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STIEMYCIN TOPICAL SOLUTION

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(leaflet continued)
Effects of other ingredients (excipients)
Stiemycin Topical Solution contains propylene
glycol, which may cause skin irritation.
3. How to Use Stiemycin Topical Solution
Always use Stiemycin Topical Solution exactly
as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
What you need to know before using
Stiemycin Topical Solution
Stiemycin Topical Solution should be
applied only to your skin.
Do not drink the solution
Do not use Stiemycin Topical Solution near
a naked flame because it is flammable.
When you use the bottle for the first time
you will need to break the seal. To do this,
remove the cap from the bottle and holding
the bottle upright, press gently on the seal
with a finger until you hear a ‘pop’. The
medicine is now ready to use.
How much to use
Apply Stiemycin Topical Solution twice a
day, in the morning and the evening.
Using the product more frequently does not
give better results.
It can take at least six to eight weeks before
you see the full benefit of Stiemycin Topical
Solution.
You should keep using the medicine
according to your doctor’s instructions up to
a maximum of 6 months.
How to apply Stiemycin Topical Solution
Completely remove any make-up.
Wash the affected area with mild soap and
warm water and gently dry.
Remove the cap.
Turn the bottle upside down and dab the
pad onto the affected area.
Use the pad to spread the solution gently
over the whole area and not just to each
individual spot.

After using Stiemycin Topical Solution
Always replace the cap securely after use
to stop the medicine from leaking or
evaporating.
Stiemycin Topical Solution contains
ingredients to help the antibiotic reach the
bottom of your hair follicles where the acne
starts. These ingredients keep the skin wet
for a few minutes after applying it.
Allow your face to dry completely before
using any make-up.
You may notice a slight smell while it dries,
this is normal.
Wash your hands after use.
If you forget to use Stiemycin Topical
Solution
Don’t apply a double dose to make up for
forgotten doses.
Apply the next dose at the usual time.
If you accidentally swallow Stiemycin
Topical Solution:
The ingredients of Stiemycin Topical Solution
are not expected to be harmful if swallowed in
the small amounts normally applied to the face.
If you do accidentally get Stiemycin Topical
Solution in your mouth, rinse at once with
plenty of water. Seek medical advice if you
swallow more than a small amount.
4. Possible side effects
Like all medicines, Stiemycin Topical Solution
can cause side effects, although not everybody
gets them. The following side effects may
happen with this medicine:
Stop using Stiemycin Topical Solution and
see a doctor straight away if:
you notice an allergic reaction (such as
swelling of your face, eyes, lips or tongue,
nettle rash or difficulty breathing).
you develop severe or prolonged diarrhoea.
The following very common side effects have
been reported (at least 1 in 10 people are
affected):
skin burning sensation
skin irritation
dry skin, especially at the start of treatment
application site stinging
redness of your skin, especially at the start
of treatment

Other side effects with frequencies that cannot
be estimated from the available data include:
allergic reaction
diarrhoea, stomach pain, stomach
discomfort,
Itching, rash
swelling on the face
Tell your doctor or pharmacist if any of
the side effects become severe or
troublesome, or if you notice any side
effects not listed in this leaflet.
5. How to store Stiemycin Topical Solution
Keep out of the sight and reach of children.
Do not store above 25°C. Keep in a cool
place. Replace cap tightly after use.
Do not use after the expiry date printed on
the bottle or carton.
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. Further Information
What Stiemycin Topical Solution contains:
The active ingredient is erythromycin 2% w/v.
Also contains propylene glycol, ethanol
absolute and laureth 4.
What Stiemycin Topical Solution looks like
and the contents of the pack
The clear colourless solution is in an amber
coloured glass bottle with a dabbing applicator
on the bottle and a white screw cap.
Your medicine is available in packs of 1 or 2
bottles each containing 25 ml solution.
Product Licence holder and Manufacturer
Manufactured by Stiefel Laboratorium GmbH.
Mühlheimer Stra e 231, Offenbach am Main,
Darmstadt D-63075 Germany. Stiefel
Laboratories Ltd, Finisklin Business Park,
Sligo, Ireland. Procured from within the EU.
Product Licence holder: Quadrant
Pharmaceuticals Ltd. Lynstock House,
Lynstock Way, Lostock, Bolton BL6 4SA.
Repackaged by Maxearn Ltd. Bolton BL6 4SA.
Stiemycin Topical Solution
PL 20774/1055

POM

Leaflet revised 23rd April 2013
Stiemycin Topical Solution is a registered
trademark of Stiefel laboratories Inc.

