DALACIN 1% Топическая эмульсия

Содержание инструкции

1. DALACIN T 1% cutaneous emulsion, gel
   1. What is Dalacin T and what is it used for
   2. What you need to know before using 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

DALACIN T 1% cutaneous emulsion, gel

Clindamycin

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Dalacin T is and what it is used for
• 2. What you need to know before using 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 is Dalacin T and what is it used for

Dalacin T contains the active ingredient clindamycin (an antibiotic that belongs to a group of medicines
called lincosamides) and is used in the treatment of acne. Clindamycin acts against bacteria that
penetrate the pores of the skin and cause the red pimples full of pus typical of acne.

2. What you need to know before using Dalacin T

Do not use Dalacin T

• if you are allergic to clindamycin, to other active ingredients similar to lincomycin or to any of the other components of this medicine (listed in section 6);
• if you have had an inflammation of the colon (colitis) in the past following the use of antibiotics.

Warnings and precautions
Consult your doctor or pharmacist before using Dalacin T.
Tell your doctor if any of the following conditions occur or worsen duringtreatment
with Dalacin T (see also section 4 “Possible side effects”):

• the onset of diarrhea. If you experience abdominal cramps and severe and prolonged diarrhea with the presence of blood and mucus in the stool, stoptreatment with this medicine and consult your doctor. These could be symptoms of an intestinal inflammation (pseudomembranous colitis) caused by the use of antibiotics. Inform your doctor immediatelyif you experience these symptoms even several weeks after stopping treatment with Dalacin T because, if neglected, the situation could worsen (see also section 4 “Possible side effects”);
• allergic reactions. In this case, stop treatment with this medicine and consult your

doctor (see section 2 “What you need to know before using Dalacin T”).
Avoid contact with eyes, mucous membranes and wounds because this medicine contains an alcoholic base that can
cause burning and irritation. If contact occurs, wash the area with plenty of fresh water.
Be careful when applying the medicine around the mouth because this medicine has an unpleasant
taste.
The use, especially if prolonged, of topical products can give rise to sensitization phenomena. In
this case, discontinue treatment and consult your doctor to establish appropriate therapy.

Children
This medicine should be used in early infancy only if strictly necessary, under the
direct supervision of the doctor.

Other medicines and Dalacin T
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
The following medicines affect the effectiveness of Dalacin T or Dalacin T affects the effectiveness of the
following medicines:

• antibiotics such as metronidazole, gentamicinand lincomycin;
• neuromuscular blocking medicines such as ether, tubocurarine, pancuronium, when clindamycin is used systemically.

When clindamycin is used systemically, it can enhance the effect of neuromuscular blocking
medicines (such as ether, tubocurarine, pancuronium).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor for advice before using this medicine.
The active ingredient of Dalacin T used topically can pass into human breast milk and can cause
adverse effects in breastfed infants, such as diarrhea, blood in the stool or skin rashes.
If you are pregnant or breastfeeding, your doctor will prescribe Dalacin T only if strictly
necessary.

Driving and operating machinery
Dalacin T does not alter or alters negligibly the ability to drive vehicles and operate machinery.

Dalacin T 1% cutaneous emulsion contains:

• cetostearyl alcohol. It can cause local skin reactions (e.g. contact dermatitis).
• methyl parahydroxybenzoate. It can cause allergic reactions (even delayed).

Dalacin T 1% gel contains propylene glycol (E1520) and methyl p-hydroxybenzoate (E218).
This medicine contains 50 mg of propylene glycol and 3 mg of methyl p-hydroxybenzoate in each gram
of gel.
Methyl p-hydroxybenzoate can cause allergic reactions (even delayed).

3. How to use Dalacin T

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
Apply a thin layer of Dalacin T to the skin area to be treated twice a day. It is not necessary to
massage the skin.
Wash your hands after each application.

If you use more Dalacin T than you should
If you have used more Dalacin T than you should, contact your doctor as you may experience
undesirable effects.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stoptreatment with this medicine immediately and contact your doctor if you experience:

• severe, persistent diarrhea or diarrhea with blood and mucus in the stool (which may be associated with stomach pain or fever). These may be symptoms of a serious intestinal inflammation (pseudomembranous colitis) (see section 2 “Warnings and precautions”).

Contact your doctor if you experience the following side effects following the use of Dalacin T emulsione
cutanea:

Very common(may affect more than 1 in 10 people):

• skin irritation
• urticaria (hives)
• dry skin

Common(may affect up to 1 in 10 people):

• increased sebum production on the skin (seborrhea)

Frequency not known(the frequency cannot be estimated from the available data):

• hair follicle infection (folliculitis)
• eye pain
• abdominal pain
• stomach and intestinal disorders
• pseudomembranous colitis
• redness of the skin with blister and scale formation (contact dermatitis)

Contact your doctor if you experience the following side effects following the use of Dalacin T gel:

Very common(may affect more than 1 in 10 people):

• skin irritation
• increased sebum production on the skin (seborrhea)
• dry skin

Common(may affect up to 1 in 10 people):

• urticaria (hives)

Uncommon(may affect up to 1 in 100 people):

• stomach and intestinal disorders

Frequency not known(the frequency cannot be estimated from the available data):

• hair follicle infection (folliculitis)
• eye pain
• abdominal pain
• pseudomembranous colitis
• redness of the skin with blister and scale formation (contact dermatitis)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
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 package, bottle and tube after
“Expiry”. The expiry date refers to the last day of that month.

Dalacin T gel
Do not store at a temperature above 25° C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dalacin T contains
The active ingredient is clindamycin (as clindamycin phosphate).

Dalacin T 1% cutaneous emulsion
100 g of emulsion contains 1.188 g of clindamycin phosphate (equivalent to 1 g of clindamycin base).
The other ingredients are: glycerol, isostearyl alcohol, cetostearyl alcohol, methyl parahydroxybenzoate
(see paragraph 2 “Dalacin T 1% cutaneous emulsion contains”), stearic acid, glyceryl monostearate,
sodium lauryl sarcosinate and purified water.

Dalacin T 1% gel
100 ml of gel contains 1.188 g of clindamycin phosphate (equivalent to 1 g of clindamycin base).
The other ingredients are: allantoin, methyl p-hydroxybenzoate (E218), propylene glycol (E1520)(see
paragraph 2 “Dalacin T 1% gel contains propylene glycol (E1520) and methyl p-hydroxybenzoate (E218)”),
polyethylene glycol 400, carbomer 934P and purified water.

Description of the appearance of Dalacin T and contents of the pack
Dalacin T 1% cutaneous emulsion is available in packs containing a 30 ml polyethylene bottle with a
polypropylene cap.
Dalacin T 1% gel is available in packs containing a 30 g tube.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Italia S.r.l.
via Isonzo, 71
04100 Latina

Manufacturer
Pfizer Service Company BVBA
Hoge Wei
1930 Zaventem
Belgium