contains the active ingredient, clomipramine hydrochloride
Consumer Medicine Information
For a copy of a large print leaflet ph: 1800 195 055 1800 195 055
What is in this leaflet
Read this leaflet carefully before taking your medicine Ask your doctor or pharmacist if you do not understand anything or are worried about taking your medicine. This leaflet answers some common questions about clomipramine.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
The information in this leaflet was last updated on the date listed on the last page. Some more recent information on your medicine may be available. Speak to your pharmacist or doctor to obtain the most up-to-date information.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.
Keep this leaflet with the medicine. You may need to read it again.
What clomipramine is used for
The name of your medicine is GenRx Clomipramine. It contains the active ingredient, clomipramine.
Clomipramine is used to treat:
obsessive compulsive disorders and phobias in adults
cataplexy associated with narcolepsy (sudden muscle weakness associated with an uncontrollable desire to sleep).
Your doctor may have prescribed it for another reason.
Ask your doctor if you have any questions about why this medicine has been prescribed for you. Clomipramine belongs to a group of medicines called tricyclic antidepressants.
These medicines are thought to work by their action on brain chemicals called amines which are involved in controlling mood.
This medicine is available only with a doctor's prescription.
Before you take clomipramine
When you must not take it
Do not take this medicine if you have an allergy to:
any medicines containing the active ingredient, clomipramine
any of the ingredients listed at the end of this leaflet
any other tricyclic antidepressants.
Do not take clomipramine if you have any of the following:
severe lactase deficiency
GenRx Clomipramine contain lactose.
Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.
Do not take this medicine if you are taking another medicine called a monoamine oxidase inhibitor (MAOI) or have been taking it within the last 14 days. Taking this medicine with a MAOI may cause a serious reaction with a sudden increase in body temperature, high blood pressure and convulsions.
Examples of MAOIs include selegiline, phenelzine, tranylcypromine and moclobemide.
Ask your doctor or pharmacist if you are not sure if you have been taking MAOIs.
Do not take this medicine if you recently had a heart attack. It may make your condition worse.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.
Before you start to take it
Tell your doctor if you have allergies to any other medicines, foods, lactose, preservatives or dyes.
GenRx Clomipramine contains lactose.
Tell your doctor if you have or have had any of the following medical conditions:
heart problems, especially an irregular heart beat
an inherited heart problem called congenital long QT syndrome
liver or kidney problems
glaucoma (increased pressure in the eye)
difficulty in passing urine
any mental illness, other than depression
a tumour of the adrenal gland (a small gland on the top of the kidney)
low potassium levels in your blood
blood pressure problems, either too high or too low
Your doctor may not want you to take this medicine or may want to take special precautions if you have any of the above conditions.
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. This medicine may affect your baby if you take it while you are pregnant, especially during the last 7 weeks of pregnancy. Your baby may have some side effects from this medicine during the first month after birth.
Tell your doctor if you are breast-feeding or plan to breast-feed. Breast-feeding is not recommended while you are taking this medicine. The active ingredient, clomipramine, passes into the breast milk and could affect your baby.
Tell your doctor if you smoke. Nicotine can affect the amount of clompiramine that is in your body. Sudden changes in your usual smoking habits can also change the effects of this medicine.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including medicines you get without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and clomipramine may interfere with each other. These include:
MAOIs (you must not take these medicines together with clomipramine)
other medicines for depression called SSRIs or SNaRIs (e.g. fluoxetine, fluvoxamine, paroxetine, sertraline)
sleeping tablets or sedatives
medicines for anxiety
medicines for other mental disorders
medicines for high blood pressure or heart problems
diuretic medicines, also called fluid or water tablets
medicines for preventing blood clots e.g. warfarin
medicines for allergies
medicines for epilepsy or convulsions (fits)
medicines for Parkinson's disease
medicines for thyroid problems
some cough and cold preparations
nicotine in medicines used to help you quit smoking e.g. nicotine patches, inhalers or chewing gum
medicines for stomach cramps, muscle spasms or travel sickness
cimetidine, a medicine for stomach ulcers
oestrogens, contained in some birth control pills and hormone replacement therapies
methylphenidate, a medicine to treat narcolepsy
disulfiram, a medicine for alcoholism
rifampicin, a medicine to treat infections.
These medicines may be affected by clomipramine or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist can tell you if you are taking any of these medicines. They may also have more information on medicines to be careful with or avoid while taking clomipramine.
Other interactions not listed above may also occur.
How to take this medicine
Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
If you do not understand the instructions on the box, ask your doctor or pharmacist for help.
How much to take
For depression, obsessive compulsive disorders and phobias, treatment is usually started with a low dose of 2 or 3 tablets (50 to 75 mg) each day. The dose can be slowly raised to 4 to 6 tablets each day. Some people will need higher doses than others because each person's body chemistry is different. Once you are feeling better, your doctor may be able to slowly reduce the dose, usually down to 2 to 4 tablets each day.
For muscle weakness accompanying narcolepsy, the dose is usually from 1 to 3 tablets (25 to 75 mg) each day.
If you are older than 65 years, your doctor will probably start with a low dose (e.g. 1 tablet each day) to help avoid side effects. The dose is gradually increased over about ten days to 2 to 3 tablets each day and kept at that dose for the rest of your treatment.
How to take it
Swallow the tablets with a full glass of water. If your stomach is upset after taking the tablets, then take your tablets with a meal or after a snack.
How long to take it
Continue taking your medicine for as long as your doctor tells you. The length of treatment will depend on your condition and how well the medicine works.
For depression, the length of treatment will depend on how quickly your symptoms improve. Most medicines of this type take time to work, so don't be discouraged if you don't feel better right away.
Some of your symptoms may improve in 1-2 weeks, but it can take up to 4-6 weeks to feel any real improvement.
Even when you feel well, you will usually have to take this medicine for several months or even longer to make sure the benefits will last.
If you forget to take it
If it is almost time for your next dose (e.g. it's due within 2-3 hours), skip the dose you missed and take your next dose when you are meant to. Otherwise, take your dose as soon as you remember and then go back to taking your doses as you would normally.
Do not take a double dose to make up for the dose that you have missed. This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital if you think you or anyone else may have taken too much clomipramine.
Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
If you take too much of your medicine, you may feel sleepy, restless or agitated. You may have stiffness or unusual muscle movements, fever, sweating, vomiting, difficulty breathing, a drop in blood pressure, fast or irregular heart beat, fits or other symptoms.
Children are much more sensitive than adults to tricyclic antidepressants. An accidental overdose is especially dangerous.
While you are taking clomipramine
Things you must do
If you become pregnant while taking this medicine, tell your doctor immediately. Your doctor can discuss with you the risks of taking this medicine while you are pregnant.
Keep all of your doctor's appointments so that your progress can be checked. Your doctor may do some tests such as blood tests or taking your blood pressure from time to time, to make sure that your medicine is working and also to prevent unwanted side effects.
Contact your doctor immediately if you or someone you know develop any of the following symptoms at any time during treatment with clomipramine:
thoughts about suicide or dying
attempts to commit suicide
new or worse depression
new or worse anxiety
feeling very agitated or restless
difficulty sleeping (insomnia)
new or worse irritability
acting aggressive, being angry, or violent
acting on dangerous impulses
an extreme increase in activity and talking
other unusual changes in behaviour or mood.
Symptoms such as these may be associated with an increased risk of suicidal thinking and behaviour and must be taken seriously.
Before having any surgery or emergency treatment, even a minor procedure, tell the doctor or dentist in charge that you are taking clomipramine or have been taking it within the last two weeks or so.
If possible, this medicine should be stopped before surgery to avoid unnecessary side effects.
Tell your doctor or dentist if your mouth feels dry and this lasts for more than 2 weeks. This medicine may cause a dry mouth. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay and gum disease. You can relieve dry mouth by frequent sips of water, sucking sugarless lollies or chewing sugarless gum.
Be sure to have regular dental checkups.
If you wear contact lenses and find that your eyes are dry, sticky and irritated, tell your doctor. These side effects could damage your eyes.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking clomipramine.
Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.
Things you must not do
Do not stop taking your medicine or lower the dose, without first checking with your doctor.
Do not run out of your medicine over weekends or public holidays. If you stop taking it suddenly, your condition may get worse or you may have unwanted side effects such as nausea, vomiting, diarrhoea and nervousness.
If possible, your doctor will gradually reduce the amount you take each day before stopping the medicine completely.
Do not take clomipramine to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else even if they have the same condition as you.
Things to be careful of
Be careful driving, operating machinery or doing jobs that require you to be alert, until you know how clomipramine affects you. This medicine may cause drowsiness, dizziness, blurred vision or sleepiness and affect alertness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
Be careful when drinking alcohol or taking pain relievers, sleeping tablets or antihistamines (medicines for colds or allergies such as hay fever) while you are taking your medicine. This medicine can increase the drowsiness caused by alcohol and by medicines that affect your nervous system.
If this medicine makes you feel lightheaded, be careful when getting up from a sitting or lying position. You can usually prevent these symptoms by getting up slowly and flexing your leg muscles and toes to get blood flowing. When getting out of bed, dangle your legs over the side for a minute or two before standing up.
Be careful to stay out of direct sunlight as much as possible until you find out if your skin is more sensitive than usual. Wear protective clothing and use a sunscreen. Do not use a sunlamp. This medicine makes some people more sensitive to sunlight.
After you have stopped taking clomipramine, you should still be careful for 1-2 weeks since some of the effects of the medicine will still be in your body.
Side effects of clomipramine
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking clomipramine. This medicine helps most people, but it may have unwanted side effects in some people.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.
If you are over 65 years of age you should be especially careful while taking this medicine. Tell your doctor immediately if you have any side effects. As people grow older, they are more likely to get side effects from medicines.
This medicine may cause confusion or disorientation, especially in older people or those with Parkinson's disease. Your family or carer should be aware of this. Special care may be needed.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following side effects and they worry you:
drowsiness, dizziness, blurred vision or difficulty focusing your eyes, especially when treatment is started or the dose is increased
lightheadedness, especially when you get up too quickly from a sitting or lying position
difficulty urinating (passing water)
dry or sticky eyes if you wear contact lenses
sweating or hot flushes
increased appetite and weight gain
tired feeling and mental dullness
feeling of unrest or anxiety
disturbed sleep or nightmares
shakiness or trembling
nausea (feeling sick), vomiting, diarrhoea
poor appetite or weight loss
sores in the mouth or on the tongue
reduced sexual desire or difficulty in reaching orgasm
swelling of the breasts or discharge of milk
swelling of the testicles
increased sensitivity to the sun
ringing in the ears
change in sense of taste.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:
signs of allergy such as rash, itching or hives on the skin; swelling of the face, lips, tongue or other part of the body; shortness of breath, wheezing or troubled breathing
constant "flu-like" symptoms (chills, fever, sore throat, aching joints, swollen glands, tiredness or lack of energy)
unusual bleeding or bruising
pain in the stomach or abdomen that is severe or doesn't go away
fast or irregular heart beat (pounding, racing, skipping beats)
muscle numbness, tingling or spasms
weakness or loss of balance
severe dizziness or drowsiness
fainting spells or seizures (fits)
difficulty in speaking or slurred speech
unusually high energy, irritability or outbursts of anger
confusion or hallucinations (seeing, hearing or feeling things that are not there)
frequent passing of large amounts of urine
yellow colour to the skin or eyes
a sudden increase in body temperature, extremely high blood pressure and severe convulsions.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.
After taking this medicine
Keep the tablets in their original packaging until it is time to take them. If you take the tablets out of their original packaging they may not keep well.
Keep your medicine in a cool dry place where the temperature is below 25°C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink.
Do not leave your medicine on a window sill or in the car on hot days. Heat and dampness can destroy some medicines.
Keep your medicine where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking clomipramine or your medicine has passed its expiry date, ask your pharmacist what to do with any medicine that is left over.
Where to go for further information
Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.
What the tablets looks like
The tablets are round, pale yellow, biconvex tablets engraved "25" on one side.
The tablets are available in blister packs of 50.
The tablets contain 25 mg clomipramine hydrochloride as the active ingredient.
The tablets also contain:
colloidal anhydrous silica
iron oxide yellow (E172).
The tablets are sucrose-free, gluten-free and tartrazine-free.
Australian Registration Number
GenRx Clomipramine 25 mg tablets: AUST R 73878
Apotex Pty Ltd
ABN 52 096 916 148
66 Waterloo Road
North Ryde NSW 2113
GenRx is a registered trade mark of Apotex Pty Ltd.
This leaflet was prepared in: December 2007
Published by MIMS/myDr November 2008
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