CIPRAMIL®

CIPRAMIL®(SIP-ra-mil)

Active ingredient(s): Citalopram hydrobromide (sigh-TALO-pram high-dro-BRO-mide)

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Consumer Medicine Information (CMI)

This leaflet provides important information about using CIPRAMIL. 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 CIPRAMIL.

Where to find information in this leaflet:

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

1. Why am I using CIPRAMIL?

CIPRAMIL contains the active ingredient citalopram hydrobromide. CIPRAMIL belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs). They are thought to work by their actions on brain chemicals called amines which are involved in controlling mood.

CIPRAMIL is used to treat depression.

Depression is longer lasting or more severe than the “low moods” everyone has from time to time due to the stress of everyday life. It 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, often waking up early, loss of sex drive, lack of energy and feeling guilty over nothing.

CIPRAMIL corrects this chemical imbalance and may help relieve the symptoms of depression.

Your doctor, however, may prescribe it for another purpose.

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

2. What should I know before I use CIPRAMIL?

Warnings

Do not use CIPRAMIL if:

• You are allergic to citalopram hydrobromide, or any of the ingredients listed at the end of this leaflet.
• you have a condition called ‘congenital long QT syndrome’. At high doses, CIPRAMIL can cause changes in the way that your heart beats. See your doctor immediately if you experience an irregular heartbeat, shortness of breath, dizziness or fainting while taking CIPRAMIL.
• Always check the ingredients to make sure you can use this medicine.
• The packaging is torn or shows signs of tampering

Check with your doctor if you:

• you have allergies to any other substances such as foods, preservatives, or dye. 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, or rash, itching or hives on the skin.
• are pregnant or intend to become pregnant.
• have any other medical conditions.
• take any medicines for any other condition.
• are lactose intolerant, as CIPRAMIL tablets contain lactose.

If you have, or have had any of the following medical conditions, tell your doctor before starting CIPRAMIL

• congenital long QT syndrome or other heart conditions. Your doctor may occasionally need to check your heartbeat and rhythm with an ECG test
• illnesses which require you to have regular blood tests
• a tendency to bleed or bruise easily
• diabetes
• kidney disease
• liver disease
• bipolar disorder (manic depression)
• a history of seizures or fits
• restlessness and/or a need to move often.
• raised intraocular pressure (fluid pressure in the eye), or if you are at risk of angle-closure glaucoma.
• epilepsy
• you are receiving electroconvulsive therapy.

Medicines like CIPRAMIL (so called SSRIs) may cause symptoms of sexual dysfunction (see Section 6. Are there any side effects). In some cases, these symptoms have continued after stopping treatment.

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?

Do not take CIPRAMIL at the same time as the following other medicines:

• pimozide, a medicine used to treat mental disorders
• monoamine oxidase inhibitors (MAOIs), such as phenelzine, tranylcypromine and moclobemide which are also used for the treatment of depression.
• monoamine oxidase inhibitors such as linezolid which is an antibiotic and selegiline which is used in the treatment of Parkinson’s Disease.

One day must elapse after you have finished taking moclobemide before you start taking CIPRAMIL If you have taken any other MAOI you will need to wait 14 days. After stopping CIPRAMIL you must allow 14 days before taking any MAOI including moclobemide.

Taking CIPRAMIL with MAOIs may cause a serious reaction with a sudden increase in body temperature, extremely high blood pressure and severe convulsions. Your doctor will know when it is safe to start CIPRAMIL after the MAOI has been stopped.

Pregnancy and breastfeeding

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

Citalopram hydrobromide has been shown to reduce the quality of sperm in animal studies, which theoretically could affect fertility. If you are intending to start a family, ask your doctor for advice.

Do not take CIPRAMIL if you are pregnant unless you and your doctor have discussed the risks and benefits involved.

Make sure your doctor and/or midwife know you are on CIPRAMIL.

When taken during pregnancy, particularly in the last three months of pregnancy, medicines like CIPRAMIL may affect the general condition of your newborn baby and may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your doctor and/or midwife immediately.

If you take CIPRAMIL near the end of your pregnancy there may be an increased risk of heavy vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking CIPRAMIL so they can advise you.

