Pomalidomide reig jofre
Poland
Table of Contents
- Package leaflet: Information for the user
- 1. What Pomalidomid Reig Jofre is and what it is used for
- 2. Important information before taking Pomalidomid Reig Jofre
- 3. How to take Pomalidomid Reig Jofre
- 4. Possible adverse reactions
- 5. How to store Pomalidomid Reig Jofre
- 6. Contents of the pack and other information
Package leaflet: Information for the user
Pomalidomid Reig Jofre, 3 mg, hard capsules
Pomalidomid Reig Jofre, 4 mg, hard capsules
Pomalidomide
Expect that Pomalidomid Reig Jofre 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 because it contains
important information for you.
- Keep this leaflet. 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 you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
- If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
Contents of the leaflet
- What Pomalidomid Reig Jofre is and what it is used for
- What you need to know before taking Pomalidomid Reig Jofre
- How to take Pomalidomid Reig Jofre
- Possible side effects
- How to store Pomalidomid Reig Jofre
- Contents of the pack and other information
1. What Pomalidomid Reig Jofre is and what it is used for
What Pomalidomid Reig Jofre is
Pomalidomid Reig Jofre contains the active substance pomalidomide. This medicine is similar to thalidomide and belongs to a group of medicines that affect the immune system (the system responsible for the body's natural defence).
What Pomalidomid Reig Jofre is used for
Pomalidomid Reig Jofre is used to treat adults with a type of cancer called "multiple myeloma".
Pomalidomid Reig Jofre is used in combination with:
- two other medicines, bortezomib (a type of 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 worsened despite having previously received at least two prior therapies containing lenalidomide and bortezomib.
What is multiple myeloma
Multiple myeloma is a 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 usually cannot be cured. However, treatment may relieve the signs and symptoms of the disease or cause them to disappear for a period of time—this is called a "response" to treatment.
How Pomalidomid Reig Jofre works
Pomalidomid Reig Jofre 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 cancer cells.
Benefits of using Pomalidomid Reig Jofre with bortezomib and dexamethasone
Pomalidomid Reig Jofre used together with bortezomib and dexamethasone in patients who have already received at least one prior therapy may delay the progression of multiple myeloma:
- Pomalidomide used with bortezomib and dexamethasone typically delayed the recurrence of multiple myeloma to 11 months—compared to 7 months in patients who received only bortezomib and dexamethasone.
Benefits of using Pomalidomid Reig Jofre with dexamethasone
Pomalidomid Reig Jofre used together with dexamethasone in patients who have already received at least two prior therapies may delay the progression of multiple myeloma:
- Pomalidomid Reig Jofre used with dexamethasone typically delayed the recurrence of multiple myeloma to 4 months—compared to 2 months in patients who received only dexamethasone.
2. Important information before taking Pomalidomid Reig Jofre
When not to take Pomalidomid Reig Jofre:
- if the patient is allergic to pomalidomide or any of the other ingredients of this medicine (listed in section 6). If an allergic reaction to the medicine is suspected, medical advice should be sought.
- if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant – because Pomalidomid Reig Jofre is expected to be harmful to the unborn child (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 necessary methods of contraception (see section "Pregnancy, contraception and breastfeeding – information for women and men"). If the patient could become pregnant, the doctor will record that the necessary measures have been taken and will provide the patient with confirmation.
If the patient is unsure whether any of the above situations apply, they should consult
their doctor, pharmacist, or nurse before starting treatment with Pomalidomid
Reig Jofre.
Warnings and precautions
Before starting treatment with Pomalidomid Reig Jofre, discuss with the doctor,
pharmacist, or nurse if:
- the patient has ever had blood clots in the past. Treatment with Pomalidomid Reig Jofre increases the risk of developing blood clots in veins and arteries. The doctor may prescribe additional treatment (e.g. warfarin) or reduce the dose of Pomalidomid Reig Jofre to lower the risk of blood clots.
- the patient has ever experienced an allergic reaction such as rash, itching, swelling, dizziness, or breathing difficulties while taking similar medicines such as 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 a condition where tumours break down rapidly, causing abnormal levels of chemical substances in the blood, which may lead to kidney failure. The patient may also experience irregular heartbeat. 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. Taking Pomalidomid Reig Jofre 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 currently or previously experienced any of the following symptoms together: facial rash or widespread rash, redness of the skin, high fever, flu-like symptoms, swollen lymph nodes (observed 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 is important to note that in patients with multiple myeloma treated with pomalidomide,
the development of additional types of cancer may occur. Therefore, the treating doctor should
carefully evaluate the benefits and risks associated with prescribing this medicine.
At any time during or after treatment, the patient should immediately inform the
doctor or nurse if any of the following occur: vision disturbances, loss of vision, double vision,
difficulty speaking, weakness in arms or legs, changes in walking or balance, persistent numbness,
reduced sensation or loss of sensation, memory loss or disorientation.
All of these symptoms may indicate a serious and potentially fatal brain disorder
called progressive multifocal leukoencephalopathy (PML). If these symptoms occurred before
treatment with Pomalidomid Reig Jofre, the patient should inform the doctor of any changes in these
symptoms.
After treatment ends, any unused capsules should be returned to the pharmacist at the pharmacy.
Children and adolescents
Pomalidomid Reig Jofre is not recommended for use in children and adolescents under
18 years of age.
Pomalidomid Reig Jofre and other medicines
The patient should inform their doctor, pharmacist, or nurse about all medicines they are currently taking
or have recently taken, as well as any medicines they plan to take, because Pomalidomid Reig Jofre may affect the action of other medicines. Other medicines may also affect the action of Pomalidomid Reig Jofre.
Before taking Pomalidomid Reig Jofre, the patient should inform the doctor, pharmacist, or
nurse, especially if they are taking any of the following medicines:
- certain antifungal medicines such as ketoconazole
- certain antibiotics (e.g. ciprofloxacin, enoxacin)
- certain antidepressants such as fluvoxamine.
Pregnancy, contraception and breastfeeding – information for women and men
As indicated below, the conditions of the Pregnancy Prevention Programme must be observed
during treatment with Pomalidomid Reig Jofre. Women taking Pomalidomid Reig Jofre
must not become pregnant, and men being treated with pomalidomide must not get their partner pregnant, because this medicine is expected to harm the unborn child.
Both the patient and their partner must use effective methods of contraception during
treatment with this medicine.
Women
Do not take Pomalidomid Reig Jofre if the patient is pregnant, suspects she may
be pregnant, or plans to become pregnant, because this medicine is expected to harm
the unborn child. Before starting treatment, the patient should inform her treating
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 entire treatment period, and for at least 4 weeks after treatment ends. The patient should discuss with her treating doctor which contraception method is best for her.
- each time the medicine is prescribed, the treating doctor will ensure that the patient understands all necessary contraception methods she must use 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, despite using preventive measures, the patient becomes pregnant:
- she must immediately stop treatment and inform her treating doctor without delay.
Breastfeeding
It is not known whether Pomalidomid Reig Jofre passes into human milk. If the patient is breastfeeding
or intends to breastfeed, she must inform her treating doctor. The treating doctor
will advise the patient whether she should stop or continue breastfeeding.
Men
Pomalidomid Reig Jofre passes into human semen.
- If the 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 the partner of a man undergoing treatment with Pomalidomid Reig Jofre becomes pregnant, the doctor must be informed immediately. The partner should also seek medical advice immediately.
The patient must not donate sperm or semen 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 Pomalidomid Reig Jofre, the patient will undergo regular blood tests.
This is because this medicine may reduce the number of blood cells that help fight infections (white blood cells) and reduce the number of cells that help stop bleeding (platelets).
The treating doctor should order blood tests for the patient:
- before treatment begins
- weekly during the first 8 weeks of treatment
- thereafter at least once a month for as long as the patient is taking Pomalidomid Reig Jofre.
The treating doctor may adjust the dose of Pomalidomid Reig Jofre or discontinue treatment based on the patient's blood test results. The treating doctor may also change the dose or stop treatment due to the patient's general health condition.
