Yomesan 500 mg Chewable tablet

YOMESAN is indicated for the treatment of the following tapeworm infections in adults and children:

• Infection by Taenia saginata (beef tapeworm)
• Infection by Taenia solium (pork tapeworm)
• Infection by Diphyllobothrium latum (fish tapeworm)
• Infection by Hymenolepis nana (dwarf tapeworm)

Posology

Infections

Patient group

Chewable tablets per day

Day 1

Day 2 to 7

• Taenia saginata
• Taenia solium
• Diphyllobothrium latum

Children aged above 6 years and adults

4 chewable tablets

Not applicable

Children aged between 2 and 6 years

2 chewable tablets

Not applicable

Children aged below 2 years

1 chewable tablet

Not applicable

• Hymenolepis nana

Children aged above 6 years and adults

4 chewable tablets

2 chewable tablets per day

Children aged between 2 and 6 years

2 chewable tablets

1 chewable tablet per day

Children aged below 2 years

1 chewable tablet

1/2 chewable tablet per day

Special Populations

Patients with hepatic impairment

Niclosamide is not absorbed appreciably from the gastrointestinal tract and does not affect hepatic function. Therefore, dosing adjustment is not required in hepatic impairment.

Patients with renal impairment

Niclosamide is not absorbed appreciably from the gastrointestinal tract and does not affect normal renal function. Therefore, dosing adjustment is not required in renal impairment.

Children

For young children, the chewable tablets should be crushed to a fine paste and given with a little water.

Method of administration

For oral use. The daily dose is taken as a single dose after breakfast. The pleasant tasting tablets should be thoroughly chewed to a fine paste and washed down with a little water. They can also be taken crushed in water.

Special monitoring advice

Elimination of the intestinal mucus produced abundantly in a tapeworm infection can be promoted by drinking acidic fruit juice, which allows easier access of the product to worms situated underneath the mucus. If constipated, regular bowel movements should always be established before treatment with YOMESAN. No special dietary measures are necessary. A saline laxative (e.g., sodium sulphate, magnesium sulphate) can be given two hours after taking the YOMESAN dose (or in the case of Hymenolepis nana, after the last dose) to ensure a rapid and complete expulsion of the worm. Without purgation, the parasite is excreted in pieces for about 2 days after the end of treatment. In the case of Taenia solium (pork tapeworm) infections, a saline laxative is imperative.

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

YOMESAN has no systemic therapeutic effects. It works by eliminating tapeworms present in the intestine. Through elimination of tapeworms, it may have an effect on cysticercosis, or echinococcosis caused by larvae (cysts) of T. solium, E. ultilocularis or E. granulosus by preventing their establishment extraintestinally in the tissue. The risk of cysticercosis existing in cases of pork tapeworm infestation is avoided by the recommended saline laxative purging, the aim being to excrete as quickly as possible the lower tapeworm segments containing the ripe eggs. This prevents the eggs being later transferred to the fingers as a result of deficient defaecation hygiene and from the fingers into the mouth of the patient, where they can cause cysticercosis.

Niclosamide is soluble in alcohol which may enhance its absorption. Therefore, YOMESAN should not be taken together with any alcohol-containing beverage (see section 4.7).

Pregnancy

During pregnancy, and especially during the first trimester, YOMESAN should be used only where it is strictly indicated.

Lactation

It is unknown whether niclosamide is excreted in human breast milk. YOMESAN should only be used in breast-feeding woman after risk/benefit evaluation by a healthcare professional.

YOMESAN may result in an impairment of the patientu2019s ability to drive or operate machinery due to central nervous system reactions (see section 4.8).

The listed adverse reactions are based on spontaneous reports, and their frequencies are therefore unknown.

Immune system disorders

• Allergic reaction (e.g., with erythema, pruritus and exanthema), anaphylactic reaction and anaphylactic shock.

Nervous system disorders

• Dizziness (light-headedness)

Vascular disorders

• Cyanosis

Gastrointestinal disorders

• Nausea, vomiting, gastrointestinal and abdominal pains, retching and diarrhoea

Skin and subcutaneous tissue disorders

• Rash, pruritus and hyperhidrosis

General disorders and administration site conditions

• Feeling unwell (fatigue)

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the risk/benefit balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

According to available evidence, the active substance of YOMESAN, niclosamide, is only slightly absorbed, so that toxic effects are not expected. Should a patient have taken a marked overdosage, for safety reasons the usual therapeutic measures for the treatment of poisoning should be applied (symptomatic therapy). No cases of overdose have been reported.