Albendazole 400 mg chewable tablets – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Albendazole 400 mg chewable tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 400 mg albendazole.

Excipient (s) with known effect:

Each tablet contains 95.187 mg of lactose and 6.213 mg of sodium.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Chewable tablet

White to off white coloured, oblong shaped, biconvex chewable tablets debossed with “AL” and “400” on either side of the breakline on one side and other side plain with an approximate length of 19.00 mm and width of 9.20 mm.

The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Albendazole 400 mg chewable tablets are used for the treatment of the following helminthoses:

Cystic echinococcosis

(Echinococcus granulosus-infection, dog tapeworm infestation)

• Inoperable progressive form
• non-radically operable progressive form
• preoperative support of surgical therapy

Alveolar echinococcosis

(Echinococcus multilocularis-infection, fox tapeworm infestation)

• Inoperable progressive form
• non-radically operable progressive form
• preoperative support of surgical therapy

A treatment test for strongyl infestation (Strongyloidiasis, Strongyloides stercoralis) is indicated.

Albendazole 400 mg chewable tablets are indicated in adults and adolescents with a body weight of ≥ 60 kg.

4.2 Posology and method of administration

Posology

The medicinal product should not be used in patients weighting < 60 kg.

Cystic or alveolar echinococcosis

One treatment cycle comprises 400 mg albendazole (1 chewable tablet) twice a day for the duration of 28 days followed by a 14-day break. At least two but not more than three treatment cycles should be carried out.

• preoperative:

If surgical treatment is intended, this should be preceded with treatment with albendazole for 2 cycles as described above.

If an operation is necessary before completion of two complete cycles, albendazole should be administered for as long as possible but not longer than for 28 days / cycle.

• postoperative:

If an operation is indispensable after less than 14 days of treatment, albendazole should be administered after the operation for at least 2 treatment cycles of 28 days each, with a 14-day interval between them.

2 complete treatment cycles should also be carried out if cysts still exist after preoperative treatment or after cyst rupture.

Confirmed diagnosis or suspicion of strongyl infestation (Strongyloidiasis)

400 mg albendazole (1 chewable tablet) once daily for 3 consecutive days

Paediatric population

Albendazole tablets should not be used in children and adolescents weighing less than 60 kg, as the safety and efficacy have not been established in this patient group.

Elderly people

Experience with older patients (65 years and older) is limited. Reports show that no dosage adjustment is required (see section 4.4.).

Dosage for renal impairment

Because the excretion of albendazole and its primary metabolite albendazole sulfoxide is negligible from the kidney, it is unlikely that the clearance of these components will be altered in patients with renal insufficiency. Adjustment of dosage is not required. Nevertheless, patients with a history of renal insufficiency should be carefully monitored.

Dosage for hepatic impairment

In patients with hepatic dysfunction the warnings should be observed (see sections 4.4 and 4.8).

Method of administration

Albendazole 400 mg chewable tablets are for oral use.

The tablets should be chewed. They should be taken with meals in the morning and in the evening.

For a better absorption of the active substance, a fat-containing diet is recommended. This should be as solid as possible and contain over 40 g of fat per meal.

4.3 Contraindications

Hypersensitivity to albendazole or to any of the excipients listed in section 6.1.

Albendazole should not be used during pregnancy or by women who are thought to be pregnant. To exclude pregnancy, a test should be carried out in women of childbearing age before starting and regularly during treatment with albendazole (see section 6). Albendazole treatment of children under 6 years of age is not recommended due to lack of therapeutic experience.

4.4 Special warnings and precautions for use

Albendazole should not be used in children and adolescents with a body weight less than 60 kg (see section 4.2).

Since albendazole is rapidly degraded in the liver to its primary pharmacologically active metabolite albendazole sulfoxide, it can be assumed that hepatic impairment has a significant effect on the pharmacokinetics of albendazole sulfoxide.

During treatment with albendazole, low to moderately elevated liver enzymes can occur, which usually return to normal after discontinuation of therapy. Incidences of hepatitis have also been reported.

Influence on hepatic enzymes

Albendazole treatment has been associated with mild to moderate elevations of hepatic enzymes. Hepatitis cases have also been reported. Hepatic enzymes generally normalise on discontinuation of treatment. Individuals with hepatic impairment must seek medical advice before starting the treatment.

Liver function tests should be performed before the start of each therapy cycle, 5 and 10 days, and then at least every 2 weeks during therapy. If the liver enzymes have significantly increased (more than twice the upper limit of the normal range), Albendazole therapy should be discontinued. Re-treatment with albendazole may be considered when the values have returned to the normal range but patients should be monitored carefully and at a shorter interval (weekly).

Patients who show abnormal levels of liver function tests (transaminases) before starting treatment with albendazole should be carefully monitored and therapy discontinued if the enzyme values are significantly increased or the blood cell counts are declining to a clinically significant extent (see section 4.8).

Treatment with albendazole can lead to myelosuppression. Therefore, monitoring should be carried out at the beginning of each treatment cycle after 5 and 10 days, and then after 14 days of treatment during each of the 28-day treatment cycles. Patients with liver disease, including hepatic echinococcosis, appear to be more susceptible to myelosuppression leading to pancytopenia, aplastic anemia, agranulocytosis, and leukopenia. In these patients the blood count should therefore be monitored more closely.

Albendazole should be discontinued if the blood cell count drops to a clinically significant extent (see section 4.8).

Albendazole should be used with caution in elderly patients and patients with renal impairment (see section 5.2).

To avoid treatment during pregnancy, please refer to section 4.3 and 4.6.

In patients treated with albendazole, an existing neurocysticercosis can be seen, especially in areas with pronounced taeniasis infection. Neurological symptoms may occur in these patients, e.g. seizures, increased cerebral pressure or focal symptoms resulting from an inflammatory reaction caused by the death of the parasites in the brain. The symptoms may occur shortly after the treatment. Immediate treatment with corticosteroids and anti-convulsants should be initiated.

The medicinal product contains lactose.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet that is to say essentially ‘sodium-free’.

4.5 Interaction with other medicinal products and other forms of interaction

Concomitant use of albendazole with Cimetidine, Praziquantel or Dexamethasone increases the concentration of active metabolite of albendazole in plasma.

Ritonavir, Phenytoin, Carbamazepine and Phenobarbital may possibly reduce the plasma concentrations of the active metabolite of albendazole, albendazole sulfoxide. The clinical relevance thereof is not known but reduced efficacy may occur, particularly in the treatment of systemic helminthoses. Patients should be monitored for effectiveness and may need alternative dosage regimens or therapies.

4.6 Fertility, pregnancy and lactation

Pregnancy

There is no suitable data from the use of albendazole in pregnant women. Data from animal studies have shown reproductive toxicity (see section 5.3). The possible risk to humans is not known. Albendazole should not be taken during pregnancy unless clearly necessary.

In order to exclude pregnancy, a test should be performed in women of childbearing age before beginning and regularly during treatment with albendazole.

Because of the teratogenic properties of the benzimidazole derivatives, it is recommended to ensure that patients of childbearing age are responsible for effective contraceptive measures. For this reason, the use of the "pill" alone is unsuitable due to unclear interactions with hormonal ovulation inhibitors. Contraception carried out just before, during, and one month after albendazole treatment.

Breast-feeding

Albendazole should not be used during lactation, as there are insufficient data for breastfeeding women or animal experiments.

Fertility

There are no data on the effect of albendazole on human fertility.

4.7 Effects on ability to drive and use machines

Albendazole has yet no evidence of a restriction on the ability to drive or use machines.

4.8 Undesirable effects

The following is a list of the undesirable effects after system organ classes and absolute frequency (all reported events). The frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1 / 1,000 to < 1/100), rare (≥ 1 / 10,000 to < 1 / 1,000), very rare (<1 / 10,000), not known (frequency cannot be estimated from the available data).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

Albendazole has only a low acute toxicity. So far, no reports of intoxications are available. Specific antidotes are not known.

Further treatment should be performed according to the clinical manifestation or according to recommendations from information centres for cases of poisoning.

Since more attention should be given to possible undesirable effects after intoxication, monitoring of the blood count and the liver values are recommended (see section 4.4).

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Anthelmintics, benzimidazole derivatives

ATC code: P02 CA03

Mechanism of action

Albendazole is a benzimidazole derivative with antiprotozoal and anthelmintic activity against intestinal and tissue parasites. Albendazole has larvicidal, ovicidal and vermicidal effects, which are presumably caused by an inhibition of the polymerisation of the tubulin of the cytoplasmic microtubule system of intestinal parasites. This leads to the interruption of the metabolism of the helminths, including an energy loss, whereby an immobilization of the sensitive helminths takes place.

These pathophysiological changes lead to the death of the parasites.

5.2 Pharmacokinetic properties

Albendazole is lipophilic and is therefore poorly absorbed after oral administration (<5%). Albendazole is subject to a high first-pass effect in the liver and is normally not detectable in the plasma. It is rapidly metabolized to the main metabolite albendazole sulfoxide, which is responsible for the anthelmintic effect. When albendazole is administered together with high-fat diet, the systemic availability increases by approximately 5-fold. Emulsified fat (e.g. in liquid food), on the other hand, does not have an improving effect on availability. After oral administration of 400 mg abendazole with a breakfast (fat content about 40 g), the maximum plasma concentration of albendazole sulfoxide was between 1.8 and 6.0 μmol/l.

The plasma half-life of albendazole sulfoxide is about 8.5 hours.

Elderly people

Although no studies have investigated the effect of age on the pharmacokinetics of albendazole sulfoxide, data from 26 patients with echinococcal cysts suggest that the pharmacokinetics of these patients (aged 79 years) are similar to those of young healthy people. The number of elderly patients treated for echinococcosis or neurocysticercosis is limited. However, no problems were observed due to the increased age of the patients.

Renal impairment

The pharmacokinetics of albendazole has not been studied in patients with renal dysfunction.

Hepatic impairment

The pharmacokinetics of albendazole has not been studied in patients with liver dysfunction.

In the cyst fluid, albendazole sulfoxide was found at a level of about 15 to 20% of the albendazole sulfoxide concentration in the blood plasma. Albendazole sulfoxide and its metabolites are excreted mainly via the bile and only to a small extent via the urine.

The elimination from the cysts is significantly slower compared to elimination from the plasma.

It can last several weeks after high and longer dosage.

5.3 Preclinical safety data

Acute toxicity

Albendazole has a low acute toxicity. The LD₅₀ after oral administration was between 500 mg/kg and > 10,000 mg/kg body weight in mice, rats, rabbits and hamsters, only in pigs the LD₅₀ was lower at 106 mg / kg body weight. Symptoms included weight loss, clonic convulsion, impact on respiration and diarrhea.

Repeated dose toxicity

Studies for up to 6 months in mice, rats and dogs revealed the hematopoietic system and the liver as the target organs of toxicity. Regular monitoring of the blood and liver values during long-term therapy is therefore recommended.

Reproductive Toxicology

The teratogenicity of anthelmintically active benzimidazole derivatives is known. In some animal models, albendazole is already present in teratogenic dosages, which correspond to or approximate the therapeutic dosage. An influence on fertility was not observed.

Mutagenic and carcinogenic potential

Albendazole has not yet been subjected to a detailed mutagenicity test. However, albendazole showed no mutagenic properties in a series of in-vitro tests (S. typhimurium Re-mutation test with or without metabolic activation, chromosome aberration test on CHO cells) and in a micronucleus test in vivo in the rat.

A cell transformation test on BALB/3T3 cells in-vitro was weakly positive only after previous metabolic activation. However, carcinogenicity studies in the rat and mouse revealed no possible carcinogenic potential.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Microcrystalline cellulose

Lactose monohydrate

Maize starch

Sodium starch glycolate (type A)

Sodium dodecyl sulphate

Povidone K30

Saccharin sodium

Croscarmellose sodium

Orange DC pH capsaroma

Peppermint DC 117 pH flavour

Colloidal anhydrous silica

Magnesium stearate

Orange DC pH capsaroma contains Acacia gum, Flavouring preparations, Butylated hydroxy anisole.

Peppermint DC 117 pH flavour contains Acacia gum, Flavouring preparations, Nature-identical flavouring substances.

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 years

Bottle:

After first opening: 100 days

6.4 Special precautions for storage

This medicinal product does not require any special storage condition.

6.5 Nature and contents of container

Alu-Alu blister (i.e OPA/Au/PVC- Alu) in cartons containing 2, 4, 6, 8, 12 or 18 chewable tablets

HDPE bottles with PP screw cap containing 60 and 100 chewable tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER

Brown & Burk UK Limited

Micro House

Bury Street

Ruislip

HA4 7TL

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 25298/0457

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

10/08/2026

10 DATE OF REVISION OF THE TEXT

10/08/2026