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5. How to store Prograf

Keep out of the sight and reach of children.

Do not use Prograf after the expiry date which is stated on the carton and blister after {EXP}. The expiry date refers to the last day of that month. Use all the capsules within 1 year of opening the aluminium wrapping. Take capsule immediately after removal from blister.

Prograf should be stored in the original package.

Protect from moisture.

If the capsules become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to disposeof medicines that are no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Prograf contains

Your medicine is called Prograf 0.5mg Capsules.

Each capsule contains 0.5mg of the active ingredient tacrolimus and also contains the following: hypromellose, lactose monohydrate, croscarmellose sodium and magnesium stearate.

The capsule shells are made of gelatin with titanium dioxide (E171) and yellow iron oxide (E172) for colouring.

The printing ink is composed of shellac, soya lecithin, hydroxypropylcellulose, simethicone and red iron oxide (E172).

What Prograf looks like and contents of the pack

Each yellow, hard gelatin capsule containing white powder is marked with ‘0.5mg' on the cap and ‘[f]607 on the body in red ink.

Prograf 0.5mg capsules are available as blister packs of 30 and 60 capsules.

Each blister strip contains 10 capsules. Three blister strips are enclosed in an aluminium wrapper with a sachet containing silica gel (a desiccant) to keep the capsules dry.

The desiccant should not be swallowed. The aluminium wrapper is contained in a carton.

POM    PL No: 06464/2759

This product is manufactured by Astellas Ireland Co. Ltd., Killorglin, Co. Kerry, Ireland and procured from within the EU and repackaged by the Product Licence Holder:

Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR

Leaflet revision and issue date: (Ref.) 28.03.2014

Prograf® is a registered trademark of Astellas.

This information is provided by Astellas Pharma Ltd, and is not associated with Waymade plc.

PROGRAF® 0.5 mg CAPSULES (tacrolimus)

Patient Information Leaflet

The name of your medicine is Prograf 0.5mg Capsules but it will be referred to as Prograf throughout the rest of this leaflet. Other strengths (1mg and 5mg) are also available.

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.    What Prograf is and what it is used for

2.    What you need to know before you take Prograf

3.    How to take Prograf

4.    Possible side effects

5.    How to store Prograf

6.    Contents of the pack and other information

1. What Prograf is and what it is used for

Prograf 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.

Prograf is used to control your body's immune response enabling your body to accept the transplanted organ. Prograf is often used in combination with other medicines that also suppress the immune system.

You may also be given Prograf for an ongoing 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 Prograf

Do not take Prograf

•    If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Prograf (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 Prograf

•    You will need to take Prograf 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 Prograf 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 Prograf 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 Prograf 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 Prograf that you receive.

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

•    Limit your exposure to sunlight and UV light whilst taking Prograf 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.

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 Prograf.

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 Prograf.

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

Prograf with food and drink

You should generally take Prograf 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 Prograf.

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.

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

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 Prograf. These effects are more frequently observed if Prograf is taken in conjunction with alcohol use.

Prograf contains lactose

• Prograf 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 Prograf

Always take Prograf exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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

This medicine should be taken twice a day. 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 Prograf dose once your condition has stabilised. Your doctor will tell you exactly how many capsules to take and how often.

Prograf is taken orally twice daily, usually in the morning and evening. You should generally take Prograf 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 Prograf. Do not swallow the desiccant contained in the foil wrapper.

If you take more Prograf than you should

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

If you forget to take Prograf

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

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

If you stop taking Prograf

Stopping your treatment with Prograf 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, Prograf can cause side effects, although not everybody gets them.

Prograf 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 Prograf you may therefore catch more infections than usual such as infections of the skin, mouth, stomach and intestines, lungs and urinary tract.

Severe effects have been reported, including allergic and anaphylactic reactions. Benign and malignant tumours have been reported following Prograf treatment as a result of immunosuppression.

Possible side effects are listed according to the following categories:

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

Common side effects are experienced in less than one in ten patients but in more than one per one hundred patients.

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

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):

•    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, 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 cramps

•    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

•    Insufficient function of your transplanted organ

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 of a 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

•    Serious illness with blistering of skin, mouth, eyes and genitals, 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

Cases of pure red cell aplasia (a very severe reduction in red blood cell counts), agranulocytosis (a severely lowered number of white blood cells) and haemolytic anaemia (decreased number of red blood cells due to abnormal breakdown) have been reported.

Reporting of side effects

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