Vaciclor 1000 mg

Leaflet attached to the packaging: patient information

Vaciclor 500 mg, 500 mg, film-coated tablets

Vaciclor 1000 mg, 1000 mg, film-coated tablets

Valaciclovir

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 to:

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

2. Important information before taking Vaciclor

When not to take Vaciclor

• if the patient is allergic to valaciclovir, acyclovir, or any of the other ingredients of this medicine (listed in section 6).
• if the patient has ever experienced a long-lasting rash associated with fever, lymph node enlargement, elevated liver enzymes, and/or eosinophilia (drug rash with eosinophilia and systemic symptoms) after taking valaciclovir.

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

Warnings and precautions

Before starting to take Vaciclor, discuss it with your 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 careful when taking Vaciclor - important information:

During treatment with valaciclovir, drug reactions known as DRESS (Drug Rash with Eosinophilia and Systemic Symptoms) with accompanying eosinophilia and systemic symptoms have been reported. DRESS initially resembles flu-like symptoms with a rash on the face, and then manifests as a long-lasting 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription, including herbal medicines. If you are taking any medicines that affect the kidneys, tell your 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 you are taking Vaciclor for the treatment of shingles or after organ transplantation, always tell your doctor or pharmacist.

Pregnancy and breastfeeding

Valaciclovir is not usually recommended during pregnancy. If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will weigh the benefits for you against the risks for your baby resulting from the use of Vaciclor during pregnancy and breastfeeding.

Driving and using machines

Vaciclor may cause side effects that affect your ability to drive or use machines. Do not drive or use machines unless you are sure you feel well.

3. How to take Vaciclor

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The dose of Vaciclor that you should take depends on the reason why your doctor has prescribed it for you. Your doctor will discuss this with you.

Treatment of shingles

• The usual dose is 1000 mg (one 1000 mg tablet or two 500 mg tablets) three times a day.
• Take Vaciclor 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.
• Take the second dose 12 hours (but not earlier than 6 hours) after the first dose.
• Take Vaciclor for only one day (two doses).

Treatment of skin and genital herpes infections caused by the 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, take Vaciclor for 5 days or up to 10 days if your doctor tells you to. If the infection recurs, the treatment time 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.
• Take Vaciclor for as long as your doctor tells you to.

Prevention of cytomegalovirus (CMV) infections

• The usual dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) four times a day.
• Take a dose every 6 hours.
• Usually start taking Vaciclor as soon as possible after the procedure.
• Take Vaciclor for about 90 days after the procedure, until your doctor tells you to stop.

Your doctor may adjust the dose of Vaciclor if:

• you are over 65 years of age.
• you have a weakened immune system.
• you have kidney disease.

If any of the above circumstances apply to you, talk to your doctor.

Taking the medicine

• Take the medicine by mouth.
• Swallow the tablets whole with water.
• Take Vaciclor at the same time every day.
• Take Vaciclor as directed by your doctor or pharmacist.

Patients over 65 years of age or with kidney disease

It is very important to drink water regularly during the day while taking Vaciclor. This will help reduce the risk of kidney or nervous system problems. Your doctor will closely monitor you for these symptoms. Nervous system problems can 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 you take too much of it for several days. If you take too many tablets, you may experience nausea, vomiting, kidney problems, disorientation, agitation, decreased consciousness, hallucinations (seeing or hearing things that do not exist), or loss of consciousness. If you take too many Vaciclor tablets, consult your doctor or pharmacist. Have the medicine package with you.

Missing a dose of Vaciclor

• If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose.
• Do not take a double dose to make up for a missed dose.

If you have any further doubts about taking this medicine, ask your 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:

Stop taking Vaciclor and contact your doctor immediately if you experience any of the following symptoms:

• Severe allergic reactions (anaphylaxis). These are rare in people taking Vaciclor. 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 can 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 when taking 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 appear 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 problems (encephalopathy)
• loss of consciousness (coma)
• disorientation (confusion) or difficulty thinking (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 you do not urinate or urinate too little.

Unknownfrequency cannot be estimated 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 you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, you can help provide more information on the safety of this medicine.

5. How to store Vaciclor

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label, carton, or bottle 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. Ask your pharmacist how to dispose of medicines no longer required. 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 authorized names in the European Economic Area, contact the marketing authorization holder's representative:

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