Metronidazole ziaja

Package leaflet: Information for the patient

Metronidazol Ziaja, 7.5 mg/g, vaginal gel
Metronidazolum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What is Metronidazol Ziaja and what is it used for
2. Important information before using Metronidazol Ziaja
3. How to use Metronidazol Ziaja
4. Possible side effects
5. How to store Metronidazol Ziaja
6. Contents of the package and other information

1. What is Metronidazol Ziaja and what is it used for

Metronidazol Ziaja belongs to a group of medicines with antibacterial action. These act by
killing many types of bacteria causing infections.
Metronidazol Ziaja is indicated for the treatment of vaginal infection (called bacterial
vaginosis, or BV for short) in adult women.
It is important that bacterial vaginosis is treated and completely cured; otherwise, the infection may recur. To prevent this, the full course of this medicine should be used as directed by the doctor.

2. Important information before using Metronidazol Ziaja

When not to use Metronidazol Ziaja

• if the patient is allergic to metronidazole, other 5-nitroimidazole derivatives, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Metronidazol Ziaja, discuss the following with your doctor or pharmacist:

• If the patient has ever had blood disorders or blood diseases.
• If the patient has or suspects vaginal candidiasis (yeast infection). Symptoms of vaginal candidiasis may become more noticeable during treatment with Metronidazol Ziaja gel, and the doctor may need to prescribe additional treatment.
• Avoid using the medicine during menstrual bleeding.
• If the patient is undergoing blood tests, as metronidazole may affect the results of certain laboratory tests.
• Avoid prolonged or unnecessary use of this medicine. As with all vaginal infections, sexual intercourse should be avoided both during the infection and throughout treatment with Metronidazol Ziaja gel.

Metronidazol Ziaja may affect the results of certain laboratory tests (e.g. AspAT,
AlAT, LDH, triglycerides, glucose hexokinase).
Children and adolescents
Metronidazol Ziaja is not recommended for use in children and adolescents under 18 years of age due to lack of data on safety and efficacy in this age group.
Elderly patients
Metronidazol Ziaja is not recommended for use in elderly patients, as safety has not been evaluated in this age group.
Metronidazol Ziaja and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines she plans to use.
Metronidazol Ziaja may enhance the effects of the following medicines:

• anticoagulant drugs of the coumarin type (e.g. warfarin), used to prevent blood clotting;
• lithium, a medicine used in the treatment of depression;
• cyclosporine, a medicine used in the treatment of autoimmune diseases and rheumatoid arthritis;
• 5-fluorouracil, a medicine used for skin conditions and cancer treatment;
• disulfiram, a medicine used in the treatment of alcohol dependence;
• any other medicines, including those available without a prescription.

Use of Metronidazol Ziaja with alcohol
Metronidazol Ziaja intensifies the toxic effects of alcohol. Consumption of alcohol during treatment may cause adverse reactions such as nausea, vomiting, dizziness, headache, or rapid heartbeat.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Driving and using machines
Metronidazol Ziaja has no influence on the ability to drive or operate machinery.
Metronidazol Ziaja contains:

• methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), therefore the medicine may cause allergic reactions (including delayed-type reactions);
• 30 mg of propylene glycol in each gram of gel, therefore the medicine may cause skin irritation.

3. How to use Metronidazol Ziaja
This medicine should always be used according to the instructions given by the doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Metronidazol Ziaja is intended for vaginal use.
Before using Metronidazol Ziaja
Proper hygiene during use of Metronidazol Ziaja gel is very important. Always:

• wash hands before opening the tube or touching applicators,
• use a new applicator for each dose,
• immediately dispose of each used applicator in a waste bin.

Recommended dose for adult patients
Insert 5 g of gel vaginally, equivalent to the capacity of one applicator, once daily at bedtime, for 5 consecutive days.
Use in elderly patients
Metronidazol Ziaja is not recommended for use in elderly patients.
Use in children and adolescents
Metronidazol Ziaja is not recommended for use in children and adolescents under 18 years of age.
Method of administration:

• Single-use applicators are provided with Metronidazol Ziaja gel to facilitate application into the vagina.
• Unscrew the cap from the tube, turn it over, and pierce the protective seal on the tube with the sharp end. Do not use if the seal is damaged.

• Screw the open end of the applicator onto the tube where the cap was removed. Gently and slowly squeeze the tube from the bottom to fill the applicator. The plunger will stop moving when the applicator is filled with the required dose of gel.
• Unscrew the applicator from the tube and replace the cap on the tube.

• Insert the applicator as deeply into the vagina as possible (preferably while lying down with knees slightly bent).

• Slowly press the plunger of the applicator to release the gel into the vagina. Continue pressing until the plunger stops and all the gel has been delivered.

• Gently remove the applicator and dispose of it in a waste container.

Perform this procedure using a fresh applicator each night for five consecutive days or as directed by the doctor. If there is no improvement after completing the full 5-day course of Metronidazol Ziaja gel, or if the patient feels worse or symptoms do not resolve after 5 days of treatment, consult a doctor.
Use of more than the recommended dose of Metronidazol Ziaja
Do not use more Metronidazol Ziaja gel than recommended. If an overdose is taken, consult your doctor or pharmacist. Using too much of this medicine may increase the risk of adverse effects (see section 4).
Missing a dose of Metronidazol Ziaja
Do not use a double dose to make up for a missed dose. Apply the gel before going to bed the next night.
Stopping treatment with Metronidazol Ziaja
Do not interrupt the 5-day treatment cycle with Metronidazol Ziaja gel without consulting your doctor. It is important to complete the full course of treatment to ensure the infection is completely resolved.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Common adverse effects (may occur in up to 1 in 10 people):

• Headache and dizziness,
• Gastrointestinal discomfort / abdominal cramps,
• Vomiting,
• Unpleasant or unusual taste in the mouth,
• Dry skin,
• Skin redness (erythema),
• Itching of the skin (pruritus),
• Skin discomfort (burning, pain, or stinging),
• Skin irritation,
• Vaginal candidiasis (yeast infection),
• Vaginal discharge,
• Pelvic discomfort,
• Itching, irritation, burning, or numbness in the vaginal area,
• Decreased appetite.

Uncommon adverse effects (may occur in up to 1 in 100 people):

• Depression,
• Feeling of fatigue,
• Feeling of irritability,
• Sleep disturbances,
• Abnormal sensory sensations in the limbs,
• Nausea,
• Diarrhea,
• Constipation,
• Abdominal bloating,
• Dry mouth or feeling of thirst,
• Metallic taste in the mouth,
• Muscle cramps,
• Darkening of urine,
• Urinary tract infections / cystitis (UTI), which may cause pain or burning during urination and increase the frequency or urgency of urination,
• Swelling of the vulva (external part of the vagina),
• Menstrual disorders such as spotting or intermenstrual bleeding, or increased discomfort during menstruation.

The following adverse effect has also been reported (frequency unknown – cannot be estimated from available data):

• Itchy rash (urticaria).

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 492 1301
Fax: +48 22 492 1309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Metronidazol Ziaja

Keep this medicine out of the sight and reach of children.
No special storage conditions are required for this medicine.
Shelf-life after first opening the tube: 1 month.
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 the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Metronidazol Ziaja contains

• The active substance is metronidazole. 1 g of vaginal gel contains 7.5 mg of metronidazole.
• The other ingredients are: carbomer, propylene glycol, disodium edetate, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium hydroxide (for pH adjustment), purified water.

What Metronidazol Ziaja looks like and contents of the pack
Metronidazol Ziaja is a clear, colourless to straw-yellow, homogeneous gel.
Packaging: an aluminium tube with a sealing membrane, internally coated with epoxy-phenolic varnish, fitted with a polyethylene (HDPE) cap equipped with a piercing device, placed together with the leaflet in a cardboard box.
Each pack includes 5 single-use applicators made of polyethylene (PE) with a plunger made of polypropylene (PP), intended for the administration of 5 g of gel into the vagina.
Pack size: 40 g
Marketing Authorisation Holder
ZIAJA Ltd Zakład Produkcji Leków sp. z o.o.
ul. Jesienna 9
80-298 Gdańsk
Tel.: +48 58 521 34 00
(logo of the marketing authorisation holder)
Manufacturer
ZIAJA Ltd Zakład Produkcji Leków sp. z o.o.
ul. Przemysłowa 12
83-050 Kolbudy