Aciclovir Accord

Leaflet attached to the packaging: patient information

Aciclovir Accord, 25 mg/ml, concentrate for solution for infusion

Aciclovirum

Read the leaflet carefully before using 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 using Aciclovir Accord
• 3. How to use 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 viruses.
Aciclovir Accord can be used for:

• treatment and prevention of herpes simplex virus infections, also known as Herpes simplex. Aciclovir Accord is mainly used in patients with reduced immunity due to bone marrow transplantation or treatment of acute leukemia;
• treatment of shingles in patients with reduced immunity and treatment of severe shingles in patients with normal immunity, caused by the varicella-zoster virus, also known as Varicella zoster;
• treatment of severe genital herpes infections;
• treatment of herpes simplex encephalitis;
• treatment of herpes virus infections in newborns.

2. Important information before using Aciclovir Accord

When not to use Aciclovir Accord:

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

Do not use Aciclovir Accord if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before using Aciclovir Accord.

Warnings and precautions

Before starting treatment with Aciclovir Accord, discuss it with your doctor or pharmacist if:

• the patient has kidney problems,
• the patient is over 65 years old. If you are unsure, consult your doctor or pharmacist before using Aciclovir Accord. It is important to drink plenty of water while taking aciclovir.

Aciclovir Accord and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, including those obtained without a prescription, including herbal medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• probenecid used to treat gout;
• cimetidine used to treat stomach ulcers;
• tacrolimus, cyclosporin, or mycophenolate mofetil used to prevent organ rejection.
• lithium
• theophylline

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Aciclovir Accord is usually used in hospitalized patients. Therefore, information on driving and using machines is not applicable.

Aciclovir Accord contains sodium

The medicine contains
26.7 mg of sodium (the main component of common salt) in each 10 ml vial. This corresponds to 1.41% of the maximum recommended daily intake of sodium in the diet for adults.
53.4 mg of sodium (the main component of common salt) in each 20 ml vial. This corresponds to 2.82% of the maximum recommended daily intake of sodium in the diet for adults.
106.8 mg of sodium (the main component of common salt) in each 40 ml vial. This corresponds to 5.65% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Aciclovir Accord

Method of administration

The patient will never administer this medicine themselves. It is always administered to the patient by a person properly trained to do so.
Before administration, the medicine will be diluted.
Aciclovir Accord is administered as a continuous infusion into the patient's vein. The medicine is administered slowly over a certain period of time.
The dose, frequency of administration, and duration of administration will depend on:

• the type of infection in the patient,
• the patient's body weight,
• the patient's age.

Usually, the dose of Aciclovir Accord used in adults is 5 mg/kg body weight or 10 mg/kg body weight administered every 8 hours.
In children aged 3 months to 12 years, the doctor calculates the dose based on body surface area.
In the treatment of herpes simplex virus infections in newborns, the recommended dose is 20 mg/kg body weight administered every 8 hours for 14-21 days.
In elderly patients with kidney problems, the doctor may reduce the dose by reducing the frequency of infusions.
The doctor may change the dose of Aciclovir Accord if:

• the patient has kidney problems. If the patient has kidney problems, it is essential to drink plenty of fluids while taking Aciclovir Accord. If this applies to you, consult your doctor before using Aciclovir Accord.

Using a higher dose of Aciclovir Accord than recommended

If it is suspected that the patient has taken too much Aciclovir Accord, tell a doctor or nurse immediately.
If the patient has taken too much Aciclovir Accord, they may:

• feel confused or agitated;
• have hallucinations (see or hear things that do not exist);
• have seizures,
• lose consciousness (coma).

4. Possible side effects

Like all medicines, Aciclovir Accord can cause side effects, although not everybody gets them.
The following side effects may occur when using this medicine:
Allergic reactions(in no more than 1 in 10,000 people)
If you experience an allergic reaction, stop using Aciclovir Accord
and go to 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 breathing problems;
• high fever (high body temperature) of unknown cause and a feeling of fainting, especially when standing.

Other side effects include:
Common(in no more than 1 in 10 people)

• nausea or vomiting;
• itchy rash, which looks like hives;
• skin reaction after exposure to light (photosensitivity);
• itching;
• swelling; redness and tenderness at the injection site;
• increased liver enzyme activity.

