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    Albendazole, 400 mg chewable tablets

    Drug formTablets

    ATC categoryAntiparasitic agents

    ATC subcategoryAntihelmintics

    Brand nameAlbendazole

    Generic nameAlbendazole

    What Albendazole is and what it is used for

    Albendazole is anthelmintic drug, which has activity against some types of worms, which parasitize in humans.

    Albendazole is used for the treatment of enterobiasis, ancylostomiasis, necatoriasis, hymenolepsiasis, taeniasis, strongyloidiasis, ascariasis, trichuriasis, clonorchiasis, opisthorchiasis, cutaneous larva migrans, giardiasis in children, cystic echinococcosis, alveolar echinococcosis, neurocysticercosis, hepaticolosis, gnathostomiasis, trichinosis, toxocariasis.

     

    What you need to know before taking Albendazole

    Don’t take Albendazole:

    • if you are pregnant, if you think you could be pregnant, or if you are planning to become pregnant,
    • if you are allergic (hypersensitive) to Albendazole or any other ingredients of Albendazole (see section What albendazole contains),
    • talk to your doctor or pharmacist, if you have questions or any doubts about this medicine.

    Don’t take Albendazole if you have any of conditions listed above.

     

    Warnings and precautions

    Talk to your doctor or pharmacist before taking Albendazole, if.

    • you have liver or kidney disfunction,
    • you have hematopoietic system disorders,
    • your body weight is less than 60 kg,
    • you are over 65 years old.

     

    Your doctor may undertake tests for liver function and blood tests before starting treatment with Albendazole and during treatment.

    If you consider, that any of this conditions relates to you, or if you have any questions or doubts about administration of this medicine, talk to your doctor or pharmacist.

     

    Children and adolescent

    Albendazole is contraindicated to children and adolescents with body weight less than 60 kg.

    Though clinical trials were carried out with taking Albendazole in adolescents and children over 6 years with body weight less than 60 kg, Albendazole use in 400 mg dosage for children under 6 years is limited.

     

    Taking other medicines with Albendazole

    You should always tell your doctor or pharmacist if you use other medicines regularly, have used other medicines recently or wish to use other medicines at the same time as Albendazole.

    You should inform your doctor, if you are taking any of these drugs.

    • phenytoin, fosphenytoin, carbamazepine, phenobarbital or primidone (drugs for treatment of epileptic seizures)
    • praziquantel and levamisole (anthelmintic drugs),
    • ritonavir (so called protease inhibitors, which are used for HIV treatment),
    • cimetidine (used for treatment of heartburn and gastric ulcer),
    • dexamethasone (glucocorticosteroid, anti-inflammator, antiallergic, anti-shock, immunosuppressive drug)
    • oral contraceptives,
    • anticoagulants (drugs for blood thinning),
    • hypoglycemic drugs for diabetes treatment,
    • theophylline (drug for treatment of broncho-obstructive syndrome of various origins (bronchial asthma, bronchitis, pulmonary emphysema).

    Taking Albendazole with food and drinks

    If you are taking Albendazole, you should not take grapefruit or grapefruit juice, as it can lead to increased levels of albendazole in blood.

     

    Pregnancy and breast feeding

    If you are pregnant, think you may be pregnant or are planning to have a baby, ask you doctor or pharmacist for advice before taking this medicine. In women with child-bearing potential treatment should be started only after a negative pregnancy test

    Women with child-bearing potential, who are taking Albendazole, need to use adequate contraception along the whole treatment up to first menstruation after therapy ending.

    It is contraindicated to use hormonal contraceptives during treatment with Albendazole. You can start to plan pregnancy only in a month after administration of the last dose of Albendazole.

    It is not known whether albendazole or its metabolites are secreted in human breast milk. Talk to your doctor before starting to take Albendazole in breast feeding period.

    If you are breast feeding or planning to breast feed, immediately inform your doctor about it.

     

    Effects on ability to drive and use machines

    This drug can cause side effects, which may affect you ability to drive and use machines. Before getting behind the wheel or using machines, make sure, that your reactions are normal.

     

    Important information about some ingredients of Albendazole

    Albendazole contains lactose monohydrate. If your doctor has told you, that you have intolerance to some types of sugar, consult with your doctor or pharmacist before taking this medicine.

     

    How to take Albendazole

    You should always take Albendazole as prescribed by your doctor. If you have any doubts about administration of this drug, you should consult with your doctor or pharmacist.

     

    The recommended dose of Albendazole is as follows:

    Intestinal parasites and cutaneous Larva Migrans

    Indications

    Age

    Dose and Period

    Enterobiasis, ancylostomiasis, ascariasis, trichuriasis, necatoriasis

    Adults and children over 6 years

    400 mg as a single dose.

    Strongyloidiasis, taeniasis, hymenolepsiasis

    Adults and children over 6 years

    400 mg, one dose per  day for 3 days. In cases of proven Hymenolepiasis, retreatment in

    10-21 days is recommended.

    Clonorchiasis, opisthorchiasis

    Adults and children over 6 years

    400 mg, two doses per day for 3 days.

    Cutaneous Larva Migrans

    Adults and children over 6 years

    400 mg, one dose per day from 1 to 3 days.

    Giardiasis

    Only for 6-12 years old children

    400 mg, one dose per day for 5 days.

     

    Systemic helminthic infections (long-term treatment with higher doses)

    Dosage regimen must be set individually depending on patient’s age, body weight and severity of infection.

    Indications

    Dose and Period

    Cystic Echinococcosis

    28 days. In inoperable form three 28-day treatment cycles are recommended, separated by a 14-day break in dosing.

    Before the surgery, two 28-day cycles are recommended, separated by a 14-day break in dosing. If preoperative course is less than for 14 days or viable cysts are found, two cycles for 28 days should be taken after surgery separated by a 14-day break in taking the drug.

    Alveolar Echinococcosis

    28 days. The second 28-day course should be repeated after two week’s break. Treatment can be continued for months or years.

    Neurocysticercosis

    Course duration is 7 to 31 days. The second course may be repeated after two week’s break.

    Hepatic capillariasis

    400 mg, one dose per day for 10 days.

    Gnathostomiasis

    400 mg, one dose per day for 10-20 days.

    Trichinellosis and Toxocarosis

    400 mg, two doses per day for 5-10 days.

     

    How to take:

    Albendazole should be taken orally, during meal. It’s recommended to take tablets in the same time each day ( for example in the morning and in the evening). If you experience difficulties swallowing the tablets whole, you are encouraged to chew the tablets with a little water, alternatively tablets may be crushed.

     

    If you take more Albendazole Tablets than you should

    If you have taken more Albendazole Tablets than you should, contact your nearest hospital casualty department or tell your doctor immediately.

     

    If you forget to take Albendazole Tablets

    If you forget a dose, take another as soon as you remember. If it is almost time for your next dose,

    then do not take the missed dose at all. Do not take a double dose to make up for a forgotten dose.

     

    Possible side effects

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

    If you notice any undesirable effect stop taking Albendazole and inform your doctor immediately or contact your nearest hospital casualty department.

    Following side effects are very rare (< 1/10000)

    • Skin disorders:

    Erythema multiforme, which is characterized by itchy, red-purple spots, which are located mainly on skin of feets and palms, genitals, on eye’s and oral cavity’s mucous membranes. Elements of rash may elevate above the skin. There also may be such symptoms as faintness and fever.

    • Other symptoms of severe skin disorders

    Change in skin’s color, bubbles and papules, pustules, peeling, redness, pain, itchiness, rash, which may be generalized. This disorders may be accompanied by fever, headache and joint pain.

     

    Pay attention to more serious symtoms

    Patients, who are being treated for parasitic infections may be diagnosed a rare but very serious disease, which is called neurocysticercosis, wherein the patient may not even guess about his condition.

    Neurocysticercos develops in a result of parasite’s getting into one’s brain in its larval phase. Albendazol is also indicated for treatment of this disease.

     

    Inform your doctor immediately, if you notice following symptoms:

    • Insufferable headache
    • Nausea and bouts of vomiting
    • Convulsions (seizures)
    • Vision disorders

     

    Other rare, but serious side effects Albendazole may cause are.

    • Urine’s color darkening or discoloration of feces
    • Yellow skin and eye sclera’s

     

    If you notice any of these symptoms contact your doctor immediately.

     

    Other possible side effects:

    Very common side effects (> 1/10)

    • Headache
    • Changes in blood tests’ results. If you have to test your blood, warn your doctor, that you are taking Albendazol.

    Common side effects (> 1/100 and < 1/10)

    • Fever
    • Dizziness
    • Stomach disorders, dizziness, vomiting and stomach pain
    • Hair thinning and hair loss, though after stopping Albendazole usage hair are restored.

     

    Uncommon side effects (> 1/1000, and < 1/100)

    • Liver diseases
    • Hematopoietic system diseases: leukopenia with subsequent developing different infection diseases (symptoms are: fever, chilly sensation, sore throat or ulcers in oral cavity).

    Very rare side effects (< 1/10000)

    • Hematopoietic system diseases, which may cause such symptoms as: fatigue, dyspnoea, hematoma and profuse bleeding (e.g. nosebleed).

     

    How to store Albendazole
    • Do not use this medicine after the expiry date which is stated on the label or carton after “EXP”. The expiry date refers to the last day of that month.
    • Store below 25°C, in a dry place, protected from light.
    • Keep this medicine out of the sight and reach of children.
    • Shelf life – 3 years.

     

    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

     

    Contents of the pack and other information

    What contains Albendazole

    Each chewable tablet contains:

    • active ingredient: albendazole – 400.0 mg
    • Other excipients: microcrystalline cellulose, lactose monohydrate, povidone, magnesium stearate, sodium starch glycolate, maize starch, sodium lauryl sulphate, color red Е-129, sodium saccharin, sodium carboxymethylcellulose, raspberry flavor.
     
    What Albendazole looks like and contents of the pack

    A pink, round, mottled, tablet with beveled edges and with raspberry odor.

    4 tablets in a plastic bottle with leaflet in the cardboard box.

     
    Prescription status

    By prescription.