Driving and using machines
While taking Pomalidomid Reig Jofre, some people may experience fatigue, dizziness, fainting, confusion, or reduced alertness. If such symptoms occur, the patient should not drive, operate tools, or use machinery.
Pomalidomid Reig Jofre contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning it is considered "sodium-free".
Pomalidomid Reig Jofre contains isomalt
If the patient has previously been diagnosed with intolerance to certain sugars, they should
consult their doctor before taking this medicine.
3. How to take Pomalidomid Reig Jofre
Pomalidomid Reig Jofre must be prescribed by a physician experienced in the treatment of
multiple myeloma.
This medicine should always be taken exactly as directed by your doctor. If you have any doubts, please consult your doctor, pharmacist, or nurse.
If doses are required that cannot be achieved with the Pomalidomid Reig Jofre 3 mg and Pomalidomid Reig Jofre 4 mg capsule products, another available medicinal product containing pomalidomide as the active substance in the appropriate strength and formulation should be used.
When to take Pomalidomid Reig Jofre with other medicines
Pomalidomid Reig Jofre with bortezomib and dexamethasone
- Please refer to the package leaflets of the medicines containing bortezomib and dexamethasone for further information on their use and effects.
- Pomalidomid Reig Jofre, bortezomib, and dexamethasone are administered in treatment cycles. Each cycle lasts 21 days (3 weeks).
- The table below shows which medicines should be taken on each day of the 3-week cycle: Each day, locate the corresponding day in the table and check which medicines need to be taken. On some days, all three medicines are taken; on other days, only two or one medicine, and on some days, no medicines are taken at all.
POM: Pomalidomid Reig Jofre; BOR: bortezomib; DEX: dexamethasone
Cycles 1 to 8 Cycle 9 and onwards
| Drug Name | |||
| Day | POM | BOR | DEX |
| 1. | √ | √ | √ |
| 2. | √ | √ | |
| 3. | √ | ||
| 4. | √ | √ | √ |
| 5. | √ | √ | |
| 6. | √ | ||
| 7. | √ | ||
| 8. | √ | √ | √ |
| 9. | √ | √ | |
| 10. | √ | ||
| 11. | √ | √ | √ |
| 12. | √ | √ | |
| 13. | √ | ||
| 14. | √ | ||
| 15. | |||
| 16. | |||
| 17. | |||
| 18. | |||
| 19. | |||
| 20. | |||
| 21. | |||
| Drug Name | |||
| Day | POM | BOR | DEX |
| 1. | √ | √ | √ |
| 2. | √ | √ | |
| 3. | √ | ||
| 4. | √ | ||
| 5. | √ | ||
| 6. | √ | ||
| 7. | √ | ||
| 8. | √ | √ | √ |
| 9. | √ | √ | |
| 10. | √ | ||
| 11. | √ | ||
| 12. | √ | ||
| 13. | √ | ||
| 14. | √ | ||
| 15. | |||
| 16. | |||
| 17. | |||
| 18. | |||
| 19. | |||
| 20. | |||
| 21. | |||
- After completing each 3-week cycle, a new cycle should be started.
Pomalidomid Reig Jofre with dexamethasone only
- Please refer to the package leaflet of dexamethasone for further information on its use and effects.
- Pomalidomid Reig Jofre and dexamethasone are administered in treatment cycles. Each cycle lasts 28 days (4 weeks).
- The following table helps to verify which medications should be taken on each day of the 4-week cycle: Each day, locate the corresponding day in the table and check which medications need to be taken. On some days, both medications should be taken; on other days, only one medication should be taken; and on some days, no medication should be taken.
POM: Pomalidomid Reig Jofre; DEX: dexamethasone
| Drug 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. | √ | |
| 23. | ||
| 24. | ||
| 25. | ||
| 26. | ||
| 27. | ||
| 28. | ||
- After completion of each 4-week cycle, a new cycle should be started.
What dose of Pomalidomid Reig Jofre should be taken with other medicines
Pomalidomid Reig Jofre with bortezomib and dexamethasone
- The recommended starting dose of Pomalidomid Reig Jofre is 4 mg once daily.
- The recommended starting dose of bortezomib will be determined by the doctor 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, for patients over 75 years of age, the recommended starting dose is 10 mg once daily.
Pomalidomid Reig Jofre with dexamethasone only
- The recommended dose of Pomalidomid Reig Jofre is 4 mg once daily.
- The recommended starting dose of dexamethasone is 40 mg once daily. However, for patients over 75 years of age, the recommended starting dose is 20 mg once daily.
The doctor may reduce the dose of Pomalidomid Reig Jofre, bortezomib, or dexamethasone, or may recommend interrupting treatment with one or more of these medicines, depending on the patient's blood test results, general condition, concomitant use of other medicines (e.g. ciprofloxacin, enoxacin, and fluvoxamine), and if treatment-related adverse reactions occur (especially rash and 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 Pomalidomid Reig Jofre
- Do not crush, open, or chew the capsules. If the powder from a damaged Pomalidomid Reig Jofre capsule comes into contact with the skin, the skin should be washed 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. Afterwards, hands should 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.
- Capsules should be swallowed whole, preferably with water.
- Capsules may be taken with or without food.
- Pomalidomid Reig Jofre should be taken at approximately the same time each day.
To remove a capsule from the blister pack, press the blister only at one end of the capsule and push the capsule through the foil. Do not press the blister in the middle of the capsule, as this may damage the capsule.
If the patient has kidney problems and is on dialysis, the treating physician will advise how and when to take Pomalidomid Reig Jofre.
Duration of treatment with Pomalidomid Reig Jofre
Treatment cycles should be continued until the doctor advises stopping treatment.
Accidental overdose of Pomalidomid Reig Jofre
If a patient takes more than the recommended dose of Pomalidomid Reig Jofre, they should immediately contact their doctor or go to a hospital. The patient should bring the medicine packaging with them.
Missed dose of Pomalidomid Reig Jofre
If a patient misses a dose of Pomalidomid Reig Jofre on the day it should have been taken, they should take the next capsule at the usual time on the following day. A double dose should not be taken to make up for the missed capsule of Pomalidomid Reig Jofre.
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 Pomalidomid Reig Jofre immediately and contact your doctor straight away – 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 fight infection);
- unexplained bleeding or bruising, 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);
- shallow breathing (due to severe chest infections, pneumonia, heart failure or blood clots);
- swelling of the face, lips, tongue and throat, possibly causing 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 appearance of the skin or the development of skin growths. If the patient notices any skin changes while taking Pomalidomid Reig Jofre, this should be reported to the 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. Contact your doctor immediately if these symptoms occur;
- widespread rash, high fever, 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 these symptoms occur, stop taking pomalidomide immediately and contact your doctor or seek urgent medical help. See also section 2.
If any of the above serious adverse reactions occur, stop taking Pomalidomid Reig Jofre immediately and contact your doctor straight away – 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, possibly leading to anaemia causing fatigue and weakness;
- low potassium levels in the blood (hypokalaemia), possibly causing 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 maintaining sleep;
- dizziness, tremor;
- muscle spasms, 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;
- rash;
- urinary tract infection, possibly causing burning during urination or increased frequency of urination.
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;
- urticaria;
- itching of the skin;
- shingles;
- heart attack (chest pain radiating to arms, neck, jaw, feeling of sweating and shortness of breath, nausea or vomiting);
- chest pain, chest infection;
- increased 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 magnesium levels in the blood (hypomagnesaemia), possibly causing fatigue, generalised weakness, muscle cramps, irritability and leading to low calcium levels in the blood (hypocalcaemia), which may cause numbness and (or) tingling of hands, feet or lips, muscle spasms, muscle weakness, dizziness, confusion;
- low phosphate levels in the blood (hypophosphataemia), possibly causing muscle weakness and irritability or confusion;
- high calcium levels in the blood (hypercalcaemia), possibly causing slowed reflexes and skeletal muscle weakness;
- high potassium levels in the blood, possibly causing irregular heartbeat;
- low sodium levels in the blood, possibly causing fatigue and confusion, muscle twitching, seizures (epileptic fits) or coma;
- high uric acid levels in the blood, which may lead to joint inflammation in the form of gout;
- low blood pressure, possibly causing dizziness or fainting;
- pain or dryness in the mouth;
- changes in taste perception;
- abdominal swelling;
- feeling confused;
- feeling depressed;
- 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 heartbeat, weight gain.
Frequency not known (frequency cannot be estimated from the available data):
- rejection of transplanted solid organs (such as heart or liver).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 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 the medicine.
5. How to store Pomalidomid Reig Jofre
Keep this medicine out of 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 apply for this medicine.
Do not use Pomalidomid Reig Jofre if you notice any damage or signs of tampering with the packaging.
Medicines should not be disposed of via wastewater or household waste. Unused medicine should be returned to a pharmacist at a pharmacy after treatment has ended. This will help protect the environment.
6. Contents of the pack and other information
What Pomalidomid Reig Jofre contains
- The active substance is pomalidomide.
- The other ingredients are: isomalt 801 (E 953), isomalt 721 (E 953), pregelatinized maize starch, and sodium stearyl fumarate.
Pomalidomid Reig Jofre 3 mg, hard capsules:
- Each hard capsule contains 3 mg of pomalidomide.
- The capsule shell contains: gelatin, titanium dioxide (E 171), brilliant blue FCF (E 133), and black ink.
Pomalidomid Reig Jofre 4 mg, hard capsules:
- Each hard capsule contains 4 mg of pomalidomide.
- The capsule shell contains: gelatin, brilliant blue FCF (E 133), titanium dioxide (E 171), erythrosine (E 127), and black ink.
The printing ink contains: shellac (E 904), concentrated ammonium hydroxide, potassium hydroxide, and iron oxide black (E 172).
What Pomalidomid Reig Jofre looks like and contents of the pack
Pomalidomid Reig Jofre 3 mg, hard capsules: Size 2 capsule (dimensions approximately 18 mm x 6 mm), with a light blue, opaque cap and a light blue, opaque body, printed in black ink with "LP" on the cap and "690" on the body, containing a yellow, granular powder.
Pomalidomid Reig Jofre 4 mg, hard capsules: Size 2 capsule (dimensions approximately 18 mm x 6 mm), with a blue, opaque cap and a blue, opaque body, printed in black ink with "LP" on the cap and "667" on the body, containing a yellow, granular powder.
Pack sizes:
Blisters made of PVC/PCTFE/ACLAR/Aluminum or blisters made of OPA/Aluminum/PVC/Aluminum, in a cardboard box:
14 hard capsules (blister packs)
14x1 capsule (perforated single-dose blisters)
21 hard capsules (blister packs)
21x1 capsule (perforated single-dose blisters)
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Reig Jofre Sp. z o.o.
ul. Ostródzka 74N
03-289 Warszawa
e-mail: [email protected]
Tel.: +48 22 487 88 49
Importer
Qualimetrix S.A.
579 Mesogeion Avenue
Agia Paraskevi
15343 Athens
Greece
Adalvo Limited
Malta Life Sciences Park
Building 1, Level 4, Sir Temi Zammit Buildings
San Gwann SGN 3000
Malta
Pharmadox Healthcare Ltd.
KW20A Kordin Industrial Park
Paola PLA 3000
Malta
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Denmark: Pomalidomide Bioglan
Finland: Pomalidomide Bioglan
France: Pomalidomide Reig Jofre 1 mg, 2 mg, 3 mg et 4 mg gélules
Spain: Pomalidomida Sala 3 mg cápsulas duras EFG
Pomalidomida Sala 4 mg cápsulas duras EFG
Netherlands: Pomalidomide Reig Jofre 1 mg harde capsules
Pomalidomide Reig Jofre 2 mg harde capsules
Pomalidomide Reig Jofre 3 mg harde capsules
Pomalidomide Reig Jofre 4 mg harde capsules
Poland: Pomalidomid Reig Jofre
Sweden: Pomalidomide Bioglan
Italy: Pomalidomide Reig Jofre