Vaciclor 500 mg

Patient Information Leaflet

Vaciclor 500 mg, 500 mg, film-coated tablets
Vaciclor 1000 mg, 1000 mg, film-coated tablets
Valaciclovirum
Please read all of this leaflet carefully before 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Vaciclor is and what it is 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 Vaciclor is and what it is 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 may 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), and also for prevention of recurrences of these infections
• Treatment of cold sores (in adults and adolescents over 12 years of age)
• Prevention of cytomegalovirus (CMV) infections after organ transplantation (in adults and adolescents over 12 years of age)
• Treatment and prevention of recurrent herpes simplex virus (HSV) eye infections (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 valacyclovir, acyclovir, or any of the other ingredients of this medicine (listed in section 6).
• if, after taking valacyclovir, the patient has ever experienced a prolonged rash associated with fever, swollen lymph nodes, increased liver enzymes, and/or eosinophilia (a drug reaction with eosinophilia and systemic symptoms).

Do not take Vaciclor if any of the above situations apply to the patient. In case of doubt, the patient should
consult their doctor or pharmacist before starting to take
Vaciclor.
Warnings and precautions
Before starting treatment with Vaciclor, discuss with a 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 is unsure whether any of the above apply, they should consult their
doctor or pharmacist before starting treatment with Vaciclor.
Exercise special caution when taking Vaciclor – important information:
During treatment with valacyclovir, a drug reaction known as DRESS (Drug Rash with Eosinophilia and Systemic Symptoms), associated with eosinophilia and systemic symptoms, has been reported. DRESS initially resembles influenza-like symptoms with a rash on the face, and then progresses to a prolonged rash with high fever, elevated liver enzymes evident in blood tests, increased white blood cell count (eosinophilia), and swollen lymph nodes.
If the patient develops a rash together with fever and swollen lymph nodes,
treatment with valacyclovir must be discontinued and the patient should contact a doctor or seek immediate
medical attention.
Preventing transmission of genital herpes to others
If the patient is taking Vaciclor to prevent transmission of genital herpes or has previously had such an infection, they should continue to practice safe sex, including using condoms. This is important to
prevent 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
Inform the doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines the patient plans to use. This includes also medicines available without a prescription, including herbal medicines.
If the patient is taking any medicines that affect the kidneys, they should inform their doctor or pharmacist. This includes medicines such as: aminoglycosides, platinum-containing organic compounds, iodinated 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
Valacyclovir is generally not recommended during pregnancy. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should
contact her doctor or pharmacist before taking this medicine. The doctor will weigh the benefits to the patient against the potential risks to the unborn child associated with the use of Vaciclor during pregnancy and breastfeeding.
Driving and operating machinery
Vaciclor may cause adverse effects that impair the ability to drive. The patient should not drive or operate machinery unless they are certain they feel well.

3. How to use Vaciclor

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
The dose of medicine that a patient should take depends on the reason why the doctor has prescribed
Vaciclor. Your doctor will discuss this with you.

Treatment of shingles (herpes zoster)

• 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 (herpes labialis)

• 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 for only one day (two doses).

Treatment of genital herpes (herpes simplex virus infection of skin and genital organs)

• The usual dose is 500 mg (one 500 mg tablet) twice a day.
• For the first episode, Vaciclor should be taken for 5 days or up to 10 days if your doctor advises. In case of recurrent infection, treatment usually lasts 3–5 days.

Prevention of recurrent herpes simplex virus infection

• The usual dose is 500 mg once daily.
• Some patients with very frequent recurrences may benefit from taking one 250 mg tablet twice daily. A 500 mg tablet may be divided into two equal 250 mg doses.
• Vaciclor should be taken for as long as your doctor advises.

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.
• Treatment with Vaciclor usually starts as soon as possible after the procedure.
• Vaciclor should be taken for approximately 90 days after the procedure, or until your doctor advises stopping.

Your 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 problems.

If any of the above conditions apply, discuss this with your doctor.

How to take the medicine

• This medicine is taken orally.
• Tablets should be swallowed whole with water. If your doctor advises splitting a 500 mg tablet to achieve a 250 mg dose, the tablet may be broken in half along the score line.
• Vaciclor should be taken at the same time each day.
• Vaciclor should be taken exactly as prescribed by your doctor or pharmacist.

Patients over 65 years of age or with kidney problems
It is very important that while taking Vaciclor, the patient drinks water regularly throughout the day. This will help reduce the risk of unwanted effects on the kidneys or nervous system. Your doctor will carefully monitor whether such symptoms occur.
Adverse effects on the nervous system may include confusion, agitation, 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 Vaciclor than prescribed
Vaciclor is usually not harmful unless the patient takes too high a dose for several days. If the patient takes too many tablets, symptoms such as nausea, vomiting, kidney problems, confusion, agitation, reduced consciousness, hallucinations (seeing things that are not there), or loss of consciousness may occur. If the patient has taken too many tablets of Vaciclor, they should contact their doctor or pharmacist immediately. Bring the medicine packaging with you.

If a dose of Vaciclor is missed

• 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, the missed dose should not be taken.
• Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Symptoms to be aware of:
Stop taking Vaciclor and contact your doctor immediately if the patient experiences any of the
following symptoms:

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

Skin rash or redness. Adverse skin reactions may present as a rash with or without blisters. Skin irritation, swelling (DRESS syndrome), fever, and flu-like symptoms may also occur.
The following adverse reactions may also occur during treatment with this medicine:
Very common adverse reactions (may occur in more than 1 in 10
patients):

• headache

Common adverse reactions (may occur in 1 in 10 patients):

• nausea
• dizziness
• vomiting
• diarrhoea
• skin reaction after exposure to sunlight (photosensitivity)
• rash
• itching (pruritus)

Uncommon adverse reactions (may occur in 1 in 100 patients):

• disorientation
• seeing or hearing things that are not real (hallucinations)
• feeling very sleepy
• tremors
• feeling agitated
  The above nervous system adverse reactions usually occur in patients with kidney disease, elderly patients, or organ transplant patients taking high doses of Vaciclor (8 g or more per day). These symptoms usually resolve after stopping Vaciclor or reducing the dose.

Other uncommon adverse reactions:

• shortness of breath (dyspnoea)
• feeling of discomfort in the stomach
• rash, sometimes itchy and resembling hives (urticaria)
• lower back pain (kidney pain)
• blood in the urine (haematuria)

Uncommon adverse reactions that may be revealed in blood test results:

• decrease in white blood cell count (leukopenia)
• decrease in platelet count involved in blood clotting (thrombocytopenia)
• increased activity of certain substances produced in the liver.

Rare adverse reactions (may occur in 1 in 1000 patients):

• unsteadiness when moving and lack of coordination (ataxia)
• slow, slurred speech (dysarthria)
• seizures
• disturbances in brain function (encephalopathy)
• loss of consciousness (coma)
• disorientation (confusion) or impaired thinking (delirium)

The above nervous system adverse reactions usually occur in patients with kidney disease, elderly patients, or organ transplant patients taking high doses of Vaciclor (8 g or more per day). These symptoms usually resolve after stopping Vaciclor or reducing the dose.
Other rare adverse reactions:

• kidney-related problems when the patient does not pass urine or passes too little urine.

Frequency not known – cannot be estimated from available data

• DRESS (Drug Rash with Eosinophilia and Systemic Symptoms), a drug reaction with accompanying eosinophilia and systemic symptoms, also known as drug hypersensitivity syndrome, characterized by widespread rash, high fever, elevated liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and possible internal organ involvement. See also section 2.
• kidney inflammation (tubulointerstitial nephritis)

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Vaciclor

Keep this medicine out of sight and reach of children.
Do not use 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 stated 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 packaging and other information

What Vaciclor contains

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

What Vaciclor looks like and contents of the pack
Vaciclor tablets are oval, white, biconvex, film-coated tablets with the following dimensions and markings:
500 mg tablets: 17.6 × 8.8 mm, with a score line and marked "VC2" on one side
1000 mg tablets: 22 × 11 mm, marked "VC3" on one side
PVC/Aluminium blisters in cardboard packaging.
Pack sizes:
500 mg film-coated tablets: packs of 8, 10 or 42 tablets
1000 mg film-coated tablets: packs of 21 or 28 tablets

Marketing Authorisation Holder
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

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

For further information about this medicinal product and its trade names in the countries of the European Economic Area, please contact the representative of the marketing authorisation holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, Poland, tel. (22) 345 93 00.