DALACIN T TOPICAL SOLUTION

Active substance: CLINDAMYCIN PHOSPHATE

View full screen / Print PDF » Download PDF ⇩

Transcript
HEAD BACK

GLUE PANEL – NO COPY

NO COPY AREA


HEAD FRONT

Package leaflet: Information for the patient

FPO 128 - 10 Mil

Dalacin T
®

Topical Solution/Topical Lotion
Clindamycin phosphate

NO COPY AREA
GLUE PANEL – NO COPY

Dalacin® T

Topical Solution/Topical Lotion

Clindamycin phosphate

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.

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 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 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.

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.
Continued overleaf...

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 Topical Solution
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 this medicine out of the
sight and reach of children.
• Do not use this medicine
after the expiry date which
is stated on the bottle and
carton after EXP. The expiry
date refers to the last day of
that month.
• Do not store above 25°C.
• Do not throw away any
medicines via wastewater or
household waste. Ask your
pharmacist how to throw
away medicines you no
longer use. These measures
will help to protect the
environment.

6. Contents of the
pack and other
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.

What Dalacin T looks like
and contents of the pack

Dalacin T Lotion is a white to
off-white aqueous emulsion in a
plastic bottle with a dispensing
cap. Bottles contain 30 ml or
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 may be
marketed.

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:
For further information on your
medicine contact Medical
Information at Pfizer Limited in
Walton Oaks, Tadworth, Surrey.
Tel: 01304 616161.
This leaflet was last revised in
06/2014.
Ref: DA15_0

10179107

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
(web4)