Active ingredient(s): clomipramine hydrochloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using Anafranil®. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Anafranil®.

Where to find information in this leaflet:

1. Why am I using Anafranil®?
2. What should I know before I use Anafranil®?
3. What if I am taking other medicines?
4. How do I use Anafranil®?
5. What should I know while using Anafranil®?
6. Are there any side effects?
7. Product details

1. Why am I using Anafranil®?

Anafranil® contains the active ingredient clomipramine hydrochloride. Anafranil® belongs to a group of medicines called tricyclic antidepressants.

Anafranil® is used to treat:

Depression is thought to be caused by a chemical imbalance in parts of the brain. This imbalance affects your whole body and can cause emotional and physical symptoms such as feeling low in spirit, loss of interest in activities, being unable to enjoy life, poor appetite or overeating, disturbed sleep, loss of sex drive, lack of energy and feelings of guilt.

The symptoms of these disorders vary from person to person. Your doctor can provide you with more information.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another purpose.

2. What should I know before I use Anafranil®?

Warnings

Do not use Anafranil® if:

• you are allergic to clomipramine, any other tricyclic antidepressant, or any of the ingredients listed at the end of this leaflet.
• you are under 18 years of age.
• Always check the ingredients to make sure you can use this medicine.
  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 start taking Anafranil® if you are already taking another medicine called a monoamineoxidase inhibitor (MAOI) or you have been taking it within the past 2 weeks.
  Taking Anafranil® together with a MAOI may cause a serious reaction with a sudden increase in body temperature, extremely high blood pressure and seizures (fits). Your doctor will know when it is safe to start Anafranil® after the MAOI has been stopped.
• Do not take Anafranil® if you are recovering from a recent 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.
  In that case, return it to your pharmacist.

Check with your doctor if you have:

• an irregular heart beat or other problems with your heart
• an inherited heart problem called congenital long QT syndrome
• increased pressure in the eye from any cause (e.g. glaucoma)
• difficulty in passing urine (water), due to prostate trouble or any other cause
• seizures (fits)
• severe liver or kidney disease
• a low level of potassium in your blood (called hypokalaemia)
• a mental disorder other than the one being treated (e.g. schizophrenia, mania)
• problems with blood pressure (either too high or too low)
• a blood disorder
• a thyroid problem
• chronic constipation
• Parkinson’s disease
• a tumour of the adrenal gland
• take any medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Anafranil should not be taken if you are pregnant unless your doctor has told you to do so. 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 the medicine during the first month after birth. Newborn infants whose mothers had taken this medicine up until delivery may show symptoms such as shortness of breath, abnormal bluish discoloration of the skin and mucous membranes, lethargy, feeding difficulties, colic, irritability, convulsions, tremor, overactive muscle tone, poor muscle tone or spasms, during the first hours or days of life. If there is a need to take Anafranil when you are pregnant, your doctor will discuss the risks and benefits to you and the unborn baby. Your doctor may also recommend gradually stopping Anafranil in the 7 weeks before giving birth.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Breast-feeding is not recommended while you are taking Anafranil®. The active ingredient passes into the breast milk and could affect your baby.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Anafranil® and affect how it works. These include:

• MAOI medicines. You must not take Anafranil® together with a MAOI (see 2. What should I know before I use Anafranil®?)
• medicines for high blood pressure or heart problems
• medicines to help you sleep or calm you down
• other medicines for depression called SSRIs or SNaRIs (e.g. fluoxetine, paroxetine, sertraline, fluvoxamine)
• medicines for other mental disorders
• medicines for seizures (fits)
• medicines to prevent blood clots (e.g. warfarin)
• diuretic medicines, also called fluid or water tablets
• some medicines for colds or allergies, including antihistamines and some nose drops
• anticholinergic medicines, which are used to relieve stomach cramps, spasms and travel sickness
• medicines for thyroid problems
• cimetidine, a medicine for stomach ulcers
• medicines for Parkinson’s disease
• oestrogens (e.g. birth control pills, hormone replacement therapy)
• nicotine in medicines used to help you quit smoking, such as nicotine patches or chewing gum
• methylphenidate (Ritalin®)
• disulfiram, a medicine for alcoholism
• rifampicin, an antibiotic
• terbinafine, a medicine used to treat skin, hair or nail infections due to fungus
• medicines used to reduce fat in blood
• grapefruit/grapefruit juice or cranberry juice.

You may need to take different amounts of your medicines or you may need to take different medicines. Your doctor and pharmacist have more information.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Anafranil®.

4. How do I use Anafranil®?

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 raised slowly up 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.
• Follow the instructions provided and use Anafranil® until your doctor tells you to stop.

When to take Anafranil®

• Take the tablets in 2 or 3 doses spread over the day unless your doctor advises you otherwise.
• If you have narcolepsy and you have trouble sleeping at night, take the last dose before evening to avoid making your insomnia worse.

How to take Anafranil®

• Swallow the tablets with a full glass of water. If your stomach is upset after taking the tablets, take them with a meal or after a snack.

How long to take Anafranil®

Take this medicine until your doctor tells you to stop treatment.

