Valaciclovir Aurobindo

Package leaflet: Information for the user

Valaciclovir Aurobindo 500 mg film-coated tablets, 1000 mg film-coated tablets

Generic 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Valaciclovir Aurobindo belongs to a group of medicines called antivirals, which work by killing or inhibiting the growth of viruses known as herpes simplex virus (HSV), varicella zoster virus (VZV), and cytomegalovirus (CMV).
Valaciclovir Aurobindo can be used:

• to treat herpes zoster (shingles) (in adults)
• to treat skin and genital infections caused by HSV (in adults and adolescents over 12 years of age). It is also used to help prevent the recurrence of these infections.
• to treat cold sores (in adults and adolescents over 12 years of age)
• to prevent cytomegalovirus (CMV) infections after organ transplantation (in adults and adolescents over 12 years of age)
• to treat and prevent HSV eye infections.

2. What you need to know before taking Valaciclovir Aurobindo

Do not take Valaciclovir Aurobindo

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

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

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

If you are not sure whether the above applies to you, talk to your doctor or pharmacist before taking
Valaciclovir Aurobindo.
Prevention of herpes transmission to others
If you are taking Valaciclovir Aurobindo for the treatment or prevention of herpes
genitalis, or if you have had genital herpes in the past, you should practice safe sex, including the use of
condoms. This is important to prevent transmission of the infection to others. You should abstain from
sexual activity if you have genital sores or blisters.
Other medicines and Valaciclovir Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must inform your doctor or pharmacist if you are taking any other medicine that affects the kidneys. This includes: aminoglycosides, platinum-containing organic compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, ciclosporin, tacrolimus, cimetidine, and probenecid.
Always inform your doctor or pharmacist about any other medicines you are taking if you are using Valaciclovir Aurobindo for the treatment of herpes zoster (shingles) or after an organ transplant.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
The use of Valaciclovir Aurobindo during pregnancy is not usually recommended. If you are pregnant, think you may be pregnant, or are planning a pregnancy, you must not take Valaciclovir Aurobindo without first consulting your doctor. Your doctor will assess the benefit you may receive from taking Valaciclovir Aurobindo while pregnant or breastfeeding against the potential risk to your baby.
Driving and using machines
Valaciclovir Aurobindo may cause side effects that could affect your ability to drive. You should not drive or operate machinery until you are certain that you are not affected.

3. How to take Valaciclovir Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The dose you should take depends on the reason your doctor has prescribed Valaciclovir Aurobindo. Your doctor will discuss this with you.

Treatment of herpes zoster (shingles)

• The recommended dose is 1000 mg (1 tablet of 1000 mg or 2 tablets of 500 mg) three times daily.
• You should take Valaciclovir Aurobindo for 7 days.

Treatment of cold sores (herpes labialis)

• The recommended dose is 2000 mg (2 tablets of 1000 mg or 4 tablets of 500 mg) twice daily.
• The second dose should be taken 12 hours (but not earlier than 6 hours) after the first dose.
• You should take Valaciclovir Aurobindo for only 1 day (two doses).

Treatment of genital and cutaneous HSV infections

• The recommended dose is 500 mg (one 500 mg tablet) twice daily.
• For the first episode, take Valaciclovir Aurobindo for 5 days, or up to 10 days if your doctor tells you to. For recurrent infections, treatment usually lasts 3–5 days.

To help prevent recurrence of HSV infection after initial infection

• The recommended dose is one 500 mg tablet daily.
• Some people with frequent recurrences may benefit from taking one 250 mg tablet twice daily.
• You should continue taking Valaciclovir Aurobindo until your doctor tells you to stop.

To prevent CMV (Cytomegalovirus) infection

• The recommended dose is 2000 mg (2 tablets of 1000 mg or 4 tablets of 500 mg) four times daily.
• Each dose should be taken approximately 6 hours apart.
• Treatment usually starts as soon as possible after transplantation.
• You should take Valaciclovir Aurobindo for approximately 90 days after transplantation, or until your doctor tells you to stop.

Your doctor may adjust the dose of Valaciclovir Aurobindo if:

• You are over 65 years of age.
• You have a weakened immune system.
• You have kidney problems. If any of the above apply to you, speak with your doctor before taking Valaciclovir Aurobindo.

Children under 12 years of age
Valaciclovir Aurobindo must not be used in children under 12 years of age.

How to take this medicine

• Take this medicine by mouth.
• Swallow the tablets whole with a glass of water.
• Take Valaciclovir Aurobindo at the same time each day.
• Follow your doctor’s or pharmacist’s instructions carefully.

People aged 65 years or older, or those with kidney problems
While taking Valaciclovir Aurobindo, it is very important to drink water regularly throughout the day. This will help reduce the risk of unwanted side effects affecting the kidneys or nervous system. Your doctor will monitor you closely for such signs. Side effects affecting the nervous system may include confusion, agitation, unusual drowsiness or lethargy, seeing things that are not there (hallucinations), or loss of consciousness.

If you take more Valaciclovir Aurobindo than you should
Valaciclovir Aurobindo is not usually dangerous unless you take too many tablets for several days. If you take too many tablets, you may experience nausea, vomiting, kidney problems, confusion, agitation, decreased level of consciousness, hallucinations, or loss of consciousness. If you take too many tablets of Valaciclovir Aurobindo, inform your doctor or pharmacist immediately. Bring the medicine pack with you.

If you forget to take Valaciclovir Aurobindo

• If you forget to take a dose, 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 forgotten dose.

If you have any doubts about how to use 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. The following side effects may occur with this medicine:
Conditions you should pay attention to:

• Severe allergic reactions ( anaphylaxis ). These reactions are rare in people taking Valaciclovir Aurobindo. Rapid onset of symptoms includes:
• flushing, skin rash with itching
• swelling of the lips, face, neck and throat causing difficulty in breathing ( angioedema )
• drop in blood pressure leading to collapse. If you experience an allergic reaction, stop taking Valaciclovir Aurobindo and see your doctor immediately.

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

• headache

Common (may affect up to 1 in 10 people)

• nausea
• dizziness
• vomiting
• diarrhoea
• skin reaction after exposure to sunlight ( photosensitivity )
• skin rash
• itching

Uncommon (may affect up to 1 in 100 people)

• feeling confused
• seeing or hearing things that are not there ( hallucinations )
• feeling very sleepy
• tremors
• feeling restless

These nervous system side effects usually occur in people with kidney problems, elderly people, or patients who have undergone organ transplantation and are taking high doses of Valaciclovir Aurobindo equal to or greater than 8 grams per day. Symptoms usually improve when treatment with Valaciclovir Aurobindo is stopped or the dose is reduced.
Other uncommon side effects:

• shortness of breath ( dyspnoea )
• stomach problems
• skin rash, sometimes with itching, rash similar to hives
• pain in the lower back (kidney pain)
• blood in the urine (haematuria).

Uncommon side effects that may be detected by blood tests:

• decrease in the number of white blood cells ( leucopenia )
• decrease in the number of platelets, cells that help blood to clot ( thrombocytopenia )
• increase in substances produced in 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
• changes in brain function ( encephalopathy )
• loss of consciousness ( coma )
• confused or disturbed thoughts ( delirium )

These nervous system side effects usually occur in people with kidney problems, elderly people, or patients who have undergone organ transplantation and are taking high doses of Valaciclovir Aurobindo equal to or greater than 8 grams per day. Symptoms usually improve when treatment with Valaciclovir Aurobindo is stopped or the dose is reduced.
Other rare side effects:

• kidney problems with little or no urine output

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
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 Valaciclovir Aurobindo

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, the box and
the bottle after "EXP.:". The expiry date refers to the last day of the month indicated.
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 Valaciclovir Aurobindo contains

• The active substance is valaciclovir. Each tablet contains valaciclovir hydrochloride (hydrate) equivalent to 500 mg of valaciclovir. Each tablet contains valaciclovir hydrochloride (hydrate) equivalent to 1000 mg of valaciclovir.
• The excipients are: Tablet core: microcrystalline cellulose, crospovidone (Type A), povidone, magnesium stearate. Coating: hypromellose, indigo carmine aluminium lake (E132), titanium dioxide (E171), macrogol 400, polysorbate.

Description of the appearance of Valaciclovir Aurobindo and contents of the pack
Valaciclovir Aurobindo 500 mg film-coated tablets:
Film-coated, capsule-shaped blue tablets with a partial score line on both sides, marked with “F” on one side and “9” and “3” on the other.
The tablet can be divided into two equal doses.
Valaciclovir Aurobindo 1000 mg film-coated tablets:
Film-coated, capsule-shaped blue tablets with a partial score line on both sides, marked with “F” on one side and “8” and “3” on the other.
The tablet can be divided into two equal doses.
Valaciclovir Aurobindo film-coated tablets are available in blister packs made of transparent PVC/PVdC with aluminium foil or in HDPE bottles.
Pack sizes:
Blister packs: 7, 10, 21, 30, 42, 50, 90 and 112 tablets.
Bottles: 30 and 500 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

Responsible manufacturer for batch release
APL Swift Services (Malta) Limited,
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia,
BBG 3000
Malta

This medicinal product is authorized in the European Economic Area countries under the following names:
France Valaciclovir Arrow 500 mg/1000 mg film-coated tablet
Germany Valaciclovir Aurobindo 500 mg Filmtabletten
Italy Valaciclovir Aurobindo
Netherlands Valaciclovir Aurobindo 500 mg filmomhulde tabletten
Portugal Valaciclovir Aurobindo
Spain Valaciclovir Aurobindo 500 mg/1000 mg comprimidos recubiertos con película EFG
United Kingdom Valaciclovir 500 mg film-coated tablets

This leaflet was last approved