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ZIDOVAL 7.5MG/G VAGINAL GEL

Active substance: METRONIDAZOLE

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Package Leaflet: Information for the user

Zidoval 7.5 mg/g Vaginal Gel
Metronidazole

Read all of this leaflet carefully before you start using this
medicine because it contains important information for you.
•  eep this leaflet. You may need to read it again.
K
•  you have any further questions, ask your doctor or pharmacist.
If
• 
This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
•  you get any side effects, talk to your doctor or pharmacist.
If
This includes any possible side effects not listed in this leaflet.
•  this leaflet, Zidoval 7.5 mg/g Vaginal Gel is called Zidoval gel.
In
What is in 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 Zidoval gel is and what it is used for
Zidoval gel belongs to a group of medicines called antibacterials.
These work by killing many kinds of bacteria that cause infections.
Zidoval gel is used to treat an infection of the vagina (called
bacterial vaginosis or BV for short) in adults. 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 cleared
completely otherwise the infection can come back. You must
take the full course of this medicine as prescribed by your doctor
to prevent this from happening.

2. What you need to know before you use Zidoval gel
Do not use Zidoval gel if:
You are allergic to metronidazole or any similar nitroimidazole
antibacterials
• 
You are allergic to parabens (a preservative agent)
• 
You are allergic to any other ingredients in Zidoval gel
(listed in section 6).
If any of the above applies to you talk to your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before using Zidoval gel if:
• 
You have ever had any blood problems or a disease affecting
the blood
• 
You have, or think you may have vaginal thrush (candidiasis).
The symptoms of vaginal thrush may become more noticeable
when you use Zidoval gel and you may need another treatment
from your doctor for this
• 
You are having your period
• 
You are having blood tests because metronidazole can interfere
with the results of some tests.
As with all vaginal infections, you should avoid sexual intercourse
during the infection and whilst you are using Zidoval gel.
Zidoval gel is not recommended for use in children under 18 years
of age or the elderly because the medicine’s safety in these groups
has not been established.

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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 that the following medicines
have:
• 
Warfarin, a medicine to prevent blood clotting
• 
Lithium, a medicine to treat mental illness
• 
Cyclosporin, a medicine used to treat autoimmune diseases
and rheumatoid arthritis
• 
5-fluorouracil, a medicine used for skin problems and the
treatment of cancer
• 
Any other medicine, including medicines obtained without a
prescription.
Zidoval gel with alcohol
Drinking alcohol whilst using Zidoval gel may make you feel or be
sick, become confused, have a headache or have an abnormally
fast heart beat. If this happens, stop drinking alcohol and consult
your doctor or pharmacist.
Pregnancy and breast–feeding
If you are pregnant, trying to become pregnant or breast-feeding,
ask your doctor or pharmacist for advice before using Zidoval gel.
Zidoval gel contains methyl parahydroxybenzoate, propyl
parahydroxybenzoate and propylene glycol
Zidoval gel contains methyl parahydroxybenzoate (E218) and
propyl parahydroxybenzoate (E216) which may cause allergic
reactions.
This medicine also contains propylene glycol (E1520) which may
cause skin irritation.

3. How to use Zidoval gel
Always use Zidoval gel exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure. Zidoval gel is
for vaginal use only.
Important:
Your doctor will choose the dose that is right for you. Your dose
will be shown clearly on the label that your pharmacist puts on
your medicine. If it does not, or you are not sure, ask your doctor
or pharmacist.
Before you apply Zidoval gel
Good hygiene whilst using Zidoval gel is very important.
Always:
• 
Wash your hands before opening the tube or touching
the applicators
• 
Use a fresh applicator for each dose.
• 
Immediately throw away each used applicator in the
waste bin.
Adult dose
• 
The dose of Zidoval gel is one 5 g application inserted into the
vagina once daily, at bedtime, for five consecutive days.
Children under 18 years and the elderly
This medicine is not recommended for use by children under
18 years of age or by the elderly.

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Instructions for use
• 
Disposable (throw away) applicators are provided with Zidoval
gel to help you put the gel into your vagina
•  pening the tube: Remove the cap from the tube of Zidoval gel
O
and pierce the sealed end of the tube with the pointed end of
the cap


•  illing the applicator: Screw the open end of an applicator on
F
to 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 and will stop moving when it holds the required
5 g dose of Zidoval gel. Remove the applicator from the tube
and replace the cap on the tube


• 
Inserting the applicator: Hold the filled applicator by its barrel
and gently insert the applicator into the vagina as far as it will
comfortably go. You may find this is easiest to do whilst lying
on your back with your knees bent

4. Possible side effects
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 sick or being sick
• 
Unpleasant taste in your mouth
• 
Unusual feeling on your tongue
• 
Vaginal thrush (candidiasis)
• Vaginal discharge
• 
Discomfort around your pelvis
• Decreased appetite.
Uncommon side effects (may affect up to 1 in 100 people)
• Depression
• Tiredness
• Feeling irritable
• 
Difficulty in sleeping
•  unusual feeling in your fingers and toes
An
• Diarrhoea
• Constipation
• 
Bloated or gurgling stomach
•  dry mouth or feeling thirsty
A
• 
Metallic taste in your mouth
• Itchy skin
• Muscle cramps
• Darkened urine
• 
Urinary tract infections (UTIs) that may cause pain or
a burning sensation when you pass water, or may make
you need to pass water more often or more urgently
• 
Swelling of your vulva (the outside of your vagina)
•  hanges in your periods such as spotting or bleeding
C
between periods or increased discomfort during your period.
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.

5. How to store Zidoval gel

•  eleasing the gel: Slowly push the plunger down into the
R
applicator to release the gel into your vagina. Continue pressing
down until the plunger stops. This will ensure you have released
the correct amount of gel

Keep out of the reach and sight of children.
Do not use Zidoval gel after the expiry date 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 away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.


• 
Remove the applicator from the vagina and throw it in the waste
bin immediately.
Repeat this procedure using a fresh applicator at bedtime for five
consecutive days, or as directed by your doctor. If after using the
full 5-day course of Zidoval gel you don‘t feel better, you should
see 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 ask your doctor or pharmacist for advice. Using
too much of this medicine can 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 forgotten dose. Apply
Zidoval gel at your next bedtime.
If you stop using Zidoval gel
Do not stop using Zidoval gel during a 5-day course of treatment
without first talking to your doctor. It is important that you take the
full course so that your infection clears up completely.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
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6. Contents of the pack and other information
What Zidoval gel contains
• 
The active substance is metronidazole. Each gram of gel contains
7.5 mg of metronidazole.
• he other ingredients are: Carbopol 974P, disodium edetate, methyl
T
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 colourless or straw coloured. It comes in a
40 g aluminium tube with a screw on plastic cap in a carton. The
carton also contains 5 disposable vaginal applicators that deliver
5 g of gel.
Marketing Authorisation Holder
Meda Pharmaceuticals Ltd, Skyway House, Parsonage Road,
Takeley, Bishop’s Stortford, CM22 6PU, United Kingdom.
Manufacturer
3M Health Care Limited, Derby Road, Loughborough, Leicester, UK.
This leaflet was last updated 05/2012

If this leaflet is difficult to see or read, or you
would like it in a different format, please contact:
Meda Pharmaceuticals Ltd. Skyway House,
Parsonage Road, Akeley, Bishop’s Stortford,
CM22 6PU, United Kingdom.
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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