Clothree

/ Teva

One vaginal tablet in the evening before bedtime, to be inserted as deep as possible into the vagina, for three consecutive nights. This is best achieved when lying back with the legs up.
Notes: Treatment during the menstrual period should not be performed. The treatment should be finished before the onset of menstruation. The sexual partner should also undergo local treatment if symptoms, e.g. pruritus, inflammation, etc. are present.

Infections in external female genital organs and vagina caused by clotrimazole-sensitive microorganisms such as fungi (Candida albicans) and Trichomonas.
During treatment of vaginitis caused by Trichomonas, this medical product must be combined with an oral trichomonacide.

Known hypersensitivity to clotrimazole or to any ingredient of the preparation.

Abnormal vaginal bleeding or a blood-stained discharge. Vulval or vaginal ulcers, blisters or sores. Lower abdominal pain or dysuria. Any adverse events such as redness, irritation or swelling associated with the treatment. Fever or chills. Nausea or vomiting. Diarrhoea. Foul (disgusting) smelling vaginal discharge. Patients should be advised to consult their physician if the symptoms have not been relieved within 3 days. This product may reduce the effectiveness and safety of latex products such as condoms and diaphragms. The effect is temporary and occurs only during treatment.
Use in Pregnancy: While controlled clinical studies in pregnant women do not exist, epidemiological investigations give no indication that harmful effects on the mother and child should be anticipated when clotrimazole is used during pregnancy. However, as with all drugs in the first 3 months of pregnancy, this product should only be used after first consulting a doctor. Sanitation of the birth canal should be ensured particularly during the last 4-6 weeks of pregnancy.
Use during Lactation: It is not known whether this drug is excreted in human milk. Therefore, the riskbenefit must be considered when administering this drug to nursing mothers.
Use in Geriatrics: Appropriate studies on the relationship of age on the effects of vaginal azoles have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date.

Rarely patients may experience local mild burning or irritation immediately after inserting the pessary. Very rarely the patient may find this intolerable and stop treatment. Other undesirable effects include: Body as a whole: allergic reactions (syncope, hypotension, dyspnea, gastrointestinal disorders, swelling of the lips, face or tongue, or hives), pain Skin and appendages: pruritis, rash, redness, irritation, blistering, vaginal burning, itching, discharge, or other irritation not present before therapy .

Laboratory tests have suggested that, when used together, this product may cause damage to latex contraceptives (see Warnings). Consequently the effectiveness of such contraceptives may be reduced. Patients should be advised to use alternative precautions for at least five days after using this product.

Pregnancy: While controlled clinical studies in pregnant women do not exist, epidemiological investigations give no indication that harmful effects on the mother and child should be anticipated when clotrimazole is used during pregnancy. However, as with all drugs in the first 3 months of pregnancy, this product should only be used after first consulting a doctor. Sanitation of the birth canal should be ensured particularly during the last 4-6 weeks of pregnancy.
Lactation: It is unknown whether this drug is excreted in human milk. Absorption into the bloodstream is very low, it’s unlikely to cause a systemic adverse effect. This medical product can be used during breastfeeding.

In the event of accidental oral ingestion, routine measures such as gastric lavage should be performed only if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting). It should be carried out only if the airway can be protected adequately.