1. Why am I taking ENLAFAX-XR?

ENLAFAX-XR contains the active ingredient venlafaxine hydrochloride. ENLAFAX-XR is used in the treatment and prevention of relapse of depression and in the treatment of social phobia (social anxiety disorder). For more information, see Section 1. Why am I taking ENLAFAX-XR? in the full CMI.

2. What should I know before I take ENLAFAX-XR?

Do not use if you have ever had an allergic reaction to venlafaxine 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 ENLAFAX-XR? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with ENLAFAX-XR 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 ENLAFAX-XR?

• Your doctor will tell you how many capsules you need to take each day. This may depend on your age, your condition and whether or not you are taking any other medicines.
• Do not divide, crush, chew or dissolve the capsules in water.

More instructions can be found in Section 4. How do I take ENLAFAX-XR? in the full CMI.

5. What should I know while taking ENLAFAX-XR?

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

6. Are there any side effects?

Speak to your doctor or pharmacist if you have: nausea, vomiting, loss of appetite, diarrhoea, constipation, change in behaviour, feeling drowsy, headache, rapid heart beat, sweating, hot flushes, rash, itchiness, weight change, blurred vision or dry mouth.

Call your doctor immediately if you have: muscle tremors, abnormal facial movements, feeling of apathy, hallucination, agitation, confusion, muscle weakness, numbness, shortness of breath, bleeding, bruising more easily or sensitivity to sunlight.

Call your doctor immediately or go to Emergency at your nearest hospital if you have: fits or seizures, signs of allergy, sudden fever with sweating, rapid heartbeat and muscle stiffness, palpitation, intense chest pain, dark or red urine, yellowing of skin or eyeballs, signs of infections, black sticky bowel motions or bloody diarrhoea.

This is not a complete list of all possible side effects. 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.

ENLAFAX^®-XR

Active ingredient: Venlafaxine hydrochloride

Consumer Medicine Information (CMI)

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

Where to find information in this leaflet:

1. Why am I taking ENLAFAX-XR?

ENLAFAX-XR contains the active ingredient venlafaxine hydrochloride. It belongs to a class of medications for depression and anxiety, called Serotonin-Noradrenaline Reuptake Inhibitors (SNRIs).

Serotonin and noradrenaline are chemical messengers that allow certain nerves in the brain to work. ENLAFAX-XR capsules increase the level of these two messengers. Experts think this is how it helps to restore your feeling of wellness.

There is no evidence that ENLAFAX-XR is addictive.

ENLAFAX-XR is used in the treatment and prevention of relapse of depression and in the treatment of social phobia (social anxiety disorder).

Depression 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 parts of the brain. This imbalance affects your whole body and can cause emotional and physical symptoms such as feeling low in spirit, lose interest in usual activities, be unable to enjoy life, have poor appetite or over eat, have disturbed sleep, often waking up early, loss of sex drive, low energy and feel guilty over nothing.

Social phobia is a fear of being embarrassed, judged or evaluated negatively in social situations, which can result in substantial impairment in the person's social emotional, interpersonal and occupational life.

Depression and anxiety are treatable illnesses. Anxiety or tension associated with the normal stress of everyday life usually does not require treatment with medicines.

Ask your doctor if you have any questions about why ENLAFAX-XR has been prescribed for you.

Your doctor may have prescribed it for another reason.

Use in Children

Do not give ENLAFAX-XR to children or adolescents under 18 years of age.

• The safety and effectiveness of ENLAFAX-XR in this age group have not been established.

2. What should I know before I take ENLAFAX-XR?

Warnings

Do not take ENLAFAX-XR if:

• you are taking other medications for depression known as monoamine oxidase inhibitors, even if you have stopped taking them now, but have taken them within the last 14 days.
• you are allergic to venlafaxine, or any of the ingredients listed at the end of this leaflet.
  Symptoms of an allergic reaction may include:
  • rash, itching or hives on the skin
  • swelling of the face, lips, tongue, throat or other parts of the body
  • shortness of breath, wheezing or troubled breathing; difficulty swallowing.

