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METRONIDAZOLE 7.5MG/G VAGINAL GEL

Active substance(s): METRONIDAZOLE / METRONIDAZOLE / METRONIDAZOLE

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Package Leaflet: Information for the user

Zidoval 7.5mg/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 see section 4.
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 of the other
ingredients of this medicine (listed in section 6).
You are allergic to any similar nitroimidazole antibacterials
You are allergic to parabens (a preservative agent)
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.
Children and adolescents
Zidoval gel is not recommended for use in children under
18 years of age because the medicine’s safety in these groups
has not been established.

Elderly
Zidoval gel is not recommended for use in the elderly because
the medicine’s safety in this group 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 or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Zidoval gel contains methyl parahydroxybenzoate (E218),
and propyl parahydroxybenzoate
which may cause allergic reactions.
Zidoval gel also contains propylene glycol (E1520) which may
cause skin irritation.

3. How to use Zidoval gel
Always use this medicine 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.
Use in children and adolescents
This medicine is not recommended for use by children under
18 years of age.
Use in the elderly
This medicine is not recommended for use 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
Tube

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
Screw onto Tube
Applicator

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 laying 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

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

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

Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use the gel after the expiry date which is stated on
the carton and tube label after ‘Exp’. The expiry date refers
to the last day of that month.
If the gel 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 other 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), propylene 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 18799/2371
Leaflet date: 15.09.2016
Zidoval is a registered trademark of Meda.

POM

Package Leaflet: Information for the user

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 see section 4.
The name of your medicine is Metronidazole 7.5mg/g
Vaginal Gel but will be referred to as Metronidazole gel
throughout this leaflet.
What is in this leaflet:
1. What Metronidazole gel is and what it is used for
2. What you need to know before you use Metronidazole gel
3. How to use Metronidazole gel
4. Possible side effects
5. How to store Metronidazole gel
6. Contents of the pack and other information.

1. What Metronidazole gel is and what it is used
for
Metronidazole gel belongs to a group of medicines called
antibacterials. These work by killing many kinds of bacteria
that cause infections.
Metronidazole gel is used to treat an infection of the vagina
(called bacterial vaginosis or BV for short) in adults.
Metronidazole 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
Metronidazole gel
Do not use Metronidazole gel if:
You are allergic to metronidazole or any of the other
ingredients of this medicine (listed in section 6).
You are allergic to any similar nitroimidazole antibacterials
You are allergic to parabens (a preservative agent)
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
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 Metronidazole 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
Metronidazole gel.
Children and adolescents
Metronidazole gel is not recommended for use in children
under 18 years of age because the medicine’s safety in these
groups has not been established.

Elderly
Metronidazole gel is not recommended for use in the elderly
because the medicine’s safety in this group has not been
established.
Other medicines and Metronidazole gel
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Metronidazole 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.
Metronidazole gel with alcohol
Drinking alcohol whilst using Metronidazole 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 or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Metronidazole gel contains methyl parahydroxybenzoate
(E218), and propyl parahydroxybenzoate
which may cause allergic reactions.
Metronidazole gel also contains propylene glycol (E1520)
which may cause skin irritation.

3. How to use Metronidazole gel
Always use this medicine exactly as your doctor has told you.
Check with your doctor or pharmacist if you are not sure.
Metronidazole 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 Metronidazole gel
Good hygiene whilst using Metronidazole 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 Metronidazole gel is one 5 g application
inserted into the vagina once daily, at bedtime, for five
consecutive days.
Use in children and adolescents
This medicine is not recommended for use by children under
18 years of age.
Use in the elderly
This medicine is not recommended for use by the elderly.
Instructions for use
Disposable (throw away) applicators are provided with
Metronidazole gel to help you put the gel into your vagina
Opening the tube: Remove the cap from the tube of
Metronidazole gel and pierce the sealed end of the tube
with the pointed end of the cap
Tube

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 gel. Remove the applicator from the tube
and replace the cap on the tube
Screw onto Tube
Applicator

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 laying 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 Metronidazole gel you don‘t feel
better, you should see your doctor again.
If you use more Metronidazole gel than you should
Do not use more Metronidazole 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 Metronidazole gel
Do not take a double dose to make up for a forgotten dose.
Apply Metronidazole gel at your next bedtime.
If you stop using Metronidazole gel
Do not stop using Metronidazole 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 Metronidazole 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 Metronidazole gel
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use the gel after the expiry date which is stated on
the carton and tube label after ‘Exp’. The expiry date refers
to the last day of that month.
If the gel 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 other information
What Metronidazole 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), propylene glycol (E1520),
sodium hydroxide (E524) and purified water.
What Metronidazole gel 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.
Metronidazole 7.5mg/g Vaginal Gel; PL 18799/2371
Leaflet date: 15.09.2016

POM

Expand Transcript

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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