Lenalidomide sandoz: detailed information

Package leaflet: Information for the patient

Lenalidomide Sandoz, 10 mg, hard capsules
Lenalidomidum
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, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, 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 or pharmacist. See section 4.

Contents of the leaflet

What Lenalidomide Sandoz is and what it is used for
What you need to know before taking Lenalidomide Sandoz
How to take Lenalidomide Sandoz
Possible side effects
How to store Lenalidomide Sandoz
Contents of the pack and other information

1. What Lenalidomide Sandoz is and what it is used for

What Lenalidomide Sandoz is
Lenalidomide Sandoz contains the active substance lenalidomide and belongs to a group of medicines that affect the immune system.

What Lenalidomide Sandoz is used for
Lenalidomide Sandoz is used in adults to treat:

multiple myeloma,
myelodysplastic syndromes,
mantle cell lymphoma,
follicular lymphoma.

Multiple myeloma
Multiple myeloma is a type of cancer that arises due to the uncontrolled growth of a certain type of white blood cells called plasma cells. These cells accumulate in the bone marrow and divide uncontrollably. This may lead to damage of bones and kidneys. Multiple myeloma is generally incurable. However, it is possible to achieve temporary significant alleviation or disappearance of symptoms. This condition is called "remission".

Newly diagnosed multiple myeloma – in patients undergoing bone marrow transplantation
Lenalidomide Sandoz is used as a single agent for maintenance therapy in patients who have responded adequately to bone marrow transplantation.

Newly diagnosed multiple myeloma – in patients not eligible for bone marrow transplantation
Lenalidomide Sandoz is taken in combination with other medicines, including:

a chemotherapy drug called "bortezomib",
an anti-inflammatory drug called "dexamethasone",
a chemotherapy drug called "melphalan", and
an immunosuppressive drug called "prednisone".

Treatment begins with Lenalidomide Sandoz in combination with other medicines, followed by continued treatment with Lenalidomide Sandoz alone.
If you are 75 years of age or older, or if you have moderate to severe kidney impairment, your doctor will perform careful assessments before starting Lenalidomide Sandoz.

Multiple myeloma – in previously treated patients
Lenalidomide Sandoz is taken together with the anti-inflammatory drug dexamethasone.
Lenalidomide Sandoz may prevent worsening of multiple myeloma symptoms. It has also been shown to delay relapse after treatment.

Myelodysplastic syndromes (MDS)
Myelodysplastic syndromes (MDS) are a group of different blood and bone marrow disorders. Abnormal blood cells are present that do not function properly. Patients may experience various symptoms, including low numbers of red blood cells (anaemia), need for blood transfusions, and risk of infections.

Lenalidomide Sandoz, used as monotherapy, is indicated for the treatment of adult patients diagnosed with MDS, if all the following conditions are met:

the patient requires regular blood transfusions due to low red blood cell count ("transfusion-dependent anaemia");
the patient has an abnormality in bone marrow cells called "isolated cytogenetic abnormality with deletion 5q". This means the patient's body does not produce enough healthy blood cells;
the patient has previously been treated with other therapies that were inappropriate or insufficiently effective.

Taking Lenalidomide Sandoz may lead to an increased production of healthy blood cells by the body, by reducing the number of abnormal cells.

This may result in a reduced need for blood transfusions. It may even become possible to discontinue transfusions altogether.

Mantle cell lymphoma (MCL)
MCL is a cancer affecting part of the immune system (lymphatic tissue). It attacks a certain type of white blood cells called B-lymphocytes or B-cells. Mantle cell lymphoma is characterized by uncontrolled growth of B-lymphocytes, leading to their accumulation in lymphatic tissue, bone marrow, or blood.
Lenalidomide Sandoz, used as monotherapy, is indicated for the treatment of adult patients who have been previously treated with other medicines.

Follicular lymphoma (FL)
Follicular lymphoma is a slowly growing malignant cancer affecting B-lymphocytes. These are a type of white blood cells that help the body fight infections. In patients with follicular lymphoma, excessive numbers of B-lymphocytes may accumulate in the blood, bone marrow, lymph nodes, and spleen.
Lenalidomide Sandoz is taken in combination with another medicine called "rituximab" for the treatment of adult patients with previously treated follicular lymphoma.

How Lenalidomide Sandoz works
The medicine works by affecting the body's immune system and directly attacking cancer cells. Its mechanism of action includes:

inhibition of cancer cell growth,
inhibition of blood vessel formation in tumours,
stimulation of part of the immune system to attack cancer cells.

2. Important information before using Lenalidomide Sandoz

Before starting treatment with Lenalidomide Sandoz, carefully read
the package leaflets of all medicinal products used in combination with Lenalidomide Sandoz.

When not to use Lenalidomide Sandoz

if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant, because Lenalidomide Sandoz may harm the unborn baby (see "Pregnancy, breastfeeding and contraception – information for women and men" in section 2);
if the patient is of childbearing potential, unless she follows all required methods to prevent pregnancy (see "Pregnancy, breastfeeding and contraception – information for women and men" in section 2). If the patient is a woman of childbearing potential, the doctor will document at every follow-up visit that necessary actions have been taken and will provide the patient with written confirmation.
if the patient is allergic to lenalidomide or to any of the excipients of this medicine (listed in section 6). If the patient suspects an allergy, she should consult her doctor.

If any of the above situations apply, do not take Lenalidomide Sandoz. In case of doubt, consult your doctor.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking Lenalidomide Sandoz if:

the patient has previously had blood clots, as she has an increased risk of developing blood clots in veins and arteries;
the patient has any signs of infection, such as cough or fever;
the patient has or has previously had a viral infection, especially hepatitis B, varicella-zoster virus (chickenpox and shingles), or HIV. In case of doubt, consult your doctor. Treatment with Lenalidomide Sandoz may reactivate the virus, leading to a recurrence of infection. The doctor should check whether the patient has ever had hepatitis B.
the patient has kidney function impairment – the doctor may adjust the dose of Lenalidomide Sandoz;
the patient has had a heart attack, blood clots, smokes, has high blood pressure, or elevated cholesterol levels;
the patient experienced an allergic reaction after taking thalidomide (another drug used to treat multiple myeloma), such as rash, itching, swelling, dizziness, or difficulty breathing;
the patient previously experienced a combination of any of the following symptoms: widespread rash, skin redness, high fever, flu-like symptoms, increased liver enzyme activity, blood test abnormalities (eosinophilia), or swollen lymph nodes – these are symptoms of a severe skin reaction called drug rash with eosinophilia and systemic symptoms (DRESS), also known as "drug hypersensitivity syndrome" (see also section 4 "Possible side effects").

If any of the above situations apply, inform your doctor, pharmacist, or nurse before starting treatment.

Contact your doctor, pharmacist, or nurse immediately if, at any time during or after treatment, the patient experiences:

vision disturbances, loss of vision, double vision, difficulty speaking, weakness in the arm or leg, changes in walking or balance, persistent numbness, reduced sensation, or loss of sensation, memory loss, or disorientation. These may be symptoms of a serious and potentially fatal brain disease called progressive multifocal leukoencephalopathy (PML). If the patient had such symptoms before lenalidomide treatment, inform the doctor of any changes.
shortness of breath, fatigue, dizziness, chest pain, rapid heartbeat, or swelling of the legs or ankles. These may be symptoms of a serious condition called pulmonary hypertension (see section 4).

Tests and examinations

Before starting and during treatment with Lenalidomide Sandoz, the patient will undergo regular blood tests, as this medicine may reduce the number of blood cells that help fight infection (white blood cells) and those involved in blood clotting (platelets).

The doctor will order blood tests:

before treatment,
weekly during the first 8 weeks of treatment,
thereafter at least once a month.

Patients with MDS taking Lenalidomide Sandoz

If the patient has myelodysplastic syndromes (MDS), there is an increased risk of developing a serious disease called acute myeloid leukemia. Furthermore, it is not known how Lenalidomide Sandoz affects the likelihood of developing acute myeloid leukemia. Therefore, the doctor may perform tests and monitor symptoms to better assess the risk of acute myeloid leukemia during treatment with Lenalidomide Sandoz.

Patients with MCL taking Lenalidomide Sandoz

The doctor will request blood tests:

before treatment,
weekly during the first 8 weeks (2 cycles) of treatment,
then every 2 weeks during cycles 3 and 4 (more information in section 3 "Treatment schedule"),
then at the beginning of each cycle, and
at least once a month.

Patients with follicular lymphoma taking Lenalidomide Sandoz

The doctor will request blood tests:

before treatment,
weekly during the first 3 weeks (1 cycle) of treatment,
then every 2 weeks during cycles 2 to 4 (more information in section 3 "Treatment schedule"),
then at the beginning of each cycle, and
at least once a month.

Before and during treatment with lenalidomide, the patient may undergo evaluation for circulatory and respiratory problems.

The doctor may perform tests to determine whether the patient has a large amount of tumor tissue in the body, including in the bone marrow. This may lead to a condition in which tumor cells break down rapidly, causing abnormal increases in various chemical substances in the blood and potentially leading to kidney failure (this condition is known as "tumor lysis syndrome").

The doctor may examine the patient's skin to check for changes such as red spots or rash.

The doctor may adjust the dose of Lenalidomide Sandoz or discontinue treatment based on blood test results and the patient's overall condition. If the disease was recently diagnosed, the doctor may also consider the patient's age and other existing medical conditions when evaluating treatment.

Blood donation

Do not donate blood during treatment and for at least 7 days after stopping treatment.

Children and adolescents

Lenalidomide Sandoz is not recommended for use in children and adolescents under 18 years of age.

Elderly patients and patients with kidney function impairment

If the patient is 75 years of age or older or has moderate to severe kidney function impairment, the doctor will perform thorough evaluations before starting treatment.

Lenalidomide Sandoz and other medicines

Inform your doctor or nurse about all medicines the patient is currently taking or has recently taken, as Lenalidomide Sandoz and certain other medicines may interact with each other.

Especially inform your doctor or nurse if the patient is taking any of the following medicines or substances:

certain contraceptives, such as oral contraceptives, as they may become less effective;
certain medicines used for heart conditions, such as digoxin;
certain medicines used to thin the blood, such as warfarin.

Pregnancy, breastfeeding and contraception – information for women and men

Pregnancy

Information for women taking Lenalidomide Sandoz

Do not take Lenalidomide Sandoz if the patient is pregnant, as it may harm the unborn baby.
Women must not become pregnant while taking Lenalidomide Sandoz. Therefore, women of childbearing potential must use effective methods of contraception (see "Contraception").
If the patient becomes pregnant while taking Lenalidomide Sandoz, she must stop treatment immediately and inform her doctor.

Information for men taking Lenalidomide Sandoz

If the male patient's partner becomes pregnant while he is taking Lenalidomide Sandoz, inform the doctor immediately. It is recommended that the partner seek medical advice.
The patient must also use effective contraception (see "Contraception").

Breastfeeding

Do not breastfeed while taking Lenalidomide Sandoz, as it is not known whether the medicine passes into breast milk.

Contraception

Information for women taking Lenalidomide Sandoz

Before starting treatment, the patient should ask her doctor whether she could become pregnant, even if she considers it unlikely.

If the patient is of childbearing potential:

she will undergo pregnancy tests under medical supervision (before each treatment cycle, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends), unless the doctor confirms surgical sterilization (tubal ligation) OR
she must use effective contraception for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after treatment ends. The doctor will advise the patient on appropriate contraceptive methods.

Information for men taking Lenalidomide Sandoz

Lenalidomide Sandoz passes into human semen. If the patient's partner is pregnant or could become pregnant and is not using effective contraception, the patient must use condoms during treatment and for at least 7 days after treatment ends, even if he has had a vasectomy. During treatment and for at least 7 days after treatment ends, the patient must not donate semen or sperm.

Driving and using machines

If after taking Lenalidomide Sandoz the patient experiences dizziness, fatigue, somnolence, a sensation of spinning, or blurred vision, she should not drive or operate machinery.

Lenalidomide Sandoz contains lactose and sodium

If the patient has been diagnosed with an intolerance to certain sugars, she should consult her doctor before using this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning it is considered "sodium-free".

3. How to take Lenalidomide Sandoz

Lenalidomide Sandoz must be administered by healthcare professionals experienced in the treatment of multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma, or follicular lymphoma.

If Lenalidomide Sandoz is used to treat multiple myeloma in patients who are not eligible for bone marrow transplantation or who have previously received other treatments, the medicine is given in combination with other drugs (see section 1 "What Lenalidomide Sandoz is for").
If Lenalidomide Sandoz is used to treat multiple myeloma in patients after bone marrow transplantation, or to treat myelodysplastic syndromes or mantle cell lymphoma, the medicine is given alone (monotherapy).
If Lenalidomide Sandoz is used to treat follicular lymphoma, it is taken together with another medicine called "rituximab".

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, consult the doctor or pharmacist.
If the patient is taking Lenalidomide Sandoz together with other medicines, they should read the package leaflets of those medicines to obtain information about their use and effects.

Treatment cycle
Lenalidomide Sandoz is taken on specific days over a period of 3 weeks (21 days).

Each 21-day period is called a "treatment cycle".
Depending on the day of the cycle, the patient may take one or more medicines. However, on some days, the patient will not take any medicines.
After completing each 21-day cycle, the patient should start a new 21-day cycle.
OR
Lenalidomide Sandoz is taken on specific days over 4 weeks (28 days).
Each 28-day period is called a "treatment cycle".
Depending on the day of the cycle, the patient takes one or more medicines. However, on some days, the patient does not take any medicines.
After completing each 28-day cycle, the patient should start a new 28-day cycle.

How much Lenalidomide Sandoz to take
Before starting treatment, the doctor will inform the patient:

how much Lenalidomide Sandoz to take;
how many other medicines (if any) the patient should take together with Lenalidomide Sandoz;
on which days of the cycle to take each of these medicines.

How and when to take Lenalidomide Sandoz

Swallow the capsule whole, preferably with water.
Do not break, open, or chew the capsule. If powder from a damaged Lenalidomide Sandoz 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.
The capsules may be taken with or without food.
The medicine should be taken on the designated days at approximately the same time each day.

Taking this medicine
To remove the capsule from the blister pack:

press only on one side of the capsule to push it through the foil,
do not press on the center of the capsule, as this may damage it.

Duration of treatment with Lenalidomide Sandoz
Lenalidomide Sandoz is administered in treatment cycles, each lasting 21 or 28 days (see above, "Treatment cycle"). Treatment should continue until the doctor advises stopping.

If you take more Lenalidomide Sandoz than you should
If the patient has taken more capsules than prescribed, they should contact their doctor immediately.

If you forget to take Lenalidomide Sandoz
If the patient forgets to take Lenalidomide Sandoz at the usual time:

if less than 12 hours have passed, take the missed dose as soon as possible;
if more than 12 hours have passed, do not take the missed dose. Take the next dose at the usual time the following day.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following serious adverse effects occur, stop taking Lenalidomide Sandoz immediately and seek medical advice – immediate treatment may be required:

hives, rash, swelling of the eyes, lips or face, difficulty breathing or itching, which may be symptoms of severe allergic reactions known as angioedema and
anaphylactic reaction;
severe allergic reaction that may start as a rash in one area, spreading to the entire body and associated with significant loss of the outer layer of skin (Stevens-Johnson syndrome and/or toxic epidermal necrolysis);
widespread rash, high fever, increased liver enzyme activity, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug rash with eosinophilia and systemic symptoms also known as “DRESS” or “drug hypersensitivity syndrome”). See also section 2.

Immediately inform your doctor if any of the following serious adverse effects occur:

fever, chills, sore throat, cough, mouth ulcers or any other signs of infection (including blood infections (sepsis));
bleeding or bruising without injury;
chest pain or leg pain;
shortness of breath;
bone pain, muscle weakness, confusion or fatigue, which may result from high calcium levels in the blood.

Lenalidomide Sandoz may cause a reduction in the number of white blood cells, which fight infection, and platelets, which help blood to clot, leading to bleeding disorders such as nosebleeds and bruising.
Lenalidomide Sandoz may also cause blood clots in the veins (venous thrombosis).
Other adverse effects
A small number of patients may develop another type of tumour, and the risk of its development may be higher when taking Lenalidomide Sandoz. For this reason, your doctor will carefully assess the benefits and risks before prescribing this medicine.
Very common adverse effects (may affect more than 1 in 10 people)

Decreased number of red blood cells, which may lead to anaemia causing tiredness and weakness;
Skin rash, itching;
Muscle cramps, muscle weakness, muscle pain, joint pain, back pain, limb pain;
Generalised swelling, including swelling of hands and feet;
Weakness, fatigue;
Fever, flu and flu-like symptoms, including fever, muscle pain, headache, ear pain, cough and chills;
Numbness, tingling or burning sensation of the skin, prickling in hands or feet, dizziness, tremor;
Decreased appetite, changes in taste perception;
Worsening of pain, increase in size or redness around a tumour;
Weight loss;
Constipation, diarrhoea, nausea, vomiting, abdominal pain, heartburn;
Low levels of potassium or calcium and (or) sodium in the blood;
Underactive thyroid gland;
Leg pain (which may be a sign of thrombosis), chest pain or shortness of breath (which may indicate presence of blood clots in the lungs, known as pulmonary embolism);
All types of infections, including sinus infection, lung infection and upper respiratory tract infections;
Shortness of breath;
Blurred vision;
Cloudy vision (cataract);
Kidney problems, including impaired kidney function or inability to maintain normal kidney function;
Abnormal liver test results;
Increased liver function test values;
Blood protein changes leading to blood vessel swelling (vasculitis);
Increased blood sugar levels (diabetes);
Decreased blood sugar levels;
Headache;
Nosebleeds;
Dry skin;
Depression, mood changes, sleep disturbances;
Cough;
Low blood pressure;
Vague feeling of physical discomfort, malaise;
Painful inflammation of the mouth, dry mouth;
Dehydration.

Common adverse effects (may affect less than 1 in 10 people)

Breakdown of red blood cells (haemolytic anaemia);
Certain types of skin tumours;
Bleeding from gums, stomach or intestines;
Increased blood pressure, slow, fast or irregular heartbeat;
Increased levels of substances produced during normal and abnormal breakdown of red blood cells;
Increased levels of a protein indicating inflammation in the body;
Darkening of the skin; skin discolouration due to bleeding under the skin, usually caused by bruising; blood-filled skin swelling, bruises;
Increased levels of uric acid in the blood;
Skin eruptions, redness of the skin, cracking, peeling or flaking of the skin, hives;
Excessive sweating, night sweats;
Difficulty swallowing, sore throat, voice quality problems or voice changes;
Nasal inflammation (rhinitis);
Passing significantly more or significantly less urine than normal, or inability to control the timing of urination;
Blood in the urine;
Shortness of breath, especially when lying down (which may be a sign of heart failure);
Erectile dysfunction;
Stroke, fainting, dizziness (inner ear disorder causing a sensation that everything is spinning), transient loss of consciousness;
Chest pain spreading to arms, neck, jaw, back or abdomen, sweating and breathlessness, nausea or vomiting, which may be signs of a heart attack (myocardial infarction);
Muscle weakness, lack of energy;
Neck pain, chest pain;
Chills;
Joint swelling;
Slowing or blockage of bile flow from the liver;
Low levels of phosphates or magnesium in the blood;
Speech difficulties;
Liver damage;
Loss of balance, difficulty moving;
Hearing loss, tinnitus (ringing in the ears);
Nerve pain, unpleasant abnormal sensations, especially in response to touch;
Excess iron in the body;
Thirst;
Confusion;
Toothache;
Falls that may lead to injury

Uncommon adverse effects (may affect less than 1 in 100 people)

Bleeding inside the skull;
Circulatory disorders;
Loss of vision;
Loss of libido;
Passing large amounts of urine accompanied by bone pain and weakness – these may be symptoms of kidney dysfunction (Fanconi syndrome);
Yellowing of the skin, mucous membranes or eyes (jaundice), pale-coloured stools, dark-coloured urine, itchy skin, rash, abdominal pain or swelling – these may be signs of liver damage (liver failure);
Abdominal pain, bloating or diarrhoea, which may be symptoms of inflammation of the large intestine (colitis or typhlitis);
Kidney tubule cell damage (known as tubular necrosis);
Skin colour changes, sensitivity to sunlight;
Tumour lysis syndrome – metabolic complications that may occur during cancer treatment, and sometimes even without treatment. These complications are caused by the products released from dying tumour cells and may include: changes in blood chemistry; high levels of potassium, phosphate and uric acid, and low calcium levels, leading to kidney dysfunction, heart rhythm disturbances, seizures, and sometimes death;
High blood pressure in the blood vessels leading to the lungs (pulmonary hypertension).

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

Sudden or mild but worsening pain in the upper abdomen and/or back, lasting for several days and possibly accompanied by nausea, vomiting, fever and rapid heartbeat. These symptoms may be caused by inflammation of the pancreas (pancreatitis);
Wheezing, shortness of breath or dry cough – these may be symptoms caused by inflammation of lung tissue;
Rare cases of muscle breakdown (muscle pain, weakness or swelling), which may lead to kidney dysfunction (rhabdomyolysis), some of which occurred when lenalidomide was taken with a statin (a cholesterol-lowering medicine), have been observed;
Skin disease caused by inflammation of small blood vessels, associated with joint pain and fever (leucocytoclastic vasculitis);
Perforation of the stomach or intestinal wall, which may lead to severe infection. Inform your doctor if you experience severe abdominal pain, fever, nausea, vomiting, blood in the stool or changes in bowel habits;
Viral infections, including shingles (a viral disease causing a painful skin rash with blisters) and reactivation of hepatitis B virus (which may cause yellowing of the skin and eyes, dark-coloured urine, pain in the right side of the abdomen, fever, nausea or vomiting);
Rejection of a transplanted organ (such as kidneys, heart).

Reporting of adverse effects
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects can 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
Adverse effects can also be reported to the responsible entity.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Lenalidomide Sandoz

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 conditions are required.
Do not use the medicine if there are visible signs of damage or if the packaging seals are broken.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Lenalidomide Sandoz contains

The active substance is lenalidomide. One capsule contains 10 mg of lenalidomide.
The other ingredients are: lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
Capsule shell: gelatin, titanium dioxide (E171), indigo carmine, lac dye (E132) and yellow iron oxide (E172).
Printing ink: shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).

What Lenalidomide Sandoz looks like and contents of the pack
The capsule has a matt yellow body and a matt green to light green cap, approximately 21.7 mm in length, marked with "L9NL" and "10".
Hard capsules are packed in blisters made of OPA/Aluminium/PVC/Aluminium foil.
Pack sizes:
OPA/Aluminium/PVC/Aluminium foil blisters: packs containing 21 hard capsules.
Single-dose blisters made of OPA/Aluminium/PVC/Aluminium foil: packs containing 21 x 1 hard capsule.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer/Importer
Synthon Hispania, S.L.
C/ Castelló no1, Pol. Las Salinas
Sant Boi de Llobregat
08830 Barcelona, Spain

Synthon BV
Microweg 22
6545 CM Nijmegen, The Netherlands

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany

Lek Pharmaceuticals d.d.
Verovškova ulica 57
Ljubljana 1526
Slovenia

For further information about this medicinal product and its names in the European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
Tel. 22 209 70 00