Bonqat - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET: Bonqat 50 mg/ml oral solution for cats

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder:

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer responsible for batch release:

Orion Corporation Orion Pharma

Tengstrominkatu 8

FI-20360 Turku

Finland

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Bonqat 50 mg/ml oral solution for cats pregabalin

• 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Each ml contains:

Active substance:

Pregabalin 50 mg

Excipient:

Sodium benzoate (E211) 2 mg

Clear, colourless solution.

• 4. INDICATION(S)

Alleviation of acute anxiety and fear associated with transportation and veterinary visits.

• 5. CONTRAINDI­CATIONS

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

• 6. ADVERSE REACTIONS

Signs of sedation (characterised by tiredness, difficulties in perception of the position and movement of the body, and problems with balance) and vomiting have been observed commonly in clinical studies. Muscle tremor, dilatated pupils, loss of appetite, weight loss and reduced number of white blood cells have been reported uncommonly in clinical studies. Salivation has been reported rarely in clinical studies. Typically, clinical signs are mild and transient.

The frequency of adverse reactions is defined using the following convention:

• – very common (more than 1 in 10 animals treated displaying adverse reaction(s))

• – common (more than 1 but less than 10 animals in 100 animals treated )

• – uncommon (more than 1 but less than 10 animals in 1 000 animals treated)

• – rare (more than 1 but less than 10 animals in 10 000 animals treated)

• – very rare (less than 1 animal in 10 000 animals treated, including isolated reports).

If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.

Cats

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

The recommended dose is 0.1 ml/kg bodyweight. Administer the product orally.

ADVICE ON CORRECT ADMINISTRATION

Give Bonqat approximately 1.5 hours before the start of the transportation/plan­ned veterinary visit. The veterinary medicinal product can be administered either directly into the mouth or mixed with small amount of food. Large amounts of food may delay the onset of effect. Use the oral syringe provided in the package for administration of the veterinary medicinal product.

See the detailed instructions for administration at the end of this leaflet.

Not applicable.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Store in a refrigerator (2°C-8°C).

Shelf life after first opening the bottle in a refrigerator: 6 months. Once opened the bottle should be stored in a refrigerator but may be stored for short periods of time (up to to 1 month in total) at or below 25°C.

Do not use this veterinary medicinal product after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

• 12. SPECIAL WARNING(S)

Special precautions for use in cats:

The safety of the veterinary medicinal product has not been established in cats weighing less than

2 kg, younger than 5 months and older than 15 years. Use only according to the benefit-risk assessment by the responsible veterinarian.

The safety of the veterinary medicinal product has only been established in healthy animals or those with mild systemic illness. It has not been established in animals with moderate or severe systemic disease e.g. moderate or severe renal, liver, or cardiovascular disease. Use only according to the benefit-risk assessment by the responsible veterinarian.

The cat’s health status needs always to be assessed by the veterinarian before prescribing the veterinary medicinal product.

The veterinary medicinal product may cause slight decrease in heart rate, respiratory rate and body temperature. As a decrease of body temperature can occur after the administration, the treated animal should be kept at a suitable ambient temperature.

Monitor the cat carefully for any symptoms of sleepiness and respiratory depression if the veterinarian informs that another medicine causing central nervous system depression has been used concomitantly with the veterinary medicinal product.

The animal owner should be advised by the prescribing veterinarian to always inform the attending veterinarian if the veterinary medicinal product has been administered to the cat prior to the veterinary visit.

If the cat spits part of the dose, vomits after treatment, or in case of excessive salivation, do not give another dose.

The effect of the veterinary medicinal product can last approximately 7 hours. In case the cat seems drowsy or shows other signs of exaggerated effects after treatment administration, keep the cat indoors and do not offer water or feed until the cat has fully recovered.

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

Exposure to the veterinary medicinal product may cause adverse effects such as dizziness, tiredness, balance problems, blurred vision and headache.

Avoid skin, eye or mucosal contact. Thoroughly wash hands immediately after administration of the veterinary medicinal product.

In case of accidental eye or mucosal contact, flush with water. Seek medical advice if symptoms (dizziness, tiredness, balance problems or blurred vision) occur.

In case of skin contact, wash with soap and water. Remove contaminated clothing.

In case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Do not drive as tiredness may occur.

Pregnancy and lactation:

Laboratory studies in rats and rabbits have shown evidence of harmful effects during pregnancy when pregabalin is administered repeatedly at very high doses (> 250-fold the recommended dose for cats). The safety of the veterinary medicinal product has not been established during pregnancy and lactation in cats. Use only according to the benefit-risk assessment by the responsible veterinarian.

Interactions

The use of other central nervous system depressants is expected to potentiate the effects of pregabalin and therefore an appropriate dose adjustment should be made by the prescribing veterinarian.

Overdose (symptoms, emergency procedures, antidotes) :

Safety following repeated administration for 6 consecutive days and at up to 5 times the recommended treatment dose was investigated in an overdose study. Overdose (3– and 5-fold higher than the recommended dose) can cause signs related to problems with balance, tiredness, vomiting and salivation at greater frequency, severity and duration than the adverse reactions observed at the recommended dose. On rare occasions loss of consciousness can be seen at the 5-fold dose.

If decrease in body temperature occurs, the cat should be kept warm.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required. These measures should help to protect the environment.

• 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency.

• 15. OTHER INFORMATION

Pack size: 1 bottle and 1 oral syringe in a cardboard box.

INSTRUCTIONS FOR ADMINISTRATION:

Remove the cap from the bottle (press down and twist). Save the cap for reclosure.

• 2. CONNECT SYRINGE

Push the plunger to the bottom of the syringe barrel to squeeze all the air out of the syringe. Push the syringe tightly into the adapter located at the top of the bottle. Use only the syringe provided with the product.

Crip plate

• 3. SELECT DOSE

Turn the bottle with the syringe in place upside down. Pull the plunger out until the black line of correct dose (ml) (prescribed by your veterinarian) can be seen under the grip plate of the syringe barrel.

If the cat weighs more than 10 kg, the total dose will need to be calculated and given in two separate doses as the syringe holds maximally only 1.0 ml of solution.

Don’t leave the filled dosing syringe unattended while preparing the cat for administration.

• 4. ADMINISTER DOSE

Gently place the syringe in the mouth of the cat and administer the dose to the base of the tongue by gradually pressing the plunger until the syringe is empty.

If the dose cannot be given directly into mouth the product can be mixed with small amount of cat’s favourite food. Do not leave additional food available for the cat after the dose has been administered as extra food may delay the onset of effect.

• 5. BACK TO PACKAGE