VIVADEX 0.5MG HARD CAPSULES

Active substance: TACROLIMUS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

VIVADEX 0.5mg HARD CAPSULES
VIVADEX 1mg HARD CAPSULES
VIVADEX 5mg HARD CAPSULES
Tacrolimus
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, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

· the corticosteroids prednisolone and methylprednisolone
· the anti-depressant nefazodone
· St. John’s Wort (Hypericum perforatum)

In this leaflet:
1. What VIVADEX is and what it is used for
2. Before you take VIVADEX
3. How to take VIVADEX
4. Possible side effects
5. How to store VIVADEX
6. Further information

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

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
VIVADEX.

Taking VIVADEX with food and drink
You should generally take VIVADEX 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 VIVADEX.

1. WHAT VIVADEX IS AND WHAT IT IS USED FOR
VIVADEX belongs to a group of medicines called immunosuppressant. Following your organ
transplant (e.g. liver, kidney, heart), your body’s immune system will try to reject the new organ.
VIVADEX is used to control your body’s immune response enabling your body to accept the
transplanted organ. VIVADEX is often used in combination with other medicines that also suppress
the immune system.

Pregnancy and breast-feeding
If you plan to become pregnant or think that you may be pregnant, ask your doctor or pharmacist
for advice before taking any medicine.
VIVADEX is excreted into breast milk. Therefore you should not breast-feed whilst receiving
VIVADEX.

You may also be given VIVADEX 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.

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

2. BEFORE YOU TAKE VIVADEX
Do not take VIVADEX
• If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of VIVADEX.
• If you are allergic (hypersensitive) to any antibiotic belonging to the subgroup of macrolide
antibiotics (e.g. erythromycin, clarithromycin, josamycin).

Important information about some of the ingredients of VIVADEX
VIVADEX 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.

Take special care with VIVADEX
- You will need to take VIVADEX 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 VIVADEX 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 VIVADEX 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 VIVADEX 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 VIVADEX 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 VIVADEX that you receive.
- Limit your exposure to sunlight and UV light whilst taking VIVADEX 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription and herbal remedies.

Irina

20.09.12

VIVADEX 0.5/1/5mg
Dexcel-Pharma

VIVADEX must not be taken with ciclosporin.
VIVADEX blood levels can be affected by other medicines you take, and blood levels of other
medicines can be affected by taking VIVADEX which may require an increase or decrease in
VIVADEX dose. In particular, you should tell your doctor if you are taking or have recently taken
medicines with active substances like:
· 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
· omeprazole or lansoprazole, used for treating stomach ulcers
· 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
· medicines known as “statins” used to treat elevated cholesterol and triglycerides
· the anti-epileptic medicines phenytoin or phenobarbital

3. HOW TO TAKE VIVADEX
Always take VIVADEX 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 VIVADEX dose once
your condition has stabilised. Your doctor will tell you exactly how many capsules to take and
how often.
VIVADEX is taken orally twice daily, usually in the morning and evening. You should generally
take VIVADEX 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 VIVADEX.
Do not swallow the desiccant contained in the foil wrapper.
If you take more VIVADEX than you should
If you have accidentally taken too much VIVADEX see your doctor or contact your nearest
hospital emergency department immediately.
If you forget to take VIVADEX
Do not take a double dose to make up for forgotten individual doses.
If you have forgotten to take your VIVADEX capsules, wait until it is time for the next dose, and
then continue as before.
If you stop taking VIVADEX
Stopping your treatment with VIVADEX 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, VIVADEX can cause side effects, although not everybody gets them.

· Serious illness with blistering of skin, mouth, eyes and genitals, increased hairiness
· Thirst, fall, feeling of tightness in your chest, decreased mobility, ulcer

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

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

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

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.

If any of the side effects gets serious or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

Very common side effects:
· 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:
· 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 throat, 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:
· 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 bleedings
· 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:
· 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

Very rare side effects:
Muscular weakness
Echocardiogram abnormal
Liver failure, narrowing of the bile vessel
Painful urination with blood in the urine
Increase of fat tissue

5. HOW TO STORE VIVADEX
Keep out of the reach and sight of children.
Take the hard capsules immediately following removal from the blister.
Store in the original package (within the foil pouch) in order to protect from moisture & light.
Do not use VIVADEX 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.
Store below 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect the
environment.
6. FURTHER INFORMATION
What VIVADEX contains
VIVADEX 0.5 mg hard capsules
The active substance is tacrolimus.
For 0.5mg: Each capsule contains 0.5mg of tacrolimus
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
VIVADEX 1 mg hard capsules
The active substance is tacrolimus.
For 1 mg: Each capsule contains 1mg of tacrolimus
The other ingredients are:
Capsule content: Povidone K-30, Croscarmellose Sodium (E 468), Lactose anhydrous,
Magnesium stearate.
Capsule shell: Titanium dioxide (E-171), Gelatin
VIVADEX 5 mg hard capsules
The active substance is tacrolimus.
For 5mg: Each capsule contains 5mg of tacrolimus
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 VIVADEX looks like and contents of the pack
VIVADEX 0.5 mg hard capsules
Ivory cap and ivory body hard shell capsules with white powder.
VIVADEX 0.5 mg hard capsules are supplied as blister strips containing 10 capsules within a
protective foil wrapper, including a desiccant protecting the capsules from moisture. The
desiccant should not be swallowed.
VIVADEX 1 mg hard capsules
White cap and white body hard shell capsules with white powder.
VIVADEX 1 mg hard capsules are supplied as blister strips containing 10 capsules within a
protective foil wrapper, including a desiccant protecting the capsules from moisture. The
desiccant should not be swallowed.
VIVADEX 5 mg hard capsules
Red cap and red body hard shell capsules with white powder.
VIVADEX 5 mg hard capsules are supplied as blister strips containing 10 capsules within a
protective foil wrapper, including a desiccant protecting the capsules from moisture. The
desiccant should not be swallowed.
VIVADEX is available in blister packs containing blister strips of 10 capsules each.
Pack sizes: 50, 60, 90,100 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder: Dexcel® - Pharma Ltd., 7 Sopwith Way, Drayton Fields,
Daventry, Northamptonshire, NN11 8PB, UK.
Manufacturer: Laboratorios Cinfa, S.A., Olaz-Chipi, 10-Polig Areta 31620 Huarte-Pamplona,
Navarra, Spain.
This leaflet was last revised in September 2012.
V-847

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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