VERMOX 100 mg Coated Tablet

Зміст інструкції

1. Vermox 100 mg tablets, 20 mg/mL oral suspension
   1. What is Vermox and what is it used for
   2. What you need to know before taking Vermox
   3. How to take Vermox
   4. Possible side effects
   5. How to store Vermox
   6. Contents of the pack and other information
2. Vermox 500 mg tablets
   1. What is Vermox and what is it used for
   2. What you need to know before taking Vermox
   3. How to take Vermox
   4. Possible side effects
   5. How to store Vermox
   6. Contents of the pack and other information

Vermox 100 mg tablets, 20 mg/mL oral suspension

mebendazole

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

• Keep this leaflet. 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Vermox is and what it is used for
• 2. What you need to know before you take Vermox
• 3. How to take Vermox
• 4. Possible side effects
• 5. How to store Vermox
• 6. Contents of the pack and other information

1. What is Vermox and what is it used for

Vermox contains the active ingredient mebendazole, which belongs to the category of medicines defined as anthelmintics.
These medicines cause the expulsion or destruction of parasitic worms in humans (worms that live
by exploiting the human organism).
In particular, this medicine has a potent activity against many parasitic worms (helminths)
of humans belonging to the classes of nematodes and cestodes.
Vermox is particularly active for infestations due to:

• Enterobius vermicularis(pinworm): worm, parasite of the digestive tract
• Ascaris lumbricoides(roundworm): worm, parasite of the intestine
• Trichuris trichiura(whipworm): worm, parasite of the cecum
• Ancylostoma duodenale(hookworm): worm, parasite of the small intestine
• Necator americanus(hookworm): worm, parasite of the intestine
• Strongyloides stercoralis(strongyloid): worm, parasite of the intestinal walls
• Taenia spp.(tapeworm): worm, parasite of the digestive tract.

Contact your doctor if you do not feel better or if you feel worse

2. What you need to know before taking Vermox

DO NOT take Vermox:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Vermox.
Glomerulonephritis (inflammatory kidney disease) and agranulocytosis (severe decrease in the number of white blood cells)
have been reported with dosages substantially higher than those recommended and for prolonged treatment
periods.

Children
Vermox may, in rare cases, induce convulsions in children, including children under 1 year of age.
Vermox should not be administered to children under 1 year of age.
Vermox may be administered to children between 1 and 2 years of age only if your doctor deems it necessary.
Your doctor will only prescribe Vermox to your child if there are no alternative therapies.
To reduce the risk of choking, VERMOX 20mg/ml oral suspension should be considered for
patients, such as young children, who have difficulty swallowing tablets.

Other medicines and Vermox
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Avoid the use of the following medicine with Vermox:

• metronidazole (an antibiotic), as Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) (severe skin and/or mucous membrane reactions induced by the drug) may occur.

Use Vermox with caution and inform your doctor or pharmacist if you are taking:

• cimetidine (a medicine used to treat stomach ulcers): the use of this medicine with Vermox may increase its effect. Use Vermox with caution if you are being treated with cimetidine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
A small amount of mebendazole is present in breast milk after oral administration. Therefore, caution should
be exercised when VERMOX is administered to breastfeeding women.

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

Vermox suspension contains methylparaben and propylparaben
Methylparaben and propylparaben may cause allergic reactions (including delayed reactions).

Vermox suspension contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this
medicine.

Vermox suspension contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per ml, i.e. it is essentially “sodium-free”.

Vermox tablets contains sunset yellow
Sunset yellow is an azo dye that may cause allergic reactions.

Vermox tablets contains sodium
This medicine contains 3.8 mg of sodium (the main component of table salt) per tablet. This
is equivalent to 0.19% of the recommended maximum daily intake with the diet of an adult.

3. How to take Vermox

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
The recommended dose varies depending on the parasite:

• 1.Enterobiasis (infection with a digestive tract parasite): the recommended dose is 100 mg (one tablet, or one 5 ml measuring spoon of suspension) orally. It is advisable to repeat the treatment after 2 and 4 weeks as the risk of new infection is very high, particularly in large social communities.
• 2.Ascariasis (infection with an intestinal parasite), trichocephaliasis (infection with an intestinal parasite of the cecum), hookworm infection (infection with a small intestine parasite) and mixed infections:the recommended dose is 100 mg (one tablet, or one 5 ml measuring spoon of suspension) orally twice a day (morning and evening) for three consecutive days, regardless of the patient's age and weight.
• 3.Taeniasis (infection with a digestive tract parasite) and strongyloidiasis (infection with parasites of the intestinal walls):
• Adults: the recommended dose is 200 mg (2 tablets, or 2 measuring spoons of 5 ml of suspension) orally, 2 times a day (morning and evening) for three consecutive days.
• Children: the recommended dose is 100 mg (one tablet or one 5 ml measuring spoon of suspension) orally twice a day (morning and evening) for three consecutive days. Also see the paragraph “Warnings and precautions” for use in children.

Method of administration
Vermox is available in tablets and suspension for oral use. One 5 ml measuring spoon of suspension contains the
same amount of active ingredient as one 100 mg tablet.

• TabletsThe tablets can be swallowed with some water, or chewed during meals. The treatment does not require a special diet, nor the use of laxatives.
• SuspensionShake the bottle with the suspension before use.

A dosage suitable for each indication allows the elimination of all worms in more than 90% of patients, even in case
of severe or mixed infections.
VERMOX oral suspension should be considered for patients, such as young children,
who have difficulty swallowing tablets.
If deemed necessary by the doctor, the tablet must be crushed before being administered to a
child. The child must always be supervised during the administration of VERMOX.

Use in children and adolescents
For children under one year of age, see paragraph “Warnings and precautions”.
VERMOX should be used in children and adolescents only if the doctor deems it necessary.

If you take more Vermox than you should
In case of accidental ingestion/intake of an excessive dose of Vermox, immediately inform your doctor or
go to the nearest hospital.
If you take high quantities, or if you are being treated for dog tapeworm or fox tapeworm, the following problems may occur, which in some cases may be serious:

• blood problems
• kidney problems
• liver problems
• hair loss which may be permanent in some cases.

Long-term treatments must be carefully monitored by the doctor.
In case of accidental ingestion/intake of an excessive dose of Vermox, abdominal cramps may occur
nausea, vomiting and diarrhea. In this case you should contact your doctor who, if appropriate, will administer
activated charcoal (which serves to absorb the amount of Vermox still present in the stomach).
There is no specific antidote. You will be given activated charcoal if appropriate.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if any of the following symptoms occur:

• A severe skin disease manifesting with skin rashes, blisters on the skin and ulcers in the mouth, inflammation of the eyes or the ano-genital region, fever.
• A reaction occurring immediately after administration and characterized by skin rash (red spots on the skin), itching, shortness of breath and/or swelling of the face.
• A severe hypersensitivity reaction (allergy) occurring immediately after administration, which may be characterized by urticaria (skin rash), itching, flushing, fainting and difficulty breathing.
• Convulsions have been reported, even in newborns. Vermox should only be administered to children under 1 year of age if specifically prescribed by a doctor.

The following side effects have occurred with Vermox:

Common side effects (may affect up to 1 in 10 people):

• Abdominal pain

Uncommon side effects (may affect up to 1 in 100 people):

• Abdominal discomfort
• Diarrhoea
• Flatulence (presence of gas in the stomach or intestines)
• Nausea
• Vomiting

Rare side effects (may affect up to 1 in 1,000 people):

• Neutropenia (reduction in the number of white blood cells in the blood)
• Allergy (anaphylactic and anaphylactoid reaction)
• Convulsions
• Dizziness
• Hepatitis
• Abnormal liver function tests (alteration of normal liver values)
• Skin rash (red spots on the skin)
• Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) (severe drug-induced skin and/or mucous membrane reaction)
• Exanthem (skin rash of pustules, vesicles and blisters)
• Angioedema (swelling of the face, mouth, lips and/or tongue)
• Urticaria (skin rash)
• Alopecia (hair loss which may be permanent in some cases)
• Inflammatory kidney diseases (glomerulonephritis) *
• Severe decrease in the number of white blood cells (agranulocytosis) *

* may occur if treated for dog tapeworm or fox tapeworm.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Vermox

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Exp. The expiry date
refers to the last day of that month. The date refers to the product in intact packaging, correctly
stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.
Storage

• Tablets: this medicine does not require any special storage conditions.
• Suspension: do not store at a temperature above 25°C.

