Efectin Er 37,5

Package Leaflet: Information for the User

Efectin ER 37.5

37.5 mg, prolonged-release hard capsules

Efectin ER 75

75 mg, prolonged-release hard capsules

Efectin ER 150

150 mg, prolonged-release hard capsules

venlafaxine

Read all of this leaflet carefully before taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

• 1. What Efectin ER is and what it is used for
• 2. Before you take Efectin ER
• 3. How to take Efectin ER
• 4. Possible side effects
• 5. How to store Efectin ER
• 6. Contents of the pack and other information

1. What Efectin ER is and what it is used for

Efectin ER contains the active substance venlafaxine.

Efectin ER is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs).

These medicines are used to treat depression and other conditions, such as anxiety disorders.

The mechanism of action of antidepressants is not fully understood, but they may help by increasing the levels of serotonin and norepinephrine in the brain.

Efectin ER is used to treat depression in adults.

Efectin ER is also used to treat generalized anxiety disorder, social anxiety disorder, and panic disorder in adults.

For the patient to feel better, it is essential that the treatment of depression and anxiety disorders is carried out correctly.

If the patient does not receive treatment, their condition may not improve, may worsen, and may become more difficult to treat.

2. Before you take Efectin ER

Do not take Efectin ER:

• If you are allergic to venlafaxine or any of the other ingredients of this medicine.
• If you are taking, or have taken within the last 14 days, any medicines known as irreversible monoamine oxidase inhibitors (MAOIs), which are used to treat depression or Parkinson's disease.

Warnings and precautions

Beforestarting treatment with Efectin ER, tell your doctor or pharmacist:

• If you are taking any other medicines that may increase the risk of serotonin syndrome (see section "Efectin ER and other medicines").
• If you have eye problems, such as certain types 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 irregular heart rhythms.
• If you have a history of seizures (epilepsy).
• If you have a history of low sodium levels in the blood (hyponatremia).
• If you have a history of bleeding disorders or if you are taking other medicines that may increase the risk of bleeding, such as warfarin (used to prevent blood clots) or if you are pregnant (see "Pregnancy and breastfeeding").
• If you or anyone in your family has a history of mania (feeling excessively excited or euphoric) or bipolar disorder.
• If you have a history of aggressive behavior.

Efectin ER may cause feelings of restlessness or an inability to sit or stand still during the first few weeks of treatment.

Do not drink alcohol while taking Efectin ER, as it may cause extreme tiredness and loss of consciousness, and may worsen symptoms of depression and other conditions, such as anxiety disorders.

Suicidal thoughts and worsening of depression or anxiety disorders

People with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide.

These thoughts may worsen when first starting treatment with antidepressants, as these medicines may take 2 weeks or longer to start working.

These thoughts may also occur when reducing the dose or stopping treatment with Efectin ER.

The risk of suicidal thoughts is higher if:

• You have had suicidal thoughts or self-harm in the past.
• You are a young adult. Clinical trials have shown an increased risk of suicidal behavior in young adults (under 25 years old) with mental health conditions who were treated with antidepressants.

If you experience suicidal thoughts or self-harm, seek medical attention immediately.

It may be helpful to tell relatives or friends that you are taking this medicine, and ask them to read this leaflet.

You may want to ask your relatives or friends to tell you if they notice any worsening of your depression or anxiety, or if they notice any disturbing changes in your behavior.

Dry mouth

Dry mouth was reported by 10% of patients treated with venlafaxine.

This may increase the risk of tooth decay.

Therefore, pay special attention to oral hygiene.

Diabetes

Efectin ER may affect blood sugar levels, and it may be necessary to adjust the dose of antidiabetic medicines.

Sexual dysfunction

Medicines like Efectin ER (SNRIs) may cause sexual dysfunction (see section 4).

In some cases, these symptoms have persisted after stopping treatment.

Children and adolescents

Efectin ER should not be used in children and adolescents under 18 years of age.

It is also important to note that patients under 18 years of age who take medicines of this class are at increased risk of side effects, such as suicidal thoughts, suicidal attempts, and hostility (especially aggression, rebelliousness, and anger).

However, your doctor may prescribe this medicine for patients under 18 years of age if they consider it necessary.

If your doctor has prescribed this medicine for a patient under 18 years of age, and you have any concerns, you should discuss them with your doctor.

Tell your doctor if any of these symptoms occur or worsen in patients under 18 years of age taking Efectin ER.

Long-term safety data on growth, maturation, and cognitive and behavioral development in this age group are not available.

Efectin ER and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

Your doctor will decide whether you can take Efectin ER with other medicines.

Do not start or stop taking any other medicines, including those available without a prescription, herbal products, or dietary supplements, without first talking to your doctor or pharmacist.

• Irreversible monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease must not be taken with Efectin ER. Tell your doctor if you have taken these medicines within the last 14 days (see section "Before you take Efectin ER").
• Serotonin syndrome: During treatment with venlafaxine, a potentially life-threatening condition or neuroleptic malignant syndrome (see section "Possible side effects") may occur, especially when taken with other medicines.

Examples of such medicines include:

• triptans (used to treat migraine headaches),
• other medicines used to treat depression, such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, or lithium,
• medicines containing amphetamine derivatives (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity),
• medicines containing the antibiotic linezolid (used to treat infections),
• medicines containing the MAOI inhibitor moclobemide (used to treat depression),
• medicines containing sibutramine (used for weight loss),
• medicines containing opioids (such as buprenorphine, tramadol, fentanyl, tapentadol, pethidine, or pentazocine) used to treat severe pain,
• medicines containing dextromethorphan (used to treat cough),
• medicines containing methadone (used to treat opioid dependence or severe pain),
• medicines containing methylene blue (used to treat high levels of methemoglobin in the blood),
• medicines containing St. John's Wort (Hypericum perforatum, herbal products or dietary supplements, used to treat mild depression),
• medicines containing tryptophan (used for sleep problems and depression),
• antipsychotic medicines (used to treat conditions with symptoms such as hearing, seeing, or feeling things that are not there, delusions, unnatural suspicion, unclear thinking, and withdrawal).

Signs and symptoms of serotonin syndrome may include:

• restlessness,
• hallucinations,
• loss of coordination,
• rapid heart rate,
• increased body temperature,
• rapid changes in blood pressure,
• overreactivity,
• diarrhea,
• coma,
• nausea,
• vomiting.

The most severe form of serotonin syndrome can resemble neuroleptic malignant syndrome.

Signs and symptoms of neuroleptic malignant syndrome may include:

• fever,
• rapid heart rate,
• sweating,
• stiff muscles,
• confusion,
• increased levels of muscle enzymes (detected in blood tests).

If you suspect serotonin syndrome, contact your doctor or go to the emergency room immediately.

If you are taking medicines that may affect your heart rhythm, tell your doctor.

Examples of such medicines include:

• anti-arrhythmic medicines, such as quinidine, amiodarone, sotalol, or dofetilide (used to treat irregular heart rhythms),
• antipsychotic medicines, such as thioridazine (see above - serotonin syndrome),
• antibiotics, such as erythromycin or moxifloxacin (used to treat bacterial infections),
• antihistamines (used to treat allergies).

The following medicines may also interact with Efectin ER, and therefore should be used with caution:

• ketoconazole (an antifungal medicine),
• haloperidol or risperidone (medicines used to treat mental disorders),
• metoprolol (a beta-blocker used to treat high blood pressure and heart conditions).

Taking Efectin ER with food, drink, and alcohol

Efectin ER should be taken with food (see section 3 "How to take Efectin ER").

Do not drink alcohol while taking Efectin ER.

Drinking alcohol may cause extreme tiredness and loss of consciousness, and may worsen symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Efectin ER should only be used during pregnancy if the potential benefits outweigh the potential risks to the unborn child.

Taking Efectin ER in the last month of pregnancy may increase the risk of severe bleeding after delivery, especially if you have a history of bleeding disorders.

If you are taking Efectin ER and become pregnant, tell your doctor or midwife so they can give you appropriate advice.

Similar medicines (SSRIs) taken during pregnancy may increase the risk of a serious condition in children called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and bluish skin.

These symptoms usually occur within 24 hours of birth.

If you notice these symptoms in your child, contact your midwife and/or doctor immediately.

If you are taking this medicine during pregnancy, after delivery, your child may experience difficulty breathing, in addition to other symptoms such as poor feeding.

If you are concerned about these symptoms in your newborn, contact your doctor and/or midwife for advice.

Efectin ER passes into breast milk.

There is a risk of affecting the baby.

Therefore, discuss this with your doctor, who will decide whether you should stop breastfeeding or stop treatment with Efectin ER.

Driving and using machines

Do not drive or operate machinery until you know how this medicine affects you.

Efectin ER 150 contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which is essentially "sodium-free".

3. How to take Efectin ER

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 depression, generalized anxiety disorder, social anxiety disorder is 75 mg once daily.

Your doctor may gradually increase the dose if necessary, up to a maximum dose of 375 mg once daily for depression.

For panic disorder, treatment should start with a lower dose (37.5 mg) and gradually increase as needed.

The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg once daily.

Efectin ER should be taken at approximately the same time each day, either in the morning or evening.

Swallow the capsules whole with a drink of water.

Do not divide, crush, chew, or dissolve them.

Efectin ER should be taken with food.

Tell your doctor if you have liver or kidney problems, as you may need a dose adjustment.

Do not stop taking this medicine without talking to your doctor (see section "Stopping treatment with Efectin ER").

If you take more Efectin ER than you should

If you have taken more Efectin ER than you should, contact your doctor or go to the emergency room immediately.

Overdose can be life-threatening, especially when taken with alcohol and/or other medicines (see section "Efectin ER and other medicines").

Symptoms of overdose may include:

• rapid heart rate,
• altered consciousness (ranging from drowsiness to coma),
• visual disturbances,
• seizures,
• vomiting.

If you forget to take Efectin ER

If you miss a dose, take it as soon as you remember.

However, if it is almost time for your next dose, skip the missed dose and take only your regular dose at the usual time.

Do not take a double dose to make up for a forgotten dose.

Do not take more than the prescribed dose in a 24-hour period.

Stopping treatment with Efectin ER

Do not stop treatment or reduce the dose without talking to your doctor, even if you feel better.

If your doctor decides that you can stop taking Efectin ER, they will tell you how to gradually reduce the dose before stopping treatment completely.

When stopping treatment, especially after sudden discontinuation or too rapid dose reduction, some patients may experience side effects, such as:

• suicidal thoughts,
• aggressive behavior,
• fatigue,
• dizziness,
• headache,
• insomnia,
• nightmares,
• dry mouth,
• loss of appetite,
• nausea,
• diarrhea,
• nervousness,
• restlessness,
• confusion,
• ringing in the ears,
• tingling or numbness,
• weakness,
• sweating,
• seizures,
• flu-like symptoms,
• visual disturbances,
• increased blood pressure (which may cause headaches, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you on how to gradually stop taking Efectin ER.

This may take several weeks or months.

In some patients, it may be necessary to taper off the medicine very slowly over a period of several months or longer.

If you experience any of these symptoms or other symptoms that are bothersome, talk to your doctor.

4. Possible side effects

Like all medicines, Efectin ER can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking Efectin ER and contact your doctor or go to the emergency room immediately:

Uncommon (may affect up to 1 in 100 people)

• swelling of the face, lips, tongue, throat, hands, or feet, and/or a raised, itchy rash (hives), difficulty swallowing or breathing.

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

• chest pain, wheezing, difficulty swallowing or breathing.
• severe skin rash, itching, or hives (angioedema), which may be accompanied by swelling of the face, lips, tongue, or throat.
• symptoms of serotonin syndrome (see section "Efectin ER and other medicines"), which may include restlessness, hallucinations, loss of coordination, rapid heart rate, increased body temperature, rapid changes in blood pressure, overreactivity, diarrhea, coma, nausea, vomiting.
• symptoms of infection, such as high fever, chills, shivering, headache, sweating, flu-like symptoms, which may be a sign of a blood disorder that increases the risk of infection.
• severe skin rash, which may lead to severe blistering and peeling of the skin.
• muscle pain, tenderness, or weakness, which may be symptoms of a condition called rhabdomyolysis.

Frequency not known (cannot be estimated from the available data)

• symptoms of a condition called takotsubo cardiomyopathy (or "broken heart syndrome"), including chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.

If you experience any of the following side effects, contact your doctor:

• cough, wheezing, and shortness of breath, which may be accompanied by a high fever.
• black (tar-like) stools or blood in the stool, which may be a sign of internal bleeding.
• itching, yellowing of the skin or whites of the eyes, or dark urine, which may be symptoms of liver inflammation.
• heart problems, such as rapid or irregular heartbeat, high blood pressure.
• vision problems, such as blurred vision, dilated pupils.
• nervous system problems, such as dizziness, tingling, seizures, or convulsions.
• psychiatric problems, such as excessive restlessness and feeling unnatural excitement.
• withdrawal symptoms (see sections "How to take Efectin ER" and "Stopping treatment with Efectin ER").
• prolonged bleeding time - if you cut yourself, the wound may bleed for longer than usual.

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

• dizziness; headache; drowsiness
• insomnia
• nausea; dry mouth; constipation
• sweating (including night sweats)

Common (may affect up to 1 in 10 people)

• decreased appetite
• disorientation; feeling detached from oneself; lack of orgasm; decreased libido; restlessness; nervousness; unusual dreams
• tremors; feeling restless or unable to sit or stand still; tingling; taste disturbances; increased muscle tone
• vision problems, including blurred vision, dilated pupils
• ringing in the ears (tinnitus)
• rapid heartbeat; palpitations
• increased blood pressure; flushing
• shortness of breath; yawning
• vomiting; diarrhea
• mild rash; itching
• increased frequency of urination; urinary retention; difficulty urinating
• irregular menstrual periods, such as heavy bleeding or more frequent irregular bleeding; ejaculation or orgasm disorders (men); erectile dysfunction (impotence)
• weakness; fatigue; chills
• weight gain; weight loss
• increased cholesterol levels in the blood

Uncommon (may affect up to 1 in 100 people)

• excessive excitement, racing thoughts, and reduced need for sleep (mania)
• hallucinations; feeling detached from reality; orgasm disorders; apathy; excessive excitement; teeth grinding
• fainting; uncontrolled muscle movements; coordination and balance problems
• dizziness (especially when standing up too quickly); decreased blood pressure
• vomiting blood; black (tar-like) stools or blood in the stool, which may be a sign of internal bleeding
• increased sensitivity to light; bruising; excessive hair loss
• urinary incontinence
• stiffness, muscle spasms, and uncontrolled muscle movements
• slight changes in liver enzyme activity in the blood

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

• seizures
• cough, wheezing, and shortness of breath, which may be accompanied by a high fever
• confusion and disorientation, often with hallucinations (delirium)
• excessive water retention in the body
• low sodium levels in the blood
• severe eye pain and decreased vision or blurred vision
• abnormal, rapid, or irregular heartbeat, which may lead to fainting
• severe abdominal or back pain (which may indicate serious problems with the intestines, liver, or pancreas)
• itching, yellowing of the skin or whites of the eyes, dark urine, or flu-like symptoms, which may be symptoms of liver inflammation

Very rare (may affect up to 1 in 10,000 people)

• prolonged bleeding, which may be a sign of a low platelet count, increasing the risk of bruising or bleeding
• unusual milk production in women
• unexpected bleeding, such as bleeding from the gums, blood in the urine or stool, or unexplained bruising or bleeding under the skin

Frequency not known (cannot be estimated from the available data)

• suicidal thoughts and behaviors; during treatment with venlafaxine or shortly after stopping treatment, there have been reports of suicidal thoughts and behaviors (see section "Before you take Efectin ER")
• aggressive behavior
• dizziness
• severe bleeding after delivery (postpartum hemorrhage), see additional information in section "Pregnancy and breastfeeding"

Efectin ER may also cause side effects that you may not be aware of, such as increased blood pressure or abnormal heart rhythm; slight changes in liver enzyme activity, sodium, or cholesterol levels in the blood.

In rare cases, Efectin ER may affect the function of platelets, increasing the risk of bleeding or bruising.

Therefore, your doctor may recommend regular blood tests, especially during long-term treatment with Efectin ER.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist.

Side effects can be reported to the national reporting system via the website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder or its representative.

Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Efectin ER

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after EXP.

The expiry date refers to the last day of that month.

