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Elify XR 75 mg. 30 capsules

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Elify XR is an antidepressant that belongs to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders.

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What is the Elifai XR and what is it used for

Elifai XR is an antidepressant that belongs to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs). This group of medicines is 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 norepinephrine in the brain. It is not completely clear how antidepressants work, but they can help by raising the levels of serotonin and norepinephrine in the brain.

Elifai XR is a treatment for adults with depression. Elifai XR is also a treatment for adults with the following anxiety disorders: generalized anxiety disorder, social anxiety disorder (fear and avoidance of social situations) and panic disorder (panic attacks). Proper treatment of depression or anxiety disorders is important to make you feel better. If left untreated, your condition may not go away and may become more serious and difficult to treat.

2. What you need to know before you take Elifay XR

Do not take Elifai XR:

- if you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).

- if you also take or have ever taken within the last 14 days any medicines known as irreversible monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease. Taking irreversible MAOI with Elifai XR can cause serious or even life-threatening side effects. You should also wait at least 7 days after you stop taking Elifai XR before taking any MAOIs (see also section “Other medicines and Elifai XR” and the information in this section on “Serotonin syndrome”).

Warnings and precautions

Talk to your doctor or pharmacist before taking Elifai XR:

• If you are using other medicines that are taken together with Elifai XR, it may increase the risk of developing serotonin syndrome (see “Other medicines and Elifai XR”).

• If you have eye problems such as certain types of glaucoma (high 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 (seizures).

• If you have a history of low blood sodium levels (hyponatraemia).

• If you have a tendency to develop bruising or a tendency to bleed easily (a history of coagulation disorders), or if you are taking other medicines that may increase your risk of bleeding, e.g. warfarin (used to prevent blood clots).

• If your cholesterol levels rise.

• If you have a history, or if someone in your family has had a mania or bipolar disorder (you feel over-excited or euphoric).

• If you have a history of aggressive behavior.

The Elifay XR can cause anxiety or inability to sit still or upright. You should tell your doctor if this happens to you.

If any of these conditions apply to you, please tell your doctor before taking Elifai XR.

Thoughts of suicide and aggravation of your depressive or anxiety disorder

If you are depressed and / or have anxiety disorders, you may sometimes have thoughts of hurting yourself or killing yourself. These may be intensified when you first start taking antidepressants, since all of these medications take time to take, usually about two weeks, but sometimes longer.

You are more likely to think:

• If you have previously thought of killing yourself or hurting yourself.

• If you are young. Information from clinical studies indicates an increased risk of suicidal behavior in adolescents (under 25 years of age) with psychiatric conditions who have been treated with antidepressants.

If you ever have thoughts of harming or killing yourself, contact your doctor or go to a hospital immediately.

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 can 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

Oral dry mouth has been reported in 10% of patients treated with venlafaxine. This can increase the risk of caries. Therefore, you should pay special attention to the hygiene of your teeth.

Children and adolescents

Elifay XR should not normally be used in children and adolescents under 18 years of age. You should also be aware that patients under 18 are at an increased risk of side effects, such as suicidal experience, suicidal thoughts and hostility (mainly aggression, opposition behavior and anger) when taking this class of medicines. However, your doctor may prescribe Elifai XR for patients under 18 years, as he / she decides whether it is in their best interest. If your doctor has prescribed Elifai

The signs and symptoms of serotonin syndrome may include a combination of the following: restlessness, hallucinations, loss of coordination, increased heart rate, fever, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome may resemble the Neuroleptic Malignant Syndrome. Signs and symptoms of neuroleptic malignant syndrome may include a combination of fever, rapid heart rate, sweating, severe muscle stiffness, confusion, increased muscle enzymes (found in blood tests).

Tell your doctor immediately or visit the emergency department of the nearest hospital if you think you are developing serotonin syndrome.

The following medicines may also interact with Elifai XR and should be used with caution. It is especially important to mention 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).

Elifai XR with food, drinks and alcohol

Elifai XR should be taken with food (see section 3 “How to take Elifai XR”)

You should avoid drinking alcohol while you are taking Elifai XR.

Pregnancy, breastfeeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

You should only use Elifay XR after discussing the potential benefits and potential risks of your unborn child with your doctor.

Make sure your midwife and / or doctor are informed that you are on treatment with Elifai XR. When taken during pregnancy, such medicines (SSRIs) may increase the risk of a serious condition for babies, known as persistent neonatal hypertension (PBC), leading to rapid breathing and bruising of the baby. These symptoms usually begin within the first 24 hours after the baby is born. If these symptoms occur in your baby, you should contact your midwife and / or doctor immediately.

If you are taking this medicine during pregnancy, your baby may have other symptoms: malnutrition in addition to difficulty breathing. If your baby has these symptoms at birth and you are worried, contact your doctor and / or your midwife for advice.

Elifai XR goes into breast milk. There is a risk of having 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 treatment with Elifai XR.

Driving and using machines

Do not drive or use any tools or machines until you understand how the Elifai XR affects you.

[For Elifai XR 37.5 mg:]

Elifay XR 37.5 mg contains Ponceau 4R red (E124). May cause allergic reactions.

[For Elifai XR 75 mg:]

Elifay XR 75 mg contains sunset yellow FCF (E110). May cause allergic reactions.

[For Elifai XR 150 mg:]

Elifay XR 150 mg contains sunset yellow FCF (E110). May cause allergic reactions. Elifai XR contains sucrose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Elifai XR

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The usual recommended starting dose for the treatment of depression, generalized anxiety disorder and social anxiety disorder is 75 mg per day. The dose may be increased gradually by your doctor and, if necessary, up to a maximum of 375 mg daily for depression. If you are being treated for a panic disorder, your doctor will start with a lower dose (37.5 mg) and then gradually increase the dose. The maximum dose for generalized anxiety disorder, social anxiety disorder and panic disorder is 225 mg / day.

Take the Elifai XR at approximately the same time each day, either in the morning or in the evening. The capsules should be swallowed whole with liquid and should not be opened, broken, chewed or dissolved.

Elifai XR should be taken with food.

If you have liver or kidney problems, talk to your doctor, as your dose of Elifai XR may need to be changed.

Do not stop taking Elifai XR without talking to your doctor (see "If you stop taking Elifai XR").

If you take more Elifai XR than you should

Call your doctor or pharmacist immediately if you have taken more than the required dose of Elifai XR prescribed by your doctor.

Symptoms of possible overdose may include palpitations, changes in wakefulness (ranging from drowsiness to coma), blurred vision, convulsions or seizures, and vomiting.

If you forget to take Elifai XR

If you miss a dose, take it right away

A complete list of side effects

Very common (may affect more than 1 in 10 people)

• Dizziness, headache, dry mouth, sweating (including night sweating)

• Nausea

Common (may affect up to 1 in 10 people)

• Reduced appetite, constipation, vomiting, high cholesterol

• Feeling isolated (distant) from oneself and reality, nervousness, confusion, unusual dreams, insomnia

• Tremor, increased muscle tone

• Trembling of the limbs

• Increased blood pressure, redness, palpitations

• Increased frequency of urination, difficulty urinating

• Reduced libido, pathological ejaculation / orgasm (men); inability to orgasm, erectile dysfunction (impotence)

• Menstrual disorders such as excessive bleeding or increased irregular bleeding

• Weakness (asthenia), sedation, shivering

• Blurred vision

• Tinnitus (tinnitus)

• Yawning

Uncommon (may affect up to 1 in 100 people)

• Bruises, black tar stools or bloody stools that may be symptoms of internal bleeding

• Gnashing of teeth, involuntary muscle movements

• Hallucinations

• General swelling of the skin, especially swelling of the face, mouth, tongue and throat or arms and legs and / or a relief itchy rash (hives)

• Sensitivity to light, abnormal hair loss, rash

• Impaired coordination and balance, feeling of dizziness (especially with fast straightening), seizures, accelerated heart rate

• Weight loss, weight gain, diarrhea

• Changed taste sensations

• Lack of feelings or emotions, excitement

• Inability to urinate

• Abnormal orgasm (women)

Rare (may affect up to 1 in 1,000 people)

• Feeling anxious or unable to stand still, convulsions or fits, feeling over-excited or euphoric

• Inability to control urination

Frequency not known (cannot be estimated from available data)

• Reduced platelet count in the blood, leading to an increased risk of bruising and bleeding; blood disorders that may lead to an increased risk of infection; small changes in blood levels of liver enzymes; decrease in blood levels of sodium

• Itching, yellowing of the skin or white of the eyes, cloudy urine or flu-like symptoms that may be symptoms of liver inflammation (hepatitis)

• Excessive water intake (a condition known as SNAX)

• Pathological separation of breast milk

• High fever and rigid muscles, confusion or agitation and sweating or sudden uncontrolled muscle movements that can be symptoms of a serious condition known as neuroleptic malignant syndrome.

• Feeling of euphoria, drowsiness, constant rapid eye movements, clumsiness, restlessness, feeling that you are drunk, sweating or stiff muscles that are symptoms of serotonin syndrome

• Disorientation and confusion, often accompanied by hallucinations (delirium)

• Stiffness, cramps and involuntary muscle movements

• Thoughts of self-harm or suicide

• Acute eye pain and decreased or blurred vision

• Low blood pressure, abnormal, accelerated or irregular heart rhythm that can lead to seizures

• Cough, wheezing, shortness of breath and fever, which are symptoms of lung inflammation associated with an increase in white blood cell count (pulmonary eosinophilia)

• Acute abdominal or back pain (which can indicate a serious bowel, liver or pancreatic problem)

• Skin rash that can lead to extensive flaking and peeling of the skin, itching, slight rash

• Unexplained muscle pain, tenderness or weakness in muscles (rhabdomyolysis)

• Biceps or tongue swelling, shortness of breath or difficulty breathing, often accompanied by skin rashes (these may be symptoms of a severe allergic reaction)

• Confusion

• Vertigo (vertigo)

• Aggression

Elifai XR sometimes causes side effects that you may not experience as a rise in blood pressure or an abnormal heart rate; slight changes in blood levels or liver enzymes, sodium or cholesterol. Less commonly, Elifay XR may reduce the function of platelets in your blood, leading to an increased risk of bleeding or bleeding. Therefore, your doctor may wish to perform blood tests from time to time, especially if you have taken Elifai XR for a long time.

How to store Elifai XR

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not dispose of medicines in sewage or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What ELIFAI XR contains

- The active substance is venlafaxine.

[For Elifai XR 37.5 mg]:

Each capsule contains venlafaxine hydrochloride (venlafaxine hydrochloride) equivalent to 37.5 mg venlafaxine.

- The other ingredients are:

Capsule Content:

sugar spheres (containing sucrose)

hydroxypropyl cellulose

hypromellose

talc

ethylcellulose dibutyl sebacate oleic acid

silica, colloidal anhydrous.

Capsule shell:

gelatin

sodium lauryl sulfate

Poncho 4R (E 124)

quinoline yellow (E 104)

titanium dioxide (E171).

[For Elifai XR 75 mg]:

Each capsule contains venlafaxine hydrochloride (venlafaxine hydrochloride) equivalent to 75 mg venlafaxine.

- The other ingredients are:

Capsule Content:

sugar spheres (containing sucrose)

hydroxypropyl cellulose

hypromellose

talc

ethylcellulose

dibutyl sebacate

oleic acid

silica, colloidal anhydrous.

Capsule shell:

gelatin

sodium lauryl sulfate

Sunset Yellow FCF (E110)

quinoline yellow (E 104)

titanium dioxide (E171).

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