Vermox - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf life and Storage Composition and pharmaceutical form

Active ingredients: Mebendazole

VERMOX 100 mg tablets
VERMOX 20 mg / ml oral suspension

Vermox package inserts are available for pack sizes:
  • VERMOX 100 mg tablets, VERMOX 20 mg / ml oral suspension
  • VERMOX 500 mg tablets

Why is Vermox used? What is it for?

PHARMACOTHERAPEUTIC CATEGORY

VERMOX (mebendazole) belongs to the category of anthelmintic drugs.

THERAPEUTIC INDICATIONS

Infestations with pinworms, roundworms, whipworms, hookworms, strongyloids, tapeworms. In particular it has a powerful activity against many parasitic worms (= helminths) of man belonging to the classes of nematodes and tapeworms. VERMOX is particularly active against:

  • Enterobius vermicularis (pinworm)
  • Ascaris lumbricoides (roundworm)
  • Trichuris trichiura (whipworm)
  • Ancylostoma duodenale (hookworm)
  • Necator americanus (hookworm)
  • Strongyloides stercoralis (strongyloid)
  • Taenia spp. (lone worm)

Contraindications When Vermox should not be used

Hypersensitivity to the active substance or to any of the excipients. VERMOX should not be administered in case of known or suspected pregnancy, nor during breastfeeding.

Precautions for use What you need to know before taking Vermox

Use in children under 1 year of age: In the absence of comprehensive documentation in children under 1 year of age and due to sporadic reports of seizures in this patient group, VERMOX should only be administered in the case of where the parasite infestation significantly interferes with nutritional status and physical development.

The results of a case-control study investigating an acute event of Stevens-Johnson syndrome / toxic epidermal necrolysis (SJS / TEN) suggested a possible relationship between SJS / TEN and the concomitant use of mebendazole and metronidazole. No further information is available. data on this type of interaction. Therefore, concomitant use of mebendazole and metronidazole should be avoided.

Interactions Which drugs or foods may change the effect of Vermox

Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.

Concomitant treatment with cimetidine may inhibit the hepatic metabolism of mebendazole, resulting in increased plasma concentrations of the drug, particularly during prolonged treatment. In this case it is recommended to determine the plasma concentration of mebendazole and to adjust the dosage.

Concomitant use of mebendazole and metronidazole should be avoided.

Warnings It is important to know that:

Pregnancy and breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine. The drug should not be administered if you are pregnant or presumed to be pregnant, or if you are breastfeeding.

Effects on ability to drive and use machines

No studies on the ability to drive and use machines have been performed.

Dose, Method and Time of Administration How to use Vermox: Posology

Dosage

1. OXYURIASES: single dose of 100 mg (one tablet, or one measuring spoon of 5 ml suspension) by mouth.

The evolutionary cycle of Enterobius, agent of oxyuriasis, is very short. Therefore the risks of reinfestation are very high, especially in large social communities. For these reasons it is recommended to repeat the treatment after 2-4 weeks.

2. ASCARIDIASIS, TRICHOCEPHALOSIS, ANKYLOSTOMIASIS AND MIXED INFESTATIONS: one dose of 100 mg (one tablet, or one measuring spoon of 5 ml suspension) orally twice a day (morning and evening). Repeat the treatment for 3 consecutive days independently the age and weight of the patient.

3. TENIASE AND STRONGYLODIASE:

Adults: although good results have been obtained at lower dosages, a dose of 200-300 mg (2-3 tablets, or 2-3 measuring spoons of 5 ml suspension) orally is recommended, divided into two daily administrations (morning and evening) for three consecutive days.

Children: one dose of 100 mg (one tablet or one measuring spoon of 5 ml suspension) orally twice a day (morning and evening) for three consecutive days For children under 1 year of age see "SPECIAL WARNINGS" item.

Method of administration

VERMOX is present in the form of tablets and suspension for oral use. One measuring spoon of suspension contains the same amount of active ingredient as one tablet.

The tablets can be swallowed with a little water, or chewed with a meal. The treatment does not require a particular dietary regime, nor the use of laxatives.

Shake the suspension before use.

A suitable dosage for each indication allows to eliminate all worms in more than 90% of patients, even in the case of severe or mixed infestations.

Overdose What to do if you have taken too much Vermox

In case of accidental ingestion / intake of an excessive dose of VERMOX, notify your doctor immediately or go to the nearest hospital.

