Dabigatran etexilate Teva 110 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Dabigatran etexilate Teva 110 mg hard capsules EFG

dabigatran etexilate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you

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

Leaflet contents

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

1. What Dabigatran Etexilate Teva is and what it is used for

Dabigatran Etexilate Teva contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body that is involved in blood clotting.

Dabigatran Etexilate Teva is used in adults to:

• prevent the formation of blood clots in the veins following knee or hip replacement surgery.

• prevent the formation of blood clots in the brain (stroke) and other blood vessels in the body if you have a type of irregular heartbeat called non-valvular atrial fibrillation and at least one additional risk factor.

• treat blood clots in the veins of the legs and lungs, and to prevent such blood clots from recurring.

Dabigatran Etexilate Teva is used in children to:

• treat blood clots and prevent their recurrence.

2. What you need to know before taking Dabigatran etexilate Teva

Do not take Dabigatran etexilate Teva

• if you are allergic to dabigatran etexilate or to any of the other ingredients of this medicine (listed in section 6).
• if you have severely reduced kidney function.
• if you are bleeding.
• if you have a disease in an organ that increases the risk of serious bleeding (for example, stomach ulcer, brain injury or bleeding, recent brain or eye surgery).
• if you have an increased tendency to bleed. This may be inherited, of unknown cause, or due to other medicines.
• if you are taking medicines to prevent blood clotting (for example, warfarin, rivaroxaban, apixaban, or heparin), except when switching between anticoagulant treatments, while you have an intravenous or arterial line and are receiving heparin through this line to keep it open, or while your normal heart rhythm is being restored by a procedure called catheter ablation for atrial fibrillation.
• if you have severely reduced liver function or a liver disease that could lead to death.
• if you are taking oral ketoconazole or itraconazole, medicines used to treat fungal infections.
• if you are taking oral cyclosporine, a medicine used to prevent organ rejection after transplantation.
• if you are taking dronedarone, a medicine used to treat abnormal heartbeats.
• if you are taking a combination product of glecaprevir and pibrentasvir, an antiviral medicine used to treat hepatitis C.
• if you have had an artificial heart valve implanted that requires lifelong anticoagulation.

Warnings and precautions

Talk to your doctor before taking Dabigatran etexilate Teva. You may also need to speak with your doctor during treatment with this medicine if you experience symptoms or if you need to undergo a surgical procedure.

Tell your doctor if you have or have had any condition or illness, particularly any of the following:

• if you have a higher risk of bleeding, for example:

• if you have recently bled.

• if you have undergone surgical removal of tissue (biopsy) within the last month.

• if you have suffered a serious injury (e.g., bone fracture, head trauma, or any injury requiring surgical treatment).

• if you have inflammation of the oesophagus or stomach.

• if you have problems with gastric juice refluxing into the oesophagus.

• if you are receiving medicines that may increase the risk of bleeding. See 'Other medicines and Dabigatran etexilate Teva' below.

• if you are taking non-steroidal anti-inflammatory drugs such as diclofenac, ibuprofen, piroxicam.

• if you have an infection of the heart (bacterial endocarditis).

• if you know you have reduced kidney function or are dehydrated (symptoms include feeling thirsty and passing reduced amounts of dark (concentrated)/foamy urine).

• if you are over 75 years old.

• if you are an adult weighing 50 kg or less.

• only if used in children: if the child has an infection around or inside the brain.

• if you have had a heart attack or have been diagnosed with conditions that increase the risk of having a heart attack.

• if you have a liver disease associated with changes in blood tests. In this case, use of this medicine is not recommended.

Take special care with Dabigatran etexilate Teva

• if you need surgery:

In this case, Dabigatran etexilate Teva should be temporarily stopped due to an increased risk of bleeding during and shortly after surgery. It is very important that you take Dabigatran etexilate Teva before and after surgery exactly at the times instructed by your doctor.

• if a procedure involves a catheter or injection into the spine (e.g., for epidural or spinal anaesthesia or for pain relief):

• it is very important that you take Dabigatran etexilate Teva before and after the procedure exactly at the times instructed by your doctor.

• inform your doctor immediately if you experience numbness or weakness in the legs or problems with the bowel or bladder after the anaesthesia wears off, as urgent medical attention is required.

• if you fall or are injured during treatment, especially if you hit your head. Seek urgent medical attention. You may need to be examined by a doctor, as the risk of bleeding may be increased.

• if you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor, who will decide whether treatment adjustment is necessary.

Other medicines and Dabigatran etexilate Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular, you must inform your doctor before taking Dabigatran etexilate Teva if you are taking any of the following medicines:

• Medicines to reduce blood clotting (e.g., warfarin, phenprocoumon, acenocoumarol, heparin, clopidogrel, prasugrel, ticagrelor, rivaroxaban, acetylsalicylic acid).
• Medicines to treat fungal infections (e.g., ketoconazole, itraconazole), unless applied only to the skin.
• Medicines to treat abnormal heart rhythms (e.g., amiodarone, dronedarone, quinidine, verapamil). If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to use a reduced dose of Dabigatran etexilate Teva depending on the condition for which it has been prescribed. See section 3.
• Medicines to prevent organ rejection after transplantation (e.g., tacrolimus, cyclosporine).
• A combination product of glecaprevir and pibrentasvir (an antiviral medicine used to treat hepatitis C).
• Non-steroidal anti-inflammatory drugs and painkillers (e.g., acetylsalicylic acid, ibuprofen, diclofenac).
• St. John’s wort, a herbal medicine for depression.
• Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors.
• Rifampicin or clarithromycin (two antibiotics).
• Antiviral medicines for HIV/AIDS (e.g., ritonavir).
• Certain medicines used to treat epilepsy (e.g., carbamazepine, phenytoin).

Pregnancy and breastfeeding

The effects of Dabigatran etexilate Teva on pregnancy and the unborn child are unknown. You must not take this medicine during pregnancy unless your doctor tells you it is safe to do so. If you are a woman of childbearing age, you should avoid becoming pregnant while taking Dabigatran etexilate Teva.

You must not breastfeed while taking Dabigatran etexilate Teva.

Driving and using machines

Dabigatran etexilate Teva has no known effects on the ability to drive or use machines.

3. How to take Dabigatran etexilate Teva

Dabigatran etexilate Teva capsules may be used in adults and children over 8 years of age who are able to swallow the capsules whole:

• Other pharmaceutical forms may be more appropriate for administration in this population, such as coated granules, which can be used in children under 12 years of age as soon as the child is able to swallow soft foods.

Always take this medicine exactly as your doctor has told you. Consult your doctor if you are unsure.

Take Dabigatran etexilate Teva as recommended for the following conditions:

Prevention of blood clots after knee or hip replacement surgery

The recommended dose is 220 mg once daily (in two 110 mg capsules).

If your renal function is reduced by more than half or if you are 75 years of age or older, the recommended dose is 150 mg once daily (taken as two 75 mg capsules).

If you are taking medications containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily (two 75 mg capsules).

If you are taking medications containing verapamil and your renal function is reduced by more than half, you should be treated with a reduced dose of Dabigatran etexilate Teva of 75 mg because your risk of bleeding may increase.

For both types of surgery, treatment should not be initiated if there is bleeding at the surgical site. If treatment cannot be started until the day after surgery, dosing should begin with two capsules once daily.

After knee replacement surgery

You should start treatment with Dabigatran etexilate Teva within 1–4 hours after completion of surgery, taking one single capsule. Afterwards, you should take two capsules once daily for a total of 10 days.

After hip replacement surgery

You should start treatment with Dabigatran etexilate Teva within 1–4 hours after completion of surgery, taking one single capsule. Afterwards, you should take two capsules once daily for a total of 28–35 days.

Prevention of blockage of brain or body blood vessels due to blood clot formation in patients with abnormal heart rhythm, and treatment of blood clots in the leg veins and lungs, including prevention of recurrence of such clots.

The recommended dose is 300 mg as one 150 mg capsule twice daily.

If you are 80 years of age or older, the recommended dose is 220 mg as one 110 mg capsule twice daily.

If you are taking medications containing verapamil, you should be treated with a reduced dose of Dabigatran etexilate Teva of 220 mg taken as one 110 mg capsule twice daily, because your risk of bleeding may increase.

