Ecoclindin

Ecoclindin, 100 mg, Vaginal Suppositories

 

Active substance: 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 further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms 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 section 4 of this leaflet.

 

Contents of the leaflet 

1. What Ecoclindin is and what it is used for.

2. What you need to know before you use Ecoclindin.

3. How to use Ecoclindin.

4. Possible side effects.

5. How to store Ecoclindin.

6. Contents of the pack and other information.

1.  What Ecoclindin is and what it is used for

 

The medicine Ecoclindin contains the active substance clindamycin and is an antibiotic of the lincosamide group.

 

Therapeutic Indications

Ecoclindin is used in adults aged 18 years and older for the treatment of bacterial vaginosis.

 

Pharmacodynamic Properties

Ecoclindin disrupts the process of protein formation in microbial cells, which is necessary for their growth and division, and thus stops microbial reproduction (bacteriostatic action).

If there is no improvement or you feel worse, you must consult a doctor.

2.  What you need to know before you use Ecoclindin

 

Contraindications

Do not use Ecoclindin:

• if you are allergic to clindamycin, lincomycin, or any other components of this medicine (listed in section 6 of this leaflet);

• if you have previously had antibiotic-associated intestinal inflammation (antibiotic-associated colitis).

 

Warnings and Precautions

Consult your doctor before using Ecoclindin .

If you develop diarrhea during the use of this medicine, especially if it is severe or persistent, or contains blood, inform your doctor immediately. This is important because diarrhea can be a sign of intestinal inflammation due to antibiotic use (pseudomembranous colitis), and you may need to discontinue the medicine and receive appropriate treatment for colitis.

During the use of Ecoclindin refrain from sexual intercourse and do not use other intravaginal products (tampons, douches).

During the use of Ecoclindin and for 72 hours after use, do not use condoms, vaginal contraceptive diaphragms, or other latex products for intravaginal use (the medicine contains components that may reduce the strength of latex or rubber products). Do not use the medicine during menstruation. You should postpone the start of therapy until your period has ended.

 

Children

Do not give this medicine to children under 18 years of age due to probable lack of safety data.

 

Other medicines and Ecoclindin

Tell your doctor if you are taking, have recently taken, or might take any other medicines. Be sure to inform your doctor:

• if you have previously been prescribed lincomycin and treatment with that medicine was ineffective;

• if you are taking medicines from the group of peripheral muscle relaxants (used for muscle relaxation), as Ecoclindin may enhance their effects.

During treatment with Ecoclindin you should not use other medicines administered by the intravaginal route.

 

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Ecoclindin should not be used in the first trimester of pregnancy, as there is insufficient safety data for its use during this period. In the second and third trimesters of pregnancy, Ecoclindin can be used only after consultation with a doctor, who will decide if this medicine is suitable for you.

It is not known whether the medicine is excreted in breast milk when used as suppositories; however, the active substance can pass into breast milk when used in other dosage forms. If you are breast-feeding, discuss the possibility of using Ecoclindin with your doctor.

 

Driving and using machines

Ecoclindin does not affect the ability to drive vehicles or operate machinery.

3.  How to use Ecoclindin

 

Always use this medicine exactly as directed by your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist.

 

Recommended dose

1 suppository once a day, preferably at bedtime.

 

Route and method of administration

Intravaginally.

Administration of suppositories:

- Remove the suppository from the blister strip;

- Lie on your back and bring your knees up towards your chest;

- Gently insert the suppository into the vagina using your middle finger as deeply as possible.

 

Duration of therapy

Use for 3 consecutive days.

 

If you use more Ecoclindin than you should

If you have used more medicine than you should, you may develop diarrhea or pseudomembranous colitis. Contact your doctor and do not use the medicine until your doctor recommends resuming treatment.

If you have questions about using the medicine, consult your doctor or pharmacist.

4. Possible side effects

 

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

 

The most serious side effect associated with the use of Ecoclindin is antibiotic-associated intestinal inflammation (pseudomembranous colitis). It occurs with unknown frequency.

If you develop severe or persistent diarrhea, or if you notice blood or mucus in your stool, inform your doctor immediately. Treatment with clindamycin should be stopped immediately, as this reaction can be life-threatening. Do not take any medicines that stop diarrhea (antidiarrheal medicines) without your doctor's recommendation.

 

Other side effects that may occur with the use of Ecoclindin.

 

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

- Infectious inflammation of the vulvar skin and vaginal mucosa caused by fungi of the genus Candida, which may be accompanied by genital itching, burning, white 'cottage cheese-like' vaginal discharge (vulvovaginal candidiasis)

- Vulvovaginal pain

- Vulvovaginal disorders

- Skin itching

- Abdominal pain

- Diarrhea

- Nausea

- Headache

- Fungal infections

- Infections caused by fungi of the genus Candida

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

- Vomiting

- Rash

- Flank pain

- Pain or discomfort in the lower back, fever, chills, nausea, weakness – signs of kidney inflammation (pyelonephritis)

- Painful urination (dysuria)

- Pain at the application site

- Itching at the application site

- Localized swelling

- Localized pain

- Localized increased temperature (hyperthermia)

- Vaginal infections

- Vaginal discharge

- Menstrual cycle disorders

If any side effects or other unusual reactions not described in this leaflet occur, consult your doctor.

 

Reporting 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 (see below). By reporting side effects, you can help provide more information on the safety of the medicine.

 

Russian Federation

Federal Service for Surveillance in Healthcare (Roszdravnadzor)

Address: 109012, Moscow, Slavianskaya Square, 4, building 1

Phones: +7 800 550 99 03, +7 (499) 578-06-70, +7 (499) 578-02-20

 

Email: pharm@roszdravnadzor.gov.ru

Website: roszdravnadzor.gov.ru

 

5. How to store Ecoclindin

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 blister strip and carton after "EXP"/"Use by:". The expiry date refers to the last day of that month.

Store in the original packaging (carton) at a temperature not exceeding 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 protect the environment.

 

6. Contents of the pack and other information

 

What Ecoclindin contains

The active substance is clindamycin.

1 suppository contains 100 mg of clindamycin (as phosphate).

The other ingredients (excipients) are: lactulose, macrogolglycerol hydroxystearate, colloidal silicon dioxide, hard fat (Suppocire AM).

 

What Ecoclindin looks like and contents of the pack

Vaginal suppositories.

Torpedo-shaped suppositories from white to almost white. White specks are allowed. An air core or funnel-shaped depression may be present.

3 suppositories are placed in a PVC/PE film blister strip. 1 blister strip, together with the package leaflet, is placed in a cardboard carton.

 

Marketing Authorization Holder

Russian Federation

JSC "AVVA RUS"

121614, Moscow, ul. Krylatskie Kholmy, 30, building 9

Tel.: +7 (495) 956-75-54

info@avva-rus.ru

 

Manufacturer

Russian Federation

JSC "AVVA RUS"

Kirov region, Kirov, Luganskaya st., 53A.

 

All consumer claims should be sent to the Marketing Authorization Holder

Russian Federation

JSC "AVVA RUS"

121614, Moscow, ul. Krylatskie Kholmy, 30, building 9

Tel.: +7 (495) 956-75-54

drug.safety@avva-rus.ru        

 

Leaflet last revised

 

Other sources of information

Detailed information about this medicine is available on the EAEU website: http://eec.eaeunion.org/