<footer=genrx paroxetine=””>

GenRx Paroxetine

Paroxetine hydrochloride
Consumer Medicine Information

For a copy of a large print leaflet Ph: 1800 195 055

eMedical provides a wide variety of prescription and non-prescription products. From aching joints to skin and hair care to weight loss, we have everything the modern patient needs to stay fit and healthy. With children’s medicines and pet products, our online chemist will take care of you and the whole family.

What is in this leaflet

This leaflet answers some common questions about GenRx Paroxetine. It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking paroxetine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Paroxetine is used for

This medicine is used to treat:

Depression
Obsessive Compulsive Disorder (OCD)
Panic Disorder
Social Anxiety Disorder or Social Phobia
Generalised Anxiety Disorder
Post-traumatic Stress Disorder

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

Depression is longer lasting and/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 usual 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. Paroxetine corrects the chemical imbalance and so helps to relieve the symptoms of depression.

It may also be used to treat irrational fears or obsessional behaviour. These can also be due to chemical imbalance in parts of the brain.

Paroxetine may also be used to help prevent panic attacks, treat patients who may avoid and/or are fearful of social situations, have excessive anxiety and worry and who feel irritable, restless and/or tense in the muscles.

Paroxetine may also be used to treat repetitive and distressing recollections of a past traumatic event.

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

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

Before you take Paroxetine

Antidepressants can increase suicidal thoughts and actions in some children and adolescents younger than 18 years of age. But suicidal thoughts and actions can also be caused by depression, a serious medical condition that is commonly treated with antidepressants. Thinking about killing yourself is called suicidality or being suicidal.

Antidepressants are used to treat depression and other illnesses. Depression and other illnesses can lead to suicide. In some children and adolescents, treatment with an antidepressant increases suicidal thinking or actions. It is important to discuss all the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your doctor, not just the use of 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 of these symptoms present (see Use in Children and Adolescents).

When you must not take it

Do not take paroxetine if:

you are pregnant or intend to become pregnant.

Studies show that use of paroxetine in early pregnancy (first 13 weeks) may be associated with an increased risk of heart 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 (see Things you must not do & Unwanted effects that may occur on stopping treatment).

you have ever had an allergy to any medicine containing paroxetine hydrochloride or to any of the ingredients listed at the end of this leaflet (see Ingredients).

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.

you are intolerant or allergic to lactose. GenRx Paroxetine contains lactose.
you have taken paroxetine 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 paroxetine with another antidepressant may cause a serious reaction.

You must not take paroxetine until 2 weeks after stopping monoamine oxidase inhibitor drugs (MAOIs).

Examples of MAOIs are phenelzine (Nardil) and tranylcypromine (Parnate).

Taking paroxetine with a MAOI may cause a serious reaction with a sudden increase in body temperature, extremely high blood pressure and severe convulsions.

Ask your doctor or pharmacist if you are not sure if you have been taking one of these medicines.

you are taking thioridazine (Melleril, Aldazine) for the treatment of schizophrenia.
you are taking pimozide (Orap) for the treatment of disturbances in thinking, feelings and behaviours.
the expiry date printed on the pack has passed.
the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

You must tell your doctor if:

you are intolerant or allergic to lactose.
you have any allergies to any other medicines, foods, preservatives or dyes.
you are pregnant or intend to become pregnant.
you are breast-feeding.

Your doctor will discuss with you the possible risks and benefits of using paroxetine involved.

you have any of the following medical conditions:
-mania or hypomania
-convulsions, fits or seizures (e.g. epilepsy)
-heart problems or heart attack
-liver problems
-kidney problems
-glaucoma (raised pressure in the eye)
-problems with blood clotting
-other psychiatric conditions (Mania / Bipolar disorder).
you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.

If you have not told your doctor about any of the above, tell him/her before you start taking paroxetine.

Taking other medicines

Tell your doctor or pharmacist if you are taking any of the following medicines.

Some medicines and paroxetine may interfere with each other.

These include:

medicines to treat depression, anxiety or schizophrenia, including monoamine oxidase inhibitors, such as phenelzine, tranylcypromine and moclobemide; tricyclic antidepressants, such as nortriptyline, amitriptyline, imipramine and desipramine; medicines used for psychiatric disorders, such as thioridazine, pimozide, risperidone or lithium; and buspirone (Buspar), for anxiety disorders
medicines to treat Parkinson`s disease, such as selegiline (Eldepryl) and procyclidine (Kemadrin)
medicines to control epilepsy or fits, such as phenytoin (Dilantin), carbamazepine (Tegretol) and sodium valproate (Epilim)
medicines to lower blood pressure or treat heart conditions, such as metoprolol (Betaloc)and flecainide (Tambocor)
non-steroidal anti-inflammatory drugs (NSAIDs) or medicines to prevent blood clots (anti-coagulants), such as warfarin (Coumadin, Marevan), and aspirin
medicines to treat stomach ulcers or reflux cimetidine (Tagamet)
medicines to treat migraine attacks and cluster headaches, such as sumatriptan, naratriptan and zolmitriptan
medicines bought over the counter, such as St John`s Wort (Hypericum perforatum) or tryptophan, contained in some multivitamin and herbal preparations
antiviral protease inhibitors, such as fosamprenavir or ritonavir.

These medicines may be affected by paroxetine or may affect how well it works. Your doctor or pharmacist will be able to tell you which medicines are safe to take with paroxetine.

How to take Paroxetine

Follow your doctors` directions about how and when to take paroxetine.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.

How much to take

The usual dose of paroxetine for depression, social anxiety disorder/social phobia, generalised anxiety disorder or post-traumatic stress disorder is one 20 mg tablet taken once each day. Your doctor may increase the dose slowly over several weeks. This may require you to break the tablet in half.

The usual dose of paroxetine for obsessions and compulsions or panic attacks is two 20 mg tablets taken once each day. Your doctor may start you on a lower dose and increase the dose slowly over several weeks. This may require you to break the tablet in half.

How to take it

Swallow the tablets with a full glass of water.

The tablets can be broken in half but should not be chewed.

Paroxetine should be taken in the morning, preferably with food.

How long to take it

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

Like other drugs of this type, paroxetine 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 or increase until the full anti-depressant effect of your medicine becomes apparent.

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.

Stopping treatment

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

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

Your doctor will tell you when and how paroxetine 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 paroxetine especially if this is done suddenly, you may experience unwanted symptoms (see Things you must not do).

Use in Children and Adolescents

Paroxetine is not recommended for use in children under 18 years.

The use of paroxetine 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 side effects.
Information from clinical trials suggested that young adults, particularly those with depression, may be at an increased risk of suicidal behaviour (including suicide attempts) when treated with paroxetine. The majority of attempted suicides in clinical trials in depression involved those aged 18 to 30 years.
Family and caregivers of children and adolescents being treated with antidepressants for major depressive disorders 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.

If you forget to take it

Do not take an extra dose. Wait until the next day and take your normal dose then.
Do not try to make up for the dose that you missed by taking more than one dose at a time.
This may increase the chance of you getting an unwanted side effect.

If you take too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at your nearest hospital, if you think that you or anyone else may have taken too much paroxetine. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Symptoms of an overdose may include nausea, vomiting, tremor, dilated pupils, dry mouth, sedation, sweating, dizziness, confusion, headache, fast heartbeat and irritability.

While you are taking Paroxetine

Things you must do

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

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

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

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.

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

If you are being treated for depression, be sure to discuss with your doctor any problems you may have and how you feel, especially any feelings of severe sadness, thoughts of suicide, bursts of unusual energy, anger or aggression, or if you become particularly agitated or restless.

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

Keep all of your doctor`s appointments so that your progress can be checked.

Your doctor may do some tests from time to time, such as checking your heart and blood pressure, to make sure the medicine is working and to prevent unwanted side effects.

Things you must not do

Do not give your medicine to anyone else, even if their symptoms seem similar to yours.
Do not take paroxetine to treat any other complaints unless your doctor tells you to.