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

• the expiry date printed on the pack has passed or if the packaging is torn or shows signs of tampering.

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

Check with your doctor or pharmacist if you:

• have any other medical conditions
• take any medicines for any other condition
• have allergies to any other medicines, foods, preservatives or dyes.

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 or pharmacist if you are pregnant or intend to become pregnant.

ENLAFAX-XR is not recommended for use during pregnancy. Your doctor will discuss the risks and benefits of taking ENLAFAX-XR if you are pregnant. One of these risks is that newborn babies, whose mothers have been taking ENLAFAX-XR in the last few months of pregnancy, may experience problems soon after delivery, including breathing difficulties, seizures and lack of oxygen in their blood.

If you take ENLAFAX-XR or similar anti-depressants mid to late in your pregnancy, you may develop a condition known as "pre-eclampsia", which is characterised by persistent high blood pressure during or after pregnancy. Symptoms of pre-eclampsia can include headaches, abdominal pain, shortness of breath or burning around the sternum, nausea and vomiting, confusion, heightened state of anxiety, and/or visual disturbances such as oversensitivity to light, blurred vision, or seeing flashing spots or auras.

If you take ENLAFAX-XR or similar antidepressants in the last month of your pregnancy, you may experience heavy vaginal bleeding shortly after birth (postpartum haemorrhage).

Continuing treatment with ENLAFAX-XR or similar antidepressants during pregnancy should be strictly as directed by your doctor. Symptoms of a relapse may occur if treatment is discontinued, even if major depression was previously under control.

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

ENLAFAX-XR passes into breast milk and there is a possibility that the breast-fed baby may be affected. For this reason, the use of ENLAFAX-XR is not recommended in breast-feeding women.

Tell your doctor if you have or have had any of the following medical conditions:

• a history of fits (seizures or convulsions)
• a personal history or family history of bipolar disorder
• a history of aggression
• a history of restlessness or difficulty sitting still
• diabetes
• blood pressure problems
• glaucoma (increased pressure in the eye)
• a tendency to bleed more than normal or you are taking medicines to prevent blood clots
• raised cholesterol levels or you are taking medicines to lower cholesterol
• problems with your kidneys or liver
• problems with your heart, especially conditions causing irregular heartbeats.

Your doctor may wish to do some heart tests such as an electrocardiogram (ECG) or blood tests during treatment with ENLAFAX-XR.

Tell your doctor if you plan to have surgery.

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

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you take any other medicines, including:

• all prescription medicines
• all medicines, vitamins, herbal supplements or natural therapies you buy without a prescription from a pharmacy, supermarket, naturopath or health food shop such as St John's Wort or tryptophan supplements.

Do not start to take any other medicine while you are taking ENLAFAX-XR, unless it is prescribed or approved by your doctor.

Some medicines may interfere with ENLAFAX-XR, or ENLAFAX-XR may interfere with these medicines. These include:

• Medications for depression known as monoamine oxidase inhibitors (such as moclobemide, linezolid, phenelzine and tranylcypromine), even if you have stopped taking them now, but have taken them within the last 14 days. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines

Allow at least 7 days after stopping ENLAFAX-XR before starting a MAOI.

Taking this medicine with a MAOI, or within 7 days of taking a MAOI, may cause a serious reaction with a sudden increase in body temperature, extremely high blood pressure and severe convulsions.

The appropriate washout period is needed to prevent severe adverse reactions.

• any other medications for depression, anxiety, obsessive-compulsive disorder or premenstrual dysphoric disorder, including St John's Wort
• medicines for treating mental disorders such as haloperidol, risperidone, lithium or clozapine
• tramadol, fentanyl, tapentadol, pethidine, methadone and pentazocine used to treat strong pain
• amphetamines used to treat attention deficit hyperactivity disorder or ADHD
• cimetidine for reflux and stomach ulcers
• triptans used to treat migraine
• amiodarone or quinidine used to treat irregular heartbeats.

