Package Insert: Information for the Patient

Lomper 20 mg/ml Oral Suspension

Mebendazole

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for your specific condition only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1.What is Lomper Oral Suspension and for what it is used

2.What you need to know before starting to take Lomper Oral Suspension

3.How to take Lomper Oral Suspension

4.Possible adverse effects

5.Storage of Lomper Oral Suspension

6.Contents of the package 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(blistering or significant peeling of the skin or in the mouth, eyes, or genital-anal region, with fever)) that may pose a life-threatening risk (see the section onpossible 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.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 it to children under 2 years of age, administering it only if the expected benefit justifies the possible risk.

Administration of 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.

The use of this medication with metronidazole should be avoided (seeWarnings and precautions).

The 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 drug. Your doctor will perform the necessary controls to adjust the medication dose.

Administration of Lomper with food

Lomper can be administered 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 possible risks against 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 20 mg/ml oral suspension contains saccharose, ethanol, methyl parahydroxybenzoate (E-218), and propyl parahydroxybenzoate (E-216)

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains 3.75 mg of ethanol (alcohol) per milliliter. The amount in 5 ml of this medication is equivalent to less than 1 ml of beer or 1 ml of wine.The small amount of alcohol in this medication has no perceptible effect.It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

This medication contains less than 1 mmol of sodium (23 mg) per 5 ml; it is essentially “sodium-free”.

This medication contains fragrances (tutti frutti essence) with allergen: citral. The citral allergen may cause allergic reactions. In addition to allergic reactions in sensitized patients, sensitization may occur in non-sensitized patients.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will establish the suitable 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 5 ml spoonful of suspension (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 spoonfuls 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:

-Oxiuriasis:

One single dose of 5 ml oral suspension (1 measuring spoon).

It is recommended to repeat the treatment after 2 and 4 weeks.

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

One 5 ml oral suspension dose (1 measuring spoon) twice a day, one in the morning and one in the afternoon, for three consecutive days.

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 Medicines 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.

Do not store at a temperature above 25°C. Store in the original packaging.

Do not use this medication after the expiration date that appears on the packaging.

The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lomper oral suspension

- The active ingredient of this medication is mebendazole. The oral suspension contains 20 mg of mebendazole per ml.

- The other components are: sodium saccharin, sucrose, microcrystalline cellulose, and sodium carboxymethylcellulose, sodium lauryl sulfate, methylparaben (E-218), propylparaben (E-216), quinoline yellow (E-104), methylcellulose, citric acid monohydrate, ethanol (part of the tutti fruti essence), purified water.

Appearance of the product and contents of the packaging

It is presented in a 30 ml plastic bottle, with a polyethylene safety cap, with a polyethylene dropper incorporated in white and a 5 ml plastic measuring spoon.

Lomper is a homogeneous yellow suspension.

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

Last review date 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