If used during pregnancy CIPRAMIL should never be stopped abruptly.

Ask your doctor or pharmacist for advice before taking any medicine.

Talk to your doctor if you are breastfeeding or intend to breastfeed. Do not take CIPRAMIL if you are breast-feeding unless you and your doctor have discussed the risks and benefits involved. It is not recommended that you breast-feed while taking CIPRAMIL as it is excreted in breast milk.

CIPRAMIL use in children and adolescents

• Do not give CIPRAMIL to a child or adolescent.

There is no experience with its use in children or adolescents under 18 years old.

CIPRAMIL use in the elderly

• CIPRAMIL can be given to elderly patients over 65 years of age with a reduced dose.

The effects of CIPRAMIL in elderly patients are similar to those in other patients.

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 CIPRAMIL and affect how it works.

• linezolid, an antibiotic
• lithium, used to treat mood swings and some types of depression
• tricyclic antidepressants, e.g. imipramine, desipramine
• some heart medications, such as beta-blockers (e.g. metoprolol) or antiarrhythmics
• sumatriptan, used to treat migraines
• tramadol and similar medicines, used to relieve pain
• medicines used to treat reflux and ulcers, such as cimetidine and omeprazole
• medicines known to prolong bleeding, e.g. aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
• warfarin, a medicine used to prevent blood clots
• St John’s Wort (Hypericum perforatum), a herbal remedy
• Ketoconazole, flucanozole and itraconazole, medicines used to treat fungal infections
• macrolide antibiotics, e.g. erythromycin and clarithromycin
• carbamazepine, a medicine used to treat convulsions
• selegiline, a medicine used to treat Parkinson’s disease
• tryptophan, an amino acid
• antipsychotics, a class of medicines used to treat certain mental and emotional conditions
• any other medicines for depression, anxiety, obsessive-compulsive disorder or pre-menstrual dysphoric disorder.

These medicines may be affected by CIPRAMIL, or may affect how well it works. You may need to use different amounts of your medicines or take different medicines. Your doctor will advise you.

Some combinations of medicines may increase the risk of serious side effects and are potentially life threatening.

Drugs that are known to affect the way the heart beats (for example some heart medicines, antibiotics, asthma medicines, antihistamines) should be avoided while taking CIPRAMIL. If it is necessary for you to be on these medicines at the same time as CIPRAMIL, your doctor may perform an ECG test to check your heart rate and rhythm.

Your doctor or pharmacist has more information on medicines to be careful with or avoid while taking CIPRAMIL.

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

4. How do I use CIPRAMIL?

How much to take

• Your doctor will decide what dose you will receive.
• The standard dose for adults for this medicine is between 20 mg and 40 mg (one to two tablets) per day.
• The recommended starting dose in elderly patients is 10 mg (half a tablet) per day but may be increased to a maximum of 20 mg (one tablet) per day by your doctor if needed.
• If you have liver problems, or are taking medicines such as cimetidine and omeprazole, the recommended starting dose is 10mg (half a tablet) per day. The dose can be increased to a maximum of 20mg (one tablet) per day.
• Your doctor may have prescribed a different dose. If you have been prescribed or are currently taking doses of CIPRAMIL greater than 40mg, talk to your doctor about reducing the dose.
• Ask your doctor or pharmacist if you are unsure of the correct dose for you. They will tell you exactly how much to take.
• Follow the instructions provided and use CIPRAMIL until your doctor tells you to stop.

When to take CIPRAMIL

• Take CIPRAMIL as a single dose either in the morning or in the evening.
• Take CIPRAMIL with or without food

How to take CIPRAMIL

• Swallow the tablets whole with a full glass of water.
• Do not chew CIPRAMIL tablets.

How long to take it

Continue to take CIPRAMIL even if it takes some time before you feel any improvement in your condition.

As with other medicines for the treatment of these conditions it may take a few weeks before you feel any improvement.

Individuals will vary greatly in their response to CIPRAMIL. Your doctor will check your progress at regular intervals.

The duration of treatment may vary for each individual, but is usually at least 6 months.

In some cases, the doctor may decide that longer treatment is necessary.

Continue taking your medicine for as long as your doctor tells you, even if you begin to feel better.