Do not stop taking your medicine or lower the dosage, without checking with your doctor.

Things to be careful of

Be careful driving or operating machinery until you know how paroxetine affects you.

This medicine may cause dizziness, drowsiness or light headedness in some people. If you have any of these symptoms, do not drive a car; operate machinery, or anything else that could be dangerous.

Be careful when drinking alcohol while you are taking this medicine.

If you drink alcohol, dizziness, drowsiness or impaired concentration may be worse. Your doctor may suggest avoiding alcohol while you are being treated with this medicine.

You should wait at least 14 days after stopping paroxetine before starting any medicines known as monoamine oxidase inhibitors (MAOIs), such as phenelzine, tranylcypromine and moclobemide.

When your doctor decides that you should stop taking paroxetine, the dose may be reduced slowly or the time between the doses increased over 1 to 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 paroxetine is stopped, particularly if stopped suddenly.

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

Side effects

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

Like other medicines, paroxetine can cause some side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

If you are over 65 years of age you may have an increased chance of getting side effects.

Ask your doctor or pharmacist to answer any questions you may have.

MILD EFFECTS
Tell your doctor or pharmacist if you notice any of the following and they worry you:

feeling sick, dry mouth, decreased appetite, constipation or diarrhoea
drowsiness, dizziness difficulty in getting to sleep
impaired sexual function
weakness
feeling sweaty or shaky
impaired concentration, confusion
blurred vision
frequent urination
headache
weight gain

MORE SERIOUS EFFECTS
Tell your doctor as soon as possible if you notice any of the following:

muscle spasms or twitches
abnormal bleeding (including vaginal and gastrointestinal bleeding) or bruising.
Stop taking paroxetine and tell your doctor immediately or go to the emergency department at your nearest hospital if any of the following happens:
allergic reaction, such as rash, itching or hives on the skin; swelling of the face, lips, tongue or other parts of the body; shortness of breath, wheezing or difficulty breathing
sudden increase in body temperature, severe convulsions (fits)
Fast heart beat, sweating, muscle spasm, racing thoughts, restlessness, chest pain
sudden onset of prolonged muscular spasms, affecting the eyes, head, neck and body
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.
Other rare events that have been reported include:
blurred vision
abnormal liver function
low levels of sodium in the blood, especially older people
hormone disturbances
mood of excitement, over-activity and uninhibited behaviour
changing emotions, including crying, changes in mood, trying to harm themselves, thoughts of suicide and attempting suicide.
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).
Unwanted effects that may occur on stopping treatment.
Symptoms may include:
dizziness,
sensory disturbances, such as pine and needles, burning sensations and electric-shock like sensations,
sleep disturbances, including intense dreams.
agitation or anxiety,
feeling sick,
shaking or tremors,
confusion,
tinnitus
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 paroxetine 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 the unwanted symptoms are too severe, see your doctor who will suggest how to manage stopping treatment more slowly.

Additional symptoms that have been experienced by children whilst stopping treatment are, changing emotions (including thoughts of suicide, mood changes and feeling tearful), abdominal pain and nervousness.

Although paroxetine 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.

This is not a complete list of all possible side effects. Others may occur in some people and there may be some side effects not yet known.

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

After taking Paroxetine

Storage

Keep it 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.

Keep your tablets in their pack until it is time to take them.

Keep your tablets in a cool, dry place where the temperature stays below 25 degrees C.

Do not store paroxetine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Disposal

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

Product description

What it looks like

GenRx Paroxetine tablets are white, oval, biconvex and film-coated. The tablets are partially scored and engraved “20” on one side. The other side is plain.

GenRx Paroxetine is available in blister packs of 30 tablets.

Ingredients

GenRx Paroxetine contains 20 mg of paroxetine (as paroxetine hydrochloride) as the active ingredient.

It also contains:

magnesium stearate
sodium starch glycollate
lactose anhydrous
hydroxypropylcellulose
hypromellose
macrogol 8000
titanium dioxide

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

Australian Register Number

AUST R 83103.

</footer=genrx>

Swisse UltiBoost Sleep Tablets (Pack of 60)