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Efexor xr 37.5 mg 14 capsules include venlafaxine

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Efexor xr 37.5 mg 14 capsules include venlafaxine

USE INSTRUCTION

EFEXOR® XR 37.5 mg Micropellet Capsules

Oral

• Active ingredient: Each micropellet capsule contains 37.5 mg of venlafaxine as a hydrochloride salt in an extended release formulation.

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You should read this USE INSTRUCTION carefully before you start using this medicine, because it contains important information for you.

• Keep these instructions for use. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, do not give it to others.

• When using this medicine, tell your doctor or doctor if you go to the hospital.

• We sleep exactly as written in this instruction. Do not use high or low doses other than the recommended dose for the medication.

In this Instructions for Use:

1. What is EFEXOR XR and what is it used for? 2. Things to watch out for before using EFEXOR XR 3. How to use EFEXOR XR? 4. What are the possible side effects? 5. Hiding the EFEXOR XR

.

1. What is EFEXOR XR and what is it used for?

• It is in the form of an extended release micropellet capsule. An antidepressant belonging to the drug group called serotonin and noradrenalin reuptake inhibitors (SNRIs).

• The box contains blister packs containing 14 micropellets capsules.

• Used in the treatment of major depression, in the treatment of panic disorder with or without agoraphobia, with recurrent major depression and new episodes (epilepsy), generalized anxiety disorder (GAD) treatment, social phobia treatment, agoraphobia (fear of the patient having panic attacks) .

2. What to watch out for before using EFEXOR XR

Antidepressants have increased the risk of suicidal thoughts and behavior (suicidal tendency) in short-term clinical trials in children and adolescents with Major Depression and other psychiatric disorders. When considering the use of EFEXOR XR or any other antidepressant in children or adolescents, the identified risk and clinical need should be balanced. See the warning about suicide. The use of antidepressants in children and young people up to the age of 24 is likely to increase suicidal thoughts or behavior. For this reason, it is necessary for the patient to be followed closely by the family, either the family or the caregivers, especially for the beginning and the first months of treatment, the unexpected change of behavior such as uneasiness the patient may show during the period of increasing / decreasing or discontinuing treatment, extreme mobility, or the possibility of suicide. EFEXOR XR is not approved for use in pediatric patients (under the age of 18).

DO NOT USE EFEXOR XR in the following situations

• If you have any allergies to venlafaxine or any of the ingredients in the formula.

• In combination with medicines called monoamine oxidase inhibitors (MAOI): You should not start venlafaxine therapy until at least 14 days have passed since MAOI treatment was discontinued. You should stop using venlafaxine at least 7 days before starting any MAOI use.

If you

are using EFEXOR XR in conjunction with EFEXOR XR, you may increase the risk of developing a serotonin syndrome or a Neuroleptic Malignant Syndrome (NMS) -like reaction (see section "Use with other medicines"). Increased risk of bone fracture has been reported in patients using drugs of the serotonin reuptake inhibitor class, including EFEXOR XR. The reason for this increase is not fully known.

• If you have eye problems such as some glaucoma (pressure increase in the eye).

• If you have a history of high blood pressure.

• If you have a history of heart problems.

• If the heart rhythm is said to be unusual,

• The diagnosis or suspected congenital prolonged QT syndrome (a condition that can lead to severe arrhythmias and sudden deaths in the heart) or Torsades de Pointes (life-threatening irregular heart rhythm) patients should be avoided.

• If you have a seizure (convulsion) background.

• If you are using medications known as "diuretics" that lose water to your body, or if your body has lost water due to any reason.

• If you have easy bruising on your skin or if you tend to bleed easily (history of bleeding disorders) or if you are using another medication that increases the risk of bleeding.

• If your cholesterol level is high.

• Mania (extreme self-esteem) or bipolar mood disorder (extreme excitement or enthusiasm) if you have a history or a manic or bipolar disorder history in a person in your family.

• If you have an aggressive behavior history.

• If you have a history of low sodium levels (hyponatremia) in your blood • If you are taking an anti-hypotensive

drug.

During the first few weeks of treatment, EFEXOR XR may cause a feeling of discomfort or restlessness. If you encounter such a condition, inform your doctor.

Please consult your doctor if these warnings apply to you, even at any time in the past.

Oral establishment: At least 10% of patients treated with venlafaxine have been reported to have mouth rash. This can cause an increase in tooth decay. For this reason, it is recommended that you pay attention to oral hygiene.

Diabetes (diabetes): Depending on the use of EFEXOR XR your blood sugar level may change. For this reason, you may need to adjust the dose of the drug you have used for diabetes.

Increased bone fracture risk: Patients who use drugs called serotonin reuptake inhibitors, including EFEXOR, have increased bone fracture risk. The mechanism that caused this risk was not fully understood.

Suicidal thoughts and deteriorating depression or anxiety disorders:

You may have the idea of ​​killing yourself if you are experiencing a psychological depression (you are depressed) or if you have certain psychiatric disorders. These considerations may increase if you start using antidepressants first or if there is any change in the total dose or dosage frequency. Information from clinical trials has shown that antidepressants increase the risk of suicidal tendencies in children, adolescents and young adults (18-24 years) with major depression and other psychiatric disorders. If you have ever thought of harming or killing yourself at any time, contact your doctor immediately or go to a hospital. Whether you are a depressed or an anxiety disorder member of a clan or a close friend, and you do not want them to read this instruction manual will help you. Tell them to report if they feel that depression or anxiety is getting worse or if they are worried about any changes in your behavior.

Use in children and adolescents under the age of 18 The EFEXOR XR is not normally used in children and adolescents under 18 years of age. You should also be aware that patients under the age of 18 use side effects when they use this class of medications, such as hostility, suicidal thoughts, and self-harm. If, however, it is determined that he or she is the best option for him, this medication may be prescribed by a physician under the age of 18. If a patient under the age of 18 is prescribing this medicine, you can ask your doctor about it. If any of the above-mentioned indications develop or worsen for patients under 18 years of age who use EFEXOR XR,

Pfleet no: 2014-0005399 & 2014-0008977 & 2015-0009532

3

notify your doctor. In addition, the effect of this drug on growth, maturation, cognition and behavioral development in patients under 18 years of age is unknown.

Use of EFEXOR XR with food and drink You should buy EFEXOR XR with food (see third division, "How to use EFEXOR XR"). You should avoid taking alcohol for as long as you use EFEXOR XR.

Consult your doctor or pharmacist before using Pregnancy Pills. If you are pregnant or are trying to conceive, tell your doctor about it. You should only use EFEXOR XR if you think it is more than the risk of potential benefits with your doctor.

Make sure that your doctor or assistant healthcare staff (eg midwife, nurse) know you are using EFEXOR XR. Some medicines similar to EFEXOR XR (serotonin reuptake inhibitors) increase the risk of developing a condition known as neonatal resistant pulmonary hypertension, which is manifested by baby's rapid breathing and crying. These symptoms usually occur within the first 24 hours of the baby's birth. If this happens to your baby, immediately contact your doctor and / or health personnel.

If you use this medicine during your pregnancy, you can see some symptoms in your baby such as not being able to feed properly and breathing. . If you have any symptoms when you are born, or if you are worried that you may be, contact your doctor and / or health personnel who may be available to you. If you notice that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Breastfeeding Consult your doctor or pharmacist before using the medicine. The EFEXOR XR has passed. There is a risk of creating an effect on the baby. So you should discuss this with your doctor, your doctor will decide whether you should stop sucking or use EFEXOR XR.

Use of the vehicle and the machine Do not use the car and any machinery until you understand how the EFEXOR XR affects you.

Use with other medicines

• Do not use EFEXOR XR if you are using medicines known as MAOI (used to treat depression and Parkinson's disease) or have used it in the last 14 days.

• "Serotonin syndrome", a potentially life-threatening condition (see "Possible Side Effects" section), may occur when taken with other serotonergic drugs, especially when treated with venlafaxine. These drugs include the following: o(used for migraine attacks)

oused for the treatment of mood disorders such as selective serotonin reuptake inhibitors (SSRI), tricyclic antidepressants or other drugs containing lithium drugs o Medicines known as MAOI, such as linezolid, which is used in the treatment of infections, and methylene blue, which are used to treat calorie high methemoglobin levels o Medicines containing sibutramine (used to lose weight) o Yellow wort (St. John's Wort as Hypericum perforatum

ofentanyl and its derivatives, tramadol, meperidine, tapentadol, metadone, pentazocine

Very strong pain relievers such aso Dextromethorphan (a drug used in the treatment of cough) o Hearing and seeing things that are not called antipsychotics medications used to treat feelings, feelings, false beliefs, unusual skepticism, unclear thoughts, and inward-closure disorders.

Serotonin syndrome may contain a mixture of the following: hallucinations, hallucinations, loss of coordination, rapid heartbeat, increased body temperature , rapid changes in blood pressure, increased reflexes, diarrhea, coma, nausea, vomiting.

The most severe form of serotonin syndrome may resemble a condition called "Neuroleptic Malignant Syndrome (NMS)". NMS findings and symptoms may include a combination of symptoms such as fever, acceleration of heart beat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (occurring in blood tests).

If you think that serotonin syndrome has come to fruition, you will receive immediate medical attention.

In addition, the following medicines may interact with EFEXOR XR and should be used with caution. If you are using any of the following drugs you are not talking to your doctor or pharmacist are particularly important:

• ketoconazole (a fungicide)

• haloperidol (to treat psychiatric disorders)

• metoprolol (high blood pressure and a medicament for treating heart problems)

If an affecting your heart rhythm If you are on medication, tell your doctor.

Examples of these drugs are:

-called antiarrhythmics, such as quinidine, amiodarone, sotalol and dofetilide

Drugs used for abnormal heart rhythms- Drugs used in the treatment of certain psychiatric disorders, called thyididazines (see also the warning for serotonin syndrome above for these group drugs) -bacterialcalled antibiotics such as erythromycin and moxifloxacin

Drugs used in the treatment ofinfections- Medicines called antihistamines for the treatment of allergy

If you are using or have recently used any medicines with or without prescription, or your pharmacist.

3. How to use EFEXOR XR?

• Instructions for proper use and dose / administration frequency: The recommended initial dose for major depression is 75 mg EFEXOR XR per day. Patients who do not respond to an initial daily dose of 75 mg may benefit from doses of up to 375 mg per day. The recommended initial dose for generalized anxiety disorder is 75 mg EFEXOR XR per day. Patients who do not respond to an initial daily dose of 75 mg may benefit from a maximum dose of 225 mg per day. The recommended dose of social phobia is 75 mg EFEXOR XR daily. There is no evidence that higher doses provide additional benefit. However, in patients who do not respond to an initial daily dose of 75 mg, the dose may be increased to a maximum of 225 mg per day. The recommended dose for panic disorder is 37.5 mg EFEXOR XR once daily for the first 7 days. The dose should then be increased to 75 mg per day. Patients who do not respond to 75 mg daily doza may benefit from a maximum dose of 225 mg per day. Dose increments should be made at intervals of about 2 weeks or more, but not at shorter intervals of 4 days.

• Application route and method: It is recommended to take EFEXOR XR with food. Each capsule should be swallowed whole as liquid. The capsule should not be divided, crushed, chewed or mixed with water. EFEXOR XR should be taken once a day and roughly the same hours (morning or evening).

• Different age groups:

Use in children: Adolescents under 18 years do not have adequate experience with the use of venlafaxine. Use in the elderly: In elderly patients, it is not advisable to adjust in usual doses only for their age.

• Specific use cases:

Kidney and liver failure: Patients with kidney and / or liver failure should take low doses of venlafaxine. If you have a liver or kidney problem, tell your doctor. Because your EFEXOR XR dose may need to be reduced.

If you have an impression that the effect of EFEXOR XR is too strong or weak, talk to your doctor or pharmacist.

If you use more EFEXOR XR than you need: A possible overdose indication may include rapid heart rate, change in awake level (ranging from sleepiness to comatose), pupil growth, seizures or crises and vomiting.

Published retrospective studies indicate that venlafaxine causes more deaths than antidepressants in the SSRI group, with less "tricyclic" group deaths than antidepressants. Studies showing the frequency, distribution and causes of the disease show that the patients treated with venlafaxine have a higher risk of suicide than those treated with antidepressants. It is not clear how much of the overdose related deaths depend on the toxicity of venlafaxine, and how many of the other properties of patients receiving venlafaxine. Use EFEXOR XR If you have used too much, talk to a doctor or pharmacist.

If you forget to use EFEXOR XR: Do not take double doses to compensate for forgotten doses.

EFEXOR XR can result in termination of treatment. Even if you feel better, do not stop your treatment or reduce your dose without your doctor's advice. If your doctor thinks you do not need to use EFEXOR XR anymore, he may tell you to slowly reduce your dose before he or she interrupts the treatment altogether. It should be known that side effects will occur when the use of EFEXOR XR in humans is discontinued, especially when the use of EFEXOR XR is abruptly stopped or the dose is reduced too quickly. In some patients there is a feeling of tiredness, dizziness, dizziness, headache, insomnia, nightmares, lack of appetite, nausea, diarrhea, irritability, agitation, confusion, ringing in the ears, tingling, weakness, sweating, seizure or flu-like symptoms were observed. Your doctor will advise you on how to gradually stop EFEXOR XR treatment. If you observe any of these and other symptoms yourself, consult your doctor for further advice.

4. What are the possible side effects? As with all medicines, there may be side effects in people sensitive to substances in the EFEXOR XR.

Stop using EFEXOR XR if you have one of the following and report it to your doctor or contact the emergency department of your nearest hospital:

• Very severe response to allergies to the body, such as difficulty in gripping, wheezing, swallowing or breathing, swelling in face, throat, sudden redness and / or warmth sensation

• Severe rash, itching or hives (usually skin rash with red or pale stains, with itchiness)

• Inelastic dyspepsia, signs and symptoms of serotonin syndrome, including hallucinations, loss of coordination, rapid heart rate, increase in body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting

Serotonin syndrome the most serious form is called Neuroleptic Malignant Syndrome (NMS). NMS indications may include such things as fever, increased heart rate, sweating, severe muscle stiffness, confusion, elevation of muscle enzymes (determined by blood testing).

Other side effects that you should tell your doctor about:

• Coughing, wheezing, insufficiency of breathing and high temperature

• Blood in black stools or stools

• Skin irritation (hepatitis) dark urine

• Heart problems such as rapid or irregular heartbeat, elevated blood pressureproblems such as

• Eyeenlargement of the eye baby, blurred visionProblemsas dizziness

•with nerves such, tingling, movement disorder, seizure or crisis

• Hyperactivity and euphoria to feel excited)such psychiatric problems

effects which can occur when• treatment terminated (see. how to use Efexor XR, effects that can occur when discontinuation of treatment with Efexor XR)

If your stools after using this medication, small white balls or granules (pellets) was the most you see Do not eliminated. EFEXOR XR capsules contain small white balls called venlafaxine, called spheroids. These spheroids are released from within the capsules. Venlafaxine, which is present on your back in your bowel and in your intestines, is slowly released. The shell of the spheroids is insoluble and exudates. For this reason, even if you have spheroids in your stomach, your drug dose has been absorbed.

List of all undesirable effects:

Very common side effects (May affect more than 1 person in 10 people)

• Headache, dry mouth, sweating (including night sweats)

• Nausea

Common side effects (1 to 10 people per 100 people )

•, decrease in appetite, constipation, vomiting, increase in cholesterol

• Rupture sensation, nervousness, confusion

increase in muscle tone

• Tingling

,Increase in blood pressure, skin flare, palpitationIncrease in blood pressure

Tinnitus• Tinnitus •• Increase in urine output, increase in urine output •, urinary difficulties

•decreased sexual desire, abnormal ejaculation / orgasm (in males), orgasm, erectile dysfunction (erectile problem)

Menstrual irregularities such as• Increase inor increase in irregular bleeding

blood• Lack of fluency (asthenia), dizziness, drowsiness, chills

• Blurred vision, eye baby enlargement and the ability to auto focus on objects close to the eye from a distance nu

• Stretching

• Fatigue

• Tinnitus • Tinnitus in the

ear

Uncommon side effects (may affect 1 to 10 people per 1000 people), which

•may be a sign of internal bleeding , blood vomiting, black stools or stools

• Creeping teeth, involuntary movements of muscles

• Hallucinations (see things that are not real)

• Blistering and / or itchy rashes, especially on face, mouth, tongue, throat or hands and feet

• Sunlight loss of

coordination and balance, dizziness (particularly when the foot is raised too fast), fainting, rapid heart beat

• Weight gain, weight loss

• Diarrhea

• Change in taste sensation

• Reduction in emotions and feelings, agitation (tension, ), feeling excessively excited

• No withdrawal

• Abnormal orgasm (women a)

• Dyspnea (difficulty in breathing)

• Feeling of on-site feeling or constant / immobile sitting or standing

• Feeling of a sense of rupture

Rare side effects (Every 1 0000 people can affect 1 to 10 people)

• Seizure or crisis

• small ablution) inability to control

• Excessive activity, quick thinking, decreased need for sleep (mania)

Frequency affects the unknown side (can not be estimated from available data)

• blood platelets in your body (platelets) in an amount of reduction may cause an increase in injury or risk of bleeding

• infection causes an increase in the risk may blood disorders, small changes in the blood and liver enzymes, reduction in blood sodium level

• itchy skin or eyes yellowing can indicate inflammation of the liver, dark urine, or flu-like symptoms (hepatitis)

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