POMALIDOMIDE 1 mg Hard Capsules

Зміст інструкції

1. Pomalidomide Teva 1 mg hard capsules, 2 mg hard capsules, 3 mg hard capsules, 4 mg hard capsules
   1. What is Pomalidomide Teva and what is it 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

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

pomalidomide

It is expected that Pomalidomide Teva will cause congenital malformations and may cause fetal death.

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

Read this leaflet carefully before 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, 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 you take 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
defenses).

What is Pomalidomide Teva used for
Pomalidomide Teva is used in the treatment of adults with a type of cancer called
“multiple myeloma”.
Pomalidomide Teva is used together with:

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

Or

• one other medicine, called “dexamethasone”, in patients in whom the multiple myeloma has worsened despite at least two other 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 causes damage to the bones and kidneys.
Multiple myeloma is generally incurable. However, treatment can reduce the signs and symptoms of the
disease or make them disappear for a certain period of time. When this happens, it is referred to as a “response”.

How does Pomalidomide Teva work
Pomalidomide Teva works in several ways:

• stopping the development of myeloma cells
• stimulating the immune system to attack cancer cells
• stopping the formation of blood vessels that feed cancer cells.

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

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

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

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

2. What you need to know before taking Pomalidomide Teva

Do not take Pomalidomide Teva

• If you are pregnant or if you think you may be pregnant, or if you are planning a pregnancy, because Pomalidomide Teva is expected to harm the fetus. (Men and women taking this medicine must read the “Pregnancy, contraception and breastfeeding – information for women and men” section below).
• If there is a possibility that you might become pregnant unless you follow all the necessary measures to avoid pregnancy (see “Pregnancy, contraception and breastfeeding – information for women and men”). If there is a possibility that you might become pregnant, on each prescription your doctor will record that the necessary measures have been taken and will provide you with this confirmation.
• If you are allergic to pomalidomide or to 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 not sure whether any of the above conditions apply to you, consult your doctor, your
pharmacist or your nurse before taking Pomalidomide Teva.

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

• you have had episodes of blood clots in the past. During treatment with Pomalidomide Teva there is a higher risk of blood clots forming in the veins (thrombi) and in the arteries. Your doctor may recommend additional treatments (e.g. warfarin) or reduce the dose of Pomalidomide Teva to reduce the likelihood of blood clots forming;
• if you have had an allergic reaction in the past, 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, have difficulty breathing, or if you smoke, have high blood pressure or high cholesterol levels;
• you have a high tumor burden throughout the body, including in the bone marrow. This could cause a condition in which the tumors break down and cause the presence of unusual levels of chemicals in the blood, which can lead to kidney failure. An irregular heartbeat may also appear. This condition is called tumor lysis syndrome;
• you have or have had neuropathy (nerve damage that causes tingling or pain in the hands or feet)
• you have or have had hepatitis B infection in the past. Treatment with Pomalidomide Teva may cause reactivation of the hepatitis B virus in patients carrying this virus, resulting in recurrence of the infection. Your doctor should check if you have ever had a hepatitis B infection;
• you have or have had any combination of the following symptoms: rash on the face or more widespread, 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, the doctor must carefully assess the benefit and risk when
prescribing this medicine.
At any time during or after treatment, immediately inform your doctor or nurse
if you experience blurred vision, loss of vision or double vision, difficulty speaking, weakness in an
arm or leg, changes in the way you walk or problems with balance, persistent numbness,
reduced sensation or loss of sensation, memory loss or confusion. These may
be symptoms of a serious brain disease that can be fatal known as
progressive multifocal leukoencephalopathy (PML). If you had these symptoms before treatment
with Pomalidomide Teva, inform your doctor of any changes in these symptoms.
At the end of treatment, 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 indicated in the Pomalidomide Teva Pregnancy Prevention
Program. Women and men taking Pomalidomide Teva must not
start a pregnancy or conceive a child, because pomalidomide is expected to be
harmful to the fetus. You and your partner must use effective contraceptive measures during
treatment with this medicine.
Women
Do not take Pomalidomide Teva if you are currently pregnant, if you suspect or are planning a
pregnancy, because this medicine is expected to be harmful to the fetus. Before starting
treatment, you must inform your doctor if there is a possibility of becoming pregnant, even
if you think it is unlikely.
If there is a possibility of becoming pregnant:

• you must use effective contraceptive methods for at least 4 weeks before starting treatment, throughout the duration of treatment and for at least 4 weeks after stopping treatment. Discuss with your doctor the best contraceptive method for you.
• On each prescription, your doctor will make sure that you understand what measures you need to take 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 end of treatment.

If you become pregnant despite preventive measures:

• you must stop treatment immediately and consult your doctor immediately

Breastfeeding
It is not known whether Pomalidomide Teva passes into breast milk. Inform your doctor if you are breastfeeding or intend
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 that she might become pregnant, you must use condoms throughout treatment and for 7 days after the end of treatment.
• If your partner becomes pregnant during treatment with Pomalidomide Teva, inform your doctor immediately. Your partner should also inform her doctor immediately.

You must not donate seminal fluid or sperm during treatment and for 7 days after the end of
treatment.

Blood donation and blood tests
You must not donate blood during treatment and for 7 days after the end of treatment.
Before and during treatment with Pomalidomide Teva you will undergo regular blood tests,
because this medicine can cause a reduction in blood cells that fight
infections (white blood cells) and cells that stop bleeding (platelets).
Your doctor will ask you to have blood tests:

• before treatment
• every week for the first 8 weeks of treatment
• at least once a month thereafter, for the entire period of treatment with Pomalidomide Teva.

Based on the results of these tests, your doctor may change the dose of Pomalidomide Teva or
stop treatment. Your doctor may also change the dose or stop treatment based on your overall health.

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 can affect the way other
medicines work and 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 antifungal medicines, such as ketoconazole
• some antibiotics (e.g. ciprofloxacin, enoxacin)
• some antidepressants, such as fluvoxamine.

Driving and using machines
Some people may experience fatigue, dizziness, feeling faint, confusion or reduced
alertness when taking Pomalidomide Teva. If this happens, do not drive vehicles and do not use
tools or machines.

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

Pomalidomide Teva contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor 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 administered by a doctor experienced in the treatment of multiple myeloma.
Take the medicine following the doctor's instructions exactly. 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
use and their effects.

• Pomalidomide Teva, bortezomib and dexamethasone are taken in “treatment cycles”. Each cycle lasts 21 days (3 weeks).
• Consult the following table to find out what to take each day of the 3-week cycle: o Every day check the chart and find the correct day to know which medicines to take. o Some days you will take all 3 medicines, some days only 2 or 1 medicine and other days no medicine.

POM:Pomalidomide Teva; BOR: Bortezomib; DEX: Dexamethasone

Cycle 1 to 8From Cycle 9 onwards
Medicine nameMedicine name
DayPOMBORDEXDayPOMBORDEX
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
its effects.

• Pomalidomide Teva and dexamethasone are taken in treatment cycles. Each cycle lasts 28 days (4 weeks).
• Consult the following table to find out what to take each day of the 4-week cycle: o Every day check the chart and find the correct day to know which medicines to take. o Some days you will take both medicines, some days only 1 medicine and other days no medicine.

POM:Pomalidomide Teva; DEX: Dexamethasone

Medicine name
DayPOMDEX
1 √ √
2 √
3 √
4 √
5 √
6 √
7 √
8 √ √
9 √
10 √
11 √
12 √
13 √
14 √
15 √ √
16 √
17 √
18 √
19 √
20 √
21 √
22 √
23
24
25
26
27
28

• After 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 initial dose of Pomalidomide Teva is 4 mg once a day.
• The recommended initial dose of bortezomib will be established by the doctor based on your height and weight (1.3 mg/m of body surface area).
• The recommended initial dose of dexamethasone is 20 mg per day. However, if you are over 75 years of age, the recommended initial dose is 10 mg per day.

Pomalidomide Teva with dexamethasone alone

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

The 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 blood tests, your
general condition, other medicines you may be taking (e.g. ciprofloxacin, enoxacin and
fluvoxamine) and if adverse effects (in particular skin rash or swelling) occur due to
treatment.
If you have liver or kidney problems, the doctor will monitor your condition very carefully
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 professionals, those providing assistance to the patient and family members must wear disposable gloves when handling the blister or capsule. The gloves should then be removed carefully to avoid skin exposure, placed in a sealable polyethylene bag and disposed of in accordance with local regulations. Then wash your hands thoroughly with soap and water. Pregnant or suspected pregnant women should not handle the blister or capsule.
• Swallow the tablets whole, preferably with water.
• The capsules can be taken with or without food.
• Take the capsules every day at approximately the same time.

To remove the capsule from the blister, press on only one side of the capsule, pushing it through the
aluminum foil. Do not press on the center of the capsule, otherwise there is a risk of breaking it.

The 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 the doctor tells you to stop the treatment.

If you take more Pomalidomide Teva than you should
If you take more Pomalidomide Teva than you should, consult your doctor or go to hospital
immediately. Bring the medicine packaging 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 next day. Do not increase the number of capsules to be taken to make up for the
omission of Pomalidomide Teva the previous day.
If you have any doubts about using 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 contact your doctor immediately if you experience any of the
following serious side effects – urgent medical treatment may be needed:

• Fever, chills, sore throat, cough, mouth sores, or any other sign of infection (due to a lower number of white blood cells, which fight infections).
• Bleeding or bruising easily, including nosebleeds and bleeding from the intestine or stomach (due to effects on blood cells called “platelets”).
• Rapid breathing, rapid heartbeat, fever and chills, decreased or absent urination, nausea and vomiting, confusion, loss of consciousness (due to a blood infection called sepsis or septic shock).
• Severe, persistent, or bloody diarrhea (possibly with stomach pain or fever) caused by bacteria called Clostridium difficile.
• Chest pain or pain and swelling in the legs, especially 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 can cause difficulty breathing (due to severe types of allergic reactions called angioedema and anaphylactic reaction).
• Certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which can cause changes in the appearance or growths on the skin. If you notice any skin changes during treatment with Pomalidomide Teva, tell your doctor as soon as possible.
• Reappearance of hepatitis B infection, which can cause yellowing of the skin and eyes, dark brown urine, right-sided abdominal pain, fever, and nausea or vomiting. Tell your doctor immediately if you notice any of these symptoms.
• Widespread rash, high temperature, swollen lymph nodes, and involvement of other organs of the body (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 these symptoms occur and seek medical attention immediately. See also section 2.

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

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

• Shortness of breath (dyspnea).
• 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 can cause anemia with resulting fatigue and weakness.
• Low levels of potassium in the blood (hypokalemia), which can cause weakness, muscle cramps, muscle pain, palpitations, tingling or numbness, shortness of breath, mood changes.
• High levels of sugar in the blood.
• Fast and irregular heartbeat (atrial fibrillation).
• Decreased appetite.
• Constipation, diarrhea, 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 the hands or feet (peripheral sensory neuropathy).
• Swelling of the body, including swelling of the arms and legs.
• Skin rashes.
• Urinary tract infection, which can cause a burning sensation during urination or the need to urinate more often.

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

• Falls.
• Bleeding inside the skull.
• Reduced ability to move or feel sensations in the hands, arms, feet, and legs due to damage to the nervous system (peripheral sensorimotor neuropathy).
• Numbness, itching, and pins and needles sensation on the skin (paresthesia).
• Feeling dizzy, with difficulty getting up and moving normally.
• Swelling caused by fluid.
• Hives.
• Itching.
• Shingles (herpes zoster).
• Heart attack (chest pain radiating to the arms, neck, jaw, sweating, and shortness of breath, nausea or vomiting).
• Chest pain, chest infection.
• Increased blood pressure.
• Simultaneous reduction in the number of red blood cells, white blood cells, and platelets (pancytopenia) which makes you more prone to bleeding and bruising. You may feel tired, weak, and short of breath and are also more likely to develop infections.
• Reduced number of lymphocytes (a type of white blood cells) often caused by infection (lymphopenia).
• Low levels of magnesium in the blood (hypomagnesemia), which can cause fatigue, generalized weakness, muscle cramps, irritability and can cause a lowering of calcium levels in the blood (hypocalcemia), with possible numbness and/or tingling of the hands, feet or lips, muscle cramps, muscle weakness, dizziness, confusion.
• Low levels of phosphate in the blood (hypophosphatemia), which can cause muscle weakness and irritability or confusion.
• High levels of calcium in the blood (hypercalcemia), which can cause slowed reflexes and skeletal muscle weakness.
• High levels of potassium in the blood, which can cause an abnormal heart rhythm.
• Low levels of sodium in the blood, which can cause fatigue and confusion, muscle spasms, seizures, or coma.
• High levels of uric acid in the blood, which can cause a form of arthritis called gout.
• Low blood pressure, which can cause dizziness or fainting.
• Painful or dry mouth.
• Altered sense of taste.
• Bloated abdomen.
• Feeling confused.
• Feeling down (depressed mood)
• Loss of consciousness, fainting.
• Blurred vision (cataracts).
• Kidney damage.
• Inability to urinate.
• Abnormalities in liver function tests.
• Pelvic pain.
• Weight loss.

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

• Stroke.
• Inflammation of the liver (hepatitis), which can cause itching, yellowing of the skin and whites of the eyes (jaundice), pale stools, dark urine, and abdominal pain.
• Breakdown of cancer cells, which releases toxic substances into the bloodstream (tumor lysis syndrome). This can cause kidney problems.
• Thyroid gland not working enough, which can cause symptoms such as fatigue, sluggishness, muscle weakness, slow heartbeat, and weight gain.

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

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed 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 which is stated on the blister and the package after
Exp/EXP. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use Pomalidomide Teva if you notice damage or signs of tampering with the packaging of the
medicine.
Do not dispose of any medicine in wastewater or household waste. Unused medicine
should be returned to the pharmacist at the end of treatment. This will help protect the environment.

6. Contents of the pack and other information

What Pomalidomide Teva contains

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

Pomalidomide Teva 1 mg hard capsules

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

Pomalidomide Teva 2 mg hard capsules

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

Pomalidomide Teva 3 mg hard capsules

• Each capsule contains 3 mg of pomalidomide.
• The capsule coating contains: brilliant blue FCF (E133), titanium dioxide (E171), gelatin, yellow iron oxide (E172)
• The inscription ink contains: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172), potassium hydroxide (E525)

Pomalidomide Teva 4 mg hard capsules

• Each capsule contains 4 mg of pomalidomide.
• The capsule coating contains: brilliant blue FCF (E133), titanium dioxide (E171), gelatin
• The inscription 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: hard gelatin capsule of approximately 14 mm with an opaque blue cap
and an opaque yellow body, bearing the inscription “T” on the cap and “1” on the body.
Pomalidomide Teva 2 mg hard capsules: hard gelatin capsule of approximately 18 mm with an opaque blue cap
and an opaque orange body, bearing the inscription “T” on the cap and “2” on the body.
Pomalidomide Teva 3 mg hard capsules: hard gelatin capsule of approximately 18 mm with an opaque blue cap
and an opaque green body, bearing the inscription “T” on the cap and “3” on the body.
Pomalidomide Teva 4 mg hard capsules: hard gelatin capsule of approximately 18 mm with an opaque blue cap
and an opaque light blue body, bearing the inscription “T” on the cap and “4” on the body.
Each pack contains 14, 14x1, 21, 21x1, 63 and 63x1 capsules. Not all pack sizes may be marketed.

Marketing Authorisation 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, 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
Tel: +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 Pharmaceuticals 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

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

FrancePortugal
Teva Santé
Tél: +33 1 55 91 78 00
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: +421257267911

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

United Kingdom (Northern Ireland)
United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 (0) 207 540 7117

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67 323 666
[email protected]