Vermox

Package Leaflet: Information for the Patient

Warning! Keep the Leaflet! Information on the Immediate Packaging in a Foreign Language.

Vermox, 100 mg,tablets
Mebendazole

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Vermox and What is it Used For
• 2. Important Information Before Taking Vermox
• 3. How to Take Vermox
• 4. Possible Side Effects
• 5. How to Store Vermox
• 6. Contents of the Packaging and Other Information

1. What is Vermox and What is it Used For

Vermox is an anti-worm medication 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), and American hookworm (Necator americanus).

2. Important Information Before Taking Vermox

When Not to Take Vermox:

Warnings and Precautions

Before starting treatment with Vermox, discuss it with your doctor or pharmacist.
Always take Vermox exactly as your doctor has told you, and continue the treatment until the symptoms disappear, under constant medical supervision.
It is very important to maintain personal hygiene during and after treatment to prevent reinfection 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 take laxatives.

Children

Seizures (convulsions) have been reported in children, including infants. Vermox should not be used in children under 1 year of age.
In children between 1 and 2 years of age, Vermox should only be used if decided by the doctor.

Vermox and Other Medications

Tell your doctor or pharmacist about all medications you are taking, have recently taken, or plan to take.
Concomitant use of cimetidine may affect the action of mebendazole. Avoid concomitant use of mebendazole with metronidazole due to the risk of serious side effects.

Taking Vermox with Food and Drink

Take the tablets with a glass of water. During treatment, it is not necessary to follow a special diet or take laxatives.

Pregnancy, Breastfeeding, and Fertility

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 medication.
As a precaution, it is recommended to avoid taking 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 Sodium

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

Vermox Contains Orange Yellow S (E 110)

The medication contains the dye orange yellow S (E 110), which may cause allergic reactions.

3. How to Take Vermox

Take this medication exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Follow the prescribed dose exactly, and medical supervision is necessary until the symptoms disappear (e.g., until the recommended stool test is performed).

Oral Administration

Take the tablets with a glass of water, preferably in the evening. The tablet can be taken whole, 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, crush the tablet. Always supervise the child when taking this medication.
During treatment, it is not necessary to follow a special diet or take laxatives.

Adults and Children Over 2 Years:

• Pinworms100 mg (1 tablet) as a single dose. Due to the risk of frequent reinfections, 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

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 Taking Vermox".

Overdose of Vermox

Accidental overdose may cause abdominal cramps, nausea, vomiting, and diarrhea. In patients treated for a long time with high doses, rare cases of transient liver disorders (hepatitis), kidney disorders (nephritis), and neutropenia (significant decrease in the number of white blood cells) have been observed.
If you have taken more than the prescribed dose of Vermox, consult your doctor or pharmacist or go to the emergency department of the nearest hospital. Take the package and the leaflet with you.

Missing a 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 then continue taking the medication as prescribed by your doctor.

Stopping Treatment with Vermox

If you stop taking Vermox, the treatment may not be effective.
If you have any further doubts about taking this medication, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Vermox can cause side effects, although not everybody gets them.
If Vermox is taken in the recommended doses, it usually does not cause any discomfort.
If you experience any of the following symptoms:

• allergic reactions (including anaphylaxis), such as 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), stop taking Vermox and contact your doctor immediately.

In clinical trials, not very common (in less than 1% of people) side effects included discomfort in the lower abdomen, bloating, diarrhea, and rash.
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.

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,
• angioedema (allergic swelling),
• 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 higher than recommended:

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

Additional Side Effects in Children

Seizures have been reported very rarely in children.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Vermox

Keep the medication out of sight and reach of children.
Store in a temperature below 25°C, in the original packaging.
Do not use this medication after the expiration date stated on the packaging.
The expiration date refers to the last day of the specified month.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This 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.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose (type A), talc, corn starch, sodium saccharin, magnesium stearate, hydrogenated vegetable oil (type I), orange flavor, colloidal silicon dioxide, sodium lauryl sulfate, orange yellow S (E 110).

What Vermox Looks Like and What the Packaging Contains

Flat, round, light orange tablets, with "JANSSEN" on one side and "Me" and "100" separated by a break line on the other side.
6 tablets in a PVC/Al blister, in a cardboard box.
For more detailed information, consult the marketing authorization holder or the parallel importer.

Marketing Authorization Holder in Romania, the Country of Export:

Janssen Pharmaceutica NV
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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization Number in Romania, the Country of Export:9447/2016/01
Parallel Import Authorization Number:816/12
Date of Approval of the Leaflet: 09.12.2022