InfoCons Consumer Protection informs you – Pomalidomide Teva – Package Leaflet

Before anything else

Read all of this leaflet carefully before you start 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse.
• This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Pomalidomide Teva is and what it is used for

What Pomalidomide Teva is Pomalidomide Teva contains the active substance ‘pomalidomide’. This medicine is related to thalidomide and belongs to a group of medicines which affect the immune system (the body’s natural defences).

What Pomalidomide Teva is used for Pomalidomide Teva is used to treat adults with a type of cancer called ‘multiple myeloma’.

Pomalidomide Teva is either used with:

• two other medicines – called ‘bortezomib’ (a type of chemotherapy medicine) and ‘dexamethasone’ (an anti -inflammatory medicine) in people who have had at least one other treatment – including lenalidomide.

Or

• one other medicine – called ‘dexamethasone’ in people whose myeloma has become worse, despite having at least two other treatments – including lenalidomide and bortezomib.

Pomalidomide Teva is expected to cause severe birth defects and may lead to the death of an unborn baby.

• Do not take this medicine if you are pregnant or could become pregnant.
• You must follow the contraception advice described in this leaflet.

62 What is multiple myeloma Multiple myeloma is a type of cancer which affects a certain type of white blood cell (called the ‘plasma cell’). These cells grow out of control and accumulate in the bone marrow. This results in damage to the bones and kidneys.

Multiple myeloma generally cannot be cured. However, treatment can reduce the signs and symptoms of the disease, or make them disappear for a period of time. When this happens, it is called ‘response’.

How Pomalidomide Teva works Pomalidomide Teva works in a number of different ways:

• by stopping the myeloma cells developing
• by stimulating the immune system to attack the cancer cells
• by stopping the formation of blood vessels supplying the cancer cells.

The benefit of using Pomalidomide Teva with bortezomib and dexamethasone When Pomalidomide Teva is used with bortezomib and dexamethasone, in people who have had at least one other treatment, it can stop multiple myeloma getting worse:

• On average, Pomalidomide Teva when used with bortezomib and dexamethasone stopped multiple myeloma from coming back for up to 11 months – compared with 7 months for those patients who only used bortezomib and dexamethasone.

The benefit of using Pomalidomide Teva with dexamethasone When Pomalidomide Teva is used with dexamethasone, in people who have had at least two other treatments, it can stop multiple myeloma getting worse:

• On average, Pomalidomide Teva when used with dexamethasone stopped multiple myeloma from coming back for up to 4 months – compared wit h 2 months for those patients who used only dexamethasone.

⚠️ 2. What you need to know before you take Pomalidomide Teva

Do not take Pomalidomide Teva

• if you are pregnant or think you may be pregnant or are planning to become pregnant – this is because Pomalidomide Teva is expected to be harmful to an unborn child. (Men and women taking this medicine must read the section “Pregnancy, contraception and br east-feeding – information for women and men” below).
• if you are able to become pregnant, unless you follow all the necessary measures to prevent you from becoming pregnant (see “Pregnancy, contraception and breast -feeding – information for women and men”) . If you are able to become pregnant, your doctor will record with each prescription that the necessary measures have been taken and will provide you with this confirmation.
• if you are allergic to pomalidomide or any of the other ingredients of this medici ne (listed in section 6). If you think you may be allergic, ask your doctor for advice.

If you are uncertain whether any of the conditions above apply to you, talk to your doctor, pharmacist or nurse before taking Pomalidomide Teva.

Warnings and precauti ons Talk to your doctor, pharmacist or nurse before taking Pomalidomide Teva if:

• you have ever had blood clots in the past. During the treatment with Pomalidomide Teva you have an increased risk of getting blood clots in your veins and arteries. Your doctor may recommend you take additional treatments (e.g. warfarin) or lower the dose of Pomalidomide Teva to reduce the chance that you get blood clots.
• you have ever had an allergi c reaction such as rash, itching, swelling, feeling dizzy or trouble 63 breathing while taking related medicines called ‘thalidomide’ or ‘lenalidomide’.
• you have had a heart attack, have heart failure, have difficulty breathing, or if you smoke, have high blood pressure or high cholesterol levels.
• you have a high total amount of tumour throughout the body, including your bone marrow. This could lead to a condition where the tumours break down and cause unusual levels of chemicals in the blood which can lead to kidney failure. You may also experience an uneven heartbeat. This condition is called tumour lysis syndrome.
• you have or have had neuropathy (nerve damage causing tingling or pain in your hands or feet).
• you have or have ever had hepatitis B infection. Tr eatment with Pomalidomide Teva may cause the hepatitis B virus to become active again in patients who carry the virus, resulting in a recurrence of the infection. Your doctor should check whether you have ever had hepatitis B infection.
• you experience or have experienced in the past a combination of any of the following symptoms: rash on face or extended rash, red skin, high fever, flu- like symptoms, enlarged lymph nodes (signs of severe skin reaction called Drug Reaction with Eosinophilia and Systemic Sym ptoms (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 patients with multiple myeloma treated with pomalidomide may dev elop additional types of cancer, therefore your doctor should carefully evaluate the benefit and risk when you are prescribed this medicine.

At any time during or after your treatment, tell your doctor or nurse immediately if you: experience blurred, loss of or double vision, difficulty speaking, weakness in an arm or a leg, a change in the way you walk or problems with your balance, persistent numbness, decreased sensation or loss of sensation, memory loss or confusion. These may all be symptoms of a seri ous and potentially fatal brain condition known as progressive multifocal leukoencephalopathy (PML). If you had these symptoms prior to treatment with Pomalidomide Teva, tell your doctor about any change in these symptoms.

At the end of the treatment you should return all unused capsules to the pharmacist.

Pregnancy, contraception and breast -feeding – information for women and men The following must be followed as stated in the Pomalidomide Teva Pregnancy Prevention Programme.

Women and men taking Pomalidomide Teva must not become pregnant or father a child. This is because pomalidomide is expected to harm the unborn baby. You and your partner should use effective methods of contraception while taking this medicine.

Women Do not take Pomalidomide Teva if you are pregnant, think you may be pregnant or are planning to become pregnant. This is because this medicine is expected to harm the unborn baby. Before starting the treatment, you should tell your doctor if you are able to become pregnant, even if you think this is unlikely.

If you are able to become pregnant:

• you must use effective methods of contraception for at least 4 weeks before starting treatment, for the whole time you are taking treatment, and until at least 4 weeks after stopping treatment. Talk to your doctor about the best method of contraception for you.
• each time your doctor writes a prescription for you, he will ensure you understand the necessary measures that have to be taken to prevent pregnancy.
• your doctor will arrange pregnancy tests before treatment, at least every 4 weeks during treatment, and at least 4 weeks after the treatment has finished.

If you become pregnant despite the prevention measures:

• you mus t stop the treatment immediately and talk to your doctor straight away.

64 Breast -feeding It is not known if Pomalidomide Teva passes into human breast milk. Tell your doctor if you are breast – feeding or intend to breast -feed. Your doctor will advise if you should stop or continue breast -feeding.

Men Pomalidomide Teva passes into human semen.

• If your partner is pregnant or able to become pregnant, you must use condoms for the whole time you are taking treatment and for 7 days after the end of treatment.
• If your partner becomes pregnant while you are taking Pomalidomide Teva, tell your doctor straight away. Your partner should al so tell her doctor straight away.

You should not donate semen or sperm during treatment and for 7 days after the end of treatment.

Blood donation and blood tests You should not donate blood during treatment and for 7 days after the end of treatment.

Before and during the treatment with Pomalidomide Teva you will have regular blood tests. This is because your medicine may cause a fall in the number of blood cells that help fight infection (white cells) and in the number of cells that help to stop bleeding (platelets).

Your doctor should ask you to have a blood test:

• before treatment
• every week for the first 8 weeks of treatment
• at least every month after that for as long as you are taking Pomalidomide Teva .

As a result of these tests, your doctor may change your dose of Pomalidomide Teva or stop your treatment. The doctor may also change the dose or stop the medicine because of your general health.

Children and adolescents

Pomalidomide Teva is not recommended for use in children and young people under 18 years.

Other medicines and Pomalidomide Teva

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This is because Pomalidomide Teva can affect the way some other medicines work. Also some other medicines can affect the way Pomalidomide Teva works.

In particular, tell your doctor, pharmacist or nurse before taking Pomalidomide Teva if you are taking any of the following medicines:

• some antifungals such as ketaconazole
• some antibiotics (for example ciprofloxacin, enoxacin)
• certain antidepressants such as fluvoxamine.

Driving and using machines

Some people fee l tired, dizzy, faint, confused or less alert when taking Pomalidomide Teva . If this happens to you, do not drive or operate tools or machinery.

Pomalidomide Teva contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium – free’.

Pomalidomide Teva contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor 65 before taking this medicinal product.

Pomalidomide Teva contains Brilliant blue FCF (E133)

This medicine contains colouring agent Brilliant blue FCF (E13 3) which may cause allergic reactions.

💊 3. How to take Pomalidomide Teva

Pomalidomide Teva must be given to you by a doctor with experience in treating multiple myeloma.

Always take your medicines exactly as your doctor has told you. Check with your doctor, pharmacist or nurse if you are not sure.

When to take Pomalidomide Teva with other medicines Pomalidomide Teva with bortezomib and dexamethasone

• See the leaflets that come with bortezomib and dexamethasone for further information on their use and effects.
• Pomalidomide Teva, bortezomib and dexamethasone are taken in ‘treatment cycles’. Each cycle lasts 21 days (3 weeks).
• Look at the chart below to see what to take on each day of the 3 -week cycle: o Each day, look down the chart and find the correct day to see which medicines to take. o Some days, you take all 3 medicines, some days just 2 or 1 medicines, and some days none at all.

POM : Pomalidomide Teva ; BOR : Bortezomib; DEX: Dex amethasone Cycle 1 to 8 Cycle 9 and onwards Medicine name Day POM BOR DEX 1 √ √ √ 2 √ √ 3 √ 4 √ 5 √ 6 √ 7 √ 8 √ √ √ 9 √ √ 10 √ 11 √ 12 √ 13 √ 14 √ Medicine name Day POM BOR DEX 1 √ √ √ 2 √ √ 3 √ 4 √ √ √ 5 √ √ 6 √ 7 √ 8 √ √ √ 9 √ √ 10 √ 11 √ √ √ 12 √ √ 13 √ 14 √

• After completing each 3 -week cycle, start a new one.

Pomalidomide Teva with dexamethasone only

• See the leaflet that comes with dexamethasone for further information on its use and effects.
• Pomalidomide Teva and dexamethasone are taken in ‘treatment cycles’. Each cycle lasts 28 days (4 weeks).
• Look at the chart below to see what to take on each day of the 4- week cycle: o Each day, look down the chart and find the correct day to see which medicines to take. o Some days, you take both medicines, some days just 1 medicine, and some days none at all.

POM : Pomalidomide Teva; DEX: Dexamethasone Medicine name Day POM DEX 1 √ √ 2 √ 3 √ 4 √ 5 √ 6 √ 7 √ 8 √ √ 9 √ 10 √ 11 √ 12 √ 13 √ 14 √ 15 √ √ 16 √ 17 √ 18 √ 19 √ 20 √ 21 √ 22 √

• After completing each 4 -week cycle, start a new one.

How much Pomalidomide Teva to take with other medicines Pomalidomide Teva with bortezomib and dexamethasone

• The recommended starting dose of Pomalidomide Teva is 4 mg per day.
• The recommended starting dose of bortezomib will be worked out by your doctor and based on your height and weight (1.3 mg/m2 body surface area).
• The recommended starting dose of dexamethasone is 20 mg per day. However, if you are over 75, the 67 recommended starting dose is 10 mg per day.

Pomalidomide Teva with dexamethasone only

• The recommended dose of Pomalidomide Teva is 4 mg per day.
• The recommended starting dose of dexamethasone is 40 mg per day. However, if you are over 75, the recommended starting dose is 20 mg per day.

Your doctor may need to reduce the dose of Pomalidomide Teva, bortezomib or dexamethasone or stop one or more of these medicines based on the results of your blood tests, your general condition, other medicines you may be taking (e.g. ciprofloxacin, enoxacin and fluvoxamine) and if you experience side effects (especially rash or swelling) from treatment.

If you suffer from liver or kidney problems your doctor will check your condition very carefully whilst you are receiving this medicine.

How to take Pomalidomide Teva

• Do not break, open or chew the capsules. If powder from a broken capsule makes 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 or capsule. Gloves should then be removed carefully to prevent skin exposure, placed in a sealable plastic polyethylene bag and disposed of in accordance with local requi rements.

Hands should then be washed thoroughly with soap and water. Women who are pregnant or suspect they may be pregnant should not handle the blister or capsule.

• Swallow the capsules whole, preferably with water.
• You can take the capsules either with o r without food.
• Take your capsules at about the same time each day.

To remove the capsule from the blister, press only one end of the capsule out to push it through the foil.

Do not apply pressure on the centre of the capsule as this can cause it to break .

Your doctor will advise you of how and when to take Pomalidomide Teva if you have kidney problems and are receiving dialysis treatment.

Duration of the treatment with Pomalidomide Teva You should continue the cycles of treatment until your doctor tells you to stop.

68 If you take more Pomalidomide Teva than you should If you take more Pomalidomide T eva than you should, talk to a doctor or go to a hospital straight away.

Take the medicine pack with you.

If you forget to take Pomalidomide Teva

If you forget to take Pomalidom ide Teva on a day when you should, take your next capsule as normal the next day. Do not increase the number of capsules you take to make up for not taking Pomalidomide Teva the previous day.

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

❗ 4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Stop taking Pomalidomide Teva and see a doctor straight away if you notice any of the following

serious side effects – you may need urgent medical treatment

• Fever, chills, sore throat, cough, mouth ulcers or any other signs of infection (due to less white blood cells, which fight infection).
• Bleeding or bruising without a cause, includin g nosebleeds and bleeding from the bowels or stomach (due to effects on blood cells called ‘platelets’).
• Rapid breathing, rapid pulse, fever and chills, passing very little to no urine, nausea and vomiting, confusion, unconsciousness (due to infection of b lood called sepsis or septic shock).
• Severe, persistent or bloody diarrhoea (possibly with stomach pain or fever) caused by bacteria called Clostridium difficile.
• Chest pain, or leg pain and swelling, especially in your lower leg or calves (caused by blood clots).
• Shortness of breath (from serious chest infection, inflammation of the lung, heart failure or blood clot).
• Swelling of face, lips, tongue and throat, which may cause difficulty breathing (due to serious types of allergic reaction called angioedema and anaphylactic reaction).
• Certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which can cause changes in the appearance of your skin or growths on your skin. If you notice any changes to your skin whilst taking Pomalidomide Teva , tell your doctor as soon as possible.
• Recurrence of hepatitis B infection, which can cause yellowing of the skin and eyes, dark brown- coloured urine, right -sided abdominal pain, fever and feeling nauseous or being sick. Tell your doctor straightaway if you notice any of these symptoms.
• Widespread rash, high body temperature, enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome, Toxic Epidermal Necrolysis or Stevens- Johnson Syndrome). Stop using pomalidomide if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2.

Stop taking Pomalidomide Teva and see a doctor straight away if you notice any of the serious side effects listed above – you may need urgent medical treatment.

Other side effects

Very common (may affect more than 1 in 10 people)

• Shortness of breath (dyspnoea).

69 • Infections of the lungs (pneumonia and bronchitis).

• Infections of the nose, sinuses and throat, caused by bacteria or viruses.
• Flu-like symptoms (influenza).
• Low red blood cells, which may cause anaemia leading to tiredness and weakness.
• Low blood levels of potassium (hypokalaemia), which may cause weakness , muscle cramps, muscle aches, palpitations, tingling or numbness, dyspnoea, mood changes.
• High blood levels of sugar.
• A fast and irregular heartbeat (atrial fibrillation).
• Loss of appetite.
• Constipation, diarrhoea or nausea.
• Being sick (vomiting).
• Abdominal pain.
• Lack of energy.
• Difficulty in falling asleep or staying asleep.
• Dizziness, tremor.
• Muscle spasm, muscle weakness.
• Bone pain, back pain.
• Numbness, tingling or burning sensation to the skin, pains in hands or feet (peripheral sensory neuropathy).
• Swelling of the body, including swelling of the arms or legs.
• Rashes.
• Urinary tract infectio n, which may cause a burning sensation when passing urine, or a need to pass urine more often.

