ZIDOVAL 0.75% VAGINAL GEL 40 G TUBE WITH 5 APPLICATORS

Name
Zidoval 7.5 mg/g Vaginal Gel
Metronidazole


What it is and what it is used for
Zidoval gel belongs to a group of medicines called antibacterials. It works by destroying many types of bacteria, which cause infections.

Zidoval gel is used to treat a vaginal infection (called bacterial vaginosis or BV for short) in adult patients. Zidoval gel is applied inside the vagina, where it destroys bacteria at the site of the infection.

It is important that bacterial vaginosis is treated and completely eliminated, otherwise the infection may recur. To prevent this from happening, it is necessary to use this medicine for the entire course of treatment, as prescribed by your doctor.


What you need to know before taking the medicine
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 similar nitroimidazole-based antibacterials.
• if you are allergic to parabens (preservatives)

If any of the above applies 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 affecting the blood
• if you have or think you have a vaginal fungus (thrush). The symptoms of a vaginal fungus may be worse when you use Zidoval gel. You may therefore need your doctor to prescribe another treatment for this problem.
• if she has her period
• if you need 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 having 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 group of patients.

Elderly people
Zidoval gel is contraindicated for use in elderly patients, as the safety of this medicine has not been established in this group of patients.


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
• Vomit
• Bad taste in 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 fungus (candidiasis)
• Vaginal secretions
• Discomfort in the pelvic area
• Reduction of 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
• Diarrhea
• Constipation
• Bloating and rumbling of the stomach
• Dry mouth or feeling thirsty
• Metallic taste in the mouth
•
• Muscle cramps
• Dark urine
• Urinary tract infections (UTIs) which may cause pain or a burning sensation when passing urine, or the need to urinate more often and more urgently
• Swelling of the vulva (outer part of the vagina)
• Changes in menstrual cycles, such as spotting or bleeding between periods, or increased discomfort during periods.

Other possible side effects (for which the frequency is not known)
• Itchy skin rash (hives).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.