Pradaxa 110 mg hard capsules

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the Patient

Pradaxa 110 mg hard capsules

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; do not pass it on to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Pradaxa is and what it is used for

Pradaxa contains the active substance dabigatran etexilate and belongs to a group of medicines called anticoagulants. It works by blocking a substance in the body involved in blood clot formation.

Pradaxa is used in adults for:

• preventing the formation of blood clots in the veins after knee or hip replacement surgery.

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

• treating blood clots in the veins of your legs and lungs and to prevent recurrence of blood clots in the veins of your legs and lungs.

Pradaxa is used in children for:

• treating blood clots and preventing the formation of new blood clots.

2. What you need to know before taking Pradaxa

Do not take Pradaxa

• 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 currently have bleeding.
• if you have a disease in an organ of your body that increases the risk of serious bleeding (e.g., stomach ulcer, brain injury or bleeding, recent brain or eye surgery).
• if you are prone to bleeding. This tendency may be congenital, of unknown cause, or caused by other medicines.
• if you are taking medicines to prevent blood clots (e.g., warfarin, rivaroxaban, apixaban, or heparin), except when switching anticoagulant therapy, while you have a venous or arterial catheter and heparin is administered through this catheter 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 suffer from a liver disease that could be life-threatening.
• 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 heart rhythm.
• 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 anticoagulant treatment.

Warnings and precautions

Talk to your doctor before starting Pradaxa. During treatment with this medicine, you may also need to consult your doctor if you experience any symptoms or if you need to undergo surgery.

Tell your doctor if you have or have had any disorder or illness, especially any of the following:

• If you have an increased risk of bleeding, for example:

• if you have recently had bleeding.

• 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 injury, or any injury requiring surgical treatment).

• if you have inflammation of the oesophagus or stomach.

• if you have gastro-oesophageal reflux (backflow of stomach juice into the oesophagus).

• if you are taking medicines that may increase the risk of bleeding. See “Other medicines and Pradaxa” below.

• if you are using anti-inflammatory medicines such as diclofenac, ibuprofen, or piroxicam.

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

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

• if you are over 75 years old.

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

• only when used in children: if the child has an infection in or around 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. Use of this medicine is not recommended in this case.

Take special care with Pradaxa

• If you need to undergo surgery:

In this case, Pradaxa should be temporarily discontinued due to an increased risk of bleeding during and shortly after surgery. It is very important that you take Pradaxa exactly as directed by your doctor before and after surgery.

• If a surgical procedure requires placement of a catheter or injection into the spinal column (e.g., for epidural or spinal anaesthesia or for pain relief):

• It is very important that you take Pradaxa exactly as directed by your doctor before and after the procedure.

• Inform your doctor immediately if you experience numbness or weakness in your legs or intestinal or bladder problems after the anaesthesia wears off, as this situation requires urgent medical attention.

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

• If you know you have a condition called antiphospholipid syndrome (an immune system disorder that increases the risk of blood clots), inform your doctor so they can decide whether your treatment needs to be adjusted.

Other medicines and Pradaxa

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. In particular, you must inform your doctor before taking Pradaxa 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 used to treat fungal infections (e.g., ketoconazole, itraconazole), except when applied only to the skin
• Medicines used to treat abnormal heart rhythm (e.g., amiodarone, dronedarone, quinidine, verapamil)

If you are taking medicines containing amiodarone, quinidine, or verapamil, your doctor may advise you to take a reduced dose of Pradaxa depending on the condition for which it has been prescribed. See section 3.

• Medicines used 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)

• Anti-inflammatory and pain-relieving medicines (e.g., acetylsalicylic acid, ibuprofen, diclofenac)

• St. John’s wort, a herbal remedy for depression

• Antidepressant medicines called selective serotonin reuptake inhibitors or serotonin and 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 Pradaxa on pregnancy and the unborn child are unknown. You should not use this medicine during pregnancy unless your doctor specifically advises that it is safe. If you are of childbearing age, you should avoid becoming pregnant while being treated with Pradaxa.

Breastfeeding is not recommended during treatment with Pradaxa.

Driving and using machines

Pradaxa has no known effects on the ability to drive or operate machinery.

3. How to take Pradaxa

Pradaxa capsules can be used in adults and children aged 8 years or older who are able to swallow the capsules whole. Pradaxa granules are available for treatment in children under 12 years of age as soon as they are able to swallow soft foods.

Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor again.

Take Pradaxa as recommended for the following situations:

Prevention of blood clots after knee or hip replacement surgery

The recommended dose is 220 mg once daily (administered as 2 capsules of 110 mg).

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 (administered as 2 capsules of 75 mg).

If you are taking medications containing amiodarone, quinidine, or verapamil, the recommended dose is 150 mg once daily (administered as 2 capsules of 75 mg).

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

In both types of surgery, treatment must not be started if there is bleeding at the surgical site. If treatment cannot be initiated until the day after surgery, dosing should begin with 2 capsules once daily.

After knee replacement surgery

Begin treatment with Pradaxa 1–4 hours after surgery, taking one single capsule. Then take 2 capsules once daily for a total of 10 days.

After hip replacement surgery

Begin treatment with Pradaxa 1–4 hours after surgery, taking one single capsule. Then take 2 capsules once daily for a total of 28–35 days.

Prevention of stroke or systemic embolism due to blood clots caused by abnormal heart rhythm, and treatment of blood clots in the veins of your legs and lungs, including prevention of recurrence of such clots

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

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

If you are taking medications containing verapamil, you should be prescribed a reduced dose of Pradaxa 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 administered as one 110 mg capsule twice daily.

You may continue taking this medicine if it becomes necessary to restore your normal heart rhythm through a procedure called cardioversion. Take Pradaxa exactly as directed by your doctor.

If you have had a medical device (vascular stent) implanted in a blood vessel to keep it open during a procedure called percutaneous coronary intervention with stent placement, you may receive treatment with Pradaxa once your doctor has determined that normal blood clotting control has been achieved. Take Pradaxa exactly as directed by your doctor.

Treatment of blood clots and prevention of recurrence of blood clots in children

Pradaxa should be taken twice daily, one dose in the morning and one dose 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 your dose during treatment. Continue taking all other medications unless your doctor tells you to stop any of them.

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

Table 1: Dosing table for Pradaxa capsules

Weight/Age Combinations	Single Dose in mg	Total Daily Dose in mg
Weight in kg	Age in years
11 to less than 13 kg	8 to less than 9 years	75	150
13 to less than 16 kg	8 to less than 11 years	110	220
16 to less than 21 kg	8 to less than 14 years	110	220
21 to less than 26 kg	8 to less than 16 years	150	300
26 to less than 31 kg	8 to less than 18 years	150	300
31 to less than 41 kg	8 to less than 18 years	185	370
41 to less than 51 kg	8 to less than 18 years	220	440
51 to less than 61 kg	8 to less than 18 years	260	520
61 to less than 71 kg	8 to less than 18 years	300	600
71 to less than 81 kg	8 to less than 18 years	300	600
81 kg or more	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 Pradaxa

Pradaxa can be taken with or without food. The capsule should be swallowed whole with a glass of water to ensure release in the stomach. Do not break, chew, or open the capsule and take only its contents, as this may increase the risk of bleeding.

Instructions for opening blister packs

The following images illustrate how to remove Pradaxa capsules from the blister:

Separate an individual blister from the strip along the perforated line.

Peel back the backing foil and remove the capsule.

• Do not push the capsules through the blister foil.
• Do not peel back the foil from the blister until the capsule is needed.

Instructions for the bottle

• Press down and twist to open.
• After removing the capsule, replace the cap on the bottle and close the bottle tightly immediately after taking your dose.

Switching anticoagulant treatment

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

If you take more Pradaxa 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 Pradaxa

Prevention of blood clots after knee or hip replacement surgery

Take the remaining daily doses of Pradaxa at the usual time on the following day.

Do not take a double dose to make up for a missed dose.

Use in adults: Prevention of stroke or systemic embolism caused by blood clots due to irregular heartbeat, 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 recurrence of blood clots

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 dose.

Do not take a double dose to make up for a missed dose.

If you stop taking Pradaxa

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

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

4. Possible adverse effects

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

Pradaxa acts on blood clotting; therefore, most adverse effects are related to signs such as bruising or bleeding. Major or severe bleeding episodes may occur, which represent the most serious adverse effects and, regardless of their location, may lead to disability, may be potentially fatal, or even result in death. In some cases, these bleedings may not be obvious.

If you experience any bleeding episode 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 close observation or switch your medication.

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

The possible adverse effects are listed below, grouped according to their frequency of occurrence.

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 present in red blood cells)
• Abnormalities in liver function tests

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

• Bleeding may occur from the nose, stomach or intestine, penis/vagina, or urinary tract (including blood in urine turning urine pink or red), from hemorrhoids, rectum, under the skin, from a joint, or at the site of an injury or after surgery
• Formation of bruises or bruising after surgery
• Detection of blood in stool in a 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 watery stools
• Feeling nauseous
• Wound discharge (leakage of fluid from a surgical wound)
• Increased liver enzymes
• Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

• Bleeding
• Bleeding may occur in the brain, at the site of a surgical incision, 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 sputum with blood streaks
• Decrease in the number of platelets in the blood
• Decrease in the number of red blood cells in the blood after surgery
• Severe allergic reaction causing difficulty breathing or dizziness
• Severe allergic reaction causing swelling of the face or throat
• Skin rash with dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in the skin affecting color and physical appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Abdominal pain or stomach ache
• Indigestion
• Difficulty swallowing
• Fluid leaking from a wound
• Fluid leaking from a wound after surgery

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

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

Prevention of stroke or systemic embolism due to blood clots caused by abnormal heart rhythm

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

• Bleeding may occur from the nose, stomach or intestine, penis/vagina, 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 pain or stomach ache
• Indigestion
• Frequent loose or watery stools
• Feeling nauseous

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

• Bleeding
• Bleeding may occur from hemorrhoids, rectum, or brain
• Bruising
• Coughing up blood or sputum with blood streaks
• Decrease in the number of platelets in the blood
• Decrease in the amount of hemoglobin in the blood (the substance present in red blood cells)
• Allergic reaction
• Sudden change in the skin affecting color and physical appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Vomiting
• Difficulty swallowing
• Abnormalities in liver function tests

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

• Bleeding may occur in a joint, at the site of a surgical incision, at a wound, 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 with dark red, raised, itchy bumps due to an allergic reaction
• Decrease in the proportion of blood cells
• Increased liver enzymes
• Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

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

In a clinical trial, the rate of heart attacks with Pradaxa was numerically higher than with warfarin. The overall incidence was low.

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

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

• Bleeding may occur from the nose, stomach or intestine, rectum, penis/vagina, 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 wound
• Bleeding may occur from hemorrhoids
• Decrease in the number of red blood cells in the blood
• Bruising
• Coughing up blood or sputum with blood streaks
• Allergic reaction
• Sudden change in the skin affecting color and physical appearance
• Itching
• Stomach or intestinal ulcer (including esophageal ulcer)
• Inflammation of the esophagus and stomach
• Reflux of gastric juice into the esophagus
• Feeling nauseous
• Vomiting
• Abdominal pain or stomach ache
• Frequent loose or watery stools
• Abnormalities in liver function tests
• Increased liver enzymes

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

• Bleeding may occur at a surgical incision site, at the site of an injection, at 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 with dark red, raised, itchy 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 present in red blood cells)
• Decrease in the proportion of blood cells
• Decrease in the number or even absence of leukocytes (which help fight infections)
• Yellowing of the skin or whites of the eyes, caused by liver or blood problems
• Hair loss

In the clinical trial program, the rate of heart attacks with Pradaxa was higher than with warfarina. The overall incidence was low. No imbalance in the rate of heart attacks was observed in patients treated with dabigatran compared to patients treated with placebo.

Treatment of blood clots and prevention of recurrence of blood clots 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 with dark red, raised, itchy bumps due to an allergic reaction
• Sudden change in the skin affecting color and physical appearance
• Bruising
• Nasal bleeding
• Reflux of gastric juice into the esophagus
• Vomiting
• Feeling nauseous
• Frequent loose or watery stools
• Indigestion
• Hair loss
• Increased liver enzymes

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

• Decrease in the number of leukocytes (which help fight infections)
• Bleeding may occur in the stomach or intestine, brain, rectum, penis/vagina, 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 present in red blood cells)
• Decrease in the proportion of blood cells
• Itching
• Coughing up blood or sputum with blood streaks
• Abdominal pain or stomach ache
• Inflammation of the esophagus and stomach
• Allergic reaction
• Difficulty swallowing
• Yellowing of the skin or whites of the eyes, caused by liver or blood problems

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

• Absence of leukocytes (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 wound, at a surgical incision, at the site of an injection, or at the site of a venous catheter insertion
• Bleeding may occur from hemorrhoids
• Stomach or intestinal ulcer (including esophageal ulcer)
• Abnormalities in liver function tests

Reporting of adverse effects

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

5. Storage of Pradaxa

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

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

Blister: Store in the original packaging to protect from moisture.

Bottle: After opening, the medicine should be used within 4 months. Keep the bottle tightly closed. Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to properly dispose of any unused medicine and its packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pradaxa

• The active substance is dabigatran. Each hard capsule contains 110 mg of dabigatran etexilate (as mesilate).

• The other components are tartaric acid, arabic gum, hypromellose, dimethicone 350, talc, and hydroxypropylcellulose.

• The capsule shell contains carrageenan, potassium chloride, titanium dioxide, indigo carmine, and hypromellose.

• The black printing ink contains shellac, black iron oxide, and potassium hydroxide.

Appearance of the product and contents of the pack

Pradaxa 110 mg are hard capsules (approx. 19 × 7 mm) with an opaque light blue cap and an opaque light blue body. The Boehringer Ingelheim logo is printed on the cap and the code “R110” on the body of the hard capsule.

This medicine is available in packs containing 10 × 1, 30 × 1 or 60 × 1 hard capsules, a multipack containing 3 packs of 60 × 1 hard capsules (180 hard capsules), or a multipack containing 2 packs of 50 × 1 hard capsules (100 hard capsules) in perforated aluminum unit-dose blisters. Additionally, Pradaxa is available in packs containing 60 × 1 hard capsules in white perforated aluminum unit-dose blisters.

This medicine is also available in polypropylene (plastic) bottles containing 60 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Boehringer Ingelheim International GmbH
Binger Strasse 173
55216 Ingelheim am Rhein
Germany

Manufacturer

Boehringer Ingelheim Pharma GmbH & Co. KG
Binger Strasse 173
55216 Ingelheim am Rhein
Germany

and

Boehringer Ingelheim France
100-104 avenue de France
75013 Paris
France

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Belgium/Belgique/Belgien Boehringer Ingelheim SComm Tél/Tel: +32 2 773 33 11	Lithuania Boehringer Ingelheim RCV GmbH & Co KG Lithuanian Branch Tel: +370 5 2595942
Bulgaria Boehringer Ingelheim EOOD – Branch Bulgaria Tel: +359 2 958 79 98	Luxembourg/Luxemburg Boehringer Ingelheim SComm Tél/Tel: +32 2 773 33 11
Czech Republic Boehringer Ingelheim spol. s r.o. Tel: +420 234 655 111	Hungary Boehringer Ingelheim RCV GmbH & Co KG Hungarian Branch Tel.: +36 1 299 8900
Denmark Boehringer Ingelheim Danmark A/S Tlf: +45 39 15 88 88	Malta Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9620
Germany Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 800 77 90 900	Netherlands Boehringer Ingelheim B.V. Tel: +31 (0) 800 22 55 889
Estonia Boehringer Ingelheim RCV GmbH & Co KG Estonian Branch Tel: +372 612 8000	Norway Boehringer Ingelheim Norway KS Tlf: +47 66 76 13 00
Greece Boehringer Ingelheim Hellas Monoprosopi E.P.E. Tel: +30 2 10 89 06 300	Austria Boehringer Ingelheim RCV GmbH & Co KG Tel: +43 1 80 105‑7870
Spain Boehringer Ingelheim España S.A. Tel: +34 93 404 51 00	Poland Boehringer Ingelheim Sp. z o.o. Tel: +48 22 699 0 699
France Boehringer Ingelheim France S.A.S. Tél: +33 3 26 50 45 33	Portugal Boehringer Ingelheim Portugal, Lda. Tel: +351 21 313 53 00
Croatia Boehringer Ingelheim Zagreb d.o.o. Tel: +385 1 2444 600	Romania Boehringer Ingelheim RCV GmbH & Co KG Vienna – Bucharest Branch Tel: +40 21 302 2800
Ireland Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9620	Slovenia Boehringer Ingelheim RCV GmbH & Co KG Ljubljana Branch Tel: +386 1 586 40 00
Iceland Vistor hf. Tel: +354 535 7000	Slovakia Boehringer Ingelheim RCV GmbH & Co KG Slovak Branch Tel: +421 2 5810 1211
Italy Boehringer Ingelheim Italia S.p.A. Tel: +39 02 5355 1	Finland Boehringer Ingelheim Finland Ky Tel: +358 10 3102 800
Cyprus Boehringer Ingelheim Hellas Monoprosopi E.P.E. Tel: +30 2 10 89 06 300	Sweden Boehringer Ingelheim AB Tel: +46 8 721 21 00
Latvia Boehringer Ingelheim RCV GmbH & Co KG Latvian Branch Tel: +371 67 240 011	United Kingdom (Northern Ireland) Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9620

Date of the most recent approval of this leaflet:

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.