Clomicalm should not be used with certain other drugs, or on dogs under 6 months of age. Care must be taken if Clomicalm is used in epileptic dogs or those with heart problems.
Below is the product datasheet. This has been provided by the manufacturer and should always be provided with the medication. Introduction 
Company name: Novartis Animal Health UK Ltd
Address: Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
Telephone: 01276 694402
Fax: 01276 694403
Presentation
Clomicalm is available in divisible, flavoured tablets of 3 dosage strengths:
Clomicalm 5mg
| Clomipramine hydrochloride
| 5.00mg (equivalent to 4.5mg Clomipramine)
| Clomicalm 20mg
| Clomipramine hydrochloride
| 20.00mg (equivalent to 17.9mg Clomipramine)
| Clomicalm 80mg
| Clomipramine hydrochloride
| 80.00mg (equivalent to 71.7mg Clomipramine)
|
Uses
As an aid in the treatment of separation-related disorders in dogs manifested by destruction and inappropriate elimination (defecation and urination) and only in combination with behavioural modification techniques.
Dosage and administration Dosage: Clomicalm is administered twice daily at a dose of 1-2mg/kg to give a total daily dose of 2-4mg/kg according to the following table:
| Dosage per administration
| Bodyweight
| Clomicalm 5mg
| Clomicalm 20mg
| Clomicalm 80mg
| 1.25-2.5kg
>2.5-5kg
| 0.5 tablet
1 tablet
|
|
| >5-10kg
>10-20kg
|
| 0.5 tablet
1 tablet
|
| >20-40kg
>40-80kg
|
|
| 0.5 tablet
1 tablet
|
Administration: Clomicalm is given orally with or without food. In clinical trials, a treatment time of 2-3 months with Clomicalm in combination with behavioural modification techniques was sufficient to control the symptoms of separation-related disorders. Some cases may require longer treatment. In cases showing no improvement after 2 months, treatment with Clomicalm should be ceased.
Contra-indications, warnings, etc Contra-indications
Known hypersensitivity to clomipramine and related tricyclic antidepressants. Do not use in male breeding dogs.
Warnings
Clomicalm may very rarely cause vomiting, changes in appetite, lethargy or an elevation in liver enzymes, which is reversible when the product is discontinued. Hepato-biliary disease has been reported, especially with pre-existing conditions, and concurrent administrations of drugs metabolised via the hepatic system. Vomiting may be reduced by co-administration with a small quantity of food. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Special precautions for use
Dog: It is recommended that Clomicalm be administered to dogs with cardiovascular dysfunction or epilepsy with caution and only after an assessment of the benefit/risk ratio. Because of its potential anticholinergic properties, Clomicalm should also be used with care in dogs with narrow angle glaucoma, reduced gastrointestinal motility or urinary retention. Clomicalm should be used under veterinary supervision. The efficacy and safety of Clomicalm has not been established in dogs weighing less than 1.25kg or under 6 months of age.
Persons administering the product: In children, accidental ingestion should be regarded as serious. There is no specific antidote. In case of accidental ingestion, seek medical advice immediately and show the product label to the physician. Overdose in human beings causes anticholinergic effects although central nervous and cardiovascular systems may also be affected. People with known hypersensitivity to clomipramine should administer the product with caution.
Use during pregnancy and lactation: The safety of the veterinary medicinal product has not been established in female dogs during pregnancy and lactation. Laboratory animal studies in mice and rats have shown evidence of embryotoxic effects.
Interaction with other medicaments: Recommendations on the interaction between Clomicalm and other medicaments are derived from studies in species other than dogs. Clomicalm may increase the effects of the anti-arrhythmic drug quinidine, anticholinergic agents (e.g. atropine), other CNS active drugs (e.g. barbiturates, benzodiazepines, general anaesthetics, neuroleptics), sympathomimetics (e.g. adrenaline) and coumarine derivatives. The administration of Clomicalm is not recommended in combination with, or within 2 weeks of therapy with, monoamine oxidase inhibitors. Simultaneous administration with cimetidine may lead to increased plasma levels of clomipramine. Plasma levels of certain anti-epileptic drugs, such as phenytoin and carbamazepine, may be increased by coadministration with Clomicalm.
Overdose: At overdose with 20mg/kg Clomicalm (5 times the maximum therapeutic dose), bradycardia and arrhythmias (atrioventricular node block and ventricular escape beats) were observed approximately 12 hours after dosing. Overdose with 40mg/kg (20 times the recommended dose) of Clomicalm produced hunched posture, tremors, flushed abdomen and decreased activity in dogs. Higher doses (500mg/kg i.e. 250 times the recommended dose) produced emesis, defecation, drooped eyes, trembling and quietness. Still higher doses (725mg/kg) produced, in addition, convulsions and death.
Environmental precautions: Any unused veterinary medicinal products or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Pharmaceutical precautions
Store product in the original container. Keep out of reach and sight of children. Accidental ingestion should be regarded as serious.
Legal category
POM-V
Packaging Quantities
Each tablet size is supplied in plastic bottles containing 30 tablets (with desiccant).
Further information
For animal treatment only. Keep out of reach and sight of children. For any information about this veterinary medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Marketing authorisation numbers
Clomicalm 5mg - EU/2/98/007/001
Clomicalm 20mg - EU/2/98/007/002
Clomicalm 80mg - EU/2/98/007/003
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