Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Vermox, 100 mg, tablets
Mebendazole
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
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. It may harm someone else, even if their symptoms are similar.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

What Vermox is and what it is used for
Important information before taking Vermox
How to take Vermox
Possible side effects
How to store Vermox
Contents of the pack and other information

1. What Vermox is and what it is used for

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

2. Information before using Vermox

When not to use Vermox

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

Warnings and precautions
Before starting treatment with Vermox, consult your doctor or pharmacist.
Vermox must always be used according to the doctor's instructions, and medical supervision must be maintained until symptoms have resolved.
It is very important to maintain personal hygiene during and after treatment to prevent reinfection and transmission of parasites to other people.
Cases of impaired liver and kidney function, as well as reduced white blood cell count (neutropenia), have been reported in patients treated with mebendazole.
There is no need to follow a special diet or use laxatives during treatment.
Children
Seizures (convulsions) have been reported in children, including infants.
Vermox must not be used in children under 1 year of age.
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In children aged 1 to 2 years, Vermox should only be used if prescribed by a doctor.
Vermox and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
Concomitant use of cimetidine may affect the efficacy of mebendazole. Concomitant use of mebendazole with metronidazole should be avoided due to the risk of serious adverse effects.
Taking Vermox with food and drink
Tablets should be taken with water. There is no need to use laxatives or follow a special diet during treatment.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
As a precaution, use of Vermox should be avoided, especially during the first trimester of pregnancy. Vermox may be used during pregnancy and breastfeeding only if prescribed by a doctor when clearly necessary.
Driving and operating machinery
Vermox has no effect or has a negligible effect on the ability to drive and operate machinery.
Vermox contains Sunset Yellow FCF (E 110)
This medicine may cause allergic reactions.
Sodium content
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Vermox

This medicine should always be taken as directed by a physician. If in doubt, consult your
doctor or pharmacist.
Strictly adhere to the prescribed dose, and medical supervision is necessary until
symptoms have resolved (e.g., until recommended stool tests are performed).
Oral administration
Tablets should be taken with water, preferably in the evening. The tablet may be swallowed
whole, chewed, or crushed to facilitate swallowing. The score line is intended only to assist
in splitting the tablet for easier swallowing and does not allow for dividing into equal doses.
Before administering the tablet to a young child, the tablet should be crushed. Always supervise
a child when administering this medicine.
No special diet or laxatives are required during treatment.
Adults and children over 2 years of age:

Pinworm infection: 100 mg (1 tablet) as a single dose. Due to the risk of frequent re-infection, repeat treatment is recommended after 2 to 4 weeks.
Ascariasis, hookworm infection, whipworm infection, and mixed infections: 200 mg daily (1 tablet in the morning and 1 tablet in the evening) for 3 consecutive days.

Use in children over 2 years of age
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In cases of pinworm infection, ascariasis, hookworm infection, whipworm infection, or mixed infections,
the dosage is the same as in adult patients, regardless of body weight or age of the child.
Use in children under 2 years of age
For children under 2 years of age, see section 2, "Important information before taking Vermox".
Use of a higher than recommended dose of Vermox
Accidental overdose may cause abdominal cramps, nausea, vomiting, and diarrhea. In patients treated
over a prolonged period with high doses, rare cases of transient liver function disorders (hepatitis),
kidney function disorders (glomerulonephritis), and neutropenia (marked decrease in granulocyte count—
a type of white blood cell) have been observed.
If an excessive dose of Vermox is taken, consult a doctor or pharmacist or go to the emergency department
of the nearest hospital. Bring the medicine carton and the package leaflet with you.
Missed dose of Vermox
Do not take a double dose to make up for a missed dose.
Take the next dose at the usual time and continue taking the medicine as directed by your doctor.
Stopping treatment with Vermox
If treatment with Vermox is discontinued prematurely, the medicine may be ineffective.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
If Vermox is used at the recommended doses, it usually does not cause any discomfort.
If any of the following symptoms occur in a patient:

hypersensitivity reactions (allergic reactions), including angioedema (sudden allergic swelling of the skin and mucous membranes of the face, throat, mouth or larynx), skin eruptions, rash and urticaria, difficulty breathing, feeling of weakness,
severe skin reactions with spreading rash, blisters and peeling skin, especially around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome) or extensive 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),

discontinue use of Vermox and contact a doctor immediately.

In clinical trials, infrequent (in less than 1% of individuals) occurrence of lower abdominal discomfort, bloating, diarrhoea and rash was observed.
The following adverse reactions have also been reported during use of Vermox:
Common adverse reactions (may occur in less than 1 in 10 people):

abdominal pain.

Uncommon adverse reactions (may occur in less than 1 in 100 people):

nausea, vomiting.

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Rare adverse reactions (may occur in less than 1 in 1,000 people):

dizziness.

Very rare adverse reactions (may occur in less than 1 in 10,000 people):

reduced number of certain types of white blood cells, leading to more frequent infections (neutropenia),
allergic reactions (including severe),
seizures,
liver function abnormalities,
hepatitis,
urticaria,
hair loss,
skin eruptions,
allergic swelling (angioedema),
severe skin reactions.

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

kidney inflammation (glomerulonephritis),
marked decrease in white blood cells, increasing the risk of infections (agranulocytosis).

Additional adverse reactions in children
Seizures in children have been very rarely reported.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Vermox

Keep this medicine out of the sight and reach of children.
Store below 25°C. Keep 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Vermox contains

The active substance is mebendazole. Each tablet contains 100 mg of mebendazole. Page 4 of 5
The other ingredients are: sodium lauryl sulfate, anhydrous colloidal silicon dioxide, magnesium stearate, sodium saccharin, talc, corn starch, microcrystalline cellulose, sodium carboxymethyl starch (type A), hydrogenated vegetable oil (type I), orange flavor, sunset yellow FCF (E 110).

What Vermox looks like and contents of the pack
Round, light orange, flat tablets with beveled edges, with a score line on one side, marked with “Me/100” on both sides of the score line and “Janssen” on the other side of the tablet.
6 tablets in a PVC/Aluminum blister pack, in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party 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, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Authorization number in Romania, the country of export: 9447/2016/01
Parallel import authorization number: 34/23
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