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
There is a high risk that Pomalidomide Glenmark will cause severe birth defects
and may result in fetal death.

• Do not take this medicine if you are pregnant or may become pregnant.
• It is essential to follow the contraceptive advice provided in this leaflet.

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

Contents of the leaflet

1. What Pomalidomide Glenmark is and what it is used for
2. Important information 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 treatment regimen containing lenalidomide; or
• one other medicine – dexamethasone in patients with multiple myeloma whose disease has worsened despite having previously received at least two prior treatment regimens 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 bone and kidney damage.
Multiple myeloma is generally considered incurable. However, treatment may relieve symptoms 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 nutrients to cancer cells.

Benefits of using Pomalidomide Glenmark with bortezomib and dexamethasone
When Pomalidomide Glenmark is used in combination with bortezomib and dexamethasone in patients who have already received at least one prior treatment, it may slow the progression of multiple myeloma:

• Pomalidomide Glenmark used with bortezomib and dexamethasone typically delayed the progression 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
When Pomalidomide Glenmark is used in combination with dexamethasone in patients who have already received at least two prior treatments, it may slow the progression of multiple myeloma:

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

2. 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 "Pregnancy, 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 measures have been taken and will provide the patient with 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 allergy to this medicine, they should consult a doctor for advice. If the patient is unsure whether any of the above situations apply, they should consult a doctor, pharmacist, or nurse before starting treatment with Pomalidomide Glenmark.

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

• the patient has ever had blood clots in the past. Treatment with Pomalidomide Glenmark increases the risk of developing blood clots in veins and arteries. The doctor may recommend additional treatment (e.g., warfarin) or reduce the dose of Pomalidomide Glenmark to lower the risk of blood clots.
• the patient has ever experienced an allergic reaction, such as rash, itching, swelling, dizziness, or difficulty breathing while taking similar medicines called "thalidomide" or "lenalidomide".
• the patient has had a heart attack, has heart failure, experiences breathing difficulties, or if they smoke, have 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, potentially leading to kidney failure. The patient may also experience heart rhythm disturbances. This condition is known as tumour lysis syndrome.
• the patient has or has had neuropathy (nerve damage causing tingling or pain in 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 recurrence of infection. The doctor should check whether the patient has previously been infected with hepatitis B virus.
• the patient has or has previously had 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").

Please note that patients with multiple myeloma treated with pomalidomide may develop
additional types of cancer. For this reason, the treating doctor should carefully assess
the benefits and risks of prescribing this medicine to the patient.
At any time during or after treatment, immediately inform the doctor or
nurse if any of 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 life-threatening brain condition 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, all unused capsules should be returned to the 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 observed during treatment with Pomalidomide Glenmark.
Women taking Pomalidomide Glenmark must not become pregnant. Partners of men treated with pomalidomide must also 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 this medicine is expected to be harmful to the fetus. Before starting treatment, the patient should inform the doctor if 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 entire treatment period, and for at least 4 weeks after treatment ends. The patient should discuss with her doctor which contraception method is best for her.
• at each prescription renewal, the treating doctor will ensure that the patient understands all necessary actions required 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:

• treatment must be stopped immediately and the doctor must be informed immediately.

Breastfeeding
It is unknown whether Pomalidomide Glenmark passes into human milk. If the patient is breastfeeding
or intends to breastfeed, she must inform her doctor. The doctor
will advise the patient whether she should stop or continue breastfeeding.
Men
Pomalidomide Glenmark is present in 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 during treatment with Pomalidomide Glenmark, the doctor must be informed immediately. The partner should also seek medical advice immediately.

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,
• then 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
Tell 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 using machines
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 take 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 directed by the physician. If in doubt, consult the doctor, pharmacist, or nurse.

When to take Pomalidomide Glenmark with other medicines

Pomalidomide Glenmark with bortezomib and dexamethasone

• Read the package leaflets for 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 should be taken on that day.
  o On some days, all three medicines are taken; on other days, only two or one medicine may be taken, or no medicine at all.

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 for 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 should be taken on that day.
  o On some days, both medicines are taken; on other days, only one medicine may be taken, or no medicine at all.

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 blood test results, the patient's general health status, concomitant use of other medicines (e.g., ciprofloxacin, enoxacin, and fluvoxamine), or if treatment-related adverse effects occur (particularly 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 then 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, 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 on dialysis, the physician will advise on how and when to take Pomalidomide Glenmark.

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

Overdose of Pomalidomide Glenmark
If an overdose of Pomalidomide Glenmark is taken, contact a doctor immediately or go to the hospital. Bring the medicine packaging with you.

Missed dose of Pomalidomide Glenmark
If a dose of Pomalidomide Glenmark is missed on a day when 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 there are any further questions about the use of this medicine, consult the doctor 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, stop taking
Pomalidomide Glenmark immediately and contact your doctor without delay – immediate
treatment may be necessary.

• fever, chills, sore throat, cough, mouth ulcers or any other signs of infection (due to reduced number of white blood cells, which help fight infections)
• unexplained bleeding or bruising, 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 lower leg (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 breathing difficulties (due to severe allergic reactions known as angioedema and anaphylactic reaction)
• certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which may cause changes in the skin's appearance or the development of skin growths. If the patient notices any skin changes while taking Pomalidomide Glenmark, this should be reported to the doctor as quickly as possible.
• reactivation of hepatitis B virus, which may cause yellowing of the skin and whites of the eyes, dark brown urine, pain in the right side of the abdomen, fever, nausea and vomiting. If the patient observes any of these symptoms, medical advice should be sought immediately.
• widespread rash, high fever, swollen lymph nodes and involvement of other organs (drug rash with eosinophilia and systemic symptoms, also known as DRESS, or toxic epidermal necrolysis or Stevens-Johnson syndrome). If any of these symptoms occur, pomalidomide should be stopped immediately and the doctor contacted or urgent medical help sought. See also section 2.

If any of the above serious adverse reactions occur, stop taking Pomalidomide Glenmark immediately and contact your doctor – immediate treatment may be necessary.
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 levels of potassium in the blood (hypokalaemia), which may cause weakness, muscle cramps, muscle pain, palpitations, tingling or numbness, shortness of breath, mood changes
• high levels of blood sugar
• fast and irregular heartbeat (atrial fibrillation)
• loss of appetite
• constipation, diarrhoea or nausea
• vomiting
• abdominal pain
• lack of energy
• difficulty falling asleep or maintaining sleep
• dizziness, tremor
• muscle cramps, muscle weakness
• bone pain, back pain
• numbness, tingling or burning sensation in the skin, pain in hands or feet (sensory peripheral neuropathy)
• body swelling, including swelling of hands and feet
• 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
• bleeding within the skull
• 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 (paraesthesia)
• sensation of spinning in the head, making it difficult to maintain proper standing posture and normal movement
• swelling due to fluid accumulation
• urticaria
• itching of the skin
• shingles
• heart attack (chest pain spreading to arms, neck, jaw, feeling of sweating and shortness of breath, nausea or vomiting)
• chest pain, infection in the chest area
• high blood pressure
• simultaneous reduction in the number of red blood cells, white blood cells and platelets (pancytopenia), leading to increased susceptibility to bleeding and bruising. The patient may feel tired, weak, short of breath and more prone to infections.
• reduced number of lymphocytes (a type of white blood cell), often caused by infection (lymphopenia)
• low levels of magnesium in the blood (hypomagnesaemia), which may cause fatigue, general weakness, muscle cramps, irritability and may lead to low levels of calcium in the blood (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 levels of phosphates in the blood (hypophosphataemia), which may cause muscle weakness, irritability or confusion
• high levels of calcium in the blood (hypercalcaemia), which may cause slowed reflexes and skeletal muscle weakness
• high levels of potassium in the blood, which may cause irregular heart rhythm
• low levels of sodium in the blood, which may cause fatigue and confusion, muscle twitching, seizures (epileptic fits) or coma
• high levels of uric acid in the blood, 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 tests
• pelvic pain
• weight loss

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

• stroke
• hepatitis, which may cause itching of the skin, 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 the available data):

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions
can also 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 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 indicated month.
No special storage instructions 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. After completion of treatment, any unused capsules should be returned to a pharmacy, which will accept them. This will help protect the environment.

6. Contents of the pack and other information

What Pomalidomide Glenmark contains

• The active substance is pomalidomide.
• The other components 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 white ink "PLM 1" along the body axis of the capsule.
Pomalidomide Glenmark 2 mg hard capsules: hard gelatin capsule with orange body and red cap, printed with white ink "PLM 2" along the body axis of the capsule.
Pomalidomide Glenmark 3 mg hard capsules: hard gelatin capsule with turquoise body and red cap, printed with white ink "PLM 3" along the body axis of the capsule.
Pomalidomide Glenmark 4 mg hard capsules: hard gelatin capsule with dark blue body and red cap, printed with white ink "PLM 4" along the body axis of the capsule.
Pack sizes available:
Each pack 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]