Valganciclovir Mylan

PACKAGE LEAFLET

Package leaflet: Information for the patient

Valganciclovir Mylan 450 mg film-coated tablets

valganciclovir
Generic Medicine
Please read this leaflet carefully before 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult 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 taking Valganciclovir Mylan
3. How to take Valganciclovir Mylan
4. Possible side effects
5. How to store Valganciclovir Mylan
6. Package contents and other information

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

Valganciclovir Mylan contains the active substance 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 substance contained in the tablets,
valganciclovir, is converted 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 infection in various organs of the body. This can be life-threatening.
Valganciclovir Mylan is used:

• for the treatment of CMV retinitis in adult patients with acquired immunodeficiency syndrome (AIDS). CMV infection of the eye's retina can lead to vision problems and even blindness
• to prevent CMV infections in adults and children who are not infected with CMV but who have received an organ transplant from a CMV-infected donor.

2. What you should 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—medicines used to treat other viral infections
• if you have low levels of white blood cells, red blood cells, or platelets (small cells involved in blood clotting) in your blood. Your doctor will perform blood tests before and during treatment with Valganciclovir Mylan tablets
• if you are undergoing radiotherapy or hemodialysis
• if you have kidney problems. Your doctor may prescribe a lower dose and carry out frequent blood tests during treatment.
• if you are currently taking ganciclovir capsules and your doctor wants to switch you to Valganciclovir Mylan, or if your doctor changes your dose. It is important that you do not take more tablets than prescribed by your doctor, as this may lead to overdose.

Other medicines and Valganciclovir Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking other medicines together with Valganciclovir Mylan may affect the levels of the medicine in your blood or cause harmful effects. Inform your doctor if you are taking medicines containing any of the following substances:

• imipenem-cilastatin (an antibiotic). Taking this with Valganciclovir Mylan may cause seizures.
• 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 to treat gout). Taking probenecid with Valganciclovir Mylan may increase ganciclovir levels in the blood.
• mycophenolate mofetil, cyclosporine, or tacrolimus (used after organ transplants).
• vincristine, vinblastine, doxorubicin, hydroxyurea, or similar medicines used to treat cancer.
• trimethoprim, trimethoprim/sulfamethoxazole combinations, or dapsone (antibiotics).
• pentamidine (a medicine used to treat parasitic infections or lung infections).
• flucytosine or amphotericin B (antifungal agents).

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine. Taking Valganciclovir Mylan during pregnancy may be harmful to the unborn baby.
Pregnancy
Do not take Valganciclovir Mylan during pregnancy unless specifically instructed 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
Women of childbearing age should use an effective method of contraception during treatment with Valganciclovir Mylan and for at least 30 days after stopping treatment.
Men whose partners are of childbearing age should use condoms during treatment with Valganciclovir Mylan and for 90 days after the end of treatment.

Driving and using machines
While taking this medicine, do not drive or operate tools or machinery if you experience dizziness, drowsiness, tiredness, unsteadiness, or confusion.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

3. How to take Valganciclovir Mylan

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Be cautious when handling the tablets. If you accidentally touch damaged tablets, wash your hands thoroughly with soap and water. If any tablet powder comes into contact with your eyes, rinse them thoroughly with sterile water or, if unavailable, with tap water.
Do not take more tablets than prescribed by your doctor; this will help you avoid overdose.

Adults:
Prevention of CMV disease in transplant patients
Start taking this medicine within 10 days after transplantation. The recommended dose is two tablets ONCE daily. Continue treatment with this dose until 100 days after transplantation. If you have received a kidney transplant, your doctor may advise you to continue taking the tablets for 200 days.

Treatment of active CMV retinitis in patients with AIDS (known as induction treatment)
The recommended dose is two tablets TWICE daily for 21 days (three weeks). Do not take this dose for longer than 21 days unless instructed otherwise by your doctor, as the risk of side effects may increase.

Long-term treatment to prevent recurrence of active inflammation in patients with AIDS and CMV retinitis (known as maintenance treatment)
The recommended dose is two tablets ONCE daily. Try to take the tablets at the same time each day. Your doctor will tell you how long you should continue taking Valganciclovir Mylan. If your retinitis worsens during treatment, your doctor may instruct 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 a lower number of tablets per day or advise you to take them only on certain days of the week. It is very important that you take only the number of tablets prescribed by your doctor.

