Lafactin

Leaflet attached to the packaging: information for the user

Lafactin, 37.5 mg, prolonged-release hard capsules

Lafactin, 75 mg, prolonged-release hard capsules

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

1. What is Lafactin and what is it used for

Lafactin contains the active substance venlafaxine. Lafactin 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. Lafactin is used to treat depression in adults. It 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 social phobia is carried out correctly. If the treatment is not started, the patient's condition may not improve, may worsen, and will be much more difficult to treat.

2. Important information before taking Lafactin

When not to take Lafactin:

• 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 irreversible monoamine oxidase inhibitors (IMAOs) used to treat depression or Parkinson's disease. Taking irreversible IMAOs at the same time as other medicines, including Lafactin, can cause severe or life-threatening side effects. Also, before starting to take any IMAO medicine, the patient should wait at least 7 days after stopping Lafactin (see also "Serotonin syndrome" and "Lafactin and other medicines").

with IMAO, the patient should tell their doctor if they have taken these medicines in the last 14 days (IMAO; see "Important information before taking Lafactin").

Warnings and precautions

Before starting treatment with Lafactin, the patient should discuss it with their doctor or pharmacist.

• If the patient is taking other medicines that may increase the risk of serotonin syndrome when taken with Lafactin (see "Lafactin 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 heart rhythm disorders in the past.
• If the patient has had seizures (epilepsy) in the past.
• If the patient has had low 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 the patient is pregnant (see "Pregnancy, breastfeeding, and fertility"), or if they are taking medicines that may increase the risk of bleeding, such as warfarin (used to prevent blood clotting).
• If the patient or anyone in their family has had mania or bipolar disorder (feeling excessively excited or euphoric) in the past.
• If the patient has had aggressive behavior in the past.

Lafactin may cause feelings of restlessness or an inability to sit or stand still during the first few weeks of treatment. If such symptoms occur, the patient should inform their doctor. Do not drink alcohol during treatment with Lafactin, as it may cause extreme fatigue and loss of consciousness. Taking Lafactin with alcohol and/or certain medicines may worsen symptoms of depression and other conditions, such as anxiety disorders. 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 thoughts or behavior may worsen when starting to take antidepressants, as these medicines usually start to work after 2 weeks, sometimes later. These thoughts may also occur when reducing the dose or stopping Lafactin. 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 adults under 25 with mental disorders who were treated with antidepressants.

If the patient experiences suicidal thoughts or self-harm, they should immediately contact their doctor or go to the hospital. It may be helpful to inform relatives or friends about the depression or anxiety disorder and ask them to read the leaflet. The patient may ask relatives or friends for help and ask them to inform them if they notice that the 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, it is essential to take good care of oral hygiene. Diabetes Venlafaxine may affect blood sugar levels. Therefore, it may be necessary to adjust the dose of antidiabetic medicines. Sexual dysfunction Medicines like Lafactin (so-called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms may persist even after stopping treatment. Children and adolescents Lafactin 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). Nevertheless, the doctor may prescribe Lafactin to patients under 18 years of age if they consider it beneficial. If the doctor has prescribed Lafactin 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 Lafactin. So far, the long-term safety of Lafactin regarding its impact on growth, maturation, and development of cognitive and behavioral functions in this age group has not been established.

Lafactin and other medicines

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

• Irreversible monoamine oxidase inhibitors used to treat depression or Parkinson's disease should not be taken with Lafactin.The patient should tell their doctor if they have taken these medicines in the last 14 days (IMAO; see "Important information before taking Lafactin").
• Serotonin syndrome:During treatment with venlafaxine, a potentially life-threatening or neuroleptic malignant syndrome-like reaction 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 amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity)
• medicines containing linezolid, an antibiotic used to treat infections
• medicines containing reversible IMAO, moclobemide (used to treat depression)
• medicines containing sibutramine (used for weight loss)
• medicines containing 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 or natural products 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 do not exist, delusions, unnatural suspicion, unclear reasoning, and withdrawal).
• medicines containing buprenorphine. These medicines may interact with Lafactin and may cause symptoms such as involuntary, rhythmic muscle contractions, including muscles that control eye movements, agitation, hallucinations, coma, excessive sweating, tremors, increased reflexes, muscle tension, and body temperature above 38°C. If such symptoms occur, the patient should contact their doctor.

Subjective and objective symptoms of serotonin syndrome may include a combination of the following: 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 neuroleptic malignant syndrome. Its subjective and objective symptoms include fever, rapid heartbeat, sweating, muscle stiffness, disorientation, increased enzyme activity in the muscles (detected in a blood test). If serotonin syndrome is suspected, the patient should immediately contact their doctor or go to the hospital.

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

Examples of such medicines:

• Antiarrhythmic 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 Lafactin, and the patient should use them with caution. It is particularly 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).

Lafactin with food, drink, and alcohol

Lafactin should be taken with food (see section 3 "How to take Lafactin"). Do not drink alcohol during treatment with Lafactin. Taking Lafactin with alcohol may cause extreme fatigue and loss of consciousness, as well as worsen symptoms of depression and other conditions, such as anxiety disorders.