The length of treatment will depend on your condition and on how well the medicine works.

For depression, the length of treatment will depend on how quickly your symptoms improve. This type of medicine takes time to work, so don’t be discouraged if you don’t feel better right away. Some of your symptoms may improve in 1 or 2 weeks but it can take up to 4 to 6 weeks to feel any real improvement. Even when you feel well, you will usually have to take Anafranil® for several months or even longer to make sure the benefits will last.

Do not stop taking Anafranil® suddenly as you could suffer possible withdrawal symptoms.

If you forget to use Anafranil®

If it is almost time for your next dose (e.g. within 2 or 3 hours), skip the dose you missed and take your next dose when you are meant to.

Otherwise, take the dose as soon as you remember, and then go back to taking the tablets as you would normally.

Do not take a double dose to make up for the dose you missed.

This may increase the chance of you getting an unwanted side effect.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much Anafranil®

If you think that you have used too much Anafranil®, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

If you take too much Anafranil®, 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 heartbeat, fits or other symptoms.

Children are much more sensitive than adults to tricyclic antidepressants. An accidental overdose is especially dangerous.

5. What should I know while using Anafranil®?

Things you should do

If you become pregnant while taking Anafranil®, tell your doctor immediately.

Your doctor can discuss with you the risks of taking it while you are pregnant.

Call your doctor straight away if you or someone you know develop any of the following:

• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling very agitated or restless
• panic attacks
• 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 Anafranil® 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.

If this medicine causes your mouth to feel dry and this problem doesn’t go away, tell your doctor or dentist. Be sure to have regular dental checkups.

Continuing dryness of the mouth may increase the chance of gum disease or cavities. You can relieve dry mouth by frequent sips of water, sucking sugarless lollies or chewing sugarless gum.

If you wear contact lenses and find that your eyes are dry, sticky or irritated, tell your doctor.

These side effects could damage your eyes.

Be sure to keep all of your doctor’s appointments so that your progress can be checked.

Your doctor may want to take some blood tests and check your heart and blood pressure from time to time.

This helps to prevent unwanted side effects.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Anafranil®.

Remind any doctor, dentist or pharmacist you visit that you are using Anafranil®.

Things you should not do

• Do not stop using this medicine suddenly.
• Do not stop taking Anafranil® or change the dose without first checking with your doctor.
• Do not let yourself run out of medicine over the weekend or on holidays.
• Do not give this medicine to anyone else, even if their condition seems similar to yours.
• Do not use it to treat any other complaints unless your doctor tells you to.

If you stop taking this medicine suddenly, your condition may worsen or you may have unwanted side effects such as headache, nausea (feeling sick), vomiting, diarrhoea and nervousness. If possible, your doctor will gradually reduce the amount you take each day before stopping the medicine completely.

Taking pain relievers, sleeping tablets or antihistamines

• Be careful when taking pain relievers, sleeping tablets or antihistamines (medicines for colds or allergies such as hay fever) while you are taking Anafranil®.
• Anafranil® can increase the drowsiness caused by medicines that affect your nervous system.

Lightheadedness

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 leg muscles and toes to get the blood flowing. When getting out of bed, dangle your legs over the side for a minute or two before standing up.

Exposure to sunlight or sunlamps

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 Anafranil®, you should still be careful for 1 or 2 weeks since some of the effects of the medicine will still be in your body.

Smoking

Tell your doctor if you smoke.

Nicotine can affect the amount of Anafranil® that is in your body. Sudden changes in your usual smoking habits can also change the effects of Anafranil®.

Lactose intolerance

Tell your doctor if you are lactose intolerant.

This medicine contains lactose.

Allergies

Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.

Your doctor will want to know if you are prone to allergies.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Anafranil® affects you.

Anafranil® may cause tiredness, dizziness, drowsiness or blurred vision in some people.

Drinking alcohol

Tell your doctor if you drink alcohol.

Anafranil® can increase the drowsiness caused by alcohol.

Looking after your medicine

• Keep your medicine in the original container until it is time to take a dose.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place at room temperature away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

A locked cupboard at least one-and a-half metres above the ground is a good place to store medicines.

When to discard your medicine

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine you have left over.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

If you are over 65 years old, you should be especially careful while taking this medicine. Report any side effects promptly to your doctor.

As people grow older, they are more likely to get side effects from medicines.

Anafranil® can 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.

Patients aged 50 years or older and taking a medicine of this group are more likely to experience bone fractures.

Patients with pre-existing heart conditions and the elderly should be monitored for heart health, as they are at an increased risk of heart attack, stroke and sudden death.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What Anafranil® contains

Do not take this medicine if you are allergic to any of these ingredients.

This medicine does not contain gluten, tartrazine or any other azo dyes.

What Anafranil® looks like

Anafranil® 25 mg tablets are round, pale yellow, sugar-coated tablets; supplied in packs of 50 tablets.

AUST R 10987

Who distributes Anafranil®

Pharmaco (Australia) Ltd
Suite 1A, Level 2, 802 Pacific Highway
Gordon NSW 2072
AUSTRALIA
Phone: 1800 201 564

This leaflet was prepared in August 2022.

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