LOMPER 100 mg TABLETS

Introduction

Patient Information Leaflet

Lomper 100 mg Tablets

Mebendazole

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

1. What Lomper Tablets are and what they are used for
2. What you need to know before you take Lomper Tablets
3. How to take Lomper Tablets
4. Possible side effects
5. Storage of Lomper Tablets
6. Contents of the pack and further information

1. What Lomper Tablets are and what they are used for

Lomper is a medicine that belongs to the group of medicines called anthelmintics.

Lomper is indicated for the treatment of the following intestinal parasitoses, both simple and mixed: Enterobiasis (Oxyuriasis), Ascariasis, Trichuriasis, Hookworm disease, and Necatoriasis.

2. What you need to know before you take Lomper Tablets

Do not take Lomper:

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

Warnings and precautions

• a possible relationship has been established between the use of mebendazole and metronidazole (a medicine used to treat bacterial and protozoal infections) simultaneously and the appearance of severe reactions (Stevens-Johnson Syndrome/toxic epidermal necrolysis (blisters or significant peeling of the skin or in the mouth, eyes, or genital area, with fever)) that can be life-threatening (see section Possible side effects)

Children and adolescents

It should not be used in children under 1 year of age, as it is not known whether mebendazole is safe in these children. Cases of convulsions have been reported in children (very rarely), including children under 1 year of age.

It is not recommended for use in children under 2 years of age, as mebendazole has not been sufficiently studied in these children. Your doctor will assess whether to administer it to children under 2 years of age, and it will only be administered if the expected benefit justifies the possible risk.

Taking Lomper with other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

The use of this medicine together with metronidazole (see Warnings and precautions) should be avoided.

The simultaneous administration with cimetidine (a medicine used to treat stomach acidity) may inhibit the metabolism of mebendazole at the liver level, which increases the plasma concentrations of the drug. Your doctor will perform the necessary checks to adjust the dose of the medicine.

Taking Lomper with food

Lomper can be administered with or without food.

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.

Pregnancy

Your doctor will assess the possible risks versus the expected therapeutic benefits of administering Lomper during pregnancy, especially during the first trimester.

Breastfeeding

If you are breastfeeding, consult your doctor first, who will decide whether you can take Lomper.

Driving and using machines

The influence of this medicine on the ability to drive and use machines is negligible or insignificant.

Lomper 100 mg Tablets contain orange yellow S (E110) and sulfites

This medicine may cause allergic reactions because it contains orange yellow S (E-110).

This medicine may rarely cause severe hypersensitivity reactions and bronchospasm because it contains sulfites.

This medicine contains less than 1mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Lomper Tablets

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will establish the appropriate dose for you and make the necessary adjustments.

If you think the action of Lomper is too strong or too weak, tell your doctor or pharmacist. Your doctor will indicate the duration of treatment with Lomper.

The recommended dose is:

• Oxyuriasis:

One tablet (a single dose of 100 mg). It is recommended to repeat the treatment after 2 and 4 weeks.

• Ascariasis, Trichuriasis, Hookworm disease, Necatoriasis, or mixed infections:

Two tablets per day, one in the morning and one in the afternoon, for three consecutive days.

Use in children and adolescents

Children from 2 years of age and adolescents:

• Oxyuriasis:

One tablet (a single dose of 100 mg). It is recommended to repeat the treatment after 2 and 4 weeks.

• Ascariasis, Trichuriasis, Hookworm disease, Necatoriasis, or mixed infections:

Two tablets per day, one in the morning and one in the afternoon, for three consecutive days.

It should be considered to use Lomper oral suspension for patients (children, adolescents, and adults) who cannot swallow tablets.

Remember to take your medicine.

If you take more Lomper than you should

If you have taken more Lomper than you should, consult your doctor or pharmacist immediately.

In case of accidental overdose, you may experience stomach cramps, nausea, vomiting, and diarrhea.

If you have taken more Lomper than recommended or for long periods, you may experience blood disorders, kidney or liver disorders, some of which can be serious, as well as hair loss, which can be permanent in some cases.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following side effects occur, stop treatment and consult your doctor:

- Allergic reactions such as blistering skin rash, facial swelling, or difficulty breathing.

- Blisters or significant peeling of the skin or in the mouth, eyes, or genital area, with fever.

- Convulsions

The following side effects have been reported. The assessment of side effects is based on the following frequency:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

Very rare: may affect up to 1 in 10,000 people

Frequency not known (cannot be estimated from the available data)

Common: abdominal pain.

Uncommon: abdominal discomfort, diarrhea, and flatulence (gas), rash (redness), nausea, and vomiting.

Rare: dizziness.

Very rare: neutropenia (severe decrease in the number of white blood cells), hypersensitivity reactions (allergic), convulsions, liver function disorders, hepatitis, toxic epidermal necrolysis, and Stevens-Johnson syndrome (blisters or significant peeling of the skin or in the mouth, eyes, or genital area, with fever), exanthema (redness), angioedema (facial swelling), urticaria (skin redness with hives), and alopecia (hair loss, which can be permanent in some cases), kidney inflammatory diseases.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lomper Tablets

Keep this medicine out of the sight and reach of children.

No special storage conditions are required. Store in the original packaging.

Do not use this medicine after the expiry date stated on the packaging. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Lomper Tablets

• The active substance of this medicine is mebendazole. Each tablet contains 100 mg of mebendazole.
• The other ingredients are: sodium saccharin, microcrystalline cellulose, sodium carboxymethylcellulose type A (derived from potato starch), talc, magnesium stearate, corn starch, anhydrous colloidal silica, orange flavor (which contains, among others, sulfite), sodium lauryl sulfate, and orange yellow S (E-110).

Appearance of the product and packaging contents

It is presented in aluminum/PVC blisters. Each pack contains 6 tablets.

The tablets are round and orange in color, scored on one side.

The score line is only for breaking and facilitating swallowing, but not for dividing into equal doses.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Manufacturer:

TOWA Pharmaceutical Europe, S.L.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Date of the last revision of this leaflet:05/2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es