VALACICLOVIR TEVA 500 mg FILM-COATED TABLETS

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

Do not take Valaciclovir Teva

• if you are allergic to valaciclovir or aciclovir or any of the other ingredients of this medicine (listed in section 6).
• if you have ever developed a widespread rash, fever, swollen lymph nodes, high liver enzymes, and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking valaciclovir.

Do not take Valaciclovir Teva if any of the above applies to you. If you are not sure, talk to 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 not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Valaciclovir Teva.

Be especially careful with Valaciclovir Teva – Important Information:

Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with the use of valaciclovir. DRESS appears initially with symptoms similar to the flu and a rash on the face that then spreads, with high body temperature, high liver enzymes seen in blood tests, and an increase in a type of white blood cell (eosinophilia) and swollen lymph nodes.

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

Preventing the spread of genital herpes to others

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

Other medicines and Valaciclovir Teva

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

Tell your doctor or pharmacist if you are taking any medicine that affects the kidneys.

These include: aminoglycosides, platinum compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, cyclosporine, tacrolimus, cimetidine, and probenecid.

Always tell your doctor or pharmacist about other medicines you are taking if you are taking Valaciclovir Teva for the treatment of shingles or after an organ transplant.

Pregnancy and breastfeeding

Valaciclovir Teva is not normally recommended for use during pregnancy. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will weigh the benefit for you against the risk for the baby if you take Valaciclovir Teva while pregnant or breastfeeding.

Driving and using machines

Valaciclovir Teva may produce side effects that affect your ability to drive. Do not drive or operate machinery unless you are sure 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 administration instructions of this medicine given by your doctor. In case of 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 right dose.

Treatment of shingles

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

Treatment of cold sores

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

Treatment of HSV skin and genital herpes infections

• The usual dose is 500 mg (one 500 mg tablet) twice a day.
• For the first infection, you should take valaciclovir for five days or up to ten days if your doctor tells you to. For recurrent infections, the treatment duration is normally 3-5 days.

Prevention of recurrent HSV infections once you have had them

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

To prevent CMV infection

• The usual dose is 2,000 mg (four 500 mg tablets) four times a day.
• You should space the doses 6 hours apart.
• Normally, you will start taking valaciclovir as soon as possible after surgery.
• You should take valaciclovir for about 90 days after surgery, until your doctor tells you to stop.

Your doctor may adjust the dose of valaciclovir if:

• you are over 65 years of age.
• your immune system is weakened.
• you have kidney problems.

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

Taking 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 as instructed by your doctor or pharmacist.

People over 65 years of age or with kidney problems

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

Your doctor will monitor you to detect signs of this. The nervous system side effects can include feeling confused or agitated, or feeling abnormally sleepy or drowsy.

Children under 12 years

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

If you take more Valaciclovir Teva than you should

Valaciclovir is not normally harmful, unless you take too much over several days. If you take too many tablets, you may have nausea, vomiting, kidney problems, feel confused, agitated, feel less alert, see things that are not there, or become unconscious. Talk to your doctor or pharmacist if you take too much valaciclovir. Take the pack with you. You can also call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Valaciclovir Teva

• If you forget to take valaciclovir, 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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Symptoms to look out for:

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

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

Skin rash or redness. The adverse skin reaction may appear as a rash with or without blisters. It can cause skin irritation, edema (DRESS syndrome), and fever and flu-like symptoms.

The following side effects can 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 sleepy
• tremors
• feeling agitated

These nervous system side 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 side effects:

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

Uncommon side effects may appear in your blood tests:

• reduction in the number of white blood cells (leukopenia)
• reduction in the number of platelets that help the blood to clot (thrombocytopenia)
• increase in substances produced by the liver.

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

• unsteadiness and lack of coordination (ataxia)
• slow and slurred speech (dysarthria)
• seizures (convulsions)
• altered brain function (encephalopathy)
• unconsciousness (coma)
• confused or disturbed thoughts (delirium)

These nervous system side 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 Valaciclovir Teva is discontinued or the dose is reduced.

Other rare side effects:

kidney problems that cause little or no urine production

Not known(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, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and possible involvement of other organs. See also section 2.
• kidney inflammation (tubulointerstitial nephritis)

Reporting of side effects

If you experience 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 to the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Valaciclovir Teva

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

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

Store below 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 protect the environment.

6. Contents of the pack and further information

Composition of Valaciclovir Teva

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

Appearance of the product and pack contents

• Valaciclovir Teva are white, biconvex, oblong, film-coated tablets engraved with “VL”, scored, 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. Clinical packs of 50 (50x1) film-coated tablets are also available.
• Not all 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, 1ª planta

28108 Alcobendas. Madrid

Manufacturer

Pharmachemie B.V.

Swensweg 5, Postbus 552,

2003 RN Haarlem

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 medicine 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 comprimidos recubiertos con película EFG

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 last revision of this leaflet:September 2021

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (https://www.aemps.gob.es/)

You can access detailed and updated information on this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70027/P_70027.html