VACICLOR 500 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Vaciclor 500 mg, 500 mg, film-coated tablets
3. Vaciclor 1000 mg, 1000 mg, film-coated tablets
   1. Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Vaciclor and what is it used for
5. Important information before taking Vaciclor
   1. When not to take Vaciclor
   2. Warnings and precautions
   3. If the patient has any doubts about the above circumstances, they should consult their doctor or pharmacist before starting to take Vaciclor.
   4. Be particularly cautious when taking Vaciclor - important information:
   5. If the patient experiences a rash in combination with fever and lymph node enlargement, they should stop taking valaciclovir and contact their doctor or seek medical help immediately.
   6. Preventing the transmission of genital herpes
   7. If the patient is taking Vaciclor to prevent the transmission of genital herpes or has had such an infection in the past, they should continue to practice safe sex, including the use of condoms. This is important to
   8. Vaciclor and other medicines
   9. Pregnancy and breastfeeding
   10. Driving and using machines
6. How to take Vaciclor
   1. Taking the medicine
   2. Patients over 65 years of age or with kidney disease
   3. Children under 12 years of age
   4. Taking more than the recommended dose of Vaciclor
   5. Missing a dose of Vaciclor
7. Possible side effects
   1. Symptoms to watch out for:
   2. The patient should stop taking Vaciclor and contact their doctor immediately if they experience any of the following symptoms:
   3. The following side effects may also occur during treatment with this medicine:
   4. Reporting side effects
8. How to store Vaciclor
9. Contents of the pack and other information
   1. What Vaciclor contains
   2. What Vaciclor looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. For more information about this medicine and its names in the Member States of the European Economic Area, please contact the representative of the marketing authorization holder:
   7. Date of last revision of the leaflet: July 2023

Leaflet accompanying the packaging: patient information

Vaciclor 500 mg, 500 mg, film-coated tablets

Vaciclor 1000 mg, 1000 mg, film-coated tablets

Valaciclovir

Please read carefully the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Vaciclor and what is it used for
• 2. Important information before taking Vaciclor
• 3. How to take Vaciclor
• 4. Possible side effects
• 5. How to store Vaciclor
• 6. Contents of the pack and other information

1. What is Vaciclor and what is it used for

Vaciclor belongs to a group of medicines called antivirals. It works by killing or inhibiting the growth of herpes simplex virus (HSV), varicella-zoster virus (VZV), and cytomegalovirus (CMV). Vaciclor can be used for:

• treatment of shingles (in adults)
• treatment of skin and genital infections caused by herpes simplex virus (in adults and adolescents over 12 years of age), as well as to prevent recurrence of these infections
• treatment of cold sores (in adults and adolescents over 12 years of age)
• prevention of cytomegalovirus (CMV) infection after organ transplantation (in adults and adolescents over 12 years of age)
• treatment and prevention of recurrent eye infections caused by herpes simplex virus (HSV) (in adults and adolescents over 12 years of age).

2. Important information before taking Vaciclor

When not to take Vaciclor

Do not take Vaciclor if the above circumstances apply to the patient. In case of doubt, consult a doctor or pharmacist before starting to take Vaciclor.

Warnings and precautions

Before starting to take Vaciclor, the patient should discuss it with their doctor or pharmacist if:

• the patient has kidney disease
• the patient has liver disease
• the patient is over 65 years of age
• the patient has a weakened immune system

If the patient has any doubts about the above circumstances, they should consult their doctor or pharmacist before starting to take Vaciclor.

Be particularly cautious when taking Vaciclor - important information:

During treatment with valaciclovir, drug reactions known as DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) have been reported, with accompanying eosinophilia and systemic symptoms. DRESS initially resembles flu-like symptoms with a rash on the face, and then manifests as a prolonged rash with high body temperature, elevated liver enzymes visible in blood tests, and an increase in white blood cell count (eosinophilia) and lymph node enlargement.

If the patient experiences a rash in combination with fever and lymph node enlargement, they should stop taking valaciclovir and contact their doctor or seek medical help immediately.

Preventing the transmission of genital herpes

If the patient is taking Vaciclor to prevent the transmission of genital herpes or has had such an infection in the past, they should continue to practice safe sex, including the use of condoms. This is important to

prevent the transmission of the infection to others. The patient should not have sexual intercourse if they have ulcers or blisters on their genitals.

Vaciclor and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines available without a prescription, including herbal medicines. If the patient is taking any medicines that affect the kidneys, they should tell their doctor or pharmacist. This includes medicines such as aminoglycosides, platinum-based compounds, iodine-based contrast agents, methotrexate, pentamidine, foscarnet, cyclosporine, tacrolimus, cimetidine, and probenecid. If the patient is taking Vaciclor for the treatment of shingles or after organ transplantation, they should always inform their doctor or pharmacist.

Pregnancy and breastfeeding

Valaciclovir is not usually recommended during pregnancy. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The doctor will weigh the benefits for the patient against the risk to the child resulting from the mother's use of Vaciclor during pregnancy and breastfeeding.

Driving and using machines

Vaciclor may cause side effects that affect the ability to drive or operate machinery. The patient should not drive or operate machinery unless they are sure they feel well.

3. How to take Vaciclor

This medicine should always be taken according to the doctor's instructions. In case of doubt, the patient should consult their doctor or pharmacist. The dose of the medicine that the patient should take depends on the reason why the doctor prescribed Vaciclor. The doctor will discuss this with the patient.

Treatment of shingles

• The usual dose is 1000 mg (one 1000 mg tablet or two 500 mg tablets) three times a day.
• Vaciclor should be taken for 7 days.

Treatment of cold sores

• The usual dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) twice a day.
• The second dose should be taken 12 hours (but not earlier than 6 hours) after the first dose.
• Vaciclor should be taken only for one day (two doses).

Treatment of skin and genital infections caused by herpes simplex virus

• The usual dose is 500 mg (one 500 mg tablet or two 250 mg tablets) twice a day.
• In the first infection, Vaciclor should be taken for 5 days or up to 10 days if the doctor prescribes it. If the infection recurs, the treatment duration is usually 3-5 days.

Prevention of recurrent herpes simplex virus infections

• The usual dose is 500 mg once a day.
• Some patients with very frequent recurrences may benefit from taking one 250 mg tablet twice a day.
• Vaciclor should be taken for as long as the doctor prescribes.

Prevention of cytomegalovirus (CMV) infection

• The usual dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) four times a day.
• The dose should be taken every 6 hours.
• Vaciclor should be started as soon as possible after the procedure.
• Vaciclor should be taken for about 90 days after the procedure, until the doctor decides to stop it.

The doctor may adjust the dose of Vaciclor if:

• the patient is over 65 years of age.
• the patient has a weakened immune system.
• the patient has kidney disease.

If any of the above circumstances apply to the patient, they should discuss it with their doctor.

Taking the medicine

• The medicine should be taken orally.
• The tablets should be swallowed whole with water.
• Vaciclor should be taken every day at the same time.
• Vaciclor should be taken according to the doctor's or pharmacist's instructions.

Patients over 65 years of age or with kidney disease

It is very important that the patient drinks water regularly throughout the day while taking Vaciclor.This will help reduce the risk of kidney or nervous system side effects. The doctor will closely monitor the patient for such symptoms. Nervous system side effects may include disorientation or agitation, or unusual drowsiness or lethargy.

Children under 12 years of age

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

Taking more than the recommended dose of Vaciclor

Vaciclor is usually not harmful, unless the patient takes too much of it for several days. If the patient takes too many tablets, they may experience nausea, vomiting, kidney problems, disorientation, agitation, decreased consciousness, hallucinations (seeing or hearing things that do not exist), or loss of consciousness. If the patient takes too many Vaciclor tablets, they should consult their doctor or pharmacist. They should have the medicine packaging with them.

Missing a dose of Vaciclor

• If the patient forgets to take a dose, they should take it as soon as they remember. However, if it is almost time for the next dose, they should not take the missed dose.
• Do not take a double dose to make up for the missed dose.

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

Symptoms to watch out for:

The patient should stop taking Vaciclor and contact their doctor immediately if they experience any of the following symptoms:

• Severe allergic reactions (anaphylaxis).These occur rarely in people taking Vaciclor. Sudden symptoms include:
• redness, itchy skin rash
• swelling of the lips, face, neck, and throat, causing difficulty breathing (angioedema)
• low blood pressure leading to fainting.

Skin rashes or redness. Unwanted skin reactions may appear as a rash with or without blisters. Skin irritation, swelling (DRESS syndrome), and fever and flu-like symptoms may occur.

The following side effects may also occur during treatment with this medicine:

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

• headache

Common side effects(may affect up to 1 in 10 people):

• nausea
• dizziness
• vomiting
• diarrhea
• skin reaction to sunlight (photosensitivity)
• rash
• itching (pruritus)

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

• disorientation
• seeing or hearing things that do not exist (hallucinations)
• feeling very sleepy
• tremors
• feeling agitated. The above nervous system side effects usually occur in people with kidney disease, the elderly, or patients who have had organ transplants and are taking high doses of Vaciclor, 8 g or more per day. They usually go away after stopping Vaciclor or reducing the dose.

Other uncommon side effects:

• shortness of breath (dyspnea)
• discomfort in the stomach
• rash, sometimes itchy, nettle-like (urticaria)
• back pain (kidney pain)
• blood in the urine (hematuria)

Uncommon side effects that may be detected in blood tests:

• decrease in white blood cell count (leukopenia)
• decrease in platelet count, which helps the blood to clot (thrombocytopenia)
• increase in the activity of certain substances produced in the liver.

Rare side effects(may affect up to 1 in 1000 people):

• unsteadiness when walking and lack of coordination (ataxia)
• slow, unclear speech (dysarthria)
• seizures
• brain disorders (encephalopathy)
• loss of consciousness (coma)
• disorientation (confusion) or impaired memory (delirium)

The above nervous system side effects usually occur in people with kidney disease, the elderly, or patients who have had organ transplants and are taking high doses of Vaciclor, 8 g or more per day. They usually go away after stopping Vaciclor or reducing the dose. Other rare side effects:

• kidney problems, when the patient does not urinate or urinates too little.

Unknown frequencycannot be determined from the available data

• DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) drug reaction with accompanying eosinophilia and systemic symptoms, also known as hypersensitivity syndrome, which is characterized by a widespread rash, high body temperature, elevated liver enzymes, blood abnormalities (eosinophilia), lymph node enlargement, and possible involvement of internal organs. See also section 2.
• kidney inflammation (interstitial nephritis)

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Vaciclor

The medicine should be stored out of sight and reach of children. Do not take this medicine after the expiry date stated on the label, carton, or container after EXP. The expiry date refers to the last day of the month. Do not store above 30°C. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Vaciclor contains

• The active substance is valaciclovir. Each tablet contains 500 mg or 1000 mg of valaciclovir (as valaciclovir hydrochloride monohydrate).
• The other ingredients are: tablet core: microcrystalline cellulose, povidone, magnesium stearate; tablet coating (Opadry White Y-5-7068): hypromellose 3 cP, hydroxypropylcellulose, titanium dioxide (E171), macrogol 400, hypromellose 50 cP.

What Vaciclor looks like and contents of the pack

Vaciclor tablets are oval, white, and film-coated, with the following dimensions and markings: 500 mg tablets: 17.6 × 8.8 mm with the marking "VC2" on one side; 1000 mg tablets: 22 × 11 mm with the marking "VC3" on one side. PVC/Aluminum blisters in a cardboard box. Pack sizes: 500 mg film-coated tablets: packs of 10 or 42; 1000 mg film-coated tablets: packs of 21 or 28.

Marketing authorization holder and manufacturer

Marketing authorization holder

Actavis Group PTC ehf. Dalshraun 1, 220 Hafnarfjörður, Iceland

Manufacturer

Balkanpharma-Dupnitsa AD, 3 Samokovsko Shosse Str., Dupnitsa 2600, Bulgaria

For more information about this medicine and its names in the Member States of the European Economic Area, please contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.

Date of last revision of the leaflet: July 2023