Venlafaxine XR Biotech 37,5 mg/75 mg/150 mg Capsules

VENLAFAXINE XR BIOTECH capsules contain venlafaxine as active ingredient in quantities of either 37,5 mg, 75 mg or 150 mg per capsule. VENLAFAXINE XR BIOTECH is an antidepressant and one of a group of medicines known as serotonin and norepinephrine reuptake inhibitors. Serotonin and norepinephrine are chemical messengers (hormones) in your brain. People that suffer from depression or anxiety usually have lower levels of serotonin and norepinephrine in the brain. VENLAFAXINE XR BIOTECH may help to increase the levels of serotonin and norepinephrine in your brain. VENLAFAXINE XR BIOTECH is therefore used in the treatment of depression, including depression with associated anxiety, as well as generalised anxiety (anxiety and uncontrollable worry for several months) and social anxiety disorder (worry about social situations which can cause you severe anxiety and distress).

Do not take VENLAFAXINE XR BIOTECH:

• If you are hypersensitive (allergic) to venlafaxine or any of the other ingredients of VENLAFAXINE XR BIOTECH.
• If you are also taking a type of medicine known as monoamine oxidase inhibitors (MAOIs) used in the treatment of depression or Parkinson’s disease.
• If you have taken MAOIs within the last fourteen days.
• VENLAFAXINE XR BIOTECH must be discontinued for at least 7 days before starting treatment with any MAOI as concomitant use may result in serious or even life-threatening side effects.
• If you are younger than 18 years of age.
• If you are pregnant or breastfeeding your baby.

Warnings and precautions

Take special care with VENLAFAXINE XR BIOTECH

Suicide/suicidal thoughts or worsening of depression: You may sometimes have thoughts of harming or killing yourself if you are suffering from depression and/or have anxiety disorders and such thoughts may be increased when you first start taking VENLAFAXINE XR BIOTECH. You may experience symptoms such as anxiety, agitation, panic attacks, difficulty sleeping (insomnia), irritability, hostility (aggressiveness), impulsivity, inability to sit still (akathisia), state of extremely energetic, talkative, and confident behaviour commonly exhibited with a flight of creative ideas (hypomania), and abnormal feeling of well-being and excitement (mania). 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. You might 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.

Use in children and adolescents under the age of 18 years:

The safety and efficacy of VENLAFAXINE XR BIOTECH in children under 18 years of age have not been established.

Serotonin syndrome:

If you are taking VENLAFAXINE XR BIOTECH in combination with particular medicines a potentially life-threatening condition, serotonin syndrome, may result. These medicines include:

• triptans (used in the treatment of migraines);
• SSRIs, SNRIs, lithium, MAOIs (used to treat depression);
• sibutramine (used in weight loss);
• St John's wort (Hypericum perforatum);
• medicines used in the treatment of severe pain, such as fentanyl and its analogues, tramadol, tapentadol, pethidine, pentazocine;
• dextromethorphan (in certain cough medicines);
• tryptophan supplements or antipsychotics and other dopamine antagonists.

You should be carefully monitored if you are starting with any of the above medicine when taking VENLAFAXINE XR BIOTECH, or when the dose is increased.

Narrow-angle glaucoma:

If you have increased eye ball pressure or are at risk for acute narrow-angle glaucoma VENLAFAXINE XR BIOTECH should be used with caution.

Blood pressure:

Regular blood pressure monitoring is advised if you suffer from high blood pressure as VENLAFAXINE XR BIOTECH can cause an increase in your blood pressure.

Heart disease and risk of irregular heartbeat:

VENLAFAXINE XR BIOTECH should be used with caution if you have a recent history of heart attack (myocardial infarction) or unstable heart disease as it has not been evaluated in these patients.

Convulsions:

If you have a history of convulsions (fits), VENLAFAXINE XR BIOTECH should be used with caution as fits can occur. You should be closely monitored. If you develop seizures the use of VENLAFAXINE XR BIOTECH should be discontinued.

Do not share medicines prescribed for you with any other person. Always take VENLAFAXINE XR BIOTECH exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is 75 mg, given once daily. If after several weeks further clinical improvement is required, your doctor may increase your dose to 150 mg, given once daily. If needed, the dose can be further increased up to 225 mg given once daily. Dose increments should be made at intervals of approximately 2 weeks or more, but not less than 4 days. The dose for depressed patients may be further increased, if needed, up to 375 mg, given once daily. You should take VENLAFAXINE XR BIOTECH with food. Each capsule should be swallowed whole with fluid. Do not divide, crush, chew or place capsule in water. VENLAFAXINE XR BIOTECH should be taken at approximately the same time either in the morning or in the evening.

If you have impaired kidney or liver function you should take lower doses VENLAFAXINE XR BIOTECH as prescribed by your doctor. Your doctor will tell you how long your treatment with VENLAFAXINE XR BIOTECH will last. If you have the impression that the effect of VENLAFAXINE XR BIOTECH is too strong or too weak, tell your doctor or pharmacist.

If you take more VENLAFAXINE XR BIOTECH than you should In the event of over dosage, consult your doctor or pharmacist. If neither is available contact the nearest hospital or poison control centre. Overdose with VENLAFAXINE XR BIOTECH was primarily reported in combination with alcohol and/or other medicines. Symptoms of overdose include fast or slow heart rate, low blood pressure, low blood sugar, spinning sensation, changes in levels of consciousness, dilated pupils, fits and vomiting. If you forget to take VENLAFAXINE XR BIOTECH: If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for forgotten individual doses. If you stop taking VENLAFAXINE XR BIOTECH: You should not suddenly stop taking VENLAFAXINE XR BIOTECH as withdrawal symptoms are well-known to occur. Symptoms of withdrawal include extremely energetic, talkative and confident behaviour commonly exhibited with a flight of creative ideas (hypomania), anxiety, agitation, nervousness, confusion, difficulty sleeping (insomnia) or other sleep disturbances, fatigue, drowsiness (somnolence), sensation of pins and needles (paraesthesia), dizziness, fits (convulsions), dizziness (vertigo), headache, flu-like symptoms, ringing in ears (tinnitus), impaired coordination and balance, shivering (tremor), sweating, dry mouth, weight loss (anorexia), diarrhoea, nausea and vomiting. On discontinuing treatment your doctor will taper down your dose over at least a two-week period.

VENLAFAXINE XR BIOTECH can have side effects. Not all side effects reported for VENLAFAXINE XR BIOTECH are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VENLAFAXINE XR BIOTECH, please consult your health care provider for advice. If any of the following happens, stop taking VENLAFAXINE XR BIOTECH and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and 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 reaction to VENLAFAXINE XR BIOTECH. 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:

The following side effects were experienced frequently:

• fast heart rate (tachycardia), rapid, strong or irregular heartbeat (palpitations)
• urinary retention/hesitation, abnormally frequent urination (pollakiuria)

The following side effects were experienced less frequently:

• heart rhythm disorders or other heart conditions
• respiratory disorders: inability to breathe and get enough oxygen into your bloodstream (interstitial lung disease) or pulmonary eosinophilia (respiratory disorder characterised by the accumulation of white blood cells in the lungs).

These are all serious side effects. You may need urgent medical attention. Tell your doctor as soon as possible if you notice any of the following:

The following side effects were experienced frequently:

• decreased appetite
• difficulty to sleep (insomnia), feeling confused, thoughts and feelings that seem unreal or not to belong to oneself (depersonalisation), abnormal dreams, nervousness, low sex drive (libido), feeling agitated, inability to achieve orgasm (anorgasmia)
• headache, dizziness, sleepiness (sedation), feeling of restlessness (akathisia), shivering (tremor), sensation of pins and needles (paraesthesia), taste disorder (dysgeusia)
• visual impairment, including blurred vision, dilated pupils (mydriasis), accommodation disorder, visual disturbance
• ringing in ears (tinnitus)
• high blood pressure, hot flushes
• yawning
• nausea (feeling sick), dry mouth, constipation, diarrhoea, vomiting (being sick)
• sweating (including night sweats)
• abnormally high level of muscle tone or tension (hypertonia)
• menstrual disorders associated with increased bleeding or increased irregular bleeding (e.g. menorrhagia, metrorrhagia), erectile dysfunction and ejaculation disorders
• unusual weakness or tiredness (fatigue), lack of energy (asthenia), chills
• increased or decreased body mass, increased blood cholesterol.

The following side effects were experienced less frequently:

• blood disorders (agranulocytosis, aplastic anaemia, pancytopenia neutropenia and thrombocytopenia)
• excessive water intake (known as syndrome of inappropriate antidiuretic hormone secretion), milky discharge from breasts (when not pregnant or breastfeeding)
• very low sodium levels (hyponatraemia)
• abnormal feeling of well-being and excitement (mania), confident behavior commonly exhibited with a flight of creative ideas (hypomania), hallucinations (hearing and seeing things that do not exist), abnormal orgasm (female), talkative and excessive grinding of the teeth and/or excessive clenching of the jaw (bruxism), a feeling that one's surroundings are not real (derealisation), lack of feeling, emotion, interest, and concern (apathy), restlessness, illusions (delirium)
• fainting (syncope), twitching of a muscle or a group of muscles (myoclonus), balance disorders, abnormal coordination, abnormality or impairment of voluntary movement (dyskinesia), fever, muscular rigidity, altered mental status (neuroleptic malignant syndrome), serotonin syndrome (characterised by high body temperature, agitation, increased reflexes, tremor, sweating, dilated pupils and diarrhoea), seizures, muscle contractions (dystonia), involuntary, repetitive body movements (tardive dyskinesia)
• increased pressure in the eye (glaucoma)
• feeling dizzy when standing up from a lying or sitting position (orthostatic hypotension), low blood pressure (hypotension)
• blood in your stools, inflammation of your pancreas (pancreatitis)
• abnormal liver function tests, jaundice (hepatitis)
• hair loss (temporary), bruising (ecchymosis), sensitivity of skin when exposed to sunlight, Stevens-Johnson syndrome (serious skin disorder), toxic epidermal necrolysis (life-threatening skin condition, characterised by skin peeling), erythema multiforme (serious skin condition of unknown cause)
• breakdown of muscle tissue (rhabdomyolysis)
• involuntary leakage of urine (urinary incontinence)
• bleeding gums (mucosal haemorrhage)
• abnormal results in blood tests.

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 side effects via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who- umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of VENLAFAXINE XR BIOTECH.

• Store at or below 25 °C. Protect from moisture.

• Keep blister strips in outer carton until required for use.

• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

• Do not use after the expiry date printed on the carton.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).