Aciclovir aurovitas

Package leaflet: Information for the user

Aciclovir Aurovitas, 400 mg, tablets
Aciclovirum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, 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 someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any 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 called antivirals. It inhibits the replication of human pathogenic viruses.
Indications for 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 their body is 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).
• Do not use Aciclovir Aurovitas if any of the above conditions apply to the patient. If the patient is unsure, they should 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, the patient should 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 the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including over-the-counter and herbal products.

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 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 them 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 directed by your doctor. If in doubt, consult your doctor or pharmacist.
Taking the medicine:

• This medicine is taken orally.
• 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 depends on the condition for which it has been prescribed. Your doctor will discuss the dosing regimen 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 daily.
• An interval of 4 hours should be maintained between doses.
• Suggested times for taking the medicine are: 7:00, 11:00, 15:00, 19:00 and 23:00.
• Aciclovir Aurovitas should be taken for seven days.

Treatment of cold sores and genital herpes

• The usual dose is one 200 mg tablet taken five times daily.
• An interval of 4 hours should be maintained between doses.
• Suggested times for taking the medicine are: 7:00, 11:00, 15:00, 19:00 and 23:00.
• Aciclovir Aurovitas should be taken for five days, or longer if directed by your doctor.

Prevention of recurrent herpes simplex

• The usual dose is one 200 mg tablet taken four times daily.
• An interval of 6 hours should be maintained between doses.
• Aciclovir Aurovitas should be taken for as long as directed by your doctor.

Prevention of herpes virus infections in patients with weakened immune systems,
meaning their body is less able to fight infections

• The usual dose is one 200 mg tablet taken four times daily.
• An interval of 6 hours should be maintained between doses.
• Aciclovir Aurovitas should be taken for as long as directed by your doctor.

Your 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 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, consult your doctor before taking Aciclovir Aurovitas.
Taking more Aciclovir Aurovitas than recommended
Aciclovir Aurovitas is generally not harmful unless taken in large amounts over several days. If you have taken too much Aciclovir Aurovitas, contact your doctor or pharmacist immediately. Bring the medicine packaging with you.
If you miss a dose of Aciclovir Aurovitas

• Take the missed dose of Aciclovir Aurovitas 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 about how to use 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.

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;
• shortness of breath, wheezing or difficulty breathing;
• collapse (fainting).

Other adverse reactions:
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 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 weak;
• agitation or confusion;
• 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 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 of Adverse Drug Reactions, 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Aciclovir Aurovitas

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and cardboard box
after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
No special storage instructions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These 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 400 mg of aciclovir.
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, with "AR" and "400" imprinted on either side of the breakline on one side and smooth on the reverse. The tablet can be divided into equal doses.
Aciclovir Aurovitas tablets are packed in PVC/aluminium blisters, in a cardboard box.
Pack sizes: 10, 25, 30, 35, 50, 70 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, local 27
01-909 Warsaw
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 countries under the following names:
Czech Republic: Aciclovir Aurovitas
Germany: Aciclovir PUREN 400 mg Tabletten
Netherlands: Aciclovir Aurobindo 400 mg, tabletten
Poland: Aciclovir Aurovitas
Portugal: Aciclovir Generis Phar
Romania: Aciclovir Aurobindo 400 mg comprimate