1. Why am I taking PAXTINE?

PAXTINE contains the active ingredient paroxetine (as hydrochloride hemihydrate).

PAXTINE is used to treat depression, panic attack prevention, anxiety and other illnesses by helping to control mood.

For more information, see Section 1. Why am I using PAXTINE? in the full CMI.

2. What should I know before I take PAXTINE?

Do not use if you have ever had an allergic reaction to PAXTINE or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use PAXTINE? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with PAXTINE and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take PAXTINE?

• The usual dose of PAXTINE for depression and social anxiety disorder/social phobia is one 20 mg tablet per day.
• To treat obsessions and compulsions or panic attacks, the usual dose of PAXTINE is two 20 mg tablets per day.
• PAXTINE tablets can be broken in half but should not be chewed or crushed.
• PAXTINE should be taken in the morning, preferably with food.

More instructions can be found in Section 4. How do I use PAXTINE? in the full CMI.

5. What should I know while taking PAXTINE?

For more information, see Section 5. What should I know while taking PAXTINE? in the full CMI.

6. Are there any side effects?

Like other medicines, PAXTINE can cause some side effects. If they occur, they are most likely to be minor and temporary.

Less serious side effects can include feeling sick, dry mouth, constipation, decreased appetite, diarrhoea, vomiting, drowsiness, dizziness, difficulty in getting to sleep, impaired sexual function, weakness, feeling sweaty or shaky, bruising, abnormal dreams (including nightmares), weight gain. Serious side effects can include allergic reaction including swelling of limbs, mouth or throat which may cause wheezing, skin rashes that may blister, sudden onset of prolonged muscular spasms.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

PAXTINE®

Active ingredient(s): paroxetine (as hydrochloride hemihydrate)

Consumer Medicine Information (CMI)

This leaflet provides important information about using PAXTINE. 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 PAXTINE.

Where to find information in this leaflet:

1. Why am I taking PAXTINE?

PAXTINE contains the active ingredient paroxetine (as hydrochloride hemihydrate).

PAXTINE belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRI) antidepressants. They are thought to work by their action on brain chemicals called amines which are involved in controlling mood.

PAXTINE is used to treat:

• depression which is longer lasting or more severe than the ‘low moods’ that everyone has from time to time. It is thought to be caused by a chemical imbalance in part of the brain that affects your whole body and can cause emotional and physical symptoms. You may feel low in spirit, lose interest in usual activities, have poor appetite or over eat, have disturbed sleep, wake up early, have low energy and feel guilty over nothing.
• irrational fears or obsessional behaviour. These can also be due to chemical imbalance in parts of the brain.
• panic attacks. PAXTINE may be used to help prevent panic attacks.
• patients who may avoid and/or are fearful of social situations.

Your doctor may decide that you should continue to use PAXTINE for some time, even when you have overcome your problem. This should prevent the problem from returning.

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 reason.

2. What should I know before I take PAXTINE?

Warnings

In some children and adolescents, treatment with an antidepressant increases suicidal thinking or actions.

• Suicidal thoughts and actions can also be caused by depression, a serious medical condition that is commonly treated with antidepressants. Thinking about killing yourself or trying to kill yourself is called suicidality or being suicidal.
• It is more important to discuss all the risks of treating depression and also all the risks of not treating it. You should discuss all treatment choices with your doctor not just antidepressants.
• Patients (and caregivers of patients) need to monitor for any worsening of their condition and/or the emergence of thoughts of suicide or suicidal behaviour or thoughts of harming themselves and to seek medical advice immediately if these symptoms present (see section 2. What should I know before I take PAXTINE?- Children and Adolescents).

There is an increased risk of breaking a bone in people taking medicines like PAXTINE. This risk is greatest during the early stages of treatment.

Do not take PAXTINE if:

• you are allergic to paroxetine, or any of the ingredients listed at the end of this leaflet. 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

Always check the ingredients to make sure you can use this medicine.

• you are pregnant or intend to become pregnant.
• you have taken PAXTINE before and became unwell, tell your doctor or pharmacist before taking the first dose.
• you are taking any other medications for the treatment of depression or have done so in the last 2 weeks.

