Faxigen xl 75 mg: detailed information

Package leaflet: Information for the user

Faxigen XL 37.5 mg, prolonged-release capsules, hard
Faxigen XL 75 mg, prolonged-release capsules, hard
Faxigen XL 150 mg, prolonged-release capsules, hard
(Venlafaxinum)
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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

What Faxigen XL is and what it is used for
What you need to know before taking Faxigen XL
How to take Faxigen XL
Possible side effects
How to store Faxigen XL
Contents of the pack and other information

1. What Faxigen XL is and what it is used for

Faxigen XL contains the active substance venlafaxine, which is an antidepressant medicine belonging to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs). Medicines in this group are used to treat depression and other conditions such as anxiety disorders.
Faxigen XL is used to treat depression in adults and to prevent recurrence of major depressive episodes. Faxigen XL 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). For patients to feel better, it is important that treatment of depression and anxiety disorders is properly managed. Without treatment, the patient's condition may not improve, may worsen, and may become more difficult to treat.

2. Important information before using Faxigen XL

When not to use Faxigen XL

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 Faxigen XL may cause severe or even life-threatening adverse reactions. The patient must wait at least 7 days after stopping Faxigen XL before starting any medicine from the group of MAOIs (see also sections "Serotonin syndrome" and "Faxigen XL with other medicines").

Warnings and precautions
Before starting treatment with Faxigen XL, discuss with your doctor or pharmacist:

If the patient is taking other medicines which, when taken together with Faxigen XL, may increase the risk of serotonin syndrome (see section "Faxigen XL with other medicines").
If the patient has eye disorders, such as certain types of glaucoma (increased pressure in the eyeball), or if an ophthalmologist has informed the patient of an increased risk of glaucoma.
If the patient has previously had high blood pressure or recently suffered a heart attack.
If the patient or anyone in their family has previously had heart diseases.
If the patient has previously had heart rhythm disorders.
If the patient has previously had seizures (epilepsy).
If the patient has previously had low sodium levels in the blood (hyponatraemia), especially if the patient is elderly and taking diuretics (tablets causing increased urine production) or is dehydrated (e.g. due to severe diarrhoea or vomiting).
If the patient is prone to bruising or bleeding (past bleeding disorders), or if taking other blood-thinning medicines which may increase the risk of bleeding, or if the patient is pregnant (see "Pregnancy and breastfeeding").
If the patient or anyone in their family has previously had mania (feelings of excessive excitement or euphoria) or bipolar affective disorder.
If the patient has previously exhibited aggressive behaviour. The patient may experience aggression, particularly during the initial stages of treatment with Faxigen XL, during dose changes, or after stopping the medicine.
If the patient has diabetes (this medicine may affect blood sugar levels).
If the patient is taking any weight-loss medicines.

During treatment

This medicine may cause increased blood pressure or increased cholesterol levels. The doctor may recommend regular monitoring of blood pressure and cholesterol levels.
If the patient experiences restlessness or an inability to sit or stand still, which may occur in the early stages of treatment, consult a doctor or pharmacist.
If the patient is undergoing urine screening tests for certain drugs, Faxigen XL may affect these results. Inform the doctor or hospital staff that the patient is taking this medicine.
Faxigen XL capsules contain granules, part of which is insoluble and may be excreted and visible in the stool.

Do not consume alcohol during treatment with Faxigen XL, as this may cause extreme
fatigue and loss of consciousness. Concurrent use with alcohol and (or) certain medicines may
worsen symptoms of depression and other conditions such as anxiety disorders.
Suicidal thoughts and worsening of depression or anxiety disorders
Sometimes people with depression and (or) anxiety disorders may experience thoughts of
self-harm or suicide. These thoughts may worsen after starting antidepressant medicines, as these
medicines take time to work, usually about 2 weeks, sometimes longer. Such thoughts may also occur
during dose reduction or when stopping treatment with Faxigen XL.
The likelihood of such thoughts is higher:

if the patient has previously had thoughts of suicide or self-harm
in young adults; clinical studies indicate a higher risk of suicidal behaviour in adults under 25 years of age suffering from psychiatric disorders and treated with an antidepressant.

If thoughts of self-harm or suicide occur, seek immediate medical help
from your doctor 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 members or
friends to inform them if they notice worsening 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 dental caries. Therefore, special attention should be paid to oral hygiene.
Diabetes
Faxigen XL may alter blood glucose levels, and therefore adjustment of antidiabetic medication dosage may be necessary.
Sexual dysfunction
Medicines such as Faxigen XL (so-called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.
Children and adolescents
Faxigen XL should not be used in children and adolescents under 18 years of age. It should also be noted that in individuals under 18 years of age, there is an increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiant behaviour, and anger) during treatment with medicines of this group. Nevertheless, a doctor may decide to prescribe this medicine to a person under 18 years of age if they consider it to be in the patient's best interest. If a doctor prescribes this medicine to someone under 18 years of age and the patient wishes to discuss this issue, they should consult the doctor again. Inform the doctor if any of the above-mentioned symptoms appear or worsen during treatment with Faxigen XL. Furthermore, the long-term safety of this medicine in this age group with regard to effects on growth, maturation, and intellectual and behavioural development has not yet been established.
Faxigen XL with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take, including those available without a prescription, natural remedies, and herbal medicines.
The treating doctor will decide whether Faxigen XL can be used together with other medicines.

Do not take venlafaxine together with monoamine oxidase inhibitors (MAOIs) used to treat depression and Parkinson's disease. Inform your doctor if you have taken these medicines within the last 14 days (MAOIs: see section "Important information before using Faxigen XL").
Serotonin syndrome: During treatment with venlafaxine, a potentially life-threatening condition or neuroleptic malignant syndrome (NMS)-like reactions (see section "Possible side effects") may occur, especially when taken together with other medicines.

Examples of such medicines include:

triptans (used to treat migraines, e.g. sumatriptan, zolmitriptan)
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, a monoamine oxidase 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 methadone (used to treat opioid dependence or severe pain)
medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood)
medicines containing St. John's wort (Hypericum perforatum, a herbal remedy used to treat mild depression)
medicines containing tryptophan (used to treat sleep problems and depression)
antipsychotic medicines (used to treat illnesses characterised by hearing, seeing, or feeling things that do not exist, false beliefs, excessive suspiciousness, unclear thinking, and social withdrawal).

Subjective and objective symptoms of serotonin syndrome may include a combination of the
following: agitation, hallucinations, lack of coordination, rapid heartbeat, elevated body temperature,
rapid fluctuations in blood pressure, hyperreflexia, diarrhoea, coma, nausea, vomiting.
In the most severe cases, serotonin syndrome may resemble neuroleptic malignant syndrome (NMS).
Subjective and objective symptoms of NMS may include a combination of fever, rapid heartbeat,
sweating, severe muscle rigidity, confusion, mood changes, and increased muscle enzyme activity
(visible in blood tests).
If serotonin syndrome or neuroleptic malignant syndrome is suspected, the patient should
immediately inform their doctor or go to the nearest hospital emergency department.
Inform your doctor if the patient is taking medicines that may affect heart rhythm.
Examples of such medicines include:

antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat heart rhythm disorders);
antipsychotics such as thioridazine (see also 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 Faxigen XL and should therefore be used with caution. It is especially important to inform your doctor or pharmacist if the patient is taking medicines containing:

medicines that inhibit certain enzymes (CYP3A4), such as:
atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (medicines used to treat HIV infection),
ketoconazole, itraconazole, voriconazole, posaconazole (antifungal medicines),
clarithromycin and telithromycin (antibiotics);
haloperidol or risperidone (medicines used to treat psychiatric disorders);
metoprolol (a beta-blocker used to treat high blood pressure and heart diseases).

Taking Faxigen XL with food, drink and alcohol
Faxigen XL should be taken with food (see section 3 "How to take Faxigen XL").
Do not consume alcohol during treatment with Faxigen XL. Concurrent use with alcohol
may cause extreme fatigue and loss of consciousness and may worsen symptoms of depression and other conditions such as anxiety disorders.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a
child, she should consult her doctor or pharmacist before using this medicine. Faxigen XL should be used only after discussing with a doctor the potential benefits and risks for the unborn child.
Ensure that the midwife and (or) doctor are informed about the patient's use of Faxigen XL. Taking similar medicines (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 skin blueness in the baby. These symptoms usually appear within the first day after birth. If these symptoms occur in the baby, contact the midwife and (or) doctor immediately.
If the patient takes this medicine during pregnancy, the newborn may experience, apart from breathing difficulties, other symptoms such as poor feeding. 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.
Taking Faxigen XL towards the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Faxigen XL, she should inform her doctor or midwife so they can provide appropriate advice.
If the patient is breastfeeding, she should consult her doctor. Faxigen XL 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 Faxigen XL.
Driving and using machines
Do not drive or operate machinery until the patient knows how this medicine affects them, as this medicine may affect judgment, thinking processes, and the ability to drive and operate machinery.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

3. How to use Faxigen XL

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.
The usual recommended starting dose for the treatment of depression, generalized anxiety disorders,
and social phobia is typically 75 mg once daily. Your doctor may gradually increase the dose if
necessary, up to a maximum dose of 375 mg daily in the treatment of depression. For panic attacks,
your doctor will start with a lower dose (37.5 mg) and then gradually increase it. The maximum
daily dose for the treatment of generalized anxiety disorders, social phobia, and panic attacks is
225 mg. Depending on your condition, your doctor may recommend taking this medicine for several
months, with regular check-ups during treatment.
Faxigen XL should be taken every day at approximately the same time, in the morning or evening.
The capsules should be swallowed whole with liquid. Do not open, crush, chew, or dissolve the
capsules.
Faxigen XL should be taken with food.
Inform your doctor if you have any liver or kidney problems, as your dose may need to be adjusted.
Do not stop taking Faxigen XL without consulting your doctor (see section "Stopping Faxigen XL").
Use in children and adolescents
The use of Faxigen XL is not recommended in children and adolescents (see section 2).
Taking more Faxigen XL than prescribed
If you take more Faxigen XL than prescribed, contact your doctor or pharmacist immediately.
Overdose can be life-threatening, especially when taken with alcohol and/or certain medicines
(see section "Faxigen XL with other medicines").
Symptoms of possible overdose may include increased or slowed heart rate, changes in the
electrical activity of the heart visible on tests, low blood pressure, dizziness, disturbances of
consciousness (ranging from drowsiness to coma), blurred vision, seizures, and vomiting.
Missed dose of Faxigen XL
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 prescribed daily dose of Faxigen XL in one
day.
Stopping Faxigen XL
Do not stop treatment or reduce the dose without consulting your doctor, even if you feel better.
If your doctor decides that you can stop taking Faxigen XL, they will advise you on how to gradually
reduce the dose before stopping completely.
Patients stopping this medicine, especially those who stop abruptly or reduce the dose too quickly,
may experience withdrawal symptoms such as suicidal thoughts, aggression, fatigue, dizziness,
feeling of emptiness in the head, headache, insomnia, nightmares, dry mouth, loss of appetite,
nausea, diarrhea, restlessness, nervousness, agitation, disorientation, ringing in the ears, tingling,
rarely a sensation of electric shock, weakness, sweating, seizures, tremor, flu-like symptoms, visual
disturbances, and high blood pressure (which may cause headache, dizziness, ringing in the ears,
sweating, etc.).
Your doctor will advise you on how to gradually discontinue Faxigen XL. This may take several
weeks or months. In some patients, a very slow tapering off over several months or longer may be
necessary. If any of the listed symptoms 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following side effects occur, discontinue use of
Faxigen XL. Seek immediate medical attention or go to the emergency department of the
nearest hospital if the patient experiences any of the following side effects:
Uncommon (may affect up to 1 in 100 patients):