If you have a potentially higher risk of bleeding, your doctor may decide to prescribe you a dose of 220 mg taken as one 110 mg capsule twice daily.

You may continue taking this medicine if a procedure called cardioversion is needed to restore normal heart rhythm. Take Dabigatran etexilate Teva as directed by your doctor.

If a medical device (stent) has been placed in a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stent placement, you may be treated with Dabigatran etexilate Teva after your doctor has determined that normal blood coagulation control has been achieved. Take Dabigatran etexilate Teva as directed by your doctor.

Treatment of blood clots and prevention of their recurrence in children

Dabigatran etexilate Teva should be taken twice daily, one dose in the morning and one in the evening, approximately at the same time each day. The dosing interval should be as close as possible to 12 hours.

The recommended dose depends on weight and age. Your doctor will determine the correct dose. Your doctor may adjust the dose as treatment progresses. Continue taking all other medications unless your doctor tells you to stop any of them.

Table 1 shows the single and total daily doses of Dabigatran etexilate Teva in milligrams (mg). The doses depend on the patient's weight in kilograms (kg) and age in years.

Table 1: Dosing table for Dabigatran etexilate Teva capsules.

Weight/age combinations	Single dose in mg	Total daily dose in mg
Weight in kg	Age in years
from 11 to less than 13 kg	From 8 to less than 9 years	75	150
from 13 to less than 16 kg	From 8 to less than 11 years	110	220
from 16 to less than 21 kg	From 8 to less than 14 years	110	220
From 21 to less than 26 kg	From 8 to less than 16 years	150	300
26 to less than 31 kg	From 8 to less than 18 years	150	300
31 to less than 41 kg	From 8 to less than 18 years	185	370
From 41 to less than 51 kg	From 8 to less than 18 years	220	440
From 51 to less than 61 kg	From 8 to less than 18 years	260	520
61 to less than 71 kg	From 8 to less than 18 years	300	600
71 to less than 81 kg	From 8 to less than 18 years	300	600
81 kg or more	From 10 to less than 18 years	300	600

Single doses requiring combinations of more than one capsule:

300 mg: two 150 mg capsules or four 75 mg capsules

260 mg: one 110 mg capsule plus one 150 mg capsule, or
one 110 mg capsule plus two 75 mg capsules

220 mg: two 110 mg capsules

185 mg: one 75 mg capsule plus one 110 mg capsule

150 mg: one 150 mg capsule or two 75 mg capsules

How to take Dabigatran etexilate Teva

Dabigatran etexilate Teva can be taken with or without food. The capsule should be swallowed whole with a glass of water to ensure delivery to the stomach. Do not break, chew, or empty the granules from the capsule, as this may increase the risk of bleeding.

Switching anticoagulant therapy

Do not change your anticoagulant treatment without specific guidance from your doctor.

If you take more Dabigatran etexilate Teva than you should

Taking too much of this medicine increases the risk of bleeding. Contact your doctor immediately if you have taken too many capsules. Specific treatment options are available.

If you forget to take Dabigatran etexilate Teva

Prevention of blood clots after knee or hip replacement surgery

Continue with your remaining daily doses of Dabigatran etexilate Teva at the usual time the next day. Do not take a double dose to make up for the missed dose.

Use in adults: Prevention of blockage of blood vessels in the brain or body due to blood clots developing from abnormal heartbeats, and treatment of blood clots in the veins of your legs and lungs, including prevention of recurrence of blood clots in the veins of your legs and lungs.

Use in children: Treatment of blood clots and prevention of their recurrence.

A missed dose may be taken up to 6 hours before the next scheduled dose.

A missed dose should be omitted if less than 6 hours remain before the next scheduled dose. Do not take a double dose to make up for a missed dose.

If you stop taking Dabigatran etexilate Teva

Take Dabigatran etexilate Teva exactly as prescribed. Do not stop taking this medicine without first consulting your doctor, as the risk of developing a blood clot may be higher if treatment is interrupted too early. Contact your doctor if you experience indigestion after taking Dabigatran etexilate Teva.

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

4. Possible adverse effects

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

Dabigatran etexilate Teva affects blood coagulation, so most side effects are related to signs such as bruising or bleeding. Serious or major bleeding may occur, which represent the most severe side effects and, regardless of their location, may become disabling, life-threatening, or even lead to death. In some cases, these bleedings may not be obvious.

If you experience any bleeding that does not stop on its own, or if you experience signs of excessive bleeding (unusual weakness, fatigue, paleness, dizziness, headache, or unexplained swelling), consult your doctor immediately. Your doctor may decide to keep you under observation or change your medication.

Inform your doctor immediately if you experience a severe allergic reaction causing difficulty breathing or dizziness.

The following is a list of possible side effects, grouped according to their likelihood.

Prevention of blood clots after knee or hip replacement surgery

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

• Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells).
• Unusual results in liver function laboratory tests

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

• Bleeding from the nose, stomach or intestines, penis, vagina, or urinary tract (including blood in urine turning urine pink or red), hemorrhoids, rectum, under the skin, in a joint, or after an injury or procedure.
• Formation of bruises or hematomas after a procedure
• Blood detected in stool by laboratory test
• Decrease in the number of red blood cells in the blood
• Decrease in the proportion of blood cells
• Allergic reaction
• Vomiting
• Frequent loose or soft stools
• Feeling unwell
• Wound discharge (fluid leaking from the surgical wound)
• Increased liver enzymes
• Yellowish discoloration of the skin or whites of the eyes, caused by liver or blood disorders.

Uncommon (may affect up to 1 in 1,000 people):

• Bleeding
• Bleeding may occur in the brain, at a surgical incision site, at the site of an injection, or at the site of a venous catheter insertion.
• Blood-tinged discharge from the site of a venous catheter insertion.
• Coughing up blood or blood-tinged sputum
• Decrease in the number of platelets in the blood
• Decrease in the number of red blood cells in the blood after a procedure.
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash characterized by raised, itchy, dark red bumps due to an allergic reaction
• Sudden change in the skin affecting its color and appearance
• Itching
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Abdominal or stomach pain
• Indigestion
• Difficulty swallowing
• Fluid leaking from a wound
• Fluid leaking from a wound after a procedure

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

• Difficulty breathing or wheezing
• Decrease in the number or even absence of white blood cells (which help fight infections)
• Hair loss

Prevention of blockage of brain or body vessels due to blood clots following abnormal heartbeats

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

• Bleeding from the nose, stomach or intestines, penis, vagina, or urinary tract (including blood in urine turning urine pink or red), or under the skin
• Decrease in the number of red blood cells in the blood
• Abdominal or stomach pain
• Indigestion
• Frequent loose or soft stools
• Feeling unwell

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

• Bleeding
• Bleeding may occur in hemorrhoids, rectum, or brain
• Bruising
• Coughing up blood or blood-tinged sputum
• Decrease in the number of platelets in the blood
• Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Allergic reaction
• Sudden change in the skin affecting its color and appearance
• Itching
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Vomiting
• Difficulty swallowing
• Unusual results in liver function laboratory tests

Uncommon (may affect up to 1 in 1,000 people):

• Bleeding may occur in a joint, at a surgical incision site, after an injury, at the site of an injection, or at the site of a venous catheter insertion
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash characterized by raised, itchy, dark red bumps due to an allergic reaction
• Decrease in the proportion of blood cells
• Increased liver enzymes
• Yellowish discoloration of the skin or whites of the eyes, caused by liver or blood disorders

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

• Difficulty breathing or wheezing
• Decrease in the number or even absence of white blood cells (which help fight infections)
• Hair loss

In a clinical study, the rate of myocardial infarction with Dabigatran etexilate Teva was numerically higher than with warfarin. The overall incidence was low.

Treatment of blood clots in the veins of the legs and lungs, including prevention of recurrence of blood clots in the veins of the legs and/or lungs

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

• Bleeding from the nose, stomach or intestines, rectum, penis, vagina, or urinary tract (including blood in urine turning urine pink or red), or under the skin
• Indigestion

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

• Bleeding
• Bleeding may occur in a joint or after an injury
• Hemorrhoids may bleed
• Decrease in the number of red blood cells in the blood
• Bruising
• Coughing up blood or blood-tinged sputum
• Allergic reaction
• Sudden change in the skin affecting its color and appearance
• Itching
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Feeling unwell
• Vomiting
• Abdominal or stomach pain
• Frequent loose or soft stools
• Unusual results in liver function laboratory tests
• Increased liver enzymes

Uncommon (may affect up to 1 in 1,000 people):

• Bleeding may occur from a surgical incision, from the site of an injection, from the site of a venous catheter insertion, or from the brain
• Decrease in the number of platelets in the blood
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash characterized by raised, itchy, dark red bumps due to an allergic reaction
• Difficulty swallowing

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

• Difficulty breathing or wheezing
• Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Decrease in the proportion of blood cells
• Decrease in the number or even absence of white blood cells (which help fight infections)
• Yellowish discoloration of the skin or whites of the eyes, caused by liver or blood disorders
• Hair loss

In the study program, the rate of myocardial infarction with Dabigatran etexilate Teva was higher than with warfarin. The overall incidence was low. No imbalance in the rate of myocardial infarction was observed in patients treated with dabigatran compared to those treated with placebo.

Treatment of blood clots and prevention of their recurrence in children

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

• Decrease in the number of red blood cells in the blood
• Decrease in the number of platelets in the blood
• Skin rash characterized by raised, itchy, dark red bumps due to an allergic reaction
• Sudden skin change affecting its color and appearance
• Bruising
• Nosebleeds
• Reflux of gastric juice into the esophagus
• Vomiting
• Feeling unwell
• Frequent loose or soft stools
• Indigestion
• Hair loss
• Increased liver enzymes

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

• Decrease in the number of white blood cells (which help fight infections)
• Bleeding may occur in the stomach or intestines, brain, rectum, penis/vagina or urinary tract (including blood in urine turning urine pink or red), or under the skin
• Decrease in the amount of hemoglobin in the blood (the substance contained in red blood cells)
• Decrease in the proportion of blood cells
• Itching
• Coughing up blood or blood-tinged sputum
• Abdominal or stomach pain
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes, caused by liver or blood disorders

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

• Absence of white blood cells (which help fight infections)
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Difficulty breathing or wheezing
• Bleeding
• Bleeding may occur in a joint or after an injury, at a surgical incision site, at the site of an injection, or at the site of a venous catheter insertion
• Bleeding from hemorrhoids may occur
• Ulcer in the stomach or intestines (including esophageal ulcer)
• Unusual results in liver function laboratory tests

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 Dabigatran etexilate Teva

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

Do not use this medicine after the expiry date stated on the carton or blister after "EXP". The expiry date refers to the last day of the month indicated.

In blister packs: Do not store above 30°C.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dabigatran etexilate Teva

• The active substance is dabigatran etexilate. Each hard capsule contains 110 mg of dabigatran etexilate (as mesilate).
• The other components are tartaric acid, hydroxypropylcellulose, talc and hypromellose.
• The capsule shell contains indigo carmine (E132), potassium chloride, carrageenan, titanium dioxide (E171) and hypromellose.

Nature of the product and contents of the pack

Dabigatran etexilate Teva 110 mg are hard capsules (approximately 19 mm) with an opaque light blue cap and an opaque light blue body, filled with whitish to yellowish granules.

Dabigatran etexilate Teva is available in packs of 10, 30, 60 or 180 hard capsules in aluminum-aluminum blisters.

Dabigatran etexilate Teva is also available in packs containing 10 x 1, 30 x 1, 60 x 1, 100 x 1 or 180 x 1 hard capsules in single-dose perforated aluminum blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder

TEVA GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Manufacturer

LABORATORIOS LICONSA S.A.

Avda. Miralcampo, Nº 7

Pol. Ind. Miralcampo

19200 Azuqueca de Henares, Guadalajara

SPAIN

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Belgium/Belgium/Belgium Teva Pharma Belgium N.V./S.A. /AG Tel/Tél: +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	Slovak Republic 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) Teva Pharmaceuticals Ireland Ireland Tel: +44 (0) 207 540 7117

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu , and on the website of the {Spanish Agency of Medicines and Medical Devices (AEMPS)} (http://www.aemps.gob.es/)}.

This leaflet can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.