Tacforius

Patient Information Leaflet

Tacforius 0.5 mg prolonged-release hard capsules, 1 mg prolonged-release hard capsules, 3 mg prolonged-release hard capsules, 5 mg prolonged-release hard capsules

tacrolimus
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

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

Contents of this leaflet

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

1. What Tacforius is and what it is used for

Tacforius contains the active substance tacrolimus. It is an immunosuppressant. After an organ transplant (liver, kidney), the body's immune system will attempt to reject the transplanted organ. Tacforius is used to control this immune response, enabling the body to accept the transplanted organ.

You may also be given Tacforius to treat ongoing rejection of a transplanted liver, kidney, heart, or other organ when one of the treatments you were receiving has proven unable to control the immune response after transplantation.

Tacforius is used in adult patients.

2. What you should know before taking Tacforius

Do not take Tacforius

• if you are allergic to tacrolimus or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to sirolimus or to any macrolide antibiotic (e.g. erythromycin, clarithromycin, josamycin).

Warnings and precautions
The immediate-release tacrolimus capsules (e.g. Tacni) and Tacforius prolonged-release capsules both
contain the active substance tacrolimus. However, Tacforius prolonged-release capsules should be taken
once daily, whereas immediate-release capsules must be taken twice daily. This is because Tacforius
capsules allow prolonged release (slower release over a longer period of time) of tacrolimus. Tacforius
prolonged-release capsules and immediate-release tacrolimus capsules are not interchangeable.
Talk to your doctor or pharmacist before taking Tacforius:

• if you are taking any of the medicines listed below under section “Other medicines and Tacforius”
• if you have or have had liver problems
• if you have had diarrhoea for more than one day
• if you have severe abdominal pain, with or without other symptoms such as chills, fever, nausea or vomiting
• if you have a disturbance in the electrical activity of the heart known as “QT prolongation”
• if you have or have had damage to the smaller blood vessels, known as thrombotic microangiopathy/thrombotic thrombocytopenic purpura/haemolytic uraemic syndrome. Inform your doctor if you develop fever, bruising under the skin (which may appear as small red spots), unexplained tiredness, confusion, yellowing of the skin or eyes, reduced urine output, loss of vision, or seizures (see section 4). The risk of developing these symptoms may increase when tacrolimus is taken together with sirolimus or everolimus.

Please avoid taking any herbal remedies, such as St John’s wort (Hypericum perforatum) or any other herbal product, as they may alter the effectiveness and required dose of Tacforius. If in doubt, please consult your doctor before taking any herbal product or remedy.
Your doctor may need to adjust your dose of Tacforius.
You should maintain regular contact with your doctor. Periodically, your doctor may consider it necessary for you to have blood and urine tests, or heart and eye examinations to determine the correct dose of Tacforius.
You should limit exposure to sunlight and UV (ultraviolet) rays while taking Tacforius.
This is because immunosuppressive therapies may increase the risk of skin cancer.
Wear protective clothing and use a sunscreen with a high protection factor.
Precautions for handling:
Avoid direct contact with any part of the body such as the skin or eyes, or inhalation of the powder contained in the capsules. In case of contact, wash the skin and eyes thoroughly.

Children and adolescents
The use of Tacforius is not recommended in children and adolescents under 18 years of age.

Other medicines and Tacforius
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The use of Tacforius together with cyclosporine (another medicine used to prevent organ transplant rejection) is not recommended.
If you see a doctor other than your transplant specialist, inform them that you are taking tacrolimus.
Your doctor may need to consult with the transplant specialist if you need to take another medicine that may increase or decrease tacrolimus blood levels.
Tacrolimus blood levels may be affected by other medicines you are taking, and conversely, the blood levels of other medicines you are taking may be altered by taking Tacforius, which may require interruption, increase, or decrease of the Tacforius dose.
Some patients have experienced increased blood levels of tacrolimus while taking other medicines. This may cause serious side effects such as kidney problems, nervous system disorders, and heart rhythm disturbances (see section 4).
An effect on Tacforius blood levels may occur soon after starting another medicine; therefore, frequent and ongoing monitoring of Tacforius blood levels may be necessary in the first days after starting the other medicine and regularly during treatment with it.
Some other medicines may cause a decrease in tacrolimus blood levels, which may increase the risk of organ transplant rejection. In particular, inform your doctor if you are taking or have recently taken medicines such as:

• antifungal and antibiotic medicines, particularly so-called macrolide antibiotics used to treat infections, e.g. ketoconazole, fluconazole, itraconazole, posaconazole, voriconazole, clotrimazole, isavuconazole, miconazole, caspofungin, telithromycin, erythromycin, clarithromycin, josamycin, azithromycin, rifampicin, rifabutin, isoniazid, and flucloxacillin
• letermovir, used to prevent a disease caused by CMV (human cytomegalovirus)
• HIV protease inhibitors (e.g. ritonavir, nelfinavir, saquinavir), the booster medicine cobicistat, and tablet combinations or non-nucleoside reverse transcriptase inhibitors of HIV (efavirenz, etravirine, nevirapine), used to treat HIV infections
• HCV protease inhibitors (e.g. telaprevir, boceprevir, the combination ombitasvir/paritaprevir/ritonavir with or without dasabuvir, elbasvir/grazoprevir, and glecaprevir/pibrentasvir) used to treat hepatitis C
• nilotinib and imatinib, idelalisib, ceritinib, crizotinib, apalutamide, enzalutamide, or mitotane (used to treat certain types of cancer)
• mycophenolic acid, used to suppress the immune system and prevent transplant rejection
• medicines for stomach ulcer or acid reflux (e.g. omeprazole, lansoprazole, or cimetidine)
• antiemetics used to treat nausea and vomiting (e.g. metoclopramide)
• cisapride or the antacid magnesium-aluminium hydroxide, used to treat heartburn
• oral contraceptive pills or other hormonal treatments containing ethinylestradiol, hormonal treatments with danazol
• medicines used to treat high blood pressure or heart problems (e.g. nifedipine, nicardipine, diltiazem, and verapamil)
• antiarrhythmic medicines (amiodarone) used to control arrhythmia (irregular heartbeat)
• medicines known as “statins” used to treat high cholesterol and triglycerides
• carbamazepine, phenytoin, or phenobarbital, used to treat epilepsy
• cannabidiol (uses include, among others, treatment of seizures)
• metamizole, used to treat pain and fever
• corticosteroids prednisolone or methylprednisolone, belonging to the class of corticosteroids used to treat inflammation or to suppress the immune system (e.g. in organ rejection)
• nefazodone, used to treat depression
• herbal preparations containing St John’s wort (Hypericum perforatum) or extracts of Schisandra sphenanthera.

Inform your doctor if you are receiving treatment for hepatitis C. Pharmacological treatment for
hepatitis C may alter liver function and affect tacrolimus blood levels. Tacrolimus blood levels may decrease or increase depending on the medicines prescribed for hepatitis C. Your doctor may need to closely monitor tacrolimus blood levels and make necessary dose adjustments of Tacforius after starting hepatitis C treatment.
Inform your doctor if you are taking or need to take ibuprofen (used to treat fever, inflammation, and pain), antibiotics (cotrimoxazole, vancomycin, or aminoglycoside antibiotics such as gentamicin), amphotericin B (used to treat fungal infections), or antiviral medicines (used to treat viral infections, e.g. aciclovir, ganciclovir, cidofovir, foscarnet).
These may worsen kidney or nervous system problems when taken together with Tacforius.
Inform your doctor if you are taking sirolimus or everolimus. When tacrolimus is taken together with sirolimus or everolimus, the risk of developing thrombotic microangiopathy, thrombotic thrombocytopenic purpura, and haemolytic uraemic syndrome may increase (see section 4).
Your doctor must be informed if, while taking Tacforius, you are taking potassium supplements or those diuretics used for heart failure, hypertension, and kidney disorders (e.g. amiloride, triamterene, or spironolactone), or the antibiotics trimethoprim or cotrimoxazole, which may increase potassium levels in the blood, non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen), used to treat fever, inflammatory conditions and pain, anticoagulants (blood thinners), or oral diabetes medicines.
If you need to be vaccinated, discuss this with your doctor first.

