Deprexor ER 75 mg. 30 capsules
Deprexor ER is an antidepressant that belongs to a group of medicines called CYP3A4 inhibitors
reuptake of serotonin and noradrenaline (SNRIs). They are used to treat depression and other conditions such as anxiety disorders.
Deprexor ER 75 mg. 30 capsules
WHAT IS A Deprexor ER AND WHAT IT IS USED
Deprexor ER is an antidepressant that belongs to a group of medicines called CYP3A4 inhibitors
reuptake of serotonin and noradrenaline (SNRIs). They are used to treat depression and other conditions such as anxiety disorders. People who are depressed and / or anxious are thought to have lower levels of serotonin and noradrenaline in the brain. The effect of antidepressants is not fully understood, but they can help normalize serotonin and noradrenaline levels in the brain.
Depressor EP is used to treat adults with depression or social anxiety disorder (fear and avoidance of social situations). Proper treatment of depression or anxiety disorders is important for you to feel better. If it is not treated, your condition may not be exacerbated and become more serious and more difficult to treat.
2. BEFORE YOU TAKE Deprexor ER
Do not take Deprexor ER
If you are allergic (hypersensitive) to venlafaxine or any of the other ingredients of the medicine;
If you are taking or have recently (over the last 14 days) treated with other medicines to treat depression or Parkinson's disease (IAEA). Taking irreversible MAOI together with other medicines, including Deprexor ER, can cause serious or even life-threatening side effects. After stopping Deprexor ER, you should wait 7 days before taking any of these medicines (see also "Serotonin Syndrome" and "Taking other medicines").
Take special care with Deprexor ER
If you use other medicines that are taken at the same time as Depressor EC may increase the risk of developing serotonin syndrome (see section "Taking other medicines");
If you have glaucoma (increased eye pressure);
If you have high blood pressure;
If you have heart problems;
If you have or have had seizures (seizures) in the past;
If you are aware that you have had low levels of sodium in your blood (hyponatraemia) in the past;
If you have a tendency to bruising or bleeding easily (a history of bleeding disorders) or if you are taking other medicines that may increase the risk of bleeding;
If your cholesterol levels rise;
If you or someone in your family has a mania or bipolar disorder (you feel over-excited or euphoric);
If you have a history of aggressive behavior.
Deprexor ER may cause a feeling of restlessness or an inability to sit comfortably in a sitting or standing position. You should tell your doctor if this happens to you.
If any of these conditions apply to you, please tell your doctor before taking Deprexor ER
Thoughts of suicide and worsening of your depressive or anxiety disorder
Sometimes, if you are in depression and / or you have anxiety disorders, you may have thoughts of being self-inflicted or suicidal. They can be tightened when you start to take antidepressants, because all these drugs take time to work, usually 2 weeks, but sometimes more. You are more likely to have such thoughts:
If you previously had thoughts of suicide or self-harm;
If you are a youth. Information from clinical trials shows an increased risk of suicidal behavior in young people (under 25 years of age) with psychiatric problems treated with antidepressant.
Contact your doctor immediately or go straight to a hospital if you have thoughts of self-harm or suicide.
It may be 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 may ask them to tell you if they think your depression or anxiety is getting worse or if they are worried about changes in your behavior.
Dry mouth was reported in 10% of patients treated with venlafaxine. This may increase the risk of caries. Therefore, you should pay special attention to the hygiene of your teeth.
Use in children and adolescents under 18 years of age
Deprexor ER is generally not used for children and adolescents under 18 years of age. When this class of medicines is used in young people under 18, there is an increased risk of side effects such as suicidal attempts, suicidal thoughts and hostility. However, at the discretion of the physician ,Deprexor ER may be prescribed for the treatment of children and adolescents under 18 years of age. If your doctor has prescribed Deprexor ER to a patient under 18 years of age, contact him / her in case you want to discuss it. You should tell your doctor if you notice any of the symptoms described or worsen in patients below 18 years of age who are taking Deprexor ER. In addition, the long-term effects of Deprexor ER on the growth, maturation and development of cognitive abilities and behavior in this age group have not yet been demonstrated.
Taking other medicines
Please tell your doctor or pharmacist
Monoamine oxidase inhibitors (MAOI: see section "Before you take Depresor EP");
Serotonin syndrome: Serotonin syndrome, which is potentially life-threatening (see section "Possible side effects"), may occur with venlafaxine, especially when taken with other medicines. Examples of such drugs include:
tryptans (used for migraine);
medicines to treat depression, for example SNRIs, SSRIs, tricyclic antidepressants or lithium-containing medicines;
medicines containing linezolid (an antibiotic used to treat infections);
medicines containing moclobemide (to treat depression);
medicines containing sibutramine (used to lose weight);
medicines containing tramadol (painkiller);
products containing St John's wort (also called Hypericum perforatum, which is a natural or herbal medicine used to treat mild depression);
products containing tryptophan (used for problems such as sleep and depression).
Signs and symptoms of serotonin syndrome may include a combination of the following: anxiety, hallucinations, loss of coordination, accelerated cardiac activity, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting. Seek immediate medical attention if you think you are receiving serotonin syndrome.
The following medicines may also interact with Depressor EP and should be used with caution. It is especially important to tell your doctor or pharmacist if you are taking medicines containing:
Ketoconazole (an antifungal medicine);
Haloperidol or risperidone (for the treatment of psychiatric conditions);
Metoprolol (a beta-blocker for the treatment of high blood pressure and heart problems).
Taking Deprexor ER with food and drink
Deprexor ER should be taken with food (see section 3 "How to take Deprexor ER").
You should avoid using alcohol while taking Deprexor ER
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or plan to become pregnant. You should only use Deprexor ER after discussing the potential benefits and potential risks to your unborn child with your doctor.
If you are taking Deprexor ER during pregnancy, tell your midwife and / or
as your baby may have withdrawal symptoms after birth. These symptoms usually begin during the first 24 hours after childbirth. These include insufficient nutrition and breathing problems. If your baby has these symptoms when he is born and you have concerns, contact your doctor and / or midwife to advise you.
Depressor EP passes into breast milk. There is a risk of having an effect on the baby. That is why you must
discuss it with your doctor and he / she will decide whether you should stop nursing or stopping
treatment with Deprexor ER
Driving and using machines
Do not drive or use any appliances or machines until you understand how Deprexor ER affects you.
3. HOW TO ACCEPT Deprexor ER
Always take Deprexor ER exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The usual starting dose for treatment of depression and social anxiety disorder is 75 mg a day. Your doctor may decide on a higher dose treatment. Dose increases gradually and, if necessary, may reach the maximum daily dose of 375 mg daily for the treatment of depression or up to 225 mg / day for the treatment of socio-anxiety disorder.
Take Depressor EP at approximately the same time each morning or evening.
Capsules should be swallowed whole with liquid. Do not open, break or chew
Depressor EP should be taken with food.
If you have liver or kidney problems talk to your doctor as your dose of Depressor EP may need to change.
Do not stop taking Depressor EP without consulting your doctor (see section "If you stop taking Depressor EP").
If you take more Deprexor ER than you need
Call your doctor or pharmacist immediately if you take more Deprexor EP than you have prescribed by your doctor.
Symptoms of eventual overdose may include accelerated palpitations, changes in the level
wakefulness (ranging from drowsiness to coma), blurred vision, convulsions or seizures and vomiting.
If you forget to take Deprexor ER
If you miss a dose, take it as soon as you remember. However, if it is time for the next dose, skip the missed dose and take only a single dose as usual. Do not take a double dose to make up for the missed dose. Do not take more than the daily amount of Deprexor ER prescribed for one day.
If you stop taking Deprexor ER
Do not stop treatment and do not lower the dose without your doctor's advice, even if you feel better. If your doctor thinks you no longer need
Serious side effects
If you notice any of the following, you may need urgent medical attention:
Heart problems such as rapid or irregular heart rhythm, increased blood pressure;
Problems with the eyes, such as blurred vision, enlarged pupils;
Nervous problems such as dizziness, needle sensations, movement disorders, convulsions or seizures;
Psychiatric problems such as hyperactivity and euphoria;
Treatment Discontinuation Syndrome (see section "How to take Depressor EP, if you stop taking Depressor EP").
Complete list of side effects
The frequency (probability of occurrence) of undesirable effects is classified as follows:
Very common: affect more than 1 user in 10;
Common: affect from 1 to 10 users per 100;
Uncommon: affects 1 to 10 users in 1,000;
Rare: affects 1 to 10 users in 10,000;
Not known: frequency can not be estimated from the available data.
Uncommon: bruising; black stools (faeces) or blood in stools, which
may be a sign of internal bleeding.
