Aciclovir Accord

Package Leaflet: Information for the Patient

Aciclovir Accord, 200 mg, Tablets

Aciclovir Accord, 400 mg, Tablets

Aciclovir Accord, 800 mg, Tablets

Aciclovir

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

• Keep this 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, tell your 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 pack 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 reduce nerve pain that may persist after the rash has gone;
• treatment of herpes, genital herpes, and other infections caused by the herpes simplex virus;
• 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 (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 you are allergic to aciclovir, valaciclovir, or any of the other ingredients of this medicine (listed in section 6).

Do not take Aciclovir Accord if any of the above applies to you.
In case of doubt, consult your doctor or pharmacist before taking Aciclovir Accord.

Warnings and precautions

Before starting to take Aciclovir Accord, discuss it with your doctor if:

• you have kidney problems,
• you are over 65 years old.

If any of the above warnings apply to you, contact your doctor.
Your doctor may reduce the dose of Aciclovir Accord.
It is important to drink enough fluids while taking Aciclovir Accord.
In case of doubt whether the above applies to you, consult your doctor or pharmacist before starting to take Aciclovir Accord.

Aciclovir Accord and other medicines

Tell your doctor or pharmacist if you are taking any of the following medicines:

• probenecid used to treat gout;
• cimetidine used to treat stomach ulcers;
• mycophenolate mofetil used to prevent organ rejection;
• valproate and phenytoin used to treat seizures;
• theophylline, a medicine for bronchial diseases.

Pregnancy and breastfeeding

Aciclovir Accord is not normally recommended during pregnancy. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice. Your doctor will consider the benefits of taking Aciclovir Accord during pregnancy for you and the risk for your baby.
The active substance of Aciclovir Accord passes into breast milk. If you are breastfeeding, consult your 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 your ability to concentrate and react. Before driving or operating machinery, make sure you are not affected by these side effects.

Aciclovir Accord contains sodium

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

3. How to take Aciclovir Accord

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Your doctor will inform you 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 approximately 4-hour intervals, omitting the night dose. Treatment should usually be continued for 5 days, but in cases of severe infections, treatment can be extended.
Children over 2 years of age 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 approximately 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 approximately 4-hour intervals, omitting the night dose. Treatment should usually be continued for 7 days.
Children over 6 years of age should usually be given 800 mg, 4 times a day; children between 2 and 6 years of age should be given 400 mg, 4 times a day; children under 2 years of age should be given 200 mg, 4 times a day.
If you have kidney problems, your doctor will adjust the dose for you.

How to take the medicine:

• Take the medicine orally.
• Swallow the tablet whole with a sufficient amount of water.
• Take Aciclovir Accord at the same time every day.
• Take Aciclovir Accord as directed by your doctor or pharmacist.
• If you have difficulty swallowing tablets, dissolve the tablet in at least 50 ml of water, which should be stirred before drinking.

Taking more than the recommended dose of Aciclovir Accord

Aciclovir Accord is usually not harmful, unless you take it in large quantities for several days. Contact your doctor or pharmacist if you have taken too much Aciclovir Accord. Bring the package with you.

Missing a dose of Aciclovir Accord

If you miss a dose of Aciclovir Accord, take it as soon as possible, but skip the missed dose if it is almost time for your next dose.
Do not take a double dose to make up for a missed dose.

4. Possible side effects

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

Symptoms to look out for:

• severe allergic reactions (anaphylaxis). These occur rarely in people taking Aciclovir Accord (may affect up to 1 in 1000 people). Rapid development of symptoms, including:
• itching skin rash (hives);
• swelling of the lips, face, neck, and throat, causing difficulty in breathing (angioedema);
• drop in blood pressure leading to fainting.
• If you experience an allergic reaction, stop taking Aciclovir Accord and go to your doctor immediately.

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

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

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

• itching rash (hives);
• hair loss.

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

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

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

• disorientation or agitation;
• tremors;
• balance problems 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, kidney area pain, or pain just above the hip (kidney-related pain);
• kidney failure.

Very rare side effects that may show up in blood tests(may affect less than 1 in 10,000 people):

• reduced red blood cell count (anemia);
• reduced white blood cell count (leukopenia);
• reduced platelet count (thrombocytopenia).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring 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, you can help provide more information on the safety of this medicine.

5. How to store Aciclovir Accord

• Keep the medicine out of the sight and reach of children.
• No special storage precautions are necessary.
• Do not use this medicine after the expiry date stated on the blister and carton after: EXP.

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 Accord contains

• The active substance 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 contents of the pack

Aciclovir Accord 200 mg, 400 mg, and 800 mg tablets are packaged in PVC/Aluminum blisters, in a cardboard box.
Package 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 either side 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: