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Newmezole Forte Vaginal Suppositories Metronidazole/Chloramphenicol/Natamycin/Hydrocortisone Acetate Read the package leaflet carefully before use as it contains important information for you. • Keep the package leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine is 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in section 4 of the package leaflet. Package leaflet content 1. What Newmezole Forte is and what it is used for 2. What you need to know before using Newmezole Forte 3. How to use Newmezole Forte 4. Possible side effects 5. How to store Newmezole Forte 6. Contents of the packaging and other information 1. What Newmezole Forte is and what it is used for Newmezole Forte belongs to a group of medicines known as antiseptics and antimicrobials for the treatment of gynecological diseases, along with corticosteroids. It is a combination medicine with antibacterial, antifungal, and antiprotozoal action. It contains the active substances metronidazole, chloramphenicol, natamycin, and hydrocortisone acetate. The medicine is used for: - Treatment of vaginitis and cervicitis caused by Gram-positive or Gram-negative aerobic and anaerobic bacteria (including Clostridium spp.); - Treatment of vaginitis and cervicitis caused by Trichomonas vaginalis in combination with other microorganisms; - Treatment of vaginitis and cervicitis caused by Mycoplasma spp. or Chlamydia spp. in combination with other microorganisms; - Treatment of fungal vaginitis caused by microorganisms of the genus Candida spp. in combination with other types of fungi; - Treatment of vaginitis caused by mixed infections: Trichomonas vaginalis, Candida spp. and Mycoplasma spp. or Chlamydia spp.; - Prevention of vaginitis and cervicitis in patients undergoing systemic treatment with immunosuppressants, cytostatics or corticosteroids, and in patients undergoing radiation therapy; - Prevention of vaginitis and cervicitis in patients undergoing surgical or diagnostic interventions in the genital area (hysterosalpingography, hydrotubation, endometrial biopsy, etc.); - Treatment of pathogenic flora before taking a smear for Papanicolaou (Pap) test, to clarify the microscopic picture and improve the interpretation of the Pap test. If there is no improvement or you feel worse, you should consult a doctor. 2. What you need to know before using Newmezole Forte Do not use Newmezole Forte: - If you are allergic (hypersensitive) to metronidazole, chloramphenicol, natamycin, and hydrocortisone acetate or any of the other ingredients of the medicine listed in section 6 of the package leaflet; - In case of bone marrow suppression (when the bone marrow produces fewer blood cells than normal); - If you have been diagnosed with acute intermittent porphyria (an inherited disorder of pigment metabolism with increased levels of porphyrins in the blood and tissues); - If you have glucose-6-phosphate dehydrogenase deficiency (an inherited disease that impairs the function of red blood cells); - If you have severe liver and/or kidney diseases; - If you are pregnant or breastfeeding; - If you are under 18 years of age. Special warnings and precautions Talk to your doctor or pharmacist before using Newmezole Forte. If there is a history of blood disease, as well as when using high doses of the medicine and/or for prolonged treatment, blood count control is necessary. In case of leukopenia, your doctor will assess the possibility of further treatment. In case of nervous system disorders (tingling, impaired coordination of movements and gait, dizziness, seizures), it is necessary to stop treatment and consult a doctor. Use with caution in patients with severe, chronic or progressive nervous system diseases, due to the risk of exacerbation of neurological diseases. Inform your doctor: - If any symptoms of an allergic reaction appear (see section 4 "Possible side effects"); - If you have nervous system disorders; - If you suffer from mental illness; - If you have blood diseases. Cases of severe liver damage/liver failure (including fatal cases) have been reported in patients with cocaine syndrome who used metronidazole-containing medicines. If you have cocaine syndrome, your doctor should check your liver function during and after treatment with metronidazole. Seek immediate medical attention and stop using the medicine if you experience the following symptoms: abdominal pain, loss of appetite, nausea, vomiting, fever, malaise, fatigue, yellowing