VALACICLOVIR 500 mg Фильм-Coated Таблетки

Содержание инструкции

1. Valaciclovir EG 500 mg film-coated tablets, 1000 mg film-coated tablets
   1. What is Valaciclovir EG and what it is used for
   2. What you need to know before you take Valaciclovir EG
   3. How to take Valaciclovir EG
   4. Possible side effects
   5. How to store Valaciclovir EG
   6. Contents of the pack and other information

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

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the
same as yours, as it may be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Valaciclovir EG belongs to a group of medicines called antivirals. It works by killing or blocking the growth of viruses called herpes simplex (HSV), varicella zoster (VZV) and cytomegalovirus (CMV).
Valaciclovir EG can be used for:

• treating shingles (in adults);
• treating HSV infections of the skin and genital herpes (in adults and adolescents over the age of 12). It is also used to help prevent the recurrence of these infections;
• treating cold sores (in adults and adolescents over the age of 12);
• preventing CMV infections after organ transplantation (in adults and adolescents over the age of 12);
• treating and preventing recurrent HSV infections of the eye (in adults and adolescents over the age of 12).

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

Do not take Valaciclovir EG

• If you are allergic to valaciclovir or to aciclovir or to any of the other ingredients of this medicine (listed in section 6).
• If you have ever developed a widespread rash associated with fever, swollen lymph nodes, increased levels of liver enzymes and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking valaciclovir.
• Do not take Valaciclovir EG if the above applies to you. If you are not sure, ask your doctor or pharmacist before taking Valaciclovir EG.

Warnings and precautions
Talk to your doctor or pharmacist before taking Valaciclovir EG 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 applies to you, ask your doctor or pharmacist before taking
Valaciclovir EG.
Take special care with valaciclovir:
Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with the use of valaciclovir,
DRESS syndrome initially manifests as flu-like symptoms and a rash on the face,
then with a widespread rash and fever, increased levels of liver enzymes and a type of white blood
cells (eosinophilia) observable from blood tests and swollen lymph nodes.
If you develop a rash associated with fever and swollen lymph nodes, stop taking valaciclovir
and contact your doctor immediately.

To prevent the transmission of genital herpes to other people
If you are taking Valaciclovir EG to treat or prevent genital herpes or if you have had
genital herpes in the past, you should have protected sexual intercourse including the use of a condom. This is
important to prevent the transmission of the infection to other people. You should not have sexual
intercourse if you have pain or blisters in the genital area.
Other medicines and Valaciclovir EG
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including over-the-counter medicines and herbal remedies.
Tell your doctor or pharmacist if you are taking any other medicine that has effects on the kidneys. These
include aminoglycosides, platinum-based compounds, iodinated contrast agents, methotrexate, pentamidine,
foscarnet, cyclosporine, tacrolimus, cimetidine and probenecid.
Always inform your doctor or pharmacist about any other medicine while you are taking Valaciclovir EG
for the treatment of shingles or after an organ transplant.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine. In general, the use of
Valaciclovir EG is not recommended during pregnancy.
The doctor will assess the benefit for you and the risk to your baby of taking
Valaciclovir EG while pregnant or breastfeeding.

Driving and using machines
Valaciclovir EG can cause side effects that affect your ability to drive.

• Do not drive or operate machinery unless you are sure you are not experiencing any effects.

3. How to take Valaciclovir EG

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The dose you need to take will depend on the reason why your doctor has prescribed Valaciclovir EG. The
doctor will discuss this with you.
Treatment of herpes zoster (shingles)

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

Treatment of cold sores

• The recommended dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) twice a day.
• The second dose must be taken 12 hours (not less than 6 hours) after the first dose
• You must take Valaciclovir EG for only one day (two doses).

Treatment of HSV infections of the skin and genital herpes

• The recommended dose is 500 mg twice a day.
• For the first infection you must take Valaciclovir EG for five days or up to ten days if your doctor recommends it. For recurrent infections the duration of treatment is normally from 3 to 5 days.

To help prevent the recurrence of HSV infections after you have had them

• The recommended dose is one 500 mg tablet once a day.
• You must take Valaciclovir EG until your doctor tells you to stop.

To prevent contracting CMV ( Cytomegalovirus) infection

• The recommended dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) four times a day.
• You must take each dose approximately 6 hours apart.
• You will normally start taking Valaciclovir EG as soon as possible after surgery.
• You will need to take Valaciclovir EG for about 90 days after surgery until your doctor tells you to stop.

Your doctor may modify the dose of Valaciclovir EG if:

• you are over 65 years of age;
• you have a weakened immune system;
• you have kidney problems.
• Tell your doctor before taking Valaciclovir EG if any of the above situations apply to you.

Taking the medicine

• Take this medicine by mouth.
• Swallow the tablets whole with a glass of water.
• Take Valaciclovir EG at the same time each day.
• Take Valaciclovir EG following the instructions of your doctor or pharmacist.

People over 65 years of age or with kidney problems
It is very important while you are taking Valaciclovir EG that you drink plenty of waterduring
the day. This will help reduce side effects that may affect the kidneys or nervous system. Your
doctor will monitor you closely for signs of these effects. Nervous system side effects
may include feeling confused or agitated, feeling unusually sleepy or
numb.

If you take more Valaciclovir EG than you should
Valaciclovir EG is normally not harmful unless you take too much and for several days. If you take
too many tablets you may experience nausea, vomiting, kidney problems, you may be confused,
agitated or feel less aware, see things that are not there or lose consciousness. Tell your doctor or
pharmacist if you have taken too much Valaciclovir EG. Bring the packaging of the medicine with you.

If you forget to take Valaciclovir EG

• If you forget to take Valaciclovir EG, take it as soon as you remember. However, if it is almost time for the 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.
The following side effects may occur with this medicine:

Conditions you should pay attention to

• severe allergic reactions ( anaphylaxis). These are rare in people taking Valaciclovir EG. Rapid development of symptoms including:
• redness, itchy rash;
• swelling of the lips, face, neck and throat causing difficulty in breathing ( angioedema);
• sudden drop in blood pressure leading to collapse.
• If you have an allergic reaction, stop taking Valaciclovir EG and contact 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);
• rash;
• itching.

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

• confusion;
• seeing or hearing things that are not there ( hallucinations);
• state of strong numbness;
• tremors;
• state of agitation.

These nervous system side effects generally occur in people with kidney problems,
in the elderly or in patients with organ transplant who are taking high doses, 8 grams or more, of Valaciclovir
EG per day. These effects usually improve when Valaciclovir EG is stopped or the dose is reduced.
Other uncommon side effects:

• shortness of breath ( dyspnoea);
• stomach disorders;
• rash, sometimes itchy, hives;
• pain in the lower back (kidney pain);
• blood in the urine ( haematuria).

Uncommon side effects that can be detected by blood tests:

• reduction in the number of white blood cells ( leucopenia);
• reduction in the number of blood plateletswhich are the cells needed for blood clotting ( thrombocytopenia);
• increase in substances produced by the liver.

Rare(may affect up to 1 in 1000 people):

• instability in walking and lack of coordination ( ataxia);
• words spoken slowly and defectively ( dysarthria);
• convulsions;
• altered brain function ( encephalopathy);
• loss of consciousness ( coma);
• confused or disturbed thinking ( delirium).

These nervous system side effects generally occur in people with kidney problems,
in the elderly or in patients with organ transplant who are taking high doses, 8 grams or more, of Valaciclovir
EG per day. These effects usually improve when Valaciclovir EG is stopped or the dose is reduced.
Other rare side effects

• kidney problems with little or no urine output.

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

• Drug reaction with eosinophilia and systemic symptoms also known as DRESS or drug hypersensitivity syndrome, characterized by widespread rash, fever, increased liver enzymes, altered blood tests (eosinophilia), enlarged lymph nodes and possible involvement of other organs. See also paragraph 2;
• an inflammation of the kidneys (tubulointerstitial nephritis).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Valaciclovir EG

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date that is reported on the pack. The expiry date (Scad) refers to the last day of that month.
• Store at a temperature below 30°C.
• Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Valaciclovir EG contains

• The active ingredient is valaciclovir. Each tablet contains 500 mg or 1000 mg of valaciclovir (as valaciclovir hydrochloride monohydrate)
• The other ingredients are: tablet core: microcrystalline cellulose, povidone, magnesium stearate; tablet coating(Opadry White Y-5-7068): hypromellose, hydroxypropyl cellulose, titanium dioxide (E171), macrogol 400.

Description of the appearance of Valaciclovir EG and contents of the pack
Valaciclovir EG consists of film-coated tablets, white in colour, biconvex with the following
dimensions and imprinted as follows:
500 mg tablets: 17.6 x 8.8 mm with VC2 imprinted on one side
1000 mg tablets: 22.0 x 11.0 mm with VC3 imprinted on one side
PVC/aluminium blisters
Packs (blisters): 10, 21, 30, 42 - 500 mg film-coated tablets
Packs (blisters): 10, 21, 42 - 1000 mg film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., Via Pavia, 6 – 20136 Milano

Manufacturers
Actavis ehf. Reykjavìkurvegur 76, IS-220 Hafnarfjörður – Iceland
Balkanpharma Dupnitsa AD, 3 Samokovsko Shosse Str., Dupnitsa 2600 – Bulgaria