TACFORIUS 0.5 мг Капсулы с пролонгированным высвобождением

Содержание инструкции

1. 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
   1. What is Tacforius and what is it 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

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

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Tacforius and what is it used for

Tacforius contains the active substance tacrolimus. It is an immunosuppressant. Following organ transplantation (liver, kidney), the body's immune system will try to reject the new organ.
Tacforius is used to control the immune response by enabling the body to
accept the transplanted organ.
You may also receive Tacforius for an ongoing rejection of the liver, kidney, heart or other transplanted organ when one of the treatments you were taking has not been able to control
this immune response after transplantation.
Tacforius is used in adult patients.

2. What you need to 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 (for example erythromycin, clarithromycin, josamycin).

Warnings and precautions
Immediate-release tacrolimus capsules (e.g. Tacni) and Tacforius prolonged-release capsules
both contain the active ingredient tacrolimus. However, Tacforius prolonged-release capsules must be
taken once a day, while immediate-release capsules must be taken twice
a day. This is because the Tacforius capsules allow a 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 mentioned below in the 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 an alteration of the electrical activity of the heart defined as “QT prolongation”.
• if you have or have had damage to the smallest blood vessels, known as thrombotic microangiopathy/thrombotic thrombocytopenic purpura/hemolytic uremic syndrome. Tell your doctor if you develop fever, bruising under the skin (which may appear as red dots), unexplained fatigue, confusion, yellowing of the skin or eyes, decreased urine production, vision loss, and seizures (see section 4). When tacrolimus is taken together with sirolimus or everolimus, the risk of developing these symptoms may increase.

Please avoid taking any herbal remedies, e.g. St John's Wort
( Hypericum perforatum) or any other herbal product as it may
alter the effectiveness and dose of Tacforius you need to receive. If you have any doubts, please consult your
doctor before taking any herbal product or remedy.
Your doctor may adjust your dose of Tacforius.
You should have regular contact with your doctor. From time to time, your doctor may feel it necessary
for you to have blood tests, urine tests, heart or eye checks to establish the correct
dose of Tacforius.
You should limit exposure to the sun and UV (ultraviolet) rays while taking Tacforius.
This is because immunosuppressive therapies can increase the risk of skin cancer.
Wear protective clothing and use a sunscreen with a high protection factor.
Precautions for handling:
You should avoid direct contact with any part of the body such as the skin or eyes or
inhalation of the powder contained in the capsules. If contact occurs, wash the skin and eyes.

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

Other medicines and Tacforius
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
The use of Tacforius together with ciclosporin (another drug used to prevent organ rejection
after transplantation) is not recommended.

If you visit a doctor other than the transplant specialist, tell them that you are taking
tacrolimus. The doctor may need to consult with the transplant specialist if they
need to use another medicine that can increase or decrease tacrolimus concentrations
in the blood.
Tacforius concentrations in the blood can be affected by other drugs you are
taking and vice versa, the concentrations in the blood of the medicines you are taking can be
altered by taking Tacforius, which may require interruption, an increase or a
decrease in the dose of Tacforius.
Some patients have shown increases in tacrolimus concentrations in the blood while
taking other medicines. This can cause serious side effects, such as kidney problems, problems
of the nervous system and heart rhythm disturbances (see section 4).
An effect on Tacforius concentrations in the blood can occur very soon after the start
of use of another medicine, so frequent and continued monitoring of Tacforius concentration in the blood may be necessary in the first few days after starting the other medicine and
frequently during treatment with the other medicine. Some other medicines may cause
a decrease in tacrolimus concentrations in the blood, which may increase the risk of organ rejection
transplanted. In particular, you should tell your doctor if you are taking or have recently taken
medicines such as:

• antifungal and antibiotic medicines, in particular the so-called macrolide antibiotics, used to treat infections, such as ketoconazole, fluconazole, itraconazole, posaconazole, voriconazole, clotrimazole, isavuconazole, miconazole, caspofungin, telitromycin, 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 cobicistat boosting medicine, and 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 organ rejection
• medicines for stomach ulcers or acid reflux (such as omeprazole, lansoprazole or cimetidine)
• antiemetics used to treat nausea and vomiting (e.g. metoclopramide)
• cisapride or magnesium-aluminium hydroxide antacid, used to treat heartburn
• the contraceptive pill or other hormonal treatments with 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 irregular heartbeat,
• medicines known as “statins” used to treat high cholesterol and triglycerides
• carbamazepine, phenytoin or phenobarbital, used to treat epilepsy
• cannabidiol (uses include, also, the 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.

Tell your doctor if you are receiving treatment for hepatitis C. Pharmacological treatment for
hepatitis C can alter liver function and affect tacrolimus concentrations in the
blood. Tacrolimus concentrations in the blood may decrease or increase depending on
the medicines prescribed for hepatitis C. Your doctor may need to carefully monitor
Tacrolimus concentrations in the blood and make the necessary dose adjustments of Tacforius
after starting treatment for hepatitis C.
Tell your doctor if you are taking or need to take ibuprofen (used to treat
fever, inflammation and pain), antibiotics (cotrimoxazole, vancomycin or aminoglycoside antibiotics, e.g. gentamicin), amphotericin B (used to treat fungal infections),
antiviral drugs (used to treat viral infections, e.g. acyclovir, ganciclovir, cidofovir,
foscarnet). These can worsen kidney or nervous system problems when taken together with
Tacforius.
Tell 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 hemolytic uremic syndrome may increase (see section 4).
The doctor must be informed if you, while taking Tacforius, are taking
potassium supplements or diuretics used for heart failure, hypertension and
kidney disease (e.g. amiloride, triamterene or spironolactone), or trimethoprim or
cotrimoxazole antibiotics that can increase potassium levels in the blood, non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen), used against fever, to treat inflammatory states
and pain, anticoagulants (blood thinners) or oral diabetes medications.
If you need to be vaccinated, talk to your doctor first.

Tacforius with food and drink
Avoid grapefruit (also the juice) while using Tacforius as it can vary the
concentration in the blood.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding
ask your doctor for advice before using this medicine.
Tacrolimus passes into breast milk. Therefore, breastfeeding is not recommended during therapy
with Tacforius.

Driving and using machines
Do not drive and do not use tools or machinery if you feel a loss of balance or drowsiness,
or have problems seeing clearly after taking Tacforius. These effects have been
found to be more pronounced if you also drink alcohol.

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

Tacforius 5 mg capsulescontains ponceau 4R
May cause allergic reactions.

3. How to take Tacforius

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
This drug must only be prescribed by a doctor with experience in treating the
transplant patient.
Make sure you always receive the same formulation of tacrolimus when you pick up your prescription,
unless your transplant specialist agrees to a change in the tacrolimus formulation.
This medicine must be taken once a day. If the appearance of this medicine is not the
same as usual, or if the dosage instructions have changed, contact your doctor or pharmacist
as soon as possible to make sure you have received the correct medicine.
The initial dose to prevent organ rejection will be established by your doctor
and calculated based on weight. The initial daily dose immediately after transplantation will generally
be within the following values:
0.10 - 0.30 mg per kg of body weight per day
depending on the transplanted organ. The same doses can be used for the treatment of rejection.
Your dose depends on your general condition and which other immunosuppressant medicine you
are taking.
Immediately after starting treatment with Tacforius, your doctor will ask you to undergo frequent
blood tests to determine the correct dose. Subsequently, you will be required to undergo blood tests
on a regular basis to determine the correct dose and to adjust that dose from time to time.
Your doctor will generally reduce your dose of Tacforius 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 as long as you need immunosuppression to
prevent rejection of the transplanted organ. You must maintain close contact with your doctor.
Tacforius must be taken once a day orally, in the morning. Take Tacforius on an empty stomach,
or 2 or 3 hours after a meal. Wait at least one hour before taking the next meal.
Take the capsules immediately after removing them from the blister. The capsules must
be swallowed wholewith 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 Emergency Room
of your nearest hospital immediately.

If you forget to take Tacforius
If you forgot to take the 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 the organ that has been
transplanted to you. Do not stop treatment unless your doctor tells you to do so.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Tacforius reduces the body's defense mechanisms (immune system) which will no longer be as
efficient in fighting infections. Therefore, you may be more susceptible to infections while
taking Tacforius.
Some infections may be serious or fatal and can include infections caused by bacteria, viruses,
fungi, parasites, or other infections.
Immediately inform your doctor if you experience signs of an 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 can occur, including allergic and anaphylactic reactions. The appearance of benign and malignant tumors has been reported following treatment with Tacforius.

Immediately inform your doctor if you have or suspect you may have any of the following
serious side effects:
Common serious 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.
• Insufficient function of the transplanted organ.
• Blurred vision.

Uncommon serious side effects (may affect up to 1 in 100 people)

• Thrombotic microangiopathy (damage to the smallest blood vessels), including hemolytic uremic syndrome, a condition with the following symptoms: reduced or absent urine output (acute kidney failure), extreme fatigue, yellowing of the skin or eyes (jaundice), and the appearance of bruises (ecchymoses) or abnormal bleeding and signs of infection.

Rare serious side effects (may affect up to 1 in 1,000 people)

• Thrombotic thrombocytopenic purpura, a condition that includes damage to the smallest blood vessels and is characterized by fever and skin bruises that may appear as red spots, with or without extreme unjustified fatigue, confusion, yellowing of the skin or eyes (jaundice), with 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 detach from large areas of the body.
• Blindness.