of the skin, dark urine, clay-colored stools, or itching of the skin. Trichomoniasis is most often associated with gonorrhea. Gonococcal infection may persist after treatment for trichomoniasis. Newmezole Forte may cause dark urine. Refrain from sexual intercourse during treatment. To prevent reinfection, simultaneous treatment of the sexual partner is necessary. Concomitant use of suppositories with condoms or vaginal diaphragms may reduce the reliability of mechanical contraception. The effectiveness of vaginal spermicides may also be reduced. Use other methods of contraception during treatment and for 5 days after its discontinuation. Do not use Newmezole Forte during menstruation. Metronidazole, which is part of the medicine, can immobilize treponemes, leading to a false-positive Nelson-Mayer test (syphilis test). Children and adolescents The medicine is contraindicated in children and adolescents under 18 years of age. Other medicines and Newmezole Forte Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking: - Ethyl alcohol or medicines containing ethyl alcohol; - Disulfiram (medicine for the treatment of alcohol dependence); - Busulfan, 5-fluorouracil (anticancer drugs); - Oral anticoagulants (warfarin), blood thinners; - Lithium preparations (used to treat mental disorders); - Cyclosporine (used after organ transplantation); - Phenytoin or phenobarbital (anticonvulsant drugs); - Antibiotics (antimicrobial drugs) such as erythromycin, clindamycin, lincomycin; - Antibiotics of the penicillin and cephalosporin groups; - Medicines that inhibit hematopoiesis (the process of formation, development, and maturation of blood cells). Newmezole Forte with food and alcohol Do not consume alcoholic beverages during treatment and for at least 24-48 hours after the end of treatment, due to possible disulfiram-like reactions (redness of the skin of the face and neck, nausea, vomiting, headache, rapid heartbeat). Pregnancy and breastfeeding If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Newmezole Forte is contraindicated during pregnancy and breastfeeding. Driving and operating machinery Since side effects such as confusion, dizziness, drowsiness, hallucinations, seizures, or transient visual disturbances (such as blurred vision or double vision) may occur during the use of the medicine, refrain from driving and operating machinery during treatment. 3. How to use Newmezole Forte Always use this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist. Dosage regimen The recommended daily dose is 1 suppository in the evening, before bedtime, for 12 days. In case of ulcerative cervicitis, the course of treatment is repeated 1-2 times until complete healing of the ulcers, with a 7-day break between courses. In case of vaginitis and cervicitis accompanied by severe inflammatory diseases of infectious origin (pelvic venous congestion syndrome, metroadnexitis, pelvioperitonitis), systemic antibiotics are prescribed on the doctor's recommendation. Special patient groups Children and adolescents The safety and efficacy of the medicine in children and adolescents have not been established, so its use in this age group is not recommended. How to use Vaginally. After removing the suppository from the contour packaging, it should be inserted deep into the vagina while lying on your back, after hygienic treatment of the external genitalia. If you have used more Newmezole Forte than you should If you have taken higher doses than prescribed, overdose of the medicine is unlikely, given the low systemic absorption of the medicine. In case of accidental ingestion of suppositories, symptoms such as vomiting, impaired coordination of movements (ataxia), and mild confusion may occur. In this case, seek immediate medical attention or go to the emergency department of the nearest hospital. If you forget to take Newmezole Forte If you forget to take the next dose, take it as soon as you remember. Do not take a double dose to make up for a missed dose. If you stop using Newmezole Forte Consult your doctor or pharmacist if you wish to stop treatment. If you have any questions about the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, Newmezole Forte can cause side effects, although not everybody gets them. 1) Serious side effects that may occur during treatment: Very rare (may affect up to 1 in 10,000 people): - Severe allergic reactions, manifested by itching, skin rash, hives, painless swelling of the