Valaciclovir Mylan Generics

PACKAGE LEAFLET: INFORMATION FOR THE USER

Valaciclovir Mylan Generics 500 mg and 1000 mg film-coated tablets

Valaciclovir
Generic medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Valaciclovir Mylan Generics is and what it is used for

Valaciclovir Mylan Generics contains the active substance valaciclovir hydrochloride hydrate.
Valaciclovir Mylan Generics belongs to a group of medicines called antivirals. It works by killing or inhibiting the growth of viruses known as herpes simplex (HSV), varicella zoster (VZV), and cytomegalovirus (CMV).
Valaciclovir Mylan Generics can be used for:

• treating shingles (in adults).
• treating HSV skin infections and genital herpes (in adults and adolescents over 12 years of age). It is also used to help prevent the recurrence of these infections.
• treating cold sores (in adults and adolescents over 12 years of age).
• preventing CMV infections after organ transplantation (in adults and adolescents over 12 years of age).
• treating and preventing recurrent HSV eye infections (in adults and adolescents over 12 years of age).

2. What you need to know before taking Valaciclovir Mylan Generics

Do not take Valaciclovir Mylan Generics

• If you are allergic (hypersensitive) to valaciclovir or aciclovir or to any of the excipients (listed in section 6). If you are unsure, consult your doctor or pharmacist before taking Valaciclovir Mylan Generics.

Warnings and precautions
Before taking Valaciclovir Mylan Generics, speak with your doctor or pharmacist if:

• you have kidney problems
• you have liver problems
• you are over 65 years of age
• your immune system is weakened
  If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking Valaciclovir Mylan Generics.

To prevent transmission of genital herpes to other people
If you are taking Valaciclovir Mylan Generics to treat or prevent genital herpes or if you have previously had genital herpes, you must practice protected sex, including the use of condoms.
This is important to prevent spreading the infection to others. You must not have sexual intercourse if you have pain or blisters in the genital area.

Children under 12 years of age
This medicine is not recommended for children under 12 years of age.

Other medicines and Valaciclovir Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription and herbal medicines.
Inform your doctor or pharmacist if you are taking any other medicine that affects the kidneys.
These include aminoglycosides, platinum-containing compounds, iodinated contrast agents, methotrexate, pentamidine, foscarnet, ciclosporin, tacrolimus, cimetidine, and probenecid.
Always inform your doctor or pharmacist about any other medicines you are taking while receiving Valaciclovir Mylan Generics for the treatment of shingles or following an organ transplant.

Pregnancy and breastfeeding
Valaciclovir Mylan Generics is generally not recommended during pregnancy. If you are pregnant, think you may be pregnant, or are planning a pregnancy, consult your doctor before taking this medicine.
Your doctor will assess the benefit to you and the risk to your unborn child of taking Valaciclovir Mylan Generics during pregnancy or while breastfeeding.

Driving and using machines
Valaciclovir Mylan Generics may cause side effects that could affect your ability to drive.
Do not drive or operate machinery unless you are sure you are not affected.

3. How to take Valaciclovir Mylan Generics

Take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The dose you should take depends on the reason your doctor has prescribed Valaciclovir Mylan Generics.
Your doctor will discuss this with you.

Treatment of herpes zoster (shingles)

• The recommended dose is 1000 mg (one 1000 mg tablet or two 500 mg tablets) three times a day.
• You should take Valaciclovir Mylan Generics for seven days.

Treatment of cold sores (herpes labialis)

• The recommended dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) twice a day.
• The second dose should be taken 12 hours (not earlier than 6 hours) after the first dose.
• You should take Valaciclovir Mylan Generics for one day only (two doses).

Treatment of HSV skin infections and genital herpes

• The recommended dose is 500 mg (one 500 mg tablet) twice a day.
• For the first infection, you should take Valaciclovir Mylan Generics for five days, or up to ten days if your doctor recommends it. For recurrent infections, the treatment duration is usually between 3 and 5 days.

To help prevent recurrence of HSV infections after they have occurred

• The recommended dose is one 500 mg tablet once daily.
• Some people with frequent recurrent infections may benefit from taking one 250 mg tablet twice daily. Valaciclovir Mylan Generics is not available in doses lower than 500 mg; lower doses are available in other medicinal products. Your doctor will be able to advise you appropriately.
• You should continue taking Valaciclovir Mylan Generics until your doctor tells you to stop.

To prevent CMV (Cytomegalovirus) infection

• The recommended dose is 2000 mg (two 1000 mg tablets or four 500 mg tablets) four times a day.
• Each dose should be taken approximately 6 hours apart.
• You will usually start taking Valaciclovir Mylan Generics as soon as possible after surgery.
• You will need to take Valaciclovir Mylan Generics for about 90 days after surgery, or until your doctor tells you to stop.

Use in children under 12 years of age
Valaciclovir is not recommended for use in children under 12 years of age due to insufficient data on safety and efficacy.

Your doctor may adjust your dose of Valaciclovir Mylan Generics if:

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

Inform your doctor before taking Valaciclovir Mylan Generics if any of the above situations apply to you.

How to take the medicine

• Take this medicine by mouth.
• Swallow the tablets whole with a glass of water.
• Take Valaciclovir Mylan Generics at the same time each day.
• Take Valaciclovir Mylan Generics exactly as directed by your doctor or pharmacist.

