Efectin Er 150

Leaflet attached to the packaging: information for the user

Efectin ER 37.5

37.5 mg, prolonged-release hard capsules

Efectin ER 75

75 mg, prolonged-release hard capsules

Efectin ER 150

150 mg, prolonged-release hard capsules

venlafaxine

You should carefully read the contents of the leaflet before taking 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.
• If you have 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 Efectin ER and what is it used for
• 2. Important information before taking Efectin ER
• 3. How to take Efectin ER
• 4. Possible side effects
• 5. How to store Efectin ER
• 6. Contents of the packaging and other information

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

Efectin ER contains the active substance venlafaxine.
Efectin ER is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). These medicines are used to treat depression and other 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 norepinephrine in the brain.
Efectin ER is used to treat depression in adults. Efectin ER is also indicated for 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). For the patient to feel better, it is essential that the treatment of depression and anxiety disorders is carried out correctly. If the patient does not undergo treatment, their condition may not improve, may worsen, and will be much more difficult to treat.

2. Important information before taking Efectin ER

When not to take Efectin 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 taking, or has taken within the last 14 days, any monoamine oxidase inhibitor (MAOI) medicines, which are used to treat depression or Parkinson's disease. Taking MAOIs with Efectin ER may cause serious or even life-threatening side effects. Before starting any MAOI medicine, the patient should also wait at least 7 days after stopping Efectin ER (see also "Efectin ER and other medicines" and the information in this section about serotonin syndrome).

Warnings and precautions

Beforestarting treatment with Efectin ER, 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 Efectin ER (see "Efectin ER and other medicines").
• If the patient has eye problems, such as certain types of glaucoma (increased pressure in the eyeball).
• If the patient has a history of high blood pressure.
• If the patient has a history of heart disease.
• If the patient has a history of heart rhythm disturbances.
• If the patient has a history of seizures (epilepsy).
• If the patient has a history of low 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 (used to prevent blood clots), or if they are pregnant (see "Pregnancy and breastfeeding").
• If the patient or anyone in their family has a history of mania (feeling excessively excited or euphoric) or bipolar disorder.
• If the patient has a history of aggressive behavior.

Efectin ER 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 while taking Efectin ER, as it may cause extreme fatigue and loss of consciousness. Taking Efectin ER with alcohol or certain other medicines may worsen symptoms 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 when first taking antidepressant medicines, as these medicines may start working after 2 weeks, and sometimes later. These thoughts may also occur when reducing the dose or stopping Efectin ER.
The risk of suicidal thoughts is higher 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 people under 25 years of age with mental disorders who are treated with antidepressant medicines.

If the patient experiences suicidal thoughts or thoughts of self-harm, they should contact their doctor or go to the hospital immediately.
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 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 worrying changes in behavior.
Dry mouth
Dry mouth was reported by 10% of patients treated with venlafaxine. It may increase the risk of tooth decay. Therefore, the patient should take special care of their oral hygiene.
Diabetes
Efectin ER may affect blood sugar levels, and it may be necessary to adjust the dose of antidiabetic medicines.
Sexual function disorders
Medicines like Efectin ER (SNRIs) may cause sexual function disorders (see section 4). In some cases, these disorders persisted after stopping treatment.

Children and adolescents

Efectin ER 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, rebellious behavior, and anger). However, the doctor may prescribe this medicine to patients under 18 years of age if they consider it beneficial. If the doctor has prescribed this medicine to a patient under 18 years of age, and the patient has any doubts, they should discuss it with their doctor again. The patient should inform their doctor if any of these symptoms occur or worsen in patients under 18 years of age taking Efectin ER. The long-term safety of Efectin ER in this age group, regarding effects on growth, maturation, and cognitive and behavioral development, has not been established.

Efectin ER and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
The doctor will decide whether to use Efectin ER with other medicines.
The patient should not start or stop taking other medicines, including those available without a prescription, herbal products, or dietary supplements, without consulting their doctor or pharmacist first.

• Monoamine oxidase inhibitors, used to treat depression or Parkinson's disease, must not be taken with Efectin ER. The patient should tell their doctor if they have taken these medicines within the last 14 days (MAOIs; see "Important information before taking Efectin ER").
• Serotonin syndrome: During treatment with venlafaxine, a life-threatening or neuroleptic malignant syndrome-like reaction may occur, especially when taken with other medicines. Examples of such medicines include:
• triptans (used to treat migraine headaches),
• other medicines used to treat depression, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, or lithium-containing medicines,
• 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 the MAO inhibitor 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 levels of methemoglobin in the blood),
• medicines containing St. John's Wort (Hypericum perforatum, herbal products or dietary supplements, 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 thinking, and withdrawal).

Subjective and objective symptoms of serotonin syndrome may include: restlessness, hallucinations, loss of coordination, rapid heart rate, elevated body temperature, rapid changes in blood pressure, overreactivity, 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 heart rate, sweating, muscle stiffness, disorientation, elevated levels of muscle enzymes (detected in blood tests).

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

If the patient is taking medicines that may affect heart rhythm, they should tell their doctor. Examples of such medicines include:

• antiarrhythmic medicines, such as quinidine, amiodarone, sotalol, or dofetilide (used to treat heart rhythm disturbances),
• antipsychotic medicines, such as thioridazine (see above - serotonin syndrome),
• antibiotics, such as erythromycin or moxifloxacin (used to treat bacterial infections),
• antihistamine medicines (used to treat allergies).

The following medicines may also interact with Efectin ER, and 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).

Taking Efectin ER with food, drink, and alcohol

Efectin ER should be taken with food (see section 3 "How to take Efectin ER").
The patient should not drink alcohol while taking Efectin ER. Taking Efectin ER with alcohol may cause extreme fatigue and loss of consciousness, as well as worsen 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 taking this medicine. Efectin ER should only be used after discussing the potential benefits and risks to the unborn child with the doctor.
Taking Efectin ER at the end of pregnancy may increase the risk of severe bleeding from the uterus, occurring shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Efectin ER, they should inform their doctor or midwife so that they can provide appropriate advice.
Similar medicines (SSRIs) taken during pregnancy may increase the risk of a serious condition in children and/or infants, called persistent pulmonary hypertension of the newborn, which causes rapid breathing and bluish discoloration. These symptoms usually occur within 24 hours of birth. If the patient notices such symptoms in their child, they should contact the midwife and/or doctor immediately.
If the patient is taking this medicine during pregnancy, after birth, the child may experience, in addition to breathing difficulties, other symptoms such as poor feeding. 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.
Efectin ER passes into breast milk. There is a risk of affecting the child. Therefore, the patient should discuss this with their doctor, who will decide whether to stop breastfeeding or stop treatment with Efectin ER.

Driving and using machines

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

Efectin ER 150 contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".

3. How to take Efectin ER

The patient should always take this medicine exactly as their doctor has told them. If they are unsure, they should ask their doctor or pharmacist.
Typically, the recommended starting dose for depression, generalized anxiety disorder, and social phobia is 75 mg once daily. The doctor may gradually increase this dose if necessary, up to a maximum dose of 375 mg once daily for depression. For panic disorder, treatment should be started with a lower dose (37.5 mg) and gradually increased. The maximum dose for generalized anxiety disorder, social phobia, and panic disorder is 225 mg once daily.
Efectin ER should be taken once daily, at approximately the same time, either in the morning or evening. The capsules should be swallowed whole with a drink of water. They should not be divided, crushed, chewed, or dissolved.
Efectin ER should be taken with food.
The patient should inform their doctor about any liver or kidney problems, as they may need to adjust the dose.
The patient should not stop taking this medicine without consulting their doctor (see "Stopping Efectin ER").

Taking a higher dose of Efectin ER than recommended

If the patient has taken more than the recommended dose of Efectin ER, they should contact their doctor immediately.
Overdose can be life-threatening, especially when taken with alcohol and/or certain other medicines (see "Efectin ER and other medicines").
Symptoms of possible overdose may include rapid heart rate, changes in consciousness (from drowsiness to coma), vision disturbances, seizures, and vomiting.

Missing a dose of Efectin ER

If the patient misses a dose, they should take it as soon as possible. However, if it is almost time for their next dose, they 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 a missed dose. The patient should not take more than the daily dose of Efectin ER prescribed by their doctor in a 24-hour period.

Stopping Efectin ER

The patient should not stop taking Efectin ER or reduce the dose without consulting their doctor, even if they feel better. If the doctor decides that it is possible to stop Efectin ER, they will tell the patient how to gradually reduce the dose before completely stopping treatment. When stopping treatment, especially after sudden discontinuation or too rapid dose reduction, the patient may experience side effects, such as suicidal thoughts, aggressive behavior, fatigue, dizziness, feeling empty-headed, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, disorientation, ringing in the ears, tingling or numbness, weakness, sweating, seizures, or flu-like symptoms, vision disturbances, and increased blood pressure (which may cause headaches, dizziness, ringing in the ears, sweating, etc.).
The doctor will advise the patient on how to gradually stop taking Efectin ER. This may take several weeks or months. In some patients, it may be necessary to stop the medicine very slowly over a period of several months or longer. If the patient experiences any of these symptoms or other symptoms that are troublesome, they should consult their doctor.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Efectin ER can cause side effects, although not everybody gets them.
If the patient experiences any of the following side effects, they should stop taking Efectin ER and contact their doctor or go to the nearest hospital emergency department:

Uncommon (may affect up to 1 in 100 people)

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

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

• Chest pain, wheezing, difficulty swallowing or breathing.
• Severe skin rash, itching, or hives (a red or pale raised rash, often itchy).
• Symptoms of serotonin syndrome, which may include: restlessness, hallucinations, loss of coordination, rapid heart rate, elevated body temperature, rapid changes in blood pressure, overreactivity, 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 heart rate, sweating, muscle stiffness, disorientation, elevated levels of muscle enzymes (detected in blood tests).
• Symptoms of infection, such as high fever, chills, shivering, headache, sweating, flu-like symptoms. This may be due to a blood disorder that increases the risk of infection.
• Severe rash, which may lead to severe blistering and peeling of the skin.
• Muscle pain of unknown cause, tenderness, or weakness. These may be symptoms of rhabdomyolysis.

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

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

If the patient experiences any of the following side effects, they should contact their doctor(the frequency of these side effects is given below in the "Other side effects" section):

• Cough, wheezing, and shortness of breath, which may be accompanied by high fever.
• Black (tar-like) stools or blood in stools, which may be a sign of internal bleeding.
• Itching, yellowing of the skin or whites of the eyes, or dark urine, which may be signs of liver inflammation.
• Heart rhythm disturbances, such as rapid or irregular heartbeat, high blood pressure.
• Vision disturbances, such as blurred vision, dilated pupils.
• Nervous system disturbances, such as dizziness, tingling, coordination disturbances (muscle spasms or stiffness), seizures or convulsions.
• Psychiatric disturbances, such as excessive restlessness and feelings of unnatural excitement.
• Withdrawal symptoms (see "How to take Efectin ER", "Stopping Efectin ER").
• Prolonged bleeding time - in case of injury, the wound may bleed slightly longer than usual.

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; agitation; nervousness; unusual dreams
• tremor; 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 (automatic change in focus from distant to near objects)
• ringing in the ears (tinnitus)
• rapid heartbeat; palpitations
• increased blood pressure; flushing
• shortness of breath; yawning
• vomiting; diarrhea
• mild rash; itching
• increased urination; urinary retention; urination problems
• irregular menstrual periods, i.e., heavy bleeding or more frequent irregular bleeding; ejaculation disorders / orgasm disorders (men); erectile dysfunction (impotence)
• weakness (asthenia); fatigue; chills
• weight gain; weight loss
• increased cholesterol levels in the blood

Uncommon (may affect up to 1 in 100 people)

• excessive excitement, racing thoughts, and reduced need for sleep (mania)
• hallucinations; feeling detached (or separated) from reality; orgasm disorders; apathy; feeling excessively excited; teeth grinding
• fainting; uncontrolled muscle movements; coordination and balance disturbances;
• dizziness (especially when standing up too quickly); decreased blood pressure;
• vomiting blood; black (tar-like) stools or blood in stools, which may be a sign of internal bleeding
• photosensitivity; 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
• cough, wheezing, and shortness of breath, which may be accompanied by high fever
• disorientation and confusion, often with hallucinations (delirium)
• excessive water retention in the body
• decreased 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 intestinal, liver, or pancreatic problems)
• 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 decreased 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 urine or vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins)

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

• suicidal thoughts and behaviors; during treatment with venlafaxine, or soon after stopping treatment, there have been reports of suicidal thoughts and behaviors (see section 2 "Important information before taking Efectin ER")
• aggressive behavior
• dizziness
• severe bleeding from the uterus, occurring shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy and breastfeeding" in section 2

Efectin ER may also 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, or cholesterol levels in the blood. In rare cases, Efectin ER may affect platelet function, increasing the risk of bruising or bleeding. Therefore, the doctor may recommend regular blood tests, especially during long-term treatment with Efectin ER.

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, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Efectin ER

The medicine should be stored out of the sight and reach of children.
The patient should not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month.
The patient should not store the medicine above 30°C.
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 Efectin ER contains

The active substance is venlafaxine.
Efectin ER 37.5
Each prolonged-release hard capsule contains 42.43 mg of venlafaxine hydrochloride, equivalent to 37.5 mg of venlafaxine as a free base.
Other ingredients:
Capsule contents: microcrystalline cellulose, ethylcellulose 50 cps, hypromellose 3 cps, hypromellose 6 cps, talc
Capsule shell: gelatin, iron oxide black, red, and yellow (E 172), titanium dioxide (E 171)
Ink for capsule printing: shellac, iron oxide red (E 172), ammonium hydroxide, simethicone, propylene glycol
Efectin ER 75
Each prolonged-release hard capsule contains 84.85 mg of venlafaxine hydrochloride, equivalent to 75 mg of venlafaxine as a free base.
Other ingredients:
Capsule contents: microcrystalline cellulose, ethylcellulose 50 cps, hypromellose 3 cps, hypromellose 6 cps, talc
Capsule shell: gelatin, iron oxide red and yellow (E 172), titanium dioxide (E 171)
Ink for capsule printing: shellac, iron oxide red (E 172), ammonium hydroxide, simethicone, propylene glycol
Efectin ER 150
Each prolonged-release hard capsule contains 169.7 mg of venlafaxine hydrochloride, equivalent to 150 mg of venlafaxine as a free base.
Other ingredients:
Capsule contents: microcrystalline cellulose, ethylcellulose 50 cps, hypromellose 3 cps, hypromellose 6 cps, talc
Capsule shell: gelatin, iron oxide red and yellow (E 172), titanium dioxide (E 171)
Ink for capsule printing: shellac, sodium hydroxide (see section 2 "Efectin ER 150 contains sodium"), povidone, titanium dioxide (E 171), propylene glycol

What Efectin ER looks like and contents of the pack

Efectin ER 37.5 is a non-transparent, prolonged-release, hard capsule (gelatin) in a light gray and peach color, 15.9 mm x 5.82 mm in size, with a red print "W" and strength "37.5".
Efectin ER 37.5 is available in:
blister packs containing 7, 10, 14, 20, 21, 28, 30, 35, 50, 60, 100 and hospital packs containing 70 (10x7, 1x70) capsules
single-dose blister packs containing 14, 28, 84, 100 capsules
HDPE (high-density polyethylene) bottles containing 7, 14, 20, 21, 35, 50, 100 and hospital packs containing 70 capsules.
Efectin ER 75 is a non-transparent, prolonged-release, hard capsule (gelatin) in a peach color, 19.4 mm x 6.91 mm in size, with a red print "W" and strength "75".
Efectin ER 75 is available in:
blister packs containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 98, 100 and hospital packs containing 500 (10x50) and 1000 (10x100) capsules
single-dose blister packs containing 14, 28, 84, 100 capsules
HDPE (high-density polyethylene) bottles containing 14, 20, 50, 100 and hospital packs containing 500 and 1000 capsules.
Efectin ER 150 is a non-transparent, prolonged-release, hard capsule (gelatin) in a dark orange color, 23.5 mm x 7.65 mm in size, with a white print "W" and strength "150".
Efectin ER 150 is available in:
blister packs containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 98, 100 and hospital packs containing 500 (10x50) and 1000 (10x100) capsules
single-dose blister packs containing 14, 28, 84, 100 capsules
HDPE (high-density polyethylene) bottles containing 14, 20, 50, 100 and hospital packs containing 500 and 1000 capsules.
Pack sizes approved for marketing in Poland:
Efectin ER 37.5 – 10 or 30 capsules
Efectin ER 75 – 14, 28, 30 or 100 capsules
Efectin ER 150 – 14, 28, 30 or 100 capsules
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Upjohn EESV
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
Netherlands
Manufacturer:
Pfizer Ireland Pharmaceuticals
Little Connell
Newbridge
Co. Kildare
Ireland
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
D-79090 Freiburg
Germany

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names*:

*[Not all medicines and their strengths may be marketed.]
To obtain more detailed information on this medicine, the patient should contact their local representative of the marketing authorization holder:

Mylan Healthcare Sp. z o.o.

phone: 22 546 64 00
Date of last revision of the leaflet:07/2023