Valaciclovir Orion

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Valaciclovir Orion 500 mg film-coated tablets

Valaciclovir

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 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 signs of illness are the same as yours.
If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

What Valaciclovir Orion is and what it is used for

What you need to know before you take Valaciclovir Orion

How to take Valaciclovir Orion

Possible side effects

How to store Valaciclovir Orion

Contents of the pack and other information

1. What Valaciclovir Orionis and what it is used for

Valaciclovir Orion 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 Orion can be used to:

treat shingles (in adults)
treat HSV infections of the skin and genital herpes (in adults and adolescents over 12 years old).

It is also used to help prevent these infections from returning.

treat cold sores (in adults and adolescents over 12 years old)
prevent infection with CMV after organ transplants (in adults and adolescents over 12 years of old)
infections in the eye

2. What you need to know before you take Valaciclovir Orion

Do not take Valaciclovir Orion

if you are allergic (hypersensitive) to valaciclovir or aciclovir or any of the other ingredients of this medicines (listed in section 6).
Don’t take Valaciclovir Orion if this applies to you. If you are not sure, talk to your doctor or pharmacist before taking Valaciclovir Orion.

Warnings and precautions

Check with your doctor or pharmacist before taking Valaciclovir Orionif:

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

If you are not sure if the above apply to you, talk to your doctor or pharmacist before taking Valaciclovir Orion.

Prevent passing genital herpes on to others

If you are taking Valaciclovir Orion to treat or prevent genital herpes, or you have had genital herpes in the past, you should still practice safe sex, including the use of condoms. This is important to prevent you passing the infection on to others. You should not have sex if you have genital sores or blisters.

Other medicines and Valaciclovir Orion

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription including herbal medicines.

Tell your doctor or pharmacist if you are taking any other medicines that affect the kidneys. These include: aminoglycosides, organoplatinum compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, ciclosporin, tacrolimus, cimetidine and probenecid.

Always tell your doctor or pharmacist about other medicines if you are taking Valaciclovir Orion for treatment of shingles or after having an organ transplant.

Pregnancy, breast-feeding and fertility

Valaciclovir Orion is not usually recommended for use during pregnancy. If you are pregnant, or think you could be, or if you are planning to become pregnant, don’t take Valaciclovir Orion without checking with your doctor. Your doctor will weigh up the benefit to you against the risk to your baby of taking Valaciclovir Orion while you're pregnant or breastfeeding.

Driving and using machines

Valaciclovir Orion can cause side effects that affect your ability to drive.

 Don’t drive or use machines unless you are sure you’re not affected.

3. How to take Valaciclovir Orion

Always take this medicine exactly as described in this leaflet or as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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

Treatment of shingles

The usual dose is 1000 mg (two 500 mg tablets) three times a day
You should take Valaciclovir Orion for seven days.

Treatment of cold sores

The usual dose is 2000 mg (four 500 mg tablets) twice a day.
The second dose should be taken 12 hours (no sooner than 6 hours) after the first dose
You should take Valaciclovir Orion for one day (two doses) only.

Treatment of HSV infections of the skin and genital herpes

The usual dose is 500 mg (one 500 mg tablet) twice a day.
For the first infection you should take Valaciclovir Orion for five days or for up to ten days if your doctor tells you to. For recurrent infection the duration of treatment is normally 3-5 days.

Helping to prevent HSV infections from returning after you have had them

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

To stop you being infected with CMV (Cytomegalovirus)

The usual dose is 2000 mg (four 500 mg tablets) four times a day.
You should take each dose about 6 hours apart.
You will usually start taking Valaciclovir Orion as soon as possible after your surgery.
You should take Valaciclovir Orion for around 90 days after your surgery, until your doctor tells you to stop.

Your doctor may adjust the dose of Valaciclovir Orion if:

you are over 65 years of age
you have a weak immune system
you have kidney problems.

 Talk to your doctor before taking Valaciclovir Orion if any of the above apply.

Taking this medicine

Take this medicine by mouth.
Swallow the tablets whole with a drink of water.
Take Valaciclovir Orion at the same time each day.
Take Valaciclovir Orion according to instructions from your doctor or pharmacist.

People over 65 years of age or with kidney problems

It is very important while you are taking Valaciclovir Orion that you drink water regularly during the day. This will help to reduce side effects that can affect the kidney or nervous system. Your doctor will closely monitor you for signs of these. Nervous system side effects might include feeling confused or agitated, or feeling unusually sleepy or drowsy.

If you take more Valaciclovir Orion than you should

Valaciclovir Orion is not usually 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 sleepy. Talk to your doctor or pharmacist if you take too much Valaciclovir Orion. Take the medicine pack with you.

If you forget to take Valaciclovir Orion

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

4. Possible side effects

Like all medicines, this medicine can cause side effects in some people. The following side effects may happen with this medicine.

Conditions you need to look out for

severe allergic reactions (anaphylaxis). These are rare in people taking Valaciclovir Orion. Rapid development of symptoms including:

flushing, itchy skin rash
swelling of the lips, face, neck and throat, causing difficulty in breathing (angiodema)
fall in blood pressure leading to collapse.

If you have an allergic reaction, stop taking Valaciclovir Orion and see a doctor straight away.

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

headache

Common (may affect up to 1 in 10 people)

feeling sick
dizziness
vomiting
diarrhoea
skin reaction after exposure to sunlight (photosensitivity).
rash
Itching (pruritus)

Uncommon (may affect up to 1 in 100 people)

feeling confused
seeing or hearing things that aren’t there (hallucinations)
feeling very drowsy
tremors
feeling agitated

These nervous system side effects usually occur in people with kidney problems, the elderly or in organ transplant patients taking high doses of 8 grams or more of Valaciclovir Orion a day. They usually get better when Valaciclovir Orion is stopped or the dose reduced.

Other uncommon side effects:

shortness of breath (dyspnoea)
stomach discomfort
rash, sometimes itchy, hive-like rash (urticaria)
low back pain (kidney pain)
blood in urine (often associated with other kidney related events)

Uncommon side effects that may show up in blood tests:

reduction in the number of white blood cells (leucopenia)
reduction in the number of blood platelets which are cells that help 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, slurred speech (dysarthria)
fits (convulsions)
altered brain function (encephalopathy)
unconsciousness (coma)
confused or disturbed thoughts

Other rare side effects:

kidney problems where you pass little or no urine.

Reporting side effects

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

You can also report side effects directly via [to be reported nationally]. By reporting side effects you can help provide more information in safety of this medicine.

5. How to store Valaciclovir Orion

Keep this medicine out of the sight and reach of children.

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

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Valaciclovir Orion contains

- The active substance is valaciclovir.

Each tablet contains 500 mg of valaciclovir as valaciclovir hydrochloride (hydrated).

- The other ingredients are:

Microcrystalline cellulose,

Crospovidone (Type A),

Povidone K90,

Magnesium stearate,

Opadry blue 13B5057 (hypromellose, indigo carmine aluminium lake (E132), titanium dioxide (E171), macrogol 400, polysorbate).

What Valaciclovir Orion looks like and contents of the pack

Film-coated tablet.

Valaciclovir Orion 500 mg film-coated tablets

Blue, film-coated, capsule shaped tablets with a partial scorebar on both sides containing ‘F’ on one side and ‘9’ and ‘3’ on the other side.

The tablet can be divided into equal halves.

Valaciclovir Orion film-coated tablets are available in clear PVC/PVdC Aluminium foil blister pack or in HDPE bottle pack.

Blister pack:

500 mg: 5, 8, 10, 21, 24, 30, 42, 50, 90 and 112 tablets

Bottle pack:

500 mg: 30 and 500 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

<[To be completed nationally]>

Manufacturer

<[To be completed nationally]>

This leaflet was last approved in 21/01/2016.