Aciclovir aurovitas

Package leaflet: Information for the user

Aciclovir Aurovitas, 200 mg, tablets
Aciclovirum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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 multiplication of viruses harmful to humans.
The indications for use of Aciclovir Aurovitas are:

• treatment of infections caused by the varicella-zoster virus;
• treatment of cold sores, genital herpes, and other infections caused by herpes simplex virus;
• prevention of recurrent herpes simplex infections;
• prevention of herpes virus infections in people with weakened immunity, meaning those whose bodies are less able to fight infections.

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).
• Aciclovir Aurovitas should not be used 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 this with a doctor or pharmacist if:

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

If in doubt whether any of 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 the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to use, including those without a prescription, such as herbal medicines.

In particular, inform the 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 or breastfeeding, suspects she may be pregnant, or is planning to have a child, 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 a vehicle or operate machinery, the patient should ensure that the medicine does not affect him/her 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 take Aciclovir Aurovitas

This medicine should always be taken exactly as your doctor has told you. If you are not sure, ask your
doctor or pharmacist.
How to take the medicine:

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

The dose of Aciclovir Aurovitas will depend on what the medicine has been prescribed for. Your doctor will discuss the treatment with you. If necessary, tablets with a strength of 800 mg are also available.
Treatment of chickenpox and shingles

• The usual dose is one 800 mg tablet taken five times a day.
• Leave 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 seven days.

Treatment of cold sores and genital herpes

• The usual dose is one 200 mg tablet taken five times a day.
• Leave 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 five days, or longer if your doctor tells you to.

Prevention of recurrent herpes simplex

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

Prevention of herpes virus infections in people with a weakened immune system,
meaning their body fights infections less effectively

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

Your doctor may adjust the dose of Aciclovir Aurovitas if:

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

If any of the above situations apply to the patient, talk to your doctor before taking Aciclovir Aurovitas.
Taking more Aciclovir Aurovitas than you should
Aciclovir Aurovitas is usually not harmful unless taken in very large amounts over several days. If you have taken too much Aciclovir Aurovitas, contact your doctor or pharmacist. Take the medicine pack with you.
If you forget to take a dose of Aciclovir Aurovitas

• Take the missed dose of Aciclovir Aurovitas 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 forgotten dose.

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 everybody 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 side 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);
• itching;
• fatigue;
• unexplained fever 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 liver enzyme activity in the blood.

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

• decrease in red blood cell count (anaemia);
• decrease in white blood cell count (leukopenia);
• decrease in platelet count (cells involved in blood clotting) (thrombocytopenia);
• feeling of weakness;
• agitation or disorientation;
• tremors or lack of coordination;
• hallucinations;
• seizures;
• drowsiness or somnolence;
• 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 side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
Side 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]
Side effects can also be reported directly to the Marketing Authorisation Holder.
Reporting side effects helps 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 carton after "Expiry date (EXP)". The expiry date refers to the last day of the stated 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. Such measures help protect the environment.

6. Contents of the pack and other information

What Aciclovir Aurovitas contains
The active substance is aciclovir. Each tablet contains 200 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, round, biconvex, uncoated tablets, embossed with the code "AR 200" on one side and smooth on the other.
Aciclovir Aurovitas tablets are packed in blisters made of PVC/Aluminium, in a cardboard box.
Pack sizes: 20, 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 European Economic Area under the following names:
Belgium: Aciclovir AB 200 mg tabletten
Czech Republic: Aciclovir Aurovitas
France: Aciclovir Arrow génériques 200 mg comprimé
Germany: Aciclovir PUREN 200 mg Tabletten
Netherlands: Aciclovir Aurobindo 200 mg, tabletten
Poland: Aciclovir Aurovitas
Portugal: Aciclovir Generis Phar
Romania: Aciclovir Aurobindo 200mg comprimate
Spain: Aciclovir Aurobindo 200 mg comprimidos EFG