Tranquiline 35 mg/ml Oral Gel for Dogs

Composition

Each ml contains:

Active substance:

Acepromazine 35.00 mg

(as acepromazine maleate) (47.50 mg)

Excipients:

Clear yellow gel.

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Pharmacological properties

4.1 ATCvet code:

QN05AA04

4.2 Pharmacodynamics

Acepromazine is a phenothiazine derivative. This group of molecules belongs to the neuroleptics: they depress the central nervous system and exert associated effects on the autonomic system. These effects are due to their interference with different neurotransmitter receptors (dopaminergic, adrenergic) and to their interference with hypothalamic performance. The sedative activity starts within 15 to 30 minutes of treatment and lasts for 6 -7 hours.

4.3 Pharmacokinetics

Acepromazine is partly absorbed from the gastrointestinal tract. Plasma protein binding is high and it is extensively distributed throughout the body tissues. Plasma levels are usually low. Acepromazine is highly metabolised, with the urine as the main route of excretion.

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Target species

Dogs.

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Indications

For sedation and anaesthetic pre-medication.

Anti-emetic effect, in case of vomiting associated with motion sickness.

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Dosage

For oral use.

Light sedation: 1.0 mg acepromazine / kg body weight.

Deeper sedation: 2.0 mg acepromazine / kg body weight.

Pre-medication: 3.0 mg acepromazine /kg body weight.

Anti-emetic effect: 1.0 mg/kg body weight.

The dose to be administered to dogs weighing ≥35 kg should not be more than 1 mg/kg for any level of sedation/premedication.

The above dosage information is provided as a guideline and should be adapted to each patient, taking into account the various factors (e.g. temperament, breed, bodyweight, nervousness etc.) that may affect the sensitivity to sedatives.

The following tables are intended as a dispensing guide, depending on the desired degree of sedation:

Particular care should be taken with regard to the accuracy of dosing. To ensure accuracy of dosing, the bodyweight of the animal to be treated should be determined prior to dosing.

Prefilled syringe

The veterinary medicinal product is filled into a 10 ml polyethylene syringe. The flanged plunger has a locking ring which should be adjusted to supply the volume required in accordance with the dosage guidelines. 1.0 ml intervals are printed on the syringe plunger, but the plunger is indented/flanged at intervals of 0.5 ml. A single turn of the locking ring will move the ring backwards allowing a dose volume of 0.5 ml to be expelled. Two turns of the locking ring will supply a dose volume of 1.0 ml. Three turns of the locking ring are required for a dose of 1.5 ml.

The syringe is brought into the animal's mouth and the appropriate dose is expelled into the animal's cheek.

The gel can also be mixed with food.

Glass bottle

The veterinary medicinal product is filled into 10 ml glass bottles with child resistant closure and supplied with a syringe with a dose graduation allowing accurate dosing. The 1 ml syringe can administer 0.05 to 1.0 ml with 0.05 ml increments. Withdraw the appropriate dose from the bottle using the supplied syringe. The syringe is brought into the animal's mouth and the appropriate dose is expelled into the animal's cheek. Some veterinary medicinal product will remain in the glass bottle, i.e. is not extractable.

The gel can also be mixed with food.

In dogs, sedation usually sets in after 15-30 minutes and lasts 6-7 hours.

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Contraindications

Do not use in cases of hypotension, post-traumatic shock or hypovolemia. Do not use in animals in a state of severe emotional excitation.

Do not use in animals suffering from hypothermia.

Do not use in animals with haematological disorders/coagulopathies or anaemia. Do not use in animals with heart and or lung failure.

Do not use in animals with an existing tendency to convulsions or with epilepsy. Do not use in dogs less than 3 months of age.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

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Adverse reactions

Dogs:

1 Inhibition of temperature regulation.

2 Transient and reversible.

3 Due to increased prolactin secretion which may lead to disturbances in fertility.

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:

The veterinary medicinal product is presented in a 10 ml prefilled syringe and 10 ml glass bottle with dosing syringe. The accuracy of dosing differs between the two presentations.

Prefilled syringe

Given the limitations of the prefilled syringe in delivering dose volumes of less than 0.5 ml, its use in animals weighing less than 17.5 kg bodyweight for sedation or in sensitive individuals and breeds is not recommended and the glass bottle with the 1 ml syringe should be used instead.

Glass bottle

Use of the veterinary medicinal product with the 1 ml dosing syringe in dogs less than 1.75 kg bodyweight should be based on a careful benefit-risk assessment by the responsible veterinarian (see section 3.9).

This veterinary medicinal product should be used with caution and with reduced dosage in the case of hepatic disease or in debilitated animals.

Acepromazine has negligible analgesic effects. Painful activities should be avoided when handling tranquillized animals, unless treated with appropriate analgesics. After administration of this veterinary medicinal product, animals should be kept in a calm place and sensorial stimuli should be avoided as far as possible.

In dogs with the ABCB1-1Δ (also called MDR1) mutation, acepromazine tends to cause more profound and prolonged sedation. In these dogs the dose should be reduced by 25% - 50%.

In some dogs, particularly Boxers and other short-nosed breeds, spontaneous fainting or syncope may occur, due to sinoatrial block caused by excessive vagal tone, and an attack may be precipitated by acepromazine, so a low dose should be used. Where there is a history of this type of syncope, or if it is suspected because of excessive sinus arrhythmia, it may be advantageous to control the dysrhythmia with atropine given just before the acepromazine.

Large breeds: it has been noted that large breeds of dogs are particularly sensitive to acepromazine and the minimum dose possible should be used in these breeds. Acepromazine should be used cautiously as a restraining agent in aggressive dogs as it may make the animal more prone to startle and react to noises or other sensory inputs.

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

Acepromazine may cause sedation. Care should be taken to avoid accidental ingestion.

To avoid accidental ingestion by a child when using the prefilled syringe: replace cap immediately after use. Keep the broached oral syringe in the original carton and make sure that the carton is closed properly. To avoid accidental ingestion by a child when using the glass bottle, do not leave the filled syringe unattended and store the properly closed bottle and used syringe in the original carton.

This veterinary medicinal product must be used and kept out of sight and reach of children.

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

DO NOT DRIVE as sedation and changes in blood pressure may occur.

People with known hypersensitivity to acepromazine or other phenothiazines or to any of the excipients should avoid contact with the veterinary medicinal product. Persons with sensitive skin or in frequent contact with the veterinary medicinal product are advised to wear impermeable gloves.

Wash hands and exposed skin thoroughly after use.

In case of accidental spillage onto the skin, immediately after exposure wash the exposed skin with large amounts of water.

This veterinary medicinal product may cause mild eye irritation. Avoid contact with eyes. If accidental eye contact occurs, flush gently with running water for 15 minutes and seek medical advice if any irritation persists.

Special precautions for the protection of the environment:

Not applicable.

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:

The safety of the veterinary medicinal product has not been established during pregnancy and lactation. The use of acepromazine during pregnancy is not recommended. Use only according to the benefit-risk assessment by the responsible veterinarian.

Fertility:

Please see also Section 3.6 concerning fertility in bitches.

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Interactions

Acepromazine potentiates the action of centrally depressant drugs.

Simultaneous administration, or administration to animals recently treated with organophosphates or procaine hydrochloride (a local anaesthetic) should be avoided, since these molecules enhance the toxic effects of acepromazine.

Since acepromazine decreases sympathetic nervous system tone, simultaneous treatment with blood pressure lowering products should not take place.

Antacids may cause a decrease in the gastrointestinal absorption of acepromazine after oral administration.

Opiates and adrenaline may enhance the hypotensive effects of acepromazine.

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Overdose

Overdosage results in an earlier onset of the sedative symptoms and in a prolonged effect.

Toxic effects are ataxia, hypotension, hypothermia and extrapyramidal effects. Antidote: Noradrenaline can be used to counteract the cardiovascular effects, but not adrenaline.

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Special warnings

None.

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Withdrawal period

Not applicable.

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Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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Immediate packaging

Prefilled syringes

Container: White, high-density polyethylene syringe barrel.

White, low-density polyethylene syringe plunger.

Closure: White, high-density polyethylene, push-fit cap.

Fill volume: 10 ml

Dosing device: The veterinary medicinal product is presented in an oral dosing syringe which is graduated at 1 ml intervals.

Glass bottles

Container: Amber Type III glass bottles of 10 ml volume.

Closure: high-density polyethylene/low-density polyethylene child resistant closures

Extractable volume: 9.8 ml of the veterinary medicinal product can be withdrawn from each 10 ml amber glass bottle

Dosing device: 1.0 ml polypropylene oral dosing syringe, graduated at 0.05 ml intervals, is supplied with the 10 ml amber glass bottle.

Not all pack sizes may be marketed.

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Storage

Do not store above 25 °C.

Do not refrigerate or freeze.

Protect from light.

Keep the broached containers in the outer carton in order to protect from light. Store in a dry place.

Do not leave the 1 ml dosing syringe containing veterinary medicinal product in the sight or reach of children.

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Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf life after first opening the immediate packaging: 3 months.

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Disposal of unused product

Medicines should not be disposed of via wastewater.

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 56190/5002 (GB) Vm 56190/3002 (NI)

8 DATE OF FIRST AUTHORISATION

17 February 2021

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

November 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: 13 March 2026

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Registration holder

Floris Holding B.V.

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