PREFAXINE 150 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. You should carefully read the contents of the leaflet before taking the medicine, 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 medicines
   4. In case of suspected serotonin syndrome, the patient should immediately tell their doctor or go to the emergency room.
   5. Prefaxine with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
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 the 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 pack
   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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). Medicines in this group are used to treat depression and other conditions, such as anxiety disorders. It is believed that in people with depression and/or anxiety, there is a lower concentration of serotonin and norepinephrine in the brain. The mechanism of action of antidepressants is not fully understood, but they may help by increasing the concentration 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 properly. If the patient does not undergo treatment, their condition may not improve, may worsen, and will be much 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 medicine (listed in section 6);
• if the patient is taking, or has taken within the last 14 days, any medicines known as irreversible monoamine oxidase inhibitors (IMAOs) used to treat depression or Parkinson's disease. Taking irreversible IMAOs with other medicines, including Prefaxine, can cause serious or even life-threatening side effects. Also, before starting to take any IMAO medicine, the patient should wait at least 7 days after stopping Prefaxine (see also the section "Prefaxine and other medicines", including "Serotonin syndrome").

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

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

Prefaxine may cause feelings of restlessness or inability to sit or stand still. If such symptoms occur, the patient should inform their doctor.
Medicines like Prefaxine (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was stopped.
The patient should consult their doctor before starting treatment with Prefaxine if any of the above cases apply to them.
Suicidal thoughts and worsening of depression or anxiety disorders
People with depression and/or anxiety disorders may sometimes think about self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressants, as these medicines usually start working after 2 weeks, sometimes later.
The occurrence of suicidal thoughts, self-harm thoughts, 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 of age with mental disorders who were treated with antidepressants.

If the patient experiences suicidal thoughts or self-harm thoughts, they should immediately contact their doctor or go to the emergency room.
It may be helpful to inform relatives or friends about depression or anxiety disorders and ask them to read this leaflet. The patient may ask their relatives or friends for help and ask them to inform them if they notice that depression or anxiety has worsened or if there are worrying 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, special attention should be paid to oral hygiene.
Diabetes
Prefaxine may change blood sugar levels. Therefore, it may be necessary to adjust the dosage of antidiabetic medicines.
Effect on urine screening tests
There have been reports of false-positive results in immunological screening tests for the presence of phencyclidine and amphetamine in the urine of patients taking venlafaxine.

Children and adolescents

Prefaxine should not be used in children and adolescents under 18 years of age. It should also be emphasized that patients under 18 years of age who take medicines in this group are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). However, the doctor may prescribe this medicine to patients under 18 years of age if they consider it beneficial for them. If the doctor has prescribed this medicine to a patient under 18 years of age, in case of any doubts, the patient should consult their doctor again 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.
So far, there is no evidence of long-term safety regarding the effect on growth, maturation, and development of cognitive and behavioral functions in this age group.

Prefaxine and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking, or have recently taken, and about medicines they plan to take.
The doctor will decide whether to use Prefaxine with other medicines.
The patient should not start or stop taking other medicines, including over-the-counter medicines, herbal or natural remedies, without first consulting their doctor or pharmacist.

• Irreversible 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 medicines within the last 14 days (IMAO; see section 2, "Important information before taking Prefaxine");
• Serotonin syndrome: during treatment with venlafaxine, a potentially life-threatening condition (see section 4, "Possible side effects"), known as serotonin syndrome, may occur, especially when taken with medicines such as:
• triptans (used to treat migraine headaches);
• medicines used to treat depression, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, or lithium-containing medicines;
• medicines containing the antibiotic linezolid (used to treat infections);
• medicines containing the reversible IMAO moclobemide (used to treat depression);
• medicines containing sibutramine (used for weight loss);
• medicines containing tramadol, fentanyl, tapentadol, pethidine, pentazocine, or buprenorphine (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 methemoglobin levels in the blood);
• medicines containing St. John's wort (Hypericum perforatum) - herbal or natural remedies used to treat mild depression;
• medicines containing tryptophan (used to treat sleep disorders and depression);
• antipsychotic medicines (used to treat conditions with symptoms such as hearing, seeing, or feeling things that do not exist, delusions, unnatural suspicion, unclear thinking, withdrawal).

Subjective and objective symptoms of serotonin syndrome may include: restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, hyperactivity, diarrhea, coma, nausea, vomiting.
The most severe form of serotonin syndrome may resemble malignant neuroleptic syndrome. Its subjective and objective symptoms include: fever, rapid heartbeat, sweating, muscle stiffness, disorientation, increased muscle enzyme levels (detected in blood tests).

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

If the patient is taking medicines that may affect heart rhythm, they should tell their doctor. Examples of such medicines:

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

The following medicines may also interact with Prefaxine, and therefore, the patient should take them with caution. It is especially important to inform the doctor if the patient is taking medicines containing:

• ketokonazole (an antifungal medicine);
• haloperidol or risperidone (medicines 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 medicine.
Prefaxine should only be used after discussing the potential benefits and possible risks to the unborn child with the doctor.
The patient should inform their doctor and/or midwife about taking Prefaxine. Taking medicines 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 bluish 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 medicine 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 stop Prefaxine therapy.

