venlafaxine hydrochloride
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Venlafaxine Actavis XR modified release capsules. It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist or asking questions.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Venlafaxine Actavis XR against the expected benefits it will have for you.
If you have any questions about Venlafaxine Actavis XR, ask your doctor or pharmacist.
Keep this leaflet with your Venlafaxine Actavis XR modified release capsules. You may need to read it again.
What Venlafaxine Actavis XR is for
The name of your medicine is Venlafaxine Actavis XR. It contains the active ingredient called venlafaxine hydrochloride.
Venlafaxine Actavis XR modified release capsules are used in the treatment and prevention of relapse of depression and panic attacks and in the treatment of 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.
How Venlafaxine Actavis XR works
Venlafaxine Actavis XR modified release capsules belong 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. Venlafaxine Actavis XR modified release capsules increase the level of these two messengers. Experts think this is how it helps to restore your feeling of wellness.
Venlafaxine Actavis XR is not addictive.
It is available only with a doctor’s prescription.
Before you take Venlafaxine Actavis XR
When you must not take Venlafaxine Actavis XR
Do not take Venlafaxine Actavis 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.
Do not take Venlafaxine Actavis XR if you are allergic to it or to any of the ingredients listed at the end of this leaflet.
Symptoms of an allergic reaction include:
- Skin 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.
Do not give Venlafaxine Actavis XR to children or adolescents under 18 years of age. The safety and effectiveness of Venlafaxine Actavis XR in this age group have not been established.
Do not use Venlafaxine Actavis XR after the expiry date (EXP) printed on the pack. If you take this medicine after the expiry date has passed, it may not work as well as it should.
Do not use Venlafaxine Actavis XR 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.
Before you start to take Venlafaxine Actavis XR
Tell your doctor or pharmacist if you have any allergies to any other medicines, food, preservatives or dyes.
Tell your doctor or pharmacist if you have allergies to the active ingredient or any of the other ingredients listed at the end of this leaflet.
Tell your doctor or pharmacist if you are pregnant or intend to become pregnant. Venlafaxine Actavis XR is not recommended for use during pregnancy. Your doctor will discuss the risks and benefits of using Venlafaxine Actavis XR if you are pregnant. One of these risks is that newborn babies, whose mothers have been taking Venlafaxine Actavis 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.
Tell your doctor or pharmacist if you are breast-feeding or planning to breast-feed. Venlafaxine Actavis 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 Actavis 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 Venlafaxine Actavis XR.
Tell your doctor if you have or have had any other medical conditions.
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 take Venlafaxine Actavis XR.
Taking other medicines
Tell your doctor or pharmacist if you take any other medicines, including
- All prescription medicines
- Medicines for weight loss
- All medicines, vitamins, herbal supplements or natural therapies you buy without a prescription from a pharmacy, supermarket, naturopath or health food shop.
Do not start to take any other medicine while you are taking Venlafaxine Actavis XR, unless it is prescribed or approved by your doctor.
Some medicines may interfere with Venlafaxine Actavis XR or Venlafaxine Actavis XR may interfere with these medicines. These include:
- Medications for depression and other uses 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.
- Any other medications for depression, anxiety, obsessive-compulsive disorder or premenstrual dysphoric disorder, including St John’s Wort
- Haloperidol, risperidone, lithium or clozapine (used to treat mental disorders)
- Tramadol, fentanyl, tapentadol, pethidine, methadone and pentazocine ( pain killers)
- Cimetidine (used to treat reflux and stomach ulcers)
- Triptans (used to treat migraine)
- Amiodarone or quinidine (used to treat irregular heart beats)
- Your doctor may wish to do some heart tests such as an electrocardiogram (ECG) or blood tests if you are using either of these medicines whilst taking Venlafaxine Actavis XR. Medicines used to prevent blood clotting such as anti-coagulants and platelet inhibitors (e.g. warfarin)
- Indinavir (an antiviral)
- Erythromycin and linezolid (used to treat infections)
- Ketoconazole or fluconazole (used as antifungal medicines)
- Medications for weight loss, including sibutramine
- Metoprolol (used to treat high blood pressure or angina).
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 or pharmacist has more information on medicines to be careful with or to avoid while taking Venlafaxine Actavis XR.
How to take Venlafaxine Actavis XR
Swallow the modified release capsules whole with a glass of water or other non-alcoholic liquid. Do not divide, crush, chew or place the modified release capsules in water.
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.
Depression and Anxiety
The usual starting dose is 75mg taken once daily. After 2 weeks, your doctor may increase the dose to 150mg a day.
Panic Attacks
The usual starting dose is 37.5 mg once daily for the first 4 to 7 days, and then increased to 75 mg once daily.
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 Actavis XR.
If you have heart problems and your doctor wishes to increase your dose of Venlafaxine Actavis XR, your doctor may first do some blood tests or heart tests such as an electrocardiogram (ECG).
When to take it
Venlafaxine Actavis XR should be taken 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.
Avoid drinking alcohol while you are using Venlafaxine Actavis XR.
How long to take Venlafaxine Actavis 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 Actavis 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 Actavis XR
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 when to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre for advice (Tel: 13 11 26), or go to Accident and Emergency at your nearest hospital if you or anyone else may have taken too much Venlafaxine Actavis XR.
Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
If you take too many Venlafaxine Actavis XR modified release 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.
While you are taking Venlafaxine Actavis XR
Things you must do
Visit your doctor regularly for a check up. Always discuss any questions you have about Venlafaxine Actavis XR modified release capsules with your doctor.
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 Actavis 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 Actavis 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 Actavis XR modified release capsules as your doctor has prescribed.
Keep enough Venlafaxine Actavis XR modified release capsules to last weekends and holidays.
You need a prescription from your doctor to get more Venlafaxine Actavis XR modified release capsules.
This medicine helps to control your condition, but 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) if treated with venlafaxine, especially during initial treatment.
Tell your doctor immediately if you experience any of the following symptoms, especially if they are severe, you have not had these symptoms before or they happen very suddenly.
- 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.
Tell your doctor immediately if you have any thoughts about suicide or doing harm to yourself.
Warning signs of suicide
All thoughts or talk about suicide or violence are serious. 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:
- 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 to be careful of
Be careful driving or operating dangerous machinery until you know how it affects you. Venlafaxine Actavis XR modified release capsules may make you feel drowsy.
If you are feeling drowsy or are uncoordinated, be careful that you do not fall over.
Venlafaxine Actavis XR, like other medicines in this class may increase your risk of bone fracture.
Things you must not do
Do not suddenly stop taking Venlafaxine Actavis XR modified release capsules 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 medication 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 Actavis XR being taken reduces the possibility of these effects occurring.
Some of these symptoms may impair driving, or the operation of dangerous machinery. These activities should be avoided if you experience these symptoms.
Do not give this medicine to anyone else even if they have the same condition as you.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Venlafaxine Actavis XR. 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.
Tell your doctor if you develop any of the following side effects and they worry you:
Stomach, bowel or urinary tract problems such as:
- Nausea or vomiting
- Loss of appetite
- Diarrhoea
- Constipation
- Difficulty passing urine, passing urine more frequently, or urinary incontinence.
Changes in your behaviour such as:
- Difficulty sleeping or abnormal dreams
- Paranoia
- Aggression
- Sexual function problems such as delayed ejaculation, problems with erection, decreased sex drive or difficulties achieving orgasm.
- Nervousness
- Teeth grinding
- Impaired coordination and balance
Difficulty thinking or working because of:
- Yawning
- Feeling sedated or drowsy
- Fainting and dizziness after standing up
- Restlessness or difficulty sitting still
- Headache
- Rapid heart beat
- Heavy or irregular menstrual periods.
Changes in your appearance such as:
- Sweating (including night sweats)
- Hot flushes
- Rash
- Hair loss
- Itchiness
- Weight loss or weight gain
- Flow of milk in women who are not breastfeeding
Changes in your sight, hearing, taste or touch such as:
- Blurred vision
- Ringing in the ears
- Altered taste or dry mouth
Tell your doctor as soon as possible if you notice any of the following:
- Muscle tremors, spasms, twitching, jerky movements or sustained muscle contractions
- Abnormal facial movements such as tongue thrusting, repetitive chewing, jaw swinging, or grimacing
- A feeling of apathy or not caring about things
- Hallucinations
- Agitation
- Confusion
- Unusually overactive
- Changes in muscle tone, muscle weakness or fatigue
- Numbness or pins and needles
- Problems with breathing, shortness of breath
- Bleeding or bruising more easily than normal
- Sensitivity to sunlight.
Tell your doctor immediately, or go to your nearest hospital if you notice any of the following:
- Fits or seizures, which may be accompanied by a sudden fever
- Signs of allergy such as rash or hives, swelling of the face, lips, tongue or throat, wheezing or difficulty breathing or swallowing
- Symptoms of sudden fever with sweating, rapid heart beat and muscle stiffness, which may lead to loss of consciousness
- Palpitations, fainting, shortness of breath or chest pain, or irregular heartbeats
- Dark, red or cola coloured urine, muscle weakness and tenderness, stiffness or aching
- Stomach pain, yellowing of the skin, nausea, fever, clammy skin and sweating
- Yellowing of the skin or eyeballs, fever, fatigue, loss of appetite, dark coloured urine or light coloured bowel movements
- A severe skin reaction with painful red areas and large blisters, accompanied by fever and chills, aching muscles and generally feeling unwell.
- Symptoms of a high fever, agitation, confusion, trembling and abrupt contractions of muscles
- Signs of an infection such as severe chills, fever, sore throat and mouth ulcers
- Black sticky bowel motions or bloody diarrhoea.
These symptoms are usually rare but may be serious and need urgent medical attention.
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.
Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list. Other side effects not listed above may also 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.
After using Venlafaxine Actavis XR
Storage
Keep your Venlafaxine Actavis XR modified release capsules in their blister pack until it is time to take them. The modified release capsules may not last as well if you take them out of the blister pack.
Keep Venlafaxine Actavis XR modified release capsules in a cool dry place where the temperature stays below 25°C.
Do not store Venlafaxine Actavis XR modified release capsules or any other medicine in the bathroom or near a sink. Do not leave Venlafaxine Actavis XR modified release capsules in the car or on windowsills. Heat and dampness can destroy some medicines.
Keep Venlafaxine Actavis XR modified release capsules and all medication 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.
Disposal
Return any unused medicine to your pharmacist.
Product description
What Venlafaxine Actavis XR looks like
There are three strengths of Venlafaxine Actavis XR modified release capsules, containing 37.5 mg, 75 mg or 150 mg of venlafaxine in a modified release formulation, which allows for once-a-day dosing. The modified release capsules have the following appearance:
Venlafaxine Actavis XR 37.5mg, grey cap/peach body with thick and thin radial circular bands on the cap and body in red ink.
Venlafaxine Actavis XR 75mg, peach cap and body with thick and thin radial circular bands on the cap and body in red ink.
Venlafaxine Actavis XR 150mg, dark orange cap and body with thick and thin radial circular bands on the cap and body in white ink.
Venlafaxine Actavis XR capsules are available in blister packs containing 28 modified release capsules.
Ingredients
Venlafaxine Actavis XR modified release capsules contain venlafaxine hydrochloride as the active ingredient.
Venlafaxine Actavis XR 37.5 mg, 75 mg and 150 mg modified release capsules contain the following inactive ingredients:
- Microcrystalline cellulose
- Povidone
- Purified talc
- Colloidal anhydrous silica
- Magnesium stearate
- Ethyl cellulose
- Copovidone
- Gelatin
- Titanium dioxide.
In addition to these, Venlafaxine Actavis XR 37.5mg modified release capsules also contain black iron oxide E172, red iron oxide E172, yellow iron oxide E172 and Tekprint SB-1033 red ink;
Venlafaxine Actavis XR 75mg modified release capsules also contain black iron oxide E172, red iron oxide E172 and Tekprint SB-1033 red ink;
Venlafaxine Actavis XR 150mg modified release capsules also contain Brilliant Blue FCF E 133, Allura Red AC E 129, Sunset Yellow FCF E 110 and Tekprint SB-0007P white ink.
Venlafaxine Actavis XR does not contain gluten, sucrose, tartrazine or any other azo dyes.
Sponsor
Medis Pharma Pty Ltd
1002/53 Walker Street
North Sydney NSW 2060 Australia
Australian registration numbers:
Venlafaxine Actavis XR 37.5mg: AUST R 200745
Venlafaxine Actavis XR 75mg: AUST R 200746
Venlafaxine Actavis XR 150mg: AUST R 200747
This leaflet was prepared in October 2016.
Published by MIMS June 2017