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

Rare (may affect up to 1 in 1,000 patients):

chest tightness, wheezing, difficulty swallowing or breathing
severe skin rash, itching or urticaria (red or pale raised areas, often accompanied by itching)
severe rash which may lead to formation of serious blisters and peeling of the skin
objective and subjective symptoms of serotonin syndrome, which may include restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapidly changing blood pressure, increased reflexes, diarrhea, drowsiness, nausea, vomiting. In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome (NMS). Objective and subjective symptoms of NMS may include a combination of fever, rapid heartbeat, excessive sweating, pronounced muscle rigidity, mental confusion, and increased muscle enzyme activity (detected in blood tests).
signs of infection such as high fever, chills, trembling, headache, sweating, flu-like symptoms. This may result from a blood disorder leading to increased risk of infection.
unexplained muscle pain, tenderness or weakness. These may be symptoms of rhabdomyolysis.

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

symptoms of a condition known as stress cardiomyopathy, including: chest pain, shortness of breath, dizziness, fainting, irregular heartbeat

Other side effects that should be reported to a doctor (the frequency of occurrence of these
side effects is listed below under "Other side effects") include:

cough, wheezing and shortness of breath, possibly accompanied by high body temperature
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, increased blood pressure
vision disturbances such as blurred vision, dilated pupils
nervous system disturbances such as dizziness, tingling sensations, movement coordination problems (muscle spasms or stiffness), seizures or convulsions
psychiatric disturbances such as excessive activity and feelings of unnatural excitement
withdrawal symptoms (see sections "How to take Faxigen XL" and "Stopping treatment with Faxigen XL")
prolonged bleeding time – in case of cuts or injury, wounds may bleed slightly longer than usual

Do not be alarmed if, after taking this medicine, the patient notices small white granules or
beads in the stool. Inside the Faxigen XL capsules are granules (small white beads) which
contain the active substance (venlafaxine). These granules are released from the capsule into
the stomach. As the granules move through the gastrointestinal tract, venlafaxine is slowly
released from them. The "coating" of these granules is insoluble and is excreted in the stool.
Therefore, even if the patient notices granules in the stool, the dose of venlafaxine has been
absorbed.
Other side effects:
Very common (may affect more than 1 in 10 patients):

dizziness; headache
nausea; dry mouth
drowsiness
excessive sweating (including night sweats)
sleep disturbances (insomnia)
constipation

Common (may affect up to 1 in 10 patients):

decreased appetite
confusion; depersonalization (feeling of detachment from oneself); absence of orgasm; reduced libido; agitation; nervousness; unusual dreams; psychomotor agitation
visual disturbances, including blurred vision; dilated pupils; inability of the eye to automatically adjust for viewing objects at different distances (accommodation)
ringing in the ears (tinnitus)
increased blood pressure; sudden flushing
yawning
vomiting; diarrhea
increased frequency of urination; urinary retention; difficulty passing urine
menstrual irregularities such as heavy bleeding or more frequent irregular bleeding; ejaculation/orgasm disorders (men); erectile dysfunction (impotence)
weakness (asthenia); fatigue; chills
increased blood cholesterol levels
shortness of breath
mild skin rash, itching
weight gain; weight loss
psychomotor agitation or inability to sit or stand still; tingling, taste disturbances, increased muscle tension
rapid heartbeat, palpitations

Uncommon (may affect up to 1 in 100 patients):

excessive activity, racing thoughts and reduced need for sleep (mania)
hallucinations; feeling detached from reality; agitation; unusual orgasms; absence of feelings or emotions; sensation of excessive excitement; teeth grinding
fainting; involuntary muscle movements; uncontrolled jerking, twitching or writhing movements; coordination and balance disturbances
dizziness (especially upon standing up too quickly); decreased blood pressure
vomiting blood, black tarry stools (faeces) or blood in the stool, which may indicate internal bleeding
sensitivity to sunlight; bruising (petechiae); abnormal hair loss, urticaria
low blood pressure
minor changes in liver enzyme activity in blood, which may be seen in blood tests
inability to control urination
stiffness, spasms and involuntary muscle movements

Rare (may affect up to 1 in 1,000 patients):

decreased sodium levels in the blood, which may be detected in blood tests
disorientation and confusion often associated with hallucinations (delirium)
cough, wheezing and shortness of breath, possibly accompanied by high body temperature
excessive water retention in the body (known as SIADH)
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 patients):

abnormal milk production in the breasts
prolonged bleeding, which may indicate reduced platelet count, meaning increased risk of bruising or bleeding
unexpected bleeding, e.g. from gums, blood in urine or vomit, or appearance of unexplained bruises or blood vessel damage (burst 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 treatment has been stopped (see section 2. Important information before taking Faxigen XL)
aggression
dizziness
severe vaginal bleeding occurring shortly after childbirth (postpartum hemorrhage), see additional information in subsection "Pregnancy and breastfeeding" in section 2.

Faxigen XL may sometimes cause side effects that the patient may not be aware of, such as increased blood pressure or abnormal heart function; minor changes in liver enzyme activity, blood sodium or cholesterol levels. Less frequently, Faxigen XL may affect platelet function, leading to an increased risk of bruising or bleeding. For this reason, the doctor may recommend periodic blood tests, especially during long-term treatment with Faxigen XL.
Additional side effects observed in children and adolescents
Although use of this medicine is not recommended in children and adolescents, additional side effects observed in this group include hostility, self-harm, abdominal pain, indigestion and nausea, and muscle pain.
Reporting of side effects
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects 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 Faxigen XL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label/carton following EXP.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Faxigen XL contains
The active substance is venlafaxine.
Each extended-release hard capsule contains venlafaxine hydrochloride equivalent to
37.5 mg, 75 mg or 150 mg of venlafaxine (as hydrochloride).
The other ingredients are:
Hypromellose
Ammonio methacrylate copolymer (type B)
Sodium lauryl sulfate
Magnesium stearate

Coating:
Methacrylic acid copolymer butyl ester, basic
[Only for 37.5 mg strength]

Capsule shell:
Titanium dioxide (E 171)
Gelatin

[Only for 75 mg strength]
Capsule shell:
Titanium dioxide (E 171)
Iron oxide red (E 172)
Gelatin

[Only for 150 mg strength]
Capsule shell:
Titanium dioxide (E 171)
Erythrosine (E 127)
Indigotine (E 132)
Gelatin

Printing ink:
Shellac
Iron oxide black (E 172).

What Faxigen XL looks like and contents of the pack
Faxigen XL 37.5 mg
Opaque white, extended-release hard capsules marked with "VEN" on the cap and "37.5" on the body of the capsule.

Faxigen XL 75 mg
Opaque beige, extended-release hard capsules marked with "VEN" on the cap and "75" on the body of the capsule.

Faxigen XL 150 mg
Opaque scarlet, extended-release hard capsules marked with "VEN" on the cap and "150" on the body of the capsule.

Faxigen XL extended-release capsules are available in blister packs containing 7, 10, 14, 20, 25, 28, 30, 50, 56, 70, 90, 100, 500 and 1000 capsules, and in bottles containing 7, 10, 14, 20, 25, 28, 30, 50, 56, 70, 90, 100 and 250 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturers
McDermott Laboratories t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland

Pharmathen S.A.
6 Dervenakion str.
153 51 Pallini, Attiki, Greece

Mylan Hungary Kft
H-2900 Komárom,
Mylan utca 1
Hungary

Pharmathen International S.A.
Sapes Industrial Park, Block 5
69300 Rodopi, Greece

Pharma Pack Kft,
2040 Budarös
Vasut u. 13, Hungary

Viatris Santé
360 Avenue Henri Schneider
69330 Meyzieu
France

Viatris Santé
1 Rue de Turin
69007 Lyon
France

Europhartech
rue Henri Matisse
63370 Lempdes, France

For further information about this medicinal product and its names in the European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 546 64 00