100 mg tablets and 20 mg/ml oral suspension
mebendazole
What Vermox is and what it is used for
Vermox is used for the treatment of roundworms in adults and children from 2 years of age.
Vermox prevents the worm’s metabolism, which leads to the death of the worm. Vermox also inhibits the development of worm eggs.
To avoid the spread of infection, it is recommended that everyone in the family is treated at the same time.
The mebendazole found in Vermox may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Vermox
Do not use Vermox
- if you are allergic to mebendazole or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Vermox should not be used in children under 1 year of age. Convulsions have been reported in children, including infants (see section 4 Undesirable effects ). Vermox should only be given to children under 2 years of age if the doctor has specifically prescribed it.
Other medicines and Vermox
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
Vermox can affect or be affected by certain medicines that contain the following active substance/substances:
- metronidazole. Medicines containing metronidazole should not be used at the same time as Vermox. Metronidazole is an antibiotic, medicine against infection by bacteria and protozoa. There is a suspicion of a connection between serious skin reactions with the simultaneous use of Vermox and metronidazole. See also section 4 Possible side effects
- of cimetidine (for stomach ulcers ). Talk to your doctor if you are using medicines containing cimetidine.
Pregnancy and breastfeeding
Pregnancy
Pregnant women should only use Vermox after a doctor’s prescription.
Experience with the use of Vermox during pregnancy is limited.
If you are pregnant, think you may be pregnant, or are planning to have a baby, always consult a doctor before using this medicine.
Breast-feeding
Vermox can pass into breast milk. Therefore, consult a doctor before use during breastfeeding.
Driving ability and use of machinery
In rare cases, dizziness and seizures have been reported in some patients using Vermox.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Vermox contains
The vermox oral suspension contains sucrose, propyl hydroxybenzoate (E216), methyl hydroxybenzoate (E218), and sodium
Vermox oral suspension contains sucrose. If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
The vermox oral suspension also contains the preservatives propyl hydroxybenzoate (E216) and methyl hydroxybenzoate (E218) which can cause an allergic reaction (possibly delayed).
The vermox oral suspension contains less than 1 mmol (23 mg) of sodium per 5 ml, i.e. it is almost “sodium-free”.
Vermox tablets contain para-orange (E110) and sodium
Vermox tablets contain the dye para-orange (E110) which can cause allergic reactions.
Vermox tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e. are almost “sodium-free”.
How to use Vermox
Always use this medicine according to this leaflet or as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Consider using Vermox oral suspension if you or your child cannot swallow the tablet.
The recommended dose for adults and children from 2 years:
For roundworms: 1 tablet or 5 ml suspension as a single dose.
Repeat the treatment after about 2 weeks. It prevents recurrence and is necessary to completely get rid of the worms. The first treatment kills the worms, but not their eggs. When the eggs hatch, a new infection may occur if you do not repeat the treatment. Contact a doctor if the symptoms do not disappear within a few days after repeated treatment.
Do not exceed dosage one.
If Vermox has been prescribed by a doctor for a different use than a tapeworm, then a different dosage may apply, contact the doctor for the appropriate dose to use.
To avoid the spread of infection, it is recommended that everyone in the family is treated at the same time.
Careful hygiene, both personal and in the environment, is essential to reduce the risk of re-infection. You should therefore follow the hygiene advice below:
- Wash the tail and adjacent skin areas daily with soap and water.
- Wash your hands often. Keep your nails short and clean.
- Sleep in pajamas or tight pants. Change underwear and pajamas daily.
- Change and wash the bedding often.
- Used clothes should be washed the same day they are changed.
- The bathtub, sink, bathroom floor, and toilet seat are washed daily.
- Pets are not affected by roundworms, but worm eggs can be found in the fur. Therefore wash dogs and cats.
Vermox should not be used in children under 1 year of age. Vermox should only be given to children under 2 years of age if the doctor has specifically prescribed it.
The suspension is shaken before use. A filled dose measure corresponds to 5 ml. The bottle has a child-resistant lid that is opened by holding it down and turning it counterclockwise.
If you have used too much Vermox
If you have ingested too much medicine or if, for example, If a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Vermox
Do not take a double dose to make up for a missed dose.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Vermox and contact your doctor immediately or go to the nearest emergency department if you experience the following:
Any of the following rare symptoms ( angioedema ):
- swelling of the face, tongue, or throat
- difficulty swallowing
- hives and difficulty breathing.
Very strong and serious rare skin side effects such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported with the use of Vermox
The skin side effects can consist of a rash with or without blisters. Skin redness, sores, or swelling in the mouth, throat, eyes, nose, and around the genitals ( Stevens-Johnson syndrome ) as well as fever and flu-like symptoms can also occur. The skin rash can develop into serious widespread skin damage (skin peeling of the epidermis and superficial mucous membranes) with life-threatening consequences.
Other side effects are
Common (may affect up to 1 in 10 users):
- abdominal pain.
Uncommon (may affect up to 1 in 100 users):
- abdominal discomfort, diarrhea, flatulence.
Rare (may affect up to 1 in 1,000 users):
- decreased number of white blood cells
- hypersensitivity reaction (including anaphylactic reactions with fever, rash, swelling, and sometimes drop in blood pressure)
- seizures, dizziness
- inflammation of the liver ( hepatitis ), liver damage
- skin rash, skin redness, hives, and hair loss.
Very rare (may affect up to 1 in 10,000 users):
- nausea, vomiting
If any side effects get worse or if you notice any side effects not mentioned in this information, contact your doctor or pharmacist.
How to store Vermox
No special storage instructions.
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging after “EXP.”. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
Vermox 100 mg tablets:
- The active substance is mebendazole.
- Other ingredients are microcrystalline cellulose, sodium starch glycolate, talc, corn starch, saccharin sodium, hydrogenated cottonseed oil, magnesium stearate, flavor (orange essence), anhydrous colloidal silicon dioxide, sodium lauryl sulfate, para-orange (E110).
Vermox 20 mg/ml oral suspension:
- The active substance is mebendazole.
- Other ingredients are sucrose, microcrystalline cellulose, and carmellose sodium, methylcellulose, methyl hydroxybenzoate (E218), sodium lauryl sulfate, propyl hydroxybenzoate (E216), flavor (banana essence), citric acid monohydrate and purified water.
Appearance and package sizes of the medicine
Vermox tablets are slightly orange, round, and marked Me/100 and JANSSEN respectively. The tablets are supplied in a pressure pack of 6 tablets.
The vermox oral suspension is milky white with a banana flavor and is supplied in a 30 ml bottle with a 5 ml dosage measure.
Janssen Pharmaceutica NV, Turnhoutseweg 30, B-2340 Beerse, Belgium.
Manufacturer of Vermox tablets
Lusomedicamenta Sociedade Técnica, Farmacêutica, SA, Estrada Consiglieri Pedroso 69 B, Queluz, 2730-055 Barcarena, Portugal.