VELAXIN 75 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Velaxin ER 37.5 mg, Prolonged-Release Hard Capsules
3. Velaxin ER 75 mg, Prolonged-Release Hard Capsules
4. Velaxin ER 150 mg, Prolonged-Release Hard Capsules
   1. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   2. Contents of the pack and other information
5. What Velaxin ER is and what it is used for
6. Before you take Velaxin ER
   1. When not to take Velaxin ER
   2. Warnings and precautions
   3. Velaxin ER with other medicines
   4. If you think you have serotonin syndrome, you should contact your doctor or go to the nearest hospital immediately.
   5. Taking Velaxin ER with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
7. How to take Velaxin ER
   1. If you take more Velaxin ER than you should
   2. If you forget to take Velaxin ER
   3. Stopping Velaxin ER treatment
8. Possible side effects
   1. Uncommon (may affect up to 1 in 100 people)
   2. Rare (may affect up to 1 in 1,000 people)
   3. Frequency not known (cannot be estimated from the available data)
   4. Other side effects
   5. Very common (may affect more than 1 in 10 people)
   6. Common (may affect up to 1 in 10 people)
   7. Uncommon (may affect up to 1 in 100 people)
   8. Rare (may affect up to 1 in 1,000 people)
   9. Very rare (may affect up to 1 in 10,000 people)
   10. Frequency not known (cannot be estimated from the available data)
   11. Reporting side effects
9. How to store Velaxin ER
10. Contents of the pack and other information
    1. What Velaxin ER contains
    2. What Velaxin ER looks like and contents of the pack
    3. Marketing authorization holder
    4. Manufacturer
    5. Date of last revision of the leaflet: 28.04.2023

Package Leaflet: Information for the User

Velaxin ER 37.5 mg, Prolonged-Release Hard Capsules

Velaxin ER 75 mg, Prolonged-Release Hard Capsules

Velaxin ER 150 mg, Prolonged-Release Hard Capsules

Venlafaxine

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get 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 Velaxin ER is and what it is used for
• 2. Before you take Velaxin ER
• 3. How to take Velaxin ER
• 4. Possible side effects
• 5. How to store Velaxin ER
• 6. Contents of the pack and other information

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

Velaxin ER contains the active substance venlafaxine. Velaxin 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 mood disorders, such as anxiety disorders. It is thought that people who are depressed and/or anxious have lower levels of serotonin and norepinephrine in the brain. The exact mechanism of action of antidepressants is not fully understood, but they are thought to work by increasing the levels of serotonin and norepinephrine in the brain.

Velaxin ER is used to treat depression in adults. Velaxin ER is also used to treat generalized anxiety disorder, social anxiety disorder, and panic disorder in adults. For depression and anxiety disorders, treatment should be started at the right time. If treatment is not started, the condition may not improve, may worsen, and may become more difficult to treat.

2. Before you take Velaxin ER

When not to take Velaxin ER

• If you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6);
• 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. Taking irreversible MAOIs with Velaxin ER can cause serious, even life-threatening, side effects.

Also, before starting to take any medicines that are MAOIs, you should wait at least 7 days after stopping Velaxin ER (see also "Velaxin ER with other medicines").

Warnings and precautions

Before starting treatment with Velaxin ER, tell your doctor or pharmacist:

• If you are taking other medicines that can increase the risk of serotonin syndrome when taken with Velaxin ER (see "Velaxin ER with other medicines");
• If you have eye problems, such as certain types of glaucoma (increased pressure in the eye);
• If you have had high blood pressure in the past;
• If you have had heart problems in the past;
• If you have had irregular heart rhythms in the past;
• If you have had seizures (epilepsy) in the past;
• If you have had low sodium levels in the blood (hyponatremia) in the past;
• If you have a tendency to bruise or bleed easily, 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 had mania (feeling excessively excited or euphoric) or bipolar disorder in the past;
• If you have had aggressive behavior in the past.

Velaxin ER may cause feelings of restlessness or an inability to sit or stand still during the first few weeks of treatment. If you experience these symptoms, you should tell your doctor. Do not drink alcohol while taking Velaxin ER, as it may cause extreme drowsiness and loss of consciousness. Taking Velaxin ER with alcohol and/or certain other medicines may increase the risk of side effects, such as increased depression and anxiety disorders.

Suicidal thoughts and worsening of depression or anxiety disorders People with depression and/or anxiety disorders may sometimes have thoughts of harming themselves or committing suicide. These thoughts may be more frequent when first starting to take antidepressants, as these medicines may take 2 weeks or longer to start working. These thoughts may also occur when the dose of Velaxin ER is decreased or treatment is stopped.

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

If you have thoughts of harming yourself or committing suicide, you should contact your doctor or go to the nearest hospital immediately. It may be helpful to tell your family or friends that you are taking Velaxin ER and ask them to read this leaflet. You may want to ask your family or friends to tell you if they notice any changes in your mood or behavior.

Dry mouth Dry mouth was reported by 10% of patients treated with venlafaxine. This may increase the risk of tooth decay. Therefore, you should pay special attention to your oral hygiene.

Diabetes Velaxin ER may affect blood sugar levels, and the dose of antidiabetic medicines may need to be adjusted.

Sexual dysfunction Medicines like Velaxin ER (SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Children and adolescents Velaxin 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 attempted suicide, suicidal thoughts, and hostility (especially aggression, oppositional behavior, and anger). However, your doctor may prescribe Velaxin ER to patients under 18 years of age if they think it is in their best interest. If your doctor has prescribed Velaxin ER for a patient under 18 years of age, and you have any concerns, you should discuss them with your doctor. You should tell your doctor if any of the above symptoms occur or worsen in patients under 18 years of age taking Velaxin ER. The long-term safety of Velaxin ER in this age group has not been established.

Velaxin ER with other medicines

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

• Irreversible MAOIs, which are used to treat depression or Parkinson's disease, must not be taken with Velaxin ER. You should tell your doctor if you have taken these medicines within the last 14 days (see "Before you take Velaxin ER").
• Serotonin syndrome: When taking venlafaxine, a potentially life-threatening condition called serotonin syndrome can occur, especially when taken with other medicines (see section 4). Examples of these 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 moclobemide, an MAOI (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 or buprenorphine (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 plant-based medicines, used to treat mild depression);
• Medicines containing tryptophan (used for sleep problems and depression);
• Antipsychotic medicines (used to treat mental health conditions, such as hallucinations, delusions, and disordered thinking).

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.

If you think you have serotonin syndrome, you should contact your doctor or go to the nearest hospital immediately.

If you are taking medicines that may affect your heart rhythm, you should tell your doctor. Examples of these 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 Velaxin ER, and you should use them with caution. It is especially important to tell your doctor if you are taking medicines that contain:

• Ketoconazole (an antifungal medicine);
• Haloperidol or risperidone (medicines used to treat mental health conditions);
• Metoprolol (a beta-blocker used to treat high blood pressure and heart conditions).

Taking Velaxin ER with food, drink, and alcohol

Velaxin ER should be taken with food (see section 3 "How to take Velaxin ER"). Do not drink alcohol while taking Velaxin ER. Taking Velaxin ER with alcohol may cause extreme drowsiness and loss of consciousness, and may increase the risk of depression and anxiety disorders.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Taking Velaxin ER at the end of pregnancy may increase the risk of severe bleeding from the uterus, which can occur shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Velaxin ER, you should tell your doctor or midwife so that they can give you appropriate advice.

Similar medicines (SSRIs) taken during pregnancy may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn, which can cause rapid breathing and bluish discoloration. These symptoms usually occur within 24 hours of birth. If you notice these symptoms in your baby, you should contact your midwife and/or doctor immediately.

If you are taking this medicine during pregnancy, after birth, your baby may experience difficulty breathing, in addition to other symptoms such as poor feeding. If you are concerned about these symptoms in your newborn, you should contact your doctor and/or midwife, who will be able to give you appropriate advice.

Velaxin ER passes into breast milk. There is a risk of side effects in the baby. The baby may become irritable, restless, and have difficulty sleeping. After stopping breastfeeding, withdrawal symptoms related to venlafaxine have been reported. Therefore, you should discuss this with your doctor, who will decide whether to stop breastfeeding or stop Velaxin ER treatment.

