Vermox

Package Leaflet: Information for the User

VERMOX, 100 mg, tablets
Mebendazole

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 pack and other information

1. What is Vermox and what is it used for

Vermox is an anthelmintic 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 taking Vermox

When not to take Vermox

Warnings and precautions

Before taking Vermox, discuss it with your doctor or pharmacist.
Always take Vermox exactly as your doctor has told you. Your doctor will need to check your progress until your symptoms have improved.
It is very important to maintain personal hygiene during and after treatment to prevent re-infection and transmission of parasites to others.
Reversible liver function disorders, hepatitis, and decreased white blood cell count (neutropenia) have been reported in patients treated with mebendazole at recommended doses. During long-term use of mebendazole in much higher doses, significant decreases in white blood cell count (agranulocytosis) and kidney inflammation (interstitial nephritis) have also been reported.
No special diet or laxatives are necessary during treatment.

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 prescribed by a doctor.

Vermox and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.
Taking cimetidine at the same time may affect the action of mebendazole.
Do not take mebendazole with metronidazole, as this may cause serious side effects.

Taking Vermox with food and drink

Swallow the tablets with water. No special diet or laxatives are necessary during treatment.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Vermox should not be used during pregnancy, especially in the first trimester.
During breastfeeding, Vermox can only be used if your doctor decides it is necessary.

Driving and using machines

Vermox has no or negligible influence on the ability to drive and use machines.

Vermox contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) sodium per tablet, which is essentially sodium-free.

3. How to take Vermox

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Follow the dosage prescribed by your doctor, and medical supervision is necessary until symptoms improve (e.g., until a stool test is performed).

Oral administration

Swallow the tablets with water, preferably in the evening. The tablet can be taken whole, chewed, or crushed to facilitate swallowing. The dividing line on the tablet only facilitates crushing to facilitate swallowing and does not allow for division into equal doses.
Before giving the tablet to a small child, crush the tablet. Always supervise the child while taking this medicine.
No special diet or laxatives are necessary during treatment.

Adults and children over 2 years of age

• Pinworms100 mg (1 tablet) as a single dose. Due to the risk of frequent re-infections with parasites, it is recommended to repeat the treatment after 2-4 weeks.
• Roundworms, whipworms, hookworms, and mixed infections200 mg per day (1 tablet in the morning and 1 tablet in the evening) for three consecutive days.

Use in children over 2 years of age

For 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 of age

Children under 2 years of age, see section 2 "Important information before taking Vermox".

Overdose of Vermox

Accidental overdose may cause abdominal cramps, nausea, vomiting, and diarrhea.
In patients treated with higher doses for a long time, reversible liver function disorders (hepatitis), kidney inflammation (interstitial nephritis), and decreased white blood cell count (neutropenia) have been observed.
If you have taken too much of this medicine, contact your doctor or pharmacist or go to the emergency department of your nearest hospital. Take the package and package leaflet with you.

Missed dose of Vermox

Do not take a double dose to make up for a forgotten dose.
Take the next dose at the usual time, then continue taking the medicine as your doctor has told you.

Stopping treatment with Vermox

If you stop taking Vermox, the treatment may not be effective.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
When Vermox is used at recommended doses, it usually does not cause any problems.
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 tongue), skin rash, urticaria, difficulty breathing, feeling of weakness,
• severe skin reactions with spreading rash with blisters and peeling 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 in 100 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 white blood cell count (neutropenia), allergic reactions (including severe), seizures, liver function disorders, hepatitis, urticaria, hair loss, skin rash, angioedema, severe skin reactions.

The following side effects have been reported very rarely (i.e., may occur in less than 1 in 10,000 people) after taking higher doses and long-term use:

• significant decrease in white blood cell count (agranulocytosis),
• kidney inflammation (interstitial nephritis).

Additional side effects in children

Seizures have been reported very rarely in children.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, 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: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Vermox

Keep this medicine out of the sight and reach of children.
No special precautions for storage are necessary.
Do not use this medicine after the expiry date stated on the carton and blister after (EXP). The expiry date refers to the last day of that month.
Medicines should 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 pack and other information

What Vermox contains

• -The active substance is mebendazole. Each tablet contains 100 mg of mebendazole.
• -The other ingredients are: sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, sodium saccharin, talc, corn starch, lactose monohydrate.

What Vermox looks like and contents of the pack

Almost white, flat tablets in the shape of a disc, with beveled edges and a slight, characteristic odor, with "VERMOX" printed on one side and a dividing line on the other side of the tablet.
The surface of the dividing line is white.
6 tablets in PVC/Aluminum blisters, in a cardboard box.

Marketing authorization holder and manufacturer

Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary
For more information, contact:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
[email protected]

Date of last revision of the package leaflet: