VALACICLOVIR ALMUS 500 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Valaciclovir Almus 500 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you:

• Keep this leaflet, you may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Valaciclovir Almus 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 can be used to:

• Treat herpes zoster (in adults).
• Treat HSV skin infections and genital herpes (in adults and adolescents over 12 years). It is also used to prevent these infections from coming back.
• Treat cold sores (in adults and adolescents over 12 years).
• Prevent CMV infection after organ transplants (in adults and adolescents over 12 years).
• Eye infections.

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

Do not take Valaciclovir Almus

• If you are allergic (hypersensitive) to valaciclovir, aciclovir, or any of the other ingredients of this medicine (see section 6).
• Do not take Valaciclovir Almus if the above point applies to you. If you are not sure, talk to your doctor or pharmacist before taking Valaciclovir Almus.
• If you have ever developed a prolonged skin rash associated with fever, swelling of the lymph nodes, elevated liver enzymes, and/or eosinophilia (Drug Reaction with Eosinophilia and Systemic Symptoms) after taking valaciclovir.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Valaciclovir Almus 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 points apply to you, talk to your doctor or pharmacist before taking Valaciclovir Almus.

If you have kidney disease or are elderly, your doctor may use a lower dose. Also, you should drink enough fluid during treatment to maintain adequate hydration.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with the use of valaciclovir. DRESS is initially manifested by symptoms similar to those of the flu, with a skin rash on the face that then spreads to other areas, high fever, elevated liver enzymes in blood tests, increased eosinophilia, and swelling of the lymph nodes.

If you develop a skin rash associated with fever and swelling of the lymph nodes, stop taking valaciclovir and contact your doctor or seek medical attention immediately.

Prevention of genital herpes transmission to others

If you are taking Valaciclovir Almus 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 the infection from being transmitted to others. You should not have sexual intercourse if you have genital ulcers or blisters.

Use of valaciclovir with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use other medicines, including those obtained without a prescription or herbal remedies.

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 Almus for the treatment of herpes zoster or after an organ transplant.

Taking Valaciclovir with food and drinks

Valaciclovir Almus can be taken with or without food.

Pregnancy and breastfeeding

Valaciclovir Almus is not normally recommended for use during pregnancy. If you are pregnant, think you may be pregnant, or are planning to become pregnant, do not take Valaciclovir Almus without consulting your doctor. Your doctor will weigh the benefit to you against the risk to the baby if you take Valaciclovir Almus while pregnant or breastfeeding.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Valaciclovir Almus may produce side effects that affect your ability to drive. Do not drive or use machines unless you are sure that it does not affect you.

3. How to take Valaciclovir Almus

Follow exactly the administration instructions of this medicine given by your doctor, if in doubt, consult your doctor or pharmacist again.

The dose you should take will depend on why your doctor has prescribed Valaciclovir Almus for you. Your doctor will tell you the correct dose.

Treatment of herpes zoster

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

Treatment of cold sores

• The usual dose is 2,000 mg (two 1,000 mg tablets or 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 Almus only for one day (two doses).

Treatment of HSV skin infections and genital herpes

• The usual dose is 500 mg (one 500 mg tablet or two 250 mg tablets) twice a day.
• For the first infection, you should take Valaciclovir Almus for 5 days or up to 10 days if your doctor tells you to. 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 a day.
• Some people with frequent recurrences may benefit from taking one 250 mg tablet twice a day.
• You should take Valaciclovir Almus until your doctor tells you to stop the treatment.

To prevent CMV infection

• The usual dose is 2,000 mg (two 1,000 mg tablets or four 500 mg tablets) four times a day.
• You should space the dose every 6 hours.
• Normally, you will start taking Valaciclovir Almus as soon as possible after surgery.
• You should take Valaciclovir Almus for about 90 days after surgery, until your doctor tells you to stop the treatment.

Your doctor may adjust the dose of Valaciclovir Almus 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 Almus if any of the above points apply to you.

Method of administration and/or route of administration

• Take this medicine orally.
• Swallow the tablets whole with a glass of water.
• Take Valaciclovir Almus at the same time every day.
• Take Valaciclovir Almus 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 Almus 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. Nervous system side effects can include feeling confused or agitated, or feeling abnormally sleepy or drowsy.

If you take more Valaciclovir than you should

Valaciclovir Almus is not normally harmful, unless you take too much for several days. If you take too many tablets, you may have nausea, vomiting, or feel confused, agitated, or abnormally drowsy. Talk to your doctor or pharmacist if you take too much Valaciclovir Almus. Take the pack with you.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service telephone 91 562 04 20 indicating the medicine and the amount ingested

If you forget to take Valaciclovir

• If you forget to take Valaciclovir Almus, 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.

4. Possible side effects

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

Symptoms to which you must be alert

• Severe allergic reactions (anaphylaxis). These are rare in people taking Valaciclovir Almus

Rapid development of symptoms, including:

• Skin rash with redness, itching
• Swelling of the lips, face, neck, and throat, which can cause difficulty breathing (angioedema)
• Drop in blood pressure that leads to collapse
• If you have an allergic reaction, stop taking Valaciclovir Almus and go to the 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
• Diarrhea
• Skin reactions after sun exposure (photosensitivity)
• Rash

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

• Difficulty breathing (dyspnea)
• Stomach pain
• Rash, sometimes with itching, hives (urticaria)
• Back pain (kidney pain)

Uncommon side effects may appear in your blood tests:

• Decrease in the number of white blood cells (leukopenia)
• Decrease in the number of platelets that help blood clot (thrombocytopenia)

• Increased liver enzymes

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

• Kidney problems that cause you to urinate little or not at all.

Very rare(may affect less than 1 in 10,000 people):

Nervous system disorders

• Agitation
• Confusion
• Tremor
• Difficulty moving
• Difficulty speaking
• Confusion or imagining things (hallucinations)
• Seizures
• Somnolence
• Encephalopathy (brain disorder)
• Coma

These effects are generally reversible and usually occurred in patients with kidney problems, elderly, or transplant patients taking high doses of 8 grams or more of Valaciclovir Almus per day. They usually improve when Valaciclovir Almus is discontinued or the dose is reduced.

These nervous system side effects usually occur in people with kidney problems, elderly, or transplant patients taking high doses of Valaciclovir Almus.

Frequency 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 fever, elevated liver enzymes, abnormal blood changes (eosinophilia), and swelling of the lymph nodes, and possibly changes in other organs. See also section 2.
• Kidney inflammation (tubulointerstitial nephritis).

If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through 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. Storage of Valaciclovir Almus

Do not store above 30°C. Store in the original package

Keep out of the reach and sight of children.

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

Do not use this medicine if you notice visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicine to a pharmacy for safe disposal. This will help protect the environment.

6. Contents of the pack and other information

Composition of Valaciclovir Almus

The active substance is valaciclovir. Each film-coated tablet contains 556.20 mg of valaciclovir hydrochloride, equivalent to 500 mg of valaciclovir.

The other ingredients are Core of the tablet: Povidone K90, pregelatinized corn starch, crospovidone, colloidal anhydrous silica, magnesium stearate, Coating: titanium dioxide (E171), hypromellose 6cP, hypromellose 3cP, polyethylene glycol 400.

Appearance of the product and contents of the pack

White, oblong tablets.

Valaciclovir Almus 500 mg film-coated tablets EFG are available in blister packs containing 10 or 42 tablets.

Other presentations:

Valaciclovir Almus 1000 mg film-coated tablets EFG: packs of 21 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

Manufacturer:

Atlantic Pharma-Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº 2 – Abrunheira

2710-089, Sintra (Portugal)

Date of the last revision of this leaflet::December 2022

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