Aciclovir Accord

Leaflet attached to the packaging: patient information

Aciclovir Accord, 200 mg, tablets

Aciclovir Accord, 400 mg, tablets

Aciclovir Accord, 800 mg, tablets

Aciclovir

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet

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

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

Aciclovir Accord contains the active substance aciclovir. It belongs to a group of medicines called antiviral medicines and prevents the multiplication of certain viruses.
Aciclovir Accord 200 mg and 400 mg can be used for:

• treatment of chickenpox and shingles; in the case of shingles, it also helps to reduce nerve pain that may persist after the rash has disappeared;
• treatment of herpes, genital herpes, and other infections caused by the herpes simplex virus (Latin: Herpes simplex);
• prevention of recurrence of herpes, genital herpes, and other infections caused by the herpes simplex virus;
• prevention of herpes infections in people with reduced immunity, making their bodies less able to fight infections.

Aciclovir Accord 800 mg can be used for:

• treatment of shingles (Latin: Herpes zoster);
• treatment of chickenpox;
• prevention of shingles and chickenpox in people with significantly reduced immunity.

2. Important information before taking Aciclovir Accord

When not to take Aciclovir Accord:

• if the patient is allergic to aciclovir, valaciclovir, or any of the other ingredients of this medicine (listed in section 6).

This medicine should not be taken if the above circumstances apply to the patient.
In case of doubts, the patient should consult a doctor or pharmacist before taking Aciclovir Accord.

Warnings and precautions

Before starting to take Aciclovir Accord, the patient should discuss it with their doctor if:

• the patient has kidney problems,
• the patient is over 65 years old.

If any of the above warnings apply to the patient, they should contact their doctor.
The doctor may reduce the dose of Aciclovir Accord.
It is important to drink enough fluids while taking Aciclovir Accord.
In case of doubts whether the above circumstances apply to the patient, they should consult a doctor or pharmacist before starting to take Aciclovir Accord.

Aciclovir Accord and other medicines

The patient should tell their doctor or pharmacist if they are taking any of the following medicines:

• probenecid used to treat gout;
• cimetidine used to treat stomach ulcers;
• mycophenolate mofetil used to prevent rejection of transplanted organs by the body;
• valproate and phenytoin used to treat seizures;
• theophylline, a medicine for bronchial diseases.

Pregnancy and breastfeeding

Aciclovir Accord is not usually recommended during pregnancy. If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult a doctor or pharmacist before taking this medicine. The doctor will weigh the benefits of using Aciclovir Accord during pregnancy for the patient and the risk to the baby.
The active substance of Aciclovir Accord passes into breast milk. If the patient is breastfeeding, they should consult a doctor before taking Aciclovir Accord.
The effect of aciclovir on female fertility is unknown.

Driving and using machines

Some side effects, such as drowsiness, may affect the ability to concentrate and react quickly. Before driving or operating machinery, the patient should make sure that they are not experiencing these side effects.

Aciclovir Accord contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Aciclovir Accord

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult a doctor or pharmacist.
The doctor will inform the patient about the correct dose, how to take the medicine, and how long to take it:

• depending on the type of infection;
• depending on whether the infection requires treatment or prevention of recurrence.

The usual dose for treating herpes simplex infections in adults is 200 mg, 5 times a day at 4-hour intervals, omitting the night dose. Treatment should usually be continued for 5 days, but in the case of severe infections, treatment can be extended.
Children over 2 years old should usually be given the same dose as adults.
The usual dose for preventing recurrence of herpes simplex infections in adults is 200 mg, 4 times a day at 6-hour intervals, omitting the night dose.
The usual dose for treating chickenpox and shingles in adults is 800 mg, 5 times a day at 4-hour intervals, omitting the night dose. Treatment should usually be continued for 7 days.
Children over 6 years old should usually be given 800 mg 4 times a day; children between 2 and 6 years old should be given 400 mg 4 times a day; children under 2 years old should be given 200 mg 4 times a day.
If the patient has kidney problems, the doctor will adjust the dose.

Administration of the medicine:

• The medicine is taken orally.
• The tablet should be swallowed whole with a sufficient amount of water.
• Aciclovir Accord should be taken every day at the same time.
• Aciclovir Accord should be taken as directed by the doctor or pharmacist.
• In case of difficulty swallowing tablets, the tablet should be dissolved in at least 50 ml of water, which should be mixed before drinking.

Taking a higher dose of Aciclovir Accord than recommended

Aciclovir Accord is usually not harmful, unless the patient takes it in large quantities for several days. The patient should consult a doctor or pharmacist if they have taken too much Aciclovir Accord. They should take the packaging with them.

Missing a dose of Aciclovir Accord

In case of missing a dose of Aciclovir Accord, the patient should take it as soon as possible, but skip the missed dose if it is almost time for the next dose.
The patient should not take a double dose to make up for the missed dose.

4. Possible side effects

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

Symptoms to watch out for:

• severe allergic reactions (anaphylaxis). They occur rarely in people taking Aciclovir Accord (may occur in less than 1 in 1000 people). Rapid development of symptoms, including:
• itchy skin rash (hives);
• swelling of the lips, face, neck, and throat causing difficulty breathing (angioedema);
• drop in blood pressure leading to fainting.
• If the patient experiences an allergic reaction, they should stop taking Aciclovir Accord and go to the doctor immediately.

Common side effects(may occur in less than 1 in 10 people):

• headache;
• dizziness;
• nausea or vomiting;
• diarrhea;
• abdominal pain;
• itching;
• skin reaction to sunlight (photosensitivity);
• fatigue;
• fever.

Uncommon side effects(may occur in less than 1 in 100 people):

• itchy rash (hives);
• hair loss.

Rare side effects(may occur in less than 1 in 1000 people):

• shortness of breath (dyspnea);
• changes in blood tests;
• swelling of the lips, face, neck, and throat causing difficulty breathing (angioedema);
• increased liver enzyme activity.

Very rare side effects(may occur in less than 1 in 10,000 people):

• disorientation or agitation;
• tremors;
• balance disorders while walking and lack of coordination (ataxia);
• slow, unclear speech (dysarthria);
• hearing or seeing things that are not there (hallucinations);
• psychotic disorders;
• seizures;
• drowsiness;
• brain damage (encephalopathy);
• loss of consciousness (coma);
• yellowing of the skin and whites of the eyes (jaundice), liver inflammation;
• back pain, in the kidney area or just above the hip (kidney pain);
• kidney failure.

Very rare side effects that may be detected in blood tests(may occur in less than 1 in 10,000 people):

• reduced number of red blood cells (anemia);
• reduced number of white blood cells (leukopenia);
• reduced number of blood platelets (thrombocytopenia).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Aciclovir Accord

• The medicine should be stored out of sight and reach of children.
• There are no special precautions for storing the medicine.
• The medicine should not be used after the expiry date stated on the blister pack and carton after: EXP.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Aciclovir Accord contains

• The active substance of the medicine is aciclovir: 200 mg, 400 mg, or 800 mg in each tablet.
• The other ingredients are: microcrystalline cellulose type 101, sodium carboxymethylcellulose (type A), povidone K25, colloidal anhydrous silica, magnesium stearate.

What Aciclovir Accord looks like and what the pack contains

Aciclovir Accord 200 mg, 400 mg, and 800 mg tablets are packaged in PVC/Aluminum blisters in a cardboard box.
Pack sizes:
200 mg: 25 and 30 tablets in a blister;
400 mg: 25, 28, 30, 35, and 60 tablets in a blister;
800 mg: 25, 30, and 35 tablets in a blister.
Not all pack sizes may be marketed.
Aciclovir Accord, 200 mg, tablets are white or almost white, round, flat tablets with beveled edges, with the inscription "LG1" on one side and smooth on the other.
Aciclovir Accord, 400 mg, tablets are white or almost white, round, flat tablets with beveled edges, with the inscription "LG" above and "2" below the break line on one side and smooth on the other.
Aciclovir Accord, 800 mg, tablets are white or almost white, oval, biconvex tablets, with the inscription "LG" and "3" on both sides of the break line on one side and smooth on the other.
Aciclovir Accord, 400 mg, and 800 mg: the break line is only to facilitate breaking and not to divide into equal doses.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa 7 Street
02-677 Warsaw
Phone: +48 22 577 28 00

Manufacturer

Accord Healthcare Polska Sp. z o.o.
Lutomierska 50 Street
95-200 Pabianice

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

Update of the leaflet: