Arilin Rapid

Package Leaflet: Information for the Patient

Arilin rapid, 1000 mg, vaginal capsules

Metronidazole

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Package 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 package 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 and some protozoa, it causes inhibition of nucleic acid synthesis, leading to the death of microorganisms. No cross-resistance with antibiotics has been observed. Arilin rapid is indicated for the treatment of trichomoniasis or non-specific bacterial vaginosis.

2. Important information before using Arilin rapid

When not to use Arilin rapid:

• if the patient is hypersensitive 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 treatment with Arilin rapid, the patient should discuss it with their doctor or pharmacist, especially if they have:

• severe liver dysfunction,
• blood disorders,
• diseases of the central or peripheral nervous system. The doctor will then carefully weigh the risks and benefits of using the medicine.

If the patient experiences any of the following symptoms during treatment with Arilin rapid, they should immediately consult a doctor and stop taking the medicine. See also section 4.

• sudden drop in blood pressure, shortness of breath, dizziness, and vomiting, impaired consciousness, cold sweats, and paleness and coolness of hands and feet. These may be symptoms of a life-threatening anaphylactic shock. Until the doctor arrives, the patient should be laid down with their legs raised, covered with a blanket to prevent hypothermia. The doctor will administer appropriate emergency measures (e.g., antihistamines, corticosteroids, sympathomimetic drugs, and if necessary, 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., special antibiotics or chemotherapeutic agents). The patient should not take drugs that inhibit intestinal motility (peristalsis).
• fever, fatigue, inflammation of the tonsils and oral cavity. These may be symptoms of agranulocytosis. If these symptoms occur, the patient should immediately consult a doctor, who will recommend a blood morphology test.
• feeling of numbness, sensory disturbances, and tingling in the limbs. These may be symptoms of peripheral neuropathy. Immediate medical attention is necessary.

In patients with Cockayne syndrome, cases of severe hepatotoxicity (acute liver failure), including fatal cases, have been reported during treatment with metronidazole. In patients with Cockayne syndrome, the doctor should monitor liver function during and after treatment with metronidazole. If the patient experiences any of the following symptoms, they should immediately inform their doctor and stop taking metronidazole: abdominal pain, loss of appetite, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, sticky 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 damage latex products (e.g., condoms, vaginal caps), thereby reducing their effectiveness.

Arilin rapid and other medicines

The patient should inform 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):

Anticoagulant medicines from the coumarin group (e.g., warfarin, acenocoumarol). The doctor should closely monitor coagulation parameters, as metronidazole increases blood coagulability and may require an increase in the dose of the anticoagulant medicine taken.

Lithium. When used concomitantly with metronidazole, an increase in lithium serum levels has been observed.

Arilin Rapid - PL 1.3.1 Summary of Product Characteristics, Labelling and Package Leaflet Package Leaflet

Page 2 02/10/2024

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 venous 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 concomitantly, the cyclosporine serum level may be elevated. Therefore, cyclosporine and creatinine levels in the serum should be closely monitored. The toxic effect of 5-fluorouracil (a chemotherapeutic agent used in the treatment of cancer) is increased, as its elimination is reduced when administered concomitantly 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) measurements in serum. Concomitant administration of metronidazole with tacrolimus (a medicine that prevents transplant rejection) leads to an increase in tacrolimus levels in the blood. Therefore, tacrolimus levels in the blood and kidney function should be frequently monitored. Concomitant 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 a doctor if they observe symptoms of heart rhythm disorders, such as dizziness, palpitations, or short-term fainting. When administered concomitantly 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 it concomitantly through laboratory tests.

Arilin rapid and alcohol

Alcohol consumed during metronidazole treatment may increase the risk of side effects, such as flushing of the skin and neck, nausea, vomiting, headaches, and dizziness (similar to disulfiram). The patient should not drink alcohol during and within 48 hours after the end of Arilin rapid treatment, as metronidazole administered vaginally may cause symptoms of alcohol intolerance.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a 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.

Arilin Rapid - PL 1.3.1 Summary of Product Characteristics, Labelling and Package Leaflet Package Leaflet

Page 3 02/10/2024

If the patient has taken a single dose of the medicine, breastfeeding should be discontinued for 24 hours, and during this time, milk should be expressed and discarded.

Driving and using 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 also consumes alcohol. Consuming alcohol during metronidazole treatment 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 as directed by the doctor. In case of doubts, the patient should consult a doctor or pharmacist. In primary infections, a single 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.

Using more than the 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 the patient has taken more than the recommended dose of the medicine, they should consult a doctor.

4. Possible side effects

Like all medicines, Arilin rapid can cause side effects, although not everybody gets them. After vaginal administration, only 20% of metronidazole is absorbed into the bloodstream, which is why 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):

• metallic taste in the mouth, bitter taste when belching, 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.

Frequently(occurring in 1 to 10 in 100 patients):

• headaches and dizziness, drowsiness, insomnia, psychotic disorders, including delusions (hallucinations) and confusion, restlessness, depression, coordination disorders (ataxia);

Arilin Rapid - PL 1.3.1 Summary of Product Characteristics, Labelling and Package Leaflet Package Leaflet

Page 5 02/10/2024

• peripheral neuropathy (feeling of numbness, sensory disturbances, 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 forms, they may lead to skin redness, blistering of the skin, allergic rhinitis (hay fever), and allergic conjunctivitis, while in severe forms, they may be life-threatening due to shortness of breath and circulatory disorders;
• dysuria (painful urination), cystitis, urinary incontinence;
• liver function disorders (increased aminotransferase activity and bilirubin levels in the blood);
• fungal infections (Candida)in the genital area;
• muscle weakness, vision disturbances.

Very rarely(occurring in less than 1 in 10,000 patients):

• anaphylactic shock (sudden drop in blood pressure due to hypersensitivity); in severe cases, shortness of breath, dizziness, and vomiting, impaired consciousness, cold sweats, and paleness and coolness of hands and feet may occur; see section 2. Warnings and precautions;
• thrombocytopenia (decrease in platelet count);
• 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 estimated from the 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); Stevens-Johnson syndrome);
• hepatitis, sometimes with jaundice. In patients treated 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 the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. 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

Arilin Rapid - PL 1.3.1 Summary of Product Characteristics, Labelling and Package Leaflet Package Leaflet

Page 6 02/10/2024

Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder. By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store Arilin rapid

The medicine should be stored out of sight and reach of children. Store at a temperature not exceeding 25 °C. Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package 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 fatty acid esters) (contains Polysorbate 65)
• Lecithin.

What Arilin rapid looks like and contents of the package

Arilin rapid is a medicine in the form of beige, torpedo-shaped vaginal capsules. The package contains 2 capsules in a blister pack of PVC/PE or aluminum/LDPE film, in a cardboard box.

Marketing authorization holder and manufacturer

Dr. August Wolff GmbH & Co. KG Arzneimittel Sudbrackstrasse 56 33611 Bielefeld, GERMANY Tel.: +49 521 8808-05 Fax: +49 521 8808-334 E-mail: aw-info@drwolffgroup.com For more detailed information on this medicine, the patient should contact the local representative of the marketing authorization holder. SOLPHARM Sp. z o.o. ul. Zakątek 1 05-270 Marki Tel.: +48 /22/ 616 28 08 E-mail: biuro@solpharm.pl

Arilin Rapid - PL 1.3.1 Summary of Product Characteristics, Labelling and Package Leaflet Package Leaflet

Page 7 02/10/2024

Date of last revision of the package leaflet: October 2024