ORIVEN 37.5 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the User
   1. Oriven, 75 mg, prolonged-release hard capsules
   2. Oriven, 150 mg, prolonged-release hard capsules
   3. Oriven, 225 mg, prolonged-release hard capsules
   4. Read all of this leaflet carefully before taking this medicine because it contains important information for you.
   5. Contents of the pack and other information
2. What Oriven is and what it is used for
3. What you need to know before you take Oriven
   1. Do not take Oriven
   2. Warnings and precautions
   3. Children and adolescents
   4. Oriven with other medicines
   5. In case of suspected serotonin syndrome, you should immediately contact your doctor or go to the hospital.
   6. Oriven with food, drink, and alcohol
   7. Pregnancy and breast-feeding
   8. Driving and using machines
   9. Oriven 150 mg hard capsules contain the colorants sunset yellow FCF (E 110) and Allura red AC (E 129)
   10. Oriven 225 mg hard capsules contain the colorant carmoisine (E 122)
4. How to take Oriven
   1. Overdose
   2. Missed dose
   3. Stopping Oriven
5. Possible side effects
   1. Other side effects that may occur
   2. Reporting side effects
6. How to store Oriven
7. Contents of the pack and other information
   1. What Oriven contains
   2. What Oriven looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer

Package Leaflet: Information for the User

Oriven, 37.5 mg, prolonged-release hard capsules

Oriven, 75 mg, prolonged-release hard capsules

Oriven, 150 mg, prolonged-release hard capsules

Oriven, 225 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 Oriven is and what it is used for
• 2. What you need to know before you take Oriven
• 3. How to take Oriven
• 4. Possible side effects
• 5. How to store Oriven
• 6. Contents of the pack and other information

1. What Oriven is and what it is used for

Oriven contains the active substance venlafaxine. Oriven is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). These medicines are used to treat depression and other conditions, such as anxiety disorders. The exact mechanism of action of antidepressants is not fully understood, but they may help by increasing the levels of serotonin and norepinephrine in the brain. Oriven is used to treat depression in adults. It is also used to treat the following anxiety disorders in adults: generalized anxiety disorder, social anxiety disorder (fear or avoidance of social situations), and panic disorder (panic attacks). Proper treatment of depression or anxiety disorders is very important for improving the patient's well-being. If left untreated, the patient's condition may not improve, and their illness may become severe and difficult to treat.

2. What you need to know before you take Oriven

Do not take Oriven

• 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 Oriven may cause serious or even life-threatening side effects. Also, before starting to take any MAOI, you should wait at least 7 days after stopping Oriven (see also the section "Oriven with other medicines" and the information in the section "Serotonin syndrome").

after stopping Oriven (see also the section "Oriven with other medicines" and the information in the section "Serotonin syndrome").

Warnings and precautions

Before starting to take Oriven, you should discuss this with your doctor or pharmacist if:

• you are taking other medicines that may increase the risk of serotonin syndrome when taken with Oriven (see the section "Oriven with other medicines").
• you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
• you have had high blood pressure in the past.
• you have had heart problems in the past.
• you have been told that you have an irregular heartbeat.
• you have had seizures (fits) in the past.
• you have had low sodium levels in your blood in the past (hyponatremia).
• you have had bleeding disorders (a tendency to bruise or bleed) or are taking other medicines that may increase the risk of bleeding, such as warfarin (a medicine used to prevent blood clots), or if you are pregnant (see the section "Pregnancy and breast-feeding").
• you or anyone in your family has had mania or bipolar disorder (a condition characterized by excessive excitement or euphoria).
• you have had aggressive behavior in the past.

Oriven may cause feelings of restlessness or an inability to sit or stand still during the first few weeks of treatment. If such symptoms occur, you should inform your doctor. Do not drink alcohol while taking Oriven, as it may cause extreme drowsiness and loss of consciousness. Taking Oriven with alcohol or certain other medicines may increase the risk of side effects, such as drowsiness, and may worsen depression and other conditions, such as anxiety disorders. Suicidal thoughts and worsening of depression or anxiety disorders People with depression or anxiety disorders may sometimes have thoughts of self-harm or suicide. These thoughts may worsen when first taking antidepressants, as these medicines may start to work after 2 weeks, and sometimes later. Such thoughts may also occur when reducing the dose or stopping Oriven. The occurrence of suicidal thoughts, self-harm, or suicide is more likely if:

• you have had suicidal thoughts or self-harm in the past;
• you are a young adult; clinical trial data suggest an increased risk of suicidal behavior in young adults under 25 years of age with psychiatric disorders who were treated with antidepressants.

If you experience suicidal thoughts or self-harm, you should immediately contact your doctor or go to the hospital. It may be helpful to inform your relatives or friends about your depression or anxiety disorder and ask them to read this leaflet. You may want to ask your relatives or friends to tell you if they notice any worsening of your depression or anxiety disorder or any worrying changes in your behavior. Dry mouth Dry mouth is reported by 10% of patients treated with venlafaxine. This condition may increase the risk of tooth decay. Therefore, you should pay special attention to oral hygiene. Diabetes Oriven may affect blood sugar levels, and therefore, a dose adjustment of antidiabetic medicines may be necessary. Sexual dysfunction Medicines like Oriven (SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Children and adolescents

Oriven 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 medicines of this class are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebelliousness, and anger). However, your doctor may prescribe this medicine to patients under 18 years of age if they consider it to be beneficial. If your doctor has prescribed this medicine to a patient under 18 years of age, and you have any concerns, you should discuss them with your doctor. You should inform your doctor if any of the above symptoms occur or worsen in patients under 18 years of age taking Oriven. The long-term safety of this medicine in terms of its effects on growth, maturation, and cognitive and behavioral development in this age group has not been established.

Oriven with other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, and about any medicines you plan to take. Your doctor will decide whether you can take Oriven with other medicines. Do not start or stop taking other medicines, including those available without a prescription, herbal, or natural products, without consulting your doctor or pharmacist first. Monoamine oxidase inhibitors, which are used to treat depression or Parkinson's disease, must notbe taken with Oriven. Tell your doctor if you have taken these medicines in the last 14 days (MAOIs; see the section "Important information before taking Oriven").

Serotonin syndrome may occur during treatment with venlafaxine, especially when taken with other medicines, such as:

• triptans (used to treat migraine headaches)
• other antidepressants, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, or lithium
• medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity)
• medicines containing the antibiotic linezolid (used to treat infections)
• medicines containing MAOIs, such as moclobemide (used to treat depression)
• medicines containing sibutramine (used for weight loss)
• medicines containing opioids (such as buprenorphine, tramadol, fentanyl, tapentadol, pethidine, or pentazocine), which are used to treat severe pain
• medicines containing dextromethorphan (used to treat cough)
• medicines containing methadone (used to treat opioid addiction 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 characterized by symptoms such as hearing, seeing, or feeling things that do not exist, delusions, suspiciousness, unclear thinking, and withdrawal)

The symptoms of serotonin syndrome may include:

• restlessness, hallucinations, loss of coordination, rapid heartbeat, high body temperature, sudden changes in blood pressure, overreactivity, diarrhea, coma, nausea, vomiting.

The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome. The symptoms of neuroleptic malignant syndrome include:

• fever, rapid heartbeat, sweating, muscle stiffness, disorientation, increased enzyme activity in the muscles (detected in blood tests).

In case of suspected serotonin syndrome, you should immediately contact your doctor or go to the hospital.

If you are taking medicines that may affect your heart rhythm, you should tell your doctor. Examples of such medicines include:

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

The following medicines may also interact with Oriven, and therefore, you should use them with caution. It is especially important to inform your doctor if you are taking medicines containing:

• ketokonazole (an antifungal medicine)
• haloperidol or risperidone (medicines used to treat psychiatric disorders)
• metoprolol (a beta-blocker used to treat high blood pressure and heart disease)

Oriven with food, drink, and alcohol

Oriven should be taken with food (see section 3 "How to take Oriven"). Do not drink alcohol while taking Oriven. Taking Oriven with alcohol may cause extreme drowsiness and loss of consciousness, and may worsen depression and other conditions, such as anxiety disorders.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Oriven should only be used during pregnancy if your doctor considers it necessary. You should ensure that your midwife and/or doctor know you are taking Oriven. When taken during pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and bluish discoloration in newborns. These symptoms usually occur within the first 24 hours after birth. If these symptoms occur in your baby, you should immediately contact your midwife and/or doctor. Taking Oriven at the end of pregnancy may increase the risk of severe bleeding from the vagina, which occurs shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Oriven, you should inform your doctor or midwife so that they can provide you with appropriate advice. If you are taking this medicine during pregnancy, your baby may experience the following symptoms after birth: poor feeding and breathing difficulties. If you are concerned about these symptoms in your newborn, you should contact your doctor and/or midwife, who will be able to provide you with appropriate advice. Venlafaxine passes into breast milk, and there is a risk of affecting the baby. Therefore, you should discuss this with your doctor, and your doctor will decide whether you should stop breast-feeding or stop taking this medicine.

Driving and using machines

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

Oriven 150 mg hard capsules contain the colorants sunset yellow FCF (E 110) and Allura red AC (E 129)

Oriven 225 mg hard capsules contain the colorant carmoisine (E 122)

The 150 mg capsule contains the colorants sunset yellow FCF (E 110) and Allura red AC (E 129), which may cause allergic reactions.

The 225 mg capsule contains the colorant carmoisine (E 122), which may cause allergic reactions.

3. How to take Oriven

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The usual recommended starting dose of venlafaxine for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg per day. Your doctor may gradually increase this dose, up to a maximum dose of 375 mg, if necessary, for the treatment of depression. For patients with panic disorder, your doctor will recommend a lower starting dose (37.5 mg), which will be gradually increased. The maximum dose for the treatment of generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg per day. Oriven 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 capsules should not be divided, crushed, broken, or chewed. Oriven should be taken with food. You should inform your doctor about any liver or kidney problems, as a dose adjustment of this medicine may be necessary. Do not stop taking this medicine without consulting your doctor (see the section "Stopping Oriven").

Overdose

If you have taken more than the prescribed dose of Oriven, you should immediately contact your doctor or pharmacist. Overdose can be life-threatening, especially when taken with alcohol or certain other medicines (see the section "Oriven with other medicines"). Symptoms of possible overdose may include rapid heartbeat, changes in consciousness (from drowsiness to coma), changes in vision, seizures or convulsions, and vomiting.

Missed dose

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 one dose at the usual time. Do not take a double dose to make up for a missed dose. Do not take more than the prescribed daily dose of Oriven.

Stopping Oriven

Do not stop taking this medicine without consulting your doctor, even if you feel better. If your doctor decides that you can stop taking Oriven, they will tell you how to do it gradually, by reducing the dose. When stopping this medicine, especially if it is stopped abruptly or the dose is reduced too quickly, you may experience side effects, such as suicidal thoughts, aggression, tiredness, dizziness, feeling empty, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, restlessness, confusion, ringing in the ears, or a feeling of electric shock, weakness, sweating, and flu-like symptoms. Your doctor will advise you on how to stop taking Oriven gradually, which may take several weeks or months. In some patients, it may be necessary to stop treatment more gradually, over several months or longer. If you experience any of the above symptoms or other symptoms that are troublesome to you, you should consult your doctor. If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Oriven can cause side effects, although not everybody gets them. If you experience any of the following side effects, you should stop taking Oriven and contact your doctor or go to the hospital immediately:

Uncommon ( may affect up to 1 in 100 people)

• swelling of the face, lips, tongue, or throat, hands, or feet, and (or) the occurrence of a raised, itchy rash, 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, itchy rash, which may be red or pale).
• symptoms of serotonin syndrome, which may include: restlessness, hallucinations, loss of coordination, rapid heartbeat, high body temperature, sudden changes in blood pressure, overreactivity, diarrhea, coma, nausea, vomiting. The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome. The symptoms of neuroleptic malignant syndrome include: fever, rapid heartbeat, sweating, muscle stiffness, disorientation, increased enzyme activity in the muscles (detected in blood tests).
• symptoms of infection, such as high fever, chills, shivering, headache, excessive sweating, flu-like symptoms. These may be signs of a blood disorder that can increase the risk of infection.
• severe skin rash, which may lead to blistering and peeling of the skin.
• unexplained muscle pain, tenderness, or weakness. This may be a sign of rhabdomyolysis.

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

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

Other side effects that you should tell your doctor aboutinclude (the frequency of these side effects is included in the list below, "Other side effects that may occur"):

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

Other side effects that may occur

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 (or separated) 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 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)
• rapid heartbeat; palpitations
• increased blood pressure; flushing
• shortness of breath; yawning
• vomiting; diarrhea
• mild skin rash; itching -
• increased frequency of urination; urinary retention; difficulty urinating
• menstrual irregularities, such as heavy bleeding or more frequent irregular bleeding; ejaculation or orgasm disorders (in 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 reduced need for sleep (mania)
• hallucinations, feeling detached (or separated) from reality; orgasm disorders; apathy; feeling overly restless; teeth grinding
• fainting; uncontrolled muscle movements; coordination and balance problems
• dizziness (especially when standing up too quickly), decreased blood pressure
• vomiting blood; black (tar-like) stools or blood in the stool, which may be signs of internal bleeding
• increased sensitivity to light; bruising; excessive hair loss
• urinary incontinence
• stiffness, muscle contractions, and uncontrolled muscle movements
• mild changes in liver enzyme activity in the blood

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

• seizures or convulsions
• cough, wheezing, 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 the syndrome of inappropriate antidiuretic hormone secretion)
• low sodium levels in the blood
• severe eye pain and vision disturbances or blurred vision
• abnormal, rapid, or irregular heartbeat, which may lead to fainting
• severe abdominal or back pain (which may indicate serious problems with the intestines, liver, or pancreas)
• itching, yellowing of the skin or whites of the eyes, dark urine, or flu-like symptoms, which may be signs of liver inflammation

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

• prolonged bleeding, which may be a sign of a reduced 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 vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins)

Frequency not known ( frequency 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 the section "Important information before taking Oriven")
• aggression
• vertigo of vestibular origin
• severe vaginal bleeding after delivery (postpartum hemorrhage), see additional information in the subsection "Pregnancy and breast-feeding" in section 2.

Venlafaxine 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. Rarely, venlafaxine may affect platelet function, leading to an increased risk of bruising or bleeding. Therefore, your doctor may recommend regular blood tests, especially during long-term treatment with Oriven.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. You can also report side effects directly to the national reporting system: Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Oriven

Keep this medicine 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. There are no special storage instructions for this medicine. 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 Oriven contains

• The active substance is venlafaxine. Each capsule contains venlafaxine hydrochloride, equivalent to 37.5 mg, 75 mg, 150 mg, or 225 mg of venlafaxine.
• The other ingredients are: capsule contents: microcrystalline cellulose, povidone, talc, colloidal anhydrous silica, magnesium stearate, ethylcellulose, copovidone.

Capsule shellOriven 37.5 mg prolonged-release hard capsules:
gelatin, titanium dioxide (E 171), iron oxide black (E 172), iron oxide red (E 172), iron oxide yellow (E 172), ink (shellac, iron oxide red (E 172)).
Oriven 75 mg prolonged-release hard capsules:
gelatin, titanium dioxide (E 171), iron oxide black (E 172), iron oxide red (E 172), ink (shellac, iron oxide red (E 172)).
Oriven 150 mg prolonged-release hard capsules:
gelatin, titanium dioxide (E 171), sunset yellow FCF (E 110), Allura red AC (E 129), brilliant blue FCF (E 133), ink (shellac, titanium dioxide (E 171)).
Oriven 225 mg prolonged-release hard capsules:
gelatin, titanium dioxide (E 171), carmoisine (E 122), ink (shellac, indigo carmine (E 132), propylene glycol, concentrated ammonia solution).

What Oriven looks like and contents of the pack

Prolonged-release hard capsules Oriven 37.5 mg:
light gray and peach-colored, opaque, size "3", hard gelatin capsule with broad and thin red bands around both parts of the capsule. The capsule is filled with 3 small coated tablets, which are white or almost white, round, and biconvex.
Oriven 75 mg:
peach-colored, opaque, size "1", hard gelatin capsule with broad and thin red bands around both parts of the capsule. The capsule is filled with 6 small coated tablets, which are white or almost white, round, and biconvex.
Oriven 150 mg:
dark orange-colored, opaque, size "0", hard gelatin capsule with broad and thin white bands around both parts of the capsule. The capsule is filled with 12 small coated tablets, which are white or almost white, round, and biconvex.
Oriven 225 mg:
pink-colored, opaque, size "00", hard gelatin capsule with broad and thin blue bands around both parts of the capsule. The capsule is filled with 18 small coated tablets, which are white or almost white, round, and biconvex.
Pack sizes:
For 37.5 mg, 75 mg, and 150 mg: 28 and 98 prolonged-release hard capsules in blisters.
For 225 mg: 28 prolonged-release hard capsules in blisters, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Orion Corporation
Orionintie 1
02200 Espoo
Finland

Manufacturer

Orion Corporation, Orion Pharma
Orionintie 1
02200 Espoo
Finland
Orion Corporation, Orion Pharma
Joensuunkatu 7
24100 Salo
Finland
To obtain more detailed information on this medicine, you should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o.o.
[email protected]
Date of last revision of the leaflet:10.05.2023