Clomipramine Sustained Release tablet

What is this medicine?

CLOMIPRAMINE is an antidepressant. It is used to treat obsessive-compulsive disorder.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• an alcohol problem
• asthma, difficulty breathing
• bipolar disease or schizophrenia
• difficulty passing urine, prostate trouble
• glaucoma
• heart disease or previous heart attack
• liver disease
• over active thyroid
• seizures
• thoughts or plans of suicide, previous suicide attempt, or family history of suicide attempt
• an unusual or allergic reaction to clomipramine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Take this medicine with food to avoid stomach upset. Take your doses at regular intervals. Do not take your medicine more often than directed. If you have been taking this medicine regularly for some time, do not suddenly stop taking it. You must gradually reduce the dose or you may get severe side effects. Ask your doctor or health care professional for advice. Even after you stop taking this medicine it can still affect your body for several days.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 10 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications

• amoxapine
• arsenic trioxide
• certain heart medicines
• cisapride
• halofantrine
• levomethadyl
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• other medicines for mental depression
• phenothiazines like perphenazine, thioridazine and chlorpromazine
• pimozide
• probucol
• procarbazine
• sparfloxacin
• St. John's Wort
• ziprasidone

This medicine may also interact with the following medications:

• atropine and related drugs like hyoscyamine, scopolamine, tolterodine and others
• barbiturate medicines for inducing sleep or treating seizures like phenobarbital
• cimetidine
• clonidine
• digoxin
• medicines for anxiety or sleeping problems
• medicines for colds, flu and breathing difficulties, like pseudoephedrine
• medicines for hay fever or allergies
• seizure or epilepsy medicine like phenytoin
• stimulants like dexmethylphenidate or methylphenidate
• thyroid hormones
• warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. It can take several days before you feel the full effect of this medicine.

Patients and their families should watch out for worsening depression or thoughts of suicide. Also watch out for sudden or severe changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, especially at the beginning of antidepressant treatment or after a change in dose, call your health care professional.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may increase dizziness and drowsiness. Avoid alcoholic drinks.

Do not treat yourself for coughs, colds, or allergies without asking your doctor or health care professional for advice. Some ingredients can increase possible side effects.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

If you are diabetic, check your blood sugar more often than usual, especially during the first few weeks of treatment with this medicine. This medicine can affect blood sugar levels. Call your doctor or health care professional for advice if you notice a change in the results of blood or urine glucose tests.

What side effects may I notice from this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breast enlargement, milk
• breathing problems
• confusion, hallucinations
• fast, irregular heartbeat
• fever with increased sweating
• muscle stiffness, spasms
• pain or difficulty passing urine, loss of bladder control
• seizures
• suicidal thoughts or other mood changes
• swelling of the testicles
• tingling, pain, or numbness in the feet or hands
• yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• change in sex drive or performance
• constipation, or diarrhea
• nausea, vomiting
• weight gain or loss

This list may not describe all possible side effects.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from moisture. Keep container tightly closed. Throw away any unused medicine after the expiration date.