VALACICLOVIR ARISTO 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Valaciclovir Aristo 500 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the Package Leaflet:

1. What is Valaciclovir Aristo and what is it used for
2. What you need to know before taking Valaciclovir Aristo
3. How to take Valaciclovir Aristo
4. Possible side effects
5. Storage of Valaciclovir Aristo
6. Contents of the pack and further information

1. What is Valaciclovir Aristo and what is it used for

Valaciclovir Aristo belongs to a group of medicines called antivirals. It works by killing or stopping the growth of viruses called herpes simplex (HSV), varicella-zoster (VZV), and cytomegalovirus (CMV).

Valaciclovir Aristo can be used to:

• treat herpes zoster (in adults)
• treat skin infections caused by herpes simplex and genital herpes (in adults and adolescents over 12 years of age). It is also used to help prevent these infections from coming back
• treat cold sores (in adults and adolescents over 12 years of age)
• prevent cytomegalovirus infection after organ transplants (in adults and adolescents over 12 years of age)
• treat eye infections.

2. What you need to know before taking Valaciclovir Aristo

Do not take Valaciclovir Aristo

• if you are allergic (hypersensitive) to valaciclovir or aciclovir or any of the other ingredients of this medicine (listed in section 6).
• Do not take Valaciclovir Aristo if this applies to you. If you are not sure, consult your doctor or pharmacist before taking Valaciclovir Aristo.

Be careful with Valaciclovir Aristo

Consult your doctor or pharmacist before taking Valaciclovir Aristo if:

• you have kidney disease
• you have liver disease
• you are over 65 years of age
• your immune system is weak

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Valaciclovir Aristo.

Avoid spreading genital herpes to others:

If you are taking Valaciclovir Aristo to treat or prevent genital herpes, or have had genital herpes in the past, you should practice safe sex, including using a condom. This is important to avoid spreading the infection to others. You should not have sexual intercourse if you have genital ulcers or blisters.

Other medicines and Valaciclovir AristoTell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription and herbal remedies.

Tell your doctor or pharmacist if you are taking any other medicine that may affect your kidneys. This includes: aminoglycosides, platinum compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, cyclosporine, tacrolimus, cimetidine, and probenecid.

Always tell your doctor or pharmacist about other medicines if you are taking valaciclovir to treat herpes or after an organ transplant.

Pregnancy and breastfeeding

Valaciclovir Aristo is not normally recommended during pregnancy. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will weigh the benefit for you against the risk to your baby of taking Valaciclovir Aristo while pregnant or breastfeeding.

Driving and using machines

Valaciclovir Aristo may cause side effects that affect your ability to drive or use machines.

Do not drive or use machines unless you are sure that you are not affected.

3. How to take Valaciclovir Aristo

Follow the instructions for taking this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

The dose you should take will depend on why your doctor has prescribed Valaciclovir Aristo for you. Your doctor will discuss this with you.

Treatment of herpes zoster

• The usual dose is 1000 mg (one 1000 mg tablet or two 500 mg tablets) three times a day.
• You should take Valaciclovir Aristo for 7 days.

Treatment of cold sores

• The usual dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) twice a day.
• The second dose should be taken 12 hours (but not before 6 hours) after the first dose.
• You should take Valaciclovir Aristo for only one day (two doses).

Treatment of skin infections caused by herpes simplex and genital herpes

• The usual dose is 500 mg (one 500 mg tablet) twice a day.

For the first infection, you should take Valaciclovir Aristo for five days or up to ten days if your doctor tells you to. For recurrent infections, the treatment duration is usually 3-5 days.

Helping to prevent herpes simplex infections from coming back

• The usual dose is one 500 mg tablet once a day.
• Some people with frequent recurrences may benefit from taking half a 500 mg tablet (250 mg) twice a day.
• You should take Valaciclovir Aristo until your doctor tells you to stop.

For treating cytomegalovirus infection

• The usual dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) four times a day.
• You should take each dose with a 6-hour interval.
• Normally, you should start taking Valaciclovir Aristo as soon as possible after the operation.
• You should take Valaciclovir Aristo for about 90 days after the operation, until your doctor tells you to stop.

Your doctor may adjust the dose of Valaciclovir Aristo if:

• you are over 65 years of age
• your immune system is weakened
• you have kidney problems

Talk to your doctor before taking Valaciclovir Aristo if any of the above applies to you.

Taking this medicine

• Take this medicine by mouth.
• Swallow the tablets whole with a little water.
• Take Valaciclovir Aristo every day at the same time.
• Take Valaciclovir Aristo according to your doctor's or pharmacist's instructions.

People over 65 years of age or with kidney problems

It is important while you are taking Valaciclovir Aristo to drink water regularlythroughout the day. This will help reduce the side effects that may affect your kidneys or central nervous system. Your doctor will closely monitor the signs that may indicate this. The central nervous system side effects could include feeling confused or agitated, or feeling unusually drowsy or dizzy.

If you take more Valaciclovir Aristo than you should

Valaciclovir is not normally harmful, unless you take too much over several days. If you take too many tablets, you may feel sick, vomit, or be confused, agitated, or unusually drowsy. Contact your doctor or pharmacist if you take too much Valaciclovir Aristo or call the Toxicology Service on 915 620 420. Take the medicine pack with you.

If you forget to take Valaciclovir Aristo

• If you forget to take Valaciclovir Aristo, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Diseases you need to be careful with:

• Severe allergic reactions (anaphylaxis). These are rare in people taking Valaciclovir Aristo. The rapid development of symptoms includes:
  • redness, skin rash with itching
  • swelling of the lips, face, neck, and throat, causing difficulty breathing (angioedema)
  • drop in blood pressure leading to collapse

If you have had an allergic reaction, stop taking Valaciclovir Aristo and see a doctor immediately.

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

• headache

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

•feeling sick

• dizziness
• vomiting
• diarrhea
• skin reaction after exposure to sunlight (photosensitivity)
• rash

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

• feeling confused
• seeing or hearing things that do not exist (hallucinations)
• feeling very drowsy
• tremors
• feeling agitated

These central nervous system side effects usually occur in people with kidney problems, the elderly, or patients who have undergone organ transplantation and are taking high doses of 8 grams or more of Valaciclovir Aristo per day. They usually improve when Valaciclovir Aristo is stopped or the dose is reduced.

Other uncommon side effects:

•difficulty breathing (dyspnea)

• stomach upset
• rash, sometimes with itching and hives
• lower back pain (kidney pain)

Uncommon side effects that may appear in blood tests:

• decrease in the number of white blood cells (leukopenia)
• decrease in the number of blood platelets, which help the blood to clot (thrombocytopenia)
• increase in substances produced by the liver

Rare (may affect up to 1 in 1,000 people):

• unsteadiness when walking and lack of coordination (ataxia)
• slow and slurred speech (dysarthria)
• seizures (convulsions)
• altered brain function (encephalopathy)
• loss of consciousness (coma)

•confused or altered thoughts

These central nervous system side effects usually occur in people with kidney problems, the elderly, or patients who have undergone organ transplantation and are taking high doses of 8 grams or more of Valaciclovir Aristo per day. They usually improve when Valaciclovir Aristo is stopped or the dose is reduced.

Other rare side effects:

• kidney problems where you urinate very little or not at all.

Frequency not known (cannot be estimated from the available data):

• inflammation of the kidneys (tubulointerstitial nephritis)

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Valaciclovir Aristo

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister, bottle, and carton after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Further information

Composition of Valaciclovir Aristo

• The active substance is Valaciclovir.

Each film-coated tablet contains 500 mg of valaciclovir (as valaciclovir hydrochloride hydrate).

• The other ingredients are microcrystalline cellulose, crospovidone (type A), povidone K90, magnesium stearate, Opadry blue 13B50578 (hypromellose, aluminum lake indigo carmine (E132), titanium dioxide (E171), macrogol 400, polysorbate)

Appearance and packaging of the product

Film-coated tablets.

Film-coated tablets with a capsule shape, blue in color with a partial notch on both sides, with an "F" on one side and a "9" and a "3" on the other.

The tablet can be divided into two equal halves.

Valaciclovir Aristo film-coated tablets are available in packs containing transparent PVC/PVdC aluminum blisters or bottles made of HDPE.

Blisters:

500 mg: 5, 10, 21, 24, 30, 42, 50, 90, and 112 tablets

Bottles:

500 mg: 30 and 500 tablets

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

You can ask for more information about this medicine from the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850 Torrejón de Ardoz, Madrid

Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark Valaciclovir Aristo 500 mg film-coated tablets

Germany Valaciclovir Aristo 500 mg film-coated tablets

Norway Valaciclovir Aristo 500 mg film-coated tablets

Spain Valaciclovir Aristo 500 mg film-coated tablets EFG

Sweden Valaciclovir Aristo 500 mg film-coated tablets

United Kingdom Valaciclovir 500 mg film-coated tablets

Date of last revision of this leaflet - December 2022

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/