The underlying illness may persist for a long time and if you stop your treatment too soon, your symptoms may return.

Do not stop taking this medicine suddenly.

If CIPRAMIL is stopped suddenly you may experience mild, but usually temporary, symptoms such as dizziness, pins and needles, sleep disturbances (vivid dreams, inability to sleep), feeling anxious or agitated, headaches, feeling sick (nausea), vomiting, sweating, tremor (shaking), feeling confused, feeling emotional or irritable, diarrhoea, visual disturbances, or fast or irregular heartbeats.

When you have completed your course of treatment, the dose of CIPRAMIL is gradually reduced over a couple of weeks rather than stopped abruptly.

Your doctor will tell you how to reduce the dosage so that you do not get these unwanted effects.

If you forget to use CIPRAMIL

CIPRAMIL should be used regularly at the same time each day. If you miss your dose at the usual time, and remember in less than 12 hours, take it straight away, and then go back to taking it as you would normally.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

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

• If you are not sure what to do, ask your doctor or pharmacist. Do not chew CIPRAMIL tablets.
• If you have trouble remembering when to take your medicine, ask your pharmacist for hints.

If you use too much CIPRAMIL

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

Symptoms of an overdose may include nausea (feeling sick), vomiting, dizziness, fast or slow heart beat or change in heart rhythm, decreased or increased blood pressure, tremor (shaking), agitation, dilated pupils of the eyes, drowsiness, sleepiness, lethargy, sweating, blueish discolouration of the skin, and an increase in rate of breathing. Convulsions or coma may occur. A condition called serotonin syndrome may occur with high fever, agitation, confusion, trembling and abrupt contractions of muscles.

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.

5. What should I know while using CIPRAMIL?

Things you should do

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

Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.

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

Persons taking CIPRAMIL may be more likely to think about killing themselves or actually trying to do so, especially when CIPRAMIL is first started or the dose is changed. Tell your doctor immediately if you have thoughts about killing yourself or if you are close to or care for someone using CIPRAMIL who talks about or shows signs of killing him or herself.

All mentions of suicide or violence must be taken seriously.

Occasionally, the symptoms of depression may include thoughts of suicide or self-harm. It is possible that these symptoms continue or get worse until the full antidepressant effect of the medicine becomes apparent. This is more likely to occur if you are a young adult, i.e. 18 to 24 years of age, and you have not used antidepressant medicines before.

Patients and care givers should pay attention for any of the following warning signs of suicide-related behaviour while taking CIPRAMIL. Tell your doctor immediately, or even go to the nearest hospital for treatment:

• thoughts or talk of death or suicide
• thoughts or talk of self-harm or harm to others
• any recent attempts of self-harm
• increase in aggressive behaviour, irritability or agitation.

Do not stop taking this medicine or change the dose without consulting your doctor, even if you experience increased anxiety at the beginning of treatment.

At the beginning of treatment, some patients may experience increased anxiety which will disappear during continued treatment.

Call your doctor straight away if you:

• become pregnant while taking CIPRAMIL
• have thoughts about killing yourself or if you are close to or care for someone using CIPRAMIL who talks about or shows signs of killing him or herself
• suddenly experience an episode of mania
• experience symptoms such as restlessness or difficulty in sitting or standing still. These symptoms can occur during the first weeks of treatment.
• suddenly experience an episode of mania. Some patients with bipolar disorder (manic depression) may enter into a manic phase. This is characterised by profuse and rapidly changing ideas, exaggerated gaiety and excessive physical activity.

Sometimes you may be unaware of the above-mentioned symptoms and therefore you may find it helpful to ask a friend or relative to help you to observe the possible signs of change in your behaviour.

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

Things you should not do

• Do not give the tablets to anyone else, even if they have the same condition as you.
• Do not take CIPRAMIL to treat any other complaints unless your doctor tells you to.
• Do not stop taking CIPRAMIL, or lower the dosage, without checking with your doctor.
• Do not let yourself run out of medicine over the weekend or on holidays.

Suddenly stopping CIPRAMIL may cause unwanted discontinuation symptoms such as dizziness, headache and nausea. Your doctor will tell you when and how CIPRAMIL should be discontinued. Your doctor will gradually reduce the amount you are using, usually over a period of one to two weeks, before stopping completely.

Driving or using machines

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

It may cause nausea, fatigue and dizziness in some people, especially early in the treatment. If you have any of these symptoms, do not drive, operate machinery, or do anything else that could be dangerous.

Drinking alcohol

Tell your doctor if you drink alcohol.

It is not advisable to drink alcohol while you are being treated for depression.

Looking after your medicine

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

Keep your tablets in the original pack until it is time to take them. If you take your tablets out of the pack, they may not keep well.

Store it in a cool dry place below 25°C 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 windowsills.

Keep it where young children cannot reach it.

When to discard your medicine (as relevant)

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.

It helps most people with depression, but it may have unwanted side effects in a few people.

The side effects of CIPRAMIL are, in general, mild and disappear after a short period of time.

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

Less serious side effects

Less serious side effects

What to do

itching ringing or other persistent noise in the ears aching muscles or joint pain flu-like symptoms, fever, runny or blocked nose, sneezing, facial pressure or pain, coughing or sore throat increased sweating increased saliva or dry mouth, taste disturbance loss of appetite or increased appetite, weight decrease or weight increase diarrhoea, constipation, flatulence, indigestion, stomach pain or discomfort dizziness nausea (feeling sick) or vomiting migraine, headache sleepiness or drowsiness, fatigue, yawning a sense of indifference to everything sexual disturbances (decreased sexual drive, problems with orgasm; problems with ejaculation or erection) problems with menstrual periods Restlessness or difficulty keeping still

Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

chest pain a fast heart rate or decrease in heart rate or irregular heartbeat shortness of breath fainting dizziness when you stand up due to low blood pressure blurred vision low sodium levels in the blood (the symptoms are feeling sick and unwell with weak muscles or feeling confused) which may be caused by SSRI antidepressants, especially in elderly patients increased tendency to develop bruises unusual bleeding, including bleeding from the stomach or bowel heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see ‘Pregnancy and breastfeeding‘ in section 2 for more information passing more urine than normal or problems when urinating tingling or numbness of the hands or feet nervousness, confusion, problems with concentration, loss of memory agitation, anxiety, worsening of depression. an increased risk of bone fractures has been observed in patients taking medicines like CIPRAMIL. thoughts of suicide serious allergic reaction (symptoms of an allergic reaction may include swelling of the face, lips, mouth or throat which may cause difficulty in swallowing or breathing, or hives) high fever, agitation, confusion, trembling and abrupt contractions of muscles (these symptoms may be signs of a rare condition called serotonin syndrome which has been reported with the combined use of antidepressants) tremors, movement disorders (involuntary movements of the muscles). fast, irregular heartbeat with feelings of dizziness or difficulty breathing high prolactin concentration in the blood which may be caused by SSRI antidepressants

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these 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 CIPRAMIL contains

Active ingredient (main ingredient)	CIPRAMIL 20 mg tablets 20 mg citalopram (as hydrobromide) per tablet
Other ingredients (inactive ingredients)	microcrystalline cellulose croscarmellose sodium glycerol hypromellose lactose macrogol 400 magnesium stearate copovidone maize starch titanium dioxide
Potential allergens	CIPRAMIL tablets contain lactose. If you are lactose intolerant, contact your doctor before taking CIPRAMIL.

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

What CIPRAMIL looks like

CIPRAMIL tablets are presented in blister strips containing 14 film-coated tablets. These blisters are packed in a carton, with each carton of CIPRAMIL film-coated tablets containing 2 blister strips, 28 tablets in total.

CIPRAMIL 20 mg film-coated tablets are oval in shape and white in colour, scored and marked with “C” and “N”. (AUST R 61164).

Who distributes CIPRAMIL

CIPRAMIL is manufactured by H. Lundbeck A/S, Denmark.

Distributed in Australia by:

Lundbeck Australia Pty Ltd
Ground Floor, 1 Innovation Road
North Ryde NSW 2113
Ph: +61 2 8669 1000

This leaflet was prepared in August 2023.

“Cipramil” is the registered trademark of H. Lundbeck A/S