Pomalidomide Teva

Patient Information Leaflet

Pomalidomide Teva 1 mg hard capsules, 2 mg hard capsules, 3 mg hard capsules, 4 mg hard capsules

pomalidomide
Pomalidomide Teva is expected to cause birth defects and may result in fetal death.

• Do not take this medicine if you are pregnant or could become pregnant.
• Follow the advice on contraceptive methods described in this leaflet.

Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What Pomalidomide Teva is and what it is used for
2. What you need to know before taking Pomalidomide Teva
3. How to take Pomalidomide Teva
4. Possible side effects
5. How to store Pomalidomide Teva
6. Contents of the pack and other information

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

What is Pomalidomide Teva
Pomalidomide Teva contains the active substance “pomalidomide”. This medicine is related to
thalidomide and belongs to a group of medicines that act on the immune system (the body’s natural
defences).
What is Pomalidomide Teva used for
Pomalidomide Teva is used to treat adults with a type of cancer called “multiple myeloma”.
Pomalidomide Teva is used in combination with:

• two other medicines, called “bortezomib” (a type of chemotherapy medicine) and “dexamethasone” (an anti-inflammatory medicine), in patients who have received at least one prior therapy including lenalidomide.

Or

• one other medicine, called “dexamethasone”, in patients whose myeloma has worsened despite having received at least two prior therapies including lenalidomide and bortezomib.

What is multiple myeloma
Multiple myeloma is a type of cancer that affects a certain type of white blood cells (called “plasma cells”). These cells grow uncontrollably and accumulate in the bone marrow.
This leads to damage to the bones and kidneys.
Multiple myeloma is generally incurable. However, treatment can reduce or eliminate signs and symptoms of the disease for a certain period of time. When this occurs, it is referred to as a “response”.
How Pomalidomide Teva works
Pomalidomide Teva works in several ways:

• by stopping the growth of myeloma cells
• by stimulating the immune system to attack cancer cells
• by inhibiting the formation of blood vessels that supply nutrients to cancer cells.

The benefit of using Pomalidomide Teva with bortezomib and dexamethasone
When Pomalidomide Teva is used together with bortezomib and dexamethasone in patients who have received at least one prior therapy, it can prevent multiple myeloma from worsening:

• On average, Pomalidomide Teva used with bortezomib and dexamethasone prevented the recurrence of multiple myeloma for up to 11 months, compared to 7 months in patients treated with bortezomib and dexamethasone alone.

The benefit of using Pomalidomide Teva with dexamethasone
When Pomalidomide Teva is used together with dexamethasone in patients who have received at least two prior therapies, it can prevent multiple myeloma from worsening:

• On average, Pomalidomide Teva used with dexamethasone prevented the recurrence of multiple myeloma for up to 4 months, compared to 2 months in patients treated with dexamethasone alone.

2. What you should know before taking Pomalidomide Teva

Do not take Pomalidomide Teva

• If you are pregnant or think you may be pregnant, or if you are planning a pregnancy, because Pomalidomide Teva is expected to be harmful to the unborn baby. (Men and women taking this medicine must read the section “Pregnancy, contraception and breastfeeding – information for women and men” below.)
• If there is any possibility that you could become pregnant unless you follow all necessary measures to avoid pregnancy (see “Pregnancy, contraception and breastfeeding – information for women and men”). If there is any possibility that you could become pregnant, your doctor will record at each prescription that the necessary precautions have been taken and will provide you with confirmation.
• If you are allergic to pomalidomide or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice.

If you are unsure whether any of the conditions listed above apply to you, consult your doctor,
pharmacist, or nurse before taking Pomalidomide Teva.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Pomalidomide Teva if:

• you have previously had episodes of blood clots. There is an increased risk of developing blood clots in the veins (thrombosis) and arteries during treatment with Pomalidomide Teva. Your doctor may recommend additional treatments (e.g. warfarin) or reduce the dose of Pomalidomide Teva to lower the risk of blood clots;
• you have previously had an allergic reaction, such as rash, itching, swelling, dizziness, or difficulty breathing, during treatment with related medicines called “thalidomide” or “lenalidomide”;
• you have had a heart attack, have heart failure, breathing difficulties, or if you smoke, have high blood pressure, or high cholesterol levels;
• you have a high tumour burden throughout the body, including in the bone marrow. This could lead to a condition in which tumours break down and cause abnormal levels of chemicals in the blood, potentially leading to kidney failure. You may also experience an irregular heartbeat. This condition is known as tumour lysis syndrome;
• you have or have previously had neuropathy (nerve damage causing tingling or pain in the hands or feet);
• you have or have previously had hepatitis B infection. Treatment with Pomalidomide Teva may reactivate the hepatitis B virus in patients carrying the virus, leading to a recurrence of infection. Your doctor must check whether you have ever had hepatitis B infection;
• you have or have previously had any combination of the following symptoms: facial or widespread rash, skin redness, high fever, flu-like symptoms, swollen lymph nodes (these are signs of a serious skin reaction called 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 patients with multiple myeloma treated with pomalidomide may develop
other types of cancer; therefore, your doctor must carefully evaluate the benefits and risks when
prescribing this medicine.
At any time during or after treatment, inform your doctor or nurse immediately if you experience blurred
vision, loss of vision, double vision, difficulty speaking, weakness in one arm or leg, changes in walking
or balance, persistent numbness, reduced sensation or loss of sensation, memory loss, or confusion. These
may be symptoms of a serious and potentially fatal brain disease known as progressive multifocal
leucoencephalopathy (PML). If you had these symptoms before starting treatment with Pomalidomide
Teva, inform your doctor of any changes in these symptoms.
After treatment ends, you must return all unused capsules to the pharmacist.
Pregnancy, contraception and breastfeeding – information for women and men
The following instructions must be followed as specified in the Pomalidomide Teva Pregnancy Prevention Programme. Women and men taking Pomalidomide Teva must not become pregnant or father a child, because pomalidomide is expected to be harmful to the unborn baby. You and your partner must use effective contraceptive measures during treatment with this medicine.
Women
Do not take Pomalidomide Teva if you are pregnant, suspect you may be pregnant, or are planning a
pregnancy, because this medicine is expected to be harmful to the unborn baby. Before starting
treatment, you must inform your doctor if there is any possibility that you could become pregnant, even
if you think it is unlikely.
If there is any possibility that you could become pregnant:

• you must use effective contraception for at least 4 weeks before starting treatment, throughout the entire treatment period, and for at least 4 weeks after stopping treatment. Consult your doctor about the most suitable contraceptive method for you.
• At each prescription, your doctor will confirm that you understand the necessary measures to prevent pregnancy.
• Your doctor will arrange pregnancy tests before treatment, at least every 4 weeks during treatment, and at least 4 weeks after treatment ends.

If you become pregnant despite preventive measures:

• you must stop treatment immediately and contact your doctor right away.

Breastfeeding
It is not known whether Pomalidomide Teva passes into breast milk. Inform your doctor if you are
breastfeeding or plan to breastfeed. Your doctor will advise you whether to stop or continue
breastfeeding.
Men
Pomalidomide Teva passes into human seminal fluid.

• If your partner is pregnant or there is a possibility she could become pregnant, you must use condoms throughout the entire treatment period and for 7 days after stopping treatment.
• If your partner becomes pregnant during treatment with Pomalidomide Teva, inform your doctor immediately. Your partner must also inform her doctor immediately.

You must not donate semen or sperm during treatment and for 7 days after stopping treatment.
Blood donation and blood tests
You must not donate blood during treatment and for 7 days after stopping treatment.
Before and during treatment with Pomalidomide Teva, you will undergo regular blood tests because this
medicine may reduce blood cells that fight infections (white blood cells) and cells that stop bleeding
(platelets).
Your doctor will ask you to have blood tests:

• before starting treatment;
• weekly for the first 8 weeks of treatment;
• at least once a month thereafter, for the entire duration of treatment with Pomalidomide Teva.

Based on the results of these tests, your doctor may adjust the dose of Pomalidomide Teva or stop
treatment. Your doctor may also adjust the dose or stop treatment based on your overall health status.
Children and adolescents
The use of Pomalidomide Teva is not recommended in children and adolescents under 18 years of age.
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 may affect the action of other medicines and other
medicines may affect the action of Pomalidomide Teva.
In particular, inform your doctor, pharmacist, or nurse before taking Pomalidomide Teva if you are
taking any of the following medicines:

• certain antifungal medicines, such as ketoconazole;
• certain antibiotics (e.g. ciprofloxacin, enoxacin);
• certain antidepressants, such as fluvoxamine.

Driving and using machines
Some people may experience fatigue, dizziness, fainting, confusion, or reduced alertness when taking
Pomalidomide Teva. If this occurs, do not drive or operate tools or machinery.
Pomalidomide Teva contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially ‘sodium-free’.
Pomalidomide Teva contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this
medicine.
Pomalidomide Teva contains Brilliant Blue FCF (E133)
This medicine contains the azo dye Brilliant Blue FCF (E133), which may cause allergic reactions.

3. How to take Pomalidomide Teva

Pomalidomide Teva must be prescribed and managed by a physician experienced in the treatment of multiple myeloma.
Always follow your doctor's instructions exactly when taking this medicine. If you have any doubts, consult your doctor, pharmacist, or nurse.

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

• Read the package leaflet of bortezomib and dexamethasone for more information about their use and side effects.
• Pomalidomide Teva, bortezomib, and dexamethasone are taken in "treatment cycles". Each cycle lasts 21 days (3 weeks).
• Refer to the table below to know which medicines to take each day during the 3-week cycle:
  o Each day, check the chart and find the correct day to determine which medicines to take.
  o On some days you will take all three medicines, on some days only two or one medicine, and on other days no medicine at all.

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

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

Pomalidomide Teva with dexamethasone alone

• Refer to the package leaflet of dexamethasone for more information about its use and side effects.
• Pomalidomide Teva and dexamethasone are taken in treatment cycles. Each cycle lasts 28 days (4 weeks).
• Refer to the table below to know which medicines to take each day during the 4-week cycle:
  o Each day, check the chart and find the correct day to determine which medicines to take.
  o On some days you will take both medicines, on some days only one medicine, and on other days no medicine 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.

Dose of Pomalidomide Teva to be taken with other medicines
Pomalidomide Teva with bortezomib and dexamethasone

• The recommended starting dose of Pomalidomide Teva is 4 mg once daily.
• The recommended starting dose of bortezomib will be determined by your doctor 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 years of age, the recommended starting dose is 10 mg per day.

Pomalidomide Teva with dexamethasone alone

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

Your doctor may need to reduce the dose of Pomalidomide Teva, bortezomib, or dexamethasone, or discontinue one or more of these medicines based on blood test results, your general condition, other medicines you may be taking (e.g., ciprofloxacin, enoxacin, and fluvoxamine), and if side effects occur (especially rash or swelling) due to treatment.
If you have liver or kidney problems, your doctor will monitor your condition very closely during treatment with this medicine.

How to take Pomalidomide Teva

• Do not break, open, or chew the capsules. If the powder from a broken capsule comes into contact with the skin, wash the skin immediately and thoroughly with soap and water.
• Healthcare providers, 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 bag, and disposed of according to local regulations. Hands should then be washed thoroughly with soap and water. Pregnant women (confirmed or suspected) must not handle the blister pack or capsule.
• Swallow the capsules whole, preferably with water.
• The capsules may be taken with or without food.
• Take the capsules at approximately the same time each day.

To remove the capsule from the blister, press on one side of the capsule, pushing it through the aluminum foil. Do not press in the center of the capsule, as this may cause it to break.

Your doctor will inform you how and when to take Pomalidomide Teva if you have kidney problems and are undergoing dialysis.

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

If you take more Pomalidomide Teva than you should
If you take more Pomalidomide Teva than prescribed, consult your doctor or go to hospital immediately. Take the medicine pack with you.

If you forget to take Pomalidomide Teva
If you forget to take Pomalidomide Teva on the prescribed day, take the next capsule as usual the following day. Do not increase the number of capsules to make up for the missed dose of Pomalidomide Teva the previous day.

If you have any doubts about using 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.

Serious side effects

Stop taking Pomalidomide Teva and contact your doctor immediately if you experience any of the following serious side effects – urgent medical treatment may be required:

• Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection (due to a lower number of white blood cells, which fight infections).
• Bleeding or bruising without reason, including nosebleeds and bleeding from the intestine or stomach (due to effects on blood cells called "platelets").
• Rapid breathing, fast pulse, fever and chills, little or no urination, nausea and vomiting, confusion, unconsciousness (due to a blood infection 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 pain and swelling in the legs, especially in the lower leg or calf (caused by blood clots).
• Shortness of breath (due to severe chest infection, lung inflammation, heart failure, or blood clot).
• Swelling of the face, lips, tongue, and throat, which may cause difficulty breathing (due to severe allergic reactions called angioedema and anaphylactic reaction).
• Certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which may cause changes in the skin's appearance or skin growths. If you notice any skin changes during treatment with Pomalidomide Teva, inform your doctor as soon as possible.
• Reactivation of hepatitis B infection, which may cause yellowing of the skin and eyes, dark brown urine, pain in the right side of the abdomen, fever, nausea or vomiting. Inform your doctor immediately if you notice any of these symptoms.
• Widespread rash, high body temperature, swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome, toxic epidermal necrolysis, or Stevens-Johnson syndrome). Stop taking pomalidomide if you experience these symptoms and contact your doctor or seek immediate medical help. See also section 2.

Stop taking Pomalidomide Teva and contact your doctor immediately if you experience any of the serious side effects listed above: urgent medical treatment may be required.

Other side effects

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

• Shortness of breath (dyspnoea).
• Lung infections (pneumonia and bronchitis).
• Infections of the nose, sinuses, and throat caused by bacteria or viruses.
• Flu-like symptoms (influenza).
• Low number of red blood cells, which may cause anaemia leading to tiredness and weakness.
• Low levels of potassium in the blood (hypokalaemia), which may cause weakness, muscle cramps, muscle pain, palpitations, tingling or numbness, shortness of breath, mood changes.
• High blood sugar levels.
• Fast and irregular heartbeat (atrial fibrillation).
• Decreased appetite.
• Constipation, diarrhoea, or nausea.
• Vomiting.
• Abdominal pain.
• Lack of energy.
• Difficulty falling asleep or staying asleep.
• Dizziness, tremor.
• Muscle spasm, muscle weakness.
• Bone pain, back pain.
• Numbness, tingling, or burning sensation on the skin, pain in hands or feet (peripheral sensory neuropathy).
• Swelling of the body, including arms and legs.
• Skin rashes.
• Urinary tract infection, which may cause a burning sensation when urinating or the need to urinate more frequently.

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

• Falls.
• Bleeding within the skull.
• Reduced ability to move or feel sensations in the hands, arms, feet, and legs due to damage to the nervous system (peripheral sensory-motor neuropathy).
• Numbness, itching, and sensations of pins and needles on the skin (paraesthesia).
• Feeling of dizziness, with difficulty standing up and moving normally.
• Swelling due to fluid retention.
• Hives.
• Itching.
• Herpes zoster (shingles).
• Heart attack (chest pain spreading to the arms, neck, jaw, feeling of sweating and shortness of breath, nausea or vomiting).
• Chest pain, chest infection.
• Increased blood pressure.
• Simultaneous reduction in red blood cells, white blood cells, and platelets (pancytopenia), increasing the risk of bleeding and bruising. You may feel tired, weak, and breathless, and you may be more likely to develop infections.
• Reduced number of lymphocytes (a type of white blood cell), often caused by infection (lymphopenia).
• Low levels of magnesium in the blood (hypomagnesaemia), which may cause tiredness, generalised weakness, muscle cramps, irritability, and may lead to low levels of calcium in the blood (hypocalcaemia), possibly causing numbness and/or tingling in the hands, feet, or lips, muscle cramps, muscle weakness, dizziness, confusion.
• Low levels of phosphate in the blood (hypophosphataemia), which may cause muscle weakness, irritability, or confusion.
• High levels of calcium in the blood (hypercalcaemia), which may cause slowed reflexes and weakness of skeletal muscles.
• High levels of potassium in the blood, which may cause an abnormal heart rhythm.
• Low levels of sodium in the blood, which may cause tiredness and confusion, muscle spasms, seizures, or coma.
• High levels of uric acid in the blood, which may cause a form of arthritis called gout.
• Low blood pressure, which may cause dizziness or fainting.
• Painful or dry mouth.
• Altered sense of taste.
• Bloating of the abdomen.
• Feeling confused.
• Feeling low in mood (depression).
• Loss of consciousness, fainting.
• Blurred vision (cataract).
• Kidney damage.
• Inability to urinate.
• Abnormal liver function tests.
• Pelvic pain.
• Weight loss.

Uncommon (may affect up to 1 in 100 people):

• Stroke.
• Inflammation of the liver (hepatitis), which may cause itching, yellowing of the skin and whites of the eyes (jaundice), pale-coloured stools, dark urine, and abdominal pain.
• Breakdown of tumour cells, causing the release of toxic substances into the bloodstream (tumour lysis syndrome). This may cause kidney problems.
• Underactive thyroid gland, which may cause symptoms such as tiredness, lethargy, muscle weakness, slow heartbeat, and 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 experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, 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 stated on the blister and carton after Scad/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 with the medicine packaging.
Do not dispose of any medicine via wastewater or household waste. Unused medicine must be returned to the pharmacist at the end of treatment. This will help protect the environment.

6. Package contents and other information

What Pomalidomide Teva contains

• The active substance is pomalidomide.
• The other ingredients are monohydrate lactose, crospovidone, povidone, sodium lauryl sulfate, sodium stearyl fumarate.

Pomalidomide Teva 1 mg hard capsule

• Each capsule contains 1 mg of pomalidomide.
• The capsule shell contains: brilliant blue FCF (E133), titanium dioxide (E171), gelatin, yellow iron oxide (E172).
• The printing ink contains: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172), potassium hydroxide (E525).

Pomalidomide Teva 2 mg hard capsule

• Each capsule contains 2 mg of pomalidomide.
• The capsule shell contains: brilliant blue FCF (E133), titanium dioxide (E171), gelatin, yellow iron oxide (E172), red iron oxide (E172).
• The printing ink contains: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (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), titanium dioxide (E171), gelatin, yellow iron oxide (E172).
• The printing ink contains: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (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), concentrated ammonia solution (E527), black iron oxide (E172), potassium hydroxide (E525).

Description of the appearance of Pomalidomide Teva and contents of the pack
Pomalidomide Teva 1 mg hard capsules: approximately 14 mm hard gelatin capsule with an opaque blue cap and an opaque yellow body, marked with "T" on the cap and "1" on the body.
Pomalidomide Teva 2 mg hard capsules: approximately 18 mm hard gelatin capsule with an opaque blue cap and an opaque orange body, marked with "T" on the cap and "2" on the body.
Pomalidomide Teva 3 mg hard capsules: approximately 18 mm hard gelatin capsule with an opaque blue cap and an opaque green body, marked with "T" on the cap and "3" on the body.
Pomalidomide Teva 4 mg hard capsules: approximately 18 mm hard gelatin capsule with an opaque blue cap and an opaque light blue body, marked with "T" on the cap and "4" on the body.
Each pack contains 14, 14x1, 21, 21x1, 63 or 63x1 capsules. Not all pack sizes may be marketed.

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

Manufacturer
Balkanpharma-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 further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A. /AG UAB Teva Baltics
Tel/Tél: +32 3 820 73 73 Tel: +370 5 266 02 03

България Luxembourg/Luxemburg
Тева Фарма ЕАД ratiopharm GmbH
Teл: +359 2 489 95 85 Tél: +49 731 402 02

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251 007 111 Tel: (+36) 1 288 6400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf: +45 44 98 55 11 Tel: +44 (0) 207 540 7117

Deutschland Nederland
ratiopharm GmbH Teva Nederland B.V.
+49 (0) 731 402 02 Tel: +31 800 0228 400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel.: +372 6610801 Tlf: +47 66 77 55 90

Ελλάδα Österreich
Teva Hellas Α.Ε. Ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 211 880 5000 Tel: +43 1970070

España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel.: + 34 91 387 32 80 Tel: +48 22 345 93 00

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda
Tél: +33 1 55 91 78 00 Tel: +351 21 476 75 50

Hrvatska România
Pliva Hrvatska d.o.o Teva Pharmaceuticals S.R.L
Tel: + 385 1 37 20 000 Tel: +40 21 230 65 24

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 (0) 207 540 7117 Tel: +386 1 58 90 390

Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o
Sími: + 354 550 3300 Telephone: +421257267911

Italia Suomi/Finland
Teva Italia S.r.l Teva Finland Oy
Tel:. +39 028917981 Puh/Tel: +358 20 180 5900

Κύπρος Sverige
TEVA HELLAS Α.Ε. Teva Sweden AB
Ελλάδα Tel: +46 (0)42 12 11 00
Τηλ: +30 211 880 5000

Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā United Kingdom (Northern Ireland)
Tel: +371 67 323 666 Teva Pharmaceuticals Ireland
[email protected] Ireland
Tel: +44 (0) 207 540 7117