EFEXIVA 75 mg. 30 capsules
Efexiva is an antidepressant that belongs to a group of drugs called serotonin reuptake inhibitors of serotonin and norepinephrine (SNRIs). This group of drugs used for the treatment of depression and other conditions such as anxiety disorders. It is believed that people who are depressed and / or anxious have lower levels of serotonin and noradrenaline in the brain. Is not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and noradrenaline in the brain.
Efexiva for treatment of adult patients with depression. Efexiva is also a treatment for adults with the following anxiety disorders: generalized anxiety disorder, social anxiety disorder (fear or avoidance of social situations) and panic disorder (panic attacks). Treating depression or anxiety disorders is important to feel better. If not treated, your condition may not go away and may become more serious and more difficult to treat.
2. Before you take Efexiva
Do not take Efexiva
If you are allergic to venlafaxine or any of the other ingredients of Efexiva;
If you are also taking or have taken any time within the last 14 days any medicines known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with other medicines, including Efexiva, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Efexiva before taking any MAOI (see also the sections "Serotonin syndrome" and "Taking other medicines").
Take special care with Efexiva
If you use other medicines that taken concomitantly with Efexiva could increase the risk of developing serotonin syndrome (see. Section "Taking other medicines");
If you have eye problems such as certain kinds of glaucoma (increased pressure in the eye);
If you have a history of high blood pressure;
If you have a history of heart problems;
If you have a history of seizures (convulsions);
If you have a history of low sodium levels in the blood (hyponatremia);
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;
If your cholesterol levels are rising;
If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling over-excited or euphoric);
If you have a history of aggressive behavior.
Efexiva may cause a sensation of restlessness or inability to sit or stand still. You should tell your doctor if this happens to you.
If any of these apply to you, please tell your doctor before taking Efexiva.
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and / or have anxiety disorders, you can sometimes have thoughts of harming or killing yourself. They can be strengthened when taking first antidepressants, since these medicines all take time before they begin to work, usually about two weeks but sometimes longer.
There are more likely to think so:
If you have previously had thoughts about killing or harming yourself;
If you are young. Information from clinical trials has shown an increased risk of suicidal behavior in young adults (under 25 years) with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself, contact your doctor or go to hospital.
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 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 behavior.
Dry mouth was reported in 10% of patients treated with venlafaxine. This may increase the risk of tooth decay (caries). Therefore you should take special care in your dental hygiene.
Your blood sugar level may be changed by the action of Efexiva. It may therefore be necessary to adjust the dose of your anti-diabetic medicine.
Use in children and adolescents under 18 years of age
Efexiva should normally not be used for children and adolescents under 18 years. Also you should know that patients under 18 have an increased risk of side effects, such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behavior and anger) when they take this class of drugs. Despite this, your doctor may prescribe Efexiva for patients under 18 because he / she decides that this is in their best interest. If your doctor has prescribed Efexiva for a patient under 18 and you want to discuss this, please go back to your doctor. You should tell your doctor if you develop or worsen any of the above symptoms when patients under 18 are taking Efexiva. Furthermore, long-term effects on safety Efexiva growth, maturation and cognitive development and behavior in this age group have not yet been demonstrated.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Your doctor should decide whether you can take Efexiva with other medicines.
Do not start or stop taking any medicines, including those bought without a prescription, natural and herbal remedies, before checking with your doctor or pharmacist.
Monoamine oxidase inhibitors (MAOIs: see. Section "Before you take Efexiva");
Serotonin syndrome: Serotonin syndrome, a potentially life-threatening condition (see. "Possible Side Effects"), may occur with venlafaxine treatment, particularly when taken with other drugs. Examples of such drugs include:
Triptans (used for migraine);
Medicines to treat depression, for instance SNRI, SSRIs. tricyclics, or medicines containing lithium;
Medicines containing linezolid, an antibiotic (used to treat infections);
Medicines containing moclobemide, a reversible MAOI (used to treat depression);
Medicines containing sibutramine (used for weight loss);
Medicines containing tramadol (a painkiller);
Products containing St. John's Wort (also called Hypericum perforatum, which is natural or herbal remedy 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: restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting. Seek immediate medical attention if you think serotonin syndrome.
The following medicines may also interact with Efexiva and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medicines containing:
Ketoconazole (an antifungal medicine);
Haloperidol or risperidone (to treat psychiatric conditions);
Metoprolol (a beta blocker for the treatment of high blood pressure and cardiac problems).
Taking Efexiva with food and drink
Efexiva should be taken with food (see. Section 3 "How to take Efexiva"). You should avoid alcohol while taking Efexiva.
Pregnancy, lactation and fertility
Tell your doctor if you are pregnant or if you are trying to become pregnant. You must use Efexiva only after discussing the potential benefits and potential risks to your unborn child with your doctor.
Make sure that your midwife or your doctor informed that taking Efexiva. When taken during pregnancy, similar drugs (SSRI) may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn, which causes shortness of breath and blueness of the baby. These symptoms usually begin during the first 24 hours after birth. If such a reaction occurs when your baby immediately contact a midwife and / or doctor.
If you take Efexiva during pregnancy unless breathing problems, your baby may have other symptoms when it is born, as malnutrition. If your baby has these symptoms when it is born and you are concerned, contact your doctor and / or midwife who will be able to advise you.
Efexiva passes into breast milk. There is a risk of an effect on the baby. Therefore, you should discuss this with your doctor and he / she will decide whether you should stop breast-feeding or stop the therapy with Efexiva.
Driving and using machines
Do not drive or use any tools or machines until you know how you affect Efexiva.
3. How to take Efexiva
Always take Efexiva exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
The usual recommended starting dose for treatment of depression, generalized anxiety disorder and social anxiety disorder is 75 mg per day. The dose may be increased gradually by the doctor and, if needed, even up to a maximum of 375 mg daily for depression. If you are being treated for panic disorder, your doctor will start with a lower dose (37,5 mg) and then increase the dose gradually. The maximum dose for generalized anxiety disorder, social anxiety disorder and panic disorder is 225 mg / day.
Take Efexiva at approximately the same time each day either in the morning or evening. The capsules should be swallowed whole with fluid and not opened, crushed, chewed or dissolved.
Efexiva should be taken with food.
If you have liver or kidney problems, talk to your doctor as you may need your dose Efexiva change.
Do not stop taking Efexiva without consulting your doctor (see. Section "If you stop taking Efexiva").
If you take more dose Efexiva
Call your doctor immediately or pharmacist if you take more Efexiva dose prescribed by your doctor.
The symptoms of a possible overdose may include a rapid heart beat, changes in level of alertness (ranging from somnolence to coma), blurred vision, seizures or fits, and vomiting.
If you forget to take Efexiva
If you miss a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and take only a single dose as usual. Do not take more than the daily amount Efexiva, which has been prescribed for a day.
If you stop taking Efexiva
Do not stop taking your treatment or reduce the dose without the advice of your doctor even if you feel better. If your doctor thinks that you no longer need Efexiva, he / she may ask you to slowly reduce your dose before stopping treatment altogether. It is known that side effects occur when people stop using Efexiva especially when Efexiva is suddenly stopped or the dose is reduced too quickly. Some patients may experience symptoms such as fatigue, dizziness, lightheadedness, headache, sleeplessness, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling or rarely sensations electric shock, weakness, sweating, seizures or flu-like symptoms.
Your doctor will advise you on how you should gradually discontinue treatment Efexiva. If you experience any of these or other symptoms that are troublesome, ask your doctor for further advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Efexiva can cause side effects, although not everybody gets them.
Do not worry if you see small white granules in your stools after taking Efexiva. Inside Efexiva capsules are spheroids or small white balls that contain the venlafaxine active ingredient. These spheroids are released from the capsule into your gastrointestinal tract. As the spheroids travel the length of your gastrointestinal tract, venlafaxine is slowly released. "Shell" of the microspheres remains undissolved and is eliminated in your stools. So even though you may see spheroids in your stools, your dose of venlafaxine has been absorbed.
If any of these effects, do not take Efexiva. Tell your doctor or go to the emergency room of the nearest hospital:
Chest tightness, wheezing, trouble swallowing or breathing;
Swelling of the face, throat, hands, or feet;
Feeling nervous or anxious, dizziness, throbbing sensations, sudden reddening of the skin and / or a warm feeling;
Severe rash, itching or hives (elevated patches of red or pale skin that often itch).
Serious side effects
If you notice any of these signs, you may need urgent medical attention:
Heart problems such as fast or irregular heartbeat, increased blood pressure;
Eye problems such as blurred vision, dilated pupils;
Nerve problems, such as dizziness, feeling of pins and needles, movement disorder, seizures or fits;
Psychiatric problems such as hyperactivity and euphoria;
Syndrome treatment discontinuation (see. Section "How to take Efexiva. If you stop taking Efexiva").
Complete list of side effects
The frequency (likelihood of occurring) of side effects is classified as follows:
very common affect more than 1 in 10 users;
common: affect 1 to 10 of 100 users;
uncommon: affect 1 to 10 of 1000 users;
rare: affect 1 to 10 of 10,000 users;
Not known: from the available data can not be estimated frequency.
Uncommon: bruising; black tarry stools (faeces) or blood in stools, which can be a sign of internal bleeding.
Not known: reduced number of platelets in your blood, leading to an increased risk of bruising or bleeding; disorders of the blood, which can lead to increased risk of infections.
Metabolic / nutritional disorders
Common: weight loss; elevated cholesterol.
Uncommon: weight gain.
Not known: slight changes in blood levels of liver enzymes; decrease in blood sodium levels; itching, yellow skin or eyes, dark urine, or flu-like symptoms, which are symptoms of inflammation of the liver (hepatitis); confusion, excessive water intake (known as SIADH); abnormal breast milk.
Very common: dry mouth; headache.
Common: abnormal dreams; decreased libido; dizziness; increased muscle tone; insomnia; nervousness; needles and chills; sedation; tremor; confusion; feeling separated (or detached) from yourself and reality.
Uncommon: lack of feeling or emotion; hallucinations; uncontrolled muscle movements; agitation; impaired coordination and balance.
Rare: a sensation of restlessness or inability to sit or stand still; convulsions or seizures; feeling over- excited or euphoric.
Not known: a high temperature with rigid muscles, confusion or agitation, and sweating, or if you experience jerky muscle movements you can not control, these may be symptoms of serious conditions known as neuroleptic malignant syndrome; euphoric feelings, drowsiness, sustained rapid eye movement, clumsiness, restlessness, feeling of being drunk, sweating or rigid muscles, which are symptoms of serotonergic syndrome; disorientation and confusion often accompanied by hallucination (delirium); stiffness, spasms and involuntary movements of the muscles; thoughts of harming or killing, dizziness, aggressiveness.
Visual disturbances and hearing
Common: blurred vision.
Uncommon: altered taste sensation; ringing in the ears (tinnitus).
Not known: severe eye pain and decreased or blurred vision.
Disorders of the heart or circulatory
Common: increased blood pressure; redness; palpitations.
Uncommon: feeling dizzy (particularly when standing up too quickly), fainting, fast heartbeat.
Not known: decrease in blood pressure; abnormal, rapid or irregular heartbeat, which can lead to fainting.
Not known: coughing, wheezing, shortness of breath and fever, which are symptoms of inflammation of the lungs associated with an increase in white blood cells (pulmonary eosinophilia).
Very common: nausea.
Common: decreased appetite; constipation; vomiting.
Uncommon: grinding of the teeth; diarrhea.
Not known: severe abdominal or back (which could indicate a serious problem in the gut, liver or pancreas).
Very common: sweating (including night sweats).