Driving and using machines

The patient should not drive or operate machinery until they know how the medicine affects them.
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is "sodium-free".

3. How to take Prefaxine

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Usually, the 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 once a day, at approximately the same time, regardless of whether the medicine is taken in the morning or evening. The capsules should be swallowed whole, with a drink of water.
The patient should not open, crush, chew, or dissolve them.
Prefaxine should be taken with food.
The patient should inform their doctor about any liver or kidney diseases, as there may be a need to change the dose.
The patient should not stop taking Prefaxine without consulting their doctor (see the section "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 heartbeat, disturbances of 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 almost 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 more than the prescribed daily dose of Prefaxine 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 stop Prefaxine, they will inform the patient how to gradually reduce the dose before completely stopping treatment. In patients stopping Prefaxine, especially in case of sudden stopping or too rapid dose reduction, 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 stop Prefaxine. If any of the above symptoms occur or worsen, or if the patient experiences other symptoms that are troublesome, they should consult their doctor.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Prefaxine can cause side effects, although not everybody gets 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 (red or pale swelling, often accompanied by itching);
• symptoms of serotonin syndrome: restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, hyperactivity, 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 heartbeat, sweating, muscle stiffness, disorientation, increased muscle enzyme levels (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;
• yellow skin or eye whites, itching, or dark urine, which may be signs of liver inflammation;
• heart rhythm disturbances, such as rapid or irregular heartbeat, high blood pressure;
• vision disturbances, such as blurred vision, dilated pupils;
• nervous system disturbances, such as dizziness, tingling, coordination disturbances, seizures, or convulsions;
• psychiatric disturbances, 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 bleeding time 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; trembling; 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; 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 disturbances (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 disturbances (women); apathy; feeling overly excited; teeth grinding;
• feeling restless or unable to sit or stand still; fainting; uncontrolled movements; coordination disturbances; taste disturbances;
• rapid heartbeat; 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 occurrence of a bulging, itchy rash; hypersensitivity 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 the available data)

• decreased platelet count, which may increase the risk of bruising or bleeding; blood disorders that may increase the risk of infection;
• severe vaginal bleeding occurring shortly after delivery (postpartum hemorrhage), see additional information in the subsection "Pregnancy and breastfeeding" in section 2;
• swelling of the face or tongue, difficulty breathing or shortness of breath, often with a 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 stopping treatment, there have been reports of suicidal thoughts and behaviors (see section 2, "Important information before taking Prefaxine");
• disorientation with frequent hallucinations (delirium); aggressive behavior;
• high fever with muscle stiffness, disorientation, or agitation, and sweating 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; muscle stiffness, spasms, and uncontrolled movements;
• severe eye pain and vision disturbances or blurred vision;
• dizziness;
• decreased blood pressure; abnormal, rapid, or irregular heartbeat, which may cause fainting; unexpected bleeding, such as bleeding from the gums, blood in the urine, or vomiting blood, 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 white blood cell count in the blood (eosinophilic pneumonia);
• severe abdominal or back pain (which may indicate serious intestinal, liver, or pancreatic problems);
• itching, yellow skin or eye whites, 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 rhythm, slight 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 occasionally recommend a blood test, especially in case of long-term use of Prefaxine.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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
Phone: +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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Prefaxine

The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT, it means the batch number.
The medicine should not be stored at temperatures above 30°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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, ammonium methacrylate copolymer (type B), sodium lauryl sulfate, magnesium stearate; capsule shell: methacrylic acid - ethyl acrylate copolymer (1:1); capsule shell ingredients: gelatin, titanium dioxide (E171); ink: shellac, iron oxide black (E172), propylene glycol (E1520).

75 mg prolonged-release, hard capsules:
capsule contents: hypromellose, ammonium methacrylate copolymer (type B), sodium lauryl sulfate, magnesium stearate;
capsule shell: methacrylic acid - ethyl acrylate copolymer (1:1);
capsule shell ingredients: 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, ammonium methacrylate copolymer (type B), sodium lauryl sulfate, magnesium stearate;
capsule shell: methacrylic acid - ethyl acrylate copolymer (1:1);
capsule shell ingredients: 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 pack

Prolonged-release, hard capsules 37.5 mg: white, opaque, hard gelatin capsules (size 0) with "VEN" printed on the cap and "37.5" on the body, containing one round, biconvex, film-coated tablet.
Prolonged-release, hard capsules 75 mg: peach, opaque, hard gelatin capsules (size 0) with "VEN" printed on the cap and "75" on the body, containing two round, biconvex, film-coated tablets.
Prolonged-release, hard capsules 150 mg: scarlet, opaque, hard gelatin capsules (size 00) with "VEN" printed 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.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Date of last revision of the leaflet: