Oriven

Leaflet attached to the packaging: 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

You should carefully read the contents of the leaflet before using 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 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 Oriven and what is it used for
• 2. Important information before using Oriven
• 3. How to use Oriven
• 4. Possible side effects
• 5. How to store Oriven
• 6. Contents of the packaging and other information

1. What is Oriven and what is it used for

Oriven contains the active substance venlafaxine.
Oriven is an antidepressant that belongs to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRI). Medicines in this group are used to treat depression and other conditions, such as anxiety disorders. The mechanism of action of antidepressants is not fully understood, but they may help by increasing the levels of serotonin and noradrenaline 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 phobia (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. Important information before using Oriven

When not to use Oriven

• 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 (IMAO) used to treat depression or Parkinson's disease. Taking irreversible IMAO simultaneously with Oriven may cause severe or life-threatening side effects. Also, before starting to take any IMAO, the patient should

wait at least 7 days after stopping Oriven (see also the section "Oriven and other medicines" and the information in the section "Serotonin syndrome").

Warnings and precautions

Before starting to use Oriven, 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 Oriven (see the section "Oriven and other medicines").
• the patient has eye diseases, such as certain types of glaucoma (increased pressure in the eyeball).
• the patient has a history of high blood pressure.
• the patient has a history of heart disease.
• the patient has been informed that they have an abnormal heart rhythm.
• the patient has a history of seizures (epileptic fits).
• the patient has a history of decreased sodium levels in the blood (hyponatremia).
• if the patient has a history of bleeding disorders (tendency to bruise or bleed) or is taking other medicines that may increase the risk of bleeding, such as warfarin (a medicine used to prevent blood clots), or if the patient is pregnant (see the section "Pregnancy and breastfeeding").
• if the patient or anyone in their family has a history of mania or bipolar disorder (feeling excessively excited or euphoric).
• if the patient has a history of aggressive behavior.

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, the patient should inform their doctor.
The patient should not drink alcohol during treatment with Oriven, as it may cause extreme fatigue and loss of consciousness. Taking Oriven with alcohol and/or certain other medicines may increase the severity 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 have thoughts of self-harm or suicide. Such thoughts may worsen at the start of treatment with antidepressants, as these medicines usually start to work after 2 weeks, and sometimes later. Such thoughts may also occur after reducing the dose or during withdrawal of Oriven.
The occurrence of suicidal thoughts, self-harm, or suicide 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 young adults under 25 years of age 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 this leaflet. The patient may ask their 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 any worrying changes in behavior.
Dry mouth
Dry mouth is reported by 10% of patients treated with venlafaxine. This condition may increase the risk of tooth decay. Therefore, the patient should take special care of their oral hygiene.
Diabetes
Oriven may affect blood sugar levels, and therefore, it may be necessary to adjust the dose of antidiabetic medicines.
Sexual dysfunction
Medicines like Oriven (so-called SNRI) may cause sexual dysfunction (see section 4). In some cases, these symptoms 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 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 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 Oriven.
So far, there is no evidence of the long-term safety of this medicine regarding its impact on growth, maturation, and development of cognitive and behavioral functions in this age group.

Oriven and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The doctor will decide whether to use Oriven 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 first.
Irreversible monoamine oxidase inhibitors used to treat depression or Parkinson's disease should not be taken with Oriven. The patient should tell their doctor if they have taken these medicines in the last 14 days (IMAO; see the section "Important information before using Oriven").
Serotonin syndrome
During treatment with venlafaxine, a potentially life-threatening or neuroleptic malignant syndrome-like reaction may occur (see section 4 "Possible side effects"), especially when taken with other medicines.

• triptans (substances used to treat migraines)
• other antidepressants, such as selective serotonin reuptake inhibitors (SSRI), noradrenaline and serotonin reuptake inhibitors (SNRI), tricyclic antidepressants, or lithium-containing medicines
• 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 IMAO, moclobemide (used to treat depression)
• medicines containing sibutramine (used for weight loss)
• medicines containing opioids (e.g., buprenorphine, 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 methemoglobin levels 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)

The subjective and objective symptoms of serotonin syndrome may include 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 muscle enzyme activity (detected in blood tests).

In case of suspected serotonin syndrome, the patient should immediately contact their doctor or go to the nearest hospital's emergency department.

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).
• antihistamines (used to treat allergies).

The following medicines may also interact with Oriven, and therefore, the patient should use 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).

Oriven with food, drink, and alcohol

Oriven should be taken with food (see section 3 "How to use Oriven").
The patient should not drink alcohol during treatment with Oriven. Taking Oriven with alcohol may cause extreme fatigue and loss of consciousness, as well as worsen the 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 baby, they should consult their doctor or pharmacist before using this medicine. Oriven should only be used after discussing the potential benefits and risks with the doctor.
The patient should make sure that their midwife and/or doctor know that they are taking Oriven. During treatment during pregnancy, similar medicines (SSRI) may increase the risk of a severe condition in newborns called persistent pulmonary hypertension in the newborn (PPHN), causing rapid breathing and bluish discoloration in newborns.
These symptoms usually occur within the first 24 hours after birth. If these symptoms occur in the baby, the patient should immediately contact their midwife and/or doctor.
Taking Oriven at the end of pregnancy may increase the risk of severe postpartum hemorrhage, especially if the patient has a history of bleeding disorders. If the patient is taking Oriven, they should inform their doctor or midwife so that they can provide appropriate advice.
If the patient is taking 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 in their newborn, they should contact their doctor and/or midwife, who will be able to provide appropriate 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 treatment with this medicine.

Driving and using machines

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

Oriven, 150 mg in capsules, contains colorants: orange yellow and Allura red

Allura

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

Oriven, 225 mg in capsules, contains the colorant carmoisine

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

3. How to use Oriven

This medicine should always be used exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The usual recommended initial dose of venlafaxine for the treatment of depression, generalized anxiety disorder, and social phobia is 75 mg per day. The doctor may gradually increase this dose, up to a maximum dose of 375 mg, if necessary, for the treatment of depression. In patients with panic disorder, the doctor will prescribe a lower initial dose (37.5 mg) and then gradually increase it. The maximum dose for the treatment of generalized anxiety disorder, social phobia, 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. The capsules should not be divided, crushed, broken, or chewed.
Oriven should be taken with food.
The patient should inform their doctor about any liver or kidney problems, as it may be necessary to adjust the dose of this medicine.
The patient should not stop treatment with this medicine without consulting their doctor (see the section "Stopping Oriven").

Taking a higher dose of Oriven than prescribed

In case of taking a higher dose of this medicine than prescribed by the doctor, the patient should immediately contact their doctor or pharmacist.
Overdose may be life-threatening, especially when taken with alcohol and/or certain other medicines (see the section "Oriven and 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.

Missing a dose of Oriven

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 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 Oriven prescribed by the doctor.

Stopping Oriven

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 Oriven, they will inform the patient how to do it, gradually reducing the dose. In patients stopping this medicine, 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, restlessness, disorientation, ringing in the ears, tingling or rarely a feeling of electric shock, weakness, sweating, seizures or convulsions, or flu-like symptoms, changes in vision, and increased blood pressure (which may cause headache, dizziness, ringing in the ears, sweating, etc.).
The doctor will advise how to gradually stop Oriven. This may take several weeks or months. In some patients, it may be necessary to stop treatment more gradually, over several months or longer. If any of the above symptoms occur or worsen, the patient should consult their doctor.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Oriven can cause side effects, although not everybody gets them.
In case of experiencing any of the following side effects, the patient should stop using Oriven and immediately contact their doctor or go to the nearest hospital's emergency department:

Uncommon ( may affect up to 1 in 100 people)

• swelling of the face, lips, tongue, or throat, hands, or feet, and/or occurrence of a bulging, 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 (red or pale swelling, often itchy).
• symptoms of serotonin syndrome, which 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. Symptoms of neuroleptic malignant syndrome may include: fever, rapid heartbeat, sweating, muscle stiffness, disorientation, increased muscle enzyme activity (detected in blood tests).
• infection symptoms, such as high fever, chills, shivering, headache, excessive sweating, flu-like symptoms. These may be due to a blood disorder that can increase the risk of infection.
• severe 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 called stress cardiomyopathy (or "broken heart syndrome"), including: chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.

Other side effects that the patient should tell their doctor aboutinclude (the frequency of these side effects is included in the list below entitled "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, or dark urine, which may be signs of liver inflammation.
• heart rhythm disorders, such as rapid or irregular heartbeat, high blood pressure.
• vision disorders, such as blurred vision, dilated pupils.
• nervous system disorders, such as dizziness, tingling, coordination disorders (muscle spasms or stiffness), seizures or convulsions.
• psychiatric disorders, such as excessive restlessness and euphoria (feeling unnatural excitement).
• withdrawal symptoms (see the sections "How to use Oriven" and "Stopping Oriven").
• prolonged bleeding time - in case of cutting or injury, 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 of detachment (or separation) from oneself; lack of orgasm; decreased libido; restlessness, nervousness; unusual dreams
• tremors; feeling of restlessness or inability to sit or stand still; tingling; taste disorders; increased muscle tension
• vision disorders, 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 rash; itching -
• increased frequency of urination; urinary retention; difficulty urinating
• menstrual irregularities, such as heavy bleeding or more frequent irregular bleeding; ejaculation disorders/orgasm (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 reduced 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 and balance disorders
• dizziness (especially when standing up too quickly), decreased blood pressure
• vomiting blood; black tar-like stools (feces) or blood in the stool, which may be signs of internal bleeding
• increased sensitivity to light; 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 or convulsions
• cough, wheezing, shortness of breath, which may be accompanied by high fever
• disorientation and confusion, often with accompanying hallucinations (delirium)
• excessive water retention in the body (so-called syndrome of inappropriate antidiuretic hormone secretion)
• decreased sodium levels in the blood
• severe eye pain and vision changes 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 signs of liver inflammation

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

• prolonged bleeding, which may be a sign of decreased platelet count, indicating an increased risk of bruising or bleeding
• unusual milk production in women
• unexpected bleeding, such as gum bleeding, blood in the urine, or appearance of unexpected bruising 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 soon after stopping treatment, there have been reports of suicidal thoughts and behaviors (see the section "Important information before using Oriven")
• aggression
• vertigo of labyrinthine origin
• severe postpartum hemorrhage, occurring shortly after delivery (postpartum hemorrhage), see additional information in the subsection "Pregnancy and breastfeeding" in section 2.

Venlafaxine may sometimes cause side effects that the patient may not be aware of, such as increased blood pressure or abnormal heart rhythm; slight changes in liver enzyme activity, sodium levels, or rarely cholesterol levels in the blood. Even more rarely, venlafaxine may affect platelet function, leading to an increased risk of bruising or bleeding. For this reason, the doctor may recommend regular blood tests, especially during long-term use of Oriven.

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. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 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 to gather more information on the safety of this medicine.

5. How to store Oriven

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.
There are no special storage instructions for this 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 Oriven contains

• The active substance of Oriven is venlafaxine. Each capsule contains venlafaxine hydrochloride, equivalent to 37.5 mg, 75 mg, 150 mg, or 225 mg of venlafaxine.
• Other ingredients: capsule contents: microcrystalline cellulose, povidone, talc, colloidal anhydrous silica, magnesium stearate, ethyl cellulose, 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), orange yellow (E 110), Allura red (E 129), brilliant blue (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 stripes 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 stripes 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 stripes 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 stripes 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 capsules in blisters.
For 225 mg: 28 prolonged-release 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 about this medicine, the patient 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