Valaciclovir 500mg Film-Coated Tablets
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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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Valaciclovir is and what it is used for
2. Before you take Valaciclovir
3. How to take Valaciclovir
4. Possible side effects
5. How to store Valaciclovir
6. Further information
Valaciclovir 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 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 old)
• treat and prevent HSV infections in the eye
Pregnancy and breast-feeding
Valaciclovir 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 without checking with your doctor. Your doctor will weigh up the benefit to you against the risk to your baby of taking valaciclovir while you're pregnant or breast-feeding.
Driving and using machines
Valaciclovir can cause side effects that affect your ability to drive.
^Don't drive or use machines unless you are sure you're not affected.
Do not take Valaciclovir:
• if you are allergic (hypersensitive) to valaciclovir or aciclovir or any of the other ingredients (listed in Section 6).
• Don't take valaciclovir if this applies to you. If you are not sure, talk to your doctor or pharmacist before taking valaciclovir
Take special care with Valaciclovir
Check with your doctor or pharmacist before taking valaciclovir if:
• 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.
Prevent passing genital herpes on to others
If you are taking valaciclovir 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.
Taking other medicines
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 for treatment of shingles or after having an organ transplant.
Always take Valaciclovir exactly 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 for you. Your doctor will discuss this with you.
Treatment of shingles
• The usual dose is 1000 mg (one 1000 mg tablet or two 500 mg tablets) three times a day.
• You should take valaciclovir for seven 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 (no sooner than 6 hours) after the first dose
• You should take valaciclovir 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 or two 250 mg tablets) twice a day.
• For the first infection you should take valaciclovir 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 one 250 mg tablet twice a day.
• You should take valaciclovir until your doctor tells you to stop.
To stop you being infected with CMV (Cytomegalovirus)
• The usual dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) four times a day.
• You should take each dose about 6 hours apart.
• You will usually start taking valaciclovir as soon as possible after your surgery.
• You should take valaciclovir for around 90 days after your surgery, until your doctor tells you to stop.
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Your doctor may adjust the dose of valaciclovir 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 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 at the same time each day.
• Take valaciclovir 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 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 than you should
Valaciclovir 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. Take the medicine pack with you.
If you forget to take Valaciclovir
• If you forget to take valaciclovir, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose.
• Don't take a double dose to make up for a forgotten dose.
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 (affects 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)
• incoherent speech, severe confusion (delirium)
• confused or disturbed thoughts
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 a day. They usually get better when valaciclovir is stopped or the dose reduced.
Other rare side effects:
• kidney problems where you pass little or no urine.
Keep out of the reach and sight of children.
Do not use Valaciclovir after the expiry date which is stated on the cartons and blisters after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
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 to protect the environment.
Like all medicines, Valaciclovir 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.
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 and see a doctor straight away.
Very Common (affects more than 1 in 10 people):
• headache
Common (affects up to 1 in 10 people)
• feeling sick
• dizziness
• vomiting
• diarrhoea
• skin reaction after exposure to sunlight (photosensitivity).
• rash
Uncommon (affects 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 a day. They usually get better when valaciclovir 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
What Valaciclovir contains
The active substance is valaciclovir.
Each film-coated tablet contains 556.275 mg valaciclovir hydrochloride equivalent to 500 mg valaciclovir.
The other ingredients are in the tablet core: Crospovidone, microcrystalline cellulose, povidone and magnesium stearate; and in the tablet coating: hypromellose, titanium dioxide (E171), macrogol 400 and polysorbate 80.
What Valaciclovir looks like and contents of the pack
Valaciclovir 500mg film-coated tablets are white to off-white capsule shaped film coated tablets with “500” debossed on one side and plain on other side. Valaciclovir tablets are packed in PVC/PE/PVDC//Aluminium-blisters.
Valaciclovir 500 mg film-coated tablets may be packed in the following pack sizes:
Carton box with blister(s) containing: 8, 10, 30, 42 or 90 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.
Manufacturers:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany or LEK S.A., ul. Domaniewska 50 C, 02-672 Warszawa, Poland or
Lek Pharmaceuticals d.d., Verovskova 57,1526 Ljubljana, Slovenia or
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia.
This leaflet was last revised in 02/2015.
SZ00000LT000
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A Artwork Proof Box Ref: V034 - Addition of pack size 8 | |
|
Proof no. Date prepared: 006.0 25/02/2015 |
Font size: 8pt |
|
Colours: Black Black 20% |
Fonts: Helvetica |
|
^ Dimensions: 165 x 310 mm |
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