If more than recommended amounts of VERMOX are taken or for prolonged periods of time, blood, kidney or liver problems may occur, some of which could be serious. Hair loss may also occur which in some cases may be permanent. In any case, long-term treatments must be carefully monitored by the doctor.

In case of accidental overdose, abdominal cramps, nausea, vomiting and diarrhea may occur. In this case you should contact your doctor who will give you activated charcoal to absorb the amount of VERMOX still in your stomach.

Although the maximum recommended treatment duration is limited to only 3 days, rare cases of reversible changes in liver function, hepatitis and neutropenia have been reported in patients treated for hydatid disease (= ecchinococcosis) with high doses and for long periods.

There is no specific antidote. Gastric lavage may be performed during the first hour after ingestion. Activated charcoal may be given if appropriate. If you have any questions about the use of VERMOX, ask your doctor or pharmacist.

Side Effects What are the side effects of Vermox

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

The following side effects have been reported that may occur during treatment with VERMOX:

  • Dizziness
  • Abdominal discomfort and pain, flatulence, diarrhea
  • Skin rash
  • Urticaria
  • Hair loss which in some cases could be permanent
  • Disorders of the blood and liver
  • Kidney problems which may occur with prolonged use of VERMOX at doses substantially higher than those recommended (much higher than those normally prescribed).

Contact your doctor immediately if any of the following symptoms occur:

  • A severe skin disease manifesting as rashes, blisters on the skin and ulcers in the mouth, inflammation in the eyes, or in the anogenital region, and fever
  • A reaction that occurs soon after administration and is characterized by skin rash, itching, shortness of breath and / or swelling of the face.
  • A severe hypersensitivity reaction occurring soon after administration which may be characterized by hives, itching, flushing, fainting and difficulty breathing, among the possible symptoms.
  • Convulsions (seizures) have been reported, including in newborns. VERMOX should only be given to children under 1 year of age if the doctor has specifically prescribed it.

Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.

If any of the side effects gets serious or if you notice any side effects not described in this leaflet, please tell your doctor.

Expiry and Retention

Expiry: see the expiry date indicated on the package.

Warning: do not use the medicine after the expiry date indicated on the package.

The date refers to the product in intact packaging, properly stored.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

storage

Tablets: the medicinal product does not require any special storage conditions.

Suspension: Store at a temperature not exceeding 25 ° C.

Childproof closure: (tablets)

Opaque blister

Childproof closure: (suspension)

Glass bottle with measuring cup

Using the measuring cup: POUR THE SUSPENSION IN THE "HOLLOW INDICATED BY THE ARROW ON THE MEASURING" (as described in the drawing)

The holes on the measuring cup allow the suspension to come out if it is mistakenly poured from the opposite side to that indicated by the arrow

Composition and pharmaceutical form

COMPOSITION

One tablet contains:

ACTIVE SUBSTANCE: mebendazole 100 mg.

EXCIPIENTS: corn starch, sodium saccharinate, sodium laurilsulfate, sunset yellow, orange flavor, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, starch glycolate sodium salt, talc, hydrogenated cottonseed oil.

One ml of oral suspension contains:

ACTIVE SUBSTANCE: mebendazole 20 mg.

EXCIPIENTS: microcrystalline cellulose and sodium carmellose, sodium lauryl sulfate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, citric acid monohydrate, methylcellulose, banana flavor, sucrose, purified water.

PHARMACEUTICAL FORM AND CONTENT

100 mg tablets - 6 tablets

20 mg / ml oral suspension - bottle of 30 ml

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

More information about Vermox can be found in the "Summary of Features" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction 04.6 Pregnancy and lactation 04.7 Effects on ability to drive and use machines 04.8 Undesirable effects 04.9 Overdose 05.0 PHARMACOLOGICAL PROPERTIES 05.1 Pharmacodynamic properties 05.2 Pharmacokinetic properties 05.3 Preclinical safety data 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the primary packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER 08.0 MARKETING AUTHORIZATION NUMBER CIO 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIO DRUGS, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON PREPARATION AND QUALITY CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

VERMOX 100 mg tablets and 20 mg / ml oral suspension

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

One tablet contains:

Active ingredient: mebendazole 100 mg

One ml of suspension for oral use contains:

Active ingredient: mebendazole 20 mg

For the full list of excipients, see section 6.1.

03.0 PHARMACEUTICAL FORM

100 mg tablets

20 mg / ml oral suspension

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Infestations with pinworms, roundworms, whipworms, hookworms, strongyloids, tapeworms.

VERMOX (mebendazole) is a synthesis derivative of benzimidazole with a powerful anthelmintic activity against nematodes and cestoids.

VERMOX is particularly active in humans against:

• Enterobius vermicularis (pinworm)

• Ascaris lumbricoides (ascarid)

• Trichuris trichiura (whipworm)

• Ancylostoma duodenale (hookworm)

• Necator Americanus (hookworm)

• Strongyloides stercolaris (strongioloide)

• Taenia spp. (lone worm)

A suitable dosage for each indication allows to eliminate all worms in more than 90% of patients, even in the case of severe or mixed infestations.

04.2 Posology and method of administration

Ossiuriasis: single dose of 100 mg (one tablet, or one measuring spoon of 5 ml suspension).

The evolutionary cycle of Enterobius, the agent of oxyuriasis, is very short. Therefore, the risks of reinfection are very high, especially in large social communities. For these reasons it is recommended to repeat the treatment after 2-4 weeks.

Ascariasis, trichocephalosis, hookworms and mixed infestations: a dose of 100 mg (one tablet or one measuring spoon of 5 ml suspension) twice a day (morning and evening), for three consecutive days, regardless of the age and weight of the patient.

Teniasis and strongyloidiasis

Adults: although good results have been obtained at lower dosages, a dose of 200-300 mg (two-three tablets, or two-three measuring spoons of 5 ml suspension) is recommended twice a day (morning and evening), for three consecutive days.

Children: one dose of 100 mg (one tablet or one measuring spoon of 5 ml suspension) twice a day (morning and evening), for three consecutive days.

For children below one year of age see section 4.4.

The tablets can be swallowed with a little water, or chewed with a meal. The treatment does not require a particular dietary regime, nor the use of laxatives. Shake the suspension before use.

04.3 Contraindications

VERMOX is contraindicated in people with hypersensitivity to the active substance or to any of the excipients.

04.4 Special warnings and appropriate precautions for use

During post-marketing experience with VERMOX, episodes of seizures have been reported very rarely in children, including children under one year of age (see section 4.8). VERMOX 100 mg should only be administered to young children in cases where which parasitic infestation significantly interferes with nutritional status and physical development.

The results of a case-control study investigating an acute event of Stevens-Johnson syndrome / toxic epidermal necrolysis (SJS / TEN) suggested a possible relationship between SJS / TEN and the concomitant use of mebendazole and metronidazole. No further information is available. data on this type of interaction. Therefore, concomitant use of mebendazole and metronidazole should be avoided.

04.5 Interactions with other medicinal products and other forms of interaction

Concomitant treatment with cimetidine may inhibit the hepatic metabolism of mebendazole resulting in increased plasma concentrations of the drug, particularly during prolonged treatments. In this case it is recommended to determine the plasma concentration of mebendazole and to adjust the dosage.

The concomitant use of mebendazole and metronidazole should be avoided (see section 4.4).

04.6 Pregnancy and breastfeeding

VERMOX should not be administered in case of confirmed or presumed pregnancy, nor during breastfeeding.

04.7 Effects on ability to drive and use machines

No studies on the ability to drive and use machines have been performed.

04.8 Undesirable effects

Data from clinical studies

The safety of VERMOX was evaluated in 6276 subjects participating in 39 clinical studies for the treatment of single or mixed parasitic infestations of the gastrointestinal tract. In these 39 clinical studies, no adverse drug reactions (ADRs) were reported in ≥1% of subjects treated with VERMOX. Adverse drug reactions (ADRs) reported by ≤1% of subjects treated with VERMOX are shown in Table 1.


Table 1. Adverse drug reactions reported by ≤1% of subjects treated with VERMOX in 39 clinical studies System and organ classification Adverse reaction Gastrointestinal disorders Abdominal pain Diarrhea Flatulence Skin and subcutaneous tissue disorders Rash

Post-marketing data

Adverse events identified during post-marketing experience with VERMOX (mebendazole) are included in Table 2. In each table the frequencies are reported according to the following convention:

Very common (≥1 / 10)

Common (≥1 / 100,

Uncommon (≥1 / 1,000 to

Rare (≥1 / 10,000,

Very rare (

In Table 2 the adverse events are presented by frequency based on spontaneous reports.


