Oriven

Package leaflet: Information for the user

Oriven, 37.5 mg, prolonged-release capsules, hard
Oriven, 75 mg, prolonged-release capsules, hard
Oriven, 150 mg, prolonged-release capsules, hard
Oriven, 225 mg, prolonged-release capsules, hard
Venlafaxine
Please read 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Oriven is and what it is used for
2. Important information before taking 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 medicine belonging to a group of medicines called serotonin-noradrenaline reuptake inhibitors (SNRIs). Medicines in this group are used in the treatment of 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 noradrenaline in the brain.
Oriven is used for the treatment of depression in adults. It is also used in 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). Appropriate treatment of depression or anxiety disorders is very important for improving the patient's well-being. Without treatment, the patient's condition may not improve, and the 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 currently taking or has taken within the last 14 days any medicine from the group of irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson's disease. Taking irreversible MAOIs together with Oriven may cause severe or even life-threatening adverse reactions. Also, before starting treatment with any MAOI medicine, the patient should

wait at least 7 days after stopping Oriven (see also the section titled “Oriven and other medicines” and information under “Serotonin syndrome”).
Warnings and precautions
Before starting treatment with Oriven, discuss this with your doctor or pharmacist if:

• the patient is taking other medicines which, when taken together with Oriven, may increase the risk of serotonin syndrome (see section “Oriven and other medicines”).
• the patient has eye diseases, such as certain types of glaucoma (increased pressure in the eyeball).
• the patient has previously experienced high blood pressure.
• the patient has previously had heart diseases.
• the patient has been informed of having an irregular heartbeat.
• the patient has previously experienced seizures (fits).
• the patient has previously experienced low sodium levels in the blood (hyponatraemia).
• if the patient has previously experienced bleeding disorders (tendency to bruise or bleed) or if taking other medicines that may increase the risk of bleeding, e.g. warfarin (a medicine used to prevent blood clots), or if the patient is pregnant (see section “Pregnancy and breastfeeding”).
• the patient or anyone in their family has previously experienced mania or bipolar disorder (feelings of excessive excitement or euphoria).
• the patient has previously experienced aggressive behaviour.

Oriven may cause feelings of restlessness or inability to sit still during the first few weeks of treatment. If such symptoms occur, inform your doctor.
Do not consume alcohol during treatment with Oriven, as this may cause extreme tiredness and loss of consciousness. Concurrent use with alcohol and (or) certain medicines may worsen symptoms of depression and other medical conditions such as anxiety disorders.
Suicidal thoughts and worsening of depression or anxiety disorders
Patients with depression and (or) anxiety disorders may sometimes have thoughts of self-harm or suicide. These thoughts may worsen at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, or sometimes longer, to start working. Such thoughts may also occur when the dose is reduced or during discontinuation of Oriven.
The occurrence of suicidal thoughts, thoughts of self-harm or suicide is more likely if:

• the patient has previously experienced suicidal thoughts or self-harm;
• the patient is a young adult; clinical trial data indicate an increased risk of suicidal behaviour in young adults under 25 years of age with psychiatric disorders who were treated with antidepressants.

If the patient experiences suicidal thoughts or thoughts of self-harm, contact a doctor immediately or go to the nearest 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 for help from relatives or friends and request them to inform the patient if they notice worsening of depression or anxiety, or concerning changes in behaviour.
Dry mouth
Dry mouth is reported by 10% of patients treated with venlafaxine. This condition may increase the risk of tooth decay. Therefore, special attention should be paid to oral hygiene.
Diabetes
Oriven may cause changes in blood glucose levels and therefore may require adjustment of the dose of antidiabetic medicines.
Sexual dysfunction
Medicines such as Oriven (so-called SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Children and adolescents
Oriven must 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 from this group are at increased risk of adverse reactions such as suicide attempts, suicidal thoughts and hostility (particularly aggression, defiant behaviour and anger). Nevertheless, a doctor may prescribe this medicine to patients under 18 years of age if they consider it beneficial. If a doctor has prescribed this medicine to a patient under 18 years of age, consult the doctor again in case of any doubts. Inform the doctor if any of the above symptoms occur or worsen in patients under 18 years of age taking Oriven.
Long-term safety regarding the effect of this medicine on growth, maturation and cognitive and behavioural development in this age group has not yet been established.
Oriven and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Your doctor will decide whether Oriven can be used together with other medicines.
Do not start or stop taking any other medicines, including over-the-counter medicines, natural or herbal remedies, without first consulting your doctor or pharmacist.
Monoamine oxidase inhibitors used to treat depression or Parkinson's disease must not be taken with Oriven. Inform your doctor if you have taken these medicines within the last 14 days (MAOIs; see section “Important information before using Oriven”).
Serotonin syndrome
During treatment with venlafaxine, a potentially life-threatening condition may occur, or symptoms resembling neuroleptic malignant syndrome (see section 4 “Possible side effects”), especially when taken together with other medicines.
These medicines include:

• triptans (substances used for migraine headaches)
• other antidepressants, e.g. selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants or medicines containing lithium
• medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy and obesity)
• medicines containing the antibiotic linezolid (a substance used to treat infections)
• medicines containing MAOIs, moclobemide (a substance used to treat depression)
• medicines containing sibutramine (a substance used for weight loss)
• medicines containing opioids (e.g. buprenorphine, tramadol, fentanyl, tapentadol, pethidine or pentazocine), substances 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 (a substance used to treat high levels of methemoglobin in the blood)
• medicines containing St. John's wort ( Hypericum perforatum , natural or herbal remedies used to treat mild depression)
• medicines containing tryptophan (used for sleep problems and depression)
• antipsychotics (used to treat diseases with symptoms such as hearing, seeing and feeling things that are not real, delusions, unnatural suspicion, unclear thinking, social withdrawal).

Subjective and objective symptoms of serotonin syndrome may include:

• restlessness, hallucinations, lack of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, hyperreflexia, diarrhoea, drowsiness, nausea, vomiting.

The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome. Its subjective and objective symptoms include: fever, rapid heart rate, sweating, muscle rigidity, disorientation, increased muscle enzyme activity (detected in blood tests).
If serotonin syndrome is suspected, inform your doctor immediately or go to the nearest hospital emergency department.
If the patient is taking medicines that may affect heart rhythm, inform the doctor.
Examples of such medicines:

• antiarrhythmics such as quinidine, amiodarone, sotalol or dofetilide (used to treat heart rhythm disorders).
• antipsychotics 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 should be used with caution. It is particularly important to inform the doctor if the patient is taking medicines containing:

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

Oriven with food, drink and alcohol
Oriven should be taken with food (see section 3 “How to take Oriven”).
Do not consume alcohol during treatment with Oriven. Concurrent use with alcohol may cause extreme tiredness and loss of consciousness and may worsen symptoms of depression and other medical conditions such as anxiety disorders.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine. Oriven may be used only after discussing with a doctor the potential benefits and potential risks to the unborn child.
Ensure that the midwife and (or) doctor knows that you are taking Oriven. During pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), causing rapid breathing and cyanosis in infants.
These symptoms usually occur within the first 24 hours after birth. If these symptoms occur in the baby, contact your midwife and (or) doctor immediately.
Taking Oriven towards the end of pregnancy may increase the risk of severe vaginal bleeding shortly after childbirth, especially if the patient has a history of blood clotting disorders. If the patient is taking Oriven, she should inform her doctor or midwife so they can provide appropriate advice.
If the patient takes this medicine during pregnancy, the newborn may experience the following symptoms after birth: feeding difficulties and breathing problems. If the patient is concerned about such symptoms in the newborn, contact the doctor and (or) midwife, who will be able to provide appropriate advice.
Venlafaxine passes into breast milk. There is a risk of effects on the infant. Therefore, this issue should be discussed with the doctor, and the doctor will decide whether breastfeeding should be discontinued or treatment with this medicine stopped.
Driving and operating machinery
Do not drive or operate machinery until the patient knows how this medicine affects them.
Oriven 150 mg capsules contain colouring agents: sunset yellow and Allura red
The 150 mg capsule contains colouring agents, sunset yellow (E 110) and Allura red (E 129), which may cause allergic reactions.
Oriven 225 mg capsules contain the colouring agent carmoisine
The 225 mg capsule contains the colouring agent carmoisine (E 122), which may cause allergic reactions.

3. How to use Oriven

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.

The usual starting dose of venlafaxine for the treatment of depression, generalised anxiety disorder and social phobia is 75 mg per day. Your doctor may gradually increase this dose, up to a maximum of 375 mg per day, 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 then be gradually increased. The maximum dose for the treatment of generalised anxiety disorder, social phobia and panic disorder is 225 mg per day.

Oriven should be taken every day at approximately the same time, regardless of whether it is taken in the morning or evening.

The capsules should be swallowed whole with liquid. Do not divide, crush, break or chew the capsules.

Oriven should be taken with food.

Inform your doctor if you have any liver or kidney problems, as your dose of this medicine may need to be adjusted.

Do not stop taking this medicine without consulting your doctor (see section "Stopping treatment with Oriven").

Taking more Oriven than prescribed

If you take more Oriven than prescribed, contact your doctor or pharmacist immediately.

Overdose can be life-threatening, especially when taken with alcohol and/or certain other medicines (see section "Oriven with other medicines").

Symptoms of overdose may include increased heart rate, disturbances in consciousness (ranging from drowsiness to coma), visual disturbances, seizures or convulsions, and vomiting.

Missing a dose of Oriven

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take only your next dose at the usual time. Do not take a double dose to make up for a missed dose. Do not take more than the daily dose of Oriven prescribed by your doctor in one day.

Stopping treatment with Oriven

Do not stop treatment or reduce the dose of Oriven without consulting your doctor, even if you feel better. If your doctor decides that Oriven should be discontinued, they will advise you on how to do so gradually by reducing the dose step by step.

Patients stopping this medicine, especially those who stop suddenly or reduce the dose too quickly, may experience adverse effects such as suicidal thoughts, aggression, fatigue, dizziness, a sensation of emptiness in the head, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness, agitation, disorientation, tinnitus, tingling or, rarely, an electric shock-like sensation, weakness, sweating, seizures, flu-like symptoms, visual disturbances and increased blood pressure (which may cause headache, dizziness, tinnitus, sweating, etc.).

Your doctor will advise you on how to gradually discontinue Oriven. This process may take several weeks or months. For some patients, a more gradual discontinuation over several months or longer may be necessary. If any of the symptoms listed above, or other bothersome symptoms, occur, consult your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
If any of the following adverse reactions occur, discontinue Oriven and contact your doctor immediately or go to the nearest hospital Emergency Department:

Not common (may affect up to 1 in 100 people)

• swelling of the face, lips, tongue or throat, hands or feet, and (or) raised, itchy rash, difficulty swallowing or breathing.

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

• chest tightness, wheezing, difficulty swallowing or breathing.
• severe skin rash, itching, urticaria (swelling with red or pale discoloration, often accompanied by itching).
• subjective and objective symptoms of serotonin syndrome, which may include: psychomotor agitation, hallucinations, loss of coordination, rapid heart rate, elevated body temperature, rapid changes in blood pressure, hyperreflexia, diarrhea, somnolence, nausea, vomiting. The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome. Symptoms of neuroleptic malignant syndrome may include fever, rapid heart rate, sweating, muscle rigidity, confusion, increased muscle enzyme activity (detected in blood tests).
• signs of infection such as high fever, chills, shivering, headache, excessive sweating, flu-like symptoms. These may result from blood disorders that can lead to an increased 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 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 adverse reactions that should be reported to your doctor include (the frequency of these adverse reactions is listed below under "Other adverse reactions that may occur"):

• cough, wheezing, and shortness of breath, possibly accompanied by high fever.
• black (tarry) 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 problems such as rapid or irregular heartbeat, elevated blood pressure.
• vision disturbances such as blurred vision, dilated pupils.
• nervous system disorders such as dizziness, tingling sensations, movement coordination problems (muscle spasms or stiffness), seizures or convulsions.
• psychiatric disorders such as excessive restlessness and euphoria (feeling of unnatural excitement).
• symptoms of drug withdrawal (see sections "How to take Oriven" and "Stopping Oriven").
• prolonged bleeding time – in case of cuts or injuries, the time required to stop bleeding may be slightly longer than usual.

Other adverse reactions 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; anorgasmia; decreased libido; restlessness, nervousness; unusual dreams
• tremor; feeling of anxiety or inability to sit still or remain motionless; tingling; taste disturbances; increased muscle tension
• vision disturbances, including blurred vision; dilated pupils; inability of the eye to accommodate (automatic focusing from distant to near objects)
• ringing in the ears (tinnitus)
• rapid heartbeat; palpitations
• increased blood pressure; sudden flushing
• shortness of breath; yawning
• vomiting; diarrhea
• mild rash; itching
• increased frequency of urination; urinary retention; problems with urination
• menstrual irregularities, such as heavy bleeding or more frequent irregular bleeding; ejaculation/orgasm disorders (men); erectile dysfunction (impotence)
• weakness (asthenia); fatigue; chills
• increased body weight; decreased body weight
• increased blood cholesterol levels

Not common (may affect up to 1 in 100 people)

• excessive excitement, racing thoughts, and reduced need for sleep (mania)
• hallucinations, feeling detached (or separated) from reality; orgasm disorders; apathy; feeling of excessive stimulation; teeth grinding
• fainting; involuntary muscle movements; coordination and balance disturbances
• dizziness (especially when standing up too quickly), decreased blood pressure
• vomiting blood; black, tarry stools (faeces) or blood in the stool, which may indicate internal bleeding
• light sensitivity; bruising; excessive hair loss
• urinary incontinence
• stiffness, spasms, and involuntary muscle movements
• slight changes in liver enzyme activity in blood

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

• seizures or convulsions
• cough, wheezing, and shortness of breath, possibly accompanied by high fever
• disorientation and confusion, often with accompanying hallucinations (delirium)
• excessive fluid retention in the body (so-called syndrome of inappropriate antidiuretic hormone secretion)
• decreased sodium levels in blood
• severe eye pain and worsening 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 reduced platelet count, indicating increased risk of bruising or bleeding
• unusual milk production in women
• unexpected bleeding, e.g. bleeding gums, blood in urine or vomit, appearance of unexpected bruises or broken blood vessels (broken veins)

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

• suicidal thoughts and behaviors; cases of suicidal thoughts and behaviors have been reported during treatment with venlafaxine or shortly after discontinuation (see section 2 "Important information before taking Oriven")
• aggression
• vertigo of labyrinthine origin
• severe vaginal bleeding occurring shortly after childbirth (postpartum hemorrhage), see additional information in subsection "Pregnancy and breastfeeding" in section 2.

Venlafaxine may sometimes cause adverse reactions that patients may not be aware of, such as increased blood pressure or abnormal heart function; slight changes in liver enzyme activity, sodium levels, or rarely cholesterol levels in blood. Very rarely, venlafaxine may affect platelet function, leading to an increased risk of bruising or bleeding. For this reason, your doctor may recommend periodic blood tests, especially during long-term treatment with Oriven.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Oriven

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
There are no special storage requirements for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This 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.
• Other ingredients: Capsule contents: microcrystalline cellulose, povidone, talc, colloidal anhydrous silica, magnesium stearate, ethylcellulose, copovidone.

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

What Oriven looks like and contents of the pack
Prolonged-release, hard capsules
Oriven 37.5 mg:
light grey and peach 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 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 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 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 capsules in blister packs.
For 225 mg: 28 prolonged-release capsules in blister packs, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]