Faxolet er

Package leaflet: Information for the user

Faxolet ER, 37.5 mg, prolonged-release capsules, hard
Faxolet ER, 75 mg, prolonged-release capsules, hard
Faxolet ER, 150 mg, prolonged-release capsules, hard
(venlafaxine)
Please 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, 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 them even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What Faxolet ER is and what it is used for
2. What you need to know before taking Faxolet ER
3. How to take Faxolet ER
4. Possible side effects
5. How to store Faxolet ER
6. Contents of the pack and other information

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

Faxolet ER contains the active substance venlafaxine.
Faxolet ER is an antidepressant medicine belonging to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs). These medicines are used in the treatment of depression and other conditions such as anxiety disorders. It is believed that people with depression and/or anxiety have lower levels of serotonin and noradrenaline in the brain. 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.
Faxolet ER is used to treat depression in adults. Faxolet ER is also indicated for the treatment of the following anxiety disorders in adults: generalized anxiety disorder, social phobia, and panic disorder (panic attacks).
For patients to feel better, it is important that depression and anxiety disorders are properly treated. If treatment is not initiated, the condition may persist or worsen and become more difficult to treat.

2. Important information before taking Faxolet ER

When not to take Faxolet ER

• 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 Faxolet ER may cause severe or even life-threatening adverse effects. At least 7 days must pass after stopping Faxolet ER before starting any MAOI treatment (see also section "Faxolet ER and other medicines" and information on serotonin syndrome below).

Warnings and precautions
Before starting treatment with Faxolet ER, discuss this with your doctor or pharmacist.

• If the patient is taking other medicines that, when used together with Faxolet ER, may increase the risk of serotonin syndrome (see section "Faxolet ER and other medicines").
• If the patient has eye disorders, such as certain types of glaucoma (increased pressure in the eyeball).
• If the patient has previously had high blood pressure.
• If the patient has previously had heart disease.
• If the patient has previously had seizures (epilepsy).
• If the patient has previously had low sodium levels in the blood (hyponatremia).
• If the patient has a tendency to bruise easily or to bleed (bleeding disorders in the past), or if taking medicines that may increase the risk of bleeding, e.g. warfarin (an anticoagulant), or if the patient is pregnant (see "Pregnancy and breastfeeding").
• If the patient or any family member has previously had mania or bipolar disorder (feelings of excessive excitement or euphoria).
• If the patient has previously exhibited aggressive behaviour.

Faxolet ER may cause feelings of restlessness or inability to sit still during the first few weeks of treatment. If such symptoms occur, inform your doctor.
Medicines such as Faxolet ER (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms may persist after discontinuation of treatment.
Suicidal thoughts and worsening of depression or anxiety disorders
Patients with depression and/or anxiety disorders may sometimes have thoughts about self-harm or suicide. These symptoms or behaviours may worsen at the beginning of antidepressant treatment, as these medicines usually take about 2 weeks or longer to take effect. Such thoughts may also occur when the dose is reduced or when treatment with Faxolet ER is discontinued.
The risk of suicidal thoughts, self-harm or suicide attempts is higher if:

• the patient has previously experienced suicidal thoughts or self-harm;
• the patient is a young adult; clinical data indicate an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders 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 family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask family or friends for help and request them to inform the patient if they notice worsening depression or anxiety, or concerning changes in behaviour.
Dry mouth
Dry mouth has been reported in 10% of patients treated with venlafaxine. This may increase the risk of dental caries. Therefore, special attention should be paid to oral hygiene.
Diabetes
Faxolet ER may alter blood glucose levels, and therefore may necessitate adjustment of the dose of antidiabetic medicines.
Children and adolescents
Faxolet ER should not be used in children and adolescents under 18 years of age. It should also be emphasized that patients under 18 years of age who take medicines of this class 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, any doubts should be discussed again with the doctor. Inform the doctor if any of the above symptoms occur or worsen in patients under 18 years of age taking Faxolet ER. Long-term safety regarding the impact on growth, maturation, and cognitive and behavioural development in this age group has not yet been established.
Faxolet ER and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned for use.
Your doctor will decide whether Faxolet ER 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 (MAOIs) used in the treatment of depression or Parkinson’s disease must not be taken with Faxolet ER. Inform your doctor if you have taken any of these medicines within the last 14 days (see section "Important information before taking Faxolet ER").
• Serotonin syndrome: Serotonin syndrome, a potentially life-threatening condition, or neuroleptic malignant syndrome-like reactions (see section "Possible side effects"), may occur during treatment with venlafaxine, especially when taken together with other medicines. Examples of such medicines include:
• triptans (used for migraine headaches)
• other medicines used to treat depression, e.g. selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, or medicines containing 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 MAO inhibitor (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 buprenorphine or methadone (used to treat opioid dependence or severe pain)
• medicines containing methylene blue (used to treat high methemoglobin levels in blood)
• medicines containing St. John’s wort (Hypericum perforatum, a natural herbal remedy used for mild depression)
• medicines containing tryptophan (used for sleep problems and depression)
• antipsychotics (used to treat conditions with symptoms such as hearing, seeing, and feeling things that do not exist, delusions, unnatural suspicion, unclear thinking, social withdrawal).

Subjective and objective symptoms of serotonin syndrome may include a combination of the following: restlessness, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, hyperreflexia, diarrhoea, coma, nausea, vomiting.
The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome. Symptoms include fever, increased heart rate, sweating, muscle rigidity, confusion, and elevated muscle enzymes (detected in blood tests).
If serotonin syndrome is suspected, contact 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 include:

• 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 Faxolet ER and should therefore be used with caution. It is especially important to inform your 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 hypertension and heart disease).

Taking Faxolet ER with food, drink and alcohol
Faxolet ER should be taken with food (see section 3 "How to take Faxolet ER").
During treatment with Faxolet ER, alcohol should be avoided.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.
Faxolet ER should only be used after discussing with the doctor the potential benefits and potential risks to the unborn child.
Ensure that the midwife and/or doctor are informed about the use of Faxolet ER. Taking similar medicinal products (SSRIs) during pregnancy may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), causing rapid breathing and bluish skin. These symptoms usually appear within the first day after birth. If they occur in the baby, contact the midwife and/or doctor immediately.
If the patient takes this medicine during pregnancy, in addition to breathing difficulties, the newborn may also experience other symptoms such as poor feeding. If such symptoms are observed in the newborn after birth and cause concern, contact the doctor and/or midwife, who will be able to provide appropriate advice.
Taking Faxolet ER late in pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Faxolet ER, she should inform her doctor or midwife so they can 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, who will decide whether to discontinue breastfeeding or stop treatment with this medicine.
Driving and operating machinery
Do not drive or operate machinery until the effect of the medicine on the patient's body is known.
Faxolet ER contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning it is considered "sodium-free".
3. How to take Faxolet ER
This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist.
The usual initial dose for treating depression, generalized anxiety disorder, and social phobia is 75 mg per day. The doctor may gradually increase the dose if necessary, up to a maximum dose of 375 mg per day in the case of depression. For panic disorder, treatment should start with a lower dose (37.5 mg), which is then gradually increased. The maximum dose for treating generalized anxiety disorder, social phobia, and panic disorder is 225 mg per day.
Faxolet ER should be taken daily at approximately the same time, either in the morning or evening. Capsules should be swallowed whole with liquid. Do not split, crush, chew, or dissolve them.
Faxolet ER should be taken with food.
Inform the doctor about any liver or kidney problems, as the dose may need to be adjusted.
Do not stop treatment with Faxolet ER without consulting the doctor (see section "Discontinuing treatment with Faxolet ER").
Taking more than the recommended dose of Faxolet ER
If more than the recommended dose of Faxolet ER is taken, contact a doctor immediately.
Symptoms of possible overdose may include rapid heartbeat, disturbances in consciousness (from drowsiness to coma), visual disturbances, seizures, or vomiting.
Missing a dose of Faxolet ER
If a dose is missed, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and take only the next scheduled 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 Faxolet ER prescribed by the doctor in one day.
Discontinuing treatment with Faxolet ER
Do not stop treatment or reduce the dose of the medicine without consulting the doctor, even if the patient feels better. If the doctor decides that Faxolet ER can be discontinued, they will inform the patient how to gradually reduce the dose before stopping treatment completely. Patients discontinuing this medicine, especially those who stop treatment suddenly or reduce the dose too quickly, may experience adverse effects such as suicidal thoughts, aggressive behaviour, fatigue, dizziness, feeling of emptiness in the head, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness, agitation, confusion, ringing in the ears, tingling sensations, or rarely electric shock-like sensations, weakness, sweating, seizures, flu-like symptoms, visual disturbances, and increased blood pressure (which may cause headache, dizziness, ringing in the ears, sweating, etc.).
The doctor will advise on how to gradually discontinue Faxolet ER. This may take several weeks or months. In some patients, very gradual discontinuation over several months or longer may be necessary. If any of the listed symptoms or other bothersome symptoms occur, consult the doctor.
If in doubt about the use of the medicine, consult the doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following adverse effects occur, discontinue Faxolet ER and contact your doctor immediately or go to the nearest hospital Emergency Department:

Not very common (may occur in fewer than 1 in 100 people)

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

Rare (may occur in fewer than 1 in 1,000 patients)

• Chest tightness, gasping, difficulty swallowing or breathing.
• Severe skin rash, itching or urticaria (red or pale raised areas, often accompanied by itching).
• Symptoms of serotonin syndrome may include: restlessness, hallucinations, loss of motor coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, hyperreflexia, diarrhea, drowsiness, 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 rigidity, confusion, increased muscle enzyme levels (detected in blood tests).
• Signs of infection such as high fever, chills, shivering, headache, sweating, flu-like symptoms. These may indicate blood disorders, which could increase the risk of infection.
• Severe rash, which may lead to the formation of severe blisters and skin peeling.
• Muscle pain of unknown origin, tenderness or weakness. These may be symptoms of rhabdomyolysis.

Frequency unknown (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.

If any of the following adverse effects occur, contact your doctor (the frequency of these adverse effects is listed below under "Other adverse effects"):

• Cough, gasping 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 feelings of unnatural excitement.
• Withdrawal symptoms (see sections "How to take Faxolet ER" and "Stopping treatment with Faxolet ER").
• Prolonged bleeding time – in case of cuts, the time required to stop bleeding may be slightly longer than usual.

Other adverse effects
Very common (may occur in more than 1 in 10 patients)

• Dizziness; headache, drowsiness
• Insomnia
• Nausea; dry mouth, constipation
• Sweating (including night sweats)

Common (may occur in fewer than 1 in 10 patients)

• Decreased appetite
• Disorientation; feeling detached (or separated) from oneself; anorgasmia; reduced libido; agitation; nervousness; unusual dreams
• Tremor; feeling of restlessness 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; inability to urinate; problems with urination
• Menstrual disorders such as heavy bleeding or more frequent irregular bleeding; ejaculation/orgasm disorders (men); erectile dysfunction (impotence)
• Weakness (asthenia); fatigue; chills
• Increased body weight, weight loss
• Increased blood cholesterol levels

Not very common (may occur in fewer than 1 in 100 patients)

• Excessive activity, racing thoughts and reduced need for sleep (mania)
• Hallucinations; feeling detached (or separated) from reality; agitation; orgasm disorders (women); apathy; feeling of excessive excitement; teeth grinding
• Fainting; uncontrolled muscle movements; coordination and balance disorders
• Dizziness (especially upon standing too quickly), low blood pressure
• Vomiting blood; black, tarry stools (faeces) or blood in the stool, which may indicate internal bleeding
• Light sensitivity; bruising; rash; excessive hair loss
• Urinary incontinence
• Muscle stiffness, spasms and uncontrolled muscle movements
• Minor changes in liver enzyme levels in blood

Rare (may occur in fewer than 1 in 1,000 patients)

• Seizures
• Cough, gasping, shortness of breath and high fever, which are symptoms of lung inflammation associated with increased white blood cell count (pulmonary eosinophilia)
• Disorientation with frequent hallucinations (delirium)
• Excessive fluid retention in the body
• Decreased sodium levels in 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 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 occur in fewer than 1 in 10,000 patients)

• Prolonged bleeding, which may be a sign of reduced platelet count, indicating increased risk of bruising or bleeding
• Abnormal milk production in women
• Unexpected bleeding, e.g. bleeding gums, blood in urine or vomit, unexpected appearance of bruises or broken blood vessels (ruptured veins)

Frequency unknown (frequency cannot be estimated from available data)

• Suicidal thoughts and behaviour; suicidal thoughts and behaviour have been reported during treatment with venlafaxine or shortly after treatment discontinuation (see section 2. Important information before using Faxolet ER)
• Dizziness
• Severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection "Pregnancy and breastfeeding" in section 2

Faxolet ER may sometimes cause adverse effects that the patient may not be aware of, such as increased blood pressure or abnormal heart function; minor changes in blood sodium, cholesterol or liver enzyme levels. In even rarer cases, Faxolet ER may impair platelet function, increasing the risk of bruising or bleeding.
Therefore, your doctor may occasionally recommend blood tests, especially during long-term treatment with Faxolet ER.

Reporting of adverse effects
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Faxolet ER

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and outer packaging.
The expiry date refers to the last day of the indicated month.
Do not store above 30 °C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the Package and Other Information

What the medicine Faxolet ER contains

• The active substance is venlafaxine. One prolonged-release hard capsule contains 37.5 mg, 75 mg, or 150 mg of venlafaxine as venlafaxine hydrochloride.
• Other ingredients are:

Faxolet ER 37.5 mg, prolonged-release hard capsules
Capsule core: hypromellose, ammonio methacrylate copolymer (type B), sodium lauryl sulfate (E487), magnesium stearate.
Coating: basic butyl methacrylate copolymer 12.5%.
Capsule shell: titanium dioxide (E171), gelatin.
Printing ink: shellac, iron oxide black (E172), propylene glycol.

Faxolet ER 75 mg, prolonged-release hard capsules
Capsule core: hypromellose, ammonio methacrylate copolymer (type B), sodium lauryl sulfate (E487), magnesium stearate.
Coating: basic butyl methacrylate copolymer 12.5%.
Capsule shell: titanium dioxide (E171), iron oxide red (E172), gelatin.
Printing ink: shellac, iron oxide black (E172), propylene glycol.

Faxolet ER 150 mg, prolonged-release hard capsules
Capsule core: hypromellose, ammonio methacrylate copolymer (type B), sodium lauryl sulfate (E487), magnesium stearate.
Coating: basic butyl methacrylate copolymer 12.5%.
Capsule shell: titanium dioxide (E171), erythrosine (E127), indigo carmine I (E132), gelatin.
Printing ink: shellac, iron oxide black (E172), propylene glycol.

What Faxolet ER looks like and contents of the pack
Faxolet ER 37.5 mg, prolonged-release hard capsules: white, opaque gelatin capsules (size 0), containing one round, biconvex coated tablet, with "VEN" printed on the cap and "37.5" on the body of the capsule.
Faxolet ER 75 mg, prolonged-release hard capsules: flesh-coloured, opaque gelatin capsules (size 0), containing two round, biconvex coated tablets, with "VEN" printed on the cap and "75" on the body of the capsule.
Faxolet ER 150 mg, prolonged-release hard capsules: scarlet, opaque gelatin capsules (size 00), containing three round, biconvex coated tablets, with "VEN" printed on the cap and "150" on the body of the capsule.

Faxolet ER 37.5 mg:
Pack contains 28 or 98 capsules.
Faxolet ER 75 mg:
Pack contains 28 or 98 capsules.
Faxolet ER 150 mg:
Pack contains 28 or 98 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland

Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Poland
Pharmathen S.A.
6, Dervenakion Str.
15351 Pallini, Attikis
Greece
Pharmathen International S.A.
Sapes Industrial Park
Block 5
69300 Rodopi
Greece

This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark: Panofen 37.5 mg, 75 mg, 150 mg depotkapsler, hårde
Greece: Velept XR 75 mg, 150 mg σκληρά καψάκια παρατεταμένης αποδέσμευσης
Spain: Venlafaxina Retard Mylan 75 mg, 150 mg cápsulas duras de liberación prolongada
Italy: Venlafaxina EG 75 mg, 150 mg capsule rigide a rilascio prolungato