Driving and using machines

Do not drive or operate machinery until you know how Velaxin ER affects you.

Velaxin ER contains sodium Velaxin ER 37.5 mg and 75 mg contain less than 1 mmol (9 mg and 18 mg, respectively) of sodium per capsule, which is essentially "sodium-free". Velaxin ER 150 mg contains 36 mg of sodium (a major component of common salt) per capsule, which corresponds to 1.8% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Velaxin ER

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual recommended starting dose for depression, generalized anxiety disorder, and 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 be started with a lower dose (37.5 mg) and gradually increased. The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg once daily.

Velaxin ER should be taken once daily, at approximately the same time, either in the morning or evening. The capsules should be swallowed whole with a drink of water. Do not divide, crush, chew, or dissolve them.

Velaxin ER should be taken with food (see section 2 "Before you take Velaxin ER").

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

Do not stop taking Velaxin ER without talking to your doctor (see "Stopping Velaxin ER treatment").

If you take more Velaxin ER than you should

If you have taken more Velaxin ER than you should, you should contact your doctor immediately.

Overdose can be life-threatening, especially when taken with alcohol and/or certain other medicines (see section 2 "Before you take Velaxin ER").

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

If you forget to take Velaxin ER

If you miss a dose, you should take it as soon as possible. However, if it is almost time for your next dose, you should 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 Velaxin ER treatment

Do not stop taking Velaxin ER without talking to your doctor, even if you feel better. If your doctor thinks it is necessary, they will tell you how to gradually reduce the dose before stopping treatment completely. When stopping treatment, especially if it is stopped abruptly or the dose is reduced too quickly, you may experience side effects, such as suicidal thoughts, aggressive behavior, tiredness, dizziness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, anxiety, confusion, ringing in the ears, tingling or numbness, weakness, sweating, seizures, or flu-like symptoms, and changes in blood pressure (which can cause headaches, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you on how to gradually stop taking Velaxin ER. This may take several weeks or months. In some patients, it may be necessary to stop the medicine very gradually over a period of several months or longer. If you experience any of these symptoms or any other symptoms that are troublesome for you, you should contact your doctor.

4. Possible side effects

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

When taking Velaxin ER, you may notice small, white granules or pellets in your stool. Inside the Velaxin ER capsules, there are granules or small, white pellets that contain the active substance, venlafaxine. These granules are released from the capsule into the gastrointestinal tract, where they slowly release venlafaxine. The skeleton of the granules does not dissolve and is eliminated in the stool. Therefore, even if you see granules in your stool, the dose of venlafaxine has been absorbed.

If you experience any of the following side effects, you should stop taking Velaxin ER and contact your doctor or go to the nearest hospital 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 (red or pale raised rash, often itchy);
• Serotonin syndrome, which can cause symptoms such as 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. Symptoms of neuroleptic malignant syndrome can include fever, rapid heart rate, sweating, stiffness, confusion, increased muscle enzymes (detected in blood tests).
• Infections, such as high fever, chills, shivering, headache, flu-like symptoms, which can be a sign of a blood disorder that increases the risk of infection.
• Severe skin rash, which can cause blisters and peeling of the skin;
• Muscle pain of unknown cause, tenderness, or weakness, which can be symptoms of rhabdomyolysis.

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

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

If you experience any of the following side effects, you should contact your doctor (the frequency of these side effects is not known):

• Cough, wheezing, and shortness of breath, which may be accompanied by high fever;
• Black (tar-like) stools or blood in stools, which may be a sign of internal bleeding;
• Itching, yellowing of the skin or whites of the eyes, dark urine, which can 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, coordination problems (muscle spasms or stiffness), seizures;
• Psychiatric problems, such as excessive restlessness and feelings of unnatural excitement;
• Withdrawal symptoms (see "Stopping Velaxin ER treatment");
• Prolonged bleeding time - in case of injury, the wound may bleed slightly longer than usual.

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 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; inability of the eye to accommodate (automatic change in focus from distant to near objects);
• 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 or more frequent bleeding;
• Ejaculation or 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 restlessness, racing thoughts, and decreased need for sleep (mania);
• Hallucinations; feeling detached from reality; orgasm disorders; apathy; excessive restlessness; 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 stools, 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;
• Mild 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 high fever;
• Disorientation and confusion, often with hallucinations (delirium);
• Excessive water retention in the body (a condition known as SIADH, or syndrome of inappropriate antidiuretic hormone secretion);
• Decreased sodium levels in the blood;
• Severe eye pain and decreased vision or blurred vision;
• Abnormal, rapid, or irregular heartbeat, which can lead to fainting;
• Severe abdominal or back pain (which can be a sign of 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 can be symptoms of liver inflammation.

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

• Prolonged bleeding, which can be a sign of decreased 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 vomit, 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; suicidal thoughts and behaviors have been reported during venlafaxine treatment or shortly after stopping treatment (see section 2 "Before you take Velaxin ER");
• Aggressive behavior;
• Dizziness;
• Severe bleeding from the uterus, which can occur shortly after delivery (postpartum hemorrhage), see additional information in section 2 "Pregnancy and breastfeeding".

Velaxin ER may also cause side effects that you may not be aware of, such as increased blood pressure or abnormal heart rhythm; mild changes in liver enzyme activity, sodium levels, or cholesterol levels in the blood. In rare cases, Velaxin ER may affect platelet function, increasing the risk of bruising or bleeding. Therefore, your doctor may recommend regular blood tests, especially during long-term treatment with Velaxin ER.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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 representative of the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Velaxin ER

Do not store above 30°C. Store in the original package to protect from moisture.

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging.

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

Do not use this medicine if you notice any visible signs of deterioration (e.g., change in color).

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Velaxin ER contains

The active substance is venlafaxine.

Velaxin ER 37.5 mg: each prolonged-release capsule contains 37.5 mg of venlafaxine (equivalent to 42.42 mg of venlafaxine hydrochloride).

Velaxin ER 75 mg: each prolonged-release capsule contains 75 mg of venlafaxine (equivalent to 84.84 mg of venlafaxine hydrochloride).

Velaxin ER 150 mg: each prolonged-release capsule contains 150 mg of venlafaxine (equivalent to 169.68 mg of venlafaxine hydrochloride).

The other ingredients are:

Velaxin ER 37.5 mg

Microcrystalline cellulose, sodium chloride, ethylcellulose, talc, dimethicone, potassium chloride, copovidone, colloidal anhydrous silica, xanthan gum, yellow iron oxide (E 172).

Capsule shell:

Erythrosine (E 127), indigo carmine (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin.

Velaxin ER 75 mg

Microcrystalline cellulose, sodium chloride, ethylcellulose, talc, dimethicone, potassium chloride, copovidone, colloidal anhydrous silica, xanthan gum, yellow iron oxide (E 172).

Capsule shell:

Red iron oxide (E 172), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin.

Velaxin ER 150 mg

Microcrystalline cellulose, sodium chloride, ethylcellulose, talc, dimethicone, potassium chloride, copovidone, colloidal anhydrous silica, xanthan gum, yellow iron oxide (E 172).

Capsule shell:

Red iron oxide (E 172), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin.

What Velaxin ER looks like and contents of the pack

Velaxin ER 37.5 mg

Hard gelatin capsules: orange cap, white body.

Velaxin ER 75 mg

Hard gelatin capsules: red cap, white body.

Velaxin ER 150 mg

Hard gelatin capsules: red cap, white body.

The pack contains 28 (2 x 14) or 30 (3 x 10) prolonged-release capsules (37.5 mg, 75 mg, and 150 mg) in a PVC/PVDC/Aluminum blister pack and a cardboard box with a patient information leaflet.

Marketing authorization holder

PROTERAPIA Spółka z o.o.

ul. Komitetu Obrony Robotników 45 D

02-146 Warszawa

Manufacturer

EGIS Pharmaceuticals PLC

1165 Budapest, Bökényföldi út 116-120.

Hungary

EGIS Pharmaceuticals PLC

9900 Körmend Mátyás király u. 65

Hungary

Date of last revision of the leaflet: 28.04.2023