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. Lafactin should only be used after discussing the potential benefits and risks to the unborn child with the doctor. The patient should ensure that their midwife and/or doctor know that they are taking Lafactin. Similar medicines (from the SSRI group) taken by women during pregnancy may increase the risk of a severe condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and blue discoloration of the baby's skin. These symptoms usually occur in the first day of the baby's life. If this happens, the patient should immediately contact their midwife and/or doctor. If the patient takes this medicine during pregnancy, after birth, the baby may experience difficulties with breathing, as well as other symptoms, such as poor feeding. If the patient is concerned about such symptoms in their newborn, they should contact their doctor and/or midwife, who will be able to provide appropriate advice. If the patient takes Lafactin at the end of pregnancy, there may be an increased risk of severe bleeding from the vagina shortly after delivery, especially if they have had bleeding disorders in the past. The patient's doctor or midwife should know that they are taking Lafactin, so they can provide advice. Venlafaxine passes into breast milk. There is a risk of affecting the baby. Therefore, the patient should discuss this with their doctor, and the doctor will decide whether to stop breastfeeding or stop Lafactin treatment.

Driving and using machines

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

Lafactin capsules contain sucrose

If the patient has been informed by their doctor that they have an intolerance to some sugars, they should contact their doctor before taking this medicine.

Lafactin contains sodium

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

3. How to take Lafactin

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist. The usual recommended starting dose for depression, generalized anxiety disorder, 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 depression. For panic disorder, treatment should be started with a lower dose (37.5 mg) and then gradually increased. The maximum dose for generalized anxiety disorder, social phobia, and panic disorder is 225 mg per day. Lafactin should be taken daily 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. They should not be divided, crushed, chewed, or dissolved. Lafactin should be taken with food. The patient should inform their doctor about any liver or kidney problems, as there may be a need to adjust the dose. The patient should not stop taking Lafactin without consulting their doctor (see "Stopping Lafactin").

Taking a higher dose of Lafactin than recommended

If the patient has taken a higher dose of Lafactin than recommended, they should immediately contact their doctor or pharmacist. Overdose can be life-threatening, especially when taken with alcohol and/or certain medicines (see "Lafactin and other medicines"). Symptoms of possible overdose may include rapid heartbeat, changes in consciousness (from drowsiness to coma), changes in vision, seizures, or vomiting.

Missing a dose of Lafactin

If the patient misses a dose, they should take it as soon as possible. However, if it is almost time for the next dose, they should skip the missed dose and take only one dose at the usual time. The patient should not take a double dose to make up for the missed dose. The patient should not take a higher dose in one day than the daily dose of Lafactin prescribed by their doctor.

Stopping Lafactin

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 Lafactin, they will inform the patient how to gradually reduce the dose before completely stopping treatment. In patients stopping Lafactin, especially when stopping treatment abruptly or reducing the dose too quickly, side effects may occur, such as suicidal thoughts, aggression, fatigue, dizziness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, disorientation, ringing in the ears, tingling or numbness, or rarely, a feeling of electric shock, weakness, sweating, seizures, or flu-like symptoms. The doctor will advise how to gradually stop Lafactin. This may take several weeks or months. In some patients, it may be necessary to stop the medicine gradually over several months or longer. If any of the above symptoms occur 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, Lafactin can cause side effects, although not everybody gets them. If the patient experiences any of the following side effects, they should stop taking Lafactin and immediately contact their doctor or go to the hospitalemergency department:

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, hives (a raised, red or pale rash, often itchy).
• 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 neuroleptic malignant syndrome. Its symptoms may include fever, rapid heartbeat, sweating, muscle stiffness, disorientation, increased enzyme activity in the muscles (detected in a blood test).
• Symptoms of infection, such as high fever, chills, shivering, headache, sweating, flu-like symptoms. This may be due to a blood disorder that increases the risk of infection.
• Severe skin rash, which may cause large blisters and skin peeling.
• Muscle pain of unknown cause, tenderness, or weakness. These may be symptoms of rhabdomyolysis (breakdown of striated muscle).

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

• Signs and symptoms of a condition called "cardiomyopathy," which may include chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.

If the patient experiences any of the following side effects, they should contact their doctor(the frequency of these side effects is listed below in the "Other side effects" section) :

• Cough, wheezing, and shortness of breath, which may be accompanied by a high temperature.
• Black (tar-like) stools or blood in the stool.
• Itching, yellowing of the skin or whites of the eyes, or dark urine, which may be symptoms of liver inflammation.
• Heart rhythm disorders, such as rapid or irregular heartbeat, elevated blood pressure.
• Vision problems, such as blurred vision, dilated pupils.
• Nervous system disorders, such as dizziness, tingling, coordination problems (muscle spasms or stiffness), seizures, or convulsions.
• Psychiatric disorders, such as excessive restlessness and unnatural excitement.
• Withdrawal symptoms (see "How to take Lafactin", "Stopping Lafactin"). Prolonged bleeding time in case of injury, the wound may bleed slightly longer than usual.

The patient may notice small white granules or balls in their stool.

