Efectin er 37.5

Package leaflet: Information for the user

Efectin ER 37.5
37.5 mg, extended-release capsules, hard
Efectin ER 75
75 mg, extended-release capsules, hard
Efectin ER 150
150 mg, extended-release capsules, hard
venlafaxine
Please read carefully all the information in this leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as 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. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

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

Efectin ER contains the active substance – venlafaxine.
Efectin ER is an antidepressant medicine belonging to a group of medicines called serotonin-norepinephrine 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 antidepressant medicines is not fully understood, but they may help by increasing the levels of serotonin and norepinephrine in the brain.
Efectin ER is used in the treatment of 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 important that treatment of depression and anxiety disorders is properly managed. If the patient does not undergo treatment, their condition may not improve, may worsen, and may become significantly more difficult to treat.

2. Information before using Efectin ER

When not to use Efectin ER:

• If the patient is allergic to venlafaxine or to 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 Efectin ER may cause severe or even life-threatening adverse reactions. Before starting treatment with any MAOI, the patient should also wait at least 7 days after stopping Efectin ER (see also section "Efectin ER with other medicines" and information in this section regarding serotonin syndrome).

Warnings and precautions
Before starting treatment with Efectin ER, discuss this with your doctor or pharmacist:

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

Efectin ER may cause feelings of restlessness or an inability to sit still during the first few weeks of treatment. If such symptoms occur, inform your doctor immediately.
Do not consume alcohol while being treated with Efectin ER, 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
Patients suffering from depression and (or) anxiety disorders may sometimes have thoughts about self-harm or suicide. These thoughts may intensify at the beginning of treatment with antidepressants, as these medicines usually take at least 2 weeks, and sometimes longer, to start working. Such thoughts may also occur when reducing the dose or stopping treatment with Efectin ER.
The occurrence of suicidal thoughts or thoughts of self-harm is more likely if:

• The patient has previously had suicidal thoughts or self-harm tendencies;
• The patient is a young adult; clinical data indicate an increased risk of suicidal behaviour in individuals under 25 years of age with psychiatric disorders who are treated with antidepressants.

If the patient experiences suicidal thoughts or thoughts of self-harm, seek medical help immediately by contacting a doctor or going 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 for help from relatives or friends and request them to inform him/her if they notice worsening of depression or anxiety, or concerning changes in behaviour.
Dry mouth
Dry mouth was reported by 10% of patients treated with venlafaxine. This may increase the risk of dental caries. Therefore, special attention should be paid to oral hygiene.
Diabetes
Efectin ER may alter blood glucose levels and therefore may require adjustment of antidiabetic medication dosage.
Sexual dysfunction
Medicines such as Efectin ER (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
Efectin 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 from this group are at increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviour, and manifestations of anger). Nevertheless, a doctor may prescribe this medicine to patients under 18 years of age if he/she considers it beneficial. If the 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 these symptoms occur or worsen in patients under 18 years of age taking Efectin ER. Long-term safety regarding the impact on growth, maturation, and cognitive and behavioural development in this age group has not yet been established.
Efectin ER with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The treating doctor will decide whether Efectin ER can be used together with other medicines.
Do not start or stop taking other medicines, including over-the-counter medicines, herbal remedies, or plant-based preparations, without first consulting your doctor or pharmacist.

• Monoamine oxidase inhibitors used to treat depression or Parkinson's disease must not be taken with Efectin ER. Inform your doctor if these medicines have been taken within the last 14 days (MAOIs; see section "Information before using Efectin ER").
• Serotonin syndrome: During treatment with venlafaxine, a life-threatening condition or reactions resembling neuroleptic malignant syndrome (see section "Possible side effects") may occur, especially when taken concomitantly with other medicines. Examples of such medicines include:
• Triptans (substances 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 opioids (e.g. buprenorphine, tramadol, fentanyl, tapentadol, pethidine, or pentazocine) used to treat severe pain,
• Medicines containing dextromethorphan (used to treat cough),
• Medicines containing methadone (used to treat opioid dependence or severe pain),
• Medicines containing methylene blue (used to treat high methemoglobin levels in the blood),
• Medicines containing St. John's wort (Hypericum perforatum, herbal or plant-based preparations used to treat mild depression),
• Medicines containing tryptophan (used for sleep problems and depression),
• Antipsychotic medicines (used to treat diseases with symptoms such as hearing, seeing, and feeling things that do not exist, delusions, unnatural suspicion, unclear thinking, and social withdrawal).

Subjective and objective symptoms of serotonin syndrome may include: motor restlessness, hallucinations, lack 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. Its subjective and objective symptoms include: fever, rapid heartbeat, sweating, muscle rigidity, disorientation, and elevated muscle enzyme levels (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:

• Antiarrhythmic medicines such as quinidine, amiodarone, sotalol, or dofetilide (used to treat cardiac arrhythmias),
• Antipsychotic medicines such as thioridazine (see above - serotonin syndrome),
• Antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections),
• Antihistamines (used to treat allergies).

The following medicines may also interact with Efectin ER 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 hypertension and heart diseases).

Taking Efectin ER with food, drink, and alcohol
Efectin ER should be taken with food (see section 3 "How to take Efectin ER").
Do not consume alcohol while being treated with Efectin ER. 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 is planning to have a baby, she should consult her doctor or pharmacist before using this medicine. Efectin ER should only be used after discussing the potential benefits and risks for the unborn child with a doctor.
Taking Efectin ER in late 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 Efectin ER, she should inform her doctor or midwife so they can provide appropriate advice.
Similar medicines (SSRIs) taken during pregnancy may increase the risk of a serious condition in newborns and (or) infants called persistent pulmonary hypertension of the newborn, causing rapid breathing and cyanosis. These symptoms usually occur within 24 hours after birth. If the patient notices such symptoms in her child, she should contact her 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, she should contact her doctor and (or) midwife, who will be able to provide appropriate advice.
Efectin ER passes into human milk. There is a risk of affecting the infant. Therefore, this issue should be discussed with the doctor, who will decide whether to discontinue breastfeeding or stop treatment with the medicine.
Driving and operating machinery
Do not drive or operate machinery until the effect of the medicine on the patient's body is known.
Efectin ER 150 contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".

3. How to use Efectin ER

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.

The usual recommended starting dose for the treatment of depression, generalized anxiety disorder, and social phobia is 75 mg once daily. Your doctor may gradually increase this dose if necessary, up to a maximum dose of 375 mg once daily in the case of depression. For panic disorder, treatment should be initiated at a lower dose (37.5 mg), which may then be gradually increased. The maximum dose for the treatment of generalized anxiety disorder, social phobia, and panic disorder is 225 mg once daily.

Efectin ER should be taken every day at approximately the same time, whether in the morning or evening. The capsules must be swallowed whole with liquid. Do not divide, crush, chew, or dissolve them.

Efectin ER 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 this medicine without consulting your doctor (see section “Discontinuing Efectin ER”).

Taking more Efectin ER than prescribed

If you take more Efectin ER than recommended, contact your doctor immediately.

Overdose can be life-threatening, especially when taken with alcohol and/or certain other medicines (see section “Efectin ER and other medicines”).

Symptoms of overdose may include rapid heartbeat, disturbances in consciousness (ranging from drowsiness to coma), visual disturbances, seizures, and vomiting.

Missing a dose of Efectin ER

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 regular time. Do not take a double dose to make up for a missed dose. Do not take more than the daily dose of Efectin ER prescribed by your doctor within a single day.

Discontinuing Efectin ER

Do not stop treatment or reduce the dose of Efectin ER without consulting your doctor, even if you feel better. If your doctor decides that Efectin ER can be discontinued, they will advise you on how to gradually reduce the dose before stopping completely.

Patients who discontinue the medicine, especially after abrupt discontinuation or too rapid dose reduction, may experience withdrawal symptoms such as suicidal thoughts, aggressive behavior, fatigue, dizziness, a sensation of emptiness in the head, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, disorientation, ringing in the ears (tinnitus), tingling or numbness, weakness, sweating, seizures, flu-like symptoms, visual disturbances, and elevated blood pressure (which may cause headaches, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you on how to gradually discontinue Efectin ER. This process may take several weeks or months. In some patients, a very slow tapering over several months or longer may be necessary. If any of the symptoms listed above occur, or any other bothersome symptoms, 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 all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, discontinue Efectin ER immediately and contact a doctor or go to the nearest hospital emergency department:

Not 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 people)

• Chest tightness, wheezing, difficulty swallowing or breathing.
• Severe skin rash, itching or urticaria (red or pale raised areas, often accompanied by itching).
• Symptoms of serotonin syndrome, which may include: psychomotor agitation, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, hyperreflexia, diarrhea, lethargy, 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, shaking, headache, sweating, flu-like symptoms. This may result from a blood disorder leading to increased risk of infection.
• Severe skin 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 (cannot be estimated based on 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 reactions occur, contact a doctor (the frequency of these adverse reactions is listed below under "Other adverse reactions"):

• 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 hepatitis.
• 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 sensation, 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 Efectin ER" and "Stopping Efectin ER").
• Prolonged bleeding time – in case of injury, the wound may bleed slightly longer than usual.

While taking this medicine, patients may notice small white granules or beads in their stool.
Inside Efectin ER capsules are granules (small white beads) containing the active substance, venlafaxine. These granules are released from the capsule into the gastrointestinal tract, travel through its entire length, and slowly release venlafaxine. The granule matrix does not dissolve and is excreted in the stool. Therefore, if granules are seen in the stool, there is no cause for concern, as the venlafaxine dose has been absorbed.

Other adverse reactions
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
• confusion; feeling detached (or separated) from oneself; anorgasmia; reduced libido; agitation; 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 (automatically adjusting focus 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; difficulty urinating
• irregular menstruation, i.e. 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 excitement; teeth grinding
• fainting; involuntary muscle movements; coordination and balance disorders
• dizziness (especially upon standing up too quickly); decreased blood pressure
• vomiting blood; black tarry stools (feces) or blood in the stool, which may indicate internal bleeding
• light sensitivity; bruising; excessive hair loss
• urinary incontinence
• stiffness, spasms and involuntary muscle movements
• minor changes in liver enzyme activity in blood

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

• convulsions
• cough, wheezing and shortness of breath, possibly accompanied by high fever
• confusion and disorientation, often with accompanying hallucinations (delirium)
• excessive fluid retention in the body
• decreased sodium levels in the 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 hepatitis

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 secretion in women
• unexpected bleeding, e.g. bleeding gums, blood in urine or vomit, appearance of unexpected bruises or broken blood vessels (ruptured veins)

Frequency unknown (cannot be estimated based on available data)

• suicidal thoughts and behaviors; cases of suicidal thoughts and behaviors have been reported during venlafaxine treatment or shortly after treatment discontinuation (see section 2. Important information before using Efectin ER)
• aggressive behavior
• dizziness
• severe vaginal bleeding occurring shortly after childbirth (postpartum hemorrhage), see additional information in subsection "Pregnancy and breastfeeding" in section 2

Efectin ER may sometimes cause adverse reactions 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. In even rarer cases, Efectin ER may impair platelet function, increasing the risk of petechiae or bleeding. Therefore, the doctor may recommend periodic blood tests, especially during long-term treatment with Efectin ER.

Reporting of adverse reactions
If any adverse effects 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 or its representative.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Efectin ER

Keep the medicine in a place that is out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton following EXP. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Medicines should not be disposed of via sewage systems 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 pack and other information

What Efectin ER contains
The active substance is venlafaxine.
Efectin ER 37.5
Each prolonged-release capsule contains 42.43 mg of venlafaxine hydrochloride,
equivalent to 37.5 mg of venlafaxine free base.
Other ingredients:
Capsule contents: microcrystalline cellulose, ethylcellulose 50 cps, hypromellose 3 cps,
hypromellose 6 cps, talc
Capsule shell: gelatin, black iron oxide, red and yellow iron oxide (E 172), titanium dioxide (E 171)
Printing ink for capsule marking: shellac, red iron oxide (E 172), ammonium hydroxide,
simethicone, propylene glycol

Efectin ER 75
Each prolonged-release capsule contains 84.85 mg of venlafaxine hydrochloride,
equivalent to 75 mg of venlafaxine free base.
Other ingredients:
Capsule contents: microcrystalline cellulose, ethylcellulose 50 cps, hypromellose 3 cps,
hypromellose 6 cps, talc
Capsule shell: gelatin, red and yellow iron oxide (E 172), titanium dioxide (E 171)
Printing ink for capsule marking: shellac, red iron oxide (E 172), ammonium hydroxide,
simethicone, propylene glycol

Efectin ER 150
Each prolonged-release capsule contains 169.7 mg of venlafaxine hydrochloride,
equivalent to 150 mg of venlafaxine free base.
Other ingredients:
Capsule contents: microcrystalline cellulose, ethylcellulose 50 cps, hypromellose 3 cps,
hypromellose 6 cps, talc
Capsule shell: gelatin, red and yellow iron oxide (E 172), titanium dioxide (E 171)
Printing ink for capsule marking: 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 an opaque, prolonged-release, hard (gelatin) capsule, light grey and peach-coloured,
measuring 15.9 mm x 5.82 mm, printed in red with "W" and strength "37.5".
Efectin ER 37.5 is available in:
blisters containing 7, 10, 14, 20, 21, 28, 30, 35, 50, 60, 100 capsules and hospital packs
containing 70 capsules (10x7, 1x70)
unit dose blisters containing 14, 28, 84, 100 capsules
plastic (HDPE) bottles containing 7, 14, 20, 21, 35, 50, 100 capsules and hospital packs
containing 70 capsules.

Efectin ER 75 is an opaque, prolonged-release, hard (gelatin) capsule, peach-coloured,
measuring 19.4 mm x 6.91 mm, printed in red with "W" and strength "75".
Efectin ER 75 is available in:
blisters containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 98, 100 capsules and hospital packs
containing 500 (10x50) and 1000 (10x100) capsules
unit dose blisters containing 14, 28, 84, 100 capsules
plastic (HDPE) bottles containing 14, 20, 50, 100 capsules and hospital packs
containing 500 and 1000 capsules.

Efectin ER 150 is an opaque, prolonged-release, hard (gelatin) capsule, dark orange-coloured,
measuring 23.5 mm x 7.65 mm, printed in white with "W" and strength "150".
Efectin ER 150 is available in:
blisters containing 7, 10, 14, 15, 20, 28, 30, 50, 56, 60, 98, 100 capsules and hospital packs
containing 500 (10x50) and 1000 (10x100) capsules
unit dose blisters containing 14, 28, 84, 100 capsules
plastic (HDPE) bottles containing 14, 20, 50, 100 capsules and hospital packs
containing 500 and 1000 capsules.

Pack sizes authorised 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart
Dublin 15
DUBLIN
Ireland

Manufacturers:
Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg Im Breisgau
Germany
FAMAR HEALTH CARE SERVICES MADRID, S.A.U.
Avda. Leganés, 62
Alcorcón
28923 Madrid
Spain

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names*:

* The list of brand names used in different countries follows in the original document.

• [Not all medicines and strengths may be marketed.]
  For more detailed information on this medicine, please contact the local representative of the marketing authorization holder:
  Viatris Healthcare Sp. z o.o.
  tel: 22 546 64 00