Zidoval

Package leaflet: Information for the user

Zidoval 7.5 mg/g Vaginal Gel

Metronidazole
Read this entire leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen.
• Throughout this patient information leaflet, Zidoval 7.5 mg Vaginal Gel will be referred to as Zidoval gel.

Contents of this leaflet

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

1. What Zidoval gel is and what it is used for

Zidoval gel belongs to a class of medicines called antibacterial agents. It works by destroying many types of bacteria that cause infections.
Zidoval gel is used to treat a vaginal infection (called bacterial vaginosis or BV, for short) in adult female patients. Zidoval gel is applied inside the vagina, where it destroys bacteria at the site of infection.
It is important that bacterial vaginosis is treated and completely eradicated, otherwise the infection may recur. To prevent this from happening, it is necessary to use this medicine for the full duration of the treatment course, as prescribed by the doctor.

2. What you should know before using Zidoval gel

Do not use Zidoval gel

• if you are allergic to metronidazole or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other antibacterial medicines containing nitroimidazoles.
• if you are allergic to parabens (preservatives).

If any of the above conditions apply to you, inform your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before using Zidoval gel:

• if you have or have previously had blood disorders or blood-related diseases
• if you have or think you may have a vaginal fungal infection (candidiasis). Symptoms of a vaginal fungal infection may be worsened when using Zidoval gel. Therefore, you may need your doctor to prescribe another treatment for this condition
• if you are menstruating
• if you need to have blood tests, as metronidazole may interfere with the results of certain laboratory analyses.

Avoid prolonged and unnecessary use.
As with all vaginal infections, you should avoid sexual intercourse during the infection and while using
Zidoval gel.
Children and adolescents
Zidoval gel is contraindicated for use in girls under 18 years of age, as the safety of this medicine has not been established in this patient group.
Elderly
Zidoval gel is contraindicated for use in elderly patients, as the safety of this medicine has not been established in this patient group.
Other medicines and Zidoval gel
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines.
Zidoval gel may increase the effect of the following medicines:

• oral anticoagulants such as warfarin, which are medicines used to prevent blood clotting
• Lithium, a medicine used to treat mental health conditions
• Cyclosporine, a medicine used to treat autoimmune diseases and rheumatoid arthritis
• 5-fluorouracil, a medicine used for skin conditions and cancer treatment
• Any other medicine, including those obtained without a prescription.

Zidoval gel and alcohol
Consuming alcohol while using Zidoval gel may cause nausea or vomiting, confusion, headache, or abnormally rapid heartbeat. If this occurs, stop consuming alcohol and consult your doctor or pharmacist.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Zidoval gel contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which may cause allergic reactions (possibly delayed).
Zidoval gel also contains 30 mg of propylene glycol (E1520) per gram. Propylene glycol may cause skin irritation.

3. How to use Zidoval gel

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

Zidoval gel is for vaginal use only.

Important:
Your doctor will choose the correct dose for you. The dose will be clearly indicated on the label applied by the pharmacist to the medicine container. If this is not the case, or if you have any doubts, ask your doctor or pharmacist.

Before applying Zidoval gel
Proper hygiene is very important when using Zidoval gel. Always do the following:

• Wash your hands before opening the tube or handling the applicators.
• Use a new applicator for each dose.
• Immediately dispose of each used applicator in the trash.

Dosage for adults

• The dose of Zidoval gel is one 5 g application inserted into the vagina once daily at bedtime, for five consecutive days.

Use in children and adolescents
This medicine is not indicated for use in girls under 18 years of age.

Use in the elderly
This medicine is not recommended for use in elderly women.

Instructions for use

• Single-use (disposable) applicators are provided with Zidoval gel to help you insert the gel into the vagina.

• Opening the tube: Remove the cap from the Zidoval gel tube and pierce the sealed end of the tube with the pointed end of the cap.

• Filling the applicator: Screw the open end of an applicator onto the open end of the tube. Gently and slowly squeeze the tube starting from the bottom to fill the applicator. The plunger will move as the applicator fills, stopping automatically when the 5 g dose of Zidoval gel is reached. Remove the applicator from the tube and replace the cap on the tube.

Screw on

• Inserting the applicator: Hold the filled applicator by the barrel and gently insert it into the vagina as far as it goes easily. Insertion may be easier when lying down with knees bent.

• Releasing the gel: Slowly press the plunger on the applicator to release the gel into the vagina. Continue pressing until the plunger stops. This ensures that the correct amount of gel has been delivered.

• Remove the applicator from the vagina and immediately dispose of it in the trash.

Repeat this procedure using a new applicator at bedtime for five consecutive days, or as directed by your doctor. If after a 5-day course of Zidoval gel you notice no improvement, you should consult your doctor again.

If you use more Zidoval gel than you should
Do not use more Zidoval gel than prescribed. If you accidentally use too much, contact your doctor or pharmacist. Using an excessive dose of this medicine may increase the risk of side effects (see section 4 below).

If you forget to use Zidoval gel
Do not use a double dose to make up for the missed dose. Apply Zidoval gel the following day at bedtime.

If you stop using Zidoval gel prematurely
Do not stop using Zidoval gel during the 5-day treatment course without first talking to your doctor. It is important to complete the full course of treatment to completely clear the infection.

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 everyone gets them.

Common side effects (may affect up to 1 in 10 people)

• Headache and dizziness
• Stomach cramps
• Vomiting
• Bad taste in the mouth
• Unusual sensation in the tongue
• Dry skin
• Skin redness (erythema)
• Itching of the skin
• Skin discomfort (burning, pain of the skin, stinging pain of the skin)
• Skin irritation
• Vaginal fungal infection (candidiasis)
• Vaginal discharge
• Pelvic discomfort
• Decreased appetite

Uncommon side effects (may affect up to 1 in 100 people)

• Feeling of nausea
• Depression
• Tiredness
• Irritability
• Difficulty sleeping
• Unusual sensation in fingers and toes
• Diarrhoea
• Constipation
• Stomach bloating and rumbling
• Dry mouth or feeling thirsty
• Metallic taste in the mouth
• Muscle cramps
• Dark urine
• Urinary tract infections (UTIs) which may cause pain or burning sensation when passing urine, or the need to urinate more frequently and urgently
• Swelling of the vulva (external part of the vagina)
• Changes in menstrual cycles, such as spotting or bleeding between periods, or increased discomfort during menstruation

Other possible side effects (frequency not known)

• Itchy skin rash (urticaria)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Zidoval gel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and tube after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
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. Contents of the pack and other information

What Zidoval gel contains

• The active substance is metronidazole. Each gram of gel contains 7.5 mg of metronidazole.
• The other components are: carbopol 974P, disodium edetate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol (E1520), sodium hydroxide (E524) and purified water.

Description of the appearance of Zidoval gel and contents of the pack
Zidoval Vaginal Gel is colourless or straw-coloured. It is supplied in a 40 g aluminium tube with a screw plastic cap, contained in a cardboard box.
The box also contains 5 single-use vaginal applicators for the administration of 5 g of gel.
Marketing Authorisation Holder
Exeltis Italia S.r.l.
Via Lombardia, 2/A
20068 Peschiera Borromeo (MI)
Italy
Manufacturer
MEDA Manufacturing – Avenue JF Kennedy, 33700 Mérignac - France