Label: information for the user

Valaciclovir Teva 500 mg film-coated tablets EFG

Read this label carefully before starting to take this medicine, as it contains important information for you.

- Keep this label, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

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

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

3.How to take Valaciclovir Teva

4.Possible side effects

5Storage of Valaciclovir Teva

6.Contents of the pack and additional information

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

Valaciclovir Teva can be used for:

• treat shingles (in adults).
• treat skin and genital herpes infections (in adults and adolescents over 12 years old). It is also used to prevent these infections from recurring.
• treat fevers (in adults and adolescents over 12 years old).
• prevent CMV infection after organ transplants (in adults and adolescents over 12 years old).
• treat and prevent recurring eye infections caused by HSV (in adults and adolescents over 12 years old).

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 associated with fever, enlarged lymph nodes, high levels of liver enzymes and/or eosinophilia (eosinophilic drug reaction and systemic symptoms) after taking valaciclovir.

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

Warnings and precautions

Consult your doctor or pharmacist before taking Valaciclovir Teva if:

• you have kidney problems
• you have liver problems
• you are over 65 years old
• your immune system is weakened

If you are unsure whether any of the above points affect you, consult 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 initially presents with flu-like symptoms and a rash on the face that then spreads, with high body temperature, elevated liver enzymes seen in blood tests, and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.

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

Prevention of genital herpes transmission to others

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

Other medicines and Valaciclovir Teva

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

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

This includes: aminoglycosides, organoplatinum compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, ciclosporin, tacrolimus, cimetidine, and probenecid.

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

Pregnancy and breastfeeding

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

Driving and operating machines

Valaciclovir Teva may cause side effects that affect your ability to drive. Do not drive or operate machines unless you are sure it will 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".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

Herpes zoster treatment

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

Febrile treatment

• 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 only for one day (two doses).

Skin and genital herpes virus infections treatment

• 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 indicates. For recurrent infections, the treatment duration is usually 3-5 days.

Prevention of recurrent infections by VHS 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 avoid CMV (citomegalovirus) infection

• The usual dose is 2,000 mg (four 500 mg tablets) four times a day.
• You should space the doses 6 hours apart.
• You should 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 valaciclovir dose if:

• You are over 65 years old.
• You have a weakened immune system.
• You have kidney problems.

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

Valaciclovir intake

• Take this medication orally.
• Swallow the tablets whole with a glass of water.
• Take valaciclovir at the same time every day.
• Take valaciclovir according to your doctor's or pharmacist's instructions.

People over 65 years old or with kidney problems

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

Your doctor will monitor you to detect any signs of this. Nervous system adverse effects may include feeling confused or agitated, or feeling abnormally sleepy or drowsy.

Children under 12 years old

Valaciclovir is not recommended for children under 12 years old.

If you take more Valaciclovir Teva than you should

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

If you forgot to take Valaciclovir Teva

• If you forget to take valaciclovir, take it as soon as you remember. However, if you have little time left for the next dose, omit the missed dose.
• Do not take a double dose to compensate for the missed doses.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

Symptoms to be aware of:

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, which causes difficulty breathing (angioedema)
• drop in blood pressure leading to collapse.

.

Skin eruptions or redness. The skin reaction can appear as eruptions with or without blisters. It can cause skin irritation, edema (DRESS syndrome) and fever and symptoms similar to the flu.

The following side effects may also occur with this medicine:

Very common(may affectmore than 1 in 10 people)

• headache

Common(may affectup to 1 in 10 people)

• nausea
• dizziness
• vomiting
• diarrhea
• skin reaction after exposure to sunlight (photosensitivity)
• eruption
• itching (pruritus)

Uncommon(may affectup to 1 in 100 people)

• feeling confused
• seeing or hearing things that do not exist (hallucinations)
• feeling very drowsy
• shaking
• feeling agitated

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

Other uncommon side effects:

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

May appear in blood tests:

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

Rare(may affectup to 1 in 1,000 people)

• unsteadiness and lack of coordination (ataxia)
• slow and slurred speech (dysarthria)
• seizures (convulsions)
• altered brain function (encephalopathy)
• loss of consciousness (coma)
• confused or disordered thinking (delirium)

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

Other rare side effects:

kidney problems that cause little or no urination

Unknown(cannot be estimated from available data)

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the carton and blister pack after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Valaciclovir Teva

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

Appearance of the product and contents of the package

• Valaciclovir Teva are white, film-coated, biconvex, oblong tablets, engraved with “VL”, a notch, and “D” on one face and smooth on the other. The tablets can be divided into equal doses.
• Valaciclovir Teva is available in package sizes of 1, 4, 6, 8, 10, 24, 30, 42, 90, and 112 film-coated tablets. Clinical packages of 50 (50x1) film-coated tablets are also available.
• Only some package sizes may be commercially available.

Holder of the Marketing Authorization and Responsible for Manufacturing

Holder of the Marketing Authorization

Teva Pharma, S.L.U.

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

28108 Alcobendas. Madrid

Responsible for Manufacturing

Pharmachemie B.V.

Swensweg 5, Postbus 552,

2003 RN Haarlem

Holland

TEVA Pharmaceutical Works Private Limited Company

Pallagiút 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

DKValaciclovir Teva 500 mg Filmovertrukne tabletter

ESValaciclovir TEVA 500 mg comprimidos recubiertos con película EFG

FIValaclovir 500 mg tabletti, kalvopäällysteinen

FRValaciclovir Teva 500 mg, Comprimé pelliculé sécable

IEValaciclovir TEVA 500 mg Film-coated Tablets

NLValaciclovir 500 PCH, filmomhulde tabletten 500 mg

Last review date of this leaflet:September 2021

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

You can access detailed and updated information about 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