VALGANCICLOVIR 450 mg Film-Coated Tablets

Зміст інструкції

1. Valganciclovir Accord 450 mg film-coated tablets
   1. What Valganciclovir Accord is and what it is used for
   2. What you need to know before taking Valganciclovir Accord
   3. How to take Valganciclovir Accord
   4. Possible side effects
   5. How to store Valganciclovir Accord
   6. Package contents and other information

Valganciclovir Accord 450 mg film-coated tablets

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

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

Valganciclovir Accord belongs to a group of medicines that acts directly by preventing the growth
of viruses. Inside the body, the active ingredient of the tablets, valganciclovir, is converted to
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 which can be life-threatening.
Valganciclovir Accord is used:

• for the treatment of CMV infections of the retina of the eye in patients with acquired immunodeficiency syndrome (AIDS). CMV infection of the retina of the eye can cause visual problems and even blindness.
• to prevent CMV infections in adults and children not infected with CMV who have received an organ transplant from a person infected with CMV.

2. What you need to know before taking Valganciclovir Accord

Do not take Valganciclovir Accord

• if you are allergic to valganciclovir or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to ganciclovir, aciclovir or valaciclovir, which are medicines used to treat other viral infections.
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Valganciclovir Accord.
Pay particular attention with Valganciclovir Accord:

• 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 have blood tests done before you start treatment with Valganciclovir Accord tablets and other tests during the period you are taking the tablets.
• if you are undergoing radiotherapy or haemodialysis.
• if you have a kidney problem. Your doctor may prescribe a reduced dose and may subject you to frequent blood tests during treatment.
• if you are taking ganciclovir capsules and your doctor wants to change your therapy to Valganciclovir Accord tablets. It is important that you do not take a number of tablets greater than that prescribed by your doctor, or you may risk an overdose.

Other medicines and Valganciclovir Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available without a prescription.
If you take other medicines at the same time as Valganciclovir Accord, the combination could
change the amount of drug that enters the bloodstream or could cause harmful effects.
Tell your doctor if you are already taking medicines that contain any of the following:

• imipenem-cilastatin (an antibiotic). Taking it at the same time as Valganciclovir Accord can cause convulsions (seizures)
• zidovudine, didanosine, lamivudine, tenofovir, abacavir, emtricitabine or similar drugs used to treat AIDS
• ribavirin, peginterferons, adefovir and entecavir used to treat hepatitis B/C
• probenecid (a medicine against gout). Taking probenecid and Valganciclovir Accord at the same time can increase the amount of ganciclovir in the blood
• mycophenolate mofetil (used after transplants)
• vincristine, vinblastine, adriamycin, hydroxyurea or similar drugs to treat cancer
• cidofovir or foscarnet, used against viral infections
• trimethoprim, trimethoprim/sulfamethoxazole combinations and dapsone (antibiotics)
• pentamidine (a drug to treat parasitic or lung infections)
• flucytosine or amphotericin B (anti-fungal agents)

Valganciclovir Accord with food and drink
Valganciclovir Accord must be taken with food. If you cannot eat for any reason, you should
still take your dose of Valganciclovir Accord as usual.

Pregnancy, breastfeeding and fertility
Do not take Valganciclovir Accord if you are pregnant unless recommended by your doctor.
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Taking Valganciclovir Accord during pregnancy may be harmful to the unborn child.
You must not take Valganciclovir Accord if you are breastfeeding. If your doctor decides to start you on
treatment with Valganciclovir Accord, stop breastfeeding before taking the tablets.

Women of childbearing potential
During treatment with Valganciclovir Accord, women of childbearing potential must use an effective
contraceptive method.

Men
Men whose partner could become pregnant must use a condom during
treatment with Valganciclovir Accord and for 90 days after the end of treatment.

Driving and using machines
Do not drive vehicles or use tools or machines if you experience dizziness, fatigue, tremor or confusion
while taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.

3. How to take Valganciclovir Accord

Take this medicine always exactly as your doctor or pharmacist has told you. If you have
doubts, ask your doctor or pharmacist.
Be careful when handling the tablets. Do not break or crush the tablets. The tablets must
be swallowed whole, and if possible, with food. If you accidentally touch any damaged
tablets, wash your hands thoroughly with soap and water. If the tablet powder comes into
contact with your eyes, rinse your eyes with sterile water or, if this is not available, with clean water.

To avoid an overdose, you must adhere to the number of tablets indicated by your doctor.
Valganciclovir Accord tablets should be taken with food, when possible - see section 2.

Adults:
Prevention of CMV disease in patients who have undergone a transplant
You should start taking this medicine within 10 days of the transplant. The recommended dose is two
tablets taken ONCE a day. You should continue with this dose for up to 100 days after the
transplant. If you have received a kidney transplant, your doctor may advise you to take the tablets for 200
days.

Treatment of active CMV retinitis in patients with AIDS (called induction treatment)
The recommended dose of Valganciclovir Accord 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, as
this may increase the risk of side effects.

Long-term treatment to prevent recurrence of active inflammation in patients with
AIDS with CMV retinitis (called maintenance treatment)
The recommended dose is two tablets ONCE a day. You should try to take the tablets
at the same time each day. Your doctor will advise you how long you should continue to take
Valganciclovir Accord. If your retinitis worsens while you are taking this dose, your doctor may tell you
to repeat the induction treatment (as above) or decide to give you another medicine to treat
CMV infection.

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

Patients with kidney problems
If your kidneys are not working properly, your doctor may prescribe you a lower number of
tablets a day or tell you to take the tablets only on certain days of the week. It is very important
that you only take the number of tablets that have been prescribed by your doctor.

Patients with liver problems
There are no studies with valganciclovir in patients with liver problems.

Use in children and adolescents
Prevention of CMV disease in patients undergoing transplantation
Children should start taking this medicine within 10 days of the transplant. The dose given
will depend on how big the child is and must be taken ONCE a day. Your doctor will decide the most appropriate dose based on height, weight and kidney function of your child. The
administration of this dose should continue for a period of up to 100 days. If your child has
undergone a kidney transplant, your doctor may indicate taking the dose for 200 days.
For children who are unable to swallow Valganciclovir Accord film-coated tablets, valganciclovir powder for oral solution may
be used.

If you take more Valganciclovir Accord than you should
If you have taken or think you have taken more tablets than you should, contact your doctor or
hospital immediately. Taking an excessive number of tablets can cause serious side effects,
especially affecting the blood or kidneys. You may need hospital treatment.

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

If you stop taking Valganciclovir Accord
You should not stop taking this medicine unless your doctor tells you to do so.
If you have any questions about using 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.

Allergic reactions
Up to 1 in 100 patients may have a sudden and severe allergic reaction to valganciclovir (anaphylactic shock). STOPtreatment with Valganciclovir Accord and go to the nearest hospital emergency room if you experience any of the following reactions:

• raised, itchy rash (urticaria)
• sudden swelling of the throat, face, lips and mouth causing difficulty swallowing or breathing
• sudden swelling of the hands, feet or ankles.

Side effects that have occurred during treatment with valganciclovir or ganciclovir are
listed below.

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

• Effects on the blood: reduction in the number of white blood cells in the blood (neutropenia) which will make you more susceptible to infections, reduction in the blood particles that carry oxygen (anaemia) which can cause fatigue and shortness of breath when you exercise
• Effects on breathing: feeling of shortness of breath or difficulty breathing (dyspnoea)
• Effects on the stomach and digestion: diarrhoea

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

• Effects on the blood: reduction in the number of leukocytes (blood cells that fight infections) in the blood (leucopenia), reduction in the number of platelets in the blood (thrombocytopenia) which can cause bruising and bleeding, and a simultaneous reduction in the number of different types of blood cells (pancytopenia)
• Effects on the nervous system: headache, difficulty sleeping (insomnia), altered taste (dysgeusia), reduced sensitivity to touch (hypoaesthesia), a sensation of pins and needles in the skin (paraesthesia), loss of sensation in the hands or feet (peripheral neuropathy), dizziness and seizures (convulsions)
• Effects on the eyes: eye pain, swelling inside the eyes (oedema), separation of the inner lining of the eye (retinal detachment) and seeing floaters
• Effects on the ears: earache
• Effects on breathing: cough
• Effects on the stomach and digestion: nausea and vomiting, stomach pain, constipation, flatulence, indigestion (dyspepsia) and difficulty swallowing (dysphagia)
• Effects on the skin: inflamed skin (dermatitis), itching and night sweats
• Effects on muscles, joints or bones: back pain, muscle (myalgia) or joint (arthralgia) pain, muscle stiffness (rigidity) and muscle cramps
• Infections: fungal infections of the mouth (oral candidiasis), infections caused by bacteria or viruses in the blood, inflammation of the tissue (cellulitis), inflammation or infection of the kidneys or bladder
• Effects on the liver: increased levels of certain liver enzymes, detectable only by blood tests.
• Effects on the kidneys: altered normal kidney function
• Effects on nutrition: loss of appetite (anorexia), weight loss
• General effects: fatigue, fever, pain, chest pain, loss of energy (asthenia) and a general feeling of being unwell
• Effects on mood or behaviour: depression, feeling anxious, confusion and unusual thoughts Uncommon(may affect up to 1 in 100 people):
• Effects on the heart: changes in normal heartbeat (arrhythmia)
• Effects on circulation: reduced blood pressure (hypotension), which can cause fainting and dizziness
• Effects on the blood: reduced production of blood cells in the bone marrow
• Effects on the nervous system: shivering or trembling (tremor)
• Effects on the eyes: red, swollen eyes (conjunctivitis), abnormal vision
• Effects on the ears: deafness
• Effects on the stomach and digestion: bloated abdomen, ulcers in the mouth, inflammation of the pancreas (pancreatitis), which can cause severe stomach and back pain
• Effects on the skin: hair loss (alopecia), itchy or swollen rash (urticaria), dry skin.
• Effects on the kidneys: blood in the urine (haematuria), kidney failure
• Effects on the liver: increased levels of a liver enzyme called alanine aminotransferase (detectable only by blood tests)
• Effects on fertility: infertility in men
• Effects on mood or behaviour: unusual changes in mood and behaviour, loss of contact with reality such as hearing voices or seeing things that are not there, feeling agitated. Rare(may affect up to 1 in 10,000 people):
• Effects on the blood: failure in the production of all types of blood cells (red blood cells, white blood cells and platelets) in the bone marrow. Separation of the inner lining of the eye (retinal detachment) has only occurred in patients with AIDS treated with valganciclovir for a CMV infection.

Additional side effects in children and adolescents
Side effects reported in children and adolescents are similar to those reported in adults.

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 www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Valganciclovir Accord

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 or the packaging, after “Exp”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 Accord contains
The active ingredient is valganciclovir 450 mg, corresponding to 496.3 mg of valganciclovir hydrochloride.
The other ingredients are:
Tablet core: microcrystalline cellulose, crospovidone type A, povidone (K-30) and stearic acid

• (50). Tablet coating: hypromellose 3 cP, hypromellose 6 cP, titanium dioxide (E171), macrogol 400, red iron oxide (E172) and polysorbate 80.

Description of the appearance of Valganciclovir Accord and package contents
Valganciclovir Accord are 450 mg film-coated tablets. The tablets are described below.
Film-coated tablets of approximately 16.7 x 7.8 mm, pink in color, oval in shape,
biconvex, with a “J” imprinted on one side and “156” on the other side.
Valganciclovir Accord is available in

• OPA-Aluminum-PVC/Aluminum blisters in a carton: 30, 60, 90 or 120 tablets
• HDPE bottle filled with purified cotton, with a child-resistant screw cap with a coating paste (made of a wax support, foil, PET and heat sealing): 60 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer Responsible for batch release
Pharmadox Healthcare, Ltd.
KW20A Kordin Industrial Park, Paola, PLA 3000
Malta
Accord Healthcare Limited
Sage House, 319 Pinner Road, Harrow, Middlesex
HA1 4HF
United Kingdom
WESSLING Hungary Kft.
Budapest, 1047,
Fóti út 56
Hungary

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations: