Valganciclovir Aurobindo: detailed information

Package leaflet: Information for the user

Valganciclovir Aurobindo 450 mg film-coated tablets

Equivalent medicine
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Valganciclovir Aurobindo is and what it is used for
What you need to know before taking Valganciclovir Aurobindo
How to take Valganciclovir Aurobindo
Possible side effects
How to store Valganciclovir Aurobindo
Contents of the pack and other information

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

Valganciclovir Aurobindo belongs to a group of medicines that act directly by preventing the growth of viruses. In the body, the active substance in the tablet, called valganciclovir, is converted into ganciclovir. Ganciclovir prevents a virus, cytomegalovirus (CMV), from multiplying and invading healthy cells. In patients with a weakened immune system, CMV can cause organ infections that may be life-threatening.

Valganciclovir Aurobindo is used:

to treat CMV retinitis in adult patients with acquired immunodeficiency syndrome (AIDS). These infections can cause vision problems and may even lead to blindness;
to prevent CMV infections in adults and children who are not infected with the virus but who have received an organ transplant from a donor who was infected with CMV.

2. What you need to know before taking Valganciclovir Aurobindo

Do not take Valganciclovir Aurobindo

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

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

if you are allergic to aciclovir, penciclovir, valaciclovir, or famciclovir, other medicines used to treat viral infections. Pay special attention with Valganciclovir Aurobindo 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 you start taking Valganciclovir Aurobindo and will prescribe further tests during treatment with the tablets;
you are undergoing radiotherapy or haemodialysis;
you have kidney problems. Your doctor may prescribe a reduced dose and may require frequent blood tests during treatment;
you are taking ganciclovir in capsules and your doctor wishes to switch your treatment to Valganciclovir Aurobindo tablets. It is important that you do not take more tablets than prescribed by your doctor, as you may risk an overdose.

Other medicines and Valganciclovir Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking other medicines together with Valganciclovir Aurobindo may alter the amount of drug entering the bloodstream or may cause harmful effects. Inform your doctor if you are already taking medicines containing any of the following active substances:

imipenem-cilastatin (an antibiotic): when taken together with Valganciclovir Aurobindo, it may cause seizures (epileptic fits);
zidovudine, didanosine, lamivudine, stavudine, tenofovir, abacavir, emtricitabine, or similar medicines used to treat AIDS;
adefovir or any other medicine used to treat hepatitis B;
probenecid (a medicine for gout). If taken at the same time as Valganciclovir Aurobindo, it may increase the amount of ganciclovir in the blood;
mycophenolate mofetil, cyclosporine, or tacrolimus (used after transplants);
vincristine, vinblastine, doxorubicin, hydroxyurea, or similar medicines used to treat cancer;
trimethoprim, trimethoprim/sulphonamide combinations, and dapsone (antibiotics);
pentamidine (a medicine to treat lung or parasitic infections);
flucytosine or amphotericin B (antifungal agents).

Valganciclovir Aurobindo with food and drink
Valganciclovir Aurobindo should be taken with food. If, for any reason, you are unable to eat, you should still take your usual dose of Valganciclovir Aurobindo.
Pregnancy, breastfeeding and fertility
If you are pregnant, you must not take Valganciclovir Aurobindo unless your doctor recommends it. You must inform your doctor if you are pregnant or planning to become pregnant. Use of Valganciclovir Aurobindo during pregnancy may harm the unborn child.
You must not take Valganciclovir Aurobindo if you are breastfeeding. If your doctor wants to start treatment with Valganciclovir Aurobindo, you must stop breastfeeding first.
Women of childbearing age must use an effective method of contraception during treatment with Valganciclovir Aurobindo and for at least 30 days after treatment ends.
Men with partners who could become pregnant must use a condom during treatment with Valganciclovir Aurobindo and continue using it for 90 days after treatment ends.
Driving and using machines
Do not drive or operate tools or machinery if, after taking the medicine, you feel dizzy, tired, confused, or experience tremors.
Ask your doctor or pharmacist for advice before taking any medicine.

3. How to take Valganciclovir Aurobindo

Take this medicine exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult 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 damaged tablets, wash your hands thoroughly with soap and water. If the powder from the tablets comes into contact with your eyes, rinse them with sterile water or, if this is not available, with clean water.
Take the number of tablets prescribed by your doctor to avoid an excessive dose.
If possible, Valganciclovir Aurobindo should be taken with food (see section 2).

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

Treatment of active CMV retinitis in patients with AIDS (called induction treatment)
The usual dose of Valganciclovir Aurobindo is two tablets TWICE daily for 21 days (three weeks). Do not take this dose for longer than 21 days unless your doctor tells you to do so, as this may increase the risk of possible side effects.

Long-term treatment to prevent recurrence of active inflammation in patients with AIDS and CMV retinitis (called maintenance treatment)
The usual dose is two tablets ONCE daily. Try to take the tablets at the same time each day. Your doctor will advise you on how long you should continue taking Valganciclovir Aurobindo. If your retinitis worsens while taking this dose, your doctor may instruct you to repeat the induction treatment (as above) or may decide to prescribe another medicine for CMV infection.

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

Patients with kidney problems
If you have kidney problems, your doctor may prescribe a lower number of tablets per day or may instruct you to take the tablets 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 has not been studied in patients with liver problems.

Use in children and adolescents:
Prevention of CMV disease in transplant patients
Children should start taking this medicine within 10 days after transplantation. The dose administered will depend on the child's size and must be taken ONCE daily. Your doctor will determine the most appropriate dose based on the child's height, weight, and kidney function. This dose should be continued for up to 100 days. If the child has received a kidney transplant, the doctor may recommend continuing the dose for 200 days.
For children unable to swallow valganciclovir coated tablets, valganciclovir powder for oral solution is available.

If you take more Valganciclovir Aurobindo than you should
If you have taken or think you have taken more tablets than you should, contact your doctor or hospital immediately. Taking too many tablets may cause serious side effects, particularly affecting the blood or kidneys. You may need to receive treatment in hospital.

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

If you stop taking Valganciclovir Aurobindo
Do not stop treatment with this medicine unless your doctor tells you to do so.
If you have any questions about how to use 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 1,000 people may experience a sudden and severe allergic reaction to valganciclovir (anaphylactic shock). If you notice any of the following conditions, STOP taking valganciclovir immediately and go to the nearest hospital emergency department:

severe 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.

Serious side effects
Inform your doctor immediately if you notice any of the following serious side effects. Your doctor may advise you to stop taking valganciclovir, and you may require urgent medical treatment.

Very common: may affect more than 1 in 10 people

decrease in the number of white blood cells – accompanied by signs of infection such as sore throat, mouth ulcers, or fever;
decrease in the number of red blood cells – signs include shortness of breath or fatigue, palpitations, or pale skin.

Common: may affect up to 1 in 10 people

blood infection (sepsis) – signs include fever, chills, palpitations, confusion, and difficulty speaking;
reduction in platelet levels – signs include increased tendency to bleed or bruise more easily than normal, blood in urine or stools, or bleeding gums, which could be severe;
severe decrease in blood cells;
pancreatitis – signs are severe abdominal pain radiating to the back;
seizures.

Uncommon: may affect up to 1 in 100 people

inadequate production of blood cells in the bone marrow;
hallucinations – hearing or seeing things that are not real;
unusual thoughts or feelings, loss of touch with reality;
impaired kidney function.

The side effects observed during treatment with valganciclovir or ganciclovir are listed below.

Other side effects
Inform your doctor or pharmacist if you notice any of the following side effects:

Very common: may affect more than 1 in 10 people

candidiasis and oral candidiasis;
upper respiratory tract infection (e.g. sinusitis, tonsillitis);
loss of appetite;
headache;
cough;
shortness of breath;
diarrhoea;
feeling unwell or malaise;
abdominal pain;
eczema;
fatigue;
fever.

Common: may affect up to 1 in 10 people

influenza;
urinary tract infection – signs include fever, more frequent urination, pain during urination;
skin and subcutaneous tissue infection;
mild allergic reaction – signs may include skin redness and itching;
weight loss;
depression, anxiety, or confusion;
difficulty sleeping;
weakness or numbness in hands or feet, which may affect balance;
altered sense of touch, tingling sensation, tickling, itching, or burning;
taste disturbances;
chills;
eye inflammation (conjunctivitis), eye pain, or vision problems;
ear pain;
low blood pressure, which may cause dizziness or fainting;
difficulty swallowing;
constipation, flatulence, indigestion, stomach ache, abdominal bloating;
mouth ulcers;
abnormalities in laboratory test results related to liver and kidney function;
night sweats;
itching, skin rash;
hair loss;
back pain, muscle or joint pain, muscle spasms;
dizziness, weakness, or general feeling of malaise.

Uncommon: may affect up to 1 in 100 people

agitation;
tremor, chills;
deafness;
irregular heartbeat;
urticaria, dry skin;
blood in urine;
infertility in men – see section “Fertility”;
chest pain.

Separation of the inner lining layer of the eye (so-called "retinal detachment") has occurred only in patients with AIDS treated with valganciclovir for CMV infection.

Other side effects in children and adolescents
The side effects reported in children and adolescents are similar to those reported in adults.

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 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 Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton after EXP. The expiry date refers to the last day of that month.
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 Aurobindo contains

The active substance is valganciclovir. Each film-coated tablet contains valganciclovir hydrochloride equivalent to 450 mg of valganciclovir.
The other ingredients are:
Tablet core: microcrystalline cellulose (grade-101 and grade-102), crospovidone (type B), povidone (K-30), magnesium stearate.
Film coating: hypromellose (3 cP, 6 cP), titanium dioxide (E171), macrogol 400, polysorbate 80, red iron oxide (E172).

What Valganciclovir Aurobindo looks like and contents of the pack
Film-coated tablet.
Pink, oval-shaped, biconvex, film-coated tablets, marked with “H” on one side and “96” on the other side. The dimensions are 16.8 mm x 7.9 mm.
Valganciclovir Aurobindo film-coated tablets are available in blisters made of polyamide/aluminium foil/PVC-aluminium foil and in HDPE bottles with a polypropylene closure and cotton wool.
Pack sizes:
Blisters: 10, 30, 60 and 100 film-coated tablets.
HDPE bottles: 60 and 1000 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) s.r.l.
Via San Giuseppe 102
21047 Saronno (VA), Italy

Manufacturers
APL Swift Services (Malta) Limited, HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta
Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom
ARROW Génériques, 26 avenue Tony Garnier, 69007 Lyon, France
Generis Farmaceutica, S.A., Rua Joao de Deus, 19, 2700-487 Amadora, Portugal

This medicinal product is authorized in the European Economic Area countries under the following names:
Cyprus: Valganciclovir Aurobindo 450 mg επικαλυμμένο με λεπτό υμένιο δισκία
Czech Republic: Valganciclovir Aurobindo 450 mg potahované tablety
Denmark: Valganciclovir “Orion”
Finland: Valganciclovir Orion 450 mg kalvopäällysteiset tabletit
France: VALGANCICLOVIR ARROW 450 mg, comprimé pelliculé
Germany: Valganciclovir PUREN 450mg Filmtabletten
Italy: Valganciclovir Aurobindo
Latvia: Valganciclovir Aurobindo 450 mg apvalkotās tabletes
Netherlands: Valganciclovir Aurobindo 450 mg, filmomhulde tabletten
Portugal: Valganciclovir Aurobindo
Romania: Valganciclovir Aurobindo 450 mg comprimate filmate
Spain: Valganciclovir Aurovitas 450 mg comprimidos recubiertos con película EFG
Sweden: Valganciclovir Orion 450 mg filmdragerade tabletter
United Kingdom: Valganciclovir 450 mg film-coated tablets