4.4       Special warnings and special precautions for use

Medical advice should be sought if this is the first time the patient has experienced symptoms of candidal vaginitis.

            Before using Canesten 200mg Pessaries, medical advice must be sought if any of the following are applicable:

            -           More than two infections of candidal vaginitis in the last 6 months.

            -           Previous history of a sexually transmitted disease or exposure to partner with sexually transmitted disease.

            -           Pregnancy or suspected pregnancy.

            -           Aged under 162 or over 60 years.

            -           Known hypersensitivity to imidazoles or other vaginal antifungal products.

            Canesten 200mg Pessaries should not be used if the patient has any of the following symptoms whereupon medical advice should be sought:

            -           Irregular vaginal bleeding

            -           Abnormal vaginal bleeding (vaginal haemorrhage) or a bloodstained 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 (temperature of 38^oC or above) or chills 
 -           Nausea or vomiting.

            -           Diarrhoea.

            -           Foul smelling vaginal discharge.

            -           Back pain.

            -           Associated shoulder pain.

Avoid contact with eyes and do not swallow.

Patients should be advised to consult their physician if the symptoms have not been relieved within one week of using Canesten 200mg Pessaries. The pessaries can be used again if the candidal infection returns after 7 days. However, if the candidal infection recurs more than twice within six months, patients should be advised to consult their physician.

            All possibly infected areas should be treated at the same time.

4.5       Interaction with other medicaments and other forms of interaction

            Laboratory tests have suggested that, when used together, this product may cause damage to latex contraceptives.  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.

Concomitant medication with vaginal clotrimazole and oral tacrolimus (FK-506; immunosuppressant) might lead to increased tacrolimus plasma levels. Patients should thus be thoroughly monitored for symptoms of tacromilus overdosage, if necessary by determination of the respective plasma levels.

 4.8       Undesirable effects

Rarely patients may experience local mild burning immediately after inserting the pessary. Very rarely the patient may find this irritation intolerable and stop treatment.

Other undesirable effects:

Body as a whole:                    allergic reaction (syncope, hypotension, dyspnea, gastrointestinal disorders), pain

            Skin and appendages:                        pruritis, rash

The listed adverse drug reactions are based on spontaneous reports, thus an organisation according to CIOMS III categories is not possible.

Immune system disorders

Allergic reaction (ME) with symptoms such as dyspnea (PT), hypotension (PT),

syncope (PT), and urticaria (ME),

Reproductive system and breast disorders

Vulvovaginal discomfort (PT), edema (PT), burning (PT), genital peeling, irritation, pruritus (ME), pelvic pain (PT), rash (ME)

Gastrointestinal disorders

Abdominal pain (ME)

5.1       Pharmacodynamic properties

            ATC Code: G01A F02

Clotrimazole is an imidazole derivative with a broad spectrum of antimycotic activity.

            Mechanism of Action

Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the cytoplasmic membrane.

Pharmacodynamic Effects

Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc.

Under appropriate test conditions, the MIC values for these types of fungi are in the region of less than 0.062 – 4 (-8.0) mg/ml substrate. The mode of action of clotrimazole is fungistatic or fungicidal depending on the concentration of clotrimazole at the site of infection. In vitro activity is limited to proliferating fungal elements; fungal spores are only slightly sensitive.

In addition to its antimycotic action, clotrimazole also acts on Trichomonas vaginalis, gram-positive microorganisms (streptococci/staphylococci) and gram-negative microorganisms (Bacteroides/Gardnerella vaginalis).  It has no effect on lactobacilli.

            In vitro, clotrimazole inhibits the multiplication of Corynebacteria and gram-positive cocci – with the exception of enterococci – in concentrations of 0.5 – 10 mg/ml substrate and exerts a trichomonacidal action at 100 mg/ml.

            Primarily resistant variants of sensitive fungal species are very rare; the development of secondary resistance by sensitive fungi has so far only been observed in very isolated cases under therapeutic conditions.

6.6.            Instructions for use and handling Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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*Note: the diagram from section 6.6 has also been removed