Lomper 20 mg/ml oral suspension
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Lomper oral suspension is and what it is used for
- 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 other information
- **Marketing Authorization Holder:**
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Lomper 20 mg/ml oral suspension
Mebendazole
Read all of 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Lomper oral suspension is and what it is used for
- What you need to know before taking Lomper oral suspension
- How to take Lomper oral suspension
- Possible side effects
- How to store Lomper oral suspension
- Contents of the pack and other information
1. What Lomper oral suspension is and what it is used for
Lomper is a medicine that belongs to a group of drugs called anthelmintics.
Lomper is indicated for the treatment of the following intestinal parasitoses, whether simple or mixed: Enterobiasis (Oxyuriasis), Ascariasis, Trichuriasis, Ancylostomiasis, Necatoriasis.
2. What you need to know before starting to take Lomper oral suspension
Do not take Lomper:
- if you are allergic to mebendazole or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
- A possible association has been established between the concomitant use of mebendazole and metronidazole (a medicine used to treat bacterial and protozoal infections) and the occurrence of severe reactions (Stevens-Johnson syndrome / toxic epidermal necrolysis (severe blistering or peeling of the skin or in the mouth, eyes, or anogenital area, accompanied by fever)), which may be life-threatening (see section Possible adverse effects).
Children and adolescents
Lomper must not be used in children under 1 year of age, as the safety of mebendazole in these children is unknown. Cases of seizures in children (very rarely), including in children under 1 year of age, have been reported.
Use is not recommended in children under 2 years of age, as mebendazole has not been sufficiently studied in this age group. Your doctor will assess whether to administer the medicine to children under two years of age and will prescribe it only if the expected benefit justifies the potential risk.
Taking Lomper with other medicines
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Concomitant use of this medicine with metronidazole should be avoided (see Warnings and precautions).
Simultaneous administration with cimetidine (a medicine used to treat stomach acid) may inhibit the hepatic metabolism of mebendazole, thereby increasing plasma concentrations of the drug. Your doctor will perform the necessary monitoring 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 might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Your doctor will evaluate the potential 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 effect of this medicine on the ability to drive and operate machinery is none or negligible.
Lomper 20 mg/ml oral suspension contains sucrose, ethanol, methyl parahydroxybenzoate (E-218), and propyl parahydroxybenzoate (E-216)
This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
This medicine contains 3.75 mg of ethanol (alcohol) per millilitre. The amount in 5 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol contained in this medicine does not produce any perceptible effect. It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).
This medicine contains less than 1 mmol of sodium (23 mg) per 5 ml; hence, it is essentially “sodium-free”.
This medicine contains flavourings (tutti frutti essence) with an allergen: citral. The allergen citral may cause allergic reactions. In addition to allergic reactions in sensitized patients, sensitization may occur in non-sensitized patients.
3. How to take Lomper oral suspension
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Your doctor will determine the appropriate dose for you and make any adjustments considered necessary.
If you think that the effect of Lomper is too strong or too weak, inform your doctor or pharmacist. Your doctor will advise you on how long you should continue treatment with Lomper.
The recommended dose is:
- Enterobiasis (pinworm infection):
One 5 ml teaspoonful of suspension (single dose of 100 mg). Repeating the treatment after 2 and 4 weeks is recommended.
- Ascariasis, Trichuriasis, Hookworm infection (Ankylostomiasis, Necatoriasis), or Mixed infections:
Two 5 ml teaspoonfuls per day, one in the morning and one in the evening, for three consecutive days.
Use in children and adolescents
Children from 2 years of age and adolescents:
- Enterobiasis (pinworm infection):
A single dose of 5 ml of oral suspension (1 measuring spoonful).
Repeating the treatment after 2 and 4 weeks is recommended.
- Ascariasis, Trichuriasis, Hookworm infection (Ankylostomiasis, Necatoriasis), or Mixed infections:
A dose of 5 ml of oral suspension (1 measuring spoonful) twice daily, once in the morning and once in the evening, for three consecutive days.
Remember to take your medicine.
Shake the suspension before use. The bottle has a child-resistant safety cap, which must be opened as follows: To open the safety cap, press down on the side (1) and turn as indicated by the arrow (2). |
|
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 prolonged periods, be aware that you may develop blood, kidney, or liver disorders, 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following adverse effects occur, stop treatment and consult your doctor:
-
Allergic reactions such as blistering rash on the skin, swelling of the face, or breathing difficulties.
-
Blisters or extensive peeling of the skin or in the mouth, eyes, or anogenital area, accompanied by fever.
-
Seizures
The following adverse effects have been reported. The assessment of adverse effects is based on the following frequency data:
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 available data)
Common: abdominal pain.
Uncommon: abdominal discomfort, diarrhoea 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), seizures, liver function abnormalities, hepatitis, toxic epidermal necrolysis and Stevens-Johnson syndrome (blisters or extensive peeling of the skin or in the mouth, eyes, or anogenital area, with fever), exanthema (redness), angioedema (swelling of the face), urticaria (red, itchy skin welts), and alopecia (hair loss, which in some cases may be permanent), inflammatory kidney diseases.
Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Lomper oral suspension
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging.
Do not use this medicine after the expiry date stated on the container.
The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the package and other information
Composition of Lomper oral suspension
- The active substance in this medicine 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, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), quinoline yellow (E-104), methylcellulose, citric acid monohydrate, ethanol (as part of tutti frutti flavoring), purified water.
Appearance of the product and contents of the container
It is supplied in a 30 ml plastic bottle with a polyethylene safety cap, an integrated polyethylene dropper (white) and a plastic measuring spoon (5 ml).
Lomper is a homogeneous yellow suspension.
Marketing Authorization Holder and Manufacturer Responsible
Marketing Authorization Holder:
Esteve Pharmaceuticals, S.A.
Passeig de la Zona Franca, 109
08038 Barcelona
Spain
Manufacturer responsible for manufacturing:
TOWA Pharmaceutical Europe, S.L.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain
Date of the most recent review of this leaflet: 05/2022
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es