Valaciclovir EG

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Equivalent medicine
Please read this leaflet carefully before 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, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 Valaciclovir EG is and what it is used for

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

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

2. What you should know before taking Valaciclovir EG

Do not take Valaciclovir EG

• If you are allergic to valaciclovir, aciclovir, or any of the other ingredients of this medicine (listed in section 6).
• If you have ever developed a widespread skin rash associated with fever, swollen lymph nodes, increased liver enzyme levels and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking valaciclovir.
• Do not take Valaciclovir EG if any of the above apply to you. If you are unsure, consult 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 weakened.

If you are unsure whether any of the above applies to you, consult 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 presents with flu-like symptoms and a skin rash on the face, followed by widespread rash and fever, increased levels of liver enzymes and a type of white blood cells (eosinophilia) detectable in blood tests, and swollen lymph nodes.
If you develop a skin rash associated with fever and swollen lymph nodes, stop taking valaciclovir immediately and contact your doctor without delay.

To prevent transmission of genital herpes to other people
If you are taking Valaciclovir EG to treat or prevent genital herpes, or if you have previously had genital herpes,
you should practice protected sex, including the use of condoms. This is important to prevent transmission of the infection to others. You should avoid sexual intercourse if you have pain or blisters in the genital area.

Other medicines and Valaciclovir EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription and herbal medicines.
Inform your doctor or pharmacist if you are taking any other medicine that affects the kidneys. These include aminoglycosides, platinum-containing compounds, iodinated contrast agents, methotrexate, pentamidine, foscarnet, ciclosporin, tacrolimus, cimetidine, and probenecid.
Always inform your doctor or pharmacist about any other medicines you are taking while being treated with Valaciclovir EG for shingles or following an organ transplant.

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

Driving and using machines
Valaciclovir EG may cause side effects that could affect your ability to drive.
→ Do not drive or operate machinery unless you are certain that you are not affected.

3. How to take Valaciclovir EG

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The dose you should take depends on why your doctor has prescribed Valaciclovir EG for you. Your doctor will discuss this with you.
The 500 mg tablet may be divided into equal doses.

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 should take Valaciclovir EG for seven days.

Treatment of cold sores (herpes labialis)

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

Treatment of HSV skin infections and genital herpes

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

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

• The recommended dose is one 500 mg tablet once a day.
• You should take Valaciclovir EG for as long as your doctor tells you to continue.

To help prevent CMV (Cytomegalovirus) infection

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

Your doctor may adjust your dose of Valaciclovir EG if:

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

How to take 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 exactly as directed by your doctor or pharmacist.

People over 65 years of age or with kidney problems
It is very important that you drink water regularly throughout the day while taking Valaciclovir EG.
This will help reduce unwanted effects that may affect the kidneys or the nervous system. Your doctor will monitor you closely for signs of these effects. Nervous system side effects may include confusion or agitation, unusual drowsiness or numbness.

If you take more Valaciclovir EG than you should
Valaciclovir EG is generally not harmful unless you take too much for several days. If you take too many tablets, you may experience nausea, vomiting, kidney problems, confusion, agitation, reduced alertness, seeing things that are not there, or loss of consciousness. Inform your doctor or pharmacist if you have taken too much Valaciclovir EG. Take the medicine pack 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 your next dose, skip the missed dose.

• Do not take a double dose to make up for the forgotten dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The following side effects may occur with this medicine:
Conditions to which you should pay attention

• severe allergic reactions (anaphylaxis). These are rare in people taking Valaciclovir EG. Rapid development of symptoms including:
• flushing, itchy skin rash;
• swelling of the lips, face, neck and throat causing breathing difficulties (angioedema);
• sudden drop in blood pressure leading to collapse. → If you experience 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);
• marked numbness;
• tremors;
• agitation.

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

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

Uncommon side effects that may be detected by blood tests:

• reduction in the number of white blood cells (leucopenia);
• reduction in the number of blood platelets, the cells responsible for blood clotting (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);
• slurred or poorly articulated speech (dysarthria);
• seizures;
• 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, elderly patients, or organ transplant patients taking high doses, 8 grams or more, of Valaciclovir EG per day. These effects usually improve when Valaciclovir EG is discontinued or the dose is reduced.
Other rare side effects:

• kidney problems with little or no urine output.

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

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

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 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 stated on the pack. The expiry date (Exp) refers to the last day of that month.
• Store below 30°C.
• Do not dispose of any medicine 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 EG contains

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

Description of the appearance of Valaciclovir EG and the 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 a score line and "VC2" imprinted on one side.
1000 mg tablets: 22.0 x 11.0 mm, with "VC3" imprinted on one side.
Blister packs in PVC/aluminium
Packs (blister): 10, 21, 30, 42 – 500 mg film-coated tablets
Packs (blister): 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, Italy

Manufacturer
Balkanpharma Dupnitsa AD, 3 Samokovsko Shosse Str., Dupnitsa 2600 – Bulgaria