Child-resistant closure: (tablets)
Opaque blister

Child-resistant closure: (suspension)
Glass bottle with measuring device

Using the measuring device: pour the suspension into the recess indicated by the arrow on the measuring device (as described in the
drawing)

The holes in the measuring device allow the suspension to escape if it is accidentally poured from the
opposite side to that indicated by the arrow.
Instructions for using the measuring device
Use the measuring device as it is positioned on the bottle. Make sure that the graduated side (the smaller side) is
higher; this is the side that should be filled. When the arrow on the side points upwards, the correct side is
facing upwards. Fill the measuring device up to the 5 mL line.

6. Contents of the pack and other information

What Vermox contains
100 mg tablets:

• The active ingredient is mebendazole
• The other ingredients are: corn starch, sodiumsaccharin, sodiumlauryl sulfate, sunset yellow, orange flavour, microcrystalline cellulose, colloidal silica, magnesium stearate, sodium glycolate starch, talc, hydrogenated cottonseed oil.

20 mg/ml oral suspension:

• The active ingredient is mebendazole
• The other ingredients are: microcrystalline cellulose and sodium carboxymethylcellulose, sodium lauryl sulfate, methyl-parahydroxybenzoate, propyl-parahydroxybenzoate, citric acid monohydrate, methylcellulose, banana flavour, sucrose, purified water.

Description of the appearance of Vermox and contents of the pack

• 100 mg tablets - 6 tablets in opaque blisters
• 20 mg/ml oral suspension - 30 ml bottle

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Janssen-Cilag SpA
Viale Fulvio Testi, 280/6
20126 Milan MI

Manufacturer
Tablets
Lusomedicamenta Sociedade Técnica Farmacêutica, S.A.
Estrada Consiglieri Pedroso 69-B
Queluz
2730-055 Barcarena
Portugal

Suspension
JANSSEN PHARMACEUTICA N.V.
Turnhoutseweg, 30
B-2340 Beerse (Belgium)

Vermox 500 mg tablets

mebendazole

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

• Keep this leaflet. 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Vermox is and what it is used for
• 2. What you need to know before you take Vermox
• 3. How to take Vermox
• 4. Possible side effects
• 5. How to store Vermox
• 6. Contents of the pack and other information

1. What is Vermox and what is it used for

Vermox contains the active ingredient mebendazole, which belongs to the category of medicines defined as anthelmintics.
These medicines cause the expulsion or destruction of parasitic worms in humans (worms that live
by exploiting the human organism).
Vermox is indicated for:

• Treatment of hydatidosis in cases where surgery is not possible. Hydatidosis is a parasitic disease caused by infestation with parasites when they are still in the larval stage (hydatids) ( E. granulosus, E.multilocularis). These parasites subsequently form larval cysts in various organs (liver, lung, etc.), called hydatid cysts.
• Pre- and post-surgical prevention of hydatidosis to prevent the risk of spread or in cases where it is not possible to completely remove or drain the hydatid cysts.

See your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Vermox

DO NOT use Vermox

• if you are allergic to mebendazole or any of the other ingredients of this medicine (listed in section 6).
• Vermox tablets should not be given to children under 1 year of age for the massive treatment of single or mixed stomach and intestinal infestations.

Warnings and precautions
Talk to your doctor or pharmacist before taking Vermox.
Glomerulonephritis (inflammatory kidney disease) and agranulocytosis (severe decrease in the number of white blood cells)
have been reported with substantially higher dosages than those recommended and for prolonged treatment
periods.

Children
Vermox may rarely induce convulsions in children, including children under 1 year of age.
Vermox should not be given to children under 1 year of age.
Vermox may be given to children between 1 and 2 years of age only if the doctor deems it necessary.

Other medicines and Vermox
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Avoid using the following medicine with Vermox:

• Metronidazole (an antibiotic), as Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) (severe skin and/or mucous membrane reactions induced by the drug) may occur.

Use Vermox with caution and inform your doctor or pharmacist if you are taking:

• Cimetidine (medicine used to treat stomach ulcers): the use of this medicine with Vermox may increase its effect. Use Vermox with caution if you are being treated with cimetidine.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding with breast milk
ask your doctor or pharmacist for advice before taking this medicine.
A small amount of mebendazole is present in breast milk after oral administration.
Therefore, caution should be exercised when VERMOX is administered to breastfeeding women.

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

Vermox contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking this
medicine.

Vermox contains sodium
This medicine contains less than 1mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.

3. How to take Vermox

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
The recommended dose is 50 or 60 mg/Kg of body weight.
This dose should be divided into 2-3 daily administrations to be taken after meals, as the presence
of fats favors the absorption of the drug. The tablets can be taken with water, chewed or swallowed
whole.
The recommended dose can be gradually reached over the first weeks of treatment.
The duration of treatment may vary from a minimum of 1 month (pre-surgical prevention) up to several months (even
for periods longer than 3 years).
VERMOX oral suspension should be used in patients such as small children who are unable to
swallow the tablet.
If deemed necessary by the doctor, the tablet should be crushed before being administered to a
child. The child should always be supervised during the intake of VERMOX.
The doctor will prescribe diagnostic tests to monitor the therapeutic effects (ultrasound, X-ray, CT scan,
scintigraphy) depending on the location of the hydatid cysts.

Use in children and adolescents
For use in children, see section “Warnings and precautions”.

If you take more Vermox than you should
In case of ingestion/intake of an excessive dose of Vermox, immediately inform your doctor or go
to the nearest hospital.
If you take quantities of Vermox higher than those recommended or for prolonged periods of time, the following problems may
occur, which in some cases may be serious:

• blood problems
• kidney problems
• liver problems
• hair loss which in some cases may be permanent. Long-term treatments must be carefully monitored by the doctor.

In case of ingestion/intake of an excessive dose of Vermox, abdominal cramps, nausea, vomiting and diarrhea may occur.
In this case, you should contact your doctor who, if appropriate, will administer
activated charcoal (which serves to absorb the amount of Vermox still present in the stomach).
There is no specific antidote. You will be given activated charcoal if appropriate.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if any of the following symptoms occur:

• A severe skin disease manifesting with skin rashes, blisters on the skin and ulcers in the mouth, eye inflammation, or in the ano-genital region, and fever.
• A reaction that occurs immediately after administration and is characterized by skin rash (red spots on the skin), itching, shortness of breath and/or facial swelling.
• A severe hypersensitivity reaction (allergy) that occurs immediately after administration, which may be characterized by urticaria (skin rash), itching, flushing, fainting and difficulty breathing.
• Convulsions have been reported, even in newborns. Vermox should not be administered to children under 1 year of age and may be administered to children between 1 and 2 years of age only if specifically prescribed by the doctor (see section “Warnings and precautions”).

The following side effects have occurred with Vermox:

Common side effects (may affect up to 1 in 10 people):

• Abdominal pain

Uncommon side effects (may affect up to 1 in 100 people):

• Abdominal discomfort
• Diarrhea
• Flatulence (presence of gas in the stomach or intestines)
• Nausea
• Vomiting

Rare side effects (may affect up to 1 in 1,000 people):

• Neutropenia (reduction in the number of white blood cells in the blood)
• Allergy (anaphylactic and anaphylactoid reaction)
• Convulsions
• Dizziness
• Hepatitis
• Abnormal liver function tests (alteration of normal liver values)
• Skin rash (red spots on the skin)
• Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) (severe drug-induced skin and/or mucous membrane reaction)
• Exanthem (skin rash of pustules, vesicles and blisters)
• Angioedema (swelling of the face, mouth, lips and/or tongue)
• Urticaria (skin rash)
• Alopecia (hair loss which may be permanent in some cases)
• Inflammatory kidney diseases (glomerulonephritis) *
• Severe decrease in the number of white blood cells (agranulocytosis) *

* may occur if treated for dog tapeworm or fox tapeworm.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Vermox

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the packaging after Scad. The expiry date refers to the last day of that month. The date refers to the product in intact packaging,
correctly stored.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Vermox contains

• The active ingredient is mebendazole
• The other ingredients are: lactose monohydrate, methylcellulose, sodium glycolate starch, microcrystalline cellulose, corn starch, magnesium stearate, anhydrous colloidal silica.

Description of the appearance of Vermox and contents of the pack
500 mg tablets - 30 tablets in opaque blisters.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Janssen-Cilag SpA
Viale Fulvio Testi, 280/6
20126 Milano MI

Manufacturer
Lusomedicamenta Sociedade Técnica Farmacêutica, S.A.
Estrada Consiglieri Pedroso 69-B
Queluz
2730-055 Barcarena - Portugal