Arilin rapid

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Arilin rapid, 1000 mg, globules
Metronidazolum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. 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 adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

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

Arilin rapid is a medicine in the form of vaginal globules containing metronidazole –
a chemotherapeutic agent belonging to the nitroimidazole group. In susceptible anaerobic bacteria and certain protozoa, metronidazole inhibits nucleic acid synthesis, leading to microbial cell death. Resistance to antibiotics has not been shown to confer resistance to metronidazole (i.e., no cross-resistance occurs).
Arilin rapid is indicated for the treatment of trichomoniasis or nonspecific 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 treatment with Arilin rapid, consult your doctor or pharmacist,
especially if the patient has:

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

If any of the following symptoms occur during treatment with Arilin rapid,
seek immediate medical help and discontinue the medicine. See also section 4.
Possible adverse effects.

• Sudden drop in blood pressure, shortness of breath, dizziness, vomiting, disturbances in consciousness, cold sweats, and pallor and coldness of hands and feet. These may be symptoms of life-threatening anaphylactic shock. Until medical help arrives, place the patient in a horizontal position with legs raised, cover with a blanket to prevent loss of body heat. The doctor will initiate appropriate emergency measures (e.g. administer antihistamines, corticosteroids, sympathomimetic drugs, and if necessary, provide respiratory support).
• Severe, prolonged diarrhoea occurring during or within the first few weeks after treatment. This may be a symptom of pseudomembranous colitis (a serious intestinal disease, most commonly caused by Clostridium difficile bacteria). This antibiotic-associated condition may be life-threatening and requires immediate medical attention. The doctor will consider appropriate treatment (e.g. recommend specific antibiotics or chemotherapeutic agents). Do not take drugs that inhibit intestinal motility (peristalsis).
• Numbness, sensory disturbances, and tingling in the limbs. These may be symptoms of peripheral neuropathy. Immediate medical help is required.
• Fever, exhaustion, tonsillitis, and oral inflammation. These may be symptoms of agranulocytosis. If any of the above symptoms occur, contact the doctor as soon as possible. The doctor will recommend a blood count test.

During treatment with metronidazole-containing medicines in patients with Cockayne syndrome,
cases of severe hepatotoxicity (acute liver failure), including fatal cases, have been reported.
In patients with Cockayne syndrome, the doctor should monitor liver function during and after
metronidazole treatment.
Inform the doctor immediately and discontinue metronidazole if the patient experiences any of the
following symptoms: abdominal pain, loss of appetite, nausea, vomiting, fever, malaise, fatigue,
jaundice, dark urine, pale or loose stools, or skin itching.
Metronidazole should not be used for longer than 10 days, except in special circumstances.
Treatment may be repeated very rarely, as damage to human germ cells cannot be excluded.
Furthermore, tumour development has been observed in animal studies.
Arilin rapid may damage latex-containing products (e.g. condoms, vaginal caps), thereby reducing
their effectiveness.

Arilin rapid and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
The following interactions have been observed after systemic administration of metronidazole
(oral, rectal, or intravenous).

Anticoagulants of the coumarin group (e.g. warfarin, acenocoumarol). The doctor should carefully monitor coagulation parameters, as metronidazole increases blood coagulability and it may be necessary to increase the dose of the anticoagulant.

Lithium. Increased serum lithium concentrations have been observed during concomitant use with metronidazole.

Barbiturates and phenytoin reduce the effectiveness of metronidazole.

Cimetidine may, in individual cases, affect the elimination of metronidazole from the body and thereby increase metronidazole serum concentrations.

Administration of silymarin/silibinin (active substances used in the treatment of liver poisoning) reduces the effectiveness of Arilin rapid.

Medicines containing diosmin (active substance used in the treatment of venous disorders) may increase metronidazole blood concentrations and consequently intensify the effect and (or) adverse effects of Arilin rapid.

Concomitant administration of cyclosporine (a medicine that suppresses or weakens the immune response) and Arilin rapid may increase serum cyclosporine concentrations. Therefore, serum cyclosporine and creatinine levels should be closely monitored.

The toxic effect of 5-fluorouracil (a chemotherapeutic agent used in cancer treatment) increases, as excretion of 5-fluorouracil is reduced when administered concomitantly with Arilin rapid.

The toxic effect of busulfan (a chemotherapeutic agent) may be significantly enhanced.

Effect on results of certain laboratory tests. Metronidazole may reduce serum aspartate aminotransferase (AspAT) enzyme activity measurements.

Concomitant administration of metronidazole and tacrolimus (a medicine used to prevent organ transplant rejection) leads to increased blood concentrations of tacrolimus. Therefore, blood tacrolimus levels and kidney function should be monitored frequently.

Concomitant use of metronidazole and amiodarone (a medicine used to treat cardiac arrhythmias) may affect heart function. Therefore, heart function should be monitored regularly with ECG. Consult a doctor if the patient experiences symptoms of cardiac arrhythmia, such as dizziness, palpitations, or brief fainting.

When administered concomitantly with antibiotics, the bioavailability of mycophenolate mofetil (a medicine that suppresses immune system activity) may be reduced. Therefore, concomitant monitoring through laboratory tests is recommended.