Store below 30°C.

Do not throw away any medicines via wastewater or household waste.

Ask your pharmacist how to throw away medicines you no longer use.

These measures will help protect the environment.

6. Contents of the pack and other information

What Efectin ER contains

The active substance is venlafaxine.

Efectin ER 37.5

Each prolonged-release hard capsule contains 42.43 mg of venlafaxine hydrochloride, equivalent to 37.5 mg of venlafaxine.

Other ingredients:

• capsule content: microcrystalline cellulose, ethylcellulose 50 cps, hypromellose 3 cps, hypromellose 6 cps, talc
• capsule shell: gelatin, iron oxide black, red, and yellow (E 172), titanium dioxide (E 171)
• printing ink: shellac, iron oxide red (E 172), ammonium hydroxide, simethicone, propylene glycol

Efectin ER 75

Each prolonged-release hard capsule contains 84.85 mg of venlafaxine hydrochloride, equivalent to 75 mg of venlafaxine.

Other ingredients:

• capsule content: microcrystalline cellulose, ethylcellulose 50 cps, hypromellose 3 cps, hypromellose 6 cps, talc
• capsule shell: gelatin, iron oxide red and yellow (E 172), titanium dioxide (E 171)
• printing ink: shellac, iron oxide red (E 172), ammonium hydroxide, simethicone, propylene glycol

Efectin ER 150

Each prolonged-release hard capsule contains 169.7 mg of venlafaxine hydrochloride, equivalent to 150 mg of venlafaxine.

Other ingredients:

• capsule content: microcrystalline cellulose, ethylcellulose 50 cps, hypromellose 3 cps, hypromellose 6 cps, talc
• capsule shell: gelatin, iron oxide red and yellow (E 172), titanium dioxide (E 171)
• printing ink: shellac, sodium hydroxide (see section "Efectin ER 150 contains sodium"), povidone, titanium dioxide (E 171), propylene glycol

What Efectin ER looks like and contents of the pack

Efectin ER 37.5 are gray and peach-colored, size 15.9 mm x 5.82 mm, with a red imprint "W" and "37.5".

Efectin ER 37.5 is available in:

• blister packs of 7, 10, 14, 20, 21, 28, 30, 35, 50, 60, 100, and hospital packs of 70 (10x7, 1x70) capsules
• single-dose blister packs of 14, 28, 84, 100 capsules
• HDPE bottles of 7, 14, 20, 21, 35, 50, 100, and hospital packs of 70 capsules

Efectin ER 75 are peach-colored, size 19.4 mm x 6.91 mm, with a red imprint "W" and "75".

Efectin ER 75 is available in:

• blister packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 98, 100, and hospital packs of 500 (10x50) and 1000 (10x100) capsules
• single-dose blister packs of 14, 28, 84, 100 capsules
• HDPE bottles of 14, 20, 50, 100, and hospital packs of 500 and 1000 capsules

Efectin ER 150 are dark orange, size 23.5 mm x 7.65 mm, with a white imprint "W" and "150".

Efectin ER 150 is available in:

• blister packs of 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 98, 100, and hospital packs of 500 (10x50) and 1000 (10x100) capsules
• single-dose blister packs of 14, 28, 84, 100 capsules
• HDPE bottles of 14, 20, 50, 100, and hospital packs of 500 and 1000 capsules

Pack sizes available in Poland:

• Efectin ER 37.5 - 10 or 30 capsules
• Efectin ER 75 - 14, 28, 30, or 100 capsules
• Efectin ER 150 - 14, 28, 30, or 100 capsules

Not all pack sizes may be available.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Upjohn EESV

Rivium Westlaan 142

2909 LD Capelle aan den IJssel

Netherlands

Manufacturer:

Pfizer Ireland Pharmaceuticals

Little Connell

Newbridge

Co. Kildare

Ireland

Pfizer Manufacturing Deutschland GmbH

Betriebsstätte Freiburg

Mooswaldallee 1

D-79090 Freiburg

Germany

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

*[Not all of these medicines and strengths may be available.]
For more information on this medicine, contact the local representative of the marketing authorization holder:

Mylan Healthcare Sp. z o.o.

tel: 22 546 64 00
Date of last revision of the leaflet:07/2023