PP5/1055/V1

2. Before you use Stiemycin Topical
Solution
Do not use Stiemycin Topical Solution if:
you are allergic to erythromycin or any of
the other ingredients of Stiemycin (listed in
Section 6).
Do not use Stiemycin Topical Solution if the
above applies to you. If you are not sure, talk
to your doctor or pharmacist before you start
using Stiemycin Topical Solution.
Stiemycin Topical Solution is for use by adults
and adolescents with acne.
It is not for use by children.
Stiemycin Topical Solution is used to treat
acne (spots). It works by fighting the bacteria
that can cause the acne spots.
1. What Stiemycin Topical Solution is and
what it is used for
Stiemycin Topical Solution contains a medicine
called erythromycin. This is an antibiotic.
In this leaflet:
1. What Stiemycin Topical Solution is and
what it is used for
2. Before you use Stiemycin Topical Solution
3. How to use Stiemycin Topical Solution
4. Possible side effects
5. How to store Stiemycin Topical Solution
6. Further Information
Read all of this leaflet carefully before you
start using this medicine.
Keep this leaflet. You may need to read it
again.
If you have further questions, ask your
doctor or pharmacist.
This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.

Pregnancy and breast-feeding
Tell your doctor if you are pregnant,
planning to become pregnant or
breastfeeding.
If you do become pregnant during
treatment with Stiemycin Topical Solution
tell your doctor.
Don’t use Stiemycin Topical Solution on
your breast if you are breast-feeding.
(leaflet continued overleaf)
Taking other medicines
Please tell your doctor or pharmacist if you are
taking any other medicines, if you have taken
any recently, or if you start taking a new one.
This includes medicines bought without a
prescription.
Stiemycin Topical Solution can affect how
other medicines work. Take care not to use
Stiemycin Topical Solution at the same time
as clindamycin-containing acne medicines
that are used on the skin.
Tell your doctor if you are taking any other
antibiotics medicine.
Take care not to apply Stiemycin Topical
Solution at the same time as other acne
products that are used on the skin, unless
your doctor or pharmacist has told you that
you can.
Only use Stiemycin Topical Solution on your
skin. Take care not to get Stiemycin Topical
Solution in your eyes, nostrils, mouth or on
your lips. If you do, rinse well with water. Take
care not to get Stiemycin Topical Solution on
any irritated areas of skin, such as cuts,
grazes, sunburn, or broken skin. Stiemycin
Topical Solution contains propylene glycol,
which may cause skin irritation.
Take special care with Stiemycin Topical
Solution:
Before you use Stiemycin Topical Solution tell
your doctor if:
you cannot tolerate or have previously had
a skin reaction or allergy to erythromycin or
any of the other ingredients of Stiemycin
Topical Solution (listed in section 6)
you have a history of inflammatory bowel
disease or antibiotic-associated colitis
(severe, prolonged or bloody diarrhoea
following antibiotic use).

Stiemycin® Topical Solution
erythromycin 2% w/v
PACKAGE LEAFLET: INFORMATION FOR THE USER

PP5/1055/V1

(leaflet continued)
Effects of other ingredients (excipients)
Stiemycin Topical Solution contains propylene
glycol, which may cause skin irritation.
3. How to Use Stiemycin Topical Solution
Always use Stiemycin Topical Solution exactly
as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
What you need to know before using
Stiemycin Topical Solution
Stiemycin Topical Solution should be
applied only to your skin.
Do not drink the solution
Do not use Stiemycin Topical Solution near
a naked flame because it is flammable.
When you use the bottle for the first time
you will need to break the seal. To do this,
remove the cap from the bottle and holding
the bottle upright, press gently on the seal
with a finger until you hear a ‘pop’. The
medicine is now ready to use.
How much to use
Apply Stiemycin Topical Solution twice a
day, in the morning and the evening.
Using the product more frequently does not
give better results.
It can take at least six to eight weeks before
you see the full benefit of Stiemycin Topical
Solution.
You should keep using the medicine
according to your doctor’s instructions up to
a maximum of 6 months.
How to apply Stiemycin Topical Solution
Completely remove any make-up.
Wash the affected area with mild soap and
warm water and gently dry.
Remove the cap.
Turn the bottle upside down and dab the
pad onto the affected area.
Use the pad to spread the solution gently
over the whole area and not just to each
individual spot.

After using Stiemycin Topical Solution
Always replace the cap securely after use
to stop the medicine from leaking or
evaporating.
Stiemycin Topical Solution contains
ingredients to help the antibiotic reach the
bottom of your hair follicles where the acne
starts. These ingredients keep the skin wet
for a few minutes after applying it.
Allow your face to dry completely before
using any make-up.
You may notice a slight smell while it dries,
this is normal.
Wash your hands after use.
If you forget to use Stiemycin Topical
Solution
Don’t apply a double dose to make up for
forgotten doses.
Apply the next dose at the usual time.
If you accidentally swallow Stiemycin
Topical Solution:
The ingredients of Stiemycin Topical Solution
are not expected to be harmful if swallowed in
the small amounts normally applied to the face.
If you do accidentally get Stiemycin Topical
Solution in your mouth, rinse at once with
plenty of water. Seek medical advice if you
swallow more than a small amount.
4. Possible side effects
Like all medicines, Stiemycin Topical Solution
can cause side effects, although not everybody
gets them. The following side effects may
happen with this medicine:
Stop using Stiemycin Topical Solution and
see a doctor straight away if:
you notice an allergic reaction (such as
swelling of your face, eyes, lips or tongue,
nettle rash or difficulty breathing).
you develop severe or prolonged diarrhoea.
The following very common side effects have
been reported (at least 1 in 10 people are
affected):
skin burning sensation
skin irritation
dry skin, especially at the start of treatment
application site stinging
redness of your skin, especially at the start
of treatment

Other side effects with frequencies that cannot
be estimated from the available data include:
allergic reaction
diarrhoea, stomach pain, stomach
discomfort,
Itching, rash
swelling on the face
Tell your doctor or pharmacist if any of
the side effects become severe or
troublesome, or if you notice any side
effects not listed in this leaflet.
5. How to store Stiemycin Topical Solution
Keep out of the sight and reach of children.
Do not store above 25°C. Keep in a cool
place. Replace cap tightly after use.
Do not use after the expiry date printed on
the bottle or carton.
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. Further Information
What Stiemycin Topical Solution contains:
The active ingredient is erythromycin 2% w/v.
Also contains propylene glycol, ethanol
absolute and laureth 4.
What Stiemycin Topical Solution looks like
and the contents of the pack
The clear colourless solution is in an amber
coloured glass bottle with a dabbing applicator
on the bottle and a white screw cap.
Your medicine is available in packs of 1 or 2
bottles each containing 25 ml solution.
Product Licence holder and Manufacturer
Manufactured by Stiefel Laboratorium GmbH.
Mühlheimer Stra e 231, Offenbach am Main,
Darmstadt D-63075 Germany. Stiefel
Laboratories Ltd, Finisklin Business Park,
Sligo, Ireland. Procured from within the EU.
Product Licence holder: Quadrant
Pharmaceuticals Ltd. Lynstock House,
Lynstock Way, Lostock, Bolton BL6 4SA.
Repackaged by Maxearn Ltd. Bolton BL6 4SA.
Stiemycin Topical Solution
PL 20774/1055

POM

Leaflet revised 23rd April 2013
Stiemycin Topical Solution is a registered
trademark of Stiefel laboratories Inc.

PP5/1055/V1

2. Before you use Stiemycin Topical
Solution
Do not use Stiemycin Topical Solution if:
you are allergic to erythromycin or any of
the other ingredients of Stiemycin (listed in
Section 6).
Do not use Stiemycin Topical Solution if the
above applies to you. If you are not sure, talk
to your doctor or pharmacist before you start
using Stiemycin Topical Solution.
Stiemycin Topical Solution is for use by adults
and adolescents with acne.
It is not for use by children.
Stiemycin Topical Solution is used to treat
acne (spots). It works by fighting the bacteria
that can cause the acne spots.
1. What Stiemycin Topical Solution is and
what it is used for
Stiemycin Topical Solution contains a medicine
called erythromycin. This is an antibiotic.
2.
3.
4.
5.
6.

In this leaflet:
1. What Stiemycin Topical Solution is and
what it is used for
Before you use Stiemycin Topical Solution
How to use Stiemycin Topical Solution
Possible side effects
How to store Stiemycin Topical Solution
Further Information
Read all of this leaflet carefully before you
start using this medicine.
Keep this leaflet. You may need to read it
again.
If you have further questions, ask your
doctor or pharmacist.
This medicine has been prescribed for you.
Do not pass it on to others. It may harm
them, even if their symptoms are the same
as yours.
If any of the side effects gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or
pharmacist.

Pregnancy and breast-feeding
Tell your doctor if you are pregnant,
planning to become pregnant or
breastfeeding.
If you do become pregnant during
treatment with Stiemycin Topical Solution
tell your doctor.
Don’t use Stiemycin Topical Solution on
your breast if you are breast-feeding.
(leaflet continued overleaf)
Taking other medicines
Please tell your doctor or pharmacist if you are
taking any other medicines, if you have taken
any recently, or if you start taking a new one.
This includes medicines bought without a
prescription.
Stiemycin Topical Solution can affect how
other medicines work. Take care not to use
Stiemycin Topical Solution at the same time
as clindamycin-containing acne medicines
that are used on the skin.
Tell your doctor if you are taking any other
antibiotics medicine.
Take care not to apply Stiemycin Topical
Solution at the same time as other acne
products that are used on the skin, unless
your doctor or pharmacist has told you that
you can.
Only use Stiemycin Topical Solution on your
skin. Take care not to get Stiemycin Topical
Solution in your eyes, nostrils, mouth or on
your lips. If you do, rinse well with water. Take
care not to get Stiemycin Topical Solution on
any irritated areas of skin, such as cuts,
grazes, sunburn, or broken skin. Stiemycin
Topical Solution contains propylene glycol,
which may cause skin irritation.
Take special care with Stiemycin Topical
Solution:
Before you use Stiemycin Topical Solution tell
your doctor if:
you cannot tolerate or have previously had
a skin reaction or allergy to erythromycin or
any of the other ingredients of Stiemycin
Topical Solution (listed in section 6)
you have a history of inflammatory bowel
disease or antibiotic-associated colitis
(severe, prolonged or bloody diarrhoea
following antibiotic use).

Stiemycin® Topical Solution
erythromycin 2% w/v
PACKAGE LEAFLET: INFORMATION FOR THE USER

PP5/1055/V1

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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