Tacforius with food and drink
Avoid grapefruit (including grapefruit juice) while taking Tacforius, as it may alter its blood concentration.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.
In a study, pregnancy outcomes were evaluated in women treated with tacrolimus and in women treated with other immunosuppressants. Although the evidence from this study is not sufficient to draw firm conclusions, higher rates of spontaneous abortion were reported among liver and kidney transplant recipients treated with tacrolimus, as well as higher rates of persistent hypertension associated with protein loss in the urine, developing during pregnancy or in the postpartum period (a condition called pre-eclampsia), among kidney transplant recipients. No increased risk of major birth defects associated with tacrolimus use was detected.
Tacrolimus passes into breast milk. Breastfeeding is therefore not recommended during treatment with Tacforius.

Driving and using machines
Do not drive or operate tools or machines if you feel unsteady or drowsy, or have problems seeing clearly after taking Tacforius. These effects may be more pronounced if you also consume alcohol.

Tacforius contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

Tacforius 5 mg capsules contain ponceau 4R
It may cause allergic reactions.

3. How to take Tacforius

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
This medicine should only be prescribed by a doctor experienced in treating transplant patients.
Make sure you always receive the same formulation of tacrolimus when collecting your prescription, unless your transplant specialist agrees to a change in the tacrolimus formulation.
This medicine must be taken once daily. If this medicine looks different than usual, or if the dose instructions have changed, contact your doctor or pharmacist as soon as possible to ensure you have received the correct medicine.
The initial dose to prevent rejection of your transplanted organ will be determined by your doctor and calculated based on your body weight. The initial daily dose immediately after transplantation will generally be within the following range:
0.10–0.30 mg per kg of body weight per day
depending on the transplanted organ. The same doses may be used for the treatment of rejection.
Your dose depends on your general condition and on any other immunosuppressive medicines you are taking.
Shortly after starting treatment with Tacforius, your doctor will ask you to have frequent blood tests to determine the correct dose. Later, you will have regular blood tests to monitor and adjust your dose as needed.
Your doctor will generally reduce your Tacforius dose once your condition has stabilized. Your doctor will tell you exactly how many capsules to take.
It is essential that you take Tacforius every day for as long as you need immunosuppression to prevent rejection of your transplanted organ. You must remain in close contact with your doctor.
Tacforius must be taken once daily by mouth in the morning. Take Tacforius on an empty stomach, or 2 or 3 hours after a meal. Wait at least one hour before eating your next meal. Take the capsules immediately after removing them from the blister pack. The capsules must be swallowed whole with a glass of water.
Do not swallow the desiccant contained in the aluminum pouch.

If you take more Tacforius than you should
If you have accidentally taken too many capsules, contact your doctor or the nearest hospital emergency department immediately.

If you forget to take Tacforius
If you forget to take your capsules in the morning, take them as soon as possible on the same day. Do not take a double dose the next morning.

If you stop taking Tacforius
Stopping treatment with Tacforius may increase the risk of rejection of your transplanted organ. Do not stop treatment unless your doctor tells you to do so.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tacforius reduces the body's defence mechanisms (immune system), so that it is no longer as effective in fighting infections. Therefore, you may be more prone to infections while taking Tacforius.
Some infections may be serious or fatal and may include those caused by bacteria, viruses, fungi, parasites or other infections.
Inform your doctor immediately if you experience signs of infection, including:

• Fever, cough, sore throat, feeling weak or generally unwell
• Memory loss, difficulty thinking, difficulty walking or loss of vision – these may be due to a very rare and serious brain infection, which can be fatal (Progressive Multifocal Leukoencephalopathy or PML)

Serious side effects, including allergic and anaphylactic reactions, may occur. Benign and malignant tumours have been reported following treatment with Tacforius.
Inform your doctor immediately if you have or suspect you may have any of the following
serious side effects:
Serious common side effects (may affect up to 1 in 10 people)

• Gastrointestinal perforation: severe abdominal pain with or without other symptoms such as chills, fever, nausea or vomiting.
• Inadequate function of the transplanted organ.
• Blurred vision.

Serious uncommon side effects (may affect up to 1 in 100 people)

• Thrombotic microangiopathy (damage to the smallest blood vessels), including haemolytic uraemic syndrome, a condition with the following symptoms: reduced or no urine output (acute kidney failure), extreme fatigue, yellowing of the skin or eyes (jaundice), appearance of bruises (ecchymoses) or abnormal bleeding, and signs of infection.

Serious rare side effects (may affect up to 1 in 1,000 people)

• Thrombotic thrombocytopenic purpura, a condition involving damage to the smallest blood vessels, characterised by fever and subcutaneous bruising that may appear as red spots, with or without unexplained extreme fatigue, confusion, yellowing of the skin or eyes (jaundice), symptoms of acute kidney failure (reduced or absent urine output), loss of vision and seizures.
• Toxic epidermal necrolysis: erosion and blistering of the skin or mucous membranes, red and swollen skin that may peel off large areas of the body.
• Blindness.

Serious very rare side effects (may affect up to 1 in 10,000 people)

• Stevens-Johnson syndrome: unexplained widespread skin pain, facial swelling, severe illness with blistering of the skin, mouth, eyes and genitals, hives, swelling of the tongue, red or purplish skin rash that spreads, skin peeling.
• Torsade de pointes: change in heart rate, which may or may not be accompanied by symptoms such as chest pain (angina), fainting, dizziness or nausea, palpitations (strong awareness of your heartbeat) and difficulty breathing.

Serious side effects – frequency not known (frequency cannot be estimated from available data)

• Opportunistic infections (bacterial, fungal, viral and protozoal): prolonged diarrhoea, fever and sore throat.
• Following treatment, benign and malignant tumours have been reported as a consequence of immunosuppression, including malignant skin cancers and a rare type of cancer that may include skin lesions, called Kaposi's sarcoma. Symptoms include skin changes such as new or changing discolouration, lesions or nodules.
• Cases of pure red cell aplasia (a very severe reduction in red blood cell count), haemolytic anaemia (reduced number of red blood cells due to abnormal destruction, accompanied by fatigue), and febrile neutropenia (a decrease in white blood cells that fight infections, accompanied by fever) have been reported. It is not known exactly how often these side effects occur. You may have no symptoms, or depending on the severity of the condition, you may experience: fatigue, apathy, unusual paleness of the skin, shortness of breath, dizziness, headache, chest pain and cold hands and feet.
• Cases of agranulocytosis (a severely reduced number of white blood cells accompanied by mouth ulcers, fever and infection(s)) have been reported. You may have no symptoms or may experience sudden fever, febrile chills and sore throat.
• Allergic and anaphylactic reactions with the following symptoms: sudden skin rash with itching (urticaria), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty swallowing or breathing), and you may feel weak.
• Posterior reversible encephalopathy syndrome (PRES): headache, confusion, mood swings, seizures and visual disturbances. These may be signs of a disorder called posterior reversible encephalopathy syndrome, which has been reported in some patients treated with tacrolimus.
• Optic neuropathy (abnormality of the optic nerve): vision problems, such as blurred vision, changes in colour vision, difficulty seeing details or restricted visual field.

The following side effects may also occur after taking Tacforius and could be serious:
Very common (may affect more than 1 in 10 people)
Increased blood glucose, diabetes mellitus, increased potassium in the blood.
Difficulty sleeping.
Tremor, headache.
Increased blood pressure.
Abnormal liver function test results.
Diarrhoea, nausea.
Kidney problems.
Common (may affect up to 1 in 10 people)
Reduction in blood cells (platelets, red blood cells or white blood cells), increased number of white blood cells, abnormalities in red blood cell count (shown in blood tests).
Decreased magnesium, phosphate, potassium, calcium or sodium in the blood, fluid retention, increased uric acid or lipid levels in the blood, reduced appetite, increased blood acidity, other changes in blood salt balance (shown in blood tests).
Anxiety symptoms, confusion and disorientation, depression, mood swings, nightmares, hallucinations, mental disorders.
Seizures, altered consciousness, tingling and numbness of hands and feet (sometimes painful), sensation of loss of balance, impaired writing ability, nervous system disorders.
Increased sensitivity to light, eye disorders.
Ringing in the ears.
Reduced blood flow in heart vessels, increased heart rate.
Bleeding, complete or partial blockage of blood vessels, low blood pressure.
Shortness of breath, changes in lung tissue, fluid accumulation around the lung, inflammation of the pharynx, cough, flu-like symptoms.
Inflammation or ulcers causing abdominal pain or diarrhoea, bleeding in the stomach, mouth inflammation or ulcers, fluid accumulation in the abdomen, vomiting, abdominal pain, indigestion, constipation, flatulence, bloating, soft stools, stomach problems.
Biliary tract disorders, yellowing of the skin due to liver problems, liver damage and inflammation.
Itching, skin rash, hair loss, acne, increased sweating.
Pain in joints, limbs, back and feet, muscle cramps.
Reduced kidney function, reduced urine production, reduced or painful urination.
General weakness, fever, swelling (oedema), pain and discomfort, increased blood alkaline phosphatase enzyme, weight gain, altered perception of temperature.
Uncommon (may affect up to 1 in 100 people)
Alterations in blood clotting processes, reduction in all types of blood cells (shown in blood tests).
Dehydration.
Reduced protein or sugar in the blood, increased phosphate in the blood.
Coma, brain haemorrhages, stroke, paralysis, brain disorders, language and speech disorders, memory problems.
Lens opacity.
Hearing impairment.
Irregular heartbeat, cessation of heartbeat, reduced cardiac output, heart muscle disorders, dilation of the heart muscle, increased heartbeat, abnormal electrocardiogram (ECG), altered heart rhythm and rate.
Blood clot in a vein of the limbs, shock.
Breathing difficulties, respiratory disorders, asthma.
Intestinal obstruction, increased blood levels of amylase enzyme, reflux of stomach contents into the throat, delayed gastric emptying.
Skin inflammation, burning sensation upon sun exposure.
Joint pain.
Inability to urinate, painful menstruation and abnormal menstrual bleeding.
Failure of multiple organs, flu-like illness, increased sensitivity to heat and cold, feeling of chest tightness, restlessness and discomfort, increased blood lactate dehydrogenase enzyme, weight loss.
Rare (may affect up to 1 in 1,000 people)
Small skin haemorrhages caused by blood clots.
Increased muscle stiffness.
Deafness.
Fluid accumulation around the heart.
Acute respiratory distress syndrome.
Cyst formation in the pancreas.
Circulatory problems in the liver.
Severe illness with blistering of the skin, mouth, eyes and genitals, increased hair growth.
Thirst, fainting, feeling of chest tightness, decreased mobility, ulcer.
Very rare (may affect up to 1 in 10,000 people)
Muscle weakness.
Abnormal echocardiogram.
Liver failure.
Painful urination with blood in the urine.
Increase in fatty tissue.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tacforius

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture.
This medicine does not require any special storage temperature.
Use all extended-release capsules within 1 year after opening the aluminium foil pouch.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tacforius contains

• The active substance is tacrolimus. Each 0.5 mg Tacforius capsule contains 0.5 mg of tacrolimus (as monohydrate). Each 1 mg Tacforius capsule contains 1 mg of tacrolimus (as monohydrate). Each 3 mg Tacforius capsule contains 3 mg of tacrolimus (as monohydrate). Each 5 mg Tacforius capsule contains 5 mg of tacrolimus (as monohydrate).
• The other components are: Capsule contents Hypromellose 2910, ethylcellulose, lactose, magnesium stearate. Capsule shell Tacforius 0.5 mg / 1 mg / 3 mg prolonged-release hard capsules: red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), gelatin. Tacforius 5 mg prolonged-release hard capsules: red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), black iron oxide (E172), ponceau 4R (E124), gelatin. Printing ink Shellac, propylene glycol, black iron oxide (E172), potassium hydroxide.

Description of the appearance of Tacforius and package contents
Tacforius 0.5 mg prolonged-release hard capsules
Hard gelatin capsules with ''TR'' printed on the light yellow cap and “0.5 mg” on the light orange body.
Tacforius 1 mg prolonged-release hard capsules
Hard gelatin capsules with ''TR'' printed on the white cap and “1 mg” on the light orange body.
Tacforius 3 mg prolonged-release hard capsules
Hard gelatin capsules with ''TR'' printed on the light orange cap and “3 mg” on the light orange body.
Tacforius 5 mg prolonged-release hard capsules
Hard gelatin capsules with ''TR'' printed on the greyish-red cap and “5 mg” on the light orange body.
Tacforius 0.5 mg / 3 mg / 5 mg prolonged-release hard capsules
Supplied in blisters or in unit-dose divisible blisters containing 10 capsules, inside an aluminium protective pouch containing a desiccant. Available in packs of 30, 50 and 100 prolonged-release capsules in blisters, and packs of 30x1, 50x1 and 100x1 prolonged-release capsules in unit-dose divisible blisters.
Tacforius 1 mg prolonged-release hard capsules
Supplied in blisters or in unit-dose divisible blisters containing 10 capsules, inside an aluminium protective pouch containing a desiccant. Available in packs of 30, 50, 60 and 100 prolonged-release capsules in blisters, and packs of 30x1, 50x1, 60x1 and 100x1 prolonged-release capsules in unit-dose divisible blisters.

Marketing Authorization Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
The Netherlands

Manufacturer
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
PLIVA Hrvatska d.o.o.
Prilaz baruna Filipovića 25
10 000 Zagreb
Croatia
Teva Czech Industries s.r.o.
Ostravská 29, c.p. 305
Opava-Komárov
Czech Republic
Teva Operations Poland Sp. z.o.o.
ul. Mogilska 80
31-546 Krakow
Poland
Teva Pharma S.L.U.
C/C, n. 4, Poligono Industrial Malpica
ES-50016 Zaragoza
Spain
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13
4042 Debrecen
Hungary

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

België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203

България Luxembourg/Luxemburg
Тева Фарма ЕАД ratiopharm GmbH
Тел.: +359 24899585 Allemagne/Deutschland
Tél/Tel: +49 73140202

Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt
Tel: +420 251007111 Tel.: +36 12886400

Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf.: +45 44985511 L-Irlanda
Tel: +44 2075407117

Deutschland Nederland
TEVA GmbH Teva Nederland B.V.
Tel: +49 73140208 Tel: +31 8000228400

Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590

Ελλάδα Österreich
TEVA HELLAS A.E. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070

España Polska
Nordic Pharma, S.A.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel.: +34 916404041 Tel.: +48 223459300

France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550

Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L
Tel: + 385 13720000 Tel: +40 212306524

Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390

Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911

Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900

Κύπρος Sverige
TEVA HELLAS A.E. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/