Not known: decreased blood platelet counts, resulting in an increased risk of platelets
bruising or bleeding; blood disorders that may lead to an increased risk of
Exchange / nutritional disorders
Common: Weight loss; increased cholesterol.
Uncommon: Weight gain.
Not known: slight changes in blood levels of liver enzymes; decrease of
blood levels of sodium; itching, yellow skin or yellowing of the eyes, dark urine or
flu-like symptoms that are symptoms of liver inflammation (hepatitis); confusion,
excessive intake of water; pathological separation of breast milk.
Nervous system disorders
Very common: dry mouth; headache.
Common: pathological dreams; decreased libido; dizziness; increased muscle tone; insomnia;
nervousness; needles and chills; calming; tremor; confusion; a sense of isolation (or separation) from oneself and reality.
Uncommon: loss of feelings or emotions; hallucinations; involuntary movements of the muscles; excitement;
distorted coordination and balance.
Rare: Feeling anxious or unable to sit comfortably in the sitting or standing
position; seizures or seizures; feeling overwhelmed or euphoric.
Not known: fever with rigid muscles, confusion or agitation
sweating, or if you experience sudden muscular movements that you can not control, these may be symptoms of serious conditions known as neuroleptic malignant syndrome; euphoric feelings, drowsiness, constant fast eye movements, clumsiness, restlessness, feeling as if you are drunk, sweating or rigid muscles that are symptoms of serotonergic syndrome; disorientation and confusion, often accompanied by hallucinations; stiffness, spasms and involuntary muscular movements; thoughts of self harm or suicide.
Vision and hearing impairment
Common: blurred vision.
Uncommon: Changed sensation of taste; ringing in the ears (tinnitus).
Not known: severe eye pain and reduced or blurred vision.
Heart or circulatory disorders
Common: Increased blood pressure; redness; palpitations.
Uncommon: feeling dizzy (especially when standing up too fast), seizures, rapid heartbeat.
Not known: decreased blood pressure; abnormal, accelerated or irregular heartbeat, which may lead to fainting.
Not known: cough, wheezing, shortness of breath and fever that are symptoms of
inflammation of the lungs associated with a rise in white blood cells (pulmonary
Very common: nausea.
Common: decreased appetite, constipation, vomiting.
Uncommon: gnashing, diarrhea.
Not known: severe abdominal or back pain (which could be serious
a problem in the intestine, liver or pancreas).
Very common: sweating (including night sweats).
Uncommon: rash; pathological hair loss.
Frequency not known: skin rash, which can cause severe bruising and bruising
skin; itching, mild rash.
Not known: unexplained muscle pain, tenderness or weakness (rhabdomyolysis).
Urinary system disorders
Common: difficulty in urine output; increased urination frequency.
Uncommon: Unavailability of urine.
Reproductive and sexual disorders
Common: pathological ejaculation / orgasm (male); lack of orgasm; erectile dysfunction (impotence); irregular menstruation such as increased bleeding or increased irregular bleeding.
Uncommon: abnormal orgasm (women).
Common: weakness (asthenia), chills.
Uncommon: sensitivity to sunlight.
Not known: swollen face or tongue, shortness of breath or difficulty in breathing, often with rashes (this can be a serious allergic reaction).
5. HOW TO STORE Deprexor ER
Store below 30 ° C.
Keep out of the reach and sight of children.
Do not use Depresor after the expiry date which is stated on the carton
The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of your unnecessary medicines. These measures will help to protect the environment.
6. ADDITIONAL INFORMATION
What Deprexor ER 75 mg capsules contain
The active substance is venlafaxine. Each prolonged-release capsule contains 75 mg of venlafaxine, such as venlafaxine hydrochloride.
The other ingredients are:
Hypromellose; ammonium methacrylate copolymer (type B); sodium lauryl sulfate; magnesium stearate; basic butyl methacrylate copolymer 12.5%; gelatin; titanium dioxide (E171); iron oxide, red (E172); shellac; iron oxide, black (E172); propylene glycol (E1520).
What Deprexor ER Capsules 75 mg looks like and what the package contains
beige-pink, opaque hard gelatin capsule # 0, which contains 2 round, biconvex film-coated tablets. In a PVC / PE / PVDC / A1 blister, 28, 30 or 100 capsules per carton, together with a leaflet.
Not all pack sizes may be marketed.