Lenalidomide sandoz: detailed information

Package leaflet: Information for the patient

Lenalidomide Sandoz, 15 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 questions, ask your doctor or pharmacist.
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 as yours.
If you experience any adverse 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 (MDS),
mantle cell lymphoma (MCL),
follicular lymphoma (FL).

Multiple myeloma
Multiple myeloma is a type of cancer that arises from 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 reduction or disappearance of disease symptoms. This condition is called "remission".

Newly diagnosed multiple myeloma – in patients who have undergone 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 who are 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 starts 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 evaluations before starting Lenalidomide Sandoz.

Multiple myeloma – in previously treated patients
Lenalidomide Sandoz is taken in combination with the anti-inflammatory medicine 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 subjective and objective symptoms, including low number of red blood cells (anaemia), need for blood transfusions, and risk of infections.

Lenalidomide Sandoz is used as monotherapy to treat 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 a bone marrow cell abnormality known as "isolated cytogenetic abnormality del(5q)", meaning the patient's body does not produce enough healthy blood cells;
the patient has previously received other treatments that were inappropriate or insufficiently effective.

Taking Lenalidomide Sandoz may increase the production of healthy blood cells by reducing the number of abnormal cells.

This may reduce the 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 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 is used as monotherapy to treat 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 used in combination with another medicine called "rituximab" to treat 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 parts 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 necessary measures 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 the necessary actions have been taken and will provide the patient with such 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 he or she may be allergic, he or she should consult a doctor.

If any of the above situations apply, do not take Lenalidomide Sandoz. If in doubt, consult a doctor.

Warnings and precautions

Before using Lenalidomide Sandoz, discuss with a doctor, pharmacist or nurse if:

the patient has previously had blood clots, as there is 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. If in doubt, consult a doctor. Treatment with Lenalidomide Sandoz may cause reactivation of the virus in carriers, 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, has previously had blood clots, smokes, has high blood pressure, or high cholesterol levels;
the patient experienced an allergic reaction after taking thalidomide (another drug used in the treatment of 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, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes – these are symptoms of a severe skin reaction called drug reaction with eosinophilia and systemic symptoms, also known as "DRESS" or "drug hypersensitivity syndrome" (see also section 4 "Possible side effects").

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

Seek immediate medical advice from a doctor, pharmacist or nurse at any time during or after treatment if the patient experiences:

vision disturbances, loss of vision or double vision, difficulty speaking, weakness in the arm or leg, change in gait or balance problems, 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 about any changes in these symptoms.
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 treatment with Lenalidomide Sandoz and during treatment, 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 that help blood clot (platelets).

The doctor will order blood tests:

before treatment,
weekly for 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 chance of developing a serious disease called acute myeloid leukaemia. Furthermore, it is not known how Lenalidomide Sandoz affects the likelihood of developing acute myeloid leukaemia. Therefore, the doctor may perform tests and assess symptoms to better predict the risk of acute myeloid leukaemia during treatment with Lenalidomide Sandoz.

Patients with MCL taking Lenalidomide Sandoz

The doctor will request blood tests:

before treatment,
weekly for the first 8 weeks (2 cycles) of treatment,
then every 2 weeks during cycles 3 and 4 (more information in section 3 "Treatment cycle"),
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 for the first 3 weeks (1 cycle) of treatment,
then every 2 weeks during cycles 2 to 4 (more information in section 3 "Treatment cycle"),
then at the beginning of each cycle and
at least once a month.

Before starting lenalidomide treatment and during treatment, the patient may be evaluated for circulatory and respiratory problems.

The doctor may perform a test to check whether the patient has a large amount of tumour tissue in the body, including in the bone marrow. This may lead to a condition in which tumour tissue breaks down rapidly, causing abnormally high levels of various chemicals in the blood and potentially leading to kidney failure (this condition is called "tumour lysis syndrome").

The doctor may examine the patient's skin to check for any 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 general condition. If the disease has been 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 assessments before starting treatment.

Lenalidomide Sandoz and other medicines

Tell the 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 the 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 immediately stop treatment and inform her doctor.

Information for men taking Lenalidomide Sandoz

If the partner of a man taking Lenalidomide Sandoz becomes pregnant, inform the doctor immediately. It is recommended that the partner seek medical advice.
The patient must also use effective contraception methods (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 the supervision of a doctor (before each treatment cycle, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends), unless the doctor confirms surgical interruption and occlusion of her fallopian tubes to prevent oocytes from reaching the uterus (tubal sterilization) AND
she must use effective methods of contraception for at least 4 weeks before starting treatment, during treatment, and for at least 4 weeks after stopping treatment. 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 stopping treatment, 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, drowsiness, a spinning sensation or blurred vision, he or 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, he or she should consult a doctor before taking this medicine.

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

3. How to take Lenalidomide Sandoz

Lenalidomide Sandoz must be prescribed and administered by medical 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 received prior treatment, the medicine is given in combination with other drugs (see section 1, "What Lenalidomide Sandoz is used 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 your doctor has instructed. If in doubt, consult your doctor or pharmacist.
If you are taking Lenalidomide Sandoz together with other medicines, you 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, you may take one or more medicines. However, on some days you will not take any medicines.
After completing each 21-day cycle, you 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, you may take one or more medicines. However, on some days you will not take any medicines.
After completing each 28-day cycle, you should start a new 28-day cycle.

How much Lenalidomide Sandoz to take
Before starting treatment, your doctor will inform you:

how much Lenalidomide Sandoz you should take;
how many other medicines (if any) you 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 the powder from a damaged Lenalidomide Sandoz capsule comes into contact with your 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 must not handle the blister pack or capsule.
The capsules may be taken with food or independently of meals.
The medicine should be taken on the scheduled days at approximately the same time each day.

How to take this medicine
To remove the 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.

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 your doctor advises otherwise.

If you take more Lenalidomide Sandoz than you should
If you take more capsules than prescribed, contact your doctor immediately.

If you miss a dose of Lenalidomide Sandoz
If you forget to take your dose of Lenalidomide Sandoz at the usual time:

if less than 12 hours have passed, take the missed capsule as soon as possible;
if more than 12 hours have passed, do not take the missed capsule. 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following serious side effects occur, stop taking Lenalidomide Sandoz and seek
immediate medical advice – immediate treatment may be necessary:

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 possibly starting as a rash in one area, spreading over the whole body and associated with significant skin loss (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 reaction 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 side 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 levels of calcium 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 (thrombosis).
Other side effects
A different type of cancer may develop in a small number of patients, and the risk of developing it may be higher when Lenalidomide Sandoz is used. For this reason, your doctor will carefully assess the benefits and risks of treatment before prescribing this medicine.
Very common side effects (may affect more than 1 in 10 people)

Reduction in red blood cells, which may lead to anaemia causing tiredness and weakness;
Rash, itching;
Muscle cramps, muscle weakness, muscle pain, muscle tenderness, bone 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 of hands or feet, dizziness, tremor;
Loss of appetite, changes in taste sensation;
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 be signs 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 abnormal kidney function or inability to maintain normal kidney function;
Abnormal liver function tests;
Increased liver function test results;
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 side effects (may affect up to 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;
Skin darkening; skin discolouration due to bleeding under the skin, usually caused by bruising; blood-filled skin swelling, bruising;
Increased levels of uric acid in the blood;
Skin eruptions, skin redness, skin cracking, peeling or flaking, 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 difficulties;
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 which may lead to injury.

Uncommon side effects (may affect up to 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 stools, dark urine, itchy skin, rash, abdominal pain or swelling – these may be symptoms 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 (called 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 breakdown products of dying tumour cells and may include: changes in blood chemistry; high levels of potassium, phosphate, uric acid and low calcium levels, leading to kidney dysfunction, heart rhythm disturbances, seizures and sometimes death;
High blood pressure in blood vessels leading to the lungs (pulmonary hypertension).

Frequency not known side 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 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) have been observed, which may lead to kidney dysfunction (rhabdomyolysis); some cases occurred when lenalidomide was given with a statin (a cholesterol-lowering medicine);
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 a very serious 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 urine, pain in the right side of the abdomen, fever, nausea or vomiting);
Rejection of transplanted organs (such as kidney, heart).

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

5. How to store Lenalidomide Sandoz

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the cardboard
package 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 evidence that the
packaging seals have been broken.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. This 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 15 mg of lenalidomide.
The other ingredients are: lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.
Capsule shell: gelatin, titanium dioxide (E171), indigo carmine, lac (E132)
Printing ink: shellac, propylene glycol, potassium hydroxide, black iron oxide (E172)

What Lenalidomide Sandoz looks like and contents of the pack
A capsule with a matte white body and a matte blue to light blue cap,
approximately 21.7 mm in length, marked with "L9NL" and "15".
Hard capsules are packed in blisters made of OPA/Aluminium/PVC/Aluminium foil.
Pack sizes:
Blisters made of OPA/Aluminium/PVC/Aluminium foil: packs contain 21 hard capsules.
Single-dose blisters made of OPA/Aluminium/PVC/Aluminium foil: packs contain 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 Member States of the European Economic Area, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00