TENICIPEN 50MG 10 TABLETS | ANTIPARASITIC DOGS AND CATS

TENICIPEN

50mg tablet

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

Active substance:

Praziquantel………………….. 50,0 mg

Excipients:

For the full list of excipients, see section 6.1.

PHARMACEUTICAL FORM

pill.

Round, white tablets with a cross-shaped break line on one side.

CLINICAL DATA

target species

Dogs and cats.

Indications for use, specifying the target species

Dogs and cats: Treatment of infestations caused by cestodes:

Echinococcus spp. (E. granulosus and E. multilocularis), Taenia spp. (T. hydatigena, T. pisiformis, T. ovis, T. taeniaeformis and T. multiceps), Mesocestoides spp. and Dipylidium caninum.

Contraindications

Do not use in case of known hypersensitivity to the active substance and/or to any of the excipients.

Special warnings for each target species

Fleas act as an intermediate host for a common type of tapeworm: Dipylidium caninum. Tapeworm infestation will most certainly recur unless control of intermediate hosts (fleas, mice, etc.) is carried out.

Tapeworm infestation is unlikely in puppies less than 6 weeks of age.

Parasite resistance to a particular class of anthelmintic may develop by using an anthelmintic of that class frequently and repeatedly.

Special precautions for use

Special precautions for use in animals

None.

Special precautions to be taken by the person administering the medicinal product to animals

In case of accidental ingestion, consult a doctor immediately and show him the package leaflet or the label.

Wash hands after administering the drug to animals.

Adverse reactions (frequency and seriousness)

Dogs: Anorexia, lethargy, diarrhea and vomiting occur rarely.

Cats: Very rarely there is diarrhea and salivation.

Use during pregnancy, lactation or lay

No contraindications have been described during these periods.

Interaction with other medicinal products and other forms of interaction

None known.

Dosage and route of administration

Orally.

It can be administered directly to animals, or crushed and mixed with food.

Posology: The recommended dose is 5 mg of praziquantel/kg bw. This is equivalent to 1 tablet per 10 kg in a single dose.

Overdose (symptoms, emergency procedures, antidotes), if necessary

Praziquantel is well tolerated and its safety margin is wide. Doses higher than those recommended may cause vomiting.

Wait time

Not applicable.

PHARMACEUTICAL DATA

• List of excipients
• Cornstarch
• Magnesium stearate
• Talc
• Sodium Starch Glycolate (Type A)
• Calcium carbonate
• Sodium sacharine
• colloidal anhydrous silica
• Sorbitol

Major incompatibilities

Not applicable.

Period of validity

Shelf life of the veterinary medicinal product packaged for sale: 3 years.

Shelf-life of split/split tablets after opening the blister pack: 2 months.

Special storage precautions

This veterinary medicinal product does not require special storage conditions.

Nature and composition of the immediate packaging

Polyvinyl chloride (PVC)/aluminium blister sealed by temperature and pressure.

Formats:

• Box with 1 blister of 2 tablets.
• Box with 1 blister of 10 tablets.
• Box with 5 blister packs of 10 tablets (50 tablets).
• Box with 100 blister packs of 10 tablets (1000 tablets).

Special precautions for disposal of unused veterinary medicinal product or, where appropriate, residues derived from its use

Any unused medicine or its residues derived from it must be disposed of in accordance with local regulations.

DATA SHEET