CLEOCIN 2% Вагинальный крем

Содержание инструкции

1. CLEOCIN 2% vaginal cream
   1. What is Cleocin and what is it used for
   2. What you need to know before you use Cleocin
   3. How to use Cleocin
   4. Possible side effects
   5. How to store Cleocin
   6. Contents of the pack and other information
2. CLEOCIN 100 mg vaginal ovule
   1. What is Cleocin and what is it used for
   2. What you need to know before you use Cleocin
   3. How to use Cleocin
   4. Possible side effects
   5. How to store Cleocin
   6. Contents of the pack and other information

CLEOCIN 2% vaginal cream

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 Cleocin is and what it is used for
• 2. What you need to know before using Cleocin
• 3. How to use Cleocin
• 4. Possible side effects
• 5. How to store Cleocin
• 6. Contents of the pack and other information

1. What is Cleocin and what is it used for

Cleocin contains the active ingredient clindamycin (an antibiotic) and is used in adultsfor the treatment of

vaginal infectionscaused by certain types of bacteria (Gardnerella vaginalis, Mobiluncus s.p.p., Bacteroides s.p.p.,

Mycoplasma hominis, Peptostreptococcus s.p.p.).

2. What you need to know before you use Cleocin

Do not use Cleocin

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

Cleocin should not be used in children.

Warnings and precautions
Talk to your doctor or pharmacist before using Cleocin.
Tell your doctor or pharmacist beforeusing this medicine if:

• you have or have had in the past stomachor intestinal diseases, including inflammation of the colon (the last part of the intestine);
• you are prone to developing allergic reactions.

Tell your doctor if any of the following conditions occur or worsen duringtreatment with
Cleocin:

• new infectionsor persistence of ongoing infections. This situation may be caused by germs that are not sensitive to Cleocin;
• the onset of diarrhea. If you experience abdominal cramps and severe, prolonged diarrhea with blood and mucus in your stools, stoptreatment with this medicine and see your doctor. These may be symptoms of intestinal inflammation (pseudomembranous colitis) caused by the use of antibiotics. Tell your doctor immediatelyif you experience these symptoms even 2 or 3 weeks after stopping treatment with Cleocin (see also section 4 “Possible side effects”);
• allergic reactions. In this case, stop treatment with this medicine and see your doctor.

As with all vaginal infections, during treatment with Cleocin, sexual intercourse is not recommended. Cleocin
may weaken condoms and diaphragms. Therefore, their use is not recommended for up to 72 hours after the end of
treatment with this medicine.
During treatment with Cleocin, the use of other vaginal products such as tampons or vaginal douches is not recommended.
Before or after starting therapy with clindamycin, your doctor may request that you investigate, with appropriate laboratory tests, the possible presence of other vaginal infections ( Trichomonas vaginalis, Candida albicans, Chlamydia

trachomatisand gonococci).

Other medicines and Cleocin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Caution is necessary when Cleocin needs to be used together with the following medicines:

• lincomycin(an antibiotic),
• medicines used to obtain muscle relaxation during surgical procedures (for example: ether, tubocurarine, pancuronium).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding with breast milk
ask your doctor for advice before taking this medicine.
It is not recommended to use Cleocin during the first 3 months of pregnancy. During the second and third trimester of
pregnancy, your doctor will prescribe Cleocin only if strictly necessary.
The active ingredient of Cleocin vaginal cream can pass into human breast milk and can cause unwanted effects
in breastfed infants, such as diarrhea, blood in the stool or skin rashes.
Your doctor will decide whether you can use this medicine during breastfeeding.

Driving and using machines
Cleocin does not impair the ability to drive vehicles and operate machinery.

Cleocin contains:

• propylene glycol. May cause skin irritation.
• cetostearyl alcohol. May cause local skin reactions (e.g. contact dermatitis).

3. How to use Cleocin

Use this medicine following exactly the instructions of your doctor. If you have any doubts, consult your doctor or the
pharmacist.
The recommended dose is 5 g of cream per day, corresponding to a full applicator, to be inserted into the vagina every
evening at bedtime for 3-7 days.

Instructions for use
Remove the cap from the cream tube.
Screw one of the supplied single-use applicators onto the tube
at the point where the cap was
removed.
Gently press the tube to allow the cream to enter
the applicator until it is completely full.
Unscrew the applicator and screw the cap back onto the tube.

Lie on your back and hold the applicator with your thumb
and middle finger.
Insert the applicator into the vagina as deeply as possible without causing discomfort.
Press the plunger all the way down to introduce
the cream into the vagina.
Remove the applicator and discard it.
Wash your hands thoroughly after applying the cream.
Avoid contact with eyes.

If you use more Cleocin than you should
If you have used more Cleocin than you should, contact your doctor as you may experience unwanted 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.
manifest.

Stoptaking 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:

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

• infections of the vulva and vagina caused by Candida(a type of fungus)

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

• fungal infections, including infections caused by a fungus called Candida
• headache, dizziness
• altered taste
• upper respiratory tract infections (e.g. nose and throat)
• abdominal pain
• constipation
• diarrhea
• nausea, vomiting
• itching in areas other than the application site
• skin rash
• back pain
• urinary tract infections
• presence of sugar and protein in the urine
• abnormalities during labor
• pain, discomfort and inflammation of the vulva and vagina
• irregular menstrual cycle, abnormal uterine bleeding
• vaginal discharge

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

• infections caused by bacteria

• allergic reactions
• vertigo
• nosebleeds
• abdominal bloating
• flatulence
• bad breath
• urticaria, skin redness
• difficulty urinating
• infections of the vulva and vagina caused by a bacterium called Trichomonas
• vaginal infections
• pain in the lower abdomen corresponding to the pelvis (pelvic pain)
• alteration of microbiological tests

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

• skin infection caused by a fungus called Candida
• hyperthyroidism
• stomach and intestinal disorders
• digestive disorder
• skin rash characterized by the appearance of red patches on the skin surrounded by small blisters
• presence of fragments of uterine tissue in abnormal locations (e.g. ovaries, tubes, vagina, intestine)
• pain and inflammation at the application site

The following additional side effects have occurred after taking medicines containing clindamycin, the
same active ingredient as Cleocin, administered orally or by injection (into a muscle or vein). It is therefore
not possible to exclude that you may also experience the following side effects after taking Cleocin:

• decreased number of white blood cells and platelets in the blood
• increased number of eosinophils (a type of white blood cells) in the blood
• serious allergic reactions that may be characterized by skin rash, fever and symptoms involving several organs
• inflammation and lesions of the esophagus
• yellowing/yellowish discoloration of the skin and the white of the eye (jaundice)
• alteration of medical tests evaluating liver function
• reactions at the level of the skin and mucous membranes characterized by the formation of blisters, red patches and scales (erythema, dermatitis)
• serious acute hypersensitivity reactions involving the skin and mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis)

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 Cleocin

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 and the tube after “Exp.”.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25° C.
Do not refrigerate or freeze.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Cleocin contains

• The active ingredient is clindamycin (as clindamycin phosphate). 100 g of cream contains 2.376 g of clindamycin phosphate, equivalent to 2 g of clindamycin.
• The other ingredients are: liquid paraffin, propylene glycol, cetostearyl alcohol(see section 2 “Cleocin contains”), polysorbate 60, cetyl palmitate, stearic acid, sorbitan monostearate, benzyl alcohol and purified water.

Description of the appearance of Cleocin and contents of the pack
The vaginal cream is packaged in an aluminium and polyethylene tube with a polypropylene cap.
Cleocin 2% vaginal cream is available in packs containing 1 tube of 21 g cream + 3 single-use polyethylene applicators or in packs containing 1 tube of 40 g cream + 7 single-use polyethylene applicators.
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 MANUFACTURING BELGIUM N.V.
Rijksweg 12
B-2870 Puurs
Belgium
Pfizer Service Company BVBA
Hoge Wei
1930 Zaventem
Belgium

CLEOCIN 100 mg vaginal ovule

clindamycin phosphate equivalent to 100 mg of 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 they have the same symptoms as you, as it may 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 Cleocin is and what it is used for
• 2. What you need to know before using Cleocin
• 3. How to use Cleocin
• 4. Possible side effects
• 5. How to store Cleocin
• 6. Contents of the pack and other information

1. What is Cleocin and what is it used for

The name of the medicine is Cleocin 100 mg Vaginal Ovules.
It is called Cleocin in this leaflet.
Cleocin is a semi-solid ovule (vaginal ovule). Introduced into the vagina, it releases a medicine called
clindamycin phosphate, belonging to the category of antibiotics.
Cleocin is used in the treatment of a bacterial infection of the vagina called bacterial vaginosis.

2. What you need to know before you use Cleocin

Do not use Cleocin:

• if you are allergic to clindamycin, to another antibiotic called lincomycin or to any of the other ingredients of this medicine (listed in section 6);
• if you have previously suffered from inflammation of the colon (colitis) when you have taken antibiotics.

Warnings and precautions
Tell your doctor or pharmacist before using Cleocin:

• if you suffer from diarrhoea or if you generally experience diarrhoea when taking antibiotics
• if you have a history of inflammatory bowel disease such as Crohn's disease or ulcerative colitis

If you develop severe or prolonged diarrhoea or with traces of blood during or after using Cleocin, tell your
doctor immediately, as it may be necessary to stop treatment. This may be a sign of
intestinal inflammation (pseudomembranous colitis), which can occur following treatment with antibiotics.
Consult your doctor to find out if you can use the medicine in the following cases:

• if you suffer from kidney, liver or immune system problems
• if you are under 16 years of age or over 65 years of age.

