Illovex XR 37,5 mg Film-Coated Tablets

ILLOVEX XR contains venlafaxine, it is an antidepressant that belongs to a group of medicines called Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. It is thought that people who are depressed and/or anxious have lower levels of serotonin and noradrenaline in the brain. It is not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and noradrenaline in the brain.

ILLOVEX XR is used:

• in the treatment of depression (which includes anxiety associated with depression), severe and persistent anxiety known as Generalised Anxiety Disorder (GAD), social anxiety disorder (also known as social phobia)
• for prevention of recurrence of major depressive episodes.

Do not take ILLOVEX XR:

• if you are hypersensitive (allergic) to venlafaxine or any of the other ingredients of ILLOVEX 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. Taking an MAOI together with ILLOVEX XR can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking ILLOVEX XR before you take any MAOI (see Other medicines with ILLOVEX XR specifically the section about Serotonin Syndrome)
• if you have high blood pressure which is not being treated with medicine
• if you have been told by your doctor that you have a high risk of serious abnormal rapid heartbeats
• if you suffer from epilepsy
• children under the age of 18 years of age (see Take special care with ILLOVEX XR)
• if you are pregnant or breastfeeding (see Pregnancy and breastfeeding).

Warnings and precautions

Take special care / Special care should be taken with ILLOVEX XR:

• if your depression worsens
• if you take other medicines which, when taken with ILLOVEX XR, could increase the risk of developing serotonin syndrome
• if you have eye problems, such as certain types of glaucoma (increased pressure in the eye)
• if you have been diagnosed with major depressive disorder
• if you have a history of heart problems as ILLOVEX XR may increase your heart rate
• if you have a history of high blood pressure as ILLOVEX XR may increase blood pressure levels
• if you have been told that you have an abnormal heart rhythm
• if you have a history of epilepsy or fits (seizures) as ILLOVEX XR may increase seizure frequency
• if you or anyone in your family has a history of mania or bipolar disorder (feeling over-excited or euphoric)
• if you have a history of aggressive behaviour as episodes of aggression may increase
• if you are taking water tablets or you have recently lost a lot of body fluids due to vomiting or diarrhoea or are elderly
• if you have a tendency to bruise or bleed easily, or you are taking medicines that may increase the risk of bleeding (e.g. warfarin used to thin the blood in the prevention of blood clots) and if you are due to have surgery as ILLOVEX XR increases the risk of blood loss during surgery
• if you are pregnant and your doctor has prescribed ILLOVEX XR for you in the month before your baby is due, there is a risk of excessive bleeding after childbirth
• if you develop a hives or a skin rash related to an allergic reaction during treatment
• if you are taking weight loss medicine. Taking ILLOVEX XR and weight loss medicine at the same time is not recommended
• if you have high cholesterol, monitoring these levels closely is recommended during treatment with ILLOVEX XR
• if you have liver or kidney problems as your dose of ILLOVEX XR may need to be adjusted
• if you are stopping the treatment with ILLOVEX XR, it should be done gradually, and you should be monitored by your healthcare professional.

Do not share medicines prescribed for you with any other person. Always take ILLOVEX XR exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults: The usual dose for ILLOVEX XR is 75 mg (given as either 1 x 75 mg tablet or 2 x 37,5 mg tablets) once a day. The dose can be increased gradually by your doctor, to a maximum of 225 mg ILLOVEX XR taken once daily if required. If you are being treated for depression, the dose may be increased up to 375 mg daily.

ILLOVEX XR tablets should be taken with food, swallowed whole, with a glass of water. ILLOVEX XR should not be divided, crushed, chewed or dissolved.

Take ILLOVEX XR once a day, every day, at about the same time each day, after food. Patients with kidney or liver problems will be prescribed a lower dose by the doctor.

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

If any of the following happens, stop using ILLOVEX 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 ILLOVEX 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:

• chest tightness, wheezing, trouble swallowing or breathing
• life threatening irregular heartbeat, rapid or slow heartbeat
• signs and symptoms of serotonin syndrome which may include restlessness, hallucinations, loss of co-ordination, fast heart-beat, palpitations, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting
• unexplained muscle pain, tenderness or weakness, abnormal muscle breakdown which can lead to kidney problems
• less urine than is normal for you
• Stevens-Johnson syndrome or other serious skin disorder (begins with flu-like symptoms, followed by a painful red or purplish rash that spreads and blisters)
• serious illness with blistering of the skin
• abnormal bleeding of skin, eye or stomach
• thinking of killing yourself (suicidal ideation) and suicidal behaviour
• having hallucinations (strange visions or sounds)
• high blood pressure or low blood pressure (feeling dizzy when standing up)
• seizures, convulsions (fits), shivering
• inflammation of the liver (hepatitis), with symptoms such as fatigue, loss of appetite and muscle or joint ache
• memory loss, impaired concentration
• very high fever, irregular pulse, accelerated heartbeat, increased rate of respiration muscle rigidity, altered mental status (symptoms of neuroleptic malignant syndrome)
• rise in pressure in your eyes.

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:
• increased cholesterol, loss of appetite, weight loss
• abnormal dreams, nervousness, unable to sleep, lower sex drive, anxiety
• dizziness, increased muscle tonus, pins and needles, tremors, metallic taste sensation persists in the mouth, sedation
• inability to change eye focus, dilated pupils, visual disturbances
• irregular heartbeats you can feel, fast heartrate/pulse
• high blood pressure, hot flushes
• yawning

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).