Sileo - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

PACKAGE LEAFLET:

Sileo 0.1 mg/ml oromucosal gel for dogs

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

Orion Corporation

Orionintie 1

FI-02200 Espoo

FINLAND

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Sileo 0.1 mg/ml oromucosal gel for dogs dexmedetomidine hydrochloride

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

Active substance:

Dexmedetomidine hydrochloride 0.1 mg/ml (equivalent to 0.09 mg/ml dexmedetomidine).

Other ingredients: Brilliant blue (E133) and tartrazine (E102).

Sileo is a translucent, green oromucosal gel.

• 4. INDICATION(S)

For the alleviation of acute anxiety and fear associated with noise in dogs.

Your dog should not be given Sileo if it:

• – has severe liver, kidney or heart disease.

• – is hypersensitive to the active substance or to any of the excipients.

• – is drowsy due to previous medication.

• 6. ADVERSE REACTIONS

Sileo may cause the following adverse reactions.

Common reactions:

• – paleness of the mucous membranes at the application site

• – tiredness (sedation)

• – vomiting

• – uncontrolled urination.

Uncommon reactions:

• – distress

• – swelling around the eyes

• – drowsiness

• – loose stools.

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.

• 7. TARGET SPECIES

Dogs

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

Oromucosal gel.

Sileo is administered onto the oral mucosa between the dog’s cheek and gum.

The Sileo oral syringe delivers the product in small increments (0.25 ml). Each increment is shown as one dot on the plunger. The dosing table provides the number of dots to be administered corresponding to the dog’s bodyweight.

The following dosing table provides the dose volume (in dots) to be administered for the corresponding bodyweight. If the dose for the dog is more than 6 dots, half of the dose should be administered to the oral mucosa on one side of the dog’s mouth and the other half of the dose onto the other side. Do not exceed the recommended dose.

Bodyweight of dog (kg)	Number of dots
2.0–5.5	1
5.6–12	2
12.1–20	3
20.1–29	4
29.1–39	5
39.1–50	6
50.1–62.5	7
62.6–75.5	8
75.6–89	9
89.1–100	10

• 9. ADVICE ON CORRECT ADMINISTRATION

Dosing should be performed by an adult. Wear impermeable disposable gloves when handling the veterinary medicinal product.

The first dose should be given as soon as the dog shows the first signs of anxiety, or when the owner detects a typical stimulus (e.g. sound of fireworks or thunder) for eliciting anxiety or fear in the respective dog. Typical signs of anxiety and fear are panting, trembling, pacing (frequent change of place, running around, restlessness), seeking people (clinging, hiding behind, pawing, following), hiding (under furniture, in dark rooms), trying to escape, freezing (absence of movements), refusing to eat food or treats, inappropriate urination, inappropriate defecation, salivation, etc.

If the fear eliciting event continues and the dog shows signs of anxiety and fear again, re-dosing can be done when 2 hours have passed from the previous dose. The product can be dosed up to 5 times during each event.

See the detailed instructions and pictures in the end of this leaflet.

• 10. WITHDRAWAL PERIOD(S)

Not applicable.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

Return the oral syringe to the outer carton immediately after each use for child safety and also in order to protect from light.

Replace cap after use.

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

Shelf life after first opening the oral syringe: 4 weeks. Add a note on the carton after “Once opened use by…” to remind you when the 4 weeks have passed.

• 12. SPECIAL WARNING(S)

Special precautions for use in animals:

Unlike most other oral veterinary products, this product is not meant to be swallowed. Instead, it must be placed onto the mucosa between the dog’s cheek and gum of the dog. Feeding and giving the dog treats within 15 minutes after administration of the gel should therefore be avoided. If the oromucosal gel is swallowed it will become less effective. In case the gel is swallowed the dog can be given another dose if necessary 2 hours after the previous dose.

In extremely nervous, excited or agitated animals the response to the medicine may be reduced.

The safety of administering Sileo to puppies younger than 16 weeks and dogs over 17 years of age has not been studied.

Special precautions to be taken by the person administering the veterinary medicinal product to animals : In case of accidental ingestion or prolonged mucosal contact, 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.

Avoid skin, eye or mucosal contact. Wear impermeable disposable gloves when handling the veterinary medicinal product.

In case of skin contact wash the skin immediately with large amounts of water and remove contaminated clothes. In case of eye or oromucosal contact, rinse abundantly with fresh water. If symptoms occur, seek the advice of a physician.

People with known hypersensitivity to dexmedetomidine or any of the excipients should avoid contact with the veterinary medicinal product.

Pregnant women should avoid contact with the product. Uterine contractions and decreased foetal blood pressure may occur after systemic exposure to dexmedetomidine.

Advice to physicians :

Dexmedetomidine, the active ingredient of Sileo, is an alpha-2 adrenoceptor agonist. Symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia. Ventricular arrhythmias have also been reported. Since effects are dose dependent they are more pronounced in small children than adults. Respiratory and haemodynamic symptoms should be treated symptomatically. The specific alpha-2 adrenoceptor antagonist, atipamezole, which is approved for use in animals, has been used in humans but only experimentally to antagonize dexmedetomidine-induced effects.

Pregnancy and lactation:

The safety of this veterinary medicinal product has not been established during pregnancy and lactation in the target species. Therefore the use of the product during pregnancy and lactation is not recommended.

Interaction with other medicinal products and other forms of interaction:

Inform your veterinary surgeon if your dog is using other medicines.

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

Overdose (symptoms, emergency procedures, antidotes):

Overdose can cause excessive tiredness. If this occurs the animal should be kept warm.

If an overdose occurs, contact a veterinary surgeon as soon as possible.

The effects of dexmedetomidine can be eliminated using a specific antidote (reversal medicine).

Information for the veterinary surgeon:

Do not exceed the recommended dose. Signs of sedation may occur when the dose is exceeded. The level and duration of sedation is dose dependent. If sedation occurs, the dog should be kept warm.

Reduced heart rate may be seen after administration of higher than recommended doses of Sileo gel. Blood pressure decreases slightly below normal levels. Respiration rate can occasionally decrease. Higher than recommended doses of Sileo gel may also induce a number of other alpha-2 adrenoceptor mediated effects, which include mydriasis, depression of motor and secretory functions of the gastrointestinal tract, temporary AV-blocks, diuresis and hyperglycaemia. A slight decrease in body temperature may be observed.

The effects of dexmedetomidine can be eliminated using a specific antidote, atipamezole (alpha-2 adrenoceptor antagonist). In case of overdose, the appropriate dose of atipamezole calculated in micrograms is 3 times (3X) the dose of administered dexmedetomidine hydrochloride in Sileo gel. Atipamezole (at the concentration of 5 mg/ml) dose in millilitres is one sixteenth (1/16th) of the dose volume of Sileo gel.

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

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

  INSTRUCTIONS FOR DOSING THE GEL:

  NEW ORAL SYRINGE SET UP BEFORE FIRST DOSING:

  
  
  
  

• 1. WEAR GLOVES

Wear impermeable disposable gloves when handling the veterinary medicinal product and handling the oral syringe.

• 2. HOLD PLUNGER

Hold the oral syringe so that you can see the dot markings on the oral syringe plunger. Hold the plunger with your left hand.

Hold the plunger with your left hand and unlock the green ring-stop by turning it towards you until it is able to slide freely.

Move the ring-stop to the opposite end of the plunger.

5. LOCkA

Hold the plunger with your right hand and lock the ring-stop by turning it away from you.

DOSE SELECTION AND DOSING:

Hold the plunger with your right hand and unlock the ring-stop by turning it towards you. Do not pull the plunger!

• 7. MOVE RING

Move the ring-stop towards the other end of the plunger for choosing the correct dose based on your veterinarian’s pres­cription.

• 8. SET DOSE AND LOCK â

Position the ring-stop so that the side nearest the barrel is in line with the graduation mark (black line), and the required number of dots shows between the ring-stop and the barrel. Lock the ring-stop by turning it away from you. Before dosing make sure that the ringstop is locked.

• 9. PULL CAP (TIGHT)

Pull the cap strongly while holding the barrel. Note the cap is very tight (pull, do not twist). Save the cap for replacement.

• 10. DOSE INTO CHEEK

Place the oral syringe tip between the dog’s cheek and gum and press the plunger until the ring-stop causes the plunger to stop.

IMPORTANT: The gel should not be swallowed. If the gel is swallowed, it may not be effective.

• 11. BACK TO PACKAGE