DALACIN T 1% TOPICAL SOLUTION

Active substance: CLINDAMYCIN

View full screen / Print PDF » Download PDF ⇩

Transcript
Dalacin T TM 1% Topical Solution

Ref: 1227/080814/1/F

(clindamycin phosphate)
Patient Information Leaflet
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 your 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.
Your medicine is called Dalacin T 1% Topical
Solution and will be referred to as Dalacin T
throughout the rest of this leaflet.
Please note that the leaflet also contains information
about other forms of the medicine, Dalacin T
topical Lotion.
What is in this leaflet:
1 What Dalacin T is and what it is used for
2 What you need to know before you use Dalacin T
3 How to use Dalacin T
4 Possible side effects
5 How to store Dalacin T
6 Contents of the pack and other information
1

What Dalacin T is and what it is used for

Dalacin T contains an antibiotic called clindamycin
phosphate and comes as either a solution
or lotion. The solution and the lotion are used on the
skin to treat acne.
2

What you need to know before you use
Dalacin T

Do not use Dalacin T:
• if you are hypersensitive (allergic) to clindamycin,
lincomycin or to any of the other ingredients of this
medicine (listed in section 6).
• If you have a history of inflammatory bowel disease
or antibiotic‑associated colitis.
Warnings and precautions
Talk to your doctor or pharmacist before using
Dalacin T if you have diarrhoea or usually get
diarrhoea when you take antibiotics.
If you develop severe or prolonged or bloody
diarrhoea during or after using Dalacin tell your
doctor immediately since it may be necessary to
interrupt the treatment. This may be a sign of bowel
inflammation (pseudomembranous colitis) which can
occur following treatment with antibiotics.
Dalacin T contains alcohol, which can cause burning
or irritation of your eyes. Keep it away from your
eyes, mouth, and cuts or grazes on your skin. If you
get any of these sensitive areas, wash it away with
plenty of cool water. Take care when using the lotion
or the topical solution around your mouth as they
each have an unpleasant taste.

Dalacin T is flammable. Do not use the solution near
flames or while you are smoking.
Other medicines and Dalacin T
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription.
Tell your doctor if you are using any skin treatments
that contain benzoyl peroxide. These medicines
should not be used at the same time as Dalacin T.
If you are going to hospital for a surgical procedure,
tell your doctor and/or anaesthetist if you are taking
drugs that cause paralysis of muscle
(neuromuscular blocking agents).
Warfarin or similar medicines – used to thin the
blood. You may be more likely to have a bleed.
Your doctor may need to take regular blood tests to
check how well your blood can clot.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you may be pregnant or
are planning to have a baby, ask your doctor
or pharmacist for advice before using this medicine.
Breast-feeding
Tell your doctor if you will be breast‑feeding while
using Dalacin T as the active substance in this
medicine may be passed into breast milk. Your
doctor will decide if Dalacin T is suitable for you.
Although it is not likely that a nursing infant will take
in very much of the active substance from
the milk it drinks, if your baby gets bloodstained
diarrhoea or shows any signs of illness, tell
your doctor at once. You should stop breast-feeding
if this happens.
Driving and using machines
No effects on the ability to drive or use machines
have been seen with Dalacin T.
Dalacin T Solution contains propylene glycol
This may cause skin irritation.
Dalacin T Lotion
contains cetostearyl alcohol and methyl
parahydroxybenzoate
Cetostearyl alcohol may cause local skin reactions
such as dermatitis (an inflammation of the skin).
Methyl parahydroxybenzoate may cause allergic
reactions that can be delayed.

3 How to use Dalacin T
Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Usually, you should use this medicine twice a day,
shake the bottle well before use. Wash the
affected area and put on a thin film of solution or
lotion.
The Dalacin T Solution bottle has an automatic pad
dispenser. Gently apply a thin film onto your skin
using the pad on the applicator.

The Dalacin T Lotion bottle has a dispensing cap.
Wash your hands before and after use and
dry them, apply a thin film of the lotion by gently
rubbing it into your skin, you may use a cotton
pad for this or you can use your fingers. Always
replace the cap after use.
If you forget to apply Dalacin T
Do not worry if you miss one or two applications; just
carry on as soon as you remember.
If you stop using Dalacin T
Do not stop using Dalacin T as soon as your acne
starts to get better. Ask your doctor when you
should stop the treatment.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Tell your doctor immediately if you develop
severe, persistent or bloody diarrhoea (which may
be associated with stomach pain or fever). This is an
uncommon side effect which may occur after
treatment with antibiotics and can be a sign of
serious bowel inflammation.
Dalacin T may make your skin dry (very common
side effect).
Other side effects that have been seen with
Dalacin T Topical Lotion and Dalacin T Topical
Solution are:
Very common: may affect more than 1 in 10
people
• Skin irritation (may cause symptoms such as
burning, itching, peeling), hives
Common: may affect up to 1 in 10 people
• Oily skin
Uncommon: may affect up to 1 in 100 people
(only seen with Dalacin T Topical solution)
• Gastrointestinal disturbances (may cause
symptoms such as diarrhoea, and nausea)
Frequency not known, but may also occur
• Severe acne (also known as gram‑negative
folliculitis), stinging of the eye, stomach pain,
inflammation of the skin caused by contact with
irritants or allergens
• Dalacin T Topical lotion may cause gastrointestinal
disturbances (with symptoms such as diarrhoea
and nausea)
Reporting of side effects
If you get any side effects, talk to your doctor or
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 Dalacin T
Keep out of the sight and reach of children.
Do not use Dalacin T after the expiry date which
is stated on the pack.
Do not store above 25°C.
If your medicine becomes discoloured or shows
any other signs of deterioration, consult your
pharmacist who will tell you what to do.

Ref: 1227/080814/1/B



6

Medicines should not be disposed of via waste
water or household waste.
Ask your pharmacist how to dispose of medicines
no longer required. These measures will help to
protect the environment.

Contents of the pack and other
information

What Dalacin T contains
The active substance is clindamycin phosphate.
Each ml of Dalacin T solution contains 10 mg of
clindamycin.
The other ingredient are: isopropyl alcohol,
propylene glycol and purified water.
What Dalacin T looks like and contents of the
pack
Dalacin T Solution is a clear colourless solution with
an alcoholic odour in a plastic bottle with a screw
cap supplied with an automatic pad dispenser and a
screw cap provided separately.
Bottle contains 30ml of Dalacin T Solution.
Manufacturer and Licence Holder
This medicine is manufactured by Pharmacia &
Upjohn Company, Kalamazoo, Michigan, USA and
is procured from within the EU and repackaged by
the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat,
Redditch, Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1227
Dalacin T 1% Topical Solution

Dalacin T is is a registered trademark of Pharmacia
& Upjohn Company LLC.
Revision date: 08/08/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel:
01527 505414 for help.

Clindamycin 1%Topical Solution

Ref: 1227/080814/2/F

(clindamycin phosphate)
Patient Information Leaflet
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 your 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.
Your medicine is called Clindamycin 1% Topical
Solution and will be referred to as Clindamycin
throughout the rest of this leaflet.
Please note that the leaflet also contains information
about other forms of the medicine, Clindamycin
topical Lotion.
What is in this leaflet:
1
2

What Clindamycin is and what it is used for
What you need to know before you use
Clindamycin

3

How to use Clindamycin

4 Possible side effects
5 How to store Clindamycin
6

Contents of the pack and other information

1

What Clindamycin is and what it is
used for

Clindamycin contains an antibiotic called
clindamycin phosphate and comes as either a
solution or lotion. The solution and the lotion are
used on the skin to treat acne.

2

What you need to know before you use
Clindamycin

Do not use Clindamycin:
• if you are hypersensitive (allergic) to clindamycin,
lincomycin or to any of the other ingredients of this
medicine (listed in section 6).
• If you have a history of inflammatory bowel disease
or antibiotic‑associated colitis.
Warnings and precautions
Talk to your doctor or pharmacist before using
Clindamycin if you have diarrhoea or usually get
diarrhoea when you take antibiotics.
If you develop severe or prolonged or bloody
diarrhoea during or after using Clindamycin tell your
doctor immediately since it may be necessary to
interrupt the treatment. This may be a sign of bowel
inflammation (pseudomembranous colitis)
which can occur following treatment with antibiotics.

Clindamycin contains alcohol, which can cause
burning or irritation of your eyes. Keep it away from
your eyes, mouth, and cuts or grazes on your skin. If
you get any of these sensitive areas, wash it away
with plenty of cool water. Take care when using
the lotion or the topical solution around your mouth
as they each have an unpleasant taste.
Clindamycin is flammable. Do not use the solution
near flames or while you are smoking.
Other medicines and Clindamycin
Tell your doctor or pharmacist
if you are taking, have recently taken or might take
any other medicines, including medicines
obtained without a prescription.
Tell your doctor if you are using any skin treatments
that contain benzoyl peroxide. These medicines
should not be used at the same time as
Clindamycin.
If you are going to hospital for a surgical procedure,
tell your doctor and/or anaesthetist if you are taking
drugs that cause paralysis of muscle
(neuromuscular blocking agents).
Warfarin or similar medicines – used to thin the
blood. You may be more likely to have a bleed.
Your doctor may need to take regular blood tests to
check how well your blood can clot.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you may be pregnant or
are planning to have a baby, ask your doctor or
pharmacist for advice before using this medicine.
Breast-feeding
Tell your doctor if you will be breast‑feeding while
using Clindamycin as the active substance in this
medicine may be passed into breast milk. Your
doctor will decide if Clindamycin is suitable for you.
Although it is not likely that a nursing infant will take
in very much of the active substance from the milk it
drinks, if your baby gets bloodstained diarrhoea or
shows any signs of illness, tell your doctor at once.
You should stop breast-feeding if this happens.
Driving and using machines
No effects on the ability to drive or use machines
have been seen with Clindamycin.
Clindamycin contains cetostearyl alcohol and
methyl parahydroxybenzoate
Cetostearyl alcohol may cause local skin reactions
such as dermatitis (an inflammation of the skin).
Methyl parahydroxybenzoate may cause allergic
reactions that can be delayed.

3 How to use Clindamycin
Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

Usually, you should use this medicine twice a day,
shake the bottle well before use. Wash the
affected area and put on a thin film of solution or
lotion.
The Clindamycin Solution bottle has an automatic
pad dispenser. Gently apply a thin film onto your
skin using the pad on the applicator.
The Clindamycin Lotion bottle has a dispensing cap.
Wash your hands before and after use and dry
them, apply a thin film of the lotion by gently rubbing
it into your skin, you may use a cotton pad for this or
you can use your fingers. Always replace the cap
after use.
If you forget to apply Clindamycin
Do not worry if you miss one or two applications; just
carry on as soon as you remember.
If you stop using Clindamycin
Do not stop using Clindamycin as soon as your acne
starts to get better. Ask your doctor when you
should stop the treatment.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Tell your doctor immediately if you develop
severe, persistent or bloody diarrhoea (which may
be associated with stomach pain or fever). This is an
uncommon side effect which may occur after
treatment with antibiotics and can be a sign of
serious bowel inflammation.
Clindamycin may make your skin dry (very common
side effect).
Other side effects that have been seen with
Clindamycin Lotion and Clindamycin Solution
are:
Very common: may affect more than 1 in 10
people
• Skin irritation (may cause symptoms such as
burning, itching, peeling), hives
Common: may affect up to 1 in 10 people
• Oily skin
Uncommon: may affect up to 1 in 100 people
(only seen with Clindamycin)
• Gastrointestinal disturbances (may cause
symptoms such as diarrhoea, and nausea)
Frequency not known, but may also occur
• Severe acne (also known as gram‑negative
folliculitis), stinging of the eye, stomach pain,
inflammation of the skin caused by contact with
irritants or allergens
• Clindamycinl lotion may cause gastrointestinal
disturbances (with symptoms such as diarrhoea
and nausea)
Reporting of side effects
If you get any side effects, talk to your doctor or
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.

Ref: 1227/080814/2/B

5







How to store Clindamycin

Keep out of sight and reach of children.
Do not use Clindamycin after the expiry date
which is stated on the pack.
Do not store above 25°C.
If your medicine becomes discoloured or shows
any other signs of deterioration, consult your
pharmacist who will tell you what to do.
Medicines should not be disposed of via waste
water 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 Clindamycin contains
The active substance is clindamycin phosphate. Each
ml of Clindamycin solution contains 10 mg of
clindamycin.
The other ingredient are: isopropyl alcohol,
propylene glycol and purified water.
What Clindamycin looks like and contents of the
pack
Clindamycin Solution is a clear colourless solution
with an alcoholic odour in a plastic bottle with a screw
cap supplied with an automatic pad dispenser and a
screw cap provided separately.
Bottle contains 30ml of Clindamycin Solution.
Manufacturer and Licence Holder
This medicine is manufactured by Pharmacia &
Upjohn Company, Kalamazoo, Michigan, USA and is
procured from within the EU and repackaged by the
Product Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about
anything, ask your doctor or pharmacist. They will
have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1227
Clindamycin 1% Topical Solution

Revision date: 08/08/14

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel:
01527 505414 for help.

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.

Hide
(web5)