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

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

Instructions for administration

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

If you take more Valganciclovir Mylan than you should
If you take or think you have taken more tablets than prescribed, contact your doctor or go to hospital immediately. Taking too many tablets may cause serious side effects, particularly affecting the blood, liver, or kidneys. Other side effects may include abdominal pain, malaise, diarrhea, seizures, and tremor. You may require hospital treatment.

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

If you stop taking Valganciclovir Mylan
Do not stop treatment with this medicine unless instructed by your doctor.

If you have any questions about the use of this medicine, consult 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 department
if you think you are experiencing any of the following side effects:
Very common (may affect more than 1 in 10 people):

• low white blood cell count leading to frequent infections, such as fever, chills, sore throat or mouth ulcers
• low red blood cell count – signs include shortness of breath or tiredness, palpitations or pale skin

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

• reduced number of platelets – signs include increased tendency to bleed and bruise more easily than normal, blood in urine or stools, or bleeding gums which could be severe
• a reduction in the number of red and white blood cells and platelets (pancytopenia)
• inflammation of the pancreas (pancreatitis) causing severe pain in the upper abdomen, often with nausea and vomiting
• seizures
• bacterial or viral infections in the blood (sepsis) which may cause high fever, chills, headache, confusion and rapid breathing
• swelling inside the eye (macular edema)
• retinal detachment (occurs when the innermost membrane of the eye (retina) becomes detached)

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

• inadequate production of blood cells in the bone marrow
• seeing, hearing or feeling things that are not real (hallucinations)
• unusual thoughts or feelings, loss of contact with reality
• impaired kidney function

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

• sudden swelling of the hands, feet or ankles.

These are serious side effects. You may need medical treatment.
Other side effects observed during treatment with valganciclovir or
ganciclovir include:
Very common (may affect more than 1 in 10 people):

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

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

• influenza
• inflammation of the skin and underlying tissues (cellulitis)
• inflammation or infection of the kidneys or bladder (which may include symptoms such as pain or discomfort during urination, blood in urine, abdominal pain, back pain, or need to urinate more frequently during the day or night)
• mild allergic reaction – signs may include skin redness and itching
• weight loss
• feeling depressed, anxious or confused
• difficulty sleeping (insomnia)
• altered taste (dysgeusia)
• reduced sensitivity to touch (hypoesthesia)
• pins and needles sensation or tingling on the skin
• loss of sensation in 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 dizziness or fainting
• difficulty swallowing (dysphagia)
• constipation, flatulence, indigestion (dyspepsia), stomach ache, abdominal bloating
• mouth ulcers
• abnormal laboratory test results for 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 leading to increased levels of creatinine in the blood (waste product)
• chills, aches, unusual weakness (asthenia), general feeling of being unwell

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

• abnormal heartbeat (arrhythmia)
• feeling agitated
• tremors
• deafness
• dry skin
• urticaria
• blood in urine
• infertility in men
• abdominal pain

Separation of the inner lining layer of the eye (so-called "retinal detachment") has occurred only in AIDS patients treated with valganciclovir (the active substance in this medicine) for CMV infection.
Side effects in children and adolescents
The side effects reported in children and adolescents are similar to those reported in adults, but may sometimes occur more frequently.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: 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 the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the carton 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 special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Valganciclovir Mylan contains
The active substance is valganciclovir. Each tablet contains 450 mg of valganciclovir (as
valganciclovir hydrochloride).
The other components 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 package contents
Valganciclovir Mylan are pink, film-coated, oval, biconvex tablets with bevelled edges, marked with "M" on one side and "V45" on the other; size 18.4 mm x 8.4 mm.
Valganciclovir Mylan is packaged in HDPE bottles with child-resistant closure containing
60 film-coated tablets, in blisters containing 60 film-coated tablets, or in unit-dose divisible blisters of 60 x 1 film-coated tablets.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani 20, 20124 Milan - 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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