SUMMARY CMI
VALGANCICLOVIR SANDOZ®
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.
1. Why am I using Valganciclovir Sandoz?
Valganciclovir Sandoz contains the active ingredient valganciclovir. Valganciclovir Sandoz acts against a virus called cytomegalovirus or CMV. Valganciclovir Sandoz is used to treat CMV eye infections in AIDS patients and to prevent CMV infection in patients following organ transplantation.
For more information, see Section 1. Why am I using Valganciclovir Sandoz? in the full CMI.
2. What should I know before I use Valganciclovir Sandoz?
Do not use if you have ever had an allergic reaction to valganciclovir or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Valganciclovir Sandoz? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Valganciclovir Sandoz and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
4. How do I use Valganciclovir Sandoz?
- Induction treatment for adults (for active CMV retinitis): 900 mg twice daily with food for 21 days.
- Maintenance treatment for adults (after induction treatment or for inactive CMV retinitis): 900 mg once daily with food.
- Prevention of CMV disease in transplantation for adults: 900 mg once daily with food, starting within 10 days post transplantation until 100 days post transplantation. If you have received a kidney transplant, the same daily dose is required until 200 days post transplantation.
More instructions can be found in Section 4. How do I use Valganciclovir Sandoz? in the full CMI.
5. What should I know while using Valganciclovir Sandoz?
Things you should do |
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Things you should not do |
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Driving or using machines |
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Looking after your medicine |
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For more information, see Section 5. What should I know while using Valganciclovir Sandoz? in the full CMI.
6. Are there any side effects?
Go to your nearest hospital if you experience: swelling of the tongue, lips or throat, any sign of infection such as fever, chills, sore throat or mouth ulcers, unexplained bruising or bleeding, hallucinations, confusion, agitation; or fits.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
FULL CMI
VALGANCICLOVIR SANDOZ®
Active ingredient(s): valganciclovir
Consumer Medicine Information (CMI)
This leaflet provides important information about using Valganciclovir Sandoz. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Valganciclovir Sandoz.
Where to find information in this leaflet:
1. Why am I using Valganciclovir Sandoz?
2. What should I know before I use Valganciclovir Sandoz?
3. What if I am taking other medicines?
4. How do I use Valganciclovir Sandoz?
5. What should I know while using Valganciclovir Sandoz?
6. Are there any side effects?
7. Product details
1. Why am I using Valganciclovir Sandoz?
Valganciclovir Sandoz contains the active ingredient valganciclovir.
In the body valganciclovir rapidly changes to ganciclovir.
Valganciclovir Sandoz belongs to a group of medicines used to prevent the growth of viruses.
Valganciclovir Sandoz acts against a virus called cytomegalovirus or CMV (a type of herpes virus). It prevents this virus from growing and multiplying in the body.
CMV causes infections, mainly in people with poor immunity. Poor immunity can be caused by HIV/AIDS or by medications taken after an organ transplant.
Valganciclovir Sandoz is used to treat CMV eye infections (known as CMV retinitis) in AIDS patients, which, if left untreated can cause blindness. It is not a cure for CMV eye infections.
Valganciclovir Sandoz is not effective against any underlying HIV infection.
Valganciclovir Sandoz is also used to prevent CMV infection in patients following organ transplantation.
Valganciclovir Sandoz is not addictive.
This medicine is available only with a doctor's prescription.
Your doctor, however, may have prescribed Valganciclovir Sandoz for another purpose.
2. What should I know before I use Valganciclovir Sandoz?
Animal and other laboratory studies have shown Valganciclovir Sandoz causes infertility, birth defects and cancer. It is possible that these effects may also occur in humans.
Warnings
Do not use Valganciclovir Sandoz if:
- you are allergic to valganciclovir, ganciclovir, valaciclovir or aciclovir, or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include:
- shortness of breath
- wheezing or difficulty breathing o swelling of the face, lips, tongue or other parts of the body
- rash, itching or hives on the skin
Always check the ingredients to make sure you can use this medicine. - you have very low blood counts for platelets (which help clotting), neutrophils (a type of white blood cell which defends against infection) or low haemoglobin (oxygen carrying substance in the blood).
Use in children
There is limited information on the safety and effectiveness of the use of valganciclovir in children. Your doctor will advise you whether Valganciclovir Sandoz is suitable for your child.
Check with your doctor if you:
- are allergic to any other medicines, foods, dyes or preservatives, especially any medicine which you have taken previously to treat your current condition
- have any other health problems, especially the following:
- you have a history of low blood counts for platelets (thrombocytopenia), neutrophils (neutropenia) or anaemia
- you have, or previously have had, poor kidney function - are pregnant or intend to become pregnant
- Valganciclovir Sandoz is not recommended for use during pregnancy. Valganciclovir may affect your developing baby if you take it during pregnancy. Your doctor will discuss the risks and benefits of using Valganciclovir Sandoz if you are pregnant. - are breast-feeding or intend to breast-feed
- It is not known whether Valganciclovir Sandoz passes into breast milk. Breast-feeding is not recommended during therapy with Valganciclovir Sandoz - are a woman who could become pregnant and you are not using contraception
- You must use a reliable form of contraception during Valganciclovir Sandoz therapy, and for at least 30 days after stopping Valganciclovir Sandoz, unless you are not sexually active. - are a sexually active man
- You should use condoms during and for at least 90 days following treatment with Valganciclovir Sandoz unless it is certain that your female partner is not at risk of pregnancy.
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Make sure your doctor is aware that you are pregnant or plan to become pregnant or are breastfeeding or intend to breastfeed. You must use a reliable form of contraception during Valganciclovir Sandoz therapy, and for at least 30 days after stopping Valganciclovir Sandoz, unless you are not sexually active.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Valganciclovir Sandoz may interfere with each other. These medicines include:
- imipenem/cilastatin (Primaxin®) a combination of medicines used to treat some infections
- probenecid (e.g. Benemid®), a medicine used to treat gout
- zidovudine (AZT), Retrovir®, Combivir®), didanosine (ddI or Videx®), stavudine, other medicines used to treat HIV infection
- medicines for the treatment of cancer such as doxorubicin, vinblastine, vincristine, hydroxyurea
- mycophenolate mofetil (CellCept®), and other medicines used to prevent organ rejection after a transplant e.g. ciclosporin, tacrolimus.
- anti-infective agents such as trimpethroprim / sulphonamides, dapsone, pentamidine, flucytosine pegylated interferons plus ribavirin and amphotericin B
These medicines may be affected by Valganciclovir Sandoz, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor or pharmacist have more information on medicines to be careful with or avoid while taking Valganciclovir Sandoz.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Valganciclovir Sandoz.
4. How do I use Valganciclovir Sandoz?
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.
How much to take
Take Valganciclovir Sandoz exactly as your doctor has prescribed. Your doctor will tell you how many Valganciclovir Sandoz tablets to take each day.
Treatment of CMV Retinitis in AIDS (adult patients)
- Induction Treatment for adults (for active CMV retinitis)
The usual dose is 900 mg (two 450 mg tablets) twice daily with food for 21 days.
- Maintenance Treatment for adults (after induction treatment or for inactive CMV retinitis)
The usual dose is 900 mg (two 450 mg tablets) once daily with food.
Prevention of CMV Disease in Transplantation for adults
The usual dose is 900 mg (two 450 mg tablets) once daily with food, starting within 10 days post transplantation until 100 days post transplantation.
If you have received a kidney transplant, the same daily dose is required until 200 days post transplantation.
Your dose may have to be reduced or stopped if you have or develop low blood counts, have kidney disease, or if you are older than 65 years.
How to take Valganciclovir Sandoz
- Swallow the tablets whole with a full glass of water. Tablets must be taken with food.
When to take Valganciclovir Sandoz
- Take your medicine at about the same time each day. Take during or immediately after a meal. If you take it on an empty stomach, it may not work as well.
- Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
How to long to take Valganciclovir Sandoz
- Continue taking your medicine for as long as your doctor tells you.
- This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.
- Continue taking your medicine until your doctor tells you to stop.
If you forget to use Valganciclovir Sandoz
Valganciclovir Sandoz should be used regularly at the same time each day. If you miss your dose at the usual time, take your dose as soon as you remember, and continue to take it as you would normally.
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you use too much Valganciclovir Sandoz
If you think that you have used too much Valganciclovir Sandoz, you may need urgent medical attention.
You should immediately:
- phone the Poisons Information Centre
(by calling 13 11 26), or - contact your doctor, or
- go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Valganciclovir Sandoz?
Things you should do
Tell any other doctors, dentists and pharmacists who treat you that you are taking Valganciclovir Sandoz.
Call your doctor straight away if you become pregnant while taking Valganciclovir Sandoz.
See your doctor regularly so that your CMV disease, blood cell counts and any other potential side effects may be monitored carefully.
If blood cell counts are low then this may reduce your ability to fight infection, or for your blood to clot efficiently. If left undetected these effects on blood cells may contribute to death or serious illness.
If you have a CMV eye infection, you must also see your doctor regularly to monitor the condition of your retina (part of the eye).
Condoms should be used by sexually active men while taking Valganciclovir Sandoz and for 90 days after stopping treatment.
Women who are of childbearing potential should use contraception during and for at least 30 days after stopping Valganciclovir Sandoz.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed. Otherwise, your doctor may think that it was not effective and change your treatment unnecessarily.
Keep all of your appointments with your doctor so that your progress can be checked.
Things you should not do
- Do not take Valganciclovir Sandoz to treat any other complaints unless your doctor tells you to.
- Do not give Valganciclovir Sandoz to anyone else even if they have the same condition as you.
- Do not stop taking Valganciclovir Sandoz or change the dosage without first checking with your doctor.
- Do not let yourself run out of medicine over the weekend or on holidays.
- Do not take any other medicines whether they require a prescription or not without first telling your doctor or consulting a pharmacist.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Valganciclovir Sandoz affects you.
Valganciclovir Sandoz may cause drowsiness, dizziness, confusion or seizures (fits) in some people and therefore may affect alertness. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
Looking after your medicine
- Keep your medicine in the original container.
- If you take it out of its original container it may not keep well.
- Keep your medicine in a cool dry place where the temperature stays below 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:
- in the bathroom or near a sink, or
- in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Less serious side effects
Less serious side effects | What to do |
| Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
Serious side effects | What to do |
| Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. |
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Valganciclovir Sandoz contains
Active ingredient (main ingredient) | valganciclovir |
Other ingredients (inactive ingredients) | microcrystalline cellulose crospovidone stearic acid povidone hypromellose titanium dioxide macrogol 400 iron oxide red polysorbate 80 |
Potential allergens | none |
Do not take this medicine if you are allergic to any of these ingredients.
What Valganciclovir Sandoz looks like
Valganciclovir Sandoz 450mg - pink, convex oral tablets with 'J' on one side and '156' on the other side.
Available in blisters of 60 tablets (Aust R 227605).
Who distributes Valganciclovir Sandoz
Sandoz Pty Ltd
100 Pacific Highway
North Sydney, NSW 2060
Australia
Tel 1800 726 369
This leaflet was prepared in September 2024.
® Registered Trade Mark. The trade marks mentioned in this material are the property of their respective owners.
Published by MIMS November 2024