Cleocin should not be used in children under 16 years of age.
As with all vaginal infections, sexual intercourse during treatment with Cleocin is not recommended.
Cleocin may reduce the effectiveness of condoms and diaphragms. Do not consider condoms or diaphragms
contraceptives effective during use of the medicine within 72 hours after treatment.
The use of other vaginal products such as tampons or douches during treatment with the ovules is not recommended.

Other medicines and Cleocin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
In particular, tell your doctor if you are taking:

• Medicines to relax muscles as Cleocin may increase the action of these medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant if you suspect or are planning a pregnancy or if you are breastfeeding, ask
your doctor or pharmacist for advice before using this medicine.
The use of Cleocin in the first three months of pregnancy is not recommended, as there is insufficient evidence of its
safety.
If you are pregnant, Cleocin should only be used after careful consultation with your doctor who will decide whether this
treatment is suitable for you.
If you are breastfeeding, your doctor will tell you if Cleocin is suitable for you as the active ingredient may pass into the milk.
Although it is unlikely that an infant could take a consistent amount of the active ingredient through the milk
they drink, if the baby develops diarrhoea with traces of blood or shows any sign of illness, tell
your doctor immediately. In this case, breastfeeding should be stopped.

Driving and using machines
It is unlikely that this medicine will impair the ability to drive and use machines.

3. How to use Cleocin

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor or
pharmacist.
Do not use the product if the packaging containing the vaginal ovules is torn, open or not completely
sealed.
You must be careful not to overheat the ovule, as heat can soften and deform it.
The recommended dose for this medicine is one ovule to be inserted into the upper part of the vagina every night before
going to sleep, for three consecutive nights. After insertion, the ovule will dissolve and disappear.

Insertion:

• Remove the ovule from the aluminum packaging.
• Lie on your back, bringing your knees to your chest.
• Insert the ovule into the vagina with the tip of your middle finger as deeply as possible without causing discomfort.

Always wash your hands after using the ovules.

If you use more Cleocin than you should
Contact your doctor. Do not use any other ovule until your doctor tells you to do so.

If you forget to use a dose of Cleocin
If you realize you have forgotten to use the ovule only a few hours late, use it immediately.
If it is almost time for the next ovule, do not consider the forgotten ovule. Take the next ovule at the usual time.
Continue to take the ovules at the scheduled time.

If you swallow an ovule
If the ovule is swallowed, contact your doctor. It is unlikely that the ovules will cause harm, but the doctor will be able to
advise you on what to do.
If you have any doubts about 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.
Report to your doctor immediately if:

• you develop severe, persistent diarrhea or diarrhea containing blood (which may be associated with stomach pain or fever). This is an uncommon side effect that can occur after treatment with antibiotics and may be a sign of serious intestinal inflammation or inflammation of the lining of the large intestine (pseudomembranous colitis).
• You experience allergic reactions or very serious skin reactions. These side effects are very rare.

Common (may affect up to 1 in 10 people)

• fungal infections, yeast infection
• headache
• stomach pain, diarrhea, nausea (feeling sick)
• itching (at a site other than the application site)
• vaginal irritation, vaginal discomfort, vaginal conditions

Uncommon (may affect up to 1 in 100 people)

• vomiting
• rash
• pain in the upper abdomen or back
• fever or chills, feeling unwell
• pain when urinating, blood in urine, cloudy or foul-smelling urine, increased frequency and urgency of urination
• vaginal infections, vaginal discharge, menstrual cycle irregularities
• pain (at the application site), itching, localized swelling

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly through the national reporting system at: http:// www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cleocin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date indicated on the packaging and on the blister after Scad.
The expiry date refers to the last day of the month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Cleocin contains

• The active ingredient is clindamycin phosphate. Each vaginal ovule contains clindamycin phosphate equivalent to 100 mg of clindamycin.
• The only excipient is saturated fatty acid triglycerides.

Description of the appearance of Cleocin and contents of the pack
Cleocin is a white or off-white vaginal ovule. It is available in a laminate blister pack containing 3
ovules, placed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Italia S.r.l.: Via Isonzo n. 71, 04100 Latina.
Manufacturer
Pfizer Manufacturing Belgium NV
Rijksweg 12

• B– 2870 Puurs Belgium

Pfizer Service Company BVBA
Hoge Wei 10, Zaventem
B-1930
Belgium

This medicinal product is authorised in the Member States of the European Economic Area under the following
names: