Ovix

Leaflet attached to the packaging: patient information

OWIX, 250 mg/5 ml, oral suspension

Pyrantel

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

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Owix and what is it used for
• 2. Important information before taking Owix
• 3. How to take Owix
• 4. Possible side effects
• 5. How to store Owix
• 6. Contents of the pack and other information

1. What is Owix and what is it used for

The active substance of the medicine is pyrantel. Owix is an antiparasitic medicine, intended for children from 2 years of age and adults for the treatment of intestinal infection with pinworms - white, thread-like parasites. The medicine works on the muscles of intestinal parasites. The paralyzed parasites are removed from the intestine as a result of intestinal peristalsis. Pyrantel does not irritate the intestines or cause the migration of worms. It acts on mature forms and parasites in the early stages of development, but does not act on larvae during their migration in tissues.

Indications:

• Pinworm infection

The condition for using the medicine is the confirmation of the presence of pinworms in the stool and/or the anal area. Pinworms are small, white, parasitic worms that live in the intestine. They look like white thread and the females are about 10 mm long. Single pinworms are hard to notice, but when they multiply excessively, white, moving worms are clearly visible in the stool. The presence of pinworms can also be confirmed by examining the anal area of a sleeping child in the evening (best 2 hours after falling asleep, when the process of laying eggs takes place). Pinworms lay a large number of small eggs that are invisible to the naked eye. After ingestion, the eggs travel through the entire digestive system of a human, down to the large intestine, and there they transform into mature individuals within 2-6 weeks. Mature females lay eggs in the anal area, causing persistent itching, leading to constant scratching. As a result, the area becomes irritated and the eggs are transferred to the hands, and then through biting nails or licking fingers to the mouth, i.e., self-infection occurs, or they are transferred to other family members through direct or indirect contact, e.g., towels, bedding, toys, furniture. Symptoms of pinworm infection are mainly observed in children. However, the disease occurs at any age, although children are often the main carriers (parasites can be infected, e.g., in nurseries, kindergartens, sandboxes). If a child has pinworms, it is very easy for other family members to become infected. Pinworm infection manifests as a strong feeling of itching in the anal area (not present in all infected individuals), usually at night, which often causes inflammatory conditions. In children infected with pinworms, irritability, nervousness, insomnia, bedwetting, or abdominal pain and loss of appetite may occur. In girls, it can lead to vulvitis and vaginitis, which manifests as itching, burning, and white discharge. In such cases, you should contact a doctor. It is very important to maintain proper hygiene, especially personal hygiene, to prevent self-infection or transmission of the infection to other people. The following rules should be applied for at least 6 weeks after the end of treatment. Prevention of pinworm infection is primarily:

• thorough and frequent hand washing before each meal preparation or consumption, after using the toilet, after touching the anal area
• thorough washing of vegetables and fruits before consumption
• cutting nails short in children and prohibiting nail biting or finger sucking
• frequent, regular change of underwear (including personal underwear and bedding)
• washing and ironing personal underwear and bedding at high temperatures
• frequent cleaning of rooms in the house, especially bedrooms and bathrooms (pinworm eggs can survive for several weeks in home conditions, especially when maintaining proper humidity and temperature)
• in the case of children, avoiding play in dirty sandboxes
• daily morning hygiene of the anal area
• wearing pajamas, underwear, and in small children, diapers before sleep.

It is important that in the case of parasitic infection, the entire family of the patient should follow increased personal hygiene. Taking into account the frequent collective occurrence of pinworm infection, treatment should be carried out simultaneously in all people living together, and it should be repeated. In case of suspected re-infection, you should contact a doctor.

2. Important information before taking Owix

When not to take Owix

• If the patient is allergic to pyrantel or any of the other ingredients of this medicine (listed in section 6).
• If the patient is taking piperazine.
• If the patient is being treated for myasthenia (a disease of skeletal muscles).

Warnings and precautions

Before starting treatment with Owix, discuss it with your doctor

• if the child is under 2 years of age
• if the patient has liver function disorders
• if the patient is malnourished or has anemia.

If the above warnings apply to the patient currently or are related to situations that have occurred in the past, they should contact their doctor.

Owix and other medicines

Tell your doctor about all medicines the patient is taking, has recently taken, or plans to take.

• The medicine may increase the concentration of theophylline (used in the treatment of asthma) in the blood.
• The medicine should not be taken at the same time as piperazine, as the effect of both medicines may be weakened.

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 taking this medicine. Pregnancy It is not recommended to take Owix during pregnancy. If treatment is necessary, they should contact their doctor. Breastfeeding It is not recommended to take Owix in women who are breastfeeding. If treatment with the product is necessary, they should stop breastfeeding.

Driving and using machines

There is no data on the effect of Owix on driving and using machines. Owix contains: sorbitol 70% (E 420), sodium benzoate (E 211), sodium, glycerol, ethanol (from aroma), geraniol (from aroma), benzyl alcohol (from aroma), propylene glycol(from aroma)

Sorbitol 70% (E 420)

Each ml of oral suspension contains 519.05 mg of sorbitol (which corresponds to 10381 mg of sorbitol in each 20 ml of suspension). Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has a rare genetic disease, fructose intolerance, in which the patient's body does not break down fructose, they should consult their doctor before taking the medicine or giving it to their child. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

Sodium benzoate (E 211)

The medicine contains 3 mg of sodium benzoate in each ml of suspension (which corresponds to 60 mg of sodium benzoate in each 20 ml of suspension).

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

Etanol

The medicine contains 0.9 mg of alcohol (ethanol) in each ml of suspension. The amount of alcohol in 1 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not cause noticeable effects.

Benzyl alcohol

The medicine contains 0.04 micrograms of benzyl alcohol in each ml of suspension (which corresponds to 0.81 micrograms of benzyl alcohol in each 20 ml of suspension). Benzyl alcohol may cause allergic reactions. 3.

How to take Owix

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.

Dosage

Adults and children The recommended dose for adults and children from 2 years of age with a body weight of 11 kg is: 11 mg/kg body weight, once. This dose should be repeated after two or three weeks from the first dose administration. Do not exceed the recommended dose of the medicine.

If symptoms persist after the second dose of Owix, consult a doctor.

The following table shows the dosage of Owix oral suspension depending on body weight:

A measuring cup with a scale is attached to the packaging to facilitate dosing. Patients with liver function disorders Patients with liver function disorders should consult their doctor before taking the medicine. The doctor may recommend a lower dose, as the medicine may have an adverse effect on the liver.

Method of administration

The medicine is taken orally, during or regardless of meals. Before use, shake the suspension to obtain a uniform mixture. There is no need to use laxatives before taking Owix.

Overdose of Owix

In case of taking a larger dose of the medicine than recommended, consult a doctor or pharmacist immediately. Main symptoms of overdose Vision disorders, disorientation, dizziness, fainting when changing position to standing, sweating, weakness, irregular heartbeat, muscle cramps and tremors, hypoxia (difficulty breathing, loss of consciousness). If you have any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Owix can cause side effects, although not everybody gets them.

Side effects:

• nausea, vomiting, appetite disorders, abdominal pain, diarrhea, increased activity of liver enzymes
• allergic skin rashes
• headache and dizziness, drowsiness or insomnia.

Reporting side effects If you experience any side effects, including any possible side effects not listed in this leaflet, you should inform your 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 Fax: +48 22 49 21 309 Website: Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Owix

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after: EXP. The expiry date refers to the last day of the month stated. Do not store above 25°C. Store in the original packaging to protect from light. After opening, the medicine can be stored for 21 days. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Owix contains

The active substance of the medicine is pyrantel. 5 ml of oral suspension contains 250 mg of pyrantel (in the form of pyrantel embonate). The other ingredients are: sodium benzoate (E 211), sodium carmellose, sorbitol 70% (E 420), glycerol, aluminum-magnesium silicate, polysorbate 80, povidone, apricot aroma (contains ethanol, propylene glycol, geraniol, benzyl alcohol), simethicone emulsion, citric acid monohydrate, sodium hydroxide, purified water.

What Owix looks like and what the pack contains

Brown glass bottle with a polyethylene cap and a tear-off ring in a cardboard box. The bottle contains 15 ml of suspension. A measuring cup with a scale is attached to the packaging.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A. ul. Pelplińska 19, 83-200 Starogard Gdański tel. +48 22 364 61 01

Manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A. Medana Branch in Sieradz ul. Władysława Łokietka 10, 98-200 Sieradz

Date of last revision of the leaflet: