Clonazepam Rosemont 0.5mg/5ml Oral Solution - Summary of Product Characteristics (SPC) by Rosemont Pharmaceuticals Limited.
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE.
Sign up to this SPC (already have an account? Log in ).
No 2-year carcinogenicity studies have been conducted with clonazepam. However, in an 18-month chronic study in rats no treatment-related histopathological changes were seen up to the highest tested dose of 300 mg/kg/day. Mutagenicity.
No adverse maternal or embryo-fetal effects were observed in either mice or rats following administration of oral clonazepam during organogenesis, at doses of up to 20 or 40 mg/kg/day, respectively.
DESCRIPTION. Clonazepam tablets USP, for oral administration, contain 0.5 mg, 1 mg or 2 mg clonazepam. In addition, each tablet also contains the following.
Clonazepam does not appear to alter the pharmacokinetics of phenytoin, carbamazepine or phenobarbital. The effect of clonazepam on the metabolism of other drugs has not been investigated.
Clonazepam is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam may be useful.
Chemically, clonazepam is 5-( 2 -chlorophenyl)-1,3-dihydro-7-nitro-2 H -1,4-benzodiazepin-2-one.
Clonazepam tablets USP, for oral administration, contain 0.5 mg, 1 mg or 2 mg Clonazepam. In addition, each tablet also contains the following inactive.
Patients, their caregivers, and families should be informed that AEDs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediay to healthcare providers.
Suicidal Thinking and Behavior: Patients, their caregivers, and families should be counseled that AEDs, including Clonazepam, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm.
What Clonazepam Rosemont 0.5mg/5ml Oral Solution is and what it is used for 2. Before you take Clonazepam Rosemont 0.5mg/5ml Oral Solution 3. How to.
The side effects below may sometimes happen.
Using benzodiazepines like Clonazepam may make you dependent on the medicine. This means that if you stop treatment quickly, or reduce the dose too quickly, you may get withdrawal symptoms. The most common symptoms can include:
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Clonazepam.
If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Clonazepam.
If you are going to have an anaesthetic for an operation or for dental treatment it is important to l your doctor or dentist that you are taking Clonazepam.
Mind and nervous system.
When you start taking Clonazepam you may notice the following effects:
Clonazepam Rosemont 0.5mg/5ml Oral Solution Clonazepam.
This medicine can affect your ability to drive.
The name of your medicine is Clonazepam Rosemont 0.5mg/5ml Oral Solution (called Clonazepam in this leaflet).
Clonazepam is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Clonazepam affects chemicals in the brain that may become unbalanced and cause anxiety. Clonazepam is used to treat seizure disorders or panic disorder.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
round, white, imprinted with R35.
round, orange, imprinted with K ROCHE, 1/2 K KLONOPIN.
You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits.