VALGANCICLOVIR 450 mg Tabletki Powlekane

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1. Valganciclovir Mylan 450 mg film-coated tablets
   1. What is Valganciclovir Mylan and what is it used for
   2. What you need to know before taking Valganciclovir Mylan
2. Valganciclovir Mylan or if your doctor changes the dose you are taking. It is important
   1. How to take Valganciclovir Mylan
   2. Possible side effects
   3. How to store Valganciclovir Mylan
   4. Contents of the pack and other information

Valganciclovir Mylan 450 mg film-coated tablets

valganciclovir

Generic Equivalent Medicine

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 Valganciclovir Mylan is and what it is used for
• 2. What you need to know before you take Valganciclovir Mylan
• 3. How to take Valganciclovir Mylan
• 4. Possible side effects
• 5. How to store Valganciclovir Mylan
• 6. Contents of the pack and other information

1. What is Valganciclovir Mylan and what is it used for

Valganciclovir Mylan contains the active ingredient valganciclovir (as valganciclovir
hydrochloride). Valganciclovir Mylan belongs to a group of medicines that act directly to
prevent the growth of viruses. In the body, the active ingredient contained in the tablets,
valganciclovir, is modified into ganciclovir. Ganciclovir prevents a virus, called
cytomegalovirus (CMV), from multiplying and invading healthy cells. In patients with a weakened
immune system, CMV can cause an infection of the body's organs. This can be
life-threatening.
Valganciclovir Mylan is used:

• in the treatment of CMV infections of the retina of the eye in adult patients with acquired immunodeficiency syndrome (AIDS). CMV infection of the retina of the eye can cause vision problems and even blindness
• in the prevention of CMV infections in adults and children not infected with CMV who have received an organ transplant from a CMV-infected donor.

2. What you need to know before taking Valganciclovir Mylan

Do not take Valganciclovir Mylan:

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Valganciclovir Mylan

• if you are allergic to aciclovir, penciclovir, valaciclovir or famciclovir, that is to say the medicines used for the treatment of other viral infections
• if you have a low number of white blood cells, red blood cells or platelets (small cells involved in blood clotting) in your blood. Your doctor will perform some blood tests before and during treatment with Valganciclovir Mylan tablets
• if you are undergoing radiotherapy or haemodialysis
• if you have kidney problems. Your doctor may prescribe a reduced dose and subject you to frequent blood tests during treatment.
• if you are taking ganciclovir in capsules and your doctor wants to switch you to a treatment with

Valganciclovir Mylan or if your doctor changes the dose you are taking. It is important

that you do not take a number of tablets higher than that prescribed by your doctor. You could
run the risk of an overdose.

Other medicines and Valganciclovir Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take other
medicines.
If you take other medicines together with Valganciclovir Mylan this combination could affect the
levels of the medicine in your blood or cause harmful effects. Tell your doctor if you are
taking medicines that contain any of the following substances:

• imipenem-cilastatin (an antibiotic). Taking it with Valganciclovir Mylan can cause convulsions.
• zidovudine, didanosine, stavudine, tenofovir or similar medicines used in the treatment of AIDS.
• adefovir (used in the treatment of hepatitis B).
• probenecid (a medicine used in the treatment of gout). Taking probenecid together with Valganciclovir Mylan can increase the levels of ganciclovir in the blood.
• mycophenolate mofetil, cyclosporine or tacrolimus (used after transplants).
• vincristine, vinblastine, doxorubicin, hydroxyurea or similar medicines for the treatment of cancer.
• trimethoprim, trimethoprim/sulfamethoxazole combinations and dapsone (antibiotics).
• pentamidine (a medicine used for the treatment of parasitic infections or lung infections).
• flucytosine or amphotericin B (antifungal agents).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor for
advice before taking this medicine. Taking Valganciclovir Mylan during pregnancy can
be harmful to the fetus.
Pregnancy
Do not take Valganciclovir Mylan if you are pregnant, unless prescribed by your doctor.
Do not take Valganciclovir Mylan if you are breastfeeding. If your doctor intends to start
treatment with Valganciclovir Mylan, you must stop breastfeeding before taking this
medicine.
Breastfeeding
During treatment with Valganciclovir Mylan and for at least 30 days after stopping the
treatment, women of childbearing potential must use an effective method of contraception.
Men, whose partners are of childbearing potential, must use condoms during treatment with
Valganciclovir Mylan and for 90 days after the end of treatment.

Driving and operating machinery
During treatment with this medicine you should not drive or operate tools or machinery if
you experience dizziness, feel sleepy, tired, unsteady or confused.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

3. How to take Valganciclovir Mylan

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Exercise caution when handling the tablets. If you accidentally touch any damaged tablets, wash your hands thoroughly with soap and water. If any tablet dust comes into contact with your eyes, rinse them abundantly with sterile water or, if not available, with tap water.

Do not take more tablets than prescribed by your doctor; this will avoid cases of overdose.
Adults:
Prevention of CMV disease in patients undergoing transplantation
Start taking this medicine within 10 days of transplantation. The recommended dose is two tablets ONCE a day. Continue treatment with this dose for up to 100 days after transplantation. If you have undergone a kidney transplant, your doctor will advise you to take the tablets for 200 days.

Treatment of active CMV retinitis in patients with AIDS (called induction treatment)
The recommended dose is two tablets TWICE a day for 21 days (three weeks). Do not take this dose for more than 21 days unless your doctor tells you to. The risk of undesirable effects may increase.

Long-term treatment to prevent recurrence of active inflammation in patients with AIDS and CMV retinitis (called maintenance treatment)
The recommended dose is two tablets ONCE a day. Try to take the tablets every day at the same time. Your doctor will tell you how long you will need to continue taking Valganciclovir Mylan. If your retinitis worsens during treatment, your doctor will tell you to repeat the induction treatment (described above) and may decide to administer another medicine for the treatment of CMV infection.

Elderly patients
Valganciclovir Mylan has not been studied in elderly patients.

Patients with kidney problems
If your kidneys are not functioning properly, your doctor may prescribe you a smaller number of tablets per day or tell you to take them only on some days of the week. It is very importantthat you only take the number of tablets prescribed by your doctor.

Patients with liver problems
Valganciclovir Mylan has not been studied in subjects with liver problems.

Use in children and adolescents
Prevention of CMV disease in patients undergoing transplantation
Children should start treatment with this medicine within 10 days of transplantation. The dose will depend on the size of the child and must be taken ONCE a day. The doctor will establish the dose based on the child's height, weight and kidney function. Your child will continue treatment with this dose for up to 100 days after transplantation. If your child has undergone a kidney transplant, the doctor may recommend continuing therapy for 200 days.

How to administer

• Take Valganciclovir Mylan preferably with a full stomach. If for any reason you are unable to eat, take your dose of Valganciclovir Mylan as usual.
• Swallow the tablet whole. Do not crush or break the tablets.
• For children who are unable to swallow the tablet whole, other formulations are available. Ask your pharmacist.

If you take more Valganciclovir Mylan than you should
If you take or believe you have taken a number of tablets higher than you should, contact your doctor or hospital immediately. Taking too many tablets can cause serious side effects, which particularly affect the blood, liver or kidneys. Other side effects include abdominal pain, malaise, diarrhea, convulsions and tremor. You may need hospital treatment.

If you forget to take Valganciclovir Mylan
If you forget to take the tablets, take the dose as soon as you remember and then the next dose at the scheduled time. Do not take a double dose to make up for the missed tablet.

If you stop taking Valganciclovir Mylan
Do not stop treatment with the medicine until your doctor tells you to.
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 everybody gets them.

Stop taking Valganciclovir Mylan and contact your doctor or go to the nearest hospital emergency room
if you experience any of the following side effects:
Very common (may affect more than 1 in 10 people):

• low white blood cell count, manifesting with frequent infections, such as fever, chills, sore throat or mouth ulcers
• low red blood cell count - signs include shortness of breath or fatigue, palpitations or pale skin.

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

• reduction in the number of platelets - signs include increased ease of bleeding and bruising compared to normal, blood in the urine or stool, or bleeding gums which may be severe
• a reduction in the number of red blood cells, white blood cells and platelets (pancytopenia)
• inflammation of the pancreas (pancreatitis) with severe pain in the upper part of the stomach, often with nausea and vomiting
• convulsions
• infections caused by bacteria or viruses in the blood (sepsis) which can cause high fever, chills, headache, confusion and rapid breathing, swelling inside the eye (macular edema),
• retinal detachment (occurs when the innermost layer of the eye (retina) detaches)

Uncommon (may affect up to 1 in 100 people)

• insufficient production of blood cells in the bone marrow;
• seeing, feeling or perceiving things that are not real (hallucinations);
• unusual thoughts or sensations, loss of contact with reality;
• kidney function impairment.

Rare (may affect up to 1 in 1,000 people)
severe allergic reaction (anaphylactic shock). You may experience:
raised, itchy rash (urticaria),
sudden swelling of the throat, face, lips and mouth which can cause difficulty swallowing or
breathing,

• sudden swelling of the hands, feet or ankles.

These are serious side effects. You may need medical attention.

Other side effects that have been reported during treatment with valganciclovir or
ganciclovir are:
Very common (may affect more than 1 in 10 people):

• thrush and oral thrush (including oral candidiasis)
• upper respiratory tract infection (e.g. sinusitis, tonsillitis)
• loss of appetite
• headache
• cough
• shortness of breath and breathing problems (dyspnea)
• diarrhea
• feeling and state of unwellness
• stomach pain (abdominal pain)
• eczema (skin inflammation)
• fatigue
• fever

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

• influenza
• skin and subcutaneous tissue inflammation (cellulitis)
• inflammation or infection of the kidneys or bladder (which may include signs such as pain or discomfort when urinating, blood in the urine, abdominal pain, back pain, needing to urinate more often during the day or night)
• mild allergic reaction - signs may include redness and itching of the skin
• weight loss
• feeling depressed, anxious or confused
• difficulty sleeping (insomnia)
• altered sense of taste (dysgeusia)
• reduced sensitivity to touch (hypoesthesia)
• tingling or pins and needles sensation on the skin
• loss of sensation in the hands or feet (peripheral neuropathy),
• dizziness
• eye inflammation (conjunctivitis), eye pain or vision problems
• spots and lines (floaters) or flashes of light in the eyes
• ear pain
• low blood pressure (hypotension) causing a feeling of lightheadedness or fainting
• difficulty swallowing (dysphagia)
• constipation, flatulence, indigestion (dyspepsia), stomach discomfort, abdominal bloating
• mouth ulcers
• abnormalities in laboratory tests of liver and kidney function
• night sweats
• skin rash, itching
• hair loss (alopecia)
• back pain, muscle pain (myalgia) or joint pain (arthralgia), muscle cramps
• kidney problems resulting in increased levels of creatinine in the blood (a waste product)
• chills, aches, unusual weakness (asthenia), general feeling of being unwell.

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

• irregular heartbeat (arrhythmia)
• feeling restless
• tremors
• hearing loss
• dry skin
• urticaria
• blood in the urine
• infertility in men
• abdominal pain

Separation of the inner lining layer of the eye (so-called “retinal detachment”) has
occurred only in patients with AIDS treated with valganciclovir (the active substance of this
medicine) for a CMV infection.

Side effects in children and adolescents
Side effects reported in children and adolescents are similar to those reported in adults,
but are sometimes more frequent.

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 through the national reporting
system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-
reazione-avversa. By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Valganciclovir Mylan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the packaging after
‘EXP’. The expiry date refers to the last day of that month.
Use within 3 months of first opening.
This medicine does not require any particular precautions for storage.
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 Valganciclovir Mylan contains
The active ingredient is valganciclovir. Each tablet contains 450 mg of valganciclovir (as
valganciclovir hydrochloride).
The other ingredients are: microcrystalline cellulose (E460); crospovidone and stearic acid (E570),
hypromellose (E464), titanium dioxide (E171), macrogol, red iron oxide (E172) and polysorbate (E433).

Description of the appearance of Valganciclovir Mylan and contents of the pack
Valganciclovir Mylan are pink, film-coated, oval, biconvex tablets, with
rounded corners and “M” imprinted on one side and “V45” on the other; dimensions 18.4 mm x 8.4 mm.
Valganciclovir Mylan is packaged in HDPE bottles with a child-resistant closure, containing
60 film-coated tablets, in blister packs of 60 film-coated tablets or in a divisible blister for
unit dose of 60 x 1 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A. via Vittor Pisani 20, 20124 Milano - Italy

Manufacturer
Mylan Hungary Kft.
H-2900 Komárom
Mylan utca 1,
Hungary
Generics [UK] Limited
Station Close
Potters Bar
Hertfordshire
EN6 1TL
United Kingdom

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