Very rare serious side effects (may affect up to 1 in 10,000 people)

• Stevens-Johnson syndrome: widespread unexplained skin pain, facial swelling, severe illness with blistering on the skin, mouth, eyes, and genitals, hives, swelling of the tongue, red or purple skin rash that spreads, and skin shedding.
• Torsades de pointes: change in heart rate that 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 based on available data)

• Opportunistic infections (bacterial, fungal, viral, and protozoal): prolonged diarrhea, fever, and sore throat.
• The appearance of benign and malignant tumors has been reported following treatment, resulting from immunosuppression.
• Cases of pure red cell aplasia (a very severe reduction in red blood cell count), hemolytic anemia (reduced number of red blood cells due to their abnormal destruction accompanied by fatigue), and febrile neutropenia (a decrease in the number of white blood cells that fight infections, accompanied by fever) have been reported. It is not known exactly how often these side effects occur. It may have no symptoms, or depending on the severity of the condition, you may experience: fatigue, apathy, abnormal paleness of the skin, shortness of breath, dizziness, headache, chest pain, and cooling of the hands and feet.
• Cases of agranulocytosis (a strongly reduced number of white blood cells accompanied by ulcers in the mouth, fever, and infection(s)) have been reported. It may not present with symptoms or may have sudden fevers, chills, and sore throat.
• Allergic and anaphylactic reactions with the following symptoms: sudden itchy skin rash (hives), swelling of the hands, feet, ankles, face, lips, mouth, or throat (which may cause difficulty swallowing or breathing) and may feel weak.
• Posterior reversible encephalopathy syndrome (PRES): headache, confusion, mood swings, seizures, and visual disturbances. These may be signs of a condition 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 color vision, difficulty seeing details, or restriction of the visual field.

The following side effects can also occur after taking Tacforius and may
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
Diarrhea, nausea
Kidney problems
Common (may affect up to 1 in 10 people)
Reduced number of blood cells (platelets, red blood cells, or white blood cells), increased
number of white blood cells, abnormalities in the number of red blood cells (detected in blood tests)
Decreased magnesium, phosphate, potassium, calcium, or sodium in the blood, increased
fluids, increased uric acid or lipid levels in the blood, decreased appetite, increased blood acidity,
other changes in blood salt balance (detected in blood tests)
Symptoms of anxiety, confusion and disorientation, depression, mood swings, nightmares, hallucinations,
mental disorders
Seizures, altered consciousness, tingling and numbness in hands and feet (sometimes
painful), sense of loss of balance, impaired ability to write, nervous system disorders
Increased sensitivity to light, eye disorders
Ringing in the ears
Reduced blood flow in the 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 diarrhea, bleeding in the
stomach, inflammation or ulcers in the mouth, fluid accumulation in the abdomen, vomiting, abdominal
pain, indigestion, constipation, flatulence, bloating, soft stools, stomach problems
Bile duct disorders, yellowing of the skin due to liver problems, liver damage and
inflammation
Itching, skin rash, hair loss, acne, increased sweating
Joint, limb, back, and foot pain, muscle cramps
Impaired kidney function, reduced urine production, painful or reduced urination
General weakness, fever, swelling (edema), pain and discomfort, increased alkaline
phosphatase in the blood, weight gain, altered perception of temperature
Uncommon (may affect up to 1 in 100 people)
Alterations in blood clotting processes, reduced number of all types of blood cells
(detected in blood tests)
Dehydration
Decreased proteins or sugar in the blood, increased phosphate in the blood
Coma, cerebral hemorrhages, stroke, paralysis, brain disorders, alterations in language and
expression, memory problems
Cataract opacity
Hearing impairment
Irregular heartbeat, heart stoppage, reduced heart output, heart muscle disorders,
dilatation of the heart muscle, increased heart rate, abnormal ECG, altered heart rate and
rhythm
Blood clot in a vein in the limbs, shock
Difficulty breathing, respiratory system disorders, asthma
Intestinal blockage, increased levels of the enzyme amylase in the blood, reflux of stomach
contents into the throat, delayed gastric emptying
Skin inflammation, burning sensation during exposure to the sun
Joint pain
Inability to urinate, painful menstruation and abnormal menstrual bleeding
Multiple organ failure, flu-like illness, increased sensitivity to heat and
cold, feeling of tightness in the chest, feeling restless and uncomfortable,
increased lactate dehydrogenase in the blood, weight loss.
Rare (may affect up to 1 in 1,000 people)
Small skin hemorrhages caused by blood clots
Increased muscle stiffness
Deafness
Fluid accumulation around the heart
Acute respiratory distress syndrome
Cyst formation in the pancreas
Problems with blood circulation in the liver
Severe illness with blistering on the skin, in the mouth, eyes, and genitals,
increased hair growth
Thirst, fainting, feeling of constriction in the chest, 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
Increased adipose tissue

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system detailed 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 which is stated on the box and on the blister after
“Exp.”. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light and moisture. This
medicine does not require any particular storage temperature.
Use all the prolonged-release capsules within 1 year of opening the aluminium packaging.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tacforius contains

• The active ingredient is tacrolimus. Each Tacforius 0.5 mg capsule contains 0.5 mg of tacrolimus (as monohydrate). Each Tacforius 1 mg capsule contains 1 mg of tacrolimus (as monohydrate). Each Tacforius 3 mg capsule contains 3 mg of tacrolimus (as monohydrate). Each Tacforius 5 mg capsule contains 5 mg of tacrolimus (as monohydrate).
• The other ingredients 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), iron oxide
yellow (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 Tacforius and contents of the pack

Tacforius 0.5 mg prolonged-release hard capsules
Hard gelatin capsules with ''TR'' imprinted on the light yellow upper part of the capsule and
“0.5 mg” on the light orange body of the same.

Tacforius 1 mg prolonged-release hard capsules
Hard gelatin capsules with ''TR'' imprinted on the white upper part of the capsule and “1 mg” on the
light orange body of the same.

Tacforius 3 mg prolonged-release hard capsules
Hard gelatin capsules with ''TR'' imprinted on the light orange upper part of the capsule and
“3 mg” on the light orange body of the same.

Tacforius 5 mg prolonged-release hard capsules
Hard gelatin capsules with ''TR'' imprinted on the greyish-red upper part of the capsule and
“5 mg” on the light orange body of the same.

Tacforius 0.5 mg / 3 mg / 5 mg prolonged-release hard capsules
Supplied in blisters or unit-dose divisible blisters of 10 capsules, inside a
protective aluminum pouch containing a desiccant. 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 are available.

Tacforius 1 mg prolonged-release hard capsules
Supplied in blisters or unit-dose divisible blisters of 10 capsules, inside a
protective aluminum pouch containing a desiccant. 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 are available.

Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031GA Haarlem
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
74770
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 on this medicinal product, please contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
Teva Pharma Belgium N.V./S.A./AG
Tél/Tel: +32 38207373

Lietuva
UAB Teva Baltics
Tel: +370 52660203

България
Тева Фарма ЕАД
Тел: +359 24899585

Luxembourg/Luxemburg
ratiopharm GmbH
Allemagne/Deutschland
Tél/Tel: +49 73140202

Česká republika
Teva Pharmaceuticals CR, s.r.o.
Tel: +420 251007111

Magyarország
Teva Gyógyszergyár Zrt
Tel: +36 12886400

Danmark
Teva Denmark A/S
Tlf: +45 44985511

Malta
Teva Pharmaceuticals Ireland
L-Irlanda
Tel: +44 2075407117

Deutschland
TEVA GmbH
Tel: +49 73140208

Nederland
Teva Nederland B.V.
Tel: +31 8000228400

Eesti
UAB Teva Baltics Eesti filiaal
Tel: +372 6610801

Norge
Teva Norway AS
Tlf: +47 66775590

Ελλάδα
Specifar A.B.E.E.
Τηλ: +30 2118805000

Österreich
ratiopharm Arzneimittel Vertriebs-GmbH
Tel: +43 1970070

España
Nordic Pharma, S.A.U.
Tel.: +34 916404041

Polska
Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +48 223459300

France
Teva Santé

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

Hrvatska
Pliva Hrvatska d.o.o.
Tel: + 385 13720000

România
Teva Pharmaceuticals S.R.L
Tel: +40 212306524

Ireland
Teva Pharmaceuticals Ireland
Tel: +44 2075407117

Slovenija
Pliva Ljubljana d.o.o.
Tel: +386 15890390

Ísland
Teva Pharma Iceland ehf.
Sími: +354 5503300

Slovenská republika
TEVA Pharmaceuticals Slovakia s.r.o.
Tel: +421 257267911

Italia
Teva Italia S.r.l.
Tel: +39 028917981

Suomi/Finland
Teva Finland Oy
Puh/Tel: +358 201805900

Κύπρος
Specifar A.B.E.E.
Ελλάδα
Τηλ: +30 2118805000

Sverige
Teva Sweden AB
Tel: +46 42121100

United Kingdom (Northern Ireland)
Teva Pharmaceuticals Ireland
Ireland
Tel: +44 2075407117
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu/

Latvija
UAB Teva Baltics filiāle Latvijā
Tel: +371 67323666