Elderly patients over 65 years of age or patients with kidney problems
It is very important that while you are taking Valaciclovir Mylan Generics, you drink water regularly
throughout the day. This will help reduce the risk of side effects affecting the kidneys or nervous system. Your doctor will monitor you closely for signs of such effects. Nervous system side effects may include confusion or agitation, unusual drowsiness, or numbness.

If you take more Valaciclovir Mylan Generics than you should
Valaciclovir Mylan Generics is generally not harmful unless taken in excessive amounts and for several days.
If you take too many tablets, you may experience nausea, vomiting, confusion, agitation, unusual drowsiness, hallucinations (seeing, feeling, or hearing things that are not real), kidney problems with reduced or no urine output, or loss of consciousness (coma). Inform your doctor or pharmacist if you have taken too much Valaciclovir Mylan Generics. Bring the medicine pack with you.

If you forget to take Valaciclovir Mylan Generics

• If you forget to take a dose, 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 the forgotten dose.

If you stop taking Valaciclovir Mylan Generics
Do not stop treatment with Valaciclovir Mylan Generics without first consulting your doctor.
If you have any further questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects,
although not everyone experiences them.
Side effects usually occur at the beginning of treatment and become milder or disappear
completely within a few weeks. Sometimes it may be difficult to distinguish between disease symptoms and
side effects.
If you think you are experiencing any of the following side effects, stop taking this medicine and contact your
doctor or go immediately to the nearest emergency room:

• severe allergic reactions (anaphylaxis). Rapid onset of symptoms including: redness, itchy rash, or swelling of the lips, face, neck, and throat causing breathing difficulties (angioedema), or sudden drop in blood pressure leading to collapse.
• kidney problems with little or no urine output.
• seizures (epilepsy)
• altered brain function (encephalopathy)
• loss of consciousness (coma)
• confused or disturbed thoughts (psychosis)

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

• headache

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

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

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

• confusion
• seeing or hearing things that are not there (hallucinations)
• severe numbness
• tremors
• agitation

These nervous system side effects generally occur in people with kidney problems,
in elderly patients, or in organ transplant patients taking high doses, 8 grams or more, of Valaciclovir
Mylan Generics per day. These effects usually improve when Valaciclovir Mylan Generics is
discontinued or the dose is reduced.
Other uncommon side effects:

• shortness of breath (dyspnoea)
• stomach discomfort
• rash, sometimes with itching, urticaria
• pain in the lower back (kidney pain)
• blood in the urine

Uncommon side effects that may be detected by blood tests:

• decrease in the number of white blood cells (leucopenia)
• decrease in the number of blood platelets, the cells responsible for blood clotting (thrombocytopenia)
• increase in substances produced by the liver.

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

• unsteadiness while walking and lack of coordination (ataxia)
• slurred or poorly articulated speech (dysarthria)

These nervous system side effects generally occur in people with kidney problems,
in elderly patients, or in organ transplant patients taking high doses, 8 grams or more, of Valaciclovir
Mylan Generics per day. These effects usually improve when Valaciclovir Mylan Generics is
discontinued or the dose is reduced.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your
doctor or pharmacist. You can also report side effects directly via
http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can
help provide more information on the safety of this medicine.

5. How to store Valaciclovir Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the carton after EXP. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Valaciclovir Mylan Generics contains
The active substance is valaciclovir hydrochloride, hydrate. Each film-coated tablet contains valaciclovir
hydrochloride, hydrate equivalent to 500 mg or 1000 mg of valaciclovir respectively.
The excipients in the tablet core are: microcrystalline cellulose, crospovidone, povidone and
magnesium stearate.
The excipients in the coating are: titanium dioxide (E171), macrogol 400, polysorbate 80 (E433) and
hypromellose (E464).

Description of the appearance of Valaciclovir Mylan Generics and packaging contents
Valaciclovir Mylan Generics are biconvex, film-coated tablets, white to off-white in colour, capsule-shaped.
The 500 mg film-coated tablets are marked “VC 500” on one side and “G” on the other side.
The 1000 mg film-coated tablets are marked “VC 1000” on one side and “G” on the other side.
Valaciclovir Mylan Generics is available in blisters packed in cartons containing 10, 21, 24, 30, 42, 60, 90, 100 and 112
film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano
Italy

Manufacturer
McDermott Laboratories Ltd T/A Gerard Laboratories
35-36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft
H-2900
Komarom, Mylan Utca 1
Hungary
Generics [UK] Limited
Station Close, Potters Bar, Hertfordshire
EN6 1TL
United Kingdom

This medicinal product is authorized in the Member States of the European Economic Area under the following
names:
Austria Valaciclovir Arcana 500 mg, 1000 mg - Filmtabletten
Belgium Valaciclovir Mylan 500 mg, 1000 mg filmomhulde tabletten
Czech Republic Valacilovir Mylan 500 mg, potahované tablety
Denmark Valaciclovir Mylan
Finland Valaciclovir Mylan
Ireland Myval
Italy Valaciclovir Mylan Generics
Norway Valaciclovir Mylan
Slovenia Valaciklovir Mylan 500 mg filmsko obložene tablete
Sweden Valaciclovir Mylan
Netherlands Valaciclovir Mylan 500 mg, filmomhulde tabletten
United Kingdom Valaciclovir 500 mg Film-coated Tablets

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