7.5 mg/g vaginal gel
metronidazole
What Zidoval gel is and what it is used for
Zidoval gel belongs to the group of antibacterial drugs. These have a killing effect on many types of bacteria that cause infection.
Zidoval gel is intended for the treatment of bacterial infection of the vagina (called bacterial vaginosis, abbreviated BV) in adults. Zidoval gel is applied directly into the vagina and thus kills the bacteria at the site of infection.
Bacterial vaginosis must be treated and cured completely, otherwise, the infection may return. You must take the full course of medication prescribed by your doctor right to the end to prevent a new infection from occurring.
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 similar antibacterial agents based on nitroimidazoles.
- if you are allergic to parabens (a type of preservative )
Talk to your doctor or pharmacist if any of the above apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before using Zidoval gel:
- if you have or have had a blood disorder.
- if you have or suspect you have a vaginal yeast infection. The symptoms of yeast infection may become more noticeable when you use Zidoval gel and you may need a different treatment for it.
- when you are menstruating.
- if you are going to have a blood test because metronidazole can affect some test results.
- Avoid prolonged and unnecessary use of this medicine.
As with all vaginal infections, intercourse should be avoided during infection and treatment with Zidoval gel.
Children and young people
Zidoval gel is not recommended for use in children and adolescents under 18 years of age as experience is lacking in these age groups.
Older
Zidoval gel is not recommended for use in the elderly as there is no experience in that age group.
Other medicines and Zidoval gel
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Zidoval gel may increase the effect of the following medicines:
- Coumarin anticoagulants (eg warfarin ), are medicines used to reduce blood coagulation (clotting ability) and prevent blood clots.
- Lithium, a drug used in the treatment of mental illness
- Cyclosporine is, a treatment against autoimmune diseases and rheumatoid arthritis
- 5-fluorouracil, a drug for skin problems and cancer treatment
- Other medicines, including non-prescription ones.
Zidoval gel with alcohol
Consuming alcohol during treatment with Zidoval gel may cause nausea, vomiting, confusion, headache, or palpitations. If this occurs, stop drinking alcohol and contact a doctor or pharmacist.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving ability and use of machinery
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Zidoval gel contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216)
which can cause allergic reactions (possibly delayed).
Zidoval gel also contains 30 mg of propylene glycol (E1520) per gram of gel. Propylene glycol can cause skin irritation.
How to use Zidoval gel
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Zidoval gel is for vaginal use only.
Important:
Always follow the doctor’s prescription and the instructions on the pharmacy label. If you are not sure, ask your doctor or pharmacist.
Before taking Zidoval gel
Good hygiene is very important when using Zidoval gel.
- always wash your hands before opening the tube or touching the applicators.
- use a new applicator for each dose.
- discard the used applicator immediately after use.
Dosage for adults
The recommended dose of Zidoval gel is 5 g (a filled applicator ) inserted into the vagina once a day, at bedtime, for five consecutive days.
Use for children and adolescents
This medicine is not recommended for children under 18 years of age.
Use for the elderly
This medicine is not recommended for the elderly.
Instructions for use
- Disposable applicators for inserting Zidoval gel into the vagina are provided in the package.
- Open the tube: Unscrew the cap and poke holes in the opening with the pointed side of the cap.
- To fill the applicator: Screw the open side of an applicator onto the opened tube. Gently squeeze the tube from the bottom to fill the applicator with gel. The piston moves at the same time as the applicator is filled and stops when the applicator contains the correct amount of 5 g Zidoval gel. Unscrew the applicator and replace the cap on the tube.
- Inserting the applicator: Hold the filled applicator upright and gently insert it into the vagina as far as it will go and feels comfortable. You may find it easiest to do this if you are lying on your back with your legs bent.
- Empty the gel: Slowly push the plunger to empty the gel into the vagina. Keep pressing until it stops. Only then have you received the correct dose of gel.
- Withdraw the applicator from the sheath and discard the applicator immediately.
Repeat this procedure with a new applicator at bedtime for five consecutive days, or as directed by the physician. If you do not feel better after the end of the treatment, contact your doctor again.
If you have used too much Zidoval gel
Do not use more Zidoval gel than recommended. If you happen to use too much medicine, the risk of side effects may increase (see section 4 below).
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Zidoval gel
Do not take a double dose to make up for a missed dose. Apply Zidoval gel next time at bedtime.
If you stop using Zidoval gel
Do not stop taking Zidoval gel during a 5-day course without first talking to your doctor. You must complete the treatment so that the infection heals completely.
If you have further questions about this medicine, contact your doctor or pharmacist.
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 users)
- Headache and dizziness
- Stomach cramps
- Vomiting
- Unpleasant taste in the mouth
- Unusual sensation on the tongue
- Dry skin
- Skin redness ( erythema )
- Itchy skin ( pruritus )
- Discomfort in the skin (burning sensation, pain in the skin/stinging sensation)
- Skin irritation
- Fungal infection in the vagina
- Abnormal discharge
- The sensation of increased pressure in the pelvic area
- Decreased appetite
Uncommon side effects (may affect up to 1 in 100 users)
- Nausea
- Depression
- Fatigue
- Feeling of irritation
- Difficulty sleeping
- Unusual sensation in fingers and toes
- Diarrhea
- Constipation
- Noisy stomach/weather tensions/gas
- Dry mouth or thirst
- Metallic taste in the mouth
- Cramps
- Dark colored urine
- Urinary tract infection that may cause pain or a burning sensation when you urinate or increase the need to urinate more often or more urgently
- Swelling of the vulva (outside of the vagina)
- Changed menstruation such as spotting or increased discomfort during menstruation.
Has been reported (occurring in an unknown number of users)
- Itchy rash ( urticaria ).
How to store Zidoval gel
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the carton and tube after EXP. The expiration date is the last day of the specified month.
Store at a maximum of 25 °C.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is metronidazole. Each gram of gel contains 7.5 mg of metronidazole.
- Other ingredients are Carbopol 974P, disodium edetate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol (E1520), sodium hydroxide (E524) and purified water.
Appearance and package sizes of the medicine
Zidoval vaginal gel is colorless or straw-colored. It is packaged in an aluminum tube containing 40 g of gel with a plastic screw cap in a cardboard box. The box also contains 5 disposable applicators, each for 5 g of gel.
Meda Manufacturing, Avenue JF Kennedy, 33700 Merignac, France.