Alpramil 4 mg/10 mg Film-coated Tablets for Cats Weighing at Least 0.5 kg

Composition

Each tablet contains:

Active substances:

Milbemycin oxime 4.0 mg

Praziquantel 10.0 mg

Excipients:

Round and convex yellow film-coated tablet with a break line on one side.

Tablets can be divided into halves.

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Pharmacological properties

4.1 ATCvet code: QP54AB51

4.2 Pharmacodynamics

Milbemycin oxime belongs to the group of macrocyclic lactones, isolated from the fermentation of Streptomyces hygroscopicus var. aureolacrimosus. It is active against mites, against larval and adult stages of nematodes as well as against larvae of Dirofilaria immitis.

The activity of milbemycin is related to its action on invertebrate neurotransmission: Milbemycin oxime, like avermectins and other milbemycins, increases nematode and insect membrane permeability to chloride ions via glutamate-gated chloride ion channels (related to vertebrate GABAA and glycine receptors). This leads to hyperpolarisation of the neuromuscular membrane and flaccid paralysis and death of the parasite.

Praziquantel is an acylated pyrazino-isoquinoline derivative. Praziquantel is active against cestodes and trematodes. It modifies the permeability for calcium (influx of Ca2+) in the membranes of the parasite inducing an imbalance in the membrane structures, leading to membrane depolarisation and almost instantaneous contraction of the musculature (tetany), rapid vacuolization of the syncytial tegument and subsequent tegumental disintegration (blebbing), resulting in easier expulsion from the gastrointestinal tract or death of the parasite.

4.3 Pharmacokinetics

After oral administration, praziquantel reaches peak plasma concentrations (Cmax 1.08 μg/ml) within 2 hours after oral administration. The half-life of elimination is around 2 hours.

After oral administration, milbemycin oxime reaches peak plasma concentrations (Cmax 1.48 μg/ml) within 3 hours. The half-life of elimination is around 22 hours (± 10 hours).

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Target species

Cats weighing at least 0.5 kg.

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Indications

Treatment of mixed infections by immature and adult cestodes and nematodes of the following species:

- Cestodes:

Dipylidium caninum Taenia spp.

Echinococcus multilocularis

- Nematodes:

Ancylostoma tubaeforme Toxocara cati

Prevention of heartworm disease (Dirofilaria immitis) if concomitant treatment against cestodes is indicated.

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Dosage

Oral use.

To ensure a correct dosage, body weight should be determined as accurately as possible.

Minimum recommended dose rate: 2 mg of milbemycin oxime and 5 mg of praziquantel per kg are given orally as a single dose.

The veterinary medicinal product should be administered with or after some food. Doing so ensures optimum protection against heartworm disease.

Depending on the bodyweight of the cat and the availability of tablet strengths, practical dosing examples are as follows:

The veterinary medicinal product can be inserted into a programme for prevention of heartworm disease if at the same time treatment against tapeworms is indicated. The veterinary medicinal product has a duration of heartworm prevention of one month. For regular prevention of heartworm disease, the use of a monosubstance is preferred.

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Contraindications

Do not use in cats of less than 6 weeks of age and/or weighing less than 0.5 kg. Do not use in cases of hypersensitivity to the active substances or to any of the excipients.

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Adverse reactions

Cats:

1 Especially in young cats.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

No studies have been performed with severely debilitated cats or individuals with seriously compromised kidney or liver function. The veterinary medicinal product is not recommended for such animals or only according to a benefit/risk assessment by the responsible veterinarian.

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

This veterinary medicinal product may be harmful when ingested, particularly for children.

Avoid accidental ingestion.

Any unused tablet parts should be discarded or returned to the open blister, inserted back into the outer packaging and used at the next administration. The veterinary medicinal product should be stored in a safe place.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Wash hands after use.

Special precautions for the protection of the environment:

Not applicable.

Other precautions:

Echinococcosis represents a hazard for humans. As Echinococcosis is a notifiable disease to the World Organisation for Animal Health (WOAH), specific guidelines on the treatment and follow-up and on the safeguard of persons need to be obtained from the relevant competent authority.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

Not applicable.

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Use during pregnancy, lactation or lay

Pregnancy and lactation:

Can be used during pregnancy and lactation.

Fertility:

Can be used in breeding animals.

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Interactions

The concurrent use of the veterinary medicinal product with selamectin is well tolerated. No interactions were observed when the recommended dose of the macrocyclic lactone selamectin was administered during treatment with the veterinary medicinal product at the recommended dose.

Although not recommended, the concomitant use of the veterinary medicinal product with a spot on containing moxidectin and imidacloprid at recommended dose rates following a single application was well tolerated in one laboratory study in 10 kittens. The safety and efficacy of the concurrent use have not been investigated in field studies. In the absence of further studies, caution should be taken in the case of concurrent use of the veterinary medicinal product with any other macrocyclic lactone. Also, no such studies have been performed with reproducing animals.

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Overdose

In case of overdose, in addition to signs observed at the recommended dose (see section 3.6), drooling was observed. This sign will usually disappear spontaneously within a day.

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Special warnings

In order to develop an effective worm control programme local epidemiological information and the risk of exposure of the cat should be taken into account. It is recommended to treat all the animals living in the same household concomitantly.

When infection with the cestode D. caninum has been confirmed, concomitant treatment against intermediate hosts, such as fleas and lice, should be discussed with a veterinarian to prevent re-infection.

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. Unnecessary use of antiparasitics or use deviating from the instructions may increase the resistance selection pressure and lead to reduced efficacy.

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Withdrawal period

Not applicable.

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Incompatibilities

Not applicable.

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Immediate packaging

PVC / PE / PVDC - Aluminium blisters containing 1, 2 or 4 tablets.

Box with 1 blister containing 1 tablet.

Box with 1 blister containing 2 tablets.

Box with 1 blister containing 4 tablets.

Box with 10 blisters each containing 1 tablet.

Box with 10 blisters each containing 2 tablets.

Box with 10 blisters each containing 4 tablets.

Box with 25 blisters each containing 1 tablet.

Box with 25 blisters each containing 2 tablets.

Box with 25 blisters each containing 4 tablets.

Not all pack sizes may be marketed.

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Storage

This veterinary medicinal product does not require any special storage conditions.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 36 months. Shelf life of divided tablets after first opening the immediate packaging: 7 days.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

The veterinary medicinal product should not enter water courses as milbemycin oxime may be dangerous for fish and other aquatic organisms.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 36408/5001 Vm 36408/3001

8 DATE OF FIRST AUTHORISATION

06 May 2022

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

December 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved 12 January 2026

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Registration holder

Alfasan Nederland B.V.

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