Inside the Lafactin capsules, there are granules (small, white balls) that contain the active substance, venlafaxine. These granules are released from the capsule into the gastrointestinal tract, passing through its entire length, slowly releasing venlafaxine.

The skeleton of the granule does not dissolve and is excreted in the stool. Therefore, if the patient notices granules in their stool, they should not be concerned, as the venlafaxine dose has been absorbed.

Other side effects

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 of detachment (or separation) from oneself, lack of orgasm, decreased libido, agitation, nervousness, unusual dreams
• tremors, feeling of restlessness or inability 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, urination problems
• irregular menstrual bleeding, such as heavy bleeding or more frequent irregular bleeding, ejaculation disorders/orgasm disorders (men), erectile dysfunction (impotence)
• weakness (asthenia), 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 decreased need for sleep (mania)
• hallucinations, feeling of detachment (or separation) from reality, orgasm disorders, apathy, feeling of excessive excitement, teeth grinding
• fainting, uncontrolled muscle movements, coordination 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 signs of internal bleeding
• photosensitivity, 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 temperature
• disorientation and confusion, often with accompanying hallucinations (delirium)
• excessive water retention in the body
• decreased sodium levels in the blood
• severe eye pain and vision problems or blurred vision
• abnormal, rapid, or irregular heartbeat, which may lead to fainting
• 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, or flu-like symptoms, which are symptoms of liver inflammation.

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

• prolonged bleeding, which may be a sign of a decreased platelet count, indicating an increased risk of bruising or bleeding
• unusual milk production in women
• unexpected bleeding, such as bleeding from the gums, blood in the urine, or vomiting blood, or the appearance of unexpected bruises or broken blood vessels (broken veins).

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 2 "Important information before taking Lafactin")
• aggressive behavior
• dizziness
• heavy bleeding from the vagina shortly after delivery (postpartum hemorrhage), for more information, see section 2: "Pregnancy, breastfeeding, and fertility".

Lafactin may sometimes cause side effects that the patient is not aware of, such as increased blood pressure or abnormal heart function; slight changes in liver enzyme activity, sodium, or cholesterol levels in the blood. In rare cases, Lafactin may affect platelet function, increasing the risk of bruising or bleeding. In this case, the doctor may recommend a blood test from time to time, especially during long-term treatment with Lafactin.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of 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, more information can be collected on the safety of this medicine.

5. How to store Lafactin

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the label, carton, and bottle after EXP. The expiry date refers to the last day of the month stated. There are no special precautions for storing the medicine. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the packaging and other information

What Lafactin contains

• The active substance of the medicine is venlafaxine. Each prolonged-release capsule contains 37.5 mg of venlafaxine (as venlafaxine hydrochloride). Each prolonged-release capsule contains 75 mg of venlafaxine (as venlafaxine hydrochloride).

Each prolonged-release capsule contains 150 mg of venlafaxine (as venlafaxine hydrochloride). The other ingredients are: Sucrose spheres, hypromellose, talc, and ethylcellulose The cap of the capsule contains: Gelatin, iron oxide red (E 172) (only for 75 mg and 150 mg), iron oxide black (E 172) (only for 37.5 mg), titanium dioxide (E 171), sodium lauryl sulfate. The body of the capsule contains: Gelatin, iron oxide red (E 172), titanium dioxide (E 171), sodium lauryl sulfate. The ink used for printing on the capsules contains: Shellac, iron oxide black (E172).

What Lafactin looks like and contents of the pack

Prolonged-release hard capsule Lafactin 37.5 mg prolonged-release hard capsules White to off-white, spherical to oval pellets in gray and peach-colored size 3 hard gelatin capsules, with "E" printed on the cap and "73" printed on the body with black edible ink. Lafactin 75 mg prolonged-release hard capsules White to off-white, spherical to oval pellets in peach-colored size 1 hard gelatin capsules, with "E" printed on the cap and "74" printed on the body with black edible ink. Lafactin 150 mg prolonged-release hard capsules White to off-white, spherical to oval pellets in dark orange size 0 hard gelatin capsules, with "E" printed on the cap and "89" printed on the body with black edible ink. Lafactin is available in the following packs: PVC/PE/PVDC/Aluminum blister: Lafactin 37.5 mg/75 mg/150 mg: 7, 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, and 100 capsules. HDPE bottle with a polypropylene cap: Lafactin 37.5 mg/75 mg/150 mg: 30, 100, and 500 capsules. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o. ul. Sokratesa 13D lokal 27 01-909 Warsaw

Manufacturer/Importer

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta ARROW Génériques 26 avenue Tony Garnier 69007 Lyon France

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

France VENLAFAXINE ARROW GÉNÉRIQUES LP 37.5 mg/ 75 mg/150 mg gélule à libération prolongée Germany Venlafaxin Aurobindo 37.5 mg/ 75 mg/150 mg Hartkapseln, retardiert Ireland Vedixal XL75 mg/150 mg prolonged-release capsules, hard Italy Venlafaxina Aurobindo Netherlands Venlafaxine Aurobindo 37,5 mg/ 75 mg/150 mg, capsules met verlengde afgifte, hard Poland Lafactin Portugal Venlafaxina Aurobindo

Date of last revision of the leaflet: 05.2023