ZIDOVAL 0,75% Vaginal gel

Зміст інструкції

1. Zidoval 7.5 mg/g Vaginal Gel
   1. What is Zidoval gel and what is it 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

Zidoval 7.5 mg/g Vaginal Gel

Metronidazole

Read this leaflet carefully before you start using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet, or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if you do not get better or if your symptoms get worse.

Contents of this leaflet

• 1. What Zidoval gel is and what it is used for
• 2. What you need to know before you use 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 is Zidoval gel and what is it used for

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

2. What you need to know before using Zidoval gel

Do not use Zidoval gel

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

If any of the above conditions apply to you, tell your doctor or pharmacist.

Warnings and precautions
Talk to your doctor or pharmacist before using Zidoval gel:

• if you have or have had any blood problems or a disease that has affected your blood
• if you have or believe you have a vaginal fungal infection (candidiasis). The 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 problem
• if you are having your menstrual period
• if you are going to have blood tests, as metronidazole may interfere with the results of some tests.

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 the age of 18, 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
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines
Zidoval gel can increase the effect exerted by the following medicines:

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

Zidoval gel with alcohol
Consuming alcohol while using Zidoval gel may cause nausea or vomiting, may cause
confusion, headache or an abnormally fast heartbeat. In this case, stop consuming
alcohol and consult your doctor or pharmacist.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine.

Zidoval gel contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)which may
cause allergic reactions (which may be 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 following the instructions of your doctor exactly. If you have any doubts, consult your doctor
or pharmacist.
Zidoval gel is for vaginal use only.

Important:
Your doctor will choose the right dose for you. The dose will be clearly indicated on the label that the
pharmacist applies to the medicine. 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 during the use of Zidoval gel. Always do the following:

• Wash your hands before opening the tube or touching the applicators.
• Use a new applicator for each dose.
• Immediately throw away each used applicator in the trash.

Dose for adults

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

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

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 puncture the sealed end of the tube with the pointed back 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 once the 5 g dose of Zidoval gel is reached. Remove the applicator from the tube and replace the cap on the tube

Screwing

• Inserting the applicator: hold the filled applicator by the barrel and gently insert the applicator into the vagina until it enters easily. Insertion may be easier in a supine position, with your knees bent

• Releasing the gel: slowly press the plunger into the applicator to release the gel into the vagina. Continue to press until the plunger stops. This will ensure that you have released the correct amount of gel

• Remove the applicator from the vagina and immediately throw it away in the trash.

Repeat this procedure using a new applicator at bedtime for five consecutive days,
or as directed by your doctor. If you do not notice any improvement after a 5-day course of Zidoval gel, you should consult your doctor again.

If you use more Zidoval gel than you should
Do not use more Zidoval gel than you should. 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 take a double dose to make up for a missed dose. Apply Zidoval gel the next day, at bedtime.

If you stop using Zidoval gel
Do not stop using Zidoval gel during the 5-day treatment course without first talking to your
doctor. It is important to follow the entire course of therapy, so as to completely eradicate the infection.
If you have any questions about using 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.

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

• Headache and dizziness
• Stomach cramps
• Vomiting
• Bad taste in the mouth
• Unusual sensation on the tongue
• Dry skin
• Redness of the skin (erythema)
• Itchy skin
• Skin discomfort (burning, skin pain, stinging skin pain)
• Skin irritation
• Vaginal thrush (candidiasis)
• Vaginal discharge
• Discomfort in the pelvic area
• Loss of appetite.

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

• Feeling of nausea
• Depression
• Fatigue
• Irritability
• Difficulty sleeping
• Unusual sensation in the fingers of hands and feet
• Diarrhea
• Constipation
• Bloating and rumbling of the stomach
• Dry mouth or feeling of thirst
• Metallic taste in the mouth
• Muscle cramps
• Dark urine
• Urinary tract infections (UTIs) that can cause pain or a burning sensation during urination, or a need to urinate more often 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 rash (urticaria).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 which is stated on the carton and the tube after EXP. The
expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in waste water 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 ingredient is metronidazole. Each gram of gel contains 7.5 mg of metronidazole.
• The other ingredients are: carbopol974P, 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 colorless or straw-colored. It is supplied in a 40 g aluminum tube with a
screw cap, inside a carton. The carton also contains 5 single-use vaginal applicators,
for administering 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