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METRONIDAZOLE 7.5MG/G VAGINAL GEL

Active substance(s): METRONIDAZOLE

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Patient Information Leaflet

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.






Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
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.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.
The name of your medicine is Zidoval 7.5mg/g Vaginal Gel
but will be referred to as Zidoval gel throughout this leaflet.

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.

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



Filling the applicator: Screw the open end of an
applicator on 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



Releasing the gel: Slowly push the plunger down into the
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



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.

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
• An unusual feeling in your fingers and toes
• Diarrhoea
• Constipation
• Bloated or gurgling stomach
• A dry mouth or feeling thirsty
• 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)
• Changes in your periods such as spotting or bleeding
between periods or increased discomfort during your
period.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard .
By reporting side effects, you can help provide more
information on the safety of this medicine.







5. How to store Zidoval gel
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton/ tube label after ‘Exp’. The expiry date
refers to the last day of that month.
Do not store above 25°C.
If your medicine becomes discoloured or show any signs
of deterioration, seek the advice of your pharmacist.
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 to
protect the environment.
6. Contents of the pack and further information

What Zidoval gel contains
• The active substance is metronidazole. Each gram of gel
contains 7.5mg metronidazole. The other ingredients are:
carbopol 974P, disodium edetate, methyl
parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216), prpylene glycol (E1520),
sodium hydroxide (E524) and purified water.
What Zidoval gel looks like and contents of the pack
Zidoval gel is colourless or straw coloured. The carton also
contains 5 vaginal applicators that deliver 5g of gel.
It comes in an aluminum tube of 40g, with plastic cap.
Manufactured by: Meda Manufacturing, Avenue JF
Kennedy, 33700 Merignac, France.
Procured from within EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK.
Zidoval 7.5mg/g Vaginal Gel; PL No: 18799/2371 POM
Leaflet date: 17.10.2014
Zidoval gel is a registered trademark of Meda.

Patient Information Leaflet

Metronidazole 7.5mg/g Vaginal Gel
Read all of this leaflet carefully before you start using
this medicine because it contains important information
for you.






Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
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.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet.
The name of your medicine is Metronidazole 7.5mg/g
Vaginal Gel but will be referred to as Metronidazole
throughout this leaflet.

What is in this leaflet:
1. What Metronidazole is and what it is used for
2. What you need to know before you use Metronidazole
3. How to use Metronidazole
4. Possible side effects
5. How to store Metronidazole
6. Contents of the pack and other information.

1. What Metronidazole is and what it is used for
Metronidazole belongs to a group of medicines called
antibacterials. These work by killing many kinds of bacteria
that cause infections.
Metronidazole is used to treat an infection of the vagina
(called bacterial vaginosis or BV for short) in adults.
Metronidazole 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
Metronidazole
Do not use Metronidazole 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 Metronidazole
(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 Metronidazole
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 Metronidazole 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
Metronidazole.
Metronidazole 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.

Other medicines and Metronidazole
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Metronidazole 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.
Metronidazole with alcohol
Drinking alcohol whilst using Metronidazole 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 breastfeeding, ask your doctor or pharmacist for advice before using
Metronidazole.
Metronidazole contains methyl parahydroxybenzoate,
propyl parahydroxybenzoate and propylene glycol
Metronidazole 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 Metronidazole
Always use Metronidazole exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not sure.
Metronidazole 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 Metronidazole
Good hygiene whilst using Metronidazole 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 Metronidazole 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.
Instructions for use
• Disposable (throw away) applicators are provided with
Metronidazole to help you put the gel into your vagina
• Opening the tube: Remove the cap from the tube of
Metronidazole and pierce the sealed end of the tube with
the pointed end of the cap







Filling the applicator: Screw the open end of an
applicator on 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
Metronidazole. 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

Releasing the gel: Slowly push the plunger down into the
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




Uncommon side effects (may affect up to 1 in 100 people)
• Depression
• Tiredness
• Feeling irritable
• Difficulty in sleeping
• An unusual feeling in your fingers and toes
• Diarrhoea
• Constipation
• Bloated or gurgling stomach
• A dry mouth or feeling thirsty
• 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)
• Changes in your periods such as spotting or bleeding
between periods or increased discomfort during your
period.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard . By reporting
side effects, you can help provide more information on the
safety of this medicine.






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 Metronidazole you don‘t feel
better, you should see your doctor again.
If you use more Metronidazole than you should
Do not use more Metronidazole 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 Metronidazole
Do not take a double dose to make up for a forgotten dose.
Apply Metronidazole at your next bedtime.
If you stop using Metronidazole
Do not stop using Metronidazole 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.

4. Possible side effects
Like all medicines Metronidazole 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.





5. How to store Zidoval gel
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is
stated on the carton/ tube label after ‘Exp’. The expiry date
refers to the last day of that month.
Do not store above 25°C.
If your medicine becomes discoloured or show any signs
of deterioration, seek the advice of your pharmacist.
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 to
protect the environment.

6. Contents of the pack and further information
What Metronidazole contains
• The active substance is metronidazole. Each gram of gel
contains 7.5mg metronidazole.
• The other ingredients are: carbopol 974P, disodium
edetate, methyl parahydroxybenzoate (E218), propyl
parahydroxybenzoate (E216), prpylene glycol (E1520),
sodium hydroxide (E524) and purified water.
What Metronidazole looks like and contents of the pack
Metronidazole gel is colourless or straw coloured. The carton
also contains 5 vaginal applicators that deliver 5g of gel.
It comes in an aluminum tube of 40g, with plastic cap.
Manufactured by: Meda Manufacturing, Avenue JF
Kennedy, 33700 Merignac, France.
Procured from within EU and repackaged by the Product
Licence holder: B&S Healthcare, Unit 4, Bradfield Road,
Ruislip, Middlesex, HA4 0NU, UK.
POM

Metronidazole 7.5mg/g Vaginal Gel; PL No: 18799/2371
Leaflet date: 17.10.2014

Expand view ⇕

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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