Active ingredients: Metronidazole
Zidoval 7.5 mg / g Vaginal gel
Why is Zidoval used? What is it for?
Zidoval gel belongs to the category 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 to the inside of 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 can recur.
To prevent this from happening, it is necessary to use this medicine for the entire course of treatment, as prescribed by the doctor.
Contraindications When Zidoval should not be used
Do not use Zidoval gel:
- if you are allergic to metronidazole or other similar nitroimidazole-based antibacterials.
- if you are allergic to other parabens (a preservative agent)
- if you are allergic to any of the other ingredients of Zidoval gel.
- If any of the above apply to you, tell your doctor or pharmacist.
Precautions for use What you need to know before taking Zidoval
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 the blood
- if you have or think you have a vaginal fungus (candidiasis). Symptoms of a vaginal fungus can be accentuated when using Zidoval gel. So you may need your doctor to prescribe another treatment for this problem
- if you are menstruating
- if you are due to have blood tests, as metronidazole can interfere with the results of some tests.
As with all vaginal infections, you must avoid having sexual intercourse during the infection and while using Zidoval gel.
Zidoval gel is contraindicated for use in girls under 18 years of age or in elderly patients, as the safety of this medicine has not been established in these patient groups.
Interactions Which drugs or foods may change the effect of Zidoval
Tell 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:
- warfarin, a drug used to prevent blood clotting
- lithium, a medicine to treat mental problems
- ciclosporin, a medicine used to treat autoimmune diseases and rheumatoid arthritis
- 5-fluorouracil, a medicine used for skin problems and for the treatment of cancer
- any other medicines, including those obtained without a prescription.
Zidoval gel with alcohol
Consuming alcohol while using Zidoval gel may make you feel sick or vomit, may cause confusion, headache or abnormally fast heart beat. In this case, stop drinking alcohol and consult your doctor or pharmacist.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant, planning to become pregnant or breast-feeding, ask your doctor or pharmacist for advice before using Zidoval gel.
Zidoval gel contains methyl parahydroxybenzoate, propll paraldroxybenzoate and propylene glycol
Zidoval gel contains methyl paraldroxybenzoate (E218) and propyl parahydroxybenzoate (E216) which can cause allergic reactions.
This medicine also contains propylene glycol (E1520), which can cause skin irritation.
Dose, Method and Time of Administration How to use Zidoval: Posology
Always use Zidoval gel exactly as your doctor has told you. If in doubt, 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 stated on the label your pharmacist places on the medicine. If not, or if you are unsure, ask your doctor or pharmacist.
Before applying Zidoval gel
Proper hygiene is very important when using Zidoval gel.
Always to do:
wash your hands before opening the tube or touching the applicators
- use a new applicator for each dose
- immediately throw any used applicator in the trash.
Adult dose
- The dose of Zidoval gel is one "application of 5 g inserted into the vagina once a day, at bedtime, for five consecutive days.
Girls under the age of 18 and elderly patients
This medicine is not indicated for use in girls under the age of 18 or elderly patients.
Instructions for Use
- Disposable applicators (disposable) are supplied together with Zidoval gel to help you insert the gel into the vagina
- Opening the tube: remove the cap from the tube of Zidoval gel and pierce 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 end of the open tube. Squeeze the tube gently and slowly 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 put the cap back on the tube
- Inserting the applicator: Hold the filled applicator by the shaft and gently insert the applicator into the vagina until it fits easily. Insertion may be easier in the supine position, with the knees bent
- Gel release: Slowly push the plunger into the applicator to release the gel into the vagina. Continue to push until the plunger stops. This will ensure that you have released the correct amount of gel
- Remove the applicator from your vagina and immediately throw it in the trash.
Repeat this procedure using a new applicator at bedtime for five consecutive days 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 forget to use Zidoval gel
Do not take a double dose to make up for a forgotten dose. Apply Zidoval gel the next day at bedtime.
If you stop taking Zidoval gel
Do not stop using Zidoval gel during your 5 day treatment course without talking to your doctor first. It is important that you follow the entire course of therapy, so as to completely eradicate the infection.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Zidoval
Do not use more Zidoval gel than you should. If you accidentally use too much, talk to your doctor or pharmacist. Using too much of this medicine may increase the risk of side effects
Side Effects What are the side effects of Zidoval
Like all medicines, Zidoval gel 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
- Feeling of nausea or vomiting
- Bad taste in the mouth
- Unusual sensation on the tongue
- Vaginal fungus (candidiasis)
- Vaginal secretions
- Discomfort in the pelvic area
- Reduction of appetite.
Uncommon side effects (may affect up to 1 in 100 people)
- Depression
- Tiredness
- Irritability
- Difficulty sleeping
- Unusual sensation in the fingers and toes
- Diarrhea
- Constipation
- Swelling and rumbling of the stomach
- Dry mouth or feeling thirsty
- Metallic taste in the mouth
- Itching
- Muscle cramps
- Dark urine
- Urinary tract infections (UTIs) which can 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 the menstrual cycle.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use Zidoval gel after the expiry date which is stated on the carton and tube. The expiry date refers to the last day of that month.
Do not store above 25 ° C.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
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.
What Zidoval gel looks like and contents of the pack
Zidoval Vaginal Gel is colorless or straw-colored. It comes in a 40g aluminum tube with a plastic screw cap inside a carton. The carton also contains 5 disposable vaginal applicators, for administering 5g of gel.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
ZIDOVALTM
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Metronidazole 0.75% w / w, 7.5 mg / g
For excipients see section 6.1.
03.0 PHARMACEUTICAL FORM
Vaginal gel.
Colorless or slightly straw-colored gel.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Zidoval vaginal gel is indicated for the treatment of bacterial vaginosis.
04.2 Posology and method of administration
Vaginal administration.
Adults:
One "application of Zidoval vaginal gel (5 g) in the vagina once a day, before going to bed, for 5 consecutive days.
Instructions for Use: Pierce the sealed end of the tube and screw the open end of the applicator firmly on. Squeeze the tube filling the applicator with gel. Remove the applicator from the tube and gently insert its full length into the vagina. Push the plunger to release the gel. Discard the applicator according to the instructions provided.
Elderly patients:
Bacterial vaginosis is not common in elderly patients and consequently no clinical evaluation has been made in patients in this age group.
Little girls:
In girls and adolescents under 18 years of age the use of the product is not recommended as safety and efficacy have not been established.
04.3 Contraindications
Zidoval vaginal gel is contraindicated in patients with a history of hypersensitivity to metronidazole, other nitroimidazoles, parabens or any other component of the gel.
04.4 Special warnings and appropriate precautions for use
Use during the menstrual period is not recommended.
Known or previously undiagnosed candidiasis may manifest "accentuation of symptoms and require therapy with a specific agent during treatment with Zidoval vaginal gel."
Metronidazole is a nitroimidazole and should be used with caution in patients with a history of blood dyscrasias.
As with all vaginal infections, sexual intercourse should be avoided during infection and during treatment with Zidoval vaginal gel.
04.5 Interactions with other medicinal products and other forms of interaction
Oral metronidazole exhibits a similar reaction to disulfiram when combined with alcohol. Acute psychotic reactions and states of confusion have occurred during concomitant use of metronidazole and disulfiram. The possibility of such reactions, at the low serum concentrations achieved with the use of Zidoval vaginal gel, is unlikely, but cannot be excluded.
Oral metronidazole has been found to increase plasma concentrations of warfarin, lithium, cyclosporine and 5-fluorouracil. Given the low plasma concentrations achieved after vaginal administration, similar effects are not expected but cannot be completely excluded.
Metronidazole can interfere with the determination of some blood chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactic dehydrogenase (LDH), triglycerides and glucose hexokinase. Values close to zero can be observed.
04.6 Pregnancy and lactation
Pregnancy:
Data concerning the treatment of a large number of patients (several hundred) during pregnancy have shown the absence of side effects of metronidazole in the fetus and newborn; however, no specific studies have been performed with Zidoval vaginal gel on pregnant women. Therefore, caution should be exercised when prescribing to pregnant women.
Feeding time:
The ratio of plasma concentrations of vaginal Zidoval gel to those of oral metronidazole is approximately 0.02. Metronidazole is excreted in breast milk at concentrations similar to those in plasma and the ratio of plasma concentrations of metronidazole in the nursing infant to the mother is approximately 0.15. Caution should be exercised when prescribing Zidoval vaginal gel to breastfeeding women.
04.7 Effects on ability to drive and use machines
None known.
04.8 Undesirable effects
In controlled clinical trials involving 759 patients, the most commonly reported adverse events were those affecting the urogenital tract (26%) and the gastrointestinal tract (14%).
04.9 Overdose
There are no reported cases of overdose in humans with Zidoval vaginal gel and no specific treatment exists. Metronidazole is readily removed from plasma by hemodialysis.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
ATC classification: G01AF01
Metronidazole is a synthetic antibacterial agent which also possesses amoebicidal activity. Zidoval vaginal gel has been shown in vivo to be active against vaginal pathogens Gardnerella vaginalis And bacteroides.
Significant increases in lactobacilli have been observed in patients with bacterial vaginosis following therapy with Zidoval.
05.2 Pharmacokinetic properties
Bioavailability studies, following single dose administration of 5 grams of Zidoval vaginal gel in 12 healthy subjects, demonstrated a mean Cmax of 237 nanograms / ml equal to approximately 2% of the mean maximum plasma concentration of a 500 tablet. mg taken orally (mean Cmax = 12,785 ng / ml). Under normal conditions of use, the formulation therefore determines minimal plasma concentrations of metronidazole.
Metronidazole has a large apparent volume of distribution and is able to pass through the blood brain barrier and the cerebrospinal fluid to reach plasma-like concentrations.
Metronidazole is metabolised in the liver by side chain oxidation to glucuronide formation, with much of the absorbed dose being excreted as metabolites. Both unchanged drug and metabolites are excreted primarily in the urine.
05.3 Preclinical safety data
At high doses, metronidazole exhibited a mutagenic effect on bacteria but not on mammalian cells in vitro or in vivo. Carcinogenic potential has been shown in mice and rats, but not in hamsters. In epidemiological studies there was no evidence of an increased risk of developing cancer following exposure to metronidazole.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Carbomer (Carbopol) 974P, edetate disodium, methyl parahydroxybenzoate, propyl parahydroxybenzoate, propylene glycol, sodium hydroxide, purified water.
06.2 Incompatibility
None known.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Store at a temperature not exceeding 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
Aluminum tube covered with epoxy phenolic resin, with polyethylene screw cap containing 40 g of product. The pack contains 5 disposable vaginal applicators, capable of releasing 5 grams of gel each.
06.6 Instructions for use and handling
Not relevant.
07.0 MARKETING AUTHORIZATION HOLDER
Meda Pharma S.p.A. - Viale Brenta 18 - 20139 Milan
08.0 MARKETING AUTHORIZATION NUMBER
AIC 034942019 / M
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
October 2000 / February 2005
10.0 DATE OF REVISION OF THE TEXT
12/09/2007
