Valaciclovir Teva 500 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Valaciclovir Teva 500 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Valaciclovir Teva belongs to a group of medicines called antivirals. It works by eliminating or stopping the growth of viruses known as herpes simplex (HSV), varicella zoster (VZV), and cytomegalovirus (CMV).

Valaciclovir Teva can be used to:

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

2. What you need to know before starting to take Valaciclovir Teva

Do not take Valaciclovir Teva

• 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 rash associated with fever, swollen lymph nodes, elevated liver enzymes, and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms).

Do not take Valaciclovir Teva if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Valaciclovir Teva.

Warnings and precautions

Talk to your doctor or pharmacist before taking Valaciclovir Teva 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 apply to you, consult your doctor or pharmacist before taking Valaciclovir Teva.

Take special care with Valaciclovir Teva – Important Information:

Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with the use of valaciclovir. DRESS initially presents with flu-like symptoms and a facial rash that then spreads, accompanied by high body temperature, elevated liver enzymes seen in blood tests, an increase in a type of white blood cells (eosinophilia), and swollen lymph nodes.

If you develop a rash associated with fever and swollen lymph nodes, stop taking valaciclovir and consult your doctor or seek immediate medical attention.

Preventing transmission of genital herpes to others

If you are taking Valaciclovir Teva to treat or prevent genital herpes, or have previously had genital herpes, you should practice safe sex, including using condoms. This is important to avoid spreading the infection to others. You should not have sexual intercourse if you have genital ulcers or blisters.

Other medicines and Valaciclovir Teva

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription or herbal medicines.

Inform your doctor or pharmacist if you are taking any 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 if you are using Valaciclovir Teva for the treatment of shingles or after an organ transplant.

Pregnancy and breastfeeding

Valaciclovir Teva is generally not recommended for use during pregnancy. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will weigh the benefits to you against the risks to the baby if you take Valaciclovir Teva during pregnancy or while breastfeeding.

Driving and using machines

Valaciclovir Teva may cause adverse effects that could affect your ability to drive. Do not drive or operate machinery unless you are certain that it does not affect you.

Valaciclovir Teva contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Valaciclovir Teva

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The dose you should take will depend on why your doctor has prescribed valaciclovir for you. Your doctor will tell you the appropriate dosage.

Treatment of shingles (herpes zoster)

• The usual dose is 1,000 mg (two 500 mg tablets) three times daily.
• You should take valaciclovir for seven days.

Treatment of cold sores (herpes labialis)

• The usual dose is 2,000 mg (four 500 mg tablets) twice daily.
• The second dose should be taken 12 hours after the first dose (not sooner than 6 hours).
• You should take valaciclovir for only one day (two doses).

Treatment of skin infections caused by HSV and genital herpes

• The usual dose is 500 mg (one 500 mg tablet) twice daily.
• For the first infection, take valaciclovir for five days or up to ten days if your doctor instructs you to do so. For recurrent infections, the treatment duration is usually 3–5 days.

Prevention of recurrent HSV infections once you have had them

• The usual dose is one 500 mg tablet once daily.
• Some people with frequent recurrences may benefit from taking half a 500 mg tablet twice daily.
• You should continue taking valaciclovir until your doctor tells you to stop.

To prevent CMV (cytomegalovirus) infection

• The usual dose is 2,000 mg (four 500 mg tablets) four times daily.
• Doses should be spaced 6 hours apart.
• You will usually start taking valaciclovir as soon as possible after surgery.
• You should take valaciclovir for about 90 days after surgery, or until your doctor tells you to stop.

Your doctor may adjust your valaciclovir dose if:

• you are over 65 years of age.

• you have a weakened immune system.

• you have kidney problems.

• Talk to your doctor before taking valaciclovir if any of the above apply to you.

How to take this medicine

• Take this medicine by mouth.
• Swallow the tablets whole with a glass of water.
• Take valaciclovir at the same time each day.
• Take valaciclovir exactly as instructed by your doctor or pharmacist.

Patients aged 65 years or older or with kidney problems

It is very important that you drink water regularly throughout the day while taking valaciclovir. This will help reduce side effects that may affect the kidneys or nervous system.

Your doctor will monitor you for signs of such effects. Nervous system side effects may include confusion, agitation, unusual drowsiness, or feeling lethargic.

Children under 12 years of age

Valaciclovir is not recommended for use in children under 12 years of age.

If you take more Valaciclovir Teva than you should

Valaciclovir is generally not harmful unless taken in excess over 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 (hallucinations), or loss of consciousness. Speak to your doctor or pharmacist if you take too much valaciclovir. Take the packaging with you. You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Valaciclovir Teva

• If you forget to take a dose, 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 a forgotten dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Symptoms to watch for:

Stop taking Valaciclovir Teva and seek immediate medical attention if you notice any of the following symptoms:

• Severe allergic reactions (anaphylaxis). These are rare in people taking Valaciclovir Teva. Rapid onset of symptoms including:
• skin rash with redness, itching
• swelling of the lips, face, neck, and throat, causing difficulty breathing (angioedema)
• drop in blood pressure leading to collapse.

Skin rashes or redness. The adverse skin reaction may appear as rashes with or without blisters. Skin irritation, edema (DRESS syndrome), fever, and flu-like symptoms may also occur.

The following side effects may also occur with this medicine:

Very common (may affect more than 1 in 10 people)

• headache

Common (may affect up to 1 in 10 people)

• nausea
• dizziness
• vomiting
• diarrhea
• skin reaction after sun exposure (photosensitivity)
• rash
• itching (pruritus)

Uncommon (may affect up to 1 in 100 people)

• feeling confused
• seeing or hearing things that are not there (hallucinations)
• feeling very drowsy
• tremors
• feeling agitated

These nervous system adverse effects usually occur in patients with kidney problems, elderly patients, or transplant patients taking high doses of 8 grams or more of Valaciclovir Teva per day. They usually improve when Valaciclovir Teva is discontinued or the dose is reduced.

Other uncommon adverse effects:

• difficulty breathing (dyspnea)
• stomach pain
• rash, sometimes with itching, hives (urticaria)
• pain in the lower back (renal pain)
• blood in the urine (hematuria)

Uncommon adverse effects may appear in blood tests:

• reduction in the number of white blood cells (leukopenia)
• reduction in the number of 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)
• slurred or slow speech (dysarthria)
• seizures (convulsions)
• altered brain function (encephalopathy)
• loss of consciousness (coma)
• confused or disturbed thoughts (delirium)

These nervous system adverse effects usually occur in people with kidney problems, elderly patients, or transplant patients taking high doses of 8 grams or more of Valaciclovir Teva per day. They usually improve when treatment with Valaciclovir Teva is stopped or the dose is reduced.

Other rare adverse effects:

• kidney problems causing reduced or no urine output

Not known (cannot be estimated from available data)

• Drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome, characterized by widespread rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes, and possibly involvement of other organs in the body. See also section 2.
• inflammation of the kidneys (tubulointerstitial nephritis)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Valaciclovir Teva

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

Store below 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valaciclovir Teva

• The active substance is valaciclovir. Each tablet contains 500 mg of valaciclovir (as valaciclovir hydrochloride dihydrate).
• The other components are corn starch, sodium croscarmellose, sodium stearate fumarate, and powdered cellulose in the tablet core; hypromellose (E464), titanium dioxide (E171), macrogol 400, and polysorbate 80 (E433) in the coating.

Appearance of the product and contents of the pack

• Valaciclovir Teva are white, biconvex, film-coated, oblong tablets, marked with "VL", a score line, and "D" on one side and smooth on the other. The tablets can be divided into equal doses.
• Valaciclovir Teva is available in pack sizes of 1, 4, 6, 8, 10, 24, 30, 42, 90 and 112 film-coated tablets. Hospital packs containing 50 (50x1) film-coated tablets are also available.
• Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11. Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid

Manufacturer

Pharmachemie B.V.

Swensweg 5, Postbus 552,

2003 RN Haarlem

The Netherlands

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

IVAX Pharmaceuticals, s.r.o.

Ostravská 29, c.p. 305, 747 70 Opava -Komárov

Czech Republic

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

DK Valaciclovir Teva 500 mg Filmovertrukne tabletter

ES Valaciclovir TEVA 500 mg film-coated tablets

FI Valaclovir 500 mg tabletti, kalvopäällysteinen

FR Valaciclovir Teva 500 mg, Comprimé pelliculé sécable

IE Valaciclovir TEVA 500 mg Film-coated Tablets

NL Valaciclovir 500 PCH, filmomhulde tabletten 500 mg

Date of the most recent revision of this leaflet: September 2021

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (https://www.aemps.gob.es/)

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70027/P_70027.html