Your doctor may do some tests such as an electrocardiogram (ECG) or blood tests if you are taking either of these medicines whilst taking ENLAFAX-XR:

• metoprolol for high blood pressure or angina
• medicines used to prevent blood clotting such as platelet inhibitors and anti-coagulants e.g., warfarin
• indinavir for viral infections
• medicines for weight loss
• antibiotics such as erythromycin and linezolid for bacterial infections
• ketoconazole or fluconazole for fungal infections.

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

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking ENLAFAX-XR.

4. How do I take ENLAFAX-XR?

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

Your doctor will tell you how many capsules you need to take each day. This may depend on your age, your condition and whether or not you are taking any other medicines.

The usual starting dose is 75mg taken once daily. After 2 weeks, your doctor may increase your dose.

Do not change dose unless your doctor tells you to.

If you have kidney or liver problems, you may need a lower dose of ENLAFAX-XR.

If you have heart problems your doctor may first do some blood tests or heart tests such as an electrocardiogram (ECG) before increasing your dose of ENLAFAX-XR.

How to take ENLAFAX-XR

• Swallow the capsules whole with a glass of water or other non-alcoholic liquid.
• DO NOT DIVIDE, CRUSH, CHEW OR DISSOLVE THE CAPSULES IN WATER.
• Taking divided, chewed or crushed ENLAFAX-XR capsules, in theory, could lead to the rapid release and absorption of venlafaxine.

When to take ENLAFAX-XR

• Take ENLAFAX-XR once daily with food, at approximately the same time each day.
• This could be either in the morning or in the evening.
• Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

How long to take ENLAFAX-XR

• Continue taking your medicine for as long as your doctor tells you.
• The length of treatment will depend on how quickly your symptoms improve. Most antidepressants 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 or 2 weeks but it can take up to another few weeks to feel any real improvement.
• Even when you feel well, it is important to keep taking your medicine. You will usually have to take ENLAFAX-XR for several months or even longer to make sure the benefits will last. Discuss this with your doctor and don't stop taking ENLAFAX-XR until gaining your doctor's agreement.

If you forget to take ENLAFAX-XR

ENLAFAX-XR should be taken regularly at the same time each day.

If it is less than 12 hours until your next dose, skip the dose you missed and then take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking 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.

Contact your doctor if you have missed more than two doses in a row.

Always finish the capsules you are taking in the current pack before you start a new pack.

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 ENLAFAX-XR

If you think that you or anyone else may have taken too much ENLAFAX-XR, urgent medical attention may be needed.

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.

If you take too many ENLAFAX-XR capsules you may:

• feel sleepy
• vomit
• have an increased heart rate or changes in heart rhythm
• have a seizure (fits)
• have breathing difficulties
• become unconscious
• have dilated pupils.

Keep the telephone number for these places handy whilst taking any medications.

5. What should I know while taking ENLAFAX-XR?

Things you should do

• Visit your doctor regularly for a check up so that your progress can be checked.

Your doctor may do some tests (such as an electrocardiogram (ECG) or blood tests) from time to time to make sure the medicine is working and to prevent unwanted side effects.

• Always discuss any questions you have about ENLAFAX-XR capsules with your doctor.
• If you are going to have surgery, tell your doctor that you are taking this medicine.

Some agents used to assist your doctor during surgery may interact with ENLAFAX-XR leading to unwanted side effects.

• If you are about to have any urine tests, tell your doctor that you are taking this medicine.

ENLAFAX-XR may interfere with the results of some tests.

• Take ENLAFAX-XR capsules as your doctor has prescribed.

Keep enough ENLAFAX-XR capsules to last weekends and holidays.

ENLAFAX-XR helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.

• Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
• Watch carefully for signs that your depression or anxiety is getting worse, especially in the first few weeks of treatment, or if your dose has changed.

Sometimes people with depression can experience a worsening of their depressive symptoms. This can happen even when taking an antidepressant.

Information from clinical trials has suggested that children, adolescents and young adults (18-24 years), particularly those with depression, may be at increased risk of suicidal behaviour (including suicide attempts) when treated with ENLAFAX-XR, especially during initial treatment.

