PREFAXINE 75 mg Capsules

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
   1. Prefaxine, 75 mg, prolonged-release hard capsules
   2. Prefaxine, 150 mg, prolonged-release hard capsules
   3. It is essential to carefully read the contents of the leaflet before taking the medication, as it contains important information for the patient.
   4. Table of contents of the leaflet
2. What is Prefaxine and what is it used for
3. Important information before taking Prefaxine
   1. When not to take Prefaxine:
   2. Children and adolescents
   3. Prefaxine and other medications
   4. In case of suspected serotonin syndrome, the patient should immediately inform their doctor or go to the emergency room.
   5. Prefaxine with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and operating machinery
4. How to take Prefaxine
   1. Taking a higher dose of Prefaxine than recommended
   2. Missing a dose of Prefaxine
   3. Stopping Prefaxine treatment
5. Possible side effects
   1. Allergic reactions
   2. Full list of side effects
   3. Very common (occurring in more than 1 in 10 patients)
   4. Common (occurring in 1 to 10 patients in 100)
   5. Uncommon (occurring in 1 to 10 patients in 1,000)
   6. Rare (occurring in 1 to 10 patients in 10,000)
   7. Frequency not known (frequency cannot be estimated from available data)
   8. Reporting side effects
6. How to store Prefaxine
7. Contents of the packaging and other information
   1. What Prefaxine contains
   2. What Prefaxine looks like and contents of the packaging
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Prefaxine, 37.5 mg, prolonged-release hard capsules

Prefaxine, 75 mg, prolonged-release hard capsules

Prefaxine, 150 mg, prolonged-release hard capsules

Venlafaxine

It is essential to carefully read the contents of the leaflet before taking the medication, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medication has been prescribed to a specific individual. It should not be given to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Prefaxine and what is it used for
• 2. Important information before taking Prefaxine
• 3. How to take Prefaxine
• 4. Possible side effects
• 5. How to store Prefaxine
• 6. Contents of the packaging and other information

1. What is Prefaxine and what is it used for

Prefaxine is an antidepressant medication belonging to a group of medications called serotonin and norepinephrine reuptake inhibitors (SNRIs). Medications in this group are used to treat depression and other conditions, such as anxiety disorders. It is believed that people with depression and/or anxiety have lower levels of serotonin and norepinephrine in the brain. The mechanism of action of antidepressant medications is not fully understood, but they may help by increasing the levels of serotonin and norepinephrine in the brain.

Prefaxine is used to treat depression in adults. Prefaxine is also indicated for the treatment of the following anxiety disorders in adults: generalized anxiety disorder, social phobia (fear or avoidance of social situations), and panic disorder (panic attacks). 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 undergo treatment, their condition may not improve, may worsen, and will be more difficult to treat.

2. Important information before taking Prefaxine

When not to take Prefaxine:

• if the patient is allergic to venlafaxine or any of the other ingredients of this medication (listed in section 6);
• if the patient is taking or has taken within the last 14 days any irreversible monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease. Taking irreversible MAOIs simultaneously with other medications, including Prefaxine, may cause severe or life-threatening side effects. Also, before starting to take any MAOI medication, the patient should wait at least 7 days after stopping Prefaxine (see also "Prefaxine and other medications" and "Serotonin syndrome").

Before starting Prefaxine, the patient should discuss the following with their doctor or pharmacist:

• if the patient is taking other medications, such as buprenorphine (an opioid medication used to treat acute or chronic pain), which may increase the risk of serotonin syndrome when taken with Prefaxine (see "Prefaxine and other medications");
• if the patient has eye diseases, such as certain types of glaucoma (increased pressure in the eyeball);
• if the patient has a history of high blood pressure;
• if the patient has a history of heart disease;
• if the patient has a history of heart rhythm disorders;
• if the patient has a history of seizures (epilepsy);
• if the patient has a history of decreased sodium levels in the blood (hyponatremia);
• if the patient has a tendency to bruise or bleed (history of bleeding disorders), or if they are taking other medications that may increase the risk of bleeding, such as warfarin (used as an anticoagulant), or if the patient is pregnant (see "Pregnancy and breastfeeding");
• if the patient has high cholesterol levels;
• if the patient or any of their family members have a history of mania or bipolar disorder (feeling excessively excited or euphoric);
• if the patient has a history of aggressive behavior.

Prefaxine may cause feelings of restlessness or inability to sit or stand still. If such symptoms occur, the patient should inform their doctor.

Medications like Prefaxine (SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was discontinued.

The patient should consult their doctor before starting Prefaxine if any of the above conditions apply to them.

Suicidal thoughts and worsening of depression or anxiety

People with depression and/or anxiety may sometimes think about self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressant medications, as these medications usually start working after 2 weeks, sometimes later.

The occurrence of suicidal thoughts, self-harm, or suicidal behavior is more likely if:

• the patient has had suicidal thoughts or self-harm in the past;
• the patient is a young adult; clinical trial data indicate an increased risk of suicidal behavior in people under 25 years old with mental disorders who were treated with antidepressant medications.

If the patient experiences suicidal thoughts or self-harm, they should immediately contact their doctor or go to the emergency room.

It may be helpful to inform family members or friends about the depression or anxiety and ask them to read this leaflet. The patient may ask their family members or friends for help and ask them to inform the patient if they notice that the depression or anxiety has worsened or if there are any concerning changes in behavior.

Dry mouth

Dry mouth is reported by 10% of patients treated with venlafaxine. This may increase the risk of tooth decay. Therefore, it is essential to take good care of oral hygiene.

Diabetes

Prefaxine may affect blood sugar levels. Therefore, it may be necessary to adjust the dosage of antidiabetic medications.

Effect on urine screening tests

False-positive results in immunological screening tests for phencyclidine and amphetamine in urine have been reported in patients taking venlafaxine.

Children and adolescents

Prefaxine should not be used in children and adolescents under 18 years of age. It should also be noted that patients under 18 years of age who take medications in this group are at increased risk of adverse reactions, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and expressions of anger). However, the doctor may prescribe this medication to patients under 18 years of age if they consider it beneficial. If the doctor prescribes this medication to a patient under 18 years of age, in case of any doubts, the patient should consult their doctor to discuss it. The patient should inform their doctor if any of the above symptoms occur or worsen in patients under 18 years of age taking Prefaxine.

Long-term safety regarding the effect on growth, maturation, and development of cognitive and behavioral functions in this age group has not been established.

Prefaxine and other medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.

The doctor will decide whether to use Prefaxine with other medications.

The patient should not start or stop taking other medications, including over-the-counter medications, herbal or natural products, without consulting their doctor or pharmacist.

• Monoamine oxidase inhibitors used to treat depression or Parkinson's disease should not be taken with Prefaxine. The patient should tell their doctor if they have taken these medications within the last 14 days (MAOIs; see section 2, "Important information before taking Prefaxine");
• Serotonin syndrome: During treatment with venlafaxine, a potentially life-threatening condition called serotonin syndrome may occur (see section 4, "Possible side effects"), especially when taken with medications such as:
• triptans (used to treat migraine headaches);
• medications used to treat depression, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, or medications containing lithium;
• medications containing the antibiotic linezolid (used to treat infections);
• medications containing the reversible MAOI moclobemide (used to treat depression);
• medications containing sibutramine (used for weight loss);
• medications containing tramadol, fentanyl, tapentadol, pethidine, pentazocine, or buprenorphine (used to treat severe pain);
• medications containing dextromethorphan (used to treat cough);
• medications containing methadone (used to treat opioid addiction or severe pain);
• medications containing methylene blue (used to treat high levels of methemoglobin in the blood);
• medications containing St. John's Wort (Hypericum perforatum) - herbal or natural products used to treat mild depression;
• medications containing tryptophan (used to treat sleep disorders and depression);
• antipsychotic medications (used to treat conditions with symptoms such as hearing, seeing, or feeling things that do not exist, delusions, unnatural suspiciousness, unclear reasoning, and withdrawal).

Subjective and objective symptoms of serotonin syndrome may include: restlessness, hallucinations, loss of coordination, rapid heart rate, elevated body temperature, rapid changes in blood pressure, overreactivity, diarrhea, coma, nausea, vomiting.

The most severe form of serotonin syndrome may resemble malignant neuroleptic syndrome. Its subjective and objective symptoms include: fever, rapid heart rate, sweating, muscle stiffness, disorientation, increased levels of muscle enzymes (detected in blood tests).

In case of suspected serotonin syndrome, the patient should immediately inform their doctor or go to the emergency room.