Arilin rapid and alcohol
Alcohol consumption during metronidazole treatment may increase the risk of adverse effects such as flushing of the skin and neck, nausea, vomiting, headache, and dizziness (a disulfiram-like reaction).
The patient should not drink alcohol during treatment and for 48 hours after discontinuation of Arilin rapid, as symptoms of alcohol intolerance may occur after vaginal administration of metronidazole.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Arilin rapid should not be used during the first trimester of pregnancy (if pregnancy is possible, a pregnancy test should be performed before starting treatment).
In the second and third trimesters of pregnancy, Arilin rapid may be used only if, in the doctor's opinion, it is necessary and other treatment methods are ineffective or contraindicated.
Arilin rapid should not be used during breastfeeding. If its use is necessary, breastfeeding must be discontinued.
If the patient has taken a single dose of the medicine, breastfeeding should be interrupted for 24 hours, during which time milk should be expressed and discarded.

Driving and operating machinery
Arilin rapid may affect reaction speed and thus the ability to drive vehicles and operate machinery. The greatest effect may occur at the beginning of treatment and when the patient consumes alcohol simultaneously. Alcohol consumption during metronidazole treatment may increase the risk of adverse effects such as flushing of the skin and neck, nausea, vomiting, headache, and dizziness.

3. How to use Arilin rapid

This medicine should always be used as directed by the physician. If in doubt, consult your doctor or pharmacist.
In primary infections, administration of a single globule (i.e. 1000 mg of metronidazole) is sufficient.
In severe and recurrent infections, a two-day course is recommended (one globule per day for two days).
The globules should be inserted deeply into the vagina, preferably in the evening, while lying on the back with knees slightly bent.
Use of a higher than recommended dose of Arilin rapid
After oral administration of doses up to 15 g of metronidazole, nausea, vomiting, hyperreflexia (exaggerated reflexes resulting e.g. from increased nervous system excitability), ataxia (lack of motor coordination, disturbances in body movement coordination), tachycardia (accelerated heart rate), shortness of breath, and confusion have been observed. No cases of death have been reported. No specific antidote is known. Complete resolution of symptoms was observed within a few days of symptomatic treatment.
If a higher than recommended dose of Arilin rapid has been taken, consult a physician.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
After vaginal administration, only 20% of metronidazole passes into the bloodstream; therefore, adverse reactions during treatment with Arilin rapid occur rarely.
The adverse reactions listed below have been observed during systemic administration of metronidazole (oral, rectal, intravenous).

Common (occurred in 1 to 10 out of 100 patients):

• metallic taste in the mouth, bitter taste during burping, coating on the tongue, inflammation of the tongue, inflammation of the oral mucosa, gastric discomfort, nausea, vomiting, loss of appetite, diarrhoea;
• darkening of urine may occur (caused by a metabolite of metronidazole). This change has no clinical significance.

Uncommon (occurred in 1 to 10 out of 1,000 patients):

• headache, dizziness, somnolence, insomnia, psychotic disorders including hallucinations (delusions) and confusion, irritability, depression, disturbances in body movement coordination (ataxia);
• peripheral neuropathy (numbness, sensory disturbances and tingling in limbs) and seizures; see section 2. Warnings and precautions;
• skin reactions (e.g. itching, urticaria with blisters and vesicles – urticarial rash);
• drug fever;
• leukopenia (reduced number of leukocytes in peripheral blood) and granulocytopenia (reduced number of granulocytes in peripheral blood) – for this reason, the doctor may recommend blood tests during prolonged treatment;
• anaphylactic reactions (rapidly developing hypersensitivity reactions); in mild form, they may lead to redness of inflamed skin, formation of blisters on the skin, allergic rhinitis (nasal catarrh) and allergic conjunctivitis; in severe cases, they may be life-threatening due to breathing difficulties and circulatory disturbances;
• dysuria (painful urination), cystitis, urinary incontinence;
• liver function disorders (increased aminotransferase activity and bilirubin concentration in blood);
• fungal infections (Candida) in the genital area;
• weakness (of muscles), visual disturbances;

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

• anaphylactic shock (sudden drop in blood pressure due to hypersensitivity); in severe cases, shortness of breath, dizziness, vomiting, disturbances in consciousness, cold sweats, pallor and coldness of hands and feet may occur; see section 2. Warnings and precautions;
• reduced number of blood platelets (thrombocytopenia);
• absence of a specific type of leukocytes (agranulocytosis);
• pancreatitis;
• pseudomembranous colitis (a severe intestinal disease presenting with persistent diarrhoea); see section 2. Warnings and precautions;
• allergic reactions caused by 3-sn-phosphatidylcholine (from soybean) – a component contained in the lecithin granules;
• joint pain;

Frequency not known (cannot be estimated from available data):

• unusual brain changes, cerebellar syndrome [e.g. speech impairment, gait disturbances, involuntary eye movements (nystagmus) and seizures];
• severe skin reactions with life-threatening systemic reactions (e.g. erythema multiforme; inflammatory skin condition with redness, bullous erythema multiforme (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome));
• hepatitis, sometimes with jaundice. In patients treated simultaneously with other antibiotics, cases of liver failure occurred, necessitating liver transplantation;
• Acute liver failure in patients with Cockayne syndrome (see section 2 "Warnings and precautions").

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Arilin rapid

Keep this medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Arilin rapid contains

• The active substance is metronidazole. Each globule contains 1000 mg of metronidazole.
• The other components are: glyceryl trialkanonate (a mixture of mono-, di- and triglycerides of saturated fatty acids and polyoxyethylene fatty acid esters), lecithin.

What Arilin rapid looks like and contents of the pack
Arilin rapid is a beige, torpedo-shaped vaginal globule. The pack contains 2 globules in a blister and a patient leaflet.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation 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, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Marketing Authorisation number in Bulgaria, the country of export: 20000474
Parallel import licence number: 133/23