Venlafaxine Viatri

Patient Information Leaflet

Venlafaxine Viatris 37.5 mg prolonged-release hard capsules, 75 mg prolonged-release hard capsules, 150 mg prolonged-release hard capsules

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Venlafaxine Viatris is and what it is used for

Venlafaxine Viatris contains the active substance venlafaxine.
Venlafaxine Viatris is an antidepressant belonging to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions, such as anxiety disorders. The exact way in which antidepressants work is not fully understood; however, they may help by increasing the levels of serotonin and norepinephrine in the brain.
Venlafaxine Viatris is a treatment for adults with depression. It is also a treatment for adults with the following anxiety disorders: generalized anxiety disorder, social anxiety disorder (fear of or tendency to avoid social situations), and panic disorder (panic attacks). Appropriate treatment of depression or anxiety disorders is important to help you feel better. If left untreated, your condition may not resolve and may become more severe and more difficult to treat.

2. What you need to know before taking Venlafaxine Viatris

Do not take Venlafaxine Viatris

• if you are allergic to venlafaxine or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking or have taken within the past 14 days any of the medicines known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson’s disease. Taking an irreversible MAOI together with Venlafaxine Viatris may result in serious or even life-threatening side effects. In addition, you must wait at least 7 days after stopping treatment with Venlafaxine Viatris before taking any MAOI (see also section “Other medicines and Venlafaxine Viatris” and the information in the same section regarding “Serotonin syndrome”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Venlafaxine Viatris:

• If you are using other medicines that, when taken together with Venlafaxine Viatris, may increase the risk of developing serotonin syndrome (see section “Other medicines and Venlafaxine Viatris”).
• If you have eye problems, such as certain types of glaucoma (increased pressure inside the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have been told you have an abnormal heart rhythm.
• If you have a history of seizures.
• If you have a history of low sodium levels in the blood (hyponatraemia).
• If you have a history of bleeding disorders (tendency to bruise easily or tendency to bleed easily), or if you are taking other medicines that may increase the risk of bleeding, such as warfarin (used to prevent blood clots), or if you are pregnant (see Pregnancy and breastfeeding).
• If you or someone in your family has previously suffered from mania or bipolar disorder (feeling overly excited or euphoric).
• If you have a history of aggressive behaviour.

During the first few weeks of treatment, Venlafaxine Viatris may cause a feeling of
restlessness or inability to sit still or remain seated. If you experience these symptoms, you should inform your doctor.
Suicidal thoughts and worsening of your depression or anxiety disorder
If you are depressed and/or suffer from anxiety disorders, you may sometimes have thoughts of harming yourself or committing suicide.
These thoughts may increase when you first start taking antidepressants, as these medicines take time to work, usually about two weeks but sometimes longer. You may also have these thoughts if your dose is reduced or when stopping treatment with Venlafaxine Viatris.
You are more likely to have these thoughts:

• If you have previously had thoughts of suicide or self-harm.
• If you are young. Information from clinical studies has shown an increased risk of suicidal behaviour in young people (under 25 years) with psychiatric disorders who were treated with an antidepressant.

If you have thoughts of harming yourself or committing suicide at any time, contact your doctor or go to the hospital immediately.
It may help to tell a relative or close friend that you are depressed or suffer from an anxiety disorder, and ask them to read this leaflet. You may ask them to inform you if they think your depression or anxiety is worsening, or if they are concerned about changes in your behaviour.
Dry mouth
Dry mouth occurs in 10% of patients treated with venlafaxine. This may increase the risk of dental caries. Therefore, you should pay particular attention to your oral hygiene.
Diabetes
Blood glucose levels may be altered by Venlafaxine Viatris. Therefore, it may be necessary to adjust the dose of your diabetes treatment.
Sexual problems
Medicines such as Venlafaxine Viatris (so-called serotonin-norepinephrine reuptake inhibitors, SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have been observed to persist after stopping treatment.
Children and adolescents
Venlafaxine Viatris is normally not to be used in children and adolescents under 18 years of age. In addition, you should know that patients under 18 years of age have a higher risk of adverse effects when taking these medicines, including suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behaviour, and anger). Nevertheless, your doctor may prescribe this medicine for patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed this medicine for a patient under 18 years of age and you wish to discuss it, speak to your doctor. You should inform your doctor if any of the listed symptoms appear or worsen when a patient under 18 years of age is taking Venlafaxine Viatris. Furthermore, the long-term effects of this medicine on growth, maturation, and cognitive and behavioural development in this age group have not been established.
Other medicines and Venlafaxine Viatris
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor will decide whether you can use Venlafaxine Viatris with other medicines.
Do not start or stop treatment with other medicines, including over-the-counter medicines and herbal preparations, without first consulting your doctor or pharmacist.

• Monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson’s disease must not be taken with Venlafaxine Viatris. Inform your doctor if you have taken these medicines within the past 14 days (MAOIs: see section “What you need to know before taking Venlafaxine Viatris”).
• Serotonin syndrome: A potentially life-threatening condition or reactions similar to Neuroleptic Malignant Syndrome (NMS) (see section “Possible side effects”) may occur during treatment with venlafaxine, especially when taken with other medicines.

Examples of these medicines include:
o Triptans (used for migraine)
o Other medicines for the treatment of depression, for example SNRIs, SSRIs, tricyclics, or medicines containing lithium
o Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity)
o Medicines containing linezolid, an antibiotic (used to treat infections)
o Medicines containing moclobemide, an MAOI (used to treat depression)
o Medicines containing sibutramine (used for weight loss)
o Medicines containing opioids (e.g. buprenorphine, tramadol, fentanyl, tapentadol, meperidine, or pentazocine) used to treat severe pain
o Medicines containing dextromethorphan (used to treat cough)
o Medicines containing methadone (used to treat opioid dependence or severe pain)
o Medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood)
o Herbal preparations containing St. John’s wort (also known as Hypericum perforatum, a natural remedy derived from a medicinal plant used to treat mild depression)
o Products containing tryptophan (used for sleep disorders and depression)
o Antipsychotics (used to treat a condition with symptoms such as hearing, seeing, or perceiving things that are not real, false beliefs, strange suspicions, confused thinking, and detachment)
Signs and symptoms of serotonin syndrome may include a combination of: restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid fluctuations in blood pressure, hyperactive reflexes, diarrhoea, coma, nausea, vomiting.
In its most severe form, serotonin syndrome may resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (determined by blood test).
If you think you may have serotonin syndrome, contact your doctor immediately or go to the nearest hospital emergency department.
You must inform your doctor if you are taking medicines that may affect heart rhythm.
Examples of these medicines include:

• Antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat abnormal heart rhythm)
• 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 interfere with Venlafaxine Viatris and should be used with caution. It is particularly important that you inform your doctor or pharmacist if you are taking medicines containing:

• Ketoconazole (an antifungal medicine)
• Haloperidol or risperidone (for the treatment of psychiatric disorders)
• Metoprolol (a beta-blocker used to treat high blood pressure and heart problems)

Venlafaxine Viatris with food, drinks and alcohol
You should take Venlafaxine Viatris with food (see section “How to take Venlafaxine Viatris”).
You must not drink alcohol while taking Venlafaxine Viatris.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. You should use Venlafaxine Viatris only after discussing with your doctor the potential benefits and potential risks to the fetus.
Ensure that your midwife and/or doctor know that you are taking Venlafaxine Viatris. When taken during pregnancy, similar medicines (called SSRIs) may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN). This condition causes the newborn to breathe rapidly and appear bluish. These symptoms usually begin within the first 24 hours of the baby’s life. If this occurs, contact your midwife and/or doctor immediately.
If you take Venlafaxine Viatris near the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after childbirth, especially if you have bleeding disorders (tendency to bleed easily). Inform your doctor or midwife that you are taking Venlafaxine Viatris so they can advise you on what to do.
If you are taking this medicine during pregnancy, in addition to breathing difficulties, another symptom your baby may have at birth is difficulty feeding adequately. If you are concerned that your baby may be showing these symptoms at birth, contact your doctor and/or midwife, who will assist you.
Venlafaxine Viatris is excreted in breast milk. There is a risk of effects on the infant. Therefore, you should discuss this with your doctor, who will decide whether you should stop breastfeeding or stop treatment with this medicine.
Driving and using machines
Do not drive and do not use tools or machinery until you know how this medicine affects you.
Venlafaxine Viatris contains sodium
Venlafaxine Viatris 150 mg contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially “sodium-free”.

3. How to take Venlafaxine Viatris

Take this medicine exactly as described in this leaflet or as directed 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 anxiety disorder is 75 mg per day. Your doctor may gradually increase the dose, and if necessary, up to a maximum dose of 375 mg per day for depression.
If you are being treated for panic disorder, your doctor will start with a lower dose (37.5 mg) and then gradually increase it. The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg per day.
Take Venlafaxine Viatris at approximately the same time each day, either in the morning or in the evening. The capsules must be swallowed whole with liquid and must not be opened, crushed, chewed, or dissolved.
You must take Venlafaxine Viatris with food.
If you have liver or kidney problems, discuss this with your doctor, as a dose adjustment of this medicine may be necessary.
Do not stop treatment with this medicine without first consulting your doctor (see section “If you stop taking Venlafaxine Viatris”).

If you take more Venlafaxine Viatris than you should
Contact your doctor or pharmacist immediately if you take more medicine than prescribed.
Symptoms of a possible overdose may include rapid heartbeat, changes in consciousness (ranging from drowsiness to coma), blurred vision, seizures, and vomiting.

If you forget to take Venlafaxine Viatris
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
Do not take more than the prescribed daily amount of Venlafaxine Viatris in a single day.

If you stop taking Venlafaxine Viatris
Do not stop treatment or reduce the dose without consulting your doctor, even if you feel better. If your doctor decides that you no longer need Venlafaxine Viatris, they may instruct you to gradually reduce the dose before stopping treatment completely.
It is known that adverse effects may occur when patients discontinue treatment with this medicine, especially if it is stopped abruptly or if the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, a feeling of mild mental confusion, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhoea, nervousness, agitation, confusion, ringing in the ears (tinnitus), tingling sensations, or rarely electric shock-like sensations, weakness, sweating, seizures, or flu-like symptoms, visual disturbances, and increased blood pressure (which may cause headache, dizziness, ringing in the ears, sweating, etc.).
Your doctor will advise you on how to gradually discontinue treatment with Venlafaxine Viatris.
This process may last for weeks or months. In some patients, a very gradual discontinuation over several months or even longer periods may be necessary. If you experience any of these or other bothersome symptoms, consult your doctor for further advice.

If you have any doubts about how to use 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 you experience any of the following effects, stop taking Venlafaxine Viatris. Contact your doctor immediately, or go to the nearest hospital emergency department:
Uncommon (may affect up to 1 in 100 people)

• Swelling of the face, mouth, tongue, throat, hands or feet and/or sudden rash with itching (urticaria), difficulty swallowing or breathing

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

• Chest tightness, wheezing, difficulty swallowing or breathing.
• Severe skin rash, itching sensation, or hives (raised red or pale patches on the skin that are often itchy).
• Signs and symptoms of serotonin syndrome may include agitation, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting. In its most severe form, serotonin syndrome may resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (detected by a blood test).
• Signs of infection, such as high temperature, chills, shivering, headache, sweating, flu-like symptoms. This may be due to a blood disorder causing an increased risk of infection.
• Severe skin rash that may cause extensive blistering and peeling of the skin.
• Unexplained muscle pain, tenderness or weakness. This may be a sign of rhabdomyolysis.

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

• Signs and symptoms of a condition called “stress cardiomyopathy”, which may include chest pain, shortness of breath, dizziness, fainting, irregular heartbeat. Other side effects that you must report to your doctor are (the frequencies of these side effects are included in the list “Other side effects”):
• Cough, wheezing and shortness of breath which may be accompanied by high temperature.
• Black (tarry) stools or blood in the stools.
• Itching, yellowing of the eyes or skin, or dark urine, which may be symptoms of liver inflammation (hepatitis).
• Heart problems, such as rapid or irregular heartbeat, increased blood pressure.
• Eye problems, such as blurred vision, dilated pupils.
• Nervous system problems, such as dizziness, tingling, movement disorders (muscle spasms or stiffness), seizures.
• Psychiatric problems, such as hyperactivity and feeling excessively excited.
• Withdrawal syndrome (see section “How to take Venlafaxine Viatris, If you stop taking Venlafaxine Viatris”).
• Prolonged bleeding – if you get cuts or wounds, it may take longer than usual to stop bleeding.

Do not be concerned if you notice small granules or white spheres in your faeces after taking this
medicine. The Venlafaxine Viatris capsules contain spheroids (small white spheres) which contain the active substance venlafaxine. These spheroids are released from the capsule in the stomach. As the spheroids pass through your gastrointestinal tract, venlafaxine is slowly released. The coating of the spheroid does not dissolve and may be found in the faeces. Therefore, even if you notice spheroids in your faeces, the medicine dose has been absorbed.
Other side effects
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)

• Reduced appetite
• Confusion; feeling detached from yourself; absence of orgasm; decreased libido; agitation; nervousness; abnormal dreams
• Tremor; feeling restless or inability to sit still or remain still; tingling; altered taste sensation; increased muscle tone
• Visual disturbances including blurred vision; dilated pupils; inability of the eye to automatically refocus from distant to near objects
• Ringing in the ears (tinnitus)
• Rapid heartbeat; palpitations
• Increased blood pressure; hot flushes
• Shortness of breath; yawning
• Vomiting; diarrhoea
• Mild rash; itching sensation
• Increased frequency of urination; inability to urinate; difficulty in urination
• Menstrual irregularities such as increased bleeding or increased irregularity of bleeding; abnormal orgasm/ejaculation (males); erectile dysfunction (impotence)
• Weakness (asthenia); fatigue; chills
• Weight gain; weight loss
• Increased cholesterol

Uncommon (may affect up to 1 in 100 people)

• Hyperactivity, racing thoughts and reduced need for sleep (mania)
• Hallucinations; feeling detached from reality; abnormal orgasm; absence of sensations or emotions; feeling overexcited; teeth grinding
• Fainting; involuntary muscle movements; impaired coordination and balance
• Dizziness (especially when standing up too quickly); low blood pressure
• Vomiting blood; black tarry stools or blood in the stools; which may be signs of internal bleeding
• Sensitivity to sunlight; bruising; abnormal hair loss
• Urinary incontinence
• Muscle stiffness, spasms and involuntary movements
• Slight changes in blood levels of liver enzymes

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

• Seizures
• Cough, wheezing and shortness of breath which may be accompanied by high temperature.
• Disorientation and confusion often accompanied by hallucinations (delirium)
• Excessive water intake (known as SIADH)
• Decreased levels of sodium in the blood
• Severe eye pain and reduced or blurred vision
• Abnormal, rapid or irregular heartbeat, which may lead to fainting
• Severe abdominal or back pain (which may indicate a serious problem with the intestine, liver or pancreas)
• Itching, yellow skin or eyes, dark urine, or flu-like symptoms, which are signs of liver inflammation (hepatitis)

Very rare (may affect less than 1 in 10,000 people)

• Prolonged bleeding, which could indicate a reduced number of platelets in the blood, leading to an increased risk of bruising or bleeding
• Abnormal production of breast milk
• Unexpected bleeding, for example bleeding gums, blood in urine or vomit, or unexpected bruising or rupture of blood vessels

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

• Suicidal thoughts and suicidal behaviour: cases of suicidal thoughts and suicidal behaviour have been reported during treatment with venlafaxine or shortly after stopping treatment with venlafaxine (see section 2, What you should know before taking Venlafaxine Viatris)
• Aggressiveness
• Vertigo
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage), see Pregnancy and breastfeeding in section 2 for further information. Sometimes Venlafaxine Viatris causes side effects that you may not be aware of, such as increases in blood pressure or abnormal heartbeat; slight changes in blood levels of liver enzymes, sodium or cholesterol. Less frequently, Venlafaxine Viatris may reduce the function of platelets in your blood, leading to an increased risk of bruising and bleeding. Therefore, your doctor may wish to carry out occasional blood tests, especially if you have been taking Venlafaxine Viatris for a long time.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Venlafaxine Viatris

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

6. Package contents and other information

What Venlafaxine Viatris contains
The active substance is venlafaxine.
Venlafaxine Viatris 37.5 mg:
Each prolonged-release capsule contains 42.43 mg of venlafaxine hydrochloride, equivalent to 37.5 mg of
venlafaxine as the free base.
The excipients are:
Capsule contents: microcrystalline cellulose, ethylcellulose, hypromellose, talc
Capsule shell: gelatin, black, red and yellow iron oxides (E172), titanium dioxide (E171)
Printing ink for the capsule: lacquer, red iron oxide (E172), ammonium hydroxide, simethicone,
propylene glycol
Venlafaxine Viatris 75 mg:
Each prolonged-release capsule contains 84.85 mg of venlafaxine hydrochloride, equivalent to 75 mg of
venlafaxine as the free base.
The excipients are:
Capsule contents: microcrystalline cellulose, ethylcellulose, hypromellose, talc
Capsule shell: gelatin, red and yellow iron oxides (E172), titanium dioxide (E171)
Printing ink for the capsule: lacquer, red iron oxide (E172), ammonium hydroxide, simethicone,
propylene glycol
Venlafaxine Viatris 150 mg:
Each prolonged-release capsule contains 169.7 mg of venlafaxine hydrochloride, equivalent to 150 mg of
venlafaxine as the free base.
The excipients are:
Capsule contents: microcrystalline cellulose, ethylcellulose, hypromellose, talc
Capsule shell: gelatin, red and yellow iron oxides (E172), titanium dioxide (E171)
Printing ink for the capsule: lacquer, sodium hydroxide (see section 2 “Venlafaxine Viatris contains sodium”), povidone, titanium dioxide (E171), propylene glycol

Description of the appearance of Venlafaxine Viatris and contents of the pack
Venlafaxine Viatris 37.5 mg is an opaque hard (gelatin) prolonged-release capsule, light grey and peach in colour, 15.9 mm x 5.82 mm in size, printed in red with a “W” and the dosage “37.5”.
Venlafaxine Viatris 37.5 mg is available in:
Blister packs containing 7, 10, 14, 20, 21, 28, 30, 35, 50, 60, 100 capsules and hospital packs containing 70 capsules (10x7, 1x70)
Unit dose blister packs containing 14, 28, 84, 100 capsules
Plastic (HDPE) bottles containing 7, 14, 20, 21, 35, 50, 100 capsules and hospital packs containing 70 capsules.

Venlafaxine Viatris 75 mg is an opaque hard (gelatin) prolonged-release capsule, peach in colour, 19.4 mm x 6.91 mm in size, printed in red with a “W” and the dosage “75”.
Venlafaxine Viatris 75 mg is available in:
Blister packs 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 blister packs containing 14, 28, 84, 100 capsules
Plastic (HDPE) bottles containing 14, 20, 50, 100 capsules and hospital packs containing 500 and 1000 capsules.

Venlafaxine Viatris 150 mg is an opaque hard (gelatin) prolonged-release capsule, dark orange in colour, 23.5 mm x 7.65 mm in size, printed in white with a “W” and the dosage “150”.
Venlafaxine Viatris 150 mg is available in:
Blister packs 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 blister packs containing 14, 28, 84, 100 capsules
Plastic (HDPE) bottles containing 14, 20, 50, 100 capsules and hospital bottles containing 500 and 1000 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris Pharma S.r.l.
Via Vittor Pisani 20
20124 Milano
Italy

Manufacturer
Pfizer Ireland Pharmaceuticals
Little Connell – Newbridge,
County Kildare
Ireland
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
Freiburg Im Breisgau
Baden-Wuerttemberg, 79090
Germany

This medicinal product is authorised in the EEA Member States under the following names:

*It is possible that not all the products and dosages listed are commercially available