Aciclovir aurovitas

Package leaflet: Information for the user

Aciclovir Aurovitas, 800 mg, tablets
Aciclovirum
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents

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

The active substance in Aciclovir Aurovitas is aciclovir. It belongs to a group of medicines known as antivirals. It inhibits the replication of viruses pathogenic to humans.
Indications for Aciclovir Aurovitas are:

• treatment of infections caused by varicella-zoster virus.

2. Important information before using Aciclovir Aurovitas

When not to use Aciclovir Aurovitas

• If the patient is allergic to aciclovir, valaciclovir, or any of the other ingredients of this medicine (listed in section 6).
• Do not use Aciclovir Aurovitas if any of the above conditions apply to the patient. If the patient is unsure, consult a doctor or pharmacist before starting treatment with Aciclovir Aurovitas.

Warnings and precautions
Before starting treatment with Aciclovir Aurovitas, discuss with a doctor or pharmacist if:

• the patient has kidney disease;
• the patient is over 65 years of age.

If in doubt whether the above conditions apply, consult a doctor or pharmacist before starting treatment with Aciclovir Aurovitas. It is very important to drink plenty of water during treatment with Aciclovir Aurovitas.

Aciclovir Aurovitas and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, herbal medicines, and dietary supplements.

In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines:

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

Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Some adverse effects, such as drowsiness or somnolence, may impair the ability to concentrate and react quickly. Before deciding to drive or operate machinery, the patient should ensure that the medicine does not affect him in this way.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, this medicine is considered "sodium-free".

3. How to use Aciclovir Aurovitas

This medicine should always be used as directed by the doctor. If in doubt, consult a doctor or pharmacist.
How to use the medicine:

• This medicine is for oral use.
• The tablet should be swallowed whole with a glass of water.
• Treatment with Aciclovir Aurovitas should be started as soon as possible.

The dose of Aciclovir Aurovitas will depend on the condition being treated. The doctor will discuss the dosing regimen with the patient.
Treatment of chickenpox and shingles

• The usual dose is one 800 mg tablet taken five times a day.
• A 4-hour interval should be maintained between doses.
• Recommended dosing times are: 7:00, 11:00, 15:00, 19:00, and 23:00.
• Aciclovir Aurovitas should be taken for seven days.

The doctor may adjust the dose of Aciclovir Aurovitas if:

• it is intended for a child;
• the patient is over 65 years of age;
• the patient has kidney disease. If the patient has kidney problems, it is important to drink plenty of fluids while taking Aciclovir Aurovitas.

If any of the above circumstances apply, the patient should consult a doctor before using Aciclovir Aurovitas.
Taking more Aciclovir Aurovitas than recommended

Aciclovir Aurovitas is usually not harmful unless taken in large amounts over several days. If too much Aciclovir Aurovitas has been taken, contact a doctor or pharmacist. Bring the medicine package with you.
If a dose of Aciclovir Aurovitas is missed

• Take the missed dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and take the next dose at the scheduled time.
• Do not take a double dose to make up for a missed dose.

If there are any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Allergic reactions (may occur in up to 1 in 1,000 patients)
If an allergic reaction occurs, stop taking Aciclovir Aurovitas and contact your doctor immediately.
Symptoms may include:

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

Other adverse effects:
Common (may occur in up to 1 in 10 patients):

• pain;
• dizziness;
• nausea or vomiting;
• diarrhoea;
• abdominal pain;
• itching;
• rash;
• skin reaction appearing after exposure to sunlight (photosensitivity);
• fatigue;
• fever of unknown cause and feeling faint, especially when standing up.

Uncommon (may occur in up to 1 in 100 patients):

• itchy rash resembling hives;
• hair loss.

Rare (may occur in up to 1 in 1,000 patients):

• effects on certain blood and urine test results;
• increased activity of liver enzymes in the blood.

Very rare (may occur in up to 1 in 10,000 patients):

• reduction in red blood cells (anaemia);
• reduction in white blood cells (leukopenia);
• reduction in platelets (cells involved in blood clotting) (thrombocytopenia);
• feeling of weakness;
• agitation or disorientation;
• tremors or lack of coordination;
• hallucinations;
• seizures;
• drowsiness or feeling sleepy;
• unsteady gait and lack of motor coordination;
• difficulty speaking;
• inability to think logically or assess situations;
• loss of consciousness (coma);
• paralysis of part or all of the body;
• disturbances in behaviour, speech and eye movements;
• stiff neck and sensitivity to light;
• hepatitis;
• yellowing of the skin and whites of the eyes (jaundice);
• kidney disorders – passing small amounts of urine or no urine;
• pain in the lower back, in the area of the kidneys or just above the hip (kidney pain).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects 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.: (22) 49 21 301, fax: (22) 49 21 309, e-mail: [email protected]
Adverse effects can also be reported to the responsible entity.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Aciclovir Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the cardboard box
after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures 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 800 mg of aciclovir.
The other ingredients are: microcrystalline cellulose (type 101), sodium carboxymethyl starch (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, elongated, biconvex, uncoated tablets, with the imprint "AR" and "800" on either side of the division line on one side and smooth on the other. The tablet can be divided into equal doses.
Aciclovir Aurovitas tablets are packed in blisters made of PVC/Aluminium foil, in a cardboard box.
Pack sizes: 25, 30, 35, 50, 70, 100 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
Poland

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 authorised in the Member States of the European Economic Area under the following names:
Belgium: Aciclovir AB 800 mg tabletten
Czech Republic: Aciclovir Aurovitas
Germany: Aciclovir PUREN 800 mg Tabletten
Netherlands: Aciclovir Aurobindo 800 mg, tabletten
Poland: Aciclovir Aurovitas
Portugal: Aciclovir Generis Phar
Spain: Aciclovir Aurobindo 800 mg comprimidos EFG