Arilin rapid

Leaflet attached to the packaging: information for the patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Arilin rapid, 1000 mg, vaginal capsules

Metronidazole

The patient should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Arilin rapid and what is it used for
• 2. Important information before using Arilin rapid
• 3. How to use Arilin rapid
• 4. Possible side effects
• 5. How to store Arilin rapid
• 6. Contents of the packaging and other information

1. What is Arilin rapid and what is it used for

Arilin rapid is a medicine in the form of vaginal capsules containing metronidazole - a chemotherapeutic agent from the nitroimidazole group. In susceptible anaerobic bacteria, as well as in some protozoa, after its administration, there is an inhibition of nucleic acid synthesis, and thus the death of microorganisms. It has not been found that microorganisms resistant to antibiotics are also resistant to metronidazole (there is no cross-resistance). Arilin rapid is indicated for use in trichomoniasis or non-specific bacterial vaginitis.

2. Important information before using Arilin rapid

When not to use Arilin rapid:

• if the patient is allergic to metronidazole, other 5-nitroimidazole derivatives, soy, peanuts, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Arilin rapid, the patient should discuss it with their doctor or pharmacist, especially if they have:

• severe liver failure,
• blood disorders,
• diseases of the central or peripheral nervous system. The doctor will then carefully weigh the risk of using the medicine against the potential benefits.

If the patient experiences any of the following symptoms during the use of Arilin rapid, they should immediately seek medical help and stop taking the medicine. See also section 4. Possible side effects.

• Sudden drop in blood pressure, shortness of breath, dizziness, and vomiting, disturbances of consciousness, cold sweats, and paleness and coldness of hands and feet. These may be symptoms of a life-threatening anaphylactic shock. Until the doctor arrives, the patient should be laid down in a horizontal position, with their legs raised upwards, covered with a blanket to prevent a drop in body temperature. The doctor will administer appropriate emergency measures (e.g., administer antihistamines, corticosteroids, sympathomimetic drugs, and, if necessary, provide respiratory support).
• Severe, prolonged diarrhea, occurring during and within a few weeks after the end of treatment. This may be a symptom of pseudomembranous colitis (a severe intestinal disease, usually caused by Clostridium difficile bacteria). This disease, associated with the use of antibiotics, can be life-threatening and requires immediate medical attention. The doctor will consider the use of appropriate treatment (e.g., prescribe specific antibiotics or chemotherapeutic agents). The patient should not take drugs that suppress intestinal movements (peristalsis).
• Fever, exhaustion, inflammation of the tonsils and oral cavity. These may be symptoms of agranulocytosis. If these symptoms occur, the patient should contact their doctor as soon as possible, who will prescribe a blood morphology test.
• Feeling of numbness, disturbances of sensation, and tingling in the limbs. These may be symptoms of peripheral neuropathy. Immediate medical attention is necessary.

During the use of metronidazole in patients with Cockayne syndrome, cases of severe hepatotoxicity (acute liver failure), including cases resulting in death, have been reported. In patients with Cockayne syndrome, the doctor should monitor liver function during and after treatment with metronidazole. The patient should immediately inform their doctor and stop taking metronidazole if they experience any of the following symptoms: abdominal pain, loss of appetite, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, clay-colored or loose stools, or skin itching. Metronidazole should not be used for more than 10 days, except in special situations. Treatment may be repeated very rarely, as it cannot be ruled out that it may damage human primary sex cells. Additionally, in animal studies, the development of various tumors has been observed. Arilin rapid may cause damage to latex products (e.g., condoms, vaginal caps), thereby reducing their effectiveness.

Arilin rapid and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The following interactions have been observed after systemic administration of metronidazole (oral, rectal, or intravenous). Blood thinners from the coumarin group (e.g., warfarin, acenocoumarol). The doctor should carefully monitor coagulation parameters, as metronidazole increases blood coagulability and may require an increase in the dose of the blood thinner. Lithium. During concurrent use with metronidazole, an increase in lithium serum concentration has been observed. Barbiturates and phenytoin reduce the effectiveness of metronidazole. Cimetidine may, in individual cases, affect the elimination of metronidazole from the body, thereby increasing its serum concentration. After administration of silymarin/silibinin (active substances used in the treatment of liver poisoning), a decrease in the effectiveness of Arilin rapid has been observed. Medicines containing diosmin (an active substance used in the treatment of vein diseases) may increase the concentration of metronidazole in the blood, thereby enhancing its effect and/or side effects. When cyclosporine (a medicine that suppresses or weakens the immune response) and Arilin rapid are administered concurrently, the cyclosporine serum concentration may be elevated. Therefore, cyclosporine and creatinine serum levels should be closely monitored. The toxic effect of 5-fluorouracil (a chemotherapeutic agent used in the treatment of tumors) is increased, as its elimination is reduced when administered concurrently with Arilin rapid. The toxic effect of busulfan (a chemotherapeutic agent) may be significantly enhanced. Effect on the results of some laboratory tests. Metronidazole may decrease the results of aspartate aminotransferase (AST) activity measurements in serum. Concurrent administration of metronidazole and tacrolimus (a medicine that prevents transplant rejection) leads to an increase in tacrolimus blood concentration. Therefore, tacrolimus blood concentration and kidney function should be frequently monitored. Concurrent use of metronidazole and amiodarone (a medicine used in the treatment of heart rhythm disorders) may affect heart function. Therefore, heart function should be regularly monitored by performing an ECG. The patient should consult their doctor if they observe symptoms of heart rhythm disorders, such as dizziness, palpitations, or short-term fainting. When metronidazole is administered concurrently with antibiotics, the availability of mycophenolate mofetil (a medicine that suppresses the immune system) in the body may be reduced. Therefore, it is recommended to monitor this concurrently through laboratory tests.

Arilin rapid and alcohol

Alcohol consumed during the use of metronidazole may increase the risk of side effects, such as flushing of the skin and neck, nausea, vomiting, headaches, and dizziness (an effect similar to disulfiram). The patient should not drink alcohol during and within 48 hours after the end of Arilin rapid treatment, as signs of alcohol intolerance may occur after vaginal administration of metronidazole.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine. Arilin rapid should not be used during the first trimester of pregnancy (if the woman could be pregnant, a pregnancy test should be performed before starting treatment). In the second and third trimesters of pregnancy, Arilin rapid can be used only if, in the doctor's opinion, it is necessary, and other treatment methods are ineffective or contraindicated. During breastfeeding, Arilin rapid should not be used. If its use is necessary, breastfeeding should be discontinued. If the patient has taken a single dose of the medicine, breastfeeding should be discontinued for 24 hours, and the milk should be expressed and discarded during this time.

Driving and operating machines

Arilin rapid may affect reaction speed and, consequently, the ability to drive vehicles and operate machines. The greatest impact may occur at the beginning of treatment and when the patient concurrently consumes alcohol. Consuming alcohol during the use of metronidazole may increase the risk of side effects, such as flushing of the skin and neck, nausea, vomiting, headaches, and dizziness.

3. How to use Arilin rapid

This medicine should always be used according to the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist. In primary infections, the administration of one capsule (i.e., 1000 mg of metronidazole) is sufficient. In severe and recurrent infections, a two-day treatment (one capsule for two days) is recommended. The capsules should be inserted deep into the vagina, preferably in the evening, lying on the back with slightly bent legs.

Use of a higher than recommended dose of Arilin rapid

After oral administration of a dose of up to 15 g of metronidazole, nausea, vomiting, hyperreflexia (increased reflexes), ataxia (loss of coordination), tachycardia (rapid heart rate), shortness of breath, and confusion have been observed. No deaths have been reported. There is no specific antidote. Complete disappearance of symptoms has been observed after a few days of symptomatic treatment. If a higher than recommended dose of the medicine is taken, the patient should consult their doctor.

4. Possible side effects

Like all medicines, Arilin rapid can cause side effects, although they do not occur in every patient. After vaginal administration, only 20% of metronidazole is absorbed into the bloodstream; therefore, side effects during treatment with Arilin rapid are rare. The following side effects have been observed during systemic administration of metronidazole (oral, rectal, or intravenous).

• Frequent(occurred in 1 to 10 out of 100 patients): metallic taste in the mouth, bitter taste when burping, coating on the tongue, inflammation of the tongue, inflammation of the oral mucosa, pressure in the stomach, nausea, vomiting, loss of appetite, diarrhea;
• darkening of urine (caused by a metronidazole metabolite). This change has no clinical significance.

Infrequent(occurred in 1 to 10 out of 1000 patients):

• headaches and dizziness, drowsiness, insomnia, psychotic disorders, including delusions (hallucinations) and confusion, restlessness, depression, coordination disorders (ataxia);
• peripheral neuropathy (feeling of numbness, disturbances of sensation, and tingling in the limbs) and seizures; see section 2. Warnings and precautions;
• skin reactions (e.g., itching, urticaria with blisters and bubbles - urticarial rash);
• drug fever;
• leukopenia (decrease in the number of white blood cells in the peripheral blood) and granulocytopenia (decrease in the number of granulocytes in the peripheral blood) - for this reason, the doctor may recommend blood tests during longer administration of the medicine;
• anaphylactic reactions (rapidly developing hypersensitivity reactions); in mild form, they may lead to skin redness, blistering, and allergic rhinitis (hay fever) and allergic conjunctivitis, in severe form - they may be life-threatening due to shortness of breath and circulatory disorders;

Rare(occurred in less than 1 out of 1000 patients):

• difficulty urinating, inflammation of the bladder, urinary incontinence;
• liver function disorders (increased activity of aminotransferases and bilirubin concentration in the blood);
• fungal infections (Candida) in the genital area;
• muscle weakness, vision disorders;

Very rare(occurred in less than 1 out of 10,000 patients):

• anaphylactic shock (sudden drop in blood pressure due to hypersensitivity); in severe cases, shortness of breath, dizziness, and vomiting, disturbances of consciousness, cold sweats, and paleness and coldness of hands and feet may occur; see section 2. Warnings and precautions;
• thrombocytopenia (decrease in the number of platelets);
• agranulocytosis (lack of a specific type of white blood cells);
• pancreatitis;
• pseudomembranous colitis (a severe intestinal disease, characterized by persistent diarrhea); see section 2. Warnings and precautions;
• allergic reactions caused by 3-sn-phosphatidylcholine (from soybeans) - a component of the lecithin contained in the capsules;
• joint pain;

Frequency not known(cannot be determined based on available data):

• atypical brain changes, cerebellar syndrome [e.g., speech impairment, gait disturbances, involuntary eye movements (nystagmus), and seizures];
• severe skin reactions with life-threatening general reactions (e.g., erythema multiforme; toxic epidermal necrolysis (Lyell's syndrome));
• hepatitis, sometimes with jaundice. In patients treated concurrently with other antibiotics, cases of liver failure requiring liver transplantation have been reported;
• Acute liver failure in patients with Cockayne syndrome (see section 2 "Warnings and precautions").

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Arilin rapid

The medicine should be stored in a place invisible and inaccessible to children. It should not be stored at a temperature above 25°C. The medicine should not be used after the expiration date stated on the packaging. The expiration date indicates the last day of the specified month. Medicines should not be disposed of in the sewage system or household waste containers. The patient should ask their pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Arilin rapid contains

• The active substance of the medicine is metronidazole. One capsule contains 1000 mg of metronidazole.
• The other ingredients are: glycerol trialkanoate (a mixture of mono-, di-, and triglycerides of saturated fatty acids and polyoxyethylated esters of fatty acids), lecithin.

What Arilin rapid looks like and what the packaging contains

Arilin rapid is a medicine in the form of beige, torpedo-shaped vaginal capsules. The packaging contains 2 capsules in a blister pack and a leaflet. For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Dr August Wolff GmbH & Co. KG Arzneimittel, Sudbrackstrasse 56, 33611 Bielefeld, Germany

Manufacturer:

Dr August Wolff GmbH & Co. KG Arzneimittel, Sudbrackstrasse 56, 33611 Bielefeld, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Marketing authorization number in Bulgaria, the country of export: 20000474

Parallel import authorization number: 133/23

Date of leaflet approval:07.07.2023
[Information about the trademark]