Ekorutel®

Package Leaflet - Patient Information

 

Ekorutel^®, 500 mg + 100 mg, Vaginal Suppositories

 

Active substances: metronidazole + miconazole

 

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 Ekorutel^® is and what it is used for.

2. What you need to know before you use Ekorutel^®.

3. How to use Ekorutel^®.

4. Possible side effects.

5. How to store Ekorutel^®.

6. Contents of the pack and other information.

 

1. What Ekorutel^® is and what it is used for

 

The medicine Ekorutel^® contains the active substances: 500 mg metronidazole and 100 mg miconazole nitrate.

Metronidazole has antibacterial and anti-trichomonal action, and miconazole nitrate has an antifungal effect.

 

Therapeutic Indications

Ekorutel^® is used in adult women aged 18 years and older for the treatment of:

- vaginal candidiasis;

- bacterial vaginosis;

- trichomonal vaginitis;

- vaginitis caused by mixed infections.

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

 

2. What you need to know before you use Ekorutel^®

 

Contraindications

Do not use Ekorutel^®:  

- if you are allergic to metronidazole, miconazole, or their derivatives, or to any of the other ingredients of this medicine listed in section 6;

- if you are in the first trimester of pregnancy; 

- if you are breast-feeding;

- if you have a diagnosed genetic blood disorder with impaired hemoglobin synthesis (porphyria);

- if you have diagnosed epilepsy;

- if you have severe liver dysfunction;

- if you are a virgin.

Warnings and precautions

Consult your doctor or pharmacist before using this medicine.

Avoid alcohol consumption during treatment and for at least 24-48 hours after finishing treatment due to possible disulfiram-like reactions (nausea, vomiting, headache, facial flushing, increase or decrease in blood pressure, etc.).

When used systemically in high doses and for long periods, metronidazole can cause damage to peripheral nerves (peripheral neuropathy) and convulsions.

The medicine should not be used in virgins and girls who have not reached puberty.

Do not use Ekorutel^® suppositories simultaneously with other vaginal products (e.g., tampons, vaginal douches, and spermicides).

Use caution when using the suppositories concurrently with contraceptive diaphragms and condoms due to potential interaction with the medicine's components. Use other methods of contraception during treatment.

Refrain from sexual intercourse during treatment. To prevent reinfection, simultaneous treatment of the sexual partner is necessary.

Do not stop treatment during menstruation. After therapy for trichomoniasis, perform follow-up tests over 3 consecutive cycles before and after menstruation.

May alter results when determining blood levels of theophylline and procainamide.

Do not swallow or use by any other route!

Metronidazole in Ekorutel^® can have a pronounced hepatotoxic (liver-damaging) effect. Therefore, if any symptoms of liver dysfunction appear (pain in the right upper abdomen, indigestion, yellowing of the skin and/or whites of the eyes, skin itching, changes in abdominal size and shape, fever), inform your doctor.

If you have diagnosed Cockayne syndrome (a rare congenital disorder characterized by nervous system developmental disorders, growth deficiency, abnormal eye sensitivity to sunlight, premature aging, and other developmental defects), inform your doctor. The doctor will assess the benefit/risk ratio of prescribing a medicine containing metronidazole for you. Stop using Ekorutel^® if any symptoms of liver dysfunction appear and inform your doctor.

During treatment with metronidazole, severe bullous skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or acute generalized exanthematous pustulosis may develop (see section 4). If symptoms or signs of these conditions develop, immediately stop treatment with Ekorutel^®.

During treatment with metronidazole, suicidal thoughts with or without depression may occur. Stop treatment and contact your doctor immediately if psychiatric disturbances occur during treatment with Ekorutel^®.

Note that metronidazole may immobilize treponemes (bacteria causing sexually transmitted infections), leading to a false-positive Nelson test (test for syphilis).

The doctor should carefully justify long-term use of metronidazole due to its potential ability to cause genetic changes (mutagenicity and carcinogenicity).

Interference with laboratory tests

Metronidazole may interfere with the results of some blood tests (determination of ALT, AST, lactate dehydrogenase, triglycerides, glucose). This may lead to false-negative results or extremely low values.

Children and adolescents

Contraindicated in virgins.

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

 

Other medicines and Ekorutel^®

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

It is important to tell your doctor if you are taking:

-       Disulfiram (medicine for treating alcoholism);

-       Warfarin (indirect anticoagulants) (blood-thinning medicines that prevent blood clots);

-       Lithium preparations (used for treating psychiatric disorders);

-       Ciclosporin (medicine that reduces immune system activity);

-       Cimetidine (anti-ulcer medicine);

-       Phenytoin, phenobarbital (anticonvulsant medicines);

-       Fluorouracil, busulfan (anti-cancer medicines);

-       Vecuronium bromide (non-depolarizing muscle relaxants) (medicines for muscle relaxation during surgery);

-       Sulfonamides (antimicrobial agents);

-       Medicines that prolong the QT interval (medicines that slow the electrical impulse conduction between the atria and ventricles of the heart).

Interaction of metronidazole with alcohol can cause disulfiram-like reactions.

 

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.

As metronidazole crosses the placental barrier and its effect on human fetal organogenesis is unknown, the use of Ekorutel^® during pregnancy is not recommended.

Metronidazole passes into breast milk, so you should avoid its use during breast-feeding.

 

Driving and using machines

Since the use of this medicine may cause side effects such as confusion, dizziness, vertigo, hallucinations, convulsions, and visual disturbances, refrain from driving vehicles and engaging in other activities requiring increased concentration during treatment.

 

3. How to use Ekorutel^®

 

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

 

Recommended dose

1 vaginal suppository at night and 1 vaginal suppository in the morning.

 

Route and method of administration

Intravaginally. Before use, free the suppository from the blister strip and insert deep into the vagina.

 

Duration of therapy

Use for 7 consecutive days.

For recurrent vaginitis or vaginitis resistant to other types of treatment, the medicine should be used for 14 days.

 

If you use more Ekorutel^® than you should

If you have used a higher dose than prescribed, contact your doctor.

Data on human overdose with intravaginal metronidazole are lacking. However, when administered vaginally, metronidazole can be absorbed in amounts sufficient to cause systemic effects.

Symptoms of metronidazole overdose: nausea, vomiting, abdominal pain, diarrhea, generalized itching, metallic taste in the mouth, movement disorders (ataxia), dizziness, paresthesia (numbness, tingling, or 'pins and needles' sensation), convulsions, peripheral neuropathy (including after prolonged use in high doses), decreased white blood cell count (leukopenia), darkening of urine.

If you accidentally take a large amount of the medicine by mouth, consult a doctor.

Gastric lavage will be performed if necessary. Do not take the medicine until your doctor recommends resuming treatment.

 

If you forget to use Ekorutel^®

Do not use a double dose to make up for a forgotten dose.

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

 

4. Possible side effects

 

Like all medicines, Ekorutel^® can cause side effects, although not everybody gets them.

Some side effects can be very serious and life-threatening – they are listed below. If you experience any of these reactions, stop using the medicine and seek immediate medical attention:

• Swelling of the face (lips, eyelids, cheeks) and oral mucosa, which may spread to the larynx, causing difficulty breathing, hoarseness, and a barking cough (angioedema);

• Fainting or loss of consciousness, low blood pressure, breathing difficulties, pale-bluish, cold, clammy skin (anaphylactic shock);

• Pustular rash on reddened and swollen skin, fever (>38°C), increased white blood cell count (acute generalized exanthematous pustulosis);

• Fever and 'malaise', followed by widespread rash on the skin and mucous membranes in the form of spots, blisters, weeping erosions, crusts (Stevens-Johnson syndrome);

• Fever and 'malaise', followed by widespread rash on the skin and mucous membranes in the form of spots, blisters, weeping erosions, crusts, skin peeling (toxic epidermal necrolysis);

• Pustular skin rash;

• Fixed drug eruption.

 

Other possible side effects that may occur with Ekorutel^®

- Pain in the upper abdomen (epigastrium)

- Nausea

- Vomiting

- Diarrhea

- Inflammation of the oral mucosa (glossitis, stomatitis)

- Taste disturbances ('metallic' taste in the mouth)

- Decreased appetite

- Loss of appetite (anorexia)

- Dry mouth

- Constipation

- Inflammation of the pancreas (pancreatitis) (reversible cases)

- Tongue discoloration/'coated' tongue (due to fungal overgrowth)

- Sensory disturbances (peripheral sensory neuropathy)

- Headache

- Convulsions

- Dizziness

- Encephalopathy reported (e.g., confusion, vertigo) and subacute cerebellar syndrome (impaired coordination and synergy of movements, ataxia, speech disorder (dysarthria), gait disturbances, nystagmus, and tremor, which are reversible after metronidazole withdrawal

- Meningitis (aseptic meningitis)

- Vertigo (frequency unknown)

- Psychotic disorders, including confusion, hallucinations

- Depression

- Insomnia

- Irritability

- Increased excitability

- Double vision (diplopia), nearsightedness (myopia), blurred vision, reduced visual acuity, color vision impairment (transient visual disturbances)

- Nerve damage (neuropathy)/inflammation of the optic nerve (optic neuritis)

- Hearing impairment/hearing loss (including sensorineural deafness)

- Tinnitus

- Slowed electrical conduction between the heart's atria and ventricles (QT prolongation), especially when metronidazole is used with other QT-prolonging medicines (frequency unknown)

- Decreased granulocyte and monocyte count (agranulocytosis)

- Decreased white blood cell count (leukopenia)

- Decreased neutrophil count (neutropenia)

- Decreased platelet count (thrombocytopenia)

- Abnormal liver function test results: high levels of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) and/or alkaline phosphatase

- Liver inflammation (cholestatic or mixed hepatitis) and liver cell damage (hepatocellular injury), sometimes accompanied by jaundice

- Cases of liver failure requiring liver transplantation (in patients treated with metronidazole in combination with other antibiotics)

- Rash

- Skin itching

- Flushing

- Skin redness (hyperemia)

- Itchy skin rash (urticaria)

- Urine discoloration (brownish-reddish color due to a metronidazole metabolite)

- Painful urination (dysuria)

- Excessive urination (polyuria)

- Bladder inflammation (cystitis)

- Urinary incontinence

- Vaginal fungal infection caused by Candida, which may be accompanied by genital itching, burning, white 'cottage cheese-like' discharge (candidiasis); candidiasis may develop after discontinuation of the medicine

- Fever

- Nasal congestion

- Joint pain (arthralgia)

- Weakness

- Burning sensation or irritation of the partner's penis

- Burning sensation or frequent urination

- Itching, burning pain, or redness of the external genital mucosa (vulvitis)

- Flattened T-wave on ECG.

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 Ekorutel^®

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 Ekorutel^® contains

The active substances are metronidazole and miconazole.

Each suppository contains 500 mg metronidazole and 100 mg miconazole nitrate.

The other ingredients (excipients) are: lactulose, macrogolglycerol hydroxystearate, hard fat.

 

What Ekorutel^® looks like and contents of the pack

Vaginal suppositories.

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

7 suppositories are placed in a PVC/PE film blister strip.

2 blister strips, together with the package leaflet, are 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/