DALACIN T TOPICAL SOLUTION

Active substance: CLINDAMYCIN PHOSPHATE

View full screen / Print PDF » Download PDF ⇩

Transcript
HEAD FRONT

HEAD BACK

GLUE PANEL – NO COPY

NO COPY AREA
DALACIN ® T
Topical Solution
Topical Lotion

FPO 128 10 mil
PACKAGE LEAFLET: INFORMATION FOR THE USER

Dalacin® T Topical Solution/Topical Lotion 10 mg/ml
10179103

NO COPY AREA
GLUE PANEL – NO COPY

3. How to use Dalacin T

Dalacin® T Topical Solution/Topical Lotion 10 mg/ml

Always use Dalacin T exactly as
your doctor has told you. You
should check with your doctor or
pharmacist if you are not sure how
to use this product.
Usually, you should use this
medicine twice a day. Wash the
affected area and put on a thin film
of solution or lotion.
The solution bottle has an automatic
pad dispenser. Gently dab the pad
onto your skin. The lotion bottle has
a dispensing cap. Gently rub the
lotion into the skin.
Always replace the cap after use.

Clindamycin phosphate

Read all of this leaflet
carefully before you start
using this medicine

solution around your mouth as they
each have an unpleasant taste.
Dalacin T Topical Solution is
flammable. Do not use the solution
near flames or while you are
smoking.

• 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. 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 get
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or your
pharmacist.

Taking other medicines

In this leaflet:
1.

2.
3.
4.
5.
6.

What Dalacin T is and what it
is used for
Before you use Dalacin T
How to use Dalacin T
Possible side effects
How to store Dalacin T
Further 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 a
lotion. The solution and the lotion
are used on the skin to treat acne.

2. Before you use
Dalacin T
Do not use Dalacin T if
you are:

• Keep out of the reach and sight of
children.
• Do not use Dalacin T after the
expiry date which is stated on the
bottle. The expiry date refers to
the last day of that month.
• Do not store above 25°C.
• 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.

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
how to use this product, ask your
doctor or pharmacist.

Pregnancy
If you are pregnant or think you
might be pregnant you should
contact your doctor before using
Dalacin T.

6. Further information
What Dalacin T contains
The active substance is clindamycin
phosphate. Each ml of Dalacin T
lotion or solution contains 10 mg of
clindamycin.
The other ingredients are:
• Lotion: glycerol, sodium lauroyl
sarcosinate, stearic acid, tegin,
cetostearyl alcohol, isostearyl
alcohol, methylparaben and water.
• Solution: isopropyl alcohol,
propylene glycol, hydrochloric
acid, sodium hydroxide and water.

4. Possible side effects

Breast-feeding

Like all medicines, Dalacin T 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 Topical Solution may make
your skin dry (very common side
effect).

Tell your doctor if you will be breastfeeding 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.

What Dalacin T looks like and
contents of the pack
Dalacin T Lotion is a white to offwhite aqueous emulsion in a plastic
bottle with a dispensing cap. Bottles
contain 30 ml and 60 ml of Dalacin
Topical Lotion.
Dalacin T Solution is a clear
colourless solution in a plastic
bottle with an automatic pad
dispenser and cap. Bottles contain
either 30 ml, 50 ml or 60 ml of
Dalacin T Solution.
Not all pack sizes are marketed.

Other side effects that have
been seen with Dalacin T
Topical Lotion and Dalacin T
Topical Solution

Important information about
some of the ingredients of
Dalacin T

Before using Dalacin T make sure
that your doctor knows 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 Topical Solution 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

5. How to store
Dalacin T

If you forget to apply
Dalacin T

No effects on the ability to drive or
use machines have been seen with
Dalacin T.

Take special care with
Dalacin T

Time/Date:

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).
Please tell your doctor if you are
taking or have recently taken any
other medicines including medicines
obtained without a prescription.

Driving and using machines

• hypersensitive (allergic) to
clindamycin, lincomycin or to any
of the other ingredients in the
medicine. Do not use if you have
a history of inflammatory bowel
disease or antibiotic-associated
colitis.

• Dalacin T Topical lotion may cause
gastrointestinal disturbances (with
symptoms such as diarrhoea and
nausea).
If any of the side effects get serious,
or if you notice any side effects not
listed in this leaflet, please tell your
doctor or pharmacist.

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 Solution contains
propylene glycol which may cause
skin irritation.
Dalacin T Lotion contains
cetostearyl alcohol which may
cause local skin reactions such as
dermatitis (an inflammation of the
skin).
Continued overleaf...

Marketing Authorisation
Holder
Pharmacia Limited, Ramsgate Road,
Sandwich, Kent, CT13 9NJ, UK.

Manufacturer
Pfizer Service Company BVBA
Hoge Wei
1930 Zaventem
Belgium.

Company Contact address:
If you have any comments on the
way this leaflet is written, please
contact Medical Information at Pfizer
Limited in Walton Oaks, Tadworth,
Surrey. Tel: 01304 616161.
This leaflet was last updated
06/2013.
Ref: DA 10_0
10179103

10179103.indd 1 6/12/13 2:40 PM



Project No.

Artwork Number

Description

Country



11784

10179103

Dalacin T Solution

UK/Malta



Dimensions

Drawing No.

SKU No.

Item

F311601708/F311626008 Insert
rev. 08JUN11 4.1875" x 15" (4.1875"x 1" folded) DWG-101457-00
Additional Info:

Colors:

EDITOR’S COPY
Black

Mgr M. Wolpert
GS N. DeShong
GA

K. Lowe

Rev

2

GA

GS: DATE:

Dieline
PR

GS / ART REV (LCA)

GS / ART REV (FA)

CHANGES

CHANGES

CHANGES

OK

OK

OK

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)