Pomalidomide glenmark

Package leaflet: Information for the patient

Pomalidomide Glenmark, 1 mg, hard capsules
Pomalidomide Glenmark, 2 mg, hard capsules
Pomalidomide Glenmark, 3 mg, hard capsules
Pomalidomide Glenmark, 4 mg, hard capsules
Pomalidomide
Pomalidomide Glenmark is expected to cause severe birth defects
and may result in fetal death.

• Do not take this medicine if you are pregnant or able to become pregnant.
• You must follow the contraception advice provided in this leaflet.

Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

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

1. What Pomalidomide Glenmark is and what it is used for

What Pomalidomide Glenmark is
Pomalidomide Glenmark contains the active substance pomalidomide. This medicine is similar to thalidomide and belongs to a group of medicines that affect the immune system (the body's natural defences).

What Pomalidomide Glenmark is used for
Pomalidomide Glenmark is used to treat adults with a type of cancer called multiple myeloma.
Pomalidomide Glenmark is used in combination with:

• two other medicines – bortezomib (a chemotherapy medicine) and dexamethasone (an anti-inflammatory medicine) in patients who have already received at least one prior therapy containing lenalidomide. or
• one other medicine – dexamethasone in patients with multiple myeloma whose disease has progressed despite having previously received at least two prior therapies containing lenalidomide and bortezomib.

What is multiple myeloma
Multiple myeloma is a type of cancer that affects a certain kind of white blood cells (called plasma cells). These cells grow uncontrollably and accumulate in the bone marrow, leading to damage of bones and kidneys.
Multiple myeloma is generally considered incurable. However, treatment may relieve both objective and subjective symptoms of the disease or cause the disease to go into remission for a period of time. This is referred to as a "response" to treatment.

How Pomalidomide Glenmark works
Pomalidomide Glenmark works in several different ways:

• By inhibiting the growth of myeloma cells,
• By stimulating the immune system to attack cancer cells,
• By inhibiting the formation of blood vessels that supply blood to cancer cells.

Benefits of using Pomalidomide Glenmark with bortezomib and dexamethasone
Pomalidomide Glenmark, when used in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy, can delay the progression of multiple myeloma:

• Pomalidomide Glenmark used with bortezomib and dexamethasone typically delayed the recurrence of multiple myeloma for up to 11 months – compared to 7 months in patients who received only bortezomib and dexamethasone.

Benefits of using Pomalidomide Glenmark with dexamethasone
Pomalidomide Glenmark, when used in combination with dexamethasone in patients who have received at least two prior therapies, can delay the progression of multiple myeloma:

• Pomalidomide Glenmark used with dexamethasone typically delayed the recurrence of multiple myeloma for up to 4 months – compared to 2 months in patients who received only dexamethasone.

2. Important information before using Pomalidomide Glenmark

When not to use Pomalidomide Glenmark

• if the patient is pregnant, suspects she may be pregnant, or plans to have a child, because Pomalidomide Glenmark is expected to be harmful to the fetus (men and women taking this medicine must read the section "Pregnancy, contraception and breastfeeding – information for women and men" below).
• if the patient could become pregnant, unless she uses all required methods of contraception (see section "Pregnacy, contraception and breastfeeding – information for women and men"). If the patient could become pregnant, the doctor will document at the time of prescribing that the necessary steps have been taken and will provide the patient with written confirmation.
• if the patient is allergic to pomalidomide or any of the other ingredients of this medicine (listed in section 6). If the patient suspects an allergic reaction to the medicine, consult a doctor for advice. If the patient is unsure whether any of the above situations apply, consult a doctor, pharmacist or nurse before starting treatment with Pomalidomide Glenmark.

Warnings and precautions
Before starting treatment with Pomalidomide Glenmark, discuss with a doctor,
pharmacist or nurse if:

• the patient has previously had blood clots. Treatment with Pomalidomide Glenmark increases the risk of blood clots in veins and arteries. The doctor may prescribe additional treatment (e.g. warfarin) or reduce the dose of Pomalidomide Glenmark to lower the risk of blood clots.
• the patient has ever experienced hypersensitivity reactions such as rash, itching, swelling, dizziness or difficulty breathing while taking similar medicines called "thalidomide" and "lenalidomide".
• the patient has had a heart attack, has heart failure, experiences breathing difficulties, or if he or she smokes, has high blood pressure or high cholesterol levels.
• the patient has extensive tumour involvement in the body, including in the bone marrow. This may lead to tumour lysis syndrome, in which tumours break down rapidly, causing abnormal levels of chemicals in the blood that may lead to kidney failure. The patient may also experience heart rhythm disturbances.
• the patient has or has had neuropathy (nerve damage causing tingling or pain in the hands or feet).
• the patient has or has had hepatitis B virus infection. Treatment with Pomalidomide Glenmark may reactivate the virus in previously infected patients, leading to a recurrence of infection. The doctor should check whether the patient has previously been infected with hepatitis B virus.
• the patient has had or currently has any of the following symptoms together: facial rash or widespread rash, redness of the skin, high fever, flu-like symptoms, swollen lymph nodes (symptoms of a severe skin reaction known as "drug reaction with eosinophilia and systemic symptoms" (DRESS) or "drug hypersensitivity syndrome"), toxic epidermal necrolysis (TEN), or Stevens-Johnson syndrome (SJS). See also section 4 "Possible side effects").

It should be noted that patients with multiple myeloma treated with pomalidomide may develop
additional types of tumours. Therefore, the treating doctor should carefully assess the benefits and risks
associated with prescribing this medicine.
At any time during or after treatment, immediately inform the doctor or nurse if the following symptoms occur:
vision disturbances, loss of vision or double vision, difficulty speaking, weakness in arms or legs, changes in walking or balance problems, persistent numbness, reduced sensation or loss of sensation, memory loss or disorientation.
These symptoms may indicate a serious and potentially fatal brain disease called progressive multifocal leukoencephalopathy (PML). If these symptoms occurred before treatment with Pomalidomide Glenmark, inform the doctor of any changes in these symptoms.
After treatment ends, return all unused capsules to a pharmacy, which will accept them.

Pregnancy, contraception and breastfeeding – information for women and men
As indicated, the conditions of the pregnancy prevention programme must be followed during treatment with Pomalidomide Glenmark.
Women taking Pomalidomide Glenmark must not become pregnant. Similarly, partners of men being treated with pomalidomide must not become pregnant, because this medicine is expected to be harmful to the fetus. The patient and his partner or her partner should use effective contraception methods during treatment with this medicine.

Women
Do not use Pomalidomide Glenmark if the patient is pregnant, suspects she may be pregnant, or plans to have a child, because the medicine is expected to be harmful to the fetus. Before starting treatment, the patient should inform the doctor that she could become pregnant, even if she considers it unlikely.
If the patient could become pregnant:

• she must use effective contraception methods for at least 4 weeks before starting treatment, throughout the treatment period, and for at least 4 weeks after treatment ends. The patient should discuss with her treating doctor which method of contraception is best for her.
• at each prescription renewal, the treating doctor will ensure that the patient understands all necessary steps to prevent pregnancy.
• the treating doctor will order pregnancy tests before treatment, no less frequently than every 4 weeks during treatment, and at least 4 weeks after treatment ends.

If the patient becomes pregnant despite using preventive methods:

• she must immediately stop treatment and inform her doctor without delay.

Breastfeeding
It is not known whether Pomalidomide Glenmark passes into human milk. If the patient is breastfeeding or intends to breastfeed, she must inform her treating doctor. The treating doctor will advise whether she should stop or continue breastfeeding.

Men
Pomalidomide Glenmark passes into human semen.

• If a man's partner is pregnant or could become pregnant, the man must use condoms throughout the entire treatment period and for 7 days after treatment ends.
• If a man's partner becomes pregnant while he is being treated with Pomalidomide Glenmark, inform the doctor immediately. The partner should also seek medical advice without delay.

The patient must not donate sperm during treatment and for 7 days after treatment ends.

Blood donation and blood tests
During treatment and for 7 days after treatment ends, the patient must not donate blood.
Before and during treatment with Pomalidomide Glenmark, the doctor will regularly order blood tests. This is necessary because this medicine may reduce the number of blood cells (white blood cells) that help fight infections and reduce the number of cells (platelets) that help stop bleeding.
The treating doctor should order blood tests:

• before treatment,
• weekly during the first 8 weeks of treatment,
• thereafter at least once a month for as long as the patient is taking Pomalidomide Glenmark.

The treating doctor may adjust the dose of Pomalidomide Glenmark or discontinue treatment based on the patient's blood test results. The treating doctor may also change the dose or discontinue treatment due to the patient's overall health status.

Children and adolescents
Pomalidomide Glenmark is not recommended for use in children and adolescents under 18 years of age.

Pomalidomide Glenmark and other medicines
Inform the doctor, pharmacist or nurse about all medicines the patient is currently taking, has recently taken, or plans to take, because Pomalidomide Glenmark may affect the action of other medicines. Other medicines may also affect the action of Pomalidomide Glenmark.
Before taking Pomalidomide Glenmark, inform the doctor, pharmacist or nurse, especially if the patient is taking any of the following medicines:

• certain antifungal medicines, such as ketoconazole
• certain antibiotics (e.g. ciprofloxacin, enoxacin)
• certain antidepressants, such as fluvoxamine.

Driving and operating machinery
While taking Pomalidomide Glenmark, some people may experience fatigue, dizziness, fainting, confusion or reduced alertness. If such symptoms occur, the patient should not drive, use tools or operate machinery.

Pomalidomide Glenmark contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning that the medicine is considered "sodium-free".

3. How to use Pomalidomide Glenmark

Pomalidomide Glenmark must be prescribed by a physician experienced in the treatment of multiple myeloma.
This medicine should always be taken exactly as instructed by the physician. If in doubt, consult the physician, pharmacist, or nurse.

When to take Pomalidomide Glenmark with other medicines
Pomalidomide Glenmark with bortezomib and dexamethasone

• Read the package leaflets included with bortezomib and dexamethasone for further information on their use and effects.
• Pomalidomide Glenmark, bortezomib, and dexamethasone are administered in treatment cycles. Each cycle lasts 21 days (3 weeks).
• Refer to the table below to determine which medicines should be taken on each day of the 3-week cycle:
  o Check the table each day to see which medicines to take.
  o On some days, all three medicines are taken; on other days, only two or one medicine may be taken, and on some days, no medicines are taken.

POM: Pomalidomide Glenmark; BOR: bortezomib; DEX: dexamethasone
Cycles 1 to 8 Cycles 9 and onwards
Medicine name Medicine name
Day POM BOR DEX Day POM BOR DEX
1 √ √ √ 1 √ √ √
2 √ √ 2 √ √
3 √ 3 √
4 √ √ √ 4 √
5 √ √ 5 √
6 √ 6 √
7 √ 7 √
8 √ √ √ 8 √ √ √
9 √ √ 9 √ √
10 √ 10 √
11 √ √ √ 11 √
12 √ √ 12 √
13 √ 13 √
14 √ 14 √
15 15
16 16
17 17
18 18
19 19
20 20
21 21

• After completing each 3-week cycle, begin a new cycle.

Pomalidomide Glenmark with dexamethasone only

• Read the package leaflet included with dexamethasone for further information on its use and effects.
• Pomalidomide Glenmark and dexamethasone are administered in treatment cycles. Each cycle lasts 28 days (4 weeks).
• Refer to the table below to determine which medicines should be taken on each day of the 4-week cycle:
  o Check the table each day to see which medicines to take.
  o On some days, both medicines are taken; on other days, only one medicine is taken, and on some days, no medicines are taken.

POM: Pomalidomide Glenmark; DEX: dexamethasone
Medicine name
Day POM DEX
1 √ √
2 √
3 √
4 √
5 √
6 √
7 √
8 √ √
9 √
10 √
11 √
12 √
13 √
14 √
15 √ √
16 √
17 √
18 √
19 √
20 √
21 √
22 √

• After completing each 4-week cycle, begin a new cycle.

What dose of Pomalidomide Glenmark should be taken with other medicines
Pomalidomide Glenmark with bortezomib and dexamethasone

• The recommended starting dose of Pomalidomide Glenmark is 4 mg once daily.
• The recommended starting dose of bortezomib will be determined by the physician based on the patient's height and body weight (1.3 mg/m² body surface area).
• The recommended starting dose of dexamethasone is 20 mg once daily. However, if the patient is over 75 years of age, the recommended starting dose is 10 mg once daily.

Pomalidomide Glenmark with dexamethasone only

• The recommended dose of Pomalidomide Glenmark is 4 mg once daily.
• The recommended starting dose of dexamethasone is 40 mg once daily. However, if the patient is over 75 years of age, the recommended starting dose is 20 mg once daily.

The physician may reduce the dose of Pomalidomide Glenmark, bortezomib, or dexamethasone, or discontinue treatment with one or more of these medicines depending on the patient's blood test results, general health status, concomitant use of other medicines (e.g. ciprofloxacin, enoxacin, and fluvoxamine), and if treatment-related adverse reactions occur (especially rash or swelling).
If the patient has liver or kidney disease, the treating physician will closely monitor the patient's health during treatment with this medicine.

How to take Pomalidomide Glenmark

• Do not break, open, or chew the capsules. If powder from a damaged capsule comes into contact with the skin, wash the skin immediately and thoroughly with soap and water.
• Healthcare professionals, caregivers, and family members should wear disposable gloves when handling the blister pack or capsule. Gloves should be carefully removed to avoid skin exposure, placed in a sealed polyethylene plastic bag, and disposed of according to local regulations. Hands should then be washed thoroughly with soap and water. Pregnant women or women who suspect they may be pregnant should not handle the blister pack or capsule.
• Swallow the capsules whole, preferably with water.
• The capsules may be taken with or without food.
• Take the capsules at approximately the same time each day.

To remove a capsule from the blister pack, press only on one side of the capsule and push it through the foil. Do not press on the center of the capsule, as this may damage it.

If the patient has kidney disease and is undergoing dialysis, the physician will advise how and when to take Pomalidomide Glenmark.

Duration of treatment with Pomalidomide Glenmark
Continue treatment cycles until the physician decides to stop treatment.

Taking more than the recommended dose of Pomalidomide Glenmark
If more than the recommended dose of Pomalidomide Glenmark is taken, contact the physician immediately or go to the hospital. Take the medicine packaging with you.

Missing a dose of Pomalidomide Glenmark
If a dose of Pomalidomide Glenmark is missed on the day it should have been taken, take the next capsule according to the prescribed dosing schedule. Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
If any of the following serious adverse reactions occur, discontinue treatment with Pomalidomide Glenmark and seek immediate medical advice – immediate treatment may be required.

• fever, chills, sore throat, cough, mouth ulcers or any other signs of infection (due to reduced number of white blood cells, which help fight infection)
• bleeding or bruising without cause, including nosebleeds, intestinal or stomach bleeding (due to the medicine's effect on blood cells called platelets)
• rapid breathing, fast heartbeat, fever and chills, passing very little or no urine, nausea and vomiting, confusion, loss of consciousness (due to a blood infection called sepsis or septic shock)
• severe, persistent or bloody diarrhoea (also with abdominal pain or fever) caused by bacteria called Clostridium difficile
• chest pain or leg pain and swelling, particularly in the calf and shin (due to blood clots)
• shortness of breath (due to severe chest infections, pneumonia, heart failure or blood clots)
• swelling of the face, lips, tongue and throat, which may cause difficulty breathing (due to severe forms of allergic reaction known as angioedema and anaphylactic reaction)
• certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which may cause changes in the appearance of the skin or the development of skin growths. If the patient notices any changes in the skin while taking Pomalidomide Glenmark, they should report it to their doctor as quickly as possible.
• reactivation of hepatitis B virus infection, which may cause yellowing of the skin and whites of the eyes, dark brown urine, abdominal pain on the right side, fever, nausea and vomiting. If the patient observes any of these symptoms, they should seek immediate medical advice.
• widespread rash, high body temperature, swollen lymph nodes and involvement of other organs (drug rash with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome, toxic epidermal necrolysis or Stevens-Johnson syndrome). If any of these symptoms occur, treatment with pomalidomide must be stopped immediately and the patient should contact their doctor or seek urgent medical help. See also section 2.

If any of the above serious adverse reactions occur, treatment with Pomalidomide Glenmark must be discontinued and immediate medical advice sought – immediate treatment may be required.
Other adverse reactions
Very common (may affect more than 1 in 10 people):

• shortness of breath (dyspnoea)
• lung infections (pneumonia and bronchitis)
• bacterial or viral infections of the nose, sinuses and throat
• flu-like symptoms (influenza)
• reduced number of red blood cells, which may lead to anaemia causing fatigue and weakness
• low blood potassium levels (hypokalaemia), which may cause weakness, muscle cramps, muscle pain, palpitations, tingling or numbness, shortness of breath, mood changes
• high blood sugar levels
• fast and irregular heartbeat (atrial fibrillation)
• loss of appetite
• constipation, diarrhoea or nausea
• vomiting
• abdominal pain
• lack of energy
• difficulty falling asleep or staying asleep
• dizziness, tremor
• muscle cramps, muscle weakness
• bone pain, back pain
• numbness, tingling or burning sensation of the skin, pain in hands or feet (sensory peripheral neuropathy)
• body swelling, including swelling of hands and feet
• skin rashes
• urinary tract infection, which may cause burning during urination or the need to urinate more frequently

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

• fall
• intracranial bleeding
• reduced ability to move or feel in hands, arms, feet and legs due to nerve damage (sensory-motor peripheral neuropathy)
• numbness, itching and tingling of the skin (paraesthesiae)
• sensation of spinning in the head making it difficult to maintain proper standing posture and normal movement
• swelling due to fluid accumulation (oedema)
• urticaria
• skin itching
• shingles (herpes zoster)
• heart attack (chest pain spreading to arms, neck, jaw, feeling of sweating and breathlessness, nausea or vomiting)
• chest pain, infection within the chest cavity
• high blood pressure
• simultaneous reduction in red blood cells, white blood cells and platelets (pancytopenia), leading to increased susceptibility to bleeding and bruising. The patient may feel tired, weak and short of breath, and be more prone to infections.
• reduced number of lymphocytes (a type of white blood cell), often caused by infection (lymphopenia)
• low blood magnesium levels (hypomagnesaemia), which may cause fatigue, generalised weakness, muscle cramps, irritability and may lead to low blood calcium levels (hypocalcaemia), which may cause numbness and (or) tingling in hands, feet or lips, muscle cramps, muscle weakness, feeling of emptiness in the head, confusion
• low blood phosphate levels (hypophosphataemia), which may cause muscle weakness, irritability or confusion
• high blood calcium levels (hypercalcaemia), which may cause slowed reflexes and skeletal muscle weakness
• high blood potassium levels, which may cause irregular heart rhythm
• low blood sodium levels, which may cause fatigue and confusion, muscle twitching, seizures (epileptic fits) or coma
• high blood uric acid levels, which may lead to joint inflammation in the form of gout
• low blood pressure, which may cause dizziness or fainting
• pain or dryness in the mouth
• changes in taste sensation
• abdominal distension
• feeling of confusion
• depression
• loss of consciousness, fainting
• clouding of the eye (cataract)
• kidney damage
• inability to pass urine
• abnormal liver function test results
• pelvic pain
• weight loss

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

• stroke
• hepatitis, which may cause skin itching, yellowing of the skin and whites of the eyes (jaundice), pale stools, dark urine and abdominal pain
• tumour lysis syndrome, which is the breakdown of tumour cells leading to the release of toxic substances into the blood. This may lead to kidney problems.
• hypothyroidism, which may cause symptoms such as fatigue, lethargy, muscle weakness, slow heart rate and weight gain

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

• rejection of solid organ transplant (such as heart or liver)

Reporting of adverse reactions
If any symptoms of adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products at 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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Pomalidomide Glenmark

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Do not use Pomalidomide Glenmark if you notice any damage or signs of tampering with the packaging.
Medicines should not be disposed of via wastewater or household waste. Any unused capsules remaining after completion of treatment should be returned to a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the package and other information

What Pomalidomide Glenmark contains

• The active substance is pomalidomide.
• The other ingredients are microcrystalline cellulose, maltodextrin and sodium stearyl fumarate.

Pomalidomide Glenmark 1 mg hard capsules:

• Each capsule contains 1 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172) and white ink.
• Printing ink contains: shellac, titanium dioxide (E 171), propylene glycol.

Pomalidomide Glenmark 2 mg hard capsules:

• Each capsule contains 2 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172) and white ink.
• Printing ink contains: shellac, titanium dioxide (E 171), propylene glycol.

Pomalidomide Glenmark 3 mg hard capsules:

• Each capsule contains 3 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), indigo carmine (E 132) and white ink.
• Printing ink contains: shellac, titanium dioxide (E 171), propylene glycol.

Pomalidomide Glenmark 4 mg hard capsules:

• Each capsule contains 4 mg of pomalidomide.
• The capsule shell contains: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), indigo carmine (E 132), erythrosine (E 127) and white ink.
• Printing ink contains: shellac, titanium dioxide (E 171), propylene glycol.

What Pomalidomide Glenmark looks like and contents of the pack
Pomalidomide Glenmark 1 mg hard capsules: hard gelatin capsule with yellow body and red cap, printed with "PLM 1" in white ink along the axis of the capsule body.
Pomalidomide Glenmark 2 mg hard capsules: hard gelatin capsule with orange body and red cap, printed with "PLM 2" in white ink along the axis of the capsule body.
Pomalidomide Glenmark 3 mg hard capsules: hard gelatin capsule with turquoise body and red cap, printed with "PLM 3" in white ink along the axis of the capsule body.
Pomalidomide Glenmark 4 mg hard capsules: hard gelatin capsule with dark blue body and red cap, printed with "PLM 4" in white ink along the axis of the capsule body.

Pack sizes:
Each package contains 14, 21, 14x1 or 21x1 capsules in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

Manufacturer
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic
Synthon Hispania S.L.
Calle De Castello 1
Sant Boi De Llobregat
08830 Barcelona
Spain
Synthon B.V.
Microweg 22
Nijmegen
6545 CM Gelderland
The Netherlands

This medicinal product is authorised in the European Economic Area under the following names:

For more detailed information on this medicinal product, please contact the local representative of the marketing authorization holder:
Glenmark Pharmaceuticals Sp. z o.o.
Dziekonskiego 3
00-728 Warsaw
Email: [email protected]