Informations for option: Tacni 1 Mg Hard Capsules, show other option

Select option:

1. Tacni 1 Mg Hard Capsules
2. Tacni 1 Mg Hard Capsules

TEVA UK Ref: 231-30-10013-D LEA TACROLIMUS (TACNI) A/S CAP TUK <CIN	Version: 1	10 November 2014

TACNI 0.5 mg, 1 mg AND 5 mg HARD CAPSULES Tacrolimus

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking this medicine.

♦    Keep this leaflet. You may need to read it again.

♦    If you have any further questions, askyourdoctor or pharmacist.

♦    This medicine hasbeen prescribed foryou. Do not pass it on to others. It may harmthem, even if their symptoms are the same as yours.

♦    If you getanyside effects,talktoyour doctoror pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

IN THIS LEAFLET:

1.    What Tacni is and what it is used for

2.    Before you take Tacni

3.    How to take Tacni

4.    Possible side effects

5.    How to store Tacni

6.    Further information ^ WHAT TACNI IS AND WHAT IT IS USED FOR

Tacni is an immunosuppressant. Following yourorgan transplant (e.g. liver, kidney, heart),your body's immune system will try to reject the neworgan.

Tacni is used to control your body's immune response enabling your bodyto acceptthe transplanted organ.

Tacni is often used in combination with other medicines that also suppress the immune system.

You may also be given Tacni for an ongoing rejection ofyourtransplanted liver, kidney, heartorother organwhenany previoustreatmentyou were taking was unable to control this immune response after yourtransplantation.

BEFORE YOU TAKE TACNI

Do not take Tacni

♦    If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Tacni. (See section 6).

♦    If you are allergic (hypersensitive)to sirolimus orto any macrolide antibiotic (e.g. erythromycin, clarithromycin, josamycin).

Take special care with Tacni

Tell your doctor if any of the following applytoyou:

♦    if you are taking any medicines mentioned below under'Using other medicines'

♦    if you have or have had liver problems

♦    if you have diarrhoea for more thanoneday

♦    if you need to receive anyvaccinations.

Yourdoctor may need to adjustyourdose of Tacni.

You should keep in regular contactwith yourdoctor. Fromtime totime,your doctor may need to do blood, urine, heart, eye tests,to setthe right dose of Tacni.

You should limit your exposure tothe sun and UV (ultraviolet) light whilst taking Tacni. This is because immunosuppressants could increase the risk of skin cancer.Wear appropriate protective clothing and use a sunscreen with a high sun protection factor.

Using other medicines

Please tell yourdoctoror pharmacist if you are taking or have recentlytaken any other medicines, including medicines obtained without a prescription and herbal preparations.

Tacni must not be taken with cyclosporine.

Tacni blood levels canbe affected by other medicinesyou take, and blood levels of other medicines canbe affected by taking Tacniwhichmayrequire an increase ordecreasein dose. In particular,you should tellyourdoctor if you are taking or have recentlytaken medicines like:

♦    antifungal medicinesand antibiotics, particularly so-called macrolide antibiotics, used totreat infections, such as ketoconazole, fluconazole, itraconazole, voriconazole, clotrimazole, erythromycin, clarithromycin,josamycin, and rifampicin

♦    HIV medicines (e.g. ritonavir), used to treat HIV infection

♦    medicines for stomach ulcer and acid reflux (e.g. omeprazole, lansoprazole or cimetidine)

♦    antiemetics, used totreat nausea and vomiting (e.g. metoclopramide)

♦    cisapride orthe antacid magnesium-aluminium-hydroxide, used totreat heartburn

♦    the contraceptive pill or other hormone treatments with ethinylestradiol, hormone treatments with danazol

♦    medicines used totreat high blood pressure or heart problems (e.g. nifedipine, nicardipine,diltiazem and verapamil)

♦    medicines known as "statins" used totreat elevated cholesterol and triglycerides

♦    phenytoin or phenobarbital, used totreat epilepsy

♦    the corticosteroids prednisolone and methylprednisolone, belonging to the class of corticosteroids used to treatinflammations or suppress the immune system (e.g. in transplant rejection)

♦    nefazodone, used to treatdepression

♦    Herbal preparations containing St. John's WortfHypericum perforatum) orother herbal preparations.

Tell your doctor if you are taking or need totake ibuprofen, amphotericin B or antivirals (e.g. aciclovir). These mayworsen kidney or nervous system problems whentaken togetherwith Tacni.

Yourdoctor also needs to know if you are taking potassium supplements or certain diuretics used for heartfailure, hypertension and kidney disease, (e.g. amiloride,triamterene,orspironolactone), non-steroidal anti-inflammatorydrugs (NSAIDs, e.g. ibuprofen) used forfever, inflammation and pain, anticoagulants (blood thinners), or oral medicines for diabetes, while you take Tacni.

If you need vaccinations, tell yourdoctor in advance thatyou are taking this medicine.

Taking Tacni with food and drink

TakeTacnion an emptystomach or2to3 hours after ameal. Waitat least 1 hour until the next meal.Avoid grapefruit (also as juice) while on treatmentwith Tacni since it can affect its levels. Pregnancy and breast-feeding

If you plan to become pregnant,thinkthatyou may be pregnant oryou are pregnant, askyour doctoror pharmacistfor advice before taking anymedicine.

Tacrolimus passes into breast milk. Therefore you should not breast-feed whilst using Tacni. Driving and using machines

Do notdrive or use anytools ormachines if you feel dizzy or sleepy,or have problems seeing clearly after taking this medicine. These effects are more frequently observed if you also drink alcohol.

Important information about some of the ingredients of Tacni

Tacni contains lactose. If you have beentold byyourdoctorthatyou have an intolerancetosome sugars, contactyourdoctor before taking this medicine.

HOW TO TAKE TACNI

Always take Tacni exactly as yourdoctor has told you. You should checkwith yourdoctoror pharmacist if you are notsure.

Make sure thatyou receive the same tacrolimus medicine everytime you collectyour prescription, unless yourtransplantspecialist has agreed to change to a differenttacrolimus medicine.

This medicine should betakentwicea day. Ifthe appearance of this medicine is notthe sameas usual, or if dosage instructions have changed,speaktoyourdoctor or pharmacist as soon as possible to make sure thatyou have the right medicine.

The starting dose to preventthe rejection ofyourtransplanted organ will be determined byyour doctor calculated according toyour bodyweight. Initial doses just after transplantation will generally be in the range of 0.075 - 0.30 mg per kg body weight per day depending on the transplanted organ.

Yourdose depends on your general condition and on which other immunosuppressive medication you are taking. Regular blood tests byyourdoctorwill be required to define the correctdose and to adjust the dose fromtime to time.Your doctorwill usually reduce yourtacrolimus capsules dose once your condition has stabilised. Your doctor will tell you exactly how many capsules totake and how often.

Tacni is taken orally twice daily, usually in the morning and evening.You should generallytake Tacrolimus capsules onan empty stomach or at least 1 hour before or2to3 hours after the meal. The capsules should be swallowed whole with a glass ofwater. Avoid grapefruit and grapefruit juice while taking Tacrolimus capsules. Do notswallowthe desiccant contained in the foil wrapper.

If you take more Tacni than you should

If you have accidentally taken too muchsee yourdoctor or contactyour nearest hospital emergency department immediately.

If you forget to take Tacni

Do nottake a double dose tomake upforforgotten individual doses.

If you have forgotten to take your capsules, wait until it is time for the next dose, and then continue as before.

If you stop taking Tacni

Stopping yourtreatment may increase the risk of rejection ofyourtransplanted organ. Do notstop yourtreatment unless yourdoctortells you to do so.

If you have anyfurtherquestions on theuse ofthis product, askyour doctoror pharmacist.

^ POSSIBLE SIDE EFFECTS

Like all medicines, Tacni can cause side effects, although not everybody gets them.

Tacni reduces your body's own defence mechanism to stopyou rejecting yourtransplanted organ. Consequently,your body will not be as good asusual at fighting infections. So if you are taking Tacni you maytherefore catch more infections than usual such as infections of the skin, mouth, stomach and intestines, lungs and urinary tract.

Severe effects may occur, including allergic and anaphylactic reactions (you may experience: a sudden itchy rash (hives), swelling of the hands,feet, ankles,face, lips, mouth orthroatfwhich maycause difficulty in swallowing or breathing), and you mayfeel you are going to faint). It may be fatal. An uncommon side effect is Haemolytic Uraemic Syndrome, a disease characterised by acute kidney insufficiency (low urine output/or no urine output), microangiopathic haemolytic anaemia (decreased numberof red blood cells with extreme tiredness, yellowing of the skin or eyes (jaudince) and a low platelet countwith abnormal bruising or bleeding and signs of infection. It may be fatal. A rare side effect is Thrombotic Thrombocytopenic Purpura (or TTP) which is characterised by fever and bruising underthe skin that may appear as red pinpointdots,with or without unexplained extreme tiredness, confusion,yellowing of the skin or eyes (jaundice), with symptoms of acute renal failure (low urine output/or no urine output). It may be fatal. Benignand malignanttumours have been reported following treatment as a result of immunosuppression. Possible side effects are listed accordingtothefollowing categories:

Very common side effects are experienced in more than one in ten patients.

Common side effects are experienced in less thanoneinten patients but in more than oneperone hundred patients.

Uncommon side effects are experienced in less than one in one hundred patients but more than one peronethousand patients.

Rare side effects are experienced in less than one per one thousand patients but more than one per ten thousand patients.

Very rare side effects are experienced in less than one perten thousand patients.

Very common side effects: affects more than 1 user in 10

♦    increased blood sugar, diabetes mellitus, increased potassium in the blood

♦    difficulty in sleeping

♦    trembling,headache

♦    increased blood pressure

♦    diarrhoea, nausea

♦    kidneyproblems.

Common side effects: affects 1 to 10 users in 100

♦    reduction in blood cell counts (platelets, red or white blood cells), increase in white blood cell counts, changes in red blood cell counts

♦    reduced magnesium, phosphate, potassium, calciumor sodium in the blood, fluid overload, increased uric acid or lipids in the blood, decreased appetite, increased acidity of the blood,other changes in the blood salts (seen in blood tests)

♦    anxiety symptoms, confusion and disorientation, depression, mood changes, nightmare, hallucination, mental disorders

♦    fits, disturbances in consciousness,tingling and numbness (sometimes painful) in the hands and feet, dizziness, impaired writing ability, nervous system disorders

♦    blurred vision, increased sensitivity to light, eye disorders

♦    ringingsoundinyourears

♦    reduced blood flow in the heartvessels,faster heartbeat

♦    bleeding, partial or complete blocking of blood vessels, reduced blood pressure

♦    shortness in breath, changes in the lung tissue, collection of liquid around the lung, inflammation of the throat, cough, flu-like symptoms

♦    inflammations or ulcers causing abdominal pain or diarrhoea, bleedings in the stomach, inflammations or ulcers in the mouth, collection offluid in the belly, vomiting, abdominal pains, indigestion, constipation, passing wind, bloating, loose stools, stomach problems

♦    changes in liver enzymes and function,yellowing of the skin dueto liver problems, liver tissue damage and inflammation of the liver

♦    itching, rash, hair loss, acne, increased sweating

♦    pain in joints, limbs or back, muscle cramps

♦    insufficient function of the kidneys, reduced production of urine, impaired or painful urination

♦    general weakness,fever, collection offluid in your body, pain and discomfort, increase of the enzyme alkaline phosphatase in your blood, weightgain,feeling feverish

♦    insufficient function ofyourtransplanted organ.

Uncommon side effects: affects 1 to 10 users in 1,000

♦    changesin blood clotting, reduction in the numberof all types of blood cells

♦    dehydration, reduced protein orsugar inthe blood, increased phosphate in the blood

♦    coma, bleeding inthe brain,stroke, paralysis, brain disorder, speech and language abnormalities, memory problems

♦    clouding of the eye lens

♦    impaired hearing

♦    irregular heartbeat,stop of heartbeat, reduced performance ofyour heart, disorder of the heart muscle, enlargementoftheheart muscle, stronger heartbeat, abnormal ECG, heart rate and pulse abnormal

♦    bloodclotinaveinofalimb,shock

♦    difficulties in breathing, respiratory tractdisorders, asthma

♦    obstruction of the gut, increased blood level of the enzyme amylase, reflux of stomach content in yourthroat, delayed emptying of the stomach

♦    dermatitis, burning sensation in the sunlight

♦    jointdisorders

♦    inabilityto urinate, painful menstruation and abnormal menstrual bleedings

♦    failure of some organs, influenza like illness, increased sensitivity to heatand cold, feeling of pressure on your chest, jittery or abnormal feeling, increase of the enzyme lactate dehydrogenase in your blood,weightloss.

Rare side effects: affects 1 to 10 users in 10,000

♦    increasedmusclestiffness

♦    blindness

♦    deafness

♦    collection of fluid around the heart

♦    acute breathlessness

♦    cystformationinyourpancreas

♦    problems with blood flow in the liver

♦    serious illness with blistering ofskin, mouth, eyes and genitals, increased hairiness

♦    thirst, fall,feeling of tightness in your chest,decreased mobility, ulcer.

Very rare side effects: affects less than 1 user in 10,000

Reporting of side effects

If you getany side effects,talktoyourdoctor, pharmacistor nurse. This includes any possible side effects not listed in this leaflet. You canalso report side effects directly via the Yellow CardScheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

HOW TO STORE TACNI

♦    Keep out of the reach and sight of children.

♦    Storebelow30°C

♦    Store in the original package (within the foil pouch) in orderto protectfrom moisture & light

♦    Do not useTacni afterthe expiry date which is stated on the carton and blister after {EXP}. Oncethe foil pouch is opened,the productshould be used within 1 year. The expiry date refers tothe last day of that month.

♦    Medicines should not be disposed ofvia wastewateror household waste. Askyour pharmacist how to dispose of medicines no longer required. These measures will help to protectthe environment.

FURTHER INFORMATION

What Tacni contains

The active substance is tacrolimus.

For0.5 mg: Each capsule contains 0.5 mg oftacrolimus The other ingredients are:

♦    Capsule content: Povidone K-30, Croscarmellose Sodium (E 468), Lactose anhydrous, Magnesium stearate.

♦    Capsule shell: Titanium dioxide (E-171), Yellow Iron Oxide (E-172), Gelatin.

For 1 mg: Each capsule contains 1 mg oftacrolimus

The other ingredients are:

♦    Capsule content: Povidone K-30, Croscarmellose Sodium (E 468), Lactose anhydrous, Magnesium stearate.

♦    Capsule shell: Titanium dioxide (E-171), Gelatin.

For5 mg: Each capsule contains 5 mg oftacrolimus The other ingredients are:

♦    Capsule content: Povidone K-30, Croscarmellose Sodium (E 468), Lactose anhydrous, Magnesium stearate.

♦    Capsule shell: Titanium dioxide (E-171), Red Iron Oxide (E-172), Gelatin.

What Tacni looks like and contents of the pack

Tacni 0.5 mg hard capsules

Ivory cap and ivory body hard shell capsules with white powder.

Tacni 1 mg hard capsules

White cap and white body hard shell capsules with white powder.

Tacni5mg hard capsules

Red cap and red body hard shell capsules with white powder.

Tacni hard capsules are supplied as blister strips containing 10 capsules within a protective foil wrapper, including a desiccant protecting the capsules from moisture. The desiccantshould not be swallowed.

Tacni is available in blister packs of 20,30,50,50x1,60,90 and 100 capsules, containing blister strips of 10 capsules each.

Not all packsizes may be marketed Marketing Authorization Holder TEVA UK Limited,

Eastbourne,

BN22 9AG.

Manufacturer Laboratories Cinfa,S.A.

Olaz-Chipi, 10-Polig Areta 31620 Huarte-Pamplona, Navarra, Spain.

This leaflet was last revised in 06/2014.

PL 00289/1620-22