Taking PAXTINE with another antidepressant can cause a serious reaction.

• you must not take PAXTINE until 2 weeks after stopping monoamine oxidase inhibitor drugs (MAOIs).

Examples of MAOIs are phenelzine and tranylcypromine. Another MAOI includes the antibiotic linezolid. There may be others so please check with your doctor. Taking PAXTINE with a MAOI may cause a serious reaction.

• you are taking or have recently taken (within the last two weeks) a medicine called methylthioninium chloride (methylene blue).
• you are taking thioridazine for the treatment of schizophrenia.
• you are taking pimozide
• the expiry date (EXP) printed on the pack has passed.
• the packaging is torn or shows signs of tampering.

Check with your doctor if you:

• are allergic to foods, dyes preservatives or any other medicines.
• have any other medical conditions such as:
  • liver problems
  • heart problems
  • kidney problems
  • epilepsy
  • mania
  • raised pressure in the eye (glaucoma)
  • problems with blood clotting
  • other psychiatric conditions (bipolar disorder)
  • diabetes
  • history of bleeding disorders, such as after childbirth
• you are pregnant or intend to become pregnant.
• you are breastfeeding or wish to breastfeed. Your doctor will discuss with you the possible risks and benefits of using PAXTINE during breastfeeding.

If you have not told your doctor about any of the above, tell them before you start taking PAXTINE.

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.

• If you take PAXTINE 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 PAXTINE so they can advise you.
• Studies show that use of paroxetine in early pregnancy (first 13 weeks) may be associated with an increased risk of some birth defects in babies.
• If you become pregnant or intend to become pregnant while taking paroxetine, you should make an appointment to see your doctor and have your treatment reviewed.
• It is important that you do not stop taking paroxetine suddenly.
• Paroxetine is a medicine that can have withdrawal side effects if stopped suddenly.

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

Your doctor can discuss with you the risks and benefits involved.

Fertility

Medicines like PAXTINE may affect your sperm. Fertility in some men may be reduced while taking PAXTINE.

Elderly

Take special care with PAXTINE if you are over 65 years of age as PAXTINE may cause a reduction in the amount of sodium within your blood which can lead to sleepiness and muscle weakness.

If you experience these symptoms, please consult your doctor as soon as possible.

Children and adolescents

PAXTINE is not recommended for use in children and adolescents under 18 years.

• The use of PAXTINE is not recommended to treat depression in children and adolescents under 18, as the drug has not been shown to be effective in this age group and there are possible unwanted effects.
• Information from clinical trials has suggested that young adults, particularly those with depression, may be at an increased risk of suicidal behaviour (including suicide attempts) when treated with PAXTINE, especially during initial treatment (generally the first one to two months).
• The majority of attempted suicides in clinical trials in depression involved patients aged 18 to 30 years.
• Family and caregivers of children and adolescents being treated with antidepressants for major depressive disorder or for any other condition (psychiatric or non-psychiatric) need to monitor them for the emergence of agitation, irritability, unusual changes in behaviour, as well as the emergence of thoughts of suicide, and to report such symptoms immediately to their doctor.
• It is particularly important that monitoring be undertaken during the initial few months of antidepressant treatment or at times of dose increase or decrease.

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 PAXTINE and affect how it works. In particular, tell your doctor if you are taking any of the following medicines which:

• treat depression, anxiety, schizophrenia or attention-deficit hyperactivity disorder (ADHD) such as tryptophan, hypericum perforatum (St John's Wort), perphenazine, risperidone, lithium or atomoxetine
• are used in anaesthesia to treat pain or chronic pain, specifically tramadol or fentanyl
• lower blood pressure or treat heart conditions, such as metoprolol or flecainide
• control epilepsy (anti-convulsants), such as phenytoin, carbamazepine, phenobarbital (phenobarbitone)
• thin blood (anti-coagulants), such as warfarin, aspirin, non-steroidal anti-inflammatory drugs (NSAIDs)
• treat Parkinson's disease, such as selegiline and procyclidine
• treat stomach ulcers, such as cimetidine
• treat migraine attacks such as sumatriptan
• treat or prevent breast cancer, specifically tamoxifen
• treat HIV infection such as a combination of fosamprenavir and ritonavir
• used in anaesthesia, such as mivacurium and suxamethonium.

