What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version considering it may have been updated since your medicine was packaged.

Beneath is a text but representation of the Patient Information Leaflet. The original leaflet tin can be viewed using the link above.

The text but version may be available in large print, Braille or sound CD. For further information telephone call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 14894/0632 .

Valaciclovir 500 mg Flick-Coated Tablets

valaciclovir

  • Proceed this leaflet. Yous may need to read it once more.
  • If you have any further questions, ask your doctor or chemist.
  • This medicine has been prescribed for y'all. Do not laissez passer information technology on to others. It may harm them, even if their signs of affliction are the same every bit yours.
  • If you lot get any side furnishings, talk to your doctor or chemist. This includes whatever possible side effects not listed in this leaflet. Meet section 4.

1. What Valaciclovir is and what it is used for
two. What you demand to know before you lot take Valaciclovir
3. How to have Valaciclovir
four. Possible side furnishings
5. How to store Valaciclovir
half dozen. Contents of the pack and other information

Valaciclovir belongs to a grouping of medicines called antivirals. It works past killing or stopping the growth of viruses chosen 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 former). It is also used to help prevent these infections from returning.
  • care for cold sores (in adults and adolescents over 12 years old)
  • prevent infection with CMV afterwards organ transplants (in adults and adolescents over 12 years old)
  • treat and prevent HSV infections of the heart that proceed to come dorsum (in adults and adolescents over 12 years former)
  • if you are allergic to valaciclovir or aciclovir or any of the other ingredients of this medicine (listed in section half dozen).
  • if you have always developed an extended rash associated with fever, enlarged lymph nodes, increased levels of liver enzymes and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking valaciclovir.
  • Do not have Valaciclovir if the above applies to you. If you are non sure, talk to your doctor or chemist before taking Valaciclovir.

Talk to your doctor or pharmacist before taking Valaciclovir if:

  • you lot have kidney issues
  • yous accept liver issues
  • you are over 65 years of age
  • your immune system is weak

If you are not sure if the in a higher place employ to you, talk to your medico or pharmacist before taking Valaciclovir.

Drug Reaction with Eosinophilia and Systemic Symptoms (Apparel) has been reported with the employ of valaciclovir. DRESS appears initially as flu like symptoms and a rash on the face then an extended rash with a high body temperature, increased levels of liver enzymes seen in claret tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

  • If you lot develop a rash associated with a fever and enlarged lymph nodes, terminate taking valaciclovir and contact your doctor or seek medical attention immediately.

Prevent passing genital herpes on to others

If you are taking Valaciclovir to treat or forestall genital herpes, or you lot accept had genital canker in the past, y'all should still practice safe sex activity, including the use of condoms. This is important to prevent you passing the infection on to others. You should not take sex if you take genital sores or blisters.

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 doc or pharmacist if you are taking whatever 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 chemist about other medicines if you are taking Valaciclovir for treatment of shingles or later on having an organ transplant.

Valaciclovir is not usually recommended for use during pregnancy. If yous are meaning, or recall y'all could be, or if you lot are planning to get meaning, don't take Valaciclovir without checking with your doctor. Your physician will counterbalance up the benefit to y'all against the take a chance to your babe of taking Valaciclovir while you're pregnant or breast-feeding.

Valaciclovir tin cause side effects that affect your ability to drive.

  • Don't drive or use machines unless y'all are sure you're not afflicted.

Always take this medicine exactly every bit your md has told you lot. You should bank check with your doc or chemist if you are not certain.

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

Treatment of shingles

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

Treatment of cold sores

  • The usual dose is 2000 mg (2 thousand mg tablets or four 500 mg tablets) twice a day.
  • The 2d dose should exist taken 12 hours (no sooner than 6 hours) after the first dose
  • You should take Valaciclovir for one mean solar day (two doses) just.

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 twenty-four hours.
  • For the showtime infection you should take Valaciclovir for 5 days or for up to ten days if your doctor tells you to. For recurrent infection the duration of handling is commonly three-5 days.

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

  • The usual dose is 1 500 mg tablet in one case a day.
  • Some people with frequent recurrences may benefit from taking ane 250 mg tablet twice a 24-hour interval.
  • Y'all should take Valaciclovir until your doctor tells you to end.

To stop yous being infected with CMV (Cytomegalovirus)

  • The usual dose is 2000 mg (ii 1000 mg tablets or 4 500 mg tablets) four times a twenty-four hours.
  • You should take each dose near half dozen hours apart.
  • You lot will usually start taking Valaciclovir equally soon every bit possible afterwards your surgery.
  • You should take Valaciclovir for effectually ninety days later your surgery, until your doctor tells you to stop.

Your doctor may accommodate the dose of Valaciclovir if:

  • you are over 65 years of historic period
  • you have a weak allowed system
  • you have kidney bug.
  • Talk to your medico before taking Valaciclovir if any of the in a higher place apply.
  • Accept this medicine by mouth.
  • Consume 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.

Information technology is very important while yous are taking Valaciclovir that yous potable water regularly during the mean solar day. This will help to reduce side furnishings that can bear upon the kidney or nervous system. Your doctor will closely monitor yous for signs of these. Nervous system side effects might include feeling confused or agitated, or feeling unusually sleepy or drowsy.

Valaciclovir is not unremarkably harmful, unless you take too much over several days. If you take too many tablets you may feel sick, vomit, get kidney problems, may exist confused, agitated, feel less aware, run into things that aren't there, or become unconscious. Talk to your doctor or pharmacist if you take too much Valaciclovir. Take the medicine pack with you.

  • If you lot forget to accept Valaciclovir, have it as presently equally you lot remember. However, if it is almost time for your next dose, skip the missed dose.
  • Practise not take a double dose to brand upward for a forgotten dose.

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

  • Stop using Valciclovir and seek medical attention immediately if yous notice any of the following symptoms:

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

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

Pare rashes or redness. The adverse reaction of the skin may announced equally rashes with or without blisters. Pare irritation, oedema (Dress syndrome) and fever and flu like symptoms may occur.

The following side furnishings may also happen with this medicine:

Very Mutual (may affect more 1 in ten people)

  • headache

Mutual (may affect up to 1 in ten people)

  • feeling sick
  • dizziness
  • vomiting
  • diarrhoea
  • peel 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 organization side effects commonly occur in people with kidney problems, the elderly or in organ transplant patients taking high doses of eight grams or more of Valaciclovir a mean solar day. They usually get meliorate when Valaciclovir is stopped or the dose reduced.

Other uncommon side effects:

  • shortness of breath (dyspnoea)
  • tummy discomfort
  • rash, sometimes itchy, hive-like rash (urticaria)
  • low back hurting (kidney pain)
  • blood in urine (haematuria)

Uncommon side effects that may testify 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 claret to clot (thrombocytopenia)
  • increase in substances produced by the liver.

Rare (may affect upwards to 1 in 1,000 people)

  • unsteadiness when walking and lack of coordination (ataxia)
  • ho-hum, slurred speech (dysarthria)
  • fits (convulsions)
  • altered brain function (encephalopathy)
  • unconsciousness (blackout)
  • confused or disturbed thoughts (delirium)

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 than of Valaciclovir a day. They normally get better when Valaciclovir is stopped or the dose reduced.

Other rare side effects:

  • kidney bug where you lot pass little or no urine.

Frequency Not Known (cannot be estimated from the available data)

Drug Reaction with Eosinophilia and Systemic Symptoms besides known as DRESS or drug reaction hypersensitivity syndrome, which is characterised past widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and possibly other trunk organs. See too department two.

If y'all become any side effects, talk to your doctor or pharmacist. This includes any possible side effects non listed in this leaflet. You can also report side effects straight via the Yellow Carte Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App shop. By reporting side effects you can help provide more than information on the safety of this medicine.

  • Keep this medicine out of the sight and reach of children.
  • Do non employ this medicine after the expiry appointment which is stated on the carton. The expiry engagement (Exp.) refers to the last day of that month.
  • Store Valaciclovir beneath 30 °C. Store Valaciclovir in the original packaging.
  • Do non throw abroad any medicines via wastewater or household waste matter. Ask your pharmacist how to throw away medicines you no longer use. These measures will assist protect the environment.
  • The agile substance is valaciclovir (equally hydrochloride)
  • The other ingredients are microcrystalline cellulose (E460), crospovidone (E1202), FD&C Blue #two Aluminium Lake (xi-xiv%) (E132), povidone (K 30) (E1201), povidone (Yard 90D) (E1201), magnesium stearate (E470b), opadry 02C 50740 Bluish consisting of: hypromellose (5 cP) (E464), titanium dioxide (E171), macrogol/PEG 400, macrogol/PEG 6000, FD&C Bluish #2 Aluminium Lake (30-36%) (E132), polysorbate 80 (E433).

Valaciclovir are blue, sheathing shaped, biconvex, motion-picture show-coated tablets with 'V' and 'five' embossed on either side of the score line on one side and a notch on either side of the score line and smooth on the other side of the tablet.

Marketing Authority Holder

Ranbaxy (UK) Limited
fifth floor
Hyde Park
Hayes 3
11 Millington Road
Hayes
UB3 4AZ
Uk

Manufacturer

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
Kingdom of the netherlands

Terapia S.A.
124 Fabricii Street
400 632 Cluj Napoca
Romania

This leaflet was last revised in Apr 2021.

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