the tube until the required amount of cream has been drawn into the syringe (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. In children and in virgin women, remove the cannula from the plunger and screw it onto the opposite end of the syringe before vaginal insertion.

To remove any possible discharge that may occur the morning after administration of the vaginal tablets or cream, it is sufficient to perform a vaginal douching or irrigation (vaginal douche performed with thermal water).

Inimur 200 mg coated tablets

The recommended dose in adults is 1 coated tablet three times daily, taken after main meals, for 7 days (this dose is also recommended for any concomitant treatment of the partner). The tablets must always be taken orally, with a large amount of liquid, and must not be chewed.

If you are a patient being treated only with Inimur 200 mg coated tablets, the recommended dose may be increased (to 4 tablets or more), according to your doctor's instructions.

Treatment of urinary tract infections

The recommended dose in adults is 1–2 coated tablets three times daily, taken after meals.

Treatment duration is typically 1–2 weeks, depending on the severity and type of infection, and may be prolonged or repeated according to the physician’s judgment.

If you use more Inimur than you should

Symptoms of overdose are not known. However, if you use more Inimur than prescribed, contact your doctor, as symptomatic and supportive treatment may be required if necessary.

If you forget to use Inimur

Do not take a double dose to make up for the missed dose.

If you stop using Inimur

Consult your doctor if you wish to discontinue treatment prematurely.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare (may affect up to 1 in 1,000 people)

• Gastrointestinal disorders, such as nausea (only for coated tablets)

Very rare

• Gastrointestinal disorders, such as vomiting (only for coated tablets)
• Hypersensitivity reactions, such as skin rashes, urticaria, or localized edema

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can 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 Inimur

Store below 25°C.
Do not use Inimur 10% vaginal cream more than 4 weeks 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 pack 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 contains
Inimur 250 mg vaginal tablets

• The active substance is nifuratel. Each vaginal tablet contains 250 mg of nifuratel.
• The other components are: maize starch, monohydrate lactose, tartaric acid, sodium bicarbonate, magnesium stearate and macrogol.

Inimur 200 mg coated tablets

• The active substance is nifuratel. Each tablet contains 200 mg of nifuratel.
• The other components are: maize starch, rice starch, talc, magnesium stearate, light magnesium carbonate, gelatin, acacia gum, sucrose, macrogol, titanium dioxide, emulsifying wax.

Inimur 10% vaginal cream

• The active substance is nifuratel. 100 g of vaginal cream contain 10 g of nifuratel.
• The other components are: xalifin 15, methyl parahydroxybenzoate, propyl parahydroxybenzoate, glycerol, liquid sorbitol (non-crystallizable), propylene glycol and purified water.

Description of the appearance of Inimur and the contents of the pack
Inimur 250 mg vaginal tablets are supplied in a box containing 10 vaginal tablets individually packaged.
Inimur 200 mg coated tablets are supplied in a box containing a blister pack of 20 coated tablets.
Inimur 10% vaginal cream is supplied in a box containing a 30 g tube of cream and a dosing syringe with an appropriate cannula.

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

Manufacturer:
Inimur 250 mg vaginal tablets and Inimur 200 mg coated tablets
Doppel Farmaceutici S.r.l. - Quinto de’ Stampi plant - Rozzano (MI)
Inimur 10% vaginal cream
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 29016 Cortemaggiore (PC)