Call your doctor straight away if you experience:

• anxiety or agitation
• panic attacks
• difficulty sleeping
• irritability
• aggressiveness
• hostility or impulsiveness
• restlessness
• overactivity or uninhibited behaviour
• other unusual changes in behaviour
• thoughts of suicide
• tremor, sweating, fast heart rate
• muscle rigidity.

Tell your doctor immediately if you experience any of the above symptoms, especially if they are severe, you have not had these symptoms before or they happen very suddenly.

Symptoms of serotonin syndrome may include mental status changes (e.g. agitation, confusion, hallucinations, and coma), autonomic instability (e.g. excessive sweating, fast heart rate, and increased body temperature), neuromuscular aberrations (e.g. overactive reflexes, incoordination, tremor) and/or gastrointestinal symptoms (e.g. nausea, vomiting, and diarrhoea).

Tell your doctor immediately if you have any thoughts about suicide or doing harm to yourself.

Warning signs of suicide

If you or someone you know is showing the following warning signs, either contact your doctor or a mental health advisor right away or go to the nearest hospital for treatment.

All thoughts or talk about suicide or violence are serious.

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

Things you should not do

Do not suddenly stop taking ENLAFAX-XR or lower the dose, without first checking with your doctor.

Check with your doctor for the best way to slowly reduce the amount of ENLAFAX-XR you are taking before stopping completely.

If you stop taking it suddenly, your condition may worsen or you may have unwanted side effects such as:

• headache
• nausea and vomiting
• dizziness
• insomnia
• nervousness
• anxiety
• confusion and agitation
• diarrhoea
• sweating
• loss of appetite
• tremor
• flu-like symptoms
• impaired coordination and balance
• tingling or numbness of the hands and feet.

Slowly reducing the amount of ENLAFAX-XR being taken reduces the possibility of these effects occurring.

Some of these symptoms may impair driving, or the operation of dangerous machinery. Avoid these activities if you experience these symptoms.

Do not take ENLAFAX-XR to treat any other complaints unless your doctor tells you to.

Do not give this medicine to anyone else even if they have the same condition as you.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how ENLAFAX-XR affects you.

ENLAFAX-XR capsules may make you feel drowsy.

Things to be careful of

If you are feeling drowsy or are uncoordinated, be careful that you do not fall over.

ENLAFAX-XR, like other medicines in this class, may increase your risk of bone fracture.

Drinking alcohol

Avoid drinking alcohol while you are taking ENLAFAX-XR.

Alcohol can cause dizziness and lightheadedness. Alcohol may also worsen your condition.

Looking after your medicine

• Store below 25°C
• Keep your capsules in their blister pack until it is time to take them. If you take the capsules out of the blister 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 and 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.

Getting rid of any unwanted medicine

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

Do not take this medicine after the expiry date.

6. Are there any side effects?

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

This medicine helps most people with depression, but it may have unwanted side effects in some people.

All medicines can have side effects. Sometimes they are serious; often they are not. You may need medical attention if you get some of the side effects.

It can be difficult to tell whether side effects are the result of taking this medicine, effects of your condition, or side effects of other medicines you may be taking. For this reason it is important to tell your doctor of any change in your condition.

Do not be alarmed by the 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

More 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.

Some of these side effects (for example, increase in blood pressure or blood cholesterol) can only be found when your doctor does tests from time to time to check your progress.

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 ENLAFAX-XR contains

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

What ENLAFAX-XR looks like

ENLAFAX-XR 75 mg capsules are flesh opaque-flesh opaque, No 0, capsules printed on cap with VEN, and on the body with 75, containing two white, round, biconvex 37.5 mg film coated tablets. (AUST R 143533).

ENLAFAX-XR 150 mg capsules are scarlet opaque scarlet-opaque, No 00, printed on cap with VEN, and on the body with 150, containing three white, round, biconvex 50 mg film coated tablets. (AUST R 143552).

Each blister pack contains 28 capsules.

Who distributes ENLAFAX-XR

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.

ENLAFAX^® is a Viatris company trade mark

ENLAFAX XR_cmi\Jul24/01