Aciclovir Aurovitas

Package Leaflet: Information for the User

Aciclovir Aurovitas, 400 mg, Tablets

Aciclovir

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Aciclovir Aurovitas and what is it used for

The active substance of Aciclovir Aurovitas is aciclovir. It belongs to a group of medicines called antivirals. It works by stopping the viruses that cause infections from multiplying in the body.

Indications for use of Aciclovir Aurovitas are:

• treatment of infections caused by the varicella-zoster virus (chickenpox and shingles);
• treatment of herpes simplex virus infections (cold sores, genital herpes, and other herpes simplex infections);
• prevention of recurrent herpes simplex infections;
• prevention of herpes simplex infections in people with weakened immune systems, which means their bodies are less able to fight infections.

2. Important information before taking Aciclovir Aurovitas

When not to take Aciclovir Aurovitas

• If you are allergic to aciclovir, valaciclovir, or any of the other ingredients of this medicine (listed in section 6).
• Do not take Aciclovir Aurovitas if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before taking Aciclovir Aurovitas.

Warnings and precautions

Before taking Aciclovir Aurovitas, discuss with your doctor or pharmacist if you:

• have kidney problems;
• are over 65 years old.

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking Aciclovir Aurovitas. It is very important to drink plenty of water while taking Aciclovir Aurovitas.

Aciclovir Aurovitas and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, including those obtained without a prescription, including herbal medicines.

• probenecid used to treat gout;
• cimetidine used to treat stomach ulcers;
• mycophenolate mofetil, used to prevent rejection of transplanted organs.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Some side effects, such as feeling drowsy or sleepy, may affect your ability to concentrate and react. Before driving or using machines, make sure that Aciclovir Aurovitas does not affect you in this way.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which means it is essentially 'sodium-free'.

3. How to take Aciclovir Aurovitas

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

How to take the medicine:

• Take the medicine by mouth.
• Swallow the tablet whole with a small amount of water.
• Start taking Aciclovir Aurovitas as soon as possible.

The dose of Aciclovir Aurovitas will depend on what it has been prescribed for. Your doctor will discuss taking the medicine with you. If necessary, 200 mg tablets are also available.

Treatment of chickenpox and shingles

• The usual dose is two 400 mg tablets taken five times a day.
• Keep a 4-hour interval between doses.
• Suggested times for taking the medicine are: 7:00, 11:00, 15:00, 19:00, and 23:00.
• Take Aciclovir Aurovitas for 7 days.

Treatment of cold sores and genital herpes

• The usual dose is one 200 mg tablet taken five times a day.
• Keep a 4-hour interval between doses.
• Suggested times for taking the medicine are: 7:00, 11:00, 15:00, 19:00, and 23:00.
• Take Aciclovir Aurovitas for 5 days or longer if your doctor advises.

Prevention of recurrent herpes simplex infections

• The usual dose is one 200 mg tablet taken four times a day.
• Keep a 6-hour interval between doses.
• Take Aciclovir Aurovitas for as long as your doctor advises.

Prevention of herpes simplex infections in people with weakened immune systems

• The usual dose is one 200 mg tablet taken four times a day.
• Keep a 6-hour interval between doses.
• Take Aciclovir Aurovitas for as long as your doctor advises.

Your doctor may adjust the dose of Aciclovir Aurovitas if:

• it is for a child;
• you are over 65 years old;
• you have kidney problems. If you have kidney problems, it is important to drink plenty of fluids while taking Aciclovir Aurovitas.

If any of the above applies to you, consult your doctor before taking Aciclovir Aurovitas.

Taking more than the recommended dose of Aciclovir Aurovitas

Aciclovir Aurovitas is not usually harmful, unless you take it in large amounts for several days. If you have taken too much Aciclovir Aurovitas, contact your doctor or pharmacist. Take the package with you.

Missing a dose of Aciclovir Aurovitas

• Take the missed dose as soon as possible. However, if it is almost time for the 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 questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Allergic reactions(may affect up to 1 in 1000 people)

If you experience an allergic reaction, stop taking Aciclovir Aurovitas and contact your doctor immediately.

• skin rash, itching, or hives;
• swelling of the face, lips, tongue, or other parts of the body;
• difficulty breathing, wheezing, or breathing problems;
• fainting (syncope).

Other side effects:

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

• pain;
• dizziness;
• nausea or vomiting;
• diarrhea;
• abdominal pain;
• itching;
• rash;
• skin reaction to sunlight (photosensitivity);
• pruritus;
• fatigue;
• fever of unknown origin and feeling faint, especially when standing up.

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

• itchy rash, which looks like hives;
• hair loss.

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

• effects on some blood and urine test results;
• increased liver enzyme activity in the blood.

Very rare(may affect up to 1 in 10,000 people):

• reduced red blood cell count (anemia);
• reduced white blood cell count (leukopenia);
• reduced platelet count (thrombocytopenia);
• feeling weak;
• agitation or confusion;
• tremors or unsteady movements;
• hallucinations;
• seizures;
• feeling drowsy or sleepy;
• unsteady walk and lack of coordination;
• speech difficulties;
• inability to think logically or assess the situation;
• loss of consciousness (coma);
• paralysis of part or all of the body;
• behavior, speech, and eye movement disorders;
• stiff neck and sensitivity to light;
• hepatitis;
• yellowing of the skin and whites of the eyes (jaundice);
• kidney problems - passing small amounts of urine or not passing urine;
• lower back pain, back pain in the kidney area, or just above the hip (kidney pain).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: (22) 49 21 301, fax: (22) 49 21 309, e-mail: ndl@urpl.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 Aciclovir Aurovitas

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton after 'EXP'. The expiry date refers to the last day of the month.

There are no special storage instructions for this medicine.

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 Aciclovir Aurovitas contains

The active substance is aciclovir. Each tablet contains 400 mg of aciclovir.

The other ingredients are: microcrystalline cellulose (type 101), sodium carboxymethylcellulose (type A), povidone K 30, colloidal anhydrous silica, magnesium stearate.

What Aciclovir Aurovitas looks like and contents of the pack

Tablet.

White or almost white, round, biconvex, uncoated tablets with the inscription "AR" and "400" on one side and smooth on the other. The tablet can be divided into equal doses.

Aciclovir Aurovitas tablets are packaged in PVC/Aluminum blisters, in a cardboard box.

Pack sizes: 10, 25, 30, 35, 50, 70, and 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.

ul. Sokratesa 13D lokal 27

01-909 Warszawa

Manufacturer/Importer

APL Swift Services (Malta) Ltd

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Generis Farmacêutica, S.A.

Rua João de Deus, n.º 19, Venda Nova

2700-487 Amadora

Portugal

Arrow Generiques – Lyon

26 avenue Tony Garnier

69007 Lyon

France

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:

Aciclovir Aurovitas

Germany:

Aciclovir PUREN 400 mg Tablets

Netherlands:

Aciclovir Aurobindo 400 mg, tablets

Poland:

Aciclovir Aurovitas

Portugal:

Aciclovir Generis Phar

Romania:

Aciclovir Aurobindo 400 mg, comprimate

Date of last revision of the package leaflet: