Package Leaflet: Information for the Patient

Lomper 100 mg Tablets

Mebendazole

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Lomper tablets

3.How to take Lomper tablets

4.Possible side effects

5.Storage of Lomper tablets

6. Contents of the pack and additional information

Lomper is a medication that belongs to the group of drugs called anthelmintics.

Lomper is indicated for the treatment of the following intestinal parasitic infections, both simple and mixed:Enterobiasis (Oxiuriasis), Ascaridiasis, Trichuriasis, Anquilostomiasis, Necatoriasis.

Do not take Lomper:

- if you are allergic to mebendazole or any of the other components of this medication (listed in section 6).

Warnings and precautions

• A possible relationship has been established between the use of mebendazole and metronidazole (a medication used to treat bacterial and protozoal infections) simultaneously and the appearance of severe reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis (blisters or significant skin or mucous membrane peeling in the mouth, eyes, or genital area, with fever)) that may pose a life-threatening risk (see section on Possible adverse effects).

Children and adolescents

This medication should not be used in children under 1 year of age, as the safety of mebendazole in these children is unknown. Cases of seizures have been reported in children (very rarely), including those under 1 year of age.

This medication 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 this medication to children under 2 years of age, administering it only if the expected benefit justifies the potential risk.

Taking Lomper with other medications

Inform your doctor or pharmacist if you are taking or have recently taken other medications, including those purchased without a prescription.

Use of this medication with metronidazole should be avoided (see section on Warnings and precautions).

Simultaneous administration with cimetidine (a medication used to treat stomach acid) may inhibit the hepatic metabolism of mebendazole, resulting in increased plasma concentrations of the medication. Your doctor will perform the necessary controls to adjust the medication dosage.

Taking Lomper with food

Lomper can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

Breastfeeding

First consult your doctor, who will decide whether you can take Lomper.

Driving and operating machinery

The influence of this medication on the ability to drive and operate machinery is negligible or insignificant.

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

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

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

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

Follow exactly the administration instructions for this medication as 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 any necessary adjustments.

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

The recommended dose is:

-Oxiuriasis:

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

-Ascaridiasis, Trichuriasis, Anquilostomiasis, 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 old and Adolescents:

-Oxiuriasis:

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

-Ascaridiasis, Trichuriasis, Anquilostomiasis, Necatoriasis or Mixed Infections:

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

Consider using Lomper oral suspension for patients (children, adolescents, and adults) who cannot swallow tablets.

Remember to take your medication.

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 of time, be aware that you may experience blood disorders, kidney or liver problems, some of which may be serious, as well as hair loss, which may be permanent in some cases.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

If any of the following adverse effects appear, discontinue treatment and consult your doctor:

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

-Significant skin blistering or peeling, or in the mouth, eyes, or genital area, with fever.

-Seizures

The following adverse effects have been described. The evaluation of adverse effects has been based on the following frequency data:

Very frequent: may affect more than 1 in 10 people

Frequent: may affect up to 1 in 10 people

Infrequent: 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

Unknown frequency (cannot be estimated from available data)

Frequent: abdominal pain.

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

Rare: dizziness.

Very rare: severe neutropenia (severe decrease in white blood cell count), hypersensitivity reactions (allergic), seizures, liver function alteration, hepatitis, toxic epidermal necrolysis, and Stevens-Johnson syndrome (significant skin blistering or peeling, or in the mouth, eyes, or genital area, with fever), exanthema (rash), angio-edema (facial swelling), urticaria (skin redness with hives), and alopecia (hair loss, which in some cases may be permanent), inflammatory kidney diseases.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

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

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Lomper tablets

- The active ingredient of this medication is mebendazole. Each tablet contains 100 mg of mebendazole.

- The other components are: sodium saccharin, microcrystalline cellulose, sodium carboxymethylcellulose type A (derived from potato starch), talc, magnesium stearate, cornstarch, anhydrous colloidal silica, orange flavor (which contains among others, sulfite), sodium lauryl sulfate, and yellow-orange S (E-110).

Appearance of the product and contents of the packaging

It is presented in an aluminum/PVC blister pack. Each package contains 6 tablets.

The tablets are orange, round, and scored on one face.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Responsible for manufacturing:

TOWA Pharmaceutical Europe, S.L.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

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

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es