Arilin® 500 mg

Arilin® 500 mg film-coated tablets contain the active ingredient metronidazole. It belongs to the nitroimidazole antibiotics and works against single-celled parasites (protozoa) and certain bacteria.

Arilin® is used for conditions including trichomoniasis and bacterial infections of the vagina (bacterial vaginosis). Trichomoniasis is caused by the single-celled parasite Trichomonas vaginalis and is transmitted almost exclusively through sexual intercourse. It mainly causes inflammation of the vagina and of the male urethra.

With trichomoniasis, the partner often carries the pathogens as well, even without symptoms. The partner should therefore be treated at the same time, and sexual intercourse should be avoided during treatment.

Inside the cells of the pathogens, metronidazole is converted into reactive breakdown products. These damage the genetic material of the parasites and bacteria, which then die. Metronidazole is effective against protozoa such as Trichomonas vaginalis and against bacteria that live without oxygen (anaerobes).

Arilin® 500 mg is used in adults, adolescents and children aged 6 years and older, including for:

• trichomoniasis
• bacterial infections of the vagina (bacterial vaginosis)
• amebiasis and giardiasis
• infections with anaerobes, e.g. originating from the female reproductive organs

Not suitable:

• Film-coated tablets, which must be swallowed whole, are not suitable for children under 6 years

General (adults and adolescents over 12 years):

• Daily dose between 250 mg and 2000 mg (½ to 4 film-coated tablets), usually divided into two to three doses
• At 1 film-coated tablet (500 mg) daily or less: treatment for 5 to 7 days
• At 2 to 4 film-coated tablets daily (1 to 2 g): a short treatment of 1 to 3 days may be sufficient

Trichomoniasis and bacterial vaginosis:

• can also be treated in adults with a single dose of 4 film-coated tablets (2 g metronidazole)

Children aged 6 to 12 years:

• Special dosage recommendations apply to children. The dose depends on the condition being treated and on age or body weight and is determined by your doctor.

Duration of treatment:

• usually no longer than 10 days
• the dose and duration are determined by your doctor

How to take:

• Swallow the film-coated tablets whole, without chewing, with sufficient liquid during or after a meal.

Important:

• Do not drink alcohol during treatment — facial flushing, nausea, vomiting, headache and dizziness may occur.
• In case of trichomoniasis, have your partner treated as well and avoid sexual intercourse until the end of treatment.
• Take a missed dose later the same day. If you only notice it the next day, discuss with your doctor whether the treatment should be extended by one day. Do not take a double dose.
• Do not stop the treatment early.

Arilin® must not be taken:

• if you are allergic to metronidazole, other 5-nitroimidazoles, wheat starch or any of the other ingredients (exceptions only in the case of a life-threatening infection when other medicines do not work)

Discuss with your doctor beforehand if you have:

• kidney or liver damage
• disorders of blood formation
• diseases of the brain, spinal cord or nerves
• Cockayne syndrome (risk of severe liver damage)

Pregnancy and breastfeeding: During pregnancy, especially in the first three months, only if your doctor considers it absolutely necessary. Metronidazole passes into breast milk: do not breastfeed during treatment; after a single dose, interrupt breastfeeding for 24 hours and express the milk.

Seek medical help immediately and stop taking the medicine if you have:

• severe, persistent diarrhea, including in the weeks after treatment
• a sudden severe allergic reaction, shortness of breath, swelling of the airways
• severe skin reactions with blisters or peeling of the skin
• fever, exhaustion, inflammation of the tonsils or the lining of the mouth (possible severe decrease in white blood cells)
• numbness or tingling in the arms and legs

Common (up to 1 in 10 people treated):

• taste disturbances such as a metallic taste, bitter belching, coated tongue, inflammation of the tongue or the lining of the mouth
• stomach pressure, nausea, vomiting, loss of appetite, diarrhea
• dark-colored urine

Uncommon (up to 1 in 100 people treated):

• headache, dizziness, drowsiness, sleep disturbances
• skin rash, itching, hives
• fungal infections in the genital area
• temporary visual disturbances
• tiredness

The complete list can be found in the package leaflet.

Tell your doctor if you are taking:

• disulfiram — confusion and mental disturbances possible
• anticoagulants (e.g. warfarin) — their effect may be increased
• lithium, cyclosporine, tacrolimus, busulfan or 5-fluorouracil — their blood levels or side effects may increase
• amiodarone — heart rhythm may be affected
• barbiturates, phenytoin or silymarin/silibinin — may weaken the effect of Arilin®
• cimetidine or diosmin — may increase the effect of Arilin®
• mycophenolate mofetil — its effect may decrease

Alcohol: Avoid while taking this medicine.