Exlov XR 50 mg/100 mg Extended-Release Tablets

EXLOV XR contains desvenlafaxine and belongs to the class of antidepressant medicines known as selective serotonin and norepinephrine reuptake inhibitors (SNRIs). EXLOV XR works on the central nervous system (CNS) to elevate mood by increasing the amount of two neurotransmitters called serotonin and norepinephrine that are available in certain parts of the brain. Serotonin and norepinephrine are chemical messengers that allow certain nerves in the brain to work.

EXLOV XR is used to treat major depressive disorder.

Do not take EXLOV XR:

• if you are hypersensitive (allergic) to desvenlafaxine, venlafaxine hydrochloride, or any of the other ingredients of EXLOV XR (see section 6)
• if you are taking, or have taken within the last 14 days, medicines known as monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson’s disease including an antibiotic called linezolid. Taking an MAOI together with EXLOV XR can cause serious or even life-threatening side effects. You must wait at least 7 days after you stop taking EXLOV XR before you take any MAOI. Serious side effects are known to occur if you take EXLOV XR soon after stopping an MAOI or if you take an MAOI soon after stopping EXLOV XR. A potentially life-threatening condition or Neuroleptic Malignant Syndrome (NMS)-like reactions may occur with desvenlafaxine treatment. You may experience overactive reflexes (muscle twitching and sudden muscle jerks), sweating, nausea, vomiting, flushing, dizziness, abnormally high body temperature and seizures (fits)
• if you are 18 years old or younger
• if you are pregnant or breastfeeding your baby.

Warnings and precautions

Take special care with EXLOV XR:

• if your depression gets worse, especially in the first few weeks of treatment or if your dose has changed. Contact your doctor if you have thoughts of suicide or self-harm, or if you experience any of the following symptoms: anxiety or agitation, panic attacks, difficulty sleeping, irritability, hostility (aggressiveness or impulsiveness), restlessness or unusual changes in behaviour
• if you or anyone in your family has a history of mania or bipolar disorder (feeling overexcited or euphoric)
• if you experience symptoms such as changes to mental health, confusion, headache, shivering, diarrhoea, muscle stiffness, high fever, agitation, hallucinations, sweating, fainting, rapid or irregular heartbeat, loss of muscle coordination and muscle twitches nausea, vomiting, and seizures as this may be signs of something called serotonin syndrome. Neuroleptic malignant syndrome and serotonin syndrome are serious and may be life-threatening, if you think you might have either of these syndromes while taking EXLOV XR, call your doctor immediately or go to the emergency department of nearest hospital. If you have severe or rapidly worsening symptoms, seek emergency treatment immediately
• if you have eye problems, such as glaucoma or increased pressure in the eye, your doctor will monitor your condition as EXLOV XR may cause dilation of the pupils (mydriasis)
• if you are discontinuing treatment with EXLOV XR, your doctor will gradually reduce your daily dose and monitor you, in order to prevent unwanted side effects
• if you are pregnant and your doctor has prescribed EXLOV XR for you in the month before your is due, there is a risk of excessive bleeding after childbirth.

Discuss the following precautions with your doctor before taking EXLOV XR:

• if you have recently suffered a heart attack or suffer from a heart disease as special care is recommended
• if you have a history of high blood pressure, EXLOV XR may increase blood pressure levels. It is advisable to check your blood pressure at regular intervals
• if you have a condition that affects the blood vessels and blood supply to the brain (cerebrovascular disease) as EXLOV XR may increase your blood pressure
• if you suffer from high cholesterol as these levels will need to be closely monitored during treatment with EXLOV XR
• if you suffer from or have a history of seizures (fits) as EXLOV XR may increase the risk for seizures
• if you have a tendency to develop bruises or a tendency to bleed easily (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding e.g., aspirin (used for pain or headache) and warfarin (used to prevent blood clots)
• if you are dehydrated, have recently suffered from diarrhoea, or vomiting, are elderly, or take diuretics (water tablets) as special care is needed. EXLOV XR may cause your body to retain water and upset your body’s balance of electrolytes (Syndrome of Inappropriate Antidiuretic Hormone - SIADH)
• EXLOV XR may cause sexual function problems like decreased sex drive, delayed ejaculation or problems achieving erections (see Possible side effects)
• if you are 65 years or older, there is a possibility of greater sensitivity to EXLOV XR
• if you are going for electroconvulsive therapy used to treat patients with severe depression or bipolar disease unresponsive to other treatment
• if you are going for urine drug screening tests for phencyclidine (PCP) or amphetamine as EXLOV XR may cause false positive test results.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you can sometimes behave aggressively, be irritable or have thoughts of harming or killing yourself. These may be increased when you first start taking antidepressants, since these medicines take time to work (usually about two weeks, but sometimes longer).

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital immediately. You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You should ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Children and adolescents

Do not give EXLOV XR to children and adolescents under 18 years because of the risk of aggressive behaviour, irritability, agitation, thoughts of harming themselves and suicide.

Other medicines and EXLOV XR

Always tell your healthcare provider if you are taking any other medicine. (This includes complementary or traditional medicines.)

Some of the medicines that may interact with EXLOV XR are:

Do not share medicines prescribed for you with any other person. Always take EXLOV XR exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. EXLOV XR should be taken at approximately the same time each day. Tablets must be swallowed whole with fluid and should not be divided, crushed, chewed, or dissolved.

Adults:

The usual dose is 50 mg taken once daily, with or without food, with a maximum dose of 100 mg per day. Your doctor will gradually increase your dose if necessary. You should inform your doctor if you have kidney problems as you may need a lower dose of EXLOV XR. Your doctor will tell you how long your treatment with EXLOV XR will last. Do not stop treatment early because unwanted side effects may occur (see If you stop taking EXLOV XR).

If you have the impression that the effect of EXLOV XR is too strong or too weak, tell your doctor or pharmacist.

If you take more EXLOV XR than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take EXLOV XR

If you forget to take EXLOV XR, talk to your doctor or nurse immediately. Do not take a double dose to make up for forgotten individual doses.

If you stop taking EXLOV XR suddenly, you may experience side effects such as dizziness, nausea, headache, tiredness, irritability, agitation or anxiety, confusion, lack of coordination, sleeping problems, prickling, or burning sensation on the skin, electric shock-like sensations, diarrhoea, abnormal dreams, fatigue, and excessive sweating. Do not stop taking EXLOV XR without consulting your doctor as your doctor will slowly decrease your dose of EXLOV XR to help avoid these side effects.

Switching to EXLOV XR from other antidepressants

If you are already using an antidepressant medicine (including venlafaxine) prescribed by your doctor, you may experience side effects when discontinuing it in order to switch to EXLOV XR. Your doctor will gradually reduce the dose of your initial antidepressant medicine to help reduce these side effects.

EXLOV XR can have side effects. Not all side effects reported for EXLOV XR are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while using EXLOV XR, please consult your doctor, pharmacist, or other healthcare professional for advice.

If any of the following happens, stop using EXLOV XR and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth, or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to EXLOV XR. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• signs and symptoms of serotonin syndrome which may include restlessness, hallucinations, loss of coordination, fast or irregular heartbeat, palpitations; increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, nausea, vomiting
• less urine than is normal for you, difficulty passing urine
• Stevens-Johnson syndrome or other serious skin disorder (begins with fever and flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters)
• intense chest pain (stress cardiomyopathy)
• inflammation of the pancreas characterised by severe upper abdominal pain, swollen and tender abdomen, nausea, vomiting, fever, and fast heartbeat (acute pancreatitis).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent side effects:
• loss of appetite
• trouble sleeping, anxiety, abnormal dreams, nervousness, irritability
• decreased sex drive, problems achieving orgasm or erection, delayed ejaculation
• dizziness, headache, drowsiness, excess sleepiness, involuntary shaking or movement, pins, and needles, altered sense of taste, disturbances in concentration
• blurred vision or dilation of the pupils
• ringing in the ears, sensation of spinning or feeling off balance
• fast or irregular heartbeat, palpitations
• sudden feeling of warmth (hot flush), increase in blood pressure
• yawning
• nausea, dry mouth, constipation, diarrhoea, vomiting
• excessive sweating
• muscle stiffness
• tiredness, chills, lack of energy and strength (asthenia), feeling jittery
• weight gain, weight loss.
• Less frequent side effects:
• low levels of sodium in the blood
• feeling disconnected or detached from your thoughts and body, feeling overexcited or overly irritable with increased energy (hypomania), hallucinations, feeling very happy, elated, or overjoyed, talking very quickly, feeling full of energy, being easily distracted, disturbed or illogical thinking (mania)
• temporary loss of consciousness (syncope), convulsions, uncontrollable muscle contraction (dystonia), movement disorder (extrapyramidal disorder)
• fainting or dizziness after standing, cold hands and feet
• nose bleeds
• abnormal hair loss, sensitivity to sunlight, severe, painless, swelling under the skin (angioedema)
• abnormal quantities of protein in the urine, difficulties passing urine
• sexual function problems, abnormal ejaculation
• increased cholesterol, abnormal liver function test, increased prolactin levels (a hormone that stimulates breast development and milk production)
• bleeding or bruising more easily than usual.

The following side effects have been reported but the frequency for them to occur is not known:

• heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see section 2 for more information.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report any side effects to SAHPRA via the online service for adverse drug reaction reporting by following the link: https://www.sahpra.org.za/Publications/Index/8 or https://www.sahpra.org.za/document/adverse-drug-reactions-and-quality-problem-reporting-form/. By reporting side effects, you can help provide more information on the safety of EXLOV XR. You can also send an email directly to the company, [email protected] to ensure safety of the product.

Store all medicines out of reach of children. Store at or below 25 °C. Keep blisters in carton until required for use. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).