CHEMICETINA
ItalyThe drug is indicated for gynecological infections caused by microorganisms sensitive to chloramphenicol, such as vaginitis, cervicitis, and cervico-endometritis.
Frequently asked questions
How should Chemicetina ovules be administered?
One ovule must be inserted deeply into the vagina once a day, at bedtime, for approximately 10 days.
When should this drug not be used?
It must not be taken by those allergic to the active substance or other components, or by those with a history of bone marrow failure.
What are the side effects of Chemicetina?
Blood changes (such as anemia or reduction of white blood cells and platelets), gastrointestinal problems (nausea, vomiting, diarrhea), hypersensitivity reactions (fever, skin rashes) and, in very rare cases, neurological problems may occur.
Are there risks during pregnancy or breastfeeding?
Yes, the active substance can pass through the placenta and have toxic effects on the fetus; during breastfeeding, attention must be paid to the possibility of toxic effects on the newborn. It is necessary to consult a doctor before use.
Can I take other medicines together with this product?
It is important to inform the doctor of any other medication taken, including non-prescription drugs. Drugs that can affect the bone marrow should be avoided, and caution should be exercised if taking tolbutamide, dicumarol, diphenylhydantoin, or phenobarbital.
What happens if an excessive dose is taken?
In case of accidental ingestion of an excessive dose, it is necessary to immediately inform a doctor or go to the nearest hospital.
Instructions for use
CHEMICETINA 250 mg suppositories
CHEMICETINA 500 mg suppositories
Chloramphenicol
THERAPEUTIC PHARMACOLOGICAL CATEGORY:
Gynaecological antimicrobials and antiseptics
ATC G01AA05
INDICATIONS AND METHOD OF USE
CHEMICETINA is indicated in gynaecological infections caused by microorganisms sensitive to chloramphenicol, including mixed bacterial flora: vaginitis, cervicitis, cervico-endometritis.
Insert one suppository deeply into the vagina at bedtime, once daily for approximately 10 days.
The use, especially prolonged, of topical products may lead to sensitization phenomena; in such cases treatment must be discontinued and appropriate therapy initiated.
Since there is a possibility that the application of these topical preparations, particularly with repeated treatments, may result in absorption of chloramphenicol, the contraindications, side effects, precautionary measures, and warnings described below must be taken into account.
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients. Chloramphenicol is contraindicated in patients with a history of bone marrow failure.
PRECAUTIONS FOR USE
Limit administration of the antibiotic to the strictly necessary period, preferably not exceeding 2 weeks.
In patients with impaired blood counts, chloramphenicol should be used with great caution. In any case, during prolonged or repeated therapy, blood counts should be monitored frequently, and treatment must be immediately discontinued if white blood cell counts fall below 4,000 per mm³ and granulocytes below 40%.
Late complications may also occur.
In patients with hepatic or renal insufficiency, due to reduced capacity to metabolize and eliminate the drug, dosage should be adjusted on an individual basis.
INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicinal products, including those without a prescription.
As a precautionary measure, avoid concomitant administration of drugs suspected of causing bone marrow depression. Treatment with chloramphenicol, as with other antibiotics, may lead to superinfections caused by bacteria resistant to the drug or by fungi.
In patients receiving tolbutamide and similar drugs, dicumarol, diphenylhydantoin, or phenobarbital, potential drug-metabolic interactions between these drugs and chloramphenicol must be considered, and respective dosages adjusted accordingly.
SPECIAL WARNINGS
Administration of chloramphenicol, especially at high doses and during prolonged or repeated treatments, may cause the onset of severe aplastic anaemia, which may manifest weeks or months after discontinuation of treatment.
As a precautionary measure, chloramphenicol should therefore not be used for chemoprophylaxis or for the treatment of trivial infections, conditions which do not justify such a risk, even if rare.
A decrease in prothrombin levels may also occur due to inhibition of intestinal bacterial flora producing vitamin K1.
Rare cases of bone marrow hypoplasia have been reported following prolonged use of topical chloramphenicol.
For this reason, the product should be used only for short periods, unless otherwise directed by a physician.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
In pregnant women, the product should be administered only when clearly needed and under direct medical supervision.
Particular caution should be exercised during breastfeeding, considering the possibility of toxic effects on the infant.
Due to the immaturity of glucuronidation in premature infants and newborns, and during pregnancy and childbirth, it should be borne in mind that the antibiotic crosses the placental barrier and may occasionally exert toxic effects on the foetus.
OVERDOSE
In case of accidental ingestion/overdose of Chemicetina, contact your doctor immediately or go to the nearest hospital.
UNDESIRABLE EFFECTS
Like all medicines, Chemicetina can cause side effects, although not everybody will experience them.
During treatment with chloramphenicol, some of the following adverse reactions may occur:
- Haematological disorders: Chloramphenicol may cause bone marrow suppression. Cases of thrombocytopenia, agranulocytosis, hypoplastic or aplastic anaemia have been reported. These are generally dose-related effects and reversible upon discontinuation of treatment. However, in very rare cases, these manifestations may occur unrelated to dosage and may be irreversible (see "Special Warnings").
- Gastrointestinal manifestations: Rarely, nausea, vomiting, glossitis, diarrhoea, enterocolitis may occur during chloramphenicol treatment.
- Neurotoxic manifestations: Very rare cases of optic or peripheral neuritis, usually following high doses administered over long periods, have been reported.
- Hypersensitivity reactions: In some cases, fever, skin rashes, anaphylactic phenomena have been observed.
- Grey syndrome: In premature infants and newborns, this syndrome has been described, beginning with abdominal distension and progressive pale cyanosis, potentially progressing to severe cardiovascular dysfunction and death. This supports the recommendations provided in the section "Pregnancy and breastfeeding".
Adhering to the instructions provided in the package leaflet reduces the risk of adverse effects.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. Adverse reactions may also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting adverse reactions helps provide more information on the safety of this medicinal product.
EXPIRY DATE AND STORAGE
Expiry date: See the date printed on the packaging.
The expiry date refers to the product in its original, unopened packaging, stored correctly.
Caution: Do not use the medicine after the expiry date stated on the packaging.
Do not store above 25°C.
Store in a dry place.
Keep this medicine out of sight and reach of children.
COMPOSITION
250 mg suppositories
One suppository contains:
Active substance: Chloramphenicol 250 mg
Excipients: Polyethylene glycol 400; Polyethylene glycol 1500; Polyethylene glycol 6000.
500 mg suppositories
One suppository contains:
Active substance: Chloramphenicol 500 mg
Excipients: Polyethylene glycol 400; Polyethylene glycol 1500; Polyethylene glycol 6000.
PHARMACEUTICAL FORM AND CONTENT:
250 mg suppositories – 3 suppositories
500 mg suppositories – 3 suppositories
MARKETING AUTHORISATION HOLDER: Farmitalia S.r.l.
Via Pinciana 25
00198 Rome
MANUFACTURER:
SPECIAL PRODUCT’S LINE S.p.A.
via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)
The original data is available in the language of the country of manufacture.
Data source: Italian Medicines Agency (AIFA)
Data last verified: September 21, 2026