Owix

Package leaflet: Information for the patient

OWIX, 250 mg/5 ml, oral suspension
Pyrantelum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the physician or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, contact your doctor.

Table of contents

1. What Owix is and what it is 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 Owix is and what it is used for

The active substance in Owix is pyrantel. Owix is an anthelmintic medicine intended for children aged 2 years and above and adults, used in the treatment of intestinal infection with pinworms – white thread-like roundworms (nematodes). The medicine acts on the muscles of intestinal parasites. Immobilized parasites are expelled from the intestine due to intestinal peristalsis. Pyrantel does not irritate the intestines nor cause migration of worms. It acts on adult forms and early developmental stages of parasites, but has no effect on larvae migrating through tissues.

Indications:

• Enterobiasis (pinworm infection)

The prerequisite for using this medicine is confirmation of the presence of pinworms in stool and/or around the anal area. Pinworms are small, white parasitic worms living in the intestine. They resemble threads of white cotton, with females measuring about 10 mm in length. Individual worms are difficult to detect, but when present in large numbers, white, moving, one-centimeter-long worms can be clearly seen in stool. The presence of pinworms may also be observed by examining the anal area of a sleeping child in the evening (preferably 2 hours after falling asleep, when egg-laying occurs).

Pinworms lay a large number of tiny eggs, invisible to the naked eye. After ingestion, the eggs travel through the human digestive tract down to the large intestine, where they develop into mature worms within 2–6 weeks. Mature females lay eggs around the anal area, causing persistent itching, leading to frequent scratching. As a result, this area becomes irritated, and eggs are transferred first onto hands, then via nail-biting or finger-sucking into the mouth, leading to self-reinfection, or spread to other family members through direct or indirect contact (e.g. towels, bed linen, toys, furniture).

Symptoms of enterobiasis are most commonly observed in children. However, the disease may occur at any age, although children are often the main carriers (infection may occur, for example, in nurseries, kindergartens, sandboxes). If a child is infected with pinworms, other household members are easily infected. Enterobiasis manifests as intense itching around the anus (not present in all infected individuals), usually at night, often leading to inflammatory conditions. Infected children may experience irritability, nervousness, insomnia, nocturnal enuresis, abdominal pain, and loss of appetite. In girls, inflammation of the vulva and vagina may occur, presenting as itching, burning, and white vaginal discharge. In such cases, consult a doctor.

Maintaining proper hygiene, especially personal hygiene, is very important to prevent self-reinfection or transmission to others. The following rules should be followed for at least 6 weeks after completion of treatment.

Prevention of enterobiasis includes:

• thorough and frequent handwashing before preparing or eating meals, after using the toilet, and after touching the anal area
• thorough washing of vegetables and fruits before consumption
• keeping children's nails short and discouraging nail-biting or finger-sucking
• frequent, regular changing of underwear (including personal underwear and bed linen)
• washing and ironing personal underwear and bed linen at high temperatures
• frequent cleaning of rooms in the home, especially bedrooms and bathrooms (pinworm eggs can survive for several weeks under household conditions, especially with adequate humidity and warmth)
• avoiding children playing in dirty sandboxes
• daily morning hygiene of the anal area
• wearing pajamas, underwear, and for small children, diapers, before bedtime.

It is important that the entire family of an infected person maintains enhanced personal hygiene. Due to the frequent occurrence of enterobiasis in groups, treatment should be administered simultaneously to all household members and should be repeated.

If reinfection is suspected, consult a doctor.

2. Important information before using Owix

When not to use 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 skeletal muscle disorder).

Warnings and precautions
Before starting to use Owix, discuss this with your doctor:

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

If any of the above warnings apply to the patient currently or relate to past medical conditions, consult a doctor.
Owix and other medicines
Inform your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

• This medicine may increase the plasma concentration of theophylline (used in the treatment of bronchial asthma).
• This medicine should not be used concomitantly with piperazine, as the efficacy of both medicines may be reduced.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Use of Owix during pregnancy is not recommended. If treatment is necessary, consult your doctor.
Breastfeeding
Use of Owix is not recommended in breastfeeding women. If treatment with this product is necessary, breastfeeding should be discontinued during treatment.
Driving and operating machinery
There is no data available on the effect of Owix on driving and operating machinery.
Owix contains: sorbitol 70% (E 420), sodium benzoate (E 211), sodium, glycerol, ethanol (from flavouring), geraniol (from flavouring), benzyl alcohol (from flavouring), propylene glycol (from flavouring)
Sorbitol 70% (E 420)
Each ml of oral suspension contains 519.05 mg of sorbitol (equivalent to 10,381 mg of sorbitol in every 20 ml of suspension).
Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the body cannot metabolise fructose, the patient should consult a doctor before taking this medicine or giving it to a 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 (equivalent to 60 mg of sodium benzoate in every 20 ml of suspension).
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".
Ethanol
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 (equivalent to 0.81 micrograms of benzyl alcohol in every 20 ml of suspension).
Benzyl alcohol may cause allergic reactions.
3. How to use Owix
This medicine should always be used exactly as described in this patient leaflet or as directed by the doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Dosage
Adults and children
The recommended dose for adults and children aged 2 years and older with body weight of at least 11 kg is:
11 mg/kg body weight as a single dose.
This dose should be repeated two or three weeks after the first dose.
Do not exceed the recommended dose.
If symptoms persist after administration of the second dose, consult a doctor.
The following table shows the dosing of Owix oral suspension according to body weight:

The package contains a measuring cup with graduations, facilitating dosing.
Patients with impaired liver function
Patients with impaired liver function should consult a doctor before taking the medicine.
The doctor may recommend a lower dose, as the medicine may adversely affect the liver.
Instructions for use
The medicine is taken orally, during or regardless of meals.
Shake well before use to obtain a homogeneous suspension.
There is no need to use laxatives prior to administration of Owix.
Use of a higher than recommended dose of Owix
If a higher than recommended dose of the medicine is taken, seek immediate advice from a doctor or
pharmacist.
Main symptoms of overdose
Visual disturbances, disorientation, dizziness, fainting upon changing to an upright position,
sweating, weakness, irregular heartbeat, muscle spasms and tremors, hypoxia (difficulty
breathing, loss of consciousness).
If you have any further doubts concerning the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects:

• nausea, vomiting, appetite disturbances, abdominal pain, diarrhoea, increased liver enzyme activity
• allergic skin rashes
• headache, dizziness, somnolence or insomnia.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform a doctor or pharmacist. Adverse effects 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:
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Owix medicine

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

6. Contents of the packaging and other information

What Owix contains
The active substance is pyrantel.
5 ml of oral suspension contains 250 mg of pyrantel (as pyrantel embonate).
The other ingredients are: sodium benzoate (E 211), sodium carboxymethylcellulose, sorbitol 70% (E 420), glycerol,
magnesium aluminium silicate, polysorbate 80, povidone, apricot flavour (containing ethanol, propylene glycol, geraniol, benzyl alcohol), simethicone emulsion, citric acid monohydrate, sodium hydroxide, purified water.

What Owix looks like and contents of the pack
A brown glass bottle with a polyethylene screw cap with tamper-evident ring, in a cardboard box.
The bottle contains 15 ml of suspension.
An oral dosing syringe with graduations is included in the packaging.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Plant in Sieradz
Władysława Łokietka Street 10, 98-200 Sieradz