Common (may affect up to 1 in 10 people)

• Fall.
• Bleeding within the skull.
• Decreased ability to move or feel (sensation) in your hands, arms, feet and legs because of nerve damage (peripheral sensorimotor neuropathy).
• Numbness, itching, and a feeling of pins and needles on your skin (paraesthesia).
• A spinning feeling in your head, making it difficult to stand up and move normally.
• Swelling caused by fluid.
• Hives (urticaria).
• Itchy skin.
• Shingles.
• Heart attack (chest pain spreading to the arms, neck, jaw, feeling sweaty and breathless, feeling sick or vomiting).
• Chest pain, chest infection.
• Increased blood pressure.
• A fall in the number of red and white blood cells and platelets at the same time (pancytopenia), which will make you more prone to bleeding and bruising. You may feel tired and weak, and short of breath and you ar e also more likely to get infections.
• Decreased number of lymphocytes (one type of white blood cells) often caused by infection (lymphopenia).
• Low blood levels of magnesium (hypomagnesaemia), which may cause tiredness, generalised weakness, muscle cramps, irritability and may result in low blood levels of calcium (hypocalcaemia), which may cause numbness and, or tingling of hands, feet, or lips, muscle cramps, muscle weakness, light -headedness, confusion.
• Low blood level of phosphate (hypophosphataemia), which may cause muscle weakness and irritability or confusion.
• High blood level of calcium (hypercalcaemia), which may cause slowing reflexes and skeletal 70 muscle weaknesses.
• High blood levels of potassium, which may cause abnormal heart rhythm.
• Low blood lev els of sodium, which may cause tiredness and confusion, muscle twitching, fits (epileptic seizures) or coma.
• High blood levels of uric acid, which may cause a form of arthritis called gout.
• Low blood pressure, which may cause dizziness or fainting.
• Sore or dry mouth.
• Changes in the way things taste.
• Swollen abdomen.
• Feeling confused.
• Feeling down (depressed mood).
• Loss of consciousness, fainting.
• Clouding of your eye (cataract).
• Damage to the kidney.
• Inability to pass urine.
• Abnormal liver test.
• Pain in the pelvis.
• Weight loss.

Uncommon (may affect up to 1 in 100 people)

• Stroke.
• Inflammation of the liver (hepatitis) which can cause itchy skin, yellowing of the skin and the whites of the eyes (jaundice), pale coloured stools, dark coloured urine and abdominal pain.
• The breakdown of cancer cells resulting in the release of toxic compounds into the bloodstream (tumour lysis syndrome). This can result in kidney problems.
• Underactive thyroid gland, which may cause symptoms such as tiredness, lethargy, muscle weakness, slow heart rate, weight gain.

Not known (frequency cannot be estimated from the available data)

• Rejection of solid organ transplant (such as heart or liver).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side e ffects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Pomalidomide Teva

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and car ton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not use Pomalidomide Teva if you notice any damage or signs of tampering to medicine

packaging.

Do not throw away any medicines via wastewater or household waste. Any unused medicine should be returned to the pharmacist at the end of treatment. These measures will help protect the 71 environment.

📦 6. Contents of the pack and other information

What Pomalidomide Teva contains

• The active substance is pomalidomide
• The other ingredients are Lactose Monohydrate, Crospovidone, Povidone, Sodium Laurilsulfate, Sodium Stearyl Fumarate Pomalidomide Teva 1 mg hard capsule
• Each capsule contains 1 mg of pomalidomide
• The capsule shell cont ains: brilliant blue FCF (E133), titanium dioxide (E171), gelatin, iron oxide yellow (E172)
• The printing ink contains: shellac (E904) , propylene glycol (E1520), ammonia solution concentrated (E527), iron oxide black (E172), potassium hydroxide (E525) Pom alidomide Teva 2 mg hard capsule
• Each capsule contains 2 mg of pomalidomide
• The capsule shell contains: brilliant blue FCF (E133), titanium dioxide (E171), gelatin, iron oxide yellow (E172) , iron oxide red (E172)
• The printing ink contains: shellac (E904) , propylene glycol (E1520), ammonia solution concentrated (E527), iron oxide black (E172), potassium hydroxide (E525) Pomalidomide Teva 3 mg hard capsule
• Each capsule contains 3 mg of pomalidomide
• The capsule shell contains: brilliant blue FCF (E133), tita nium dioxide (E171), gelatin, iron oxide yellow (E172)
• The printing ink contains: shellac (E904) , propylene glycol (E1520), ammonia solution concentrated (E527), iron oxide black (E172), potassium hydroxide (E525) Pomalidomide Teva 4 mg hard capsule
• Each capsule contains 4 mg of pomalidomide
• The capsule shell contains: brilliant blue FCF (E133), titanium dioxide (E171), gelatin
• The printing ink contains: shellac (E904) , propylene glycol (E1520), ammonia solution concentrated (E527), iron oxide black (E172), potassium hydroxide (E525)

What Pomalidomide Teva looks like and contents of the pack

Pomalidomide Teva 1 mg hard capsules: Hard gelatin capsule of approximately 14 mm with blue opaque cap and yellow opaque body imprinting “T” on the cap and “1” on the body.

Pomalidomide Teva 2 mg hard capsules: Hard gelatin capsule of approximately 18 mm with blue opaque cap and orange opaque body imprinting “T” on the cap and “2” on the body.

Pomalidomide Teva 3 mg hard capsules: Hard gelatin capsule of approximately 18 mm with blue opaque cap and green opaque body imprinting “T” on the cap and “3” on the body.

Pomalidomide Teva 4 mg hard capsules: Hard gelatin capsule of approximately 18 mm with blue opaque cap and light blue opaque body imprinting “T” on the cap and “4” on the body.

Each pack contains 14, 14×1, 21, 21×1, 63 and 63×1 capsules. Not all pack sizes may be marketed.

72 Marketing Authorisation Holder TEVA GmbH Graf-Arco -Str. 3 89079 Ulm Germany

Manufacturer

Balkan pharma -Dupnitsa AD 3 Samokovsko Shosse Str.

Dupnitsa 2600, Bulgaria Merckle GmbH Graf-Arco -Str. 3, 89079 Ulm, Germany Actavis Group PTC ehf.

Dalshraun 1 IS-220 Hafnarfjordur, Iceland For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Teva Pharma Belgium N.V./S.A. /AG Tel/Tél: +32 3 820 73 73 Lietuva UAB Teva Baltics Tel: +370 5 266 02 03 България Тева Фарма ЕАД Teл: +359 2 489 95 85 Luxembourg/Luxemburg ratiopharm GmbH Tél: +49 731 402 02 Česká republika Teva Pharmaceuticals CR, s.r.o.

Tel: +420 251 007 111 Danmark Teva Denmark A/S Tlf: +45 44 98 55 11 Magyarország Teva Gyógyszergyár Zrt.

Tel: (+36) 1 288 6400 Malta Teva Ph armaceuticals Ireland Tel: +44 (0) 207 540 7117 Deutschland ratiopharm GmbH +49 (0) 731 402 02 Nederland Teva Nederland B.V.

Tel: +31 800 0228 400 Eesti UAB Teva Baltics Eesti filiaal Tel.: +372 6610801 Norge Teva Norway AS Tlf: +47 66 77 55 90 Ελλάδα Teva Hellas Α.Ε.

Τηλ: +30 211 880 5000 Österreich Ratiopharm Arzneimittel Vertriebs -GmbH Tel: +43 1970070 73 España Teva Pharma, S.L.U.

Tel.: + 34 91 387 32 80 Polska Teva Pharmaceuticals Polska Sp. z o.o.

Tel: + 48 22 345 93 00 France Teva Santé Tél: +33 1 55 91 78 00 Portugal Teva Pharma – Produtos Farmacêuticos, Lda Tel: +351 21 476 75 50 Hrvatska Pliva Hrvatska d.o.o Tel: + 385 1 37 20 000 Ireland Teva Pharmaceuticals Ireland Tel: +44 (0) 207 540 7117 România Teva Pharmaceuticals S.R.L Tel: +40 21 230 65 24 Slovenija Pliva Ljubljana d.o.o.

Tel: +386 1 58 90 390 Ísland Teva Pharma Iceland ehf.

Sími: + 354 550 3300 Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o Telephone: +421257267 911 Italia Teva Italia S.r.l Tel:. +39 028917981 Suomi/Finland Teva Finland Oy Puh/Tel: +358 20 180 5900 Κύπρος TEVA HELLAS Α.Ε.

Ελλάδα Τηλ: +30 211 880 5000 Sverige Teva Sweden AB Tel: +46 (0)42 12 11 00 Latvija UAB Teva Baltics filiāle Latvijā Tel: +371 67 323 666 [email protected] United Kingdom (Northern Ireland) United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 (0) 207 540 7117

This leaflet was last revised in

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Pomalidomide Teva (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/24/1868).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.