Vermox

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Vermox, 100 mg, tablets

Mebendazole

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read 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 disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Vermox and what is it used for
• 2. Important information before using Vermox
• 3. How to use Vermox
• 4. Possible side effects
• 5. How to store Vermox
• 6. Package contents and other information

1. What is Vermox and what is it used for

Vermox is an anti-worm medicine with a broad spectrum of action, used in the treatment of adults and children.
Vermox is indicated for the treatment of parasitic infections of the gastrointestinal tract (infestations), single or mixed, caused by the following parasite species: human pinworm (Enterobius vermicularis), whipworm (Trichuris trichiura), human roundworm (Ascaris lumbricoides),
hookworm (Ancylostoma duodenale), American hookworm (Necator americanus).

2. Important information before using Vermox

When not to use Vermox

• if the patient is allergic to mebendazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Vermox, the patient should discuss it with their doctor or pharmacist.
Vermox should always be used in accordance with the doctor's recommendations, and constant medical supervision is necessary until the symptoms disappear.
It is very important to maintain personal hygiene during and after treatment to prevent re-infection and transmission of parasites to other people.
There have been reports of liver, kidney, and blood disorders (neutropenia) in patients treated with mebendazole.
During treatment, it is not necessary to follow a special diet or use laxatives.

Children

There have been reports of seizures (convulsions) in children, including infants.
Vermox should not be used in children under 1 year of age.
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In children between 1 and 2 years of age, Vermox should only be used if prescribed by a doctor.

Vermox and other medicines

The patient should inform their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
Concomitant use of cimetidine may affect the action of mebendazole. It is recommended to avoid concomitant use of mebendazole with metronidazole due to the risk of serious side effects.

Using Vermox with food and drink

Tablets should be taken with water. During treatment, it is not necessary to follow a special diet or use laxatives.

Pregnancy, breastfeeding, and fertility

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 using this medicine.
As a precaution, it is recommended to avoid using Vermox, especially during the first trimester of pregnancy. During pregnancy and breastfeeding, Vermox can only be used if the doctor decides it is necessary.

Driving and using machines

Vermox does not affect or has negligible effects on the ability to drive and use machines.

Vermox contains orange yellow S (E 110)

The medicine may cause allergic reactions.

Vermox contains sodium

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

3. How to use Vermox

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
The patient should strictly follow the prescribed dose and medical supervision is necessary until the symptoms disappear (e.g., until the recommended stool test is performed).

Oral administration

Tablets should be taken with water, preferably in the evening. The tablet can be taken whole or can be chewed or crushed to facilitate swallowing. The break line is only to facilitate breaking and not to divide into equal doses.
Before giving the tablet to a small child, the tablet should be crushed. The child should always be supervised while taking this medicine.
During treatment, it is not necessary to follow a special diet or use laxatives.

Adults and children over 2 years:

• -Pinworms 100 mg (1 tablet) once. Due to the risk of frequent re-infections with parasites, it is recommended to repeat the treatment after 2 to 4 weeks.
• -Roundworms, whipworms, hookworms, and mixed infections 200 mg per day (1 tablet in the morning and 1 tablet in the evening) for 3 consecutive days.

Use in children over 2 years

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In the case of pinworms, roundworms, whipworms, hookworms, or mixed infections, the dosage is the same as for adults, regardless of the child's weight and age.

Use in children under 2 years

Children under 2 years, see section 2 "Important information before using Vermox".

Using a higher dose of Vermox than recommended

Accidental overdose may cause abdominal cramps, nausea, vomiting, and diarrhea. In patients treated for a long time with high doses of the medicine, rare cases of transient liver disorders (hepatitis), kidney disorders (nephritis), and neutropenia (significant decrease in the number of white blood cells) have been observed.
In case of overdose, the patient should consult their doctor or pharmacist or go to the emergency department of the nearest hospital. The patient should take the package and leaflet with them.

Missing a dose of Vermox

The patient should not take a double dose to make up for a missed dose.
The next dose should be taken at the usual time, and then the patient should continue taking the medicine according to the doctor's recommendations.

Stopping treatment with Vermox

If treatment with Vermox is stopped, the medicine may not be effective.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Vermox can cause side effects, although not everybody gets them.
If Vermox is used in the recommended doses, it usually does not cause any discomfort.
If the patient experiences any of the following symptoms:

• allergic reactions (hypersensitivity), including angioedema (sudden allergic swelling of the skin and mucous membranes of the face, throat, mouth, or larynx), skin rashes, hives, and itching, difficulty breathing, feeling of weakness,
• severe skin reactions with spreading rash and blistering skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) or severe skin peeling (toxic epidermal necrolysis),
• fatigue, loss of appetite, abdominal pain, vomiting, pale stools, dark urine, yellowing of the skin or whites of the eyes (hepatitis),
• frequent infections (neutropenia, agranulocytosis), the patient should stop using Vermox and contact their doctor immediately.

In clinical trials, not very common (in less than 1% of people) cases of discomfort in the lower abdomen, bloating, diarrhea, and rash have been observed.
During treatment with Vermox, the following side effects have also been reported:
Common side effects (may affect up to 1 in 10 people):

• abdominal pain.

Uncommon side effects (may affect up to 1 in 100 people):

• nausea, vomiting.

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Rare side effects (may affect up to 1 in 1,000 people):

• dizziness.

Very rare side effects (may affect up to 1 in 10,000 people):

• decreased number of certain types of white blood cells, leading to more frequent infections (neutropenia),
• allergic reactions (including severe),
• seizures,
• liver disorders,
• hepatitis,
• hives,
• hair loss,
• skin rashes,
• allergic edema (angioedema),
• severe skin reactions.

The following side effects have been reported very rarely (i.e., may affect less than 1 in 10,000 people) with long-term use in doses significantly exceeding the recommended:

• kidney inflammation (nephritis),
• significant decrease in the number of white blood cells, increasing the risk of infections (agranulocytosis).

Additional side effects in children

Very rare cases of seizures have been reported in children.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. 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
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Vermox

The medicine should be stored out of 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 packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Vermox contains

• The active substance of the medicine is mebendazole. Each tablet contains 100 mg of mebendazole. Page 4 5
• Other ingredients are: sodium lauryl sulfate, anhydrous colloidal silica, magnesium stearate, sodium saccharin, talc, corn starch, microcrystalline cellulose, sodium carboxymethylcellulose (type A), hydrogenated vegetable oil (type I), orange flavor, orange yellow S (E 110).

What Vermox looks like and what the pack contains

Round, light orange, flat tablets with beveled edges, with a break line on one side, with the inscription "Me/100" on both sides of the break line and the inscription "Janssen" on the other side of the tablet.
6 tablets in a PCV/Aluminum blister pack, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

Janssen Pharmaceutica N.V., Turnhoutseweg 30, B-2340 Beerse, Belgium

Manufacturer:

Lusomedicamenta Sociedade Técnica Farmacêutica, S.A., Estrada Consiglieri Pedroso 69-B, Queluz de Baixo, 2730-055 Barcarena, Portugal

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Romanian marketing authorization number, country of export: 9447/2016/01

Parallel import authorization number: 34/23 Date of leaflet approval: 03.03.2023

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