Table 2. Adverse drug reactions identified during post-marketing experience with VERMOX divided by frequency category estimated from spontaneous reporting frequencies System and organ classification Adverse reaction Frequency Disorders of the blood and lymphatic system Very rare Neutropenia Disorders of the immune system Very rare Hypersensitivity reactions such as anaphylactic and anaphylactoid reactions Nervous system disorders Very rare Convulsions Gastrointestinal disorders Very rare Abdominal pain Hepatobiliary disorders Very rare Hepatitis, abnormal liver function tests Skin and subcutaneous tissue disorders Very rare Toxic epidermal necrolysis, Steven-Johnson syndrome, exanthema, angioedema, urticaria, alopecia

04.9 Overdose

In patients treated at substantially higher dosages than recommended or for prolonged periods of time, the following adverse reactions have been reported rarely: reversible liver function disorders, hepatitis, neutropenia and glomerulonephritis. With the exception of glomerulonephritis, these adverse reactions have also been reported in patients treated at standard doses (see section 4.8.2).

Symptoms

In case of accidental overdose, abdominal cramps, nausea, vomiting and diarrhea may occur.

Treatment

There is no specific antidote. Gastric lavage may be performed during the first hour after ingestion. Activated charcoal may be given if appropriate.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: Anthelmintics for oral administration, benzimidazole derivatives.

ATC code: P02CA01

For therapeutic indications (see section 4.1), mebendazole acts locally in the lumen of the stomach by interfering with cellular tubulin formations in the intestine of parasites. Mebendazole binds specifically to tubulin and causes ultrastructural degenerative changes in the intestine. This process results in a block of the absorption of glucose by the parasites with an upset of their digestive functions which thus leads to an autolytic process.

There is no evidence that VERMOX is effective in the treatment of cysticercosis.

05.2 Pharmacokinetic properties

After oral administration of 0.1 mg / kg body weight of radiolabelled mebendazole, minimal absorption from the gastrointestinal tract was observed. At normal therapeutic doses the bioavailability is low, because the drug undergoes a marked metabolic first pass effect and also because of its poor solubility. About 90% of the absorbed fraction is bound to plasma proteins.

05.3 Preclinical safety data

For acute administration:

LD50 (albino rat, per os): 1500 mg / kg; lung

LD50 (albino mouse, per os): 1500 mg / kg

For prolonged administration:

Albino rat per os (28 days): max dose that did not cause alterations 200 mg / kg / day

Albino rat per os (180 days): max dose that did not cause alterations 40 mg / kg / day

Dog per os (180 days): max dose that did not cause alterations 40 mg / kg / day

Absence of suspected histological manifestations of carcinogenesis.

Fetal toxicity:

Albino rat, per os: increase in resorptions (30 mg / kg / day)

Rabbit, orally: max dose that did not cause alterations: 30 mg / kg / day.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

One tablet contains:

Excipients: corn starch, sodium saccharinate, sodium lauryl sulfate, sunset yellow, orange flavor, microcrystalline cellulose, colloidal silica, magnesium stearate, starch glycolate sodium salt, talc, hydrogenated cottonseed oil.

One ml of suspension for oral use contains:

Excipients: microcrystalline cellulose and sodium carmellose, sodium lauryl sulfate, methyl para-hydroxybenzoate, propyl para-hydroxybenzoate, citric acid monohydrate, methylcellulose, banana flavor, sucrose, purified water.

06.2 Incompatibility

VERMOX 100 mg tablets: not relevant.

VERMOX 20 mg / ml oral suspension: in the absence of incompatibility studies, this medicinal product must not be mixed with other products.

06.3 Period of validity

100 mg tablets: 3 years

20 mg / ml oral suspension: 4 years

06.4 Special precautions for storage

Tablets: the medicinal product does not require any special storage conditions

Suspension: Store at a temperature not exceeding 25 ° C

06.5 Nature of the immediate packaging and contents of the package

6 tablets of 100 mg in opaque blister.

Bottle of 30 ml of oral suspension.

06.6 Instructions for use and handling

The solution must be shaken before use.

Using the measuring cup: POUR THE SUSPENSION IN THE "HOLLOW INDICATED BY THE ARROW ON THE MEASURING"

The holes on the measuring cup allow the suspension to come out if it is mistakenly poured from the opposite side to that indicated by the arrow.

07.0 MARKETING AUTHORIZATION HOLDER

JANSSEN-CILAG SpA

via M.Buonarroti 23

20093 Cologno Monzese (Milan)

08.0 MARKETING AUTHORIZATION NUMBER

AIC n. 023821010 - 100 mg tablets 6 tablets

AIC n. 023821022 - 20 mg / ml oral suspension bottle of 30 ml

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

June 2000 / June 2005

10.0 DATE OF REVISION OF THE TEXT

AIFA Determination of April 19, 2010

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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