SUMMARY CMI
Venlafaxine generichealth XR
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
1. Why am I using Venlafaxine generichealth XR?
Venlafaxine generichealth XR contains the active ingredient venlafaxine hydrochloride. Venlafaxine generichealth XR is used in the treatment and prevention of relapse of depression. It is also used in the treatment of panic attacks and anxiety, including avoidance or fear of social situations.
For more information, see Section 1. Why am I using Venlafaxine generichealth XR? in the full CMI.
2. What should I know before I use Venlafaxine generichealth 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 Venlafaxine generichealth XR? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Venlafaxine generichealth 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 Venlafaxine generichealth XR?
- Swallow the capsules whole with a glass of water. Do not divide, crush, chew or dissolve the capsules in water.
- 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.
More instructions can be found in Section 4. How do I take Venlafaxine generichealth XR? in the full CMI.
5. What should I know while using Venlafaxine generichealth XR?
Things you should do |
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Things you should not do |
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Driving or using machines |
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Drinking alcohol |
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Looking after your medicine |
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For more information, see Section 5. What should I know while using Venlafaxine generichealth XR? in the full CMI.
6. Are there any side effects?
Common side effects include nausea; vomiting; loss of appetite; diarrhoea; constipation; change in behaviour; feeling drowsy; headache; rapid heartbeat; sweating; hot flushes; rash; itchiness; weight change; blurred vision; dry mouth. Serious side effects include muscle tremors; abnormal facial movements; feeling of apathy; hallucinations; agitation; confusion; muscle weakness; numbness; shortness of breath; bleeding; bruising more easily than normal; sensitivity to sunlight; 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 infection; black sticky bowel motions; bloody diarrhoea; high fever; confusion; abrupt muscle contraction.
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.
FULL CMI
Venlafaxine generichealth XR
Active ingredient(s): venlafaxine hydrochloride
Consumer Medicine Information (CMI)
This leaflet provides important information about using Venlafaxine generichealth 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 using Venlafaxine generichealth XR.
Where to find information in this leaflet:
1. Why am I using Venlafaxine generichealth XR?
2. What should I know before I use Venlafaxine generichealth XR?
3. What if I am taking other medicines?
4. How do I take Venlafaxine generichealth XR?
5. What should I know while using Venlafaxine generichealth XR?
6. Are there any side effects?
7. Product details
1. Why am I using Venlafaxine generichealth XR?
Venlafaxine generichealth XR contains the active ingredient venlafaxine hydrochloride. Venlafaxine generichealth XR belongs to a class of medicines used 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. Venlafaxine generichealth XR capsules increase the level of these two messengers. Experts think this is how it helps to restore your feeling of wellness.
Venlafaxine generichealth XR is not addictive.
Venlafaxine generichealth XR is used in the treatment and prevention of relapse of depression. It is also used in the treatment of panic attacks and anxiety, including avoidance or fear of social situations.
Depression can affect your whole body and may cause emotional and physical symptoms such as feeling low in spirit, being unable to enjoy life, poor appetite or overeating, disturbed sleep, loss of sex drive, lack of energy and feeling guilty over nothing.
Excessive anxiety is a condition in which you feel constantly and uncontrollably worried and distressed. It may also make you feel irritable, and cause difficulty in thinking and sleeping. Other common symptoms associated with anxiety may include a dry mouth, a lump in the throat, cold clammy hands, diarrhoea and nausea.
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 this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.
2. What should I know before I use Venlafaxine generichealth XR?
Warnings
Do not use Venlafaxine generichealth 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. - this medicine after the expiry date (EXP) printed on the pack has passed.
- 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 if you:
- have any other medical conditions, including:
- 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 heartbeat.
Your doctor may wish to do some heart tests such as an electrocardiogram (ECG) or blood tests during treatment with Venlafaxine generichealth XR. - take any medicines for any other condition.
- plan to have surgery.
- have allergies to any other medicines, foods,
preservatives or dyes.
If you have not told your doctor about any of the above, tell them before you start taking Venlafaxine generichealth XR.
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.
Venlafaxine generichealth XR is not recommended for use during pregnancy. Your doctor will discuss the risks and benefits of using this medicine if you are pregnant. One of these risks is that newborn babies, whose mothers have been taking Venlafaxine generichealth 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 Venlafaxine generichealth 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 preeclampsia can include headaches, abdominal pain, shortness of breath or burning behind 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 Venlafaxine generichealth 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 Venlafaxine generichealth 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 if you are breastfeeding or intend to breastfeed.
Venlafaxine generichealth XR passes into breast milk and there is a possibility that the breast-fed baby may be affected. For this reason, the use of Venlafaxine generichealth XR is not recommended in breastfeeding women.
Use in Children
Do not give Venlafaxine generichealth XR to children or adolescents under 18 years of age.
The safety and effectiveness of Venlafaxine generichealth XR in this age group have not been established.
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.
Do not start to take any other medicine while you are taking Venlafaxine generichealth XR, unless it is prescribed or approved by your doctor.
Some medicines may interfere with Venlafaxine generichealth XR, or Venlafaxine generichealth 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 Venlafaxine generichealth XR before starting an MAOI. Taking this medicine with an MAOI, or within 7 days of taking an 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 and methadone used to treat strong pain.
- medicines used to treat Attention Deficit Hyperactivity Disorder (ADHD) such as dexamphetamine and lisdexamphetamine.
- cimetidine for reflux and stomach ulcers.
- triptans used to treat migraine.
- amiodarone or quinidine used to treat irregular heartbeat.
Your doctor may do some tests such as an electrocardiogram (ECG) or blood tests if you are taking either of these medicines whilst taking Venlafaxine generichealth XR. - metoprolol for high blood pressure or angina.
- medicines used to prevent blood clotting such as anti-coagulants and platelet inhibitors.
- indinavir for viral infections.
- antibiotics such as erythromycin and linezolid for bacterial infections.
- ketoconazole or fluconazole for fungal infections.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Venlafaxine generichealth XR.
4. How do I take Venlafaxine generichealth XR?
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.
- Follow the instructions provided and use Venlafaxine generichealth XR until your doctor tells you to stop.
- Do not change your dose unless your doctor tells you to.
- If you have kidney or liver problems, you may need a lower dose of Venlafaxine generichealth 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 Venlafaxine generichealth XR
Depression and Anxiety
- The usual starting dose is 75 mg taken once daily. After 2 weeks, your doctor may increase the dose to 150 mg a day.
Panic attacks
- The usual starting dose is 37.5 mg taken once daily for the first 4 to 7 days, then increased to 75 mg taken once daily.
When to take Venlafaxine generichealth XR
- Take your medicine 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 to take Venlafaxine generichealth 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.
- Do not be concerned if you see small white granules or balls in your stools after taking Venlafaxine generichealth XR.
Inside Venlafaxine generichealth XR capsules are spheroids or small white balls that contain the venlafaxine active ingredient. These spheroids are released from the capsule into your gastrointestinal tract. As the spheroids travel the length of your gastrointestinal tract, venlafaxine is slowly released. The spheroid ‘shell’ remains undissolved and is eliminated in your stools. Therefore, even though you may see spheroids in your stools, your dose of venlafaxine has been absorbed. - How long to take Venlafaxine generichealth XR
Continue taking your medicine for as long as your doctor tells you. - Although you may begin to feel better after two weeks, it may take several weeks before you feel much better. It is important to give Venlafaxine generichealth XR time to work.
This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.
If you forget to take Venlafaxine generichealth XR
Venlafaxine generichealth XR should be used 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.
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 Venlafaxine generichealth XR
If you think that you have taken too much Venlafaxine generichealth XR, you may need urgent medical attention.
If you take too many Venlafaxine generichealth 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.
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 Venlafaxine generichealth XR?
Things you should do
Visit your doctor regularly for a checkup 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 Venlafaxine generichealth 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 Venlafaxine generichealth XR leading to unwanted side effects.
If you are about to have any urine tests, tell your doctor that you are taking this medicine.
It may interfere with the results of some tests.
Take Venlafaxine generichealth XR capsules as your doctor has prescribed.
Keep enough Venlafaxine generichealth XR capsules to last weekends and holidays.
This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.
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 Venlafaxine generichealth XR, especially during initial treatment.
Call your doctor straight away if you:
- experience any of the following symptoms:
- 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. - experience symptoms of serotonin syndrome, which may include:
- mental status changes (eg. agitation, confusion, hallucinations, and coma);
- autonomic instability (eg. excessive sweating, fast heart rate, and increased body temperature);
- neuromuscular aberrations (eg. overactive reflexes, unco-ordination, tremor); and/or
- gastrointestinal symptoms (eg. nausea, vomiting, and diarrhoea). - have any thoughts about suicide or doing harm to yourself.
Remind any doctor, dentist or pharmacist you visit that you are using Venlafaxine generichealth XR.
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 stop taking this medicine suddenly or lower the dose if you have been taking it for some time. If possible, your doctor will gradually reduce the amount you take each day before stopping the medicine 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 Venlafaxine generichealth XR being taken reduces the possibility of these effects occurring. - Do not give this medicine to anyone else even if they have the same condition as you.
Things to be careful of
If you are feeling drowsy or are uncoordinated, be careful that you do not fall over.
Venlafaxine generichealth XR, like other medicines in this class, may increase your risk of bone fracture.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Venlafaxine generichealth XR affects you.
Venlafaxine generichealth XR may make you feel drowsy. Some of the aforementioned symptoms may impair driving, or the operation of dangerous machinery. Avoid these activities if you experience these symptoms.
Drinking alcohol
Avoid drinking alcohol while you are taking Venlafaxine generichealth XR.
Alcohol can cause dizziness and lightheadedness. Alcohol may also worsen your condition.
Looking after your medicine
- Store your medicine below 30°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 on 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.
Keep it where young children cannot reach it.
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. If it has expired or is damaged, return it to your pharmacist for disposal.
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.
Less serious side effects
Less serious side effects | What to do |
Stomach, bowel or urinary tract problems:
| 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 |
| 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.
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 Venlafaxine generichealth XR contains
Active ingredient (main ingredient) | Venlafaxine hydrochloride |
Other ingredients (inactive ingredients) | Hypromellose Sodium lauryl sulfate Magnesium stearate Ammonio methacrylate copolymer Basic butylated methacrylate copolymer Empty hard gelatin capsule size 0 Coni-Snap flesh opaque Body & Cap (PI 13180) )(for 75 mg capsule only) Empty hard gelatin capsule size 00 Coni-Snap scarlet opaque Body & Cap (PI 13182) (for 150 mg capsule only) |
Do not take this medicine if you are allergic to any of these ingredients.
What Venlafaxine generichealth XR looks like
Venlafaxine generichealth XR is… (AUST R XXXXXX).
Venlafaxine generichealth XR 75 mg capsules have an opaque, flesh-coloured body and lid, containing two round, biconvex, film-coated tablets (AUST R 151884).
Venlafaxine generichealth XR 150 mg capsules have an opaque, scarlet-coloured body and lid, containing three round, biconvex, film-coated tablets (AUST R 151876).
Who distributes Venlafaxine generichealth XR
Generic Health Pty Ltd
Suite 2, Level 2
19-23 Prospect Street
Box Hill, VIC, 3128
Australia [email protected]
+61 3 9809 7900
www.generichealth.com.au
This leaflet was prepared in August 2024.
Published by MIMS January 2025