Uncommon(in no more than 1 in 100 people)

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

Rare(in no more than 1 in 10,000 people)

• headache or dizziness;
• diarrhea or abdominal pain;
• feeling tired;
• fever;
• effects on some blood and urine test results;
• weakness;
• agitation or confusion;
• shivering or tremors;
• hallucinations (seeing or hearing things that do not exist);
• seizures;
• feeling of unusual sleepiness;
• balance problems while walking and lack of coordination;
• speech difficulties;
• inability to think logically or assess the situation;
• loss of consciousness (coma);
• weakness of part or all of the body;
• behavior, speech, or eye movement disorders;
• stiff neck and sensitivity to light;
• hepatitis;
• yellowing of the skin and whites of the eyes (jaundice);
• kidney problems related to passing small amounts of urine or complete inability to pass urine;
• back pain, in the kidney area or above the hip (kidney pain).

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 Adverse Reaction Monitoring 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.
Store in a temperature below 25°C.
Do not use this medicine after the expiry date stated on the label and carton after: EXP.
The expiry date refers to the last day of the month.
Unused solution should be discarded.
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.

Each ml of concentrate contains 25 mg of aciclovir as sodium salt.
Each 10 ml vial contains 250 mg of aciclovir as sodium salt.
Each 20 ml vial contains 500 mg of aciclovir as sodium salt.
Each 40 ml vial contains 1 g of aciclovir as sodium salt.

• Other ingredients are sodium hydroxide and/or hydrochloric acid; water for injections. Sodium hydroxide and/or hydrochloric acid are used to adjust the pH of the solution.

What Aciclovir Accord looks like and contents of the pack

This medicine is a concentrate for solution for infusion. It is provided as a clear, colorless or almost colorless solution in a glass vial. It is a concentrated solution that is diluted and then administered by infusion (drip).
The pH value is 10.7-11.7.
The vial is made of colorless glass type I with a capacity of 10 ml, 20 ml, or 50 ml (filling capacity of 10 ml, 20 ml, and 40 ml) and is closed with a rubber stopper and an aluminum flip-off cap.
Pack sizes: 1, 5, or 10 vials.
Not all pack sizes may be marketed.

Marketing authorization holder

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw

Manufacturer/Importer

LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
08040 Barcelona
Spain
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000, Malta

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

Date of last revision of the leaflet:

Information intended for healthcare professionals only

For single use only. Discard any unused amount of solution. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Based on the calculated dose, determine the appropriate number and size of vials needed.
Method of administration
The required dose of aciclovir should be administered as a slow intravenous infusion over at least one hour.
Aciclovir Accord can be administered using an infusion pump with controlled infusion rate.
Additionally, Aciclovir Accord can be further diluted to ensure that the concentration of aciclovir administered by intravenous infusion does not exceed 5 mg/ml (0.5% w/v).
Add the required volume of Aciclovir Accord to the chosen infusion solution according to the following recommendations and shake vigorously to ensure complete mixing of the contents.
In children and newborns, when the smallest infusion volume is indicated, it is recommended to dilute in such a way that 4 ml of solution (100 mg of aciclovir) is added to 20 ml of infusion solution.
In adults, it is recommended to use infusion bags containing 100 ml of infusion solution, even if this results in an aciclovir concentration significantly below 5 mg/ml (0.5% w/v). Thus, one infusion bag of 100 ml can be used for any dose between 250 mg and 500 mg of aciclovir (10 ml to 20 ml of solution), while for doses of 500 mg to 1000 mg, a second bag must be used.
After dilution according to the recommended scheme, aciclovir is compatible with the following infusion solutions and remains stable for up to 24 hours at room temperature (below 25°C):

• sodium chloride infusion solution (0.45% w/v and 0.9% w/v)
• sodium chloride (0.18% w/v) and glucose (4% w/v) infusion solution
• sodium chloride (0.45% w/v) and glucose (2.5% w/v) infusion solution
• multicomponent sodium lactate solution (Hartmann's solution) for infusion.

After dilution according to the above scheme, aciclovir will ensure a concentration not exceeding 5 mg/ml (0.5% w/v).
Given the absence of antimicrobial preservatives, dilution of the medicinal product should be performed under aseptic conditions directly before use, and any unused solution should be discarded.
If visible precipitation or crystallization occurs before administration or during infusion, the solution should be discarded.
Compatibility has been demonstrated with polypropylene syringes, infusion sets other than polyvinyl chloride (PVC), and infusion bags other than polyvinyl chloride (PVC).