These medicines may be affected by PAXTINE or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

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

4. How do I take PAXTINE?

How much to take

• The usual dose of PAXTINE for depression, social anxiety disorder/social phobia is one 20 mg tablet per day. Your doctor may increase the dose slowly over several weeks. This may require you to break the tablet in half.
• To treat obsessions and compulsions or panic attacks, the usual dose of PAXTINE is two 20 mg tablets per day. Your doctor may start you on a lower dose (half a tablet) and increase the dose slowly over several weeks. This may require you to break the tablet in half.
• Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

When to take PAXTINE

• PAXTINE should be taken in the morning, preferable with food.
• Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

How to take PAXTINE

• Take PAXTINE with a full glass of water or another liquid.
• PAXTINE tablets can be broken in half along the break line if required but should not be chewed or crushed.

How long to take PAXTINE

Keep taking you PAXTINE for as long as your doctor tells you.

Your doctor may decide that you should continue to use PAXTINE for some time, even when you have overcome your problem. For best effect PAXTINE must be taken regularly.

Your doctor will tell you when and how PAXTINE should be discontinued.

Your doctor will usually recommend that you stop treatment by slowly reducing the dosage over a period of several weeks. When you stop treatment with PAXTINE, especially if this is done suddenly, you may experience unwanted symptoms. Please see Section 6. Are there any side effects?

If you forget to take PAXTINE

• If you miss your dose at the usual time and it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
• Otherwise, take the missed dose as soon as you remember, and then go back to taking your medicine as you would normally.
• Do not take a double dose to make up for the dose you missed.
• If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much PAXTINE

If you think that you or anyone else has taken too much PAXTINE, urgent medical attention may be needed.

If you take too much PAXTINE, symptoms include sedation, blood pressure changes, involuntary muscle contractions and facial flush. It rarely can lead to seizures, heart rhythm changes and unconsciousness. For more information see Section 6. Are there any side effects?

You should immediately:

• phone the Poisons Information Centre
  (Australia telephone 13 11 26) for advice, 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.

You may need urgent medical attention.

5. What should I know while taking PAXTINE?

Things you should do

• Remind any doctor, dentist or pharmacist you visit that you are using PAXTINE.
• Keep all of your doctor's appointments so that your progress can be checked.

Your doctor may want to do some blood tests and check your heart and blood pressure from time to time. This helps to prevent unwanted side effects.

Call your doctor straight away if you:

• For any reason, have not taken your medicine exactly as directed. Otherwise, your doctor may think that it was not working as it should and change your treatment unnecessarily.

Like other drugs of this type PAXTINE will not relieve your symptoms straight away. People generally start feeling better in a few weeks or so. Occasionally, the symptoms of depression or other psychiatric conditions may include thoughts of harming yourself or committing suicide. It is possible that these symptoms may continue to increase until the full antidepressant effect of your medicine becomes apparent, especially when PAXTINE is first started or when the dose is changed. People who are close to individuals taking PAXTINE can help by paying attention to changes in their moods or actions.

Tell your doctor if you feel the tablets are not helping your condition.

If you are being treated for depression, discuss with your doctor any problems you may have and how you feel, especially any feelings of severe sadness or bursts of unusual energy or anger.

This will help your doctor determine the best treatment for you.

All thoughts of suicide must be taken seriously. Contact your doctor right away if someone taking PAXTINE talks about or shows signs of killing him or herself. Tell your doctor immediately or go to the nearest hospital if you have any distressing thoughts or experiences during this initial period or at any other time.

Also contact your doctor if you experience any worsening of your depression/other symptoms at any time during your treatment.

Tell your doctor or go to the nearest hospital immediately if you experience symptoms of serotonin syndrome or neuroleptic malignant syndrome, which are rare life-threatening conditions. These symptoms include high body temperature, stiffness, involuntary muscle jerks, confusion, extreme agitation, delirium and coma.

Things you should not do

• Do not stop using this medicine suddenly.

Suddenly stopping PAXTINE may cause symptoms like dizziness, trouble sleeping, shaking, feeling anxious, nausea, sweating or tinnitus.

• Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
• Do not use PAXTINE to treat any other complaints unless your doctor says to.

Driving or using machines

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

Tests have shown that PAXTINE does not have a marked effect on driving ability. However, PAXTINE may cause drowsiness, dizziness or lightheadedness in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous. Make sure you know how to react to PAXTINE before you drive a car or operate machinery.

Drinking alcohol

Tell your doctor if you drink alcohol.

Although drinking moderate amounts of alcohol is unlikely to affect your response to PAXTINE, it is best to avoid alcohol while you take this medicine.

Looking after your medicine

• Store below 25°C.
• Keep your tablets in the blister pack until it is time to take them.

If you take the tablets out of the pack they may not keep well.

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

Store it in a cool dry place, 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.

Heat or dampness can destroy some medicines.

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.

Stopping treatment

Do not stop taking PAXTINE even if you begin to feel better.

Your doctor may decide that you should continue to use PAXTINE for some time, even when you have overcome your problem. For best effect PAXTINE must be taken regularly.

Your doctor will tell you when and how PAXTINE should be discontinued.

When your doctor decides that you should stop taking PAXTINE the dose may be reduced slowly or the time between doses increased over 1 or 2 weeks. Some people may have symptoms such as dizziness, anxiety, sleep disturbances, pins and needles, electric shock sensations or feeling sick and sweating if PAXTINE is stopped, particularly if stopped suddenly.

Although PAXTINE is not recommended for children under 18 years of age, additional symptoms that have been experienced by children whilst stopping treatment are abdominal pain, nervousness and mood changes.

Please see additional information under Section 6. Are there any side effects?

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 or the packaging is torn or shows signs of tampering.

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.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking PAXTINE.

Do not be alarmed by the following list of side effects. You may not experience any of them.

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

Serious side effects

Other rare events that have been reported with PAXTINE include:

• blurred vision
• abnormal liver function
• low levels of sodium un the blood, especially in older people
• bleeding disorders, including nose bleeds and gastrointestinal bleeding which occurs vary rarely
• hormone disturbances
• mood of excitement, over-activity and uninhibited behaviour
• confusion
• seizures
• rash caused by light
• itchy rash, hives, swelling of the face, lips, mouth, tongue or throat
• akathisia (restlessness or difficulty keeping still, caused by medicines to treat mental disorders).
• irresistible urge to move legs (Restless Legs Syndrome)
• menstrual period disorder (including heavy periods, bleeding between periods and absence of periods).
• heavy vaginal bleeding shortly after birth
• severe allergic reactions

Unwanted effects that may occur on stopping treatment:

Symptoms may include

• dizziness
• sensory disturbances such as, pins and needles, burning sensations and electric shock-like sensations
• sleep disturbances, including intense dreams
• agitation or anxiety
• feeling sick
• shaking or tremors
• confusion
• sweating
• headache
• diarrhoea

These are likely to occur in the first few days of stopping treatment or very rarely if you miss a dose. However, they are more likely to occur if you stop taking PAXTINE too quickly.

Therefore, always consult your doctor before stopping your medicine. For the majority of patients, symptoms go away on their own within a few weeks.

However, if you feel that unwanted symptoms are too severe, see your doctor who will suggest how to manage stopping treatment more slowly.

Although PAXTINE Is not recommended for children under 18 years of age, the most common unwanted effects in children under 18 are:

• decreased appetite
• tremor (uncontrollable trembling)
• sweating
• hyperactivity
• hostile/unfriendly behaviour
• agitation
• changing emotions, including crying, changes in mood, trying to harm themselves, thoughts of suicide and attempting suicide

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 PAXTINE contains

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

What PAXTINE looks like

PAXTINE tablets are white, round film-coated tablets marked P/2 and G. (AUST R 227120)

Available in blister packs of 30 tablets.

Who distributes PAXTINE

Alphapharm Pty Ltd trading as Viatris

Level 1, 30 The Bond

30-34 Hickson Road

Millers Point NSW 2000

www.viatris.com.au

Phone: 1800 274 276

This leaflet was prepared in July 2024.

PAXTINE® is a Viatris company trade mark

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