Pomalidomide Teva 4 mg hard capsules EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Pomalidomida Teva 1 mg hard capsules

Pomalidomida Teva 2 mg hard capsules

Pomalidomida Teva 3 mg hard capsules

Pomalidomida Teva 4 mg hard capsules

pomalidomide

Pomalidomide Teva is expected to cause severe birth defects and may result in fetal death. Do not take this medicine if you are pregnant or may be pregnant. You must follow the contraceptive measures described in this leaflet.

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

What Pomalidomida Teva is

Pomalidomida Teva contains the active substance "pomalidomide". This medicine is related to thalidomide and belongs to a group of medicines that affect the immune system (the body's natural defenses).

What Pomalidomida Teva is used for

Pomalidomida Teva is used to treat adults with a type of cancer called "multiple myeloma".

Pomalidomida Teva is used with:

• Two other medicines called "bortezomib" (a type of chemotherapy medicine) and "dexamethasone" (an anti-inflammatory medicine) in people who have received at least one other treatment, including lenalidomide.

Or

• One other medicine called "dexamethasone" in people whose myeloma has worsened despite having received at least two other types of treatment, including the medicines lenalidomide and bortezomib.

What is multiple myeloma

Multiple myeloma is a type of cancer that affects a specific type of white blood cells (called "plasma cells"). These cells grow uncontrollably and accumulate in the bone marrow, damaging bones and kidneys.

Multiple myeloma usually cannot be cured. However, treatment can reduce or eliminate the signs and symptoms of the disease for a period of time. When this occurs, it is referred to as a "response".

How Pomalidomida Teva works

Pomalidomida Teva works in several ways:

• It stops the growth of myeloma cells;
• It stimulates the immune system to attack cancer cells;
• It inhibits the formation of blood vessels that supply nutrients to cancer cells.

Benefit of using Pomalidomida Teva with bortezomib and dexamethasone

When Pomalidomida Teva is used with bortezomib and dexamethasone in people who have received at least one other treatment, it can delay the progression of multiple myeloma:

• On average, the combination of Pomalidomida Teva with bortezomib and dexamethasone prevented the recurrence of multiple myeloma for up to 11 months, compared with 7 months in patients receiving only bortezomib and dexamethasone.

Benefit of using Pomalidomida Teva with dexamethasone

When Pomalidomida Teva is used with dexamethasone in people who have received at least two other treatments, it can delay the progression of multiple myeloma:

• On average, the combination of Pomalidomida Teva and dexamethasone prevented the recurrence of multiple myeloma for up to 4 months, compared with 2 months in patients receiving dexamethasone alone.

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

Do not take Pomalidomide Teva:

• if you are pregnant, think you might be pregnant, or intend to become pregnant, as Pomalidomide Teva is expected to be harmful to the fetus. (Men and women taking this medicine should read the section “Pregnancy, contraception, and breastfeeding – information for women and men” below);
• if you could become pregnant, unless you are taking all necessary measures to prevent pregnancy (see “Pregnancy, contraception, and breastfeeding – information for women and men”). If you could become pregnant, your doctor will document with each prescription that all necessary precautions have been taken and will provide you with this confirmation;
• if you are allergic to pomalidomide or to any of the other components of this medicine (listed in section 6). If you think you may be allergic, consult your doctor.

If you are unsure whether any of the above situations apply to you, consult your doctor, pharmacist, or nurse before starting to take Pomalidomide Teva.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to take Pomalidomide Teva if:

• you have ever had blood clots in the past. During treatment with Pomalidomide Teva, you have an increased risk of developing blood clots in your veins or arteries. Your doctor may recommend additional treatments (e.g., warfarin) or reducing your dose of Pomalidomide Teva to lower your risk of developing blood clots;
• you have previously experienced an allergic reaction, such as rash, itching, swelling, dizziness, or breathing problems while taking related medicines called “thalidomide” or “lenalidomide”;
• you have had a heart attack, have heart failure, have difficulty breathing, or if you are a smoker, have high blood pressure or high cholesterol levels;
• you have a high total tumor burden in the body, including in the bone marrow. This could lead to a condition in which tumors break down and release unusual levels of chemicals into the blood, which in turn may cause kidney failure. You may also experience irregular heartbeats. This condition is called tumor lysis syndrome;
• you suffer from or have previously had neuropathy (nerve damage causing tingling or pain in your feet or hands);
• you have or have previously had hepatitis B virus infection. Treatment with Pomalidomide Teva may reactivate the hepatitis B virus in patients who carry the virus, causing the infection to reappear (recurrence). Your doctor should check whether you have ever had hepatitis B virus infection.
• you are experiencing or have previously experienced a combination of any of the following symptoms: facial or widespread rash, skin redness, high fever, flu-like symptoms, swollen lymph nodes (symptoms of a serious skin reaction called drug reaction with eosinophilia and systemic symptoms or DRESS syndrome, 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, so 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 or double vision, difficulty speaking, weakness in one arm or leg, a change in the way you walk or problems with balance, persistent numbness, reduced sensation, or loss of sensation, memory loss, or confusion. All of these may be symptoms of a serious and potentially life-threatening brain disease called progressive multifocal leukoencephalopathy (PML). If you had any of these symptoms before starting treatment with Pomalidomide Teva, inform your doctor if you notice 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

You must follow the instructions outlined in the Pomalidomide Teva Pregnancy Prevention Programme. Men and women taking Pomalidomide Teva must not father children or become pregnant. This is because pomalidomide is expected to be harmful to the fetus. You and your partner must use effective contraceptive methods while taking this medicine.

Women

Do not take Pomalidomide Teva if you are pregnant, think you might be pregnant, or intend to become pregnant. This is because this medicine is expected to be harmful to the fetus. Before starting treatment, you must inform your doctor if there is any possibility you could become pregnant, even if you think this is unlikely.

If you could become pregnant:

• you must use effective contraceptive methods starting at least 4 weeks before beginning treatment, throughout the entire time you are taking the medicine, and for at least
• 4 weeks after stopping treatment. Your doctor will advise you on the most appropriate contraceptive methods;
• each time your doctor prescribes a new prescription, they will confirm that you understand the necessary measures to prevent pregnancy;
• your doctor will schedule pregnancy tests before treatment, at least every 4 weeks during treatment, and at least 4 weeks after stopping treatment.

If you become pregnant despite preventive measures:

• you must stop treatment immediately and inform your doctor immediately.

Lactation

It is unknown whether Pomalidomide Teva passes into human breast milk. Inform your doctor if you are breastfeeding or intend to breastfeed. Your doctor will advise you whether you can continue or should stop breastfeeding.

Men

Pomalidomide Teva passes into human semen.

• If your partner is pregnant or could become pregnant, you must use condoms throughout the entire time you are taking the medicine and for 7 days after stopping treatment.
• If your partner becomes pregnant while you are taking 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 starting treatment with Pomalidomide Teva and during treatment, you will have periodic blood tests. This is because your medicine may cause a decrease in the number of blood cells that help fight infections (white blood cells) and in the number of cells that help stop bleeding (platelets).

Your doctor will request that you have a blood test:

• before starting treatment;
• weekly during the first 8 weeks of treatment;
• at least once a month while continuing to take Pomalidomide Teva.

Your doctor may adjust the dose of Pomalidomide Teva or interrupt your treatment, depending on the results of these tests. Your doctor may also adjust the dose or interrupt this medicine due to your overall health condition.

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

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines. This is because Pomalidomide Teva may affect how other medicines work. In addition, some medicines may affect how Pomalidomide Teva works.

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 use of machines

Some people experience fatigue, fainting, confusion, or reduced level of consciousness while 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 of sodium (23 mg) per capsule; essentially, it is “sodium-free”.

Pomalidomide Teva contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

Pomalidomide Teva contains Brilliant Blue FCF (E133)

This medicine contains the colourant Brilliant Blue FCF (E133), which may cause allergic reactions.

3. How to take Pomalidomida Teva

Pomalidomida Teva must be prescribed and administered by a physician experienced in the treatment of multiple myeloma.

Always follow exactly the instructions provided by your doctor. If you are unsure, consult your doctor, pharmacist, or nurse.

When to take Pomalidomida Teva with other medicines

Pomalidomida Teva in combination with bortezomib and dexamethasone

• Refer to the package leaflet for bortezomib and dexamethasone for additional information on their use and effects.

• Pomalidomida Teva, bortezomib, and dexamethasone are taken in treatment cycles. Each cycle lasts 21 days (3 weeks).

• Refer to the following chart to see which medicines to take each day of the 3-week cycle:

• Each day, check the chart and identify the correct day to see which medicines you should take.

• On some days you will take all three medicines, on other days only one or two, and on some days none of them.

POM: Pomalidomida Teva; BOR: bortezomib; DEX: dexamethasone

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

Pomalidomida Teva with dexamethasone alone

• Refer to the package leaflet for dexamethasone for additional information on its use and effects.

• Pomalidomida Teva and dexamethasone are taken in treatment cycles. Each cycle lasts 28 days (4 weeks).

• Refer to the following chart to see which medicines to take each day of the 4-week cycle:

• Each day, check the chart and identify the correct day to see which medicines you should take.

• On some days you will take both medicines, on other days only one, and on some days neither.

POM: Pomalidomida Teva; DEX: dexamethasone

	Name of the medication
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		√
23
24
25
26
27
28

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

How much Pomalidomida Teva to take with other medicines

Pomalidomida Teva with bortezomib and dexamethasone

• The recommended starting dose of Pomalidomida Teva is 4 mg once daily.
• The recommended starting dose of bortezomib will be calculated 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 once daily. However, if you are over 75 years of age, the recommended starting dose is 10 mg once daily.

Pomalidomida Teva with dexamethasone only

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

Your doctor may need to reduce the dose of Pomalidomida Teva, bortezomib, or dexamethasone, or interrupt one or more of these medicines, depending on your blood test results and general condition, whether you are taking other medicines (e.g., ciprofloxacin, enoxacin, and fluvoxamine), and if you experience adverse effects (especially rash or swelling) as a result of treatment.

If you have liver or kidney problems, your doctor will carefully monitor your condition while you are receiving this medicine.

How to take Pomalidomida 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, 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 sealable polyethylene plastic bag, and disposed of according to local requirements. Hands should then be thoroughly washed with soap and water. Pregnant women or women who suspect they may be pregnant must not handle the blister pack or capsule.
• Swallow the capsules whole, preferably with water.
• You may take the capsules with or without food.
• Take the capsules at approximately the same time each day.

To remove the capsule from the blister, press only one end of the capsule so it pushes through the foil. Do not press in the middle of the capsule, as this may break it.

Your doctor will advise you on how and when to take Pomalidomida Teva if you have kidney problems and are undergoing dialysis treatment.

Duration of treatment with Pomalidomida Teva

You should continue treatment cycles until your doctor tells you to stop.

If you take more Pomalidomida Teva than you should

If you take more Pomalidomida Teva than you should, inform your doctor or go to the hospital immediately. Bring the medicine packaging with you.

If you forget to take Pomalidomida Teva

If you forget to take Pomalidomida Teva on the day you were supposed to, take the next capsule the following day at your usual time. Do not take extra capsules to make up for the missed dose of Pomalidomida Teva.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects

If you experience any of the following serious adverse effects, stop treatment with Pomalidomide Teva and contact a doctor immediately, as you may require urgent medical treatment:

• Fever, chills, sore throat, cough, mouth ulcers, or any other sign of infection (due to decreased white blood cells responsible for fighting infection).
• Bleeding or bruising without apparent cause, including nosebleeds and intestinal or stomach bleeding (due to effects on blood cells called "platelets").
• Rapid breathing, fast pulse, fever and chills, little or no urine output, nausea and vomiting, confusion, unconsciousness (due to a blood infection called sepsis or septic shock).
• Severe, persistent, or bloody diarrhoea (possibly accompanied by stomach pain or fever) caused by the bacterium Clostridium difficile.
• Chest or leg pain and swelling, especially in the lower leg or calves (caused by blood clots).
• Difficulty breathing (due to a severe chest infection, lung inflammation, heart failure, or blood clots).
• Swelling of the face, lips, tongue, and throat, which may cause breathing difficulties (due to severe allergic reactions known as angioedema and anaphylactic reaction).
• Certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which may cause changes in the appearance of the skin or lumps on the skin. If you notice any skin changes while taking Pomalidomide Teva, inform your doctor as soon as possible.
• Reactivation of hepatitis B virus infection, which may cause yellowing of the skin and eyes, dark brown urine, right-sided abdominal pain, fever, nausea, or malaise. Inform your doctor immediately if you notice any of these symptoms.
• Widespread rash, high body temperature, enlarged lymph nodes, and effects on other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome 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 attention. See also section 2.

If you experience any of the following serious adverse effects, stop treatment with Pomalidomide Teva and contact a doctor immediately, as you may require urgent medical treatment.

Other adverse effects

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

• Difficulty breathing (dyspnoea).
• Lung infection (pneumonia and bronchitis).
• Infections of the nose, sinuses, and throat caused by bacteria or viruses.
• Flu-like symptoms (influenza).
• Low red blood cell count, which may lead to anaemia causing fatigue and weakness.
• Low levels of potassium in the blood (hypokalaemia), which may cause weakness, cramps and muscle pain, palpitations, tingling or numbness, dyspnoea, and mood changes.
• High blood sugar levels.
• Fast and irregular heartbeat (atrial fibrillation).
• Loss of appetite.
• Constipation, diarrhoea, or nausea.
• Vomiting.
• Abdominal pain.
• Lack of energy.
• Difficulty falling or staying asleep.
• Dizziness, tremor.
• Muscle spasms, muscle weakness.
• Bone pain, back pain.
• Numbness, tingling, or burning sensation in the skin, pain in hands or feet (peripheral sensory neuropathy).
• Generalised swelling, including swelling of 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):

• Fall.
• Bleeding inside the skull.
• Reduced ability to move or feel (sensation) in the hands, feet, and legs due to neurological damage (peripheral sensory-motor neuropathy).
• Numbness, itching, or tingling in the skin (paraesthesia).
• Sensation of dizziness or vertigo, making it difficult to stand and move normally.
• Swelling due to fluid retention.
• Hives (urticaria).
• Itching of the skin.
• Shingles (herpes zoster).
• Heart attack (chest pain spreading to arms, neck, and jaw, sweating, shortness of breath, nausea or vomiting).
• Chest pain, chest infection.
• Increased blood pressure.
• Reduction in the number of red blood cells, white blood cells, and platelets simultaneously (pancytopenia), making you more prone to bleeding and bruising. You may feel tired and weak and have difficulty breathing. You will also be more susceptible to infections.
• Decreased number of lymphocytes (a type of white blood cell), often due to infection (lymphopenia).
• Low levels of magnesium in the blood (hypomagnesaemia), which may cause fatigue, generalised weakness, muscle cramps, and irritability, and may lead to low levels of calcium in the blood (hypocalcaemia), which can cause numbness 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 slow reflexes and cause skeletal muscle weakness.
• High levels of potassium in the blood, which may cause an abnormal heart rhythm.
• Low levels of sodium in the blood, which may cause fatigue and confusion, muscle twitching, seizures (epileptic convulsions), or coma.
• High levels of uric acid in the blood, which may cause a type of arthritis called gout.
• Low blood pressure, which may cause dizziness or fainting.
• Mouth pain or dryness.
• Changes in taste.
• Bloating.
• Confusion.
• Feeling low (depressive mood).
• Loss of consciousness, fainting.
• Clouding of the eye (cataract).
• Kidney damage.
• Inability to urinate.
• Abnormal results in 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 itchy skin, yellowing of the skin and whites of the eyes (jaundice), pale stools, dark urine, and abdominal pain.
• Breakdown of tumour cells resulting in the release of toxic substances into the bloodstream (tumour lysis syndrome). This may lead to kidney problems.
• Underactive thyroid gland, which may cause symptoms such as fatigue, lethargy, muscle weakness, slow heart rate, and weight gain.

Frequency not known (cannot be estimated from available data):

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

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 the outer carton following EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not use Pomalidomide Teva if you notice any visible signs of deterioration or evidence of improper handling of the medicine.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pomalidomide Teva

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

Pomalidomide Teva 1 mg hard capsules

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

Pomalidomide Teva 2 mg hard capsules

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

Pomalidomide Teva 3 mg hard capsules

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

Pomalidomide Teva 4 mg hard capsules

• Each capsule contains 4 mg of pomalidomide.
• The capsule shell contains: Brilliant Blue FCF (E133), titanium dioxide (E171), and gelatin.
• The printing ink contains: shellac (E904), propylene glycol (E1520), concentrated ammonia solution (E527), black iron oxide (E172), and potassium hydroxide (E525).

Appearance of the product 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, printed 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, printed 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, printed 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, printed with “T” on the cap and “4” on the body.

Each pack contains 14, 14 x 1, 21, 21 x 1, 63 or 63 x 1 capsules. Only certain 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 more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgium Teva Pharma Belgium N.V./S.A. /AG Tel/Tel: +32 3 820 73 73	Lithuania UAB Teva Baltics Tel: +370 5 266 02 03
	Luxembourg/Luxembourg ratiopharm GmbH Tél: +49 731 402 02
Czech Republic Teva Pharmaceuticals CR, s.r.o. Tel: +420 251 007 111	Hungary Teva Gyógyszergyár Zrt. Tel: (+36) 1 288 6400
Denmark Teva Denmark A/S Tlf.: +45 44 98 55 11	Malta Teva Pharmaceuticals Ireland Tel: +44 (0) 207 540 7117
Germany ratiopharm GmbH +49 (0) 731 402 02	Netherlands Teva Nederland B.V. Tel: +31 800 0228 400
Estonia UAB Teva Baltics Eesti filiaal Tel.: +372 6610801	Norway Teva Norway AS Tlf: +47 66 77 55 90
	Austria Ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
Spain Teva Pharma, S.L.U. Tel.: +34 91 387 32 80	Poland 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
Croatia Pliva Hrvatska d.o.o Tel: +385 1 37 20 000	Romania Teva Pharmaceuticals S.R.L Tel: +40 21 230 65 24
Ireland Teva Pharmaceuticals Ireland Tel: +44 (0) 207 540 7117	Slovenia Pliva Ljubljana d.o.o. Tel: +386 1 58 90 390
Iceland Teva Pharma Iceland ehf. Sími: +354 550 3300	Slovakia TEVA Pharmaceuticals Slovakia s.r.o Telephone: +421257267911
Italy Teva Italia S.r.l Tel.: +39 028917981	Finland Teva Finland Oy Puh/Tel: +358 20 180 5900
	Sweden Teva Sweden AB Tel: +46 (0)42 12 11 00
Latvia UAB Teva Baltics filiale Latvija 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

Date of last review of this leaflet: