Arilin Rapid

Leaflet attached to the packaging: information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Arilin Rapid

1000 mg, vaginal capsules

Metronidazole

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

• You should keep this leaflet so that you can read it again if necessary.
• In case of any doubts, you 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 tell their doctor or pharmacist. 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, metronidazole inhibits the synthesis of nucleic acids, leading to the death of microorganisms. No cross-resistance to metronidazole has been observed in microorganisms resistant to antibiotics. Arilin Rapid is indicated for the treatment of 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 other component of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Arilin Rapid, you should discuss it with your doctor or pharmacist, especially if you have:

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

If the patient experiences any of the following symptoms during treatment with Arilin Rapid, they should immediately seek medical help 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 the hands and feet. These may be symptoms of life-threatening anaphylactic shock.

Until the doctor arrives, the patient should be placed in a horizontal position, with their legs raised, covered with a blanket to prevent a drop in body temperature. The doctor will administer appropriate emergency measures (e.g., administer antihistamines, corticosteroids, sympathomimetic agents, 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 using appropriate treatment (e.g., prescribe specific antibiotics or chemotherapeutic agents). You should not take medications that suppress intestinal motility (peristalsis).
• Fever, exhaustion, tonsillitis, and oral cavity inflammation. These may be symptoms of agranulocytosis. After the appearance of these symptoms, you should contact your doctor as soon as possible, who will prescribe 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.

During treatment with metronidazole, cases of severe hepatotoxicity (acute liver failure), including fatal cases, have been reported in patients with Cockayne syndrome. In patients with Cockayne syndrome, the doctor should monitor liver function during and after treatment with metronidazole. You should immediately inform your doctor and stop taking metronidazole if you 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 excluded that it may cause damage to 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

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you 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 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 venous diseases) may increase the concentration of metronidazole in the blood, thereby enhancing its effect and/or side effects.

When metronidazole and cyclosporine (a medicine that suppresses or weakens the immune response) are administered concomitantly, the cyclosporine serum concentration may be increased. 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 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 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.

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. You should consult your doctor if you experience symptoms of heart rhythm disorders, such as dizziness, palpitations, or short-term fainting.

When metronidazole is 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 this 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). You should not drink alcohol during and within 48 hours after the end of Arilin Rapid treatment, as metronidazole may cause symptoms of alcohol intolerance after vaginal administration.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine. Arilin Rapid should not be used during the first trimester of pregnancy (if you could be pregnant, you should have a pregnancy test 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, you should not use Arilin Rapid. If its use is necessary, you should stop breastfeeding. If you have taken a single dose of the medicine, you should stop breastfeeding for 24 hours and discard the expressed milk during this time.

Driving and operating machines

Arilin Rapid may affect your reaction speed and, therefore, your ability to drive and operate machines. The greatest impact may occur at the beginning of treatment and when you consume alcohol concomitantly. 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 your doctor. If you have any doubts, you should consult your 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 per day for two days) is recommended. The capsules should be inserted deep into the vagina, preferably in the evening, while lying on your back with your legs slightly bent.

Using a higher dose of Arilin Rapid than recommended

After oral administration of a dose of up to 15 g of metronidazole, nausea, vomiting, hyperreflexia (increased reflexes), ataxia (impaired 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 you have taken a higher dose of the medicine than recommended, you should consult your 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; 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 belching, coating on the tongue, glossitis (inflammation of the tongue), stomatitis (inflammation of the oral mucosa), abdominal pain, 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, dizziness, drowsiness, insomnia, psychotic disturbances, including delusions (hallucinations) and confusion, restlessness, depression, coordination disorders (ataxia);
• peripheral neuropathy (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);
• drug fever;
• leukopenia (reduced white blood cell count) and granulocytopenia (reduced granulocyte count); the doctor may prescribe blood tests during prolonged treatment;
• anaphylactic reactions (rapidly developing hypersensitivity reactions); in mild forms, they may lead to skin redness, blistering, allergic rhinitis (hay fever), and allergic conjunctivitis; 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 concentration in the blood);
• Candida (fungal) infections in the genital area;
• muscle weakness, vision disturbances.

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, impaired consciousness, cold sweats, and paleness and coolness of the hands and feet may occur; see section 2, Warnings and precautions;
• thrombocytopenia (reduced platelet count);
• agranulocytosis (reduced count of a specific type of white blood cell);
• 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, Stevens-Johnson syndrome, toxic epidermal necrolysis);
• hepatitis, sometimes with jaundice. In patients treated concomitantly 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 you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, you can help gather more information on the safety of this medicine.

5. How to store Arilin Rapid

The medicine should be stored out of sight and reach of children. Do not store above 25°C. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. 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 polyoxyethylene esters of fatty acids) and 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 of PVC/PE or Al/PE foil, in a cardboard box. For more detailed information, you 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:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in Bulgaria, the country of export:20000474

Parallel import authorization number: 336/24

Date of leaflet approval: 09.09.2024

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