lips, tongue, face or throat, sudden difficulty breathing when speaking or swallowing (angioedema), including anaphylactic shock (sudden severe, sometimes fatal allergic reaction characterized by difficulty breathing, sharp drop in blood pressure, and sudden onset of swelling/puffiness); - Encephalopathy (brain disease), manifested by confusion, fever, headache, hallucinations, paralysis, hypersensitivity to light, visual field and eye movement disorders, neck muscle stiffness; - Subacute cerebellar syndrome (manifested by impaired coordination of movements (ataxia), speech and gait disorders, nystagmus (rapid, repetitive, and involuntary eye movements), tremor). Frequency not known (cannot be estimated from available data): - Red or purple spots on the skin of the palms and soles, areas resembling hives, sensitive zones around the mouth, eyes, and genitals (erythema multiforme); - Severe skin rash accompanied by itching, blistering in the mouth, throat, eyes, genitals, and other areas of the skin and mucous membranes (Stevens-Johnson syndrome); - Reactions in which large areas of the outer layers of the skin peel off from the deeper layers (toxic epidermal necrolysis); - Nervous system disorders (neuropathy)/optic nerve neuritis; - Aseptic meningitis. If such serious side effects occur, stop using Newmezole Forte and seek immediate medical attention. 2) Other possible side effects: Rare (may affect up to 1 in 1,000 people): - Changes in peripheral blood count detected during blood tests (agranulocytosis, neutropenia, thrombocytopenia, pancytopenia, leukopenia); Very rare (may affect up to 1 in 10,000 people): - Psychotic disorders, including confusion and hallucinations; - Drowsiness, dizziness, seizures, headache; - Transient visual disturbances, such as diplopia (double vision), myopia (decreased distance vision); - Pancreatitis; - Changes in liver function tests (changes in liver enzymes (AST, ALT, alkaline phosphatase), cholestatic or mixed hepatitis, liver damage, sometimes accompanied by jaundice (yellowing of the skin and mucous membranes, whites of the eyes); liver failure requiring liver transplantation has been reported); - Skin rash, pustular rash (vesicles filled with cloudy fluid, pus), itching, facial redness; - Muscle pain (myalgia) and localized joint pain (arthralgia). Frequency not known (cannot be estimated from available data): - Loss of appetite (anorexia); - Depressed mood; - Tingling sensation, numbness, impaired coordination of movements, dizziness (peripheral sensory neuropathy), seizures or transient epileptic seizures; - Hearing impairment/hearing loss (sensorineural hearing loss), ringing in the ears (tinnitus); - Epigastric pain, nausea, vomiting, diarrhea, inflammation of the tongue with a feeling of dry mouth, inflammation of the oral mucosa (stomatitis), taste disturbances (metallic taste), change in tongue color/ "hairy tongue"; - Skin rash that appears in the same place with each application of the medicine (fixed drug eruption); - Dark urine color; - Peeling of the skin in the genital area, itching, skin rash, swelling, erythema, erosion, discomfort, burning sensation, irritation, tingling, pain in the pelvic and vaginal area, vaginal bleeding. 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 package leaflet. By reporting side effects, you are helping to provide more information about the safety of this medicine. 5. How to store Newmezole Forte Keep this medicine out of the sight and reach of children. Store at a temperature not exceeding 25°C. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment. 6. Contents of the packaging and other information Newmezole Forte contains: - Active substances: metronidazole, chloramphenicol, natamycin, hydrocortisone acetate. Each suppository contains 500 mg of metronidazole, 200 mg of chloramphenicol, 100 mg of natamycin, and 15 mg of hydrocortisone acetate. - Other ingredient is: hard fat. Appearance of Newmezole Forte and contents of the packaging Suppositories are cylindrical-conical in shape, with a shiny or matte surface, from light yellow to yellow or light brown. On longitudinal section, the presence of an air and porous core and a funnel-shaped depression is allowed. Newmezole Forte is packed in 7 suppositories in a PVC/PE film contour cell pack. 1 contour cell pack with a package leaflet in a cardboard box. Dispensing rule: Pharmaceutical product group II, dispensed by prescription form №3 See also: Newmezole Vaginal 6 Suppositories