CHEMICETINA 500 mg Vaginal Suppository

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1. CHEMICETINA 250 mg vaginal suppositories, 500 mg vaginal suppositories

CHEMICETINA 250 mg vaginal suppositories, 500 mg vaginal suppositories

Chloramphenicol
PHARMACOTHERAPEUTIC CATEGORY:
Gynecological antimicrobials and antiseptics
ATC G01AA05

INDICATIONS AND MODE OF USE
CHEMICETINA is indicated in gynecological infections caused by microorganisms sensitive to
chloramphenicol, even when it comes to mixed bacterial flora: vaginitis, cervicitis, cervico-endometritis.
Introduce deeply into the vagina one suppository, at bedtime, once a day, for about 10 days.
The use, especially if prolonged, of topical products can cause sensitization phenomena, in
such cases it is necessary to interrupt the treatment and adopt a suitable therapy.
Since there is a possibility that the application of these two local preparations, especially for repeated treatments,
may lead to absorption of chloramphenicol, contraindications, side effects, precautionary measures, and warnings reported below must be considered.

CONTRAINDICATIONS
Hypersensitivity to the active ingredient or to any of the excipients. Chloramphenicol is contraindicated in patients
with a history of bone marrow failure.

PRECAUTIONS FOR USE
Limit the administration of the antibiotic to the strictly necessary period, possibly no longer than 2
weeks.
In patients with impaired blood dyscrasia, chloramphenicol should be used with considerable caution, in
any case, in prolonged or repeated therapies, monitor blood dyscrasia frequently, immediately interrupting
treatment if leukocytes fall below 4000 per mmc and granulocytes below 40%; late complications are also possible.
In patients with hepatic or renal insufficiency, considering the reduced ability to metabolize and
eliminate the drug, the dosage should be adjusted on a case-by-case basis.

INTERACTIONS
Inform your doctor or pharmacist if you have recently taken any other medicines, including those without
a prescription.
Avoid, as a precaution, the simultaneous administration of drugs that are suspected of being able to
cause bone marrow depression. Treatment with chloramphenicol, as with other antibiotics, can lead to
superinfections by insensitive bacterial agents or fungi.
In patients treated with tolbutamide and similar drugs, dicoumarol, diphenylhydantoin or phenobarbital, it is
necessary to consider the drug-metabolic interactions existing between these drugs and chloramphenicol
and appropriately modify the respective dosages.

SPECIAL WARNINGS
The administration of chloramphenicol, especially in high doses and prolonged and repeated therapies, can cause
the onset of a serious syndrome of aplastic anemia, sometimes detectable weeks or months after
discontinuation of treatment.
As a precaution, it is therefore advisable not to use chloramphenicol in chemoprophylaxis or in
therapy for trivial infections, events that do not justify such a risk, even if rare.
A decrease in prothrombin levels due to inhibition of vitamin K1-producing intestinal bacterial flora is also possible.
Rare cases of bone marrow hypoplasia following prolonged use of chloramphenicol for topical use have been described.
For this reason, the product should be used for short periods, unless explicitly indicated by the doctor.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
In pregnant women, the product should be administered only in cases of real need, under the direct
control of the doctor.
Particular precautions must be taken during breastfeeding, considering the possibility of toxic effects
on the infant.
Considering the inefficiency of glucuronoconjugation in premature infants and newborns, during pregnancy
and during childbirth, consider that the antibiotic crosses the placental barrier and can sometimes
exert toxic effects on the fetus.

OVERDOSE
In case of accidental ingestion/intake of an excessive dose of Chemicetina, immediately inform
your doctor or go to the nearest hospital.

UNDESIRABLE EFFECTS
Like all medicines, Chemicetina can cause side effects, although not everyone experiences them.
During treatment with chloramphenicol, some of the following side effects may occur:

• 1. Hematological alterations: chloramphenicol can cause bone marrow depression: cases of thrombocytopenia, agranulocytosis, hypoplastic or aplastic anemia have been described; these are generally manifestations related to the dose and reversible upon cessation of treatment; however, in very rare cases, these manifestations can occur without relation to dosages and have an irreversible character (see “Special warnings”).
• 2. Gastrointestinal manifestations: rarely, during treatment with chloramphenicol, nausea, vomiting, glossitis, diarrhea, enterocolitis may occur.
• 3. Neurotoxic manifestations: very rare cases of optic or peripheral neuritis have been reported, generally following high doses, administered for a long time.
• 4. Hypersensitivity reactions: in some cases, fever, skin rashes, anaphylactic reactions have been observed.
• 5. Grey syndrome: this syndrome has been described in premature infants and newborns, which, starting with abdominal distension and progressive pale cyanosis, can also evolve with severe cardiovascular dysfunction and exitus; this justifies what is recommended in the paragraph “Pregnancy and breastfeeding”.

Reporting of adverse reactions
If you experience any side effects, including those not listed in this leaflet, tell your
doctor or pharmacist. Adverse reactions can also be reported directly through the
national reporting system at www.agenziafarmaco.gov.it/it/responsabili . Reporting
of adverse reactions helps to provide more information on the safety of this medicine.

EXPIRY DATE AND STORAGE
Expiry date: See the expiry date printed on the packaging.
The expiry date refers to the product in intact packaging, stored correctly.

Warning: Do not use the medicine after the expiry date printed on the packaging.
Do not store at a temperature above 25°C.
Store in a dry place.

Keep the medicine out of the sight and reach of children.
COMPOSITION
250 mg suppositories
One suppository contains: Active ingredient: Chloramphenicol 250 mg
Excipients: Polyethylene glycol 400; Polyethylene glycol 1500; Polyethylene glycol 6000.

500 mg suppositories
One suppository contains: Active ingredient: 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

A.I.C. HOLDER:Farmitalia S.r.l. – Viale Alcide De Gasperi 165/B- 95127 Catania

PRODUCER:
SPECIAL PRODUCT’S LINE S.p.A. Strada Paduni, 240 – 03012 Anagni (FR)