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
It should be expected that Pomalidomide Glenmark will cause severe birth defects
and may lead to fetal death.

• Do not take this medicine if you are pregnant or may become pregnant.
• You must follow the contraceptive 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 someone else, even if their symptoms are the same.
• If you experience any adverse reactions, 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 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 treatment regimens including lenalidomide and bortezomib.

What is multiple myeloma
Multiple myeloma is a type of cancer that affects a certain type of white blood cells (called plasma cells). These cells grow uncontrollably and accumulate in the bone marrow, causing damage to bones and kidneys.
Multiple myeloma is generally incurable. However, treatment may relieve signs and 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 treatment, can slow 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 treatments, can slow 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 (both 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 the 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 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 allergy to this medicine, consult a doctor. 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 the 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 had 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, has breathing difficulties, or if the patient 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 and release abnormal levels of chemicals, potentially leading 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 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 been previously infected with hepatitis B virus.
• the patient has had or currently has any of the following symptoms: facial rash or widespread rash, redness of the skin, high fever, flu-like symptoms, swollen lymph nodes (symptoms of a serious 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 evaluate the benefits and risks of 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 of 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, any 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 followed during treatment with Pomalidomide Glenmark.
Women taking Pomalidomide Glenmark must not become pregnant, and 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 methods of contraception 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 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 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, at least 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 the doctor without delay.

Breastfeeding
It is not known whether Pomalidomide Glenmark passes into human milk. If the patient is breastfeeding or plans to breastfeed, she must inform her doctor. The doctor will advise whether breastfeeding should be stopped or continued.
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 being treated with Pomalidomide Glenmark causes his partner to become pregnant, 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,
• 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 interrupt 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 or has recently taken, as well as any medicines the patient 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 it 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 as directed 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 are to 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, and on some days, no medicines are taken at all.

POM: Pomalidomide Glenmark; BOR: bortezomib; DEX: dexamethasone
Cycles 1 to 8 Cycles 9 and onwards
Medicine Medicine
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 are to be taken on that day.
  o On some days, both medicines are taken; on other days, only one medicine is taken, and on some days, no medicines are taken at all.

POM: Pomalidomide Glenmark; DEX: dexamethasone
Medicine
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 interrupt 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 effects 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 the 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 how and when to take Pomalidomide Glenmark.

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

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

Missed dose of Pomalidomide Glenmark
If the patient misses a dose of Pomalidomide Glenmark 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 you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
If any of the following serious side effects occur, stop taking Pomalidomide Glenmark and seek
immediate medical advice – 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 infection)
• bleeding or bruising without cause, including nosebleeds, intestinal or stomach bleeding (due to the effect of the medicine 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 difficulty breathing (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 appearance of the skin or the development of skin growths. If the patient notices any skin changes while taking Pomalidomide Glenmark, they should report it to their doctor as soon 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 fever, swollen lymph nodes and involvement of other organs (drug reaction 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 immediate medical help. See also section 2.

If any of the above serious side effects occur, stop taking Pomalidomide Glenmark and seek
immediate medical advice – immediate treatment may be necessary.
Other side effects
Very common (may affect more than 1 in 10 people):

• shortness of breath (dyspnoea)
• lung infections (pneumonia and bronchitis)
• infections of the nose, sinuses and throat caused by bacteria or viruses
• 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)
• swelling of the body, including hands and feet
• rashes
• urinary tract infection, which may cause burning when passing urine or a need to pass urine more frequently

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

• fall
• bleeding inside 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 (hives)
• itching of the skin
• shingles (herpes zoster)
• heart attack (chest pain spreading to arms, neck, jaw, accompanied by sweating and shortness of breath, nausea or vomiting)
• chest pain, chest infection
• 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 blood magnesium levels (hypomagnesaemia), which may cause fatigue, general 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 heartbeat
• low blood sodium levels, which may cause fatigue and confusion, muscle twitching, seizures (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
• mouth pain or dryness
• changes in taste sensation
• abdominal bloating
• feeling confused
• 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 – breakdown of tumour cells leading to 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, weight gain

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

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

Reporting of side effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Side effects can also be reported to the marketing authorisation holder.
Reporting side effects helps to provide more information on the safety of the 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 pack and the outer carton after EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Do not use Pomalidomide Glenmark if you notice any damage to the packaging or signs of tampering.
Medicines should not be disposed of via wastewater or household waste. After treatment is completed, any unused capsules should be returned to a pharmacy that accepts 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 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 (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 (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 (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 (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 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, contact the local representative of the marketing authorization holder:
Glenmark Pharmaceuticals Sp. z o.o.
Dziekonskiego 3
00-728 Warsaw
Email: [email protected]