PATIENT INFORMATION LEAFLET

Valaciclovir Almus 1000 mg Film-Coated Tablets

Read this 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 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 leaflet. See section 4.

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 for:

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

Do not take Valaciclovir

• If you are allergic (hypersensitive) to valaciclovir, aciclovir, or any of the other components of the medication (See section 6).
• Do not take Valaciclovir Almus if the above point affects you. If you are unsure, speak with your doctor or pharmacist before taking Valaciclovir Almus. If you have ever developed a prolonged skin rash associated with fever, lymph node swelling, elevated liver enzymes, and/or eosinophilia (drug reaction with eosinophilia and systemic symptoms) after taking valaciclovir.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Valaciclovir Almus 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 Almus.

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

Valaciclovir has been associated with a condition called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) in some cases.DRESS initially presents with flu-like symptoms, followed by a skin rash on the face that spreads to other areas, high fever, elevated liver enzymes in blood tests, eosinophilia, and lymph node swelling.

If you develop a skin rash associated with fever and lymph node swelling, stop taking valaciclovir and 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 transmitting the infection to others. Do not have sex if you have genital ulcers or blisters.

Use of valaciclovir with other medications

Inform your doctor or pharmacist if you are using, have used, or may need to use other medications, including those purchased without a prescription or herbal medications.

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

Examples include aminoglycosides, organoplatinum compounds, iodinated contrast media, methotrexate, pentamidine, foscarnet, cyclosporine, tacrolimus, cimetidine, and probenecid. Always inform your doctor or pharmacist about other medications you are taking if you are taking Valaciclovir Almus for the treatment of shingles 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 usually not 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 benefits for you against the risks to the baby if you take Valaciclovir Almus while pregnant or breastfeeding.

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

Valaciclovir Almus may cause side effects that affect your ability to drive. Do not drive or operate machinery unless you are sure it does not affect you.

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 Almus. Your doctor will indicate the appropriate dosage.

Herpes zoster treatment

• 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.

Febrile treatment

• 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 only take Valaciclovir Almus for one day (two doses).

Epidermal VHS and genital herpes infections treatment

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

Prevention of recurrent VHS 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 two 250 mg tablets twice a day.
• You should take Valaciclovir Almus until your doctor tells you to stop treatment.

To avoid CMV (cytomegalovirus) 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.
• You should 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 treatment.

Your doctor may adjust the Valaciclovir Almus dose if:

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

Speak with your doctor before taking Valaciclovir Almus if any of the above points affect you.

Form of use and/or administration route

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

People over 65 years old or with kidney problems

It is very important that while taking Valaciclovir Almus, you drink water regularly throughout the day. This will help you reduce the adverse effects that can affect the kidneys or the 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.

If you take more Valaciclovir than you should

Valaciclovir Almus is usually not harmful, unless you take too much over several days. If you take too many tablets, you may experience nausea, vomiting, or feel confused, agitated, or abnormally drowsy. Speak with your doctor or pharmacist if you take too much Valaciclovir Almus. Bring the packaging with you.

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

If you forgot to take Valaciclovir

• If you forget to take Valaciclovir Almus, take it as soon as you remember. However, if it is almost time for the next dose, omit the missed dose.
• Do not take a double dose to compensate for the missed dose.

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

Symptoms to be aware of

• Severe adverse 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 causes difficulty breathing (angioedema)
• Drop in blood pressure leading to collapse
• If you have an allergic reaction, stop taking Valaciclovir Almus and see your doctor immediately.

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

• Headache

Common(may affect between 1 and 10 in 100 people)

• Nausea
• Dizziness
• Vomiting
• Diarrhea
• Skin reactions after exposure to sunlight (photosensitivity)
• Rash

Uncommon(may affect between 1 and 10 in 1,000 people):

• Difficulty breathing (dyspnea)
• Abdominal pain
• Rash, sometimes with itching, hives (urticaria)
• Pain in the lower back (kidney pain)

Side effects may appear in your blood tests:

• Reduction in the number of white blood cells (leucopenia)
• Reduction in the number of platelets, which help blood to clot (thrombocytopenia)

• Increased substances produced by the liver

Rare(may affect between 1 and 10 in 10,000 people):

• Kidney problems that cause little or no urination.

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

Neurological disorders

These effects are generally reversible and usually appeared in patients with renal impairment or predisposing factors.

These neurological side effects usually occur in people with kidney problems, the elderly, or patients who have undergone transplantation and are taking high doses of8 gramsor more of Valaciclovir

Almus per day. They usually improve when Valaciclovir Almus is stopped or the dose is reduced.

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

If you consider that any of the side effects you experience are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 Vigilance 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.

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

Keep out of the reach and sight of children.

Do not use this medicine after the expiration date that appears on the packaging. The expiration date (EXP) is the last day of the month indicated.

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

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.This will help protect the environment.

Composition of Valaciclovir Almus

The active ingredient is valaciclovir. Each coated tablet contains 1112.40 mg of valaciclovir hydrochloride, equivalent to 1000 mg of valaciclovir.

The other components areTablet core: Povidone K90, Maize pregelatinised starch, Crospovidone, Anhydrous colloidal silica, Magnesium stearate,Coating: Titanium dioxide (E171), Hypromellose 6cP, Hypromellose 3cP, Polyethylene glycol 400 and Polysorbate 80.

Appearance of the product and content of the container

Oval-shaped tablets, white in color.

Valaciclovir Almus 1000 mg coated tablets with EFG film coating are presented in containers with blisters containing 21 tablets.

Other presentations:

Valaciclovir Almus 500 mg coated tablets with EFG film coating: containers of 10 or 42 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email:[email protected]

Responsible manufacturer:

Atlantic Pharma-Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº 2 – Abrunheira

2710-089, Sintra (Portugal)

Last review date of this leaflet:December 2022

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