If the patient is taking medications that may affect heart rhythm, they should inform their doctor.

Examples of such medications:

• antiarrhythmic medications, such as quinidine, amiodarone, sotalol, or dofetilide (used to treat heart rhythm disorders).
• Antipsychotic medications, such as thioridazine (see above - serotonin syndrome).
• Antibiotics, such as erythromycin or moxifloxacin (used to treat bacterial infections).
• Antihistamine medications (used to treat allergies).

The following medications may also interact with Prefaxine and should be used with caution. It is especially important to inform the doctor if the patient is taking medications containing:

• ketokonazole (an antifungal medication);
• haloperidol or risperidone (medications used to treat mental disorders);
• metoprolol (a beta-blocker used to treat high blood pressure and heart disease);
• oral contraceptives.

Prefaxine with food, drink, and alcohol

Prefaxine should be taken with food (see section 3, "How to take Prefaxine").

The patient should not drink alcohol while taking Prefaxine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.

Prefaxine should only be used after discussing the potential benefits and risks with the doctor.

The patient should inform their doctor and/or midwife about taking Prefaxine. Taking medications with similar effects (SSRIs) during pregnancy may increase the risk of a severe condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN). This condition is characterized by rapid breathing and blue discoloration. Symptoms usually appear within 24 hours of birth. If such symptoms occur in the newborn, the patient should immediately contact their doctor and/or midwife.

If the patient takes this medication during pregnancy, the following symptoms may occur in the baby after birth: poor feeding and breathing difficulties. If the patient is concerned about such symptoms after the baby is born, they should contact their doctor and/or midwife, who will be able to provide appropriate advice.

Taking Prefaxine at the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Prefaxine, they should inform their doctor or midwife so that they can provide appropriate advice.

Prefaxine passes into breast milk. There is a risk of affecting the baby. Therefore, the patient should discuss this with their doctor, who will decide whether to stop breastfeeding or discontinue Prefaxine treatment.

Driving and operating machinery

The patient should not drive or operate machinery until they know how the medication affects them.

The medication contains less than 1 mmol (23 mg) of sodium per capsule, which means it is considered "sodium-free".

3. How to take Prefaxine

This medication should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

The usual recommended initial dose for the treatment of depression and social phobia is 75 mg per day.

This dose may be gradually increased by the doctor if necessary, up to a maximum dose of 375 mg per day for the treatment of depression. The maximum dose for the treatment of social phobia is 225 mg per day.

Prefaxine should be taken daily at approximately the same time, regardless of whether the medication is taken in the morning or evening. The capsules should be swallowed whole with a drink.

They should not be opened, crushed, chewed, or dissolved.

Prefaxine should be taken with food.

The patient should inform their doctor about any liver or kidney diseases, as it may be necessary to adjust the dose.

The patient should not stop taking Prefaxine without consulting their doctor (see "Stopping Prefaxine treatment").

Taking a higher dose of Prefaxine than recommended

In case of taking a higher dose of Prefaxine than recommended, the patient should immediately contact their doctor.

Symptoms of possible overdose may include: rapid heart rate, changes in consciousness (from drowsiness to coma), vision disturbances, seizures, and vomiting.

Missing a dose of Prefaxine

In case of missing a dose, the patient should take it as soon as possible. However, if it is close to the time for the next dose, the patient should skip the missed dose and take only one dose at the usual time. The patient should not take a higher dose than the daily dose of Prefaxine prescribed by the doctor in one day.

Stopping Prefaxine treatment

The patient should not stop treatment or reduce the dose without consulting their doctor, even if they feel better. If the doctor decides that it is possible to discontinue Prefaxine, they will inform the patient how to gradually reduce the dose before completely stopping treatment. In patients who stop taking Prefaxine, especially if treatment is stopped abruptly or the dose is reduced too quickly, side effects may occur, such as feeling tired, dizziness, feeling empty-headed, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, disorientation, ringing in the ears, tingling or numbness, weakness, sweating, seizures, or flu-like symptoms.

The doctor will inform the patient how to gradually discontinue Prefaxine. If any of the above symptoms occur or worsen, the patient should consult their doctor.

In case of any further doubts about taking this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Prefaxine can cause side effects, although not everyone will experience them.

Allergic reactions

In case of any of the following side effects, the patient should stop taking Prefaxine and immediately contact their doctor or go to the emergency room:

• chest tightness, wheezing, difficulty swallowing or breathing;
• swelling of the face, throat, hands, or feet;
• feeling anxious or restless, dizziness, feeling pulsating, sudden flushing of the skin, and/or feeling warm;
• severe rash, itching, hives (swelling with red or pale color, often accompanied by itching);
• symptoms of serotonin syndrome: restlessness, hallucinations, loss of coordination, rapid heart rate, elevated body temperature, rapid changes in blood pressure, overreactivity, diarrhea, coma, nausea, vomiting. The most severe form of serotonin syndrome may resemble malignant neuroleptic syndrome. Symptoms of malignant neuroleptic syndrome may include: fever, rapid heart rate, sweating, muscle stiffness, disorientation, increased levels of muscle enzymes (detected in blood tests).

In case of any of the following side effects, the patient should contact their doctor:

• cough, wheezing, shortness of breath, and high fever;
• black (tar-like) stools or blood in stools;
• yellowing of the skin or whites of the eyes, itching, or dark urine, which may be symptoms of liver inflammation;
• heart rhythm disorders, such as rapid or irregular heart rate, high blood pressure;
• vision disturbances, such as blurred vision, dilated pupils;
• nervous system disorders, such as dizziness, feeling tingling, coordination disorders, seizures, or convulsions;
• psychiatric disorders, such as excessive restlessness and euphoria (feeling unnatural excitement);
• withdrawal symptoms (see sections "How to take Prefaxine" and "Stopping Prefaxine treatment");
• prolonged bleeding time - in case of injury, the time it takes for bleeding to stop may be slightly longer than usual.

Full list of side effects

Very common (occurring in more than 1 in 10 patients)

• dizziness, headache;
• nausea, dry mouth;
• sweating (including night sweats).

Common (occurring in 1 to 10 patients in 100)

• decreased appetite;
• disorientation; feeling detached (or separated) from oneself; lack of orgasm; decreased libido; nervousness; insomnia; unusual dreams;
• drowsiness; tremors; tingling; increased muscle tension;
• vision disturbances, including blurred vision; dilated pupils; inability of the eye to accommodate (automatically change focus from distant to near objects);
• ringing in the ears (tinnitus);
• palpitations;
• increased blood pressure; sudden flushing;
• yawning;
• vomiting; constipation; diarrhea;
• increased frequency of urination; difficulty urinating;
• abnormal menstrual bleeding, such as heavy or more frequent irregular bleeding; ejaculation or orgasm disorders (men); erectile dysfunction (impotence);
• weakness (asthenia); fatigue;
• increased cholesterol levels in the blood.

Uncommon (occurring in 1 to 10 patients in 1,000)

• hallucinations; feeling detached (or separated) from reality; agitation; orgasm disorders (women); apathy; feeling excessively excited; teeth grinding;
• feeling restless or unable to sit or stand still; fainting; uncontrolled muscle movements; coordination disorders; taste disturbances;
• rapid heart rate; dizziness (especially when standing up too quickly);
• shortness of breath;
• vomiting blood; black (tar-like) stools or blood in stools, which may be signs of internal bleeding;
• generalized skin swelling, especially of the face, lips, tongue, throat, or hands and feet, and/or the occurrence of a bulging, itchy rash; sensitivity to light; bruising; rash; excessive hair loss;
• urinary retention;
• weight gain; weight loss.

Rare (occurring in 1 to 10 patients in 10,000)

• seizures;
• urinary incontinence;
• excessive excitement, racing thoughts, and decreased need for sleep (mania).

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

• decreased platelet count, which may increase the risk of bruising or bleeding; blood disorders that may increase the risk of infection;
• severe postpartum hemorrhage (see additional information in subsection "Pregnancy and breastfeeding" in section 2);
• swelling of the face or tongue, difficulty breathing, or rash (may indicate a severe allergic reaction);
• syndrome of inappropriate antidiuretic hormone secretion (SIADH);
• decreased sodium levels in the blood;
• suicidal thoughts and behaviors; during treatment with venlafaxine or shortly after discontinuation, cases of suicidal thoughts and behaviors have been reported (see section 2, "Important information before taking Prefaxine");
• disorientation with frequent hallucinations (delirium); aggressive behavior;
• high fever with muscle stiffness, disorientation, or agitation, and/or uncontrolled muscle movements, which may be symptoms of a severe condition called malignant neuroleptic syndrome; feeling euphoric, drowsy, persistent rapid eye movements, clumsiness, restlessness, feeling drunk, sweating, or muscle stiffness, which are symptoms of serotonin syndrome; stiffness, muscle spasms, and uncontrolled muscle movements;
• severe eye pain and vision disturbances or blurred vision;
• dizziness;
• decreased blood pressure; abnormal, rapid, or irregular heart rate, which may cause fainting; unexpected bleeding, such as bleeding from the gums, blood in urine or vomit, or unexpected appearance of bruises or broken blood vessels (broken veins);
• cough, wheezing, shortness of breath, and high fever, which may be symptoms of pneumonia associated with an increased number of white blood cells in the blood (eosinophilic pneumonia);
• severe abdominal or back pain (which may indicate serious intestinal, liver, or pancreatic problems);
• itching, yellowing of the skin or whites of the eyes, dark urine, which may be symptoms of liver inflammation; flu-like symptoms;
• skin rash that may lead to blistering and peeling; itching; mild rash;
• unexplained muscle pain, tenderness, or weakness (rhabdomyolysis);
• abnormal milk secretion in women.

Prefaxine may sometimes cause side effects that the patient is not aware of, such as increased blood pressure or abnormal heart rate, minor changes in liver enzyme levels, sodium, or cholesterol levels in the blood. In rare cases, Prefaxine may affect platelet function, leading to an increased risk of bruising or bleeding.

Therefore, the doctor will periodically recommend blood tests, especially in case of long-term use of Prefaxine.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C

02-222 Warsaw

Tel.: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

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

By reporting side effects, it will be possible to gather more information on the safety of the medication.

5. How to store Prefaxine

The medication should be stored out of sight and reach of children.

The patient should not use this medication after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.

The inscription on the packaging after the abbreviation EXP indicates the expiration date, and after the abbreviation Lot/LOT, it indicates the batch number.

The medication should not be stored at temperatures above 30°C.

Medications should not be disposed of in wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the packaging and other information

What Prefaxine contains

• The active substance of Prefaxine is venlafaxine. Each prolonged-release hard capsule contains 37.5 mg, 75 mg, or 150 mg of venlafaxine (as venlafaxine hydrochloride).
• Other ingredients are: 37.5 mg prolonged-release hard capsules: capsule contents: hypromellose, ammonio methacrylate copolymer (type B), sodium lauryl sulfate, magnesium stearate; capsule shell: methacrylic acid - ethyl acrylate copolymer (1:1); capsule shell: gelatin, titanium dioxide (E171); ink: shellac, iron oxide black (E172), propylene glycol (E1520).

75 mg prolonged-release hard capsules:

capsule contents: hypromellose, ammonio methacrylate copolymer (type B), sodium lauryl sulfate, magnesium stearate;

capsule shell: methacrylic acid - ethyl acrylate copolymer (1:1);

capsule shell: gelatin, titanium dioxide (E171), iron oxide red (E172);

ink: shellac, iron oxide black (E172), propylene glycol (E1520).

150 mg prolonged-release hard capsules:

capsule contents: hypromellose, ammonio methacrylate copolymer (type B), sodium lauryl sulfate, magnesium stearate;

capsule shell: methacrylic acid - ethyl acrylate copolymer (1:1);

capsule shell: gelatin, titanium dioxide (E171), erythrosine (E127), indigo carmine (E132);

ink: shellac, iron oxide black (E172), propylene glycol (E1520).

What Prefaxine looks like and contents of the packaging

37.5 mg prolonged-release hard capsules: white, opaque, hard gelatin capsules (size 0) with the inscription VEN on the cap and 37.5 on the body, containing one round, biconvex, film-coated tablet.

75 mg prolonged-release hard capsules: pink, opaque, hard gelatin capsules (size 0) with the inscription VEN on the cap and 75 on the body, containing two round, biconvex, film-coated tablets.

150 mg prolonged-release hard capsules: scarlet, opaque, hard gelatin capsules (size 00) with the inscription VEN on the cap and 150 on the body, containing three round, biconvex, film-coated tablets.

Packaging contains 28 prolonged-release hard capsules.

Marketing authorization holder and manufacturer

Polpharma S.A.

ul. Pelplińska 19, 83-200 Starogard Gdański

tel. +48 22 364 61 01

Date of last revision of the leaflet: