SAME SIZE ARTWORK

LEAFLET SIZE: 170 mm x 480 mm

Package leaflet: Information for the user

Altrudyntc 5mg Hard Capsules Tacrolimus

Read all of this leaflet carefully before you start

taking this medicine because it contains important

information for you.

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

•    If you have any further questions, ask your doctor or pharmacist.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    WhatAltrudynt is and what it is used for

2.    What you need to know before you take Altrudynt

3.    How to take Altrudynt

4.    Possible side effects

5.    How to store Altrudynt

6.    Contents of the pack and other information

1. What Altrudynt is and what it is used for

Altrudynt belongs to a group of medicines called immunosuppressants. Following your organ transplant (e.g. liver, kidney, heart), your body's immune system will try to reject the new organ. Altrudynt is used to control your body's immune response enabling your body to accept the transplanted organ.

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

You may also be given Altrudynt for an on-going rejection of your transplanted liver, kidney, heart or other organ or if any previous treatment you were taking was unable to control this immune response after your transplantation.

2. What you need to know before you take Altrudynt

Do not take Altrudynt:

•    if you are allergic to Altrudynt or any of the other ingredients of this medicine (listed in section 6).

•    if you are allergic (hypersensitive) to any antibiotic belonging to the subgroup of macrolide antibiotics (e.g. erythromycin, clarithromycin, josamycin).

Warnings and precautions

Talk to your doctor or pharmacist before taking Altrudynt.

•    You will need to take Altrudynt every day as long as you need immunosuppression to prevent rejection of your transplanted organ. You should keep in regular contact with your doctor.

•    Whilst you are taking Altrudynt your doctor may want to carry out a number of tests (including blood, urine, heart function, visual and neurological tests) from time to time. This is quite normal and will help your doctor to decide on the most appropriate dose of Altrudynt for you.

•    Please avoid taking any herbal remedies, e.g. St. John's wort (Hypericum perforatum) or any other herbal products as this may affect the effectiveness and the dose of Altrudynt that you need to receive. If in doubt please consult your doctor prior to taking any herbal products or remedies.

•    If you have liver problems or have had a disease which may have affected your liver, please tell your doctor as this may affect the dose of Altrudynt that you receive.

•    If you feel strong abdominal pain accompanied or not with other symptoms, such as chills, fever, nausea or vomiting, please tell your doctor.

•    If you have diarrhoea for more than one day, please tell your doctor, because it might be necessary to adapt the dose of Altrudynt that you receive.

•    If you have an alteration of the electrical activity of your heart called “QT prolongation”. Your doctor will advise you about this.

•    Limit your exposure to sunlight and UV light whilst taking Altrudynt by wearing appropriate protective clothing and using a sunscreen with a high sun protection factor. This is because of the potential risk of malignant skin changes with immunosuppressive therapy.

•    If you need to have any vaccinations, please inform your doctor beforehand. Your doctor will advise you on the best course of action.

•    Patients treated with Altrudynt have been reported to have an increased risk of developing lymphoproliferative disorders (see section 4). Ask your doctor for specific advice on these disorders.

Other medicines and Altrudynt

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Altrudynt must not be taken with ciclosporin. Altrudynt blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking Altrudynt, which may require interruption, an increase or a decrease in Altrudynt dose. In particular, you should tell your doctor or pharmacist if you are taking or have recently taken medicines such as:

•    antifungal medicines and antibiotics (particularly so-called macrolide antibiotics) used to treat infections e.g ketoconazole, fluconazole, itraconazole, voriconazole, clotrimazole, erythromycin, clarithromycin, josamycin, and rifampicin

•    HIV protease inhibitors (e.g. ritonavir, nelfinavir, saquinavir), used to treat HIV infection

•    HCV protease inhibitors (e.g telaprevir, boceprevir), used to treat hepatitis C infection

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

•    antiemetics, used to treat nausea and vomiting (e.g. metoclopramide)

•    magnesium-aluminium-hydroxide (antacid), used to treat heartburn

•    hormone treatments with ethinylestradiol (e.g. the oral contraceptive pill) or danazol

•    medicines for high blood pressure or heart problems such as nifedipine, nicardipine, diltiazem and verapamil

•    anti-arrhythmic medicines (amiodarone) used to control arrhythmia (uneven beating of the heart)

•    medicines known as “statins” used to treat elevated cholesterol and triglycerides

•    the anti-epileptic medicines phenytoin or phenobarbital

•    the corticosteroids prednisolone and methyl-prednisolone

•    the anti-depressant nefazodone

•    Herbal preparations containing St. John's Wort (Hypericum perforatum) or extracts of Schisandra sphenanthera.

Tell your doctor if you are taking or need to take ibuprofen, amphotericin B, or antivirals (e.g. aciclovir). These may worsen kidney or nervous system problems when taken together with Altrudynt . Your doctor also needs to know if you are taking potassium supplements or potassium-sparing diuretics (e.g. amiloride, triamterene, or spironolactone), certain pain killers (so-called NSAIDs, e.g. ibuprofen), anticoagulants, or oral medication for diabetic treatment, while you take Altrudynt.

If you need to have any vaccinations, please inform your doctor beforehand.

Altrudynt with food and drink

You should generally take Altrudynt on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal. Grapefruit and grapefruit juice should be avoided while taking Altrudynt.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Altrudynt is excreted into breast milk. Therefore you should not breast-feed whilst receiving Altrudynt.

Driving and using machines

Do not drive or use any tools or machines if you feel dizzy or sleepy, or have problems seeing clearly after taking Altrudynt. These effects are more frequently observed if Altrudynt is taken in conjunction with alcohol use.

Altrudynt contains lactose

Altrudynt contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product

3. How to take Altrudynt

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Make sure that you receive the same Altrudynt medicine every time you collect your prescription, unless your transplant specialist has agreed to change to a different Altrudynt medicine.

If the appearance of this medicine is not the same as usual, or if dosage instructions have changed, speak to your doctor or pharmacist as soon as possible to make sure that you have the right medicine.

The starting dose to prevent the rejection of your transplanted organ will be determined by your doctor, calculated according to your body weight. 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.

Your dose depends on your general condition and on which other immunosuppressive medication you are taking. Regular blood tests by your doctor will be required to define the correct dose and to adjust the dose from time to time. Your doctor will usually reduce your Altrudynt dose once your condition has stabilised. Your doctor will tell you exactly how many capsules to take and how often.

Altrudynt is taken orally twice daily, usually in the morning and evening. You should generally take Altrudynt on an empty stomach or at least 1 hour before or 2 to 3 hours after the meal. The capsules should be swallowed whole with a glass of water. Take the capsules immediately following removal from the blister. Avoid grapefruit and grapefruit juice while taking Altrudynt.

If you take more Altrudynt than you should

If you have accidentally taken too much Altrudynt, see your doctor or contact your nearest hospital emergency department immediately.

If you forget to take Altrudynt

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

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

If you stop taking Altrudynt

Stopping your treatment with Altrudynt may increase the risk of rejection of your transplanted organ.

Do not stop your treatment unless your doctor tells you to do so.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

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

Severe side effects may occur, including the ones listed below. Tell your doctor immediately if you have or suspect you may have any of the following serious side effects:

•    Opportunistic infections (bacterial, fungal, viral and protozoal): prolonged diarrhoea, fever and sore throat.

•    Benign and malignant tumours have been reported following treatment as a result of immunosuppression.

•    Thrombotic Thrombocytopenic Purpura (or TTP) a condition characterised by fever and bruising under the skin that may appear as red pinpoint dots, with or without unexplained extreme tiredness, confusion, yellowing of the skin or eyes (jaundice), with symptoms of acute renal failure (low or no urine output).

•    Cases of pure red cell aplasia (a very severe reduction in red blood cell counts) and haemolytic anaemia (decreased number of red blood cells due to abnormal breakdown accompanied with tiredness) have been reported. You may have no symptoms or depending on the severity of the condition, you may feel: fatigue, apathy, abnormal paleness of the skin (pallor), shortness of breath, dizziness, headache, chest pain and coldness in hands and feet.

•    Cases of agranulocytosis (a severely lowered number of white blood cells accompanied with ulcers in the mouth, fever and infection(s)). You may have no symptoms or you may feel sudden fever, rigors and sore throat.

•    Allergic and anaphylactic reactions with the following symptoms: a sudden itchy rash (hives), swelling of hands, feet, ankle, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing) and you may feel you are going to faint.

•    Posterior Reversible Encephalopathy Syndrome (PRES): headache, altered mental status, seizures, and visual disturbances.

•    Torsades de Pointes: change in the heart frequency that can be accompanied or not by symptoms, such as chest pain (angina), faint, vertigo or nausea, palpitations (feeling the heartbeat) and difficulty breathing.

•    Gastrointestinal perforation: strong abdominal pain accompanied or not with other symptoms, such as chills, fever, nausea or vomiting.

•    Stevens-Johnson syndrome: unexplained widespread skin pain, facial swelling, serious illness with blistering of skin, mouth, eyes and genitals, hives, tongue swelling, red or purple skin rash that spreads, skin shedding.

•    Toxic epidermal necrolysis: erosion and blistering of skin or mucous membranes, red swollen skin that can detach in large parts of the body.

•    Haemolytic uraemic syndrome, a condition with the following symptoms: low or no urine output (acute renal failure), extreme tiredness, yellowing of the skin or eyes (jaundice) and abnormal bruising or bleeding and signs of infection.

•    Insufficient function of your transplanted organ The side effects listed below may also occur after receiving Altrudynt:

Very common side effects (may affect more than 1 in 10 people):

•    Increased blood sugar, diabetes mellitus, increased potassium in the blood

•    Difficulty in sleeping

•    Trembling, headache

•    Increased blood pressure

•    Diarrhoea, nausea

•    Kidney problems

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

•    Reduced magnesium, phosphate, potassium, calcium or 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

•    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

•    Ringing sound in your ears

•    Reduced blood flow in the heart vessels, 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 pharynx, cough, flu-like symptoms

•    Inflammations or ulcers causing abdominal pain or diarrhoea, bleeds in the stomach, inflammations or ulcers in the mouth, collection of fluid in the belly, vomiting, abdominal pains, indigestion, constipation, flatulence, bloating, loose stools, stomach problems

•    Changes in liver enzymes and function, yellowing of the skin due to liver problems, liver tissue damage and inflammation of the liver

•    Itching, rash, hair loss, acne, increased sweating

•    Pain in joints, limbs or back, muscle spasms

•    Insufficient function of the kidneys, reduced production of urine, impaired or painful urination

•    General weakness, fever, collection of fluid in your body, pain and discomfort, increase of the enzyme alkaline phosphatase in your blood, weight gain, feeling of temperature disturbed

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

•    Changes in blood clotting, reduction in all blood cell counts

•    Dehydration, reduced protein or sugar in the blood, increased phosphate in the blood

•    Coma, bleeding in the brain, stroke, paralysis, brain disorder, speech and language abnormalities, memory problems

•    Blurring of the vision due to abnormality in the lens of the eye

•    Impaired hearing

•    Irregular heartbeat, stop of heartbeat, reduced performance of your heart, disorder of the heart muscle, enlargement of the heart muscle, stronger heartbeat, abnormal ECG, heart rate and pulse abnormal

•    Blood clot in a vein ofa limb, shock

•    Difficulties in breathing, respiratory tract disorders, asthma

•    Obstruction of the gut, increased blood level of the enzyme amylase, reflux of stomach content in your throat, delayed emptying of the stomach

•    Dermatitis, burning sensation in the sunlight

•    Joint disorders

•    Inability to urinate, painful menstruation and abnormal menstrual bleeding

•    Failure of some organs, influenza like illness, increased sensitivity to heat and cold, feeling of pressure on your chest, jittery or abnormal feeling, increase of the enzyme lactate dehydrogenase in your blood, weight loss

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

•    Small bleeds in your skin due to blood clots

•    Increased muscle stiffness

•    Blindness

•    Deafness

•    Collection of fluid around the heart

•    Acute breathlessness

•    Cyst formation in your pancreas

•    Problems with blood flow in the liver

•    Increased hairiness

•    Thirst, fall, feeling of tightness in your chest, decreased mobility, ulcer

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

•    Muscular weakness

•    Echocardiogram abnormal

•    Liver failure, narrowing of the bile vessel

•    Painful urination with blood in the urine

•    Increase of fat tissue Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Altrudynt

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

Take the hard capsules immediately following removal from the blister.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. Once the foil pouch is opened, the product should be used within 1 year. The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the outer packaging (pouch), in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Altrudynt contains

-    The active substance is Tacrolimus (as monohydrate)

-    The other ingredient(s) (excipient(s) are: Hypromellose 2910 (E464), Crosmellose sodium, Lactose monohydrate and Magnesium Stearate (E572).

-    Capsule shell of 5 mg contains: Gelatin (E441), Iron oxide red (E172), Iron oxide black (E172), Erythrosine (E127), Titanium dioxide (EH1) and Printing ink (White).

-    Printing Ink: Shellac (E904), Propylene Glycol, Potassium Hydroxide and Titanium Dioxide (E171).

What Altrudynt looks like and contents of the pack

Altrudynt 5 mg Hard Capsules

Size '4' hard gelatin capsule with greyish red cap and greyish red body, imprinted with “G” on cap and “687” on body in white ink; filled with white to off-white granular powder.

Capsules packed in blisters of PVC/PVDC base film and aluminium lidding foil. Such blisters are packed along with silica gel desiccant pouch in an aluminium pouch in cardboard cartons. The desiccant should not be swallowed.

Packs of 20, 30, 50, 60, 90 and 100 hard capsules in

blisters. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Glenmark Pharmaceuticals Europe Limited

Laxmi House, 2B Draycott Avenue

Harrow, Middlesex HA3 0BU, United Kingdom

Manufacturers

Glenmark Pharmaceuticals Europe Limited Building 2, Croxley Green Business Park,

Croxley Green, Hertfordshire, WD18 8YA United Kingdom or

Glenmark Pharmaceuticals s.r.o.

Fibichova 143,

566 17 Vysoke Myto, Czech Republic This leaflet was last revised in 08/2016.

Date: 12.08.2016

Version: 03 (UK)