Ovix

Package Leaflet: Information for the Patient

OWIX, 250 mg, Tablets

Pyrantel

Read the package 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 package leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If you do not feel better or feel worse, you should contact your 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 aged 6 and over 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 movement 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 cotton threads, and the females are about 10 mm long. Single pinworms are difficult to notice, but when they multiply excessively, white, moving worms can be seen 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 human digestive system, 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 (infection with parasites can occur, for example, 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 your 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
• keeping children's fingernails short and prohibiting nail biting or finger sucking
• frequent, regular changing 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 domestic conditions, especially when maintaining proper humidity and temperature)
• in the case of children, avoiding playing in dirty sandboxes
• daily morning hygiene of the anal area
• wearing pajamas, underwear, and in the case of small children, diapers before sleep.

It is important that in the case of parasite infection, the entire family of the patient should follow enhanced personal hygiene. Considering 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 your doctor.

2. Important information before taking Owix

When not to take Owix

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

Warnings and precautions

Before starting treatment with Owix, you should discuss it with your doctor

• if you have liver function disorders;
• if you are malnourished or have anemia.

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

Owix and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan 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.

Owix with food and drink

Take the medicine during or after a meal.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine.
Pregnancy
It is not recommended to take Owix during pregnancy. If treatment is necessary, you should contact your doctor.
Breastfeeding
It is not recommended to take Owix while breastfeeding. If treatment with the medicine is necessary, you should stop breastfeeding.
Fertility
There is no available data on the effect of the medicine on fertility.

Driving and using machines

There is no available data on the effect of Owix on driving and using machines.

3. How to take Owix

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Dosage
The dose should be repeated after 2 or 3 weeks from the first dose. Do not exceed the recommended dose of the medicine.
After 14 days from the end of treatment, control parasitological tests should be performed.

If symptoms persist after the second dose of the medicine, you should contact your doctor.

Due to the pharmaceutical form of Owix, 250 mg, tablets, it is not intended for use in children under 6 years of age.
There is a medicine containing pyrantel in the form of an oral suspension available on the market, intended for use in small children as well.
The following table shows the dosage of Owix tablets depending on the patient's body weight.

Patients with liver function disorders
Patients with liver function disorders should contact 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
Take the medicine orally during or after a meal, with water. Before swallowing, the tablet should be thoroughly chewed or crushed.

Using a higher dose of Owix than recommended

In case of taking a higher dose of the medicine than recommended, you should immediately contact your doctor or pharmacist.
After overdose, the following symptoms may occur: vision disturbances, disorientation, dizziness, fainting, or a feeling of dizziness when getting up from a lying or sitting position, sweating, unprecedented feeling of fatigue or weakness, irregular heartbeat; cramps, tremors, and muscle weakness; feeling of exhaustion, breathing difficulties, loss of consciousness.
In case of any further doubts related to the use of this medicine, you should contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, Owix can cause side effects, although not everybody gets them.
After taking the medicine, side effects do not occur frequently and disappear after stopping treatment.

Side effects that occur rarely (less than 1 in 1000 patients)

• nausea, vomiting, stomach pain, and cramps, diarrhea, loss of appetite
• headache, dizziness, drowsiness, insomnia
• rash
• weakness
• transient increase in liver enzyme activity (enzymes that determine liver function).

Side effects that occur with an unknown frequency (frequency cannot be determined based on available data)

• urinary urgency
• hallucinations with disorientation, paresthesia (feeling of numbness, tingling in limbs)
• fever
• hearing disorders.

Reporting side effects

If you experience any side effects, including any 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 of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
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, you can help gather more information on the safety of the medicine.

5. How to store Owix

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging.
Do not use this medicine after the expiry date stated on the carton. The expiry date stated on the carton is the last day of the stated month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
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. Each tablet contains 250 mg of pyrantel in the form of pyrantel embonate.
• The other ingredients of the medicine are: potato starch, povidone, anhydrous colloidal silica, ethyl cellulose, magnesium stearate, orange flavor.

What Owix looks like and what the pack contains

Owix tablets are round, flat on both sides, with a dividing line; yellowish-gray with a slight greenish tint, with faint speckles on the surface, with an orange scent. The tablet can be divided into equal doses.
The pack contains 3 tablets.

Marketing authorization holder and manufacturer

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

Date of the last update of the leaflet: