ACICLOVIR ACCORD 250 mg POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

Introduction

Package Leaflet: Information for the User

Aciclovir Accord 250 mg powder for solution for injection and infusion EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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 signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

1. What is Aciclovir Accord and what is it used for
2. What you need to know before you use Aciclovir Accord
3. How to use Aciclovir Accord
4. Possible side effects
5. Storage of Aciclovir Accord
6. Contents of the pack and other information

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

Aciclovir Accord is a medicine that contains the active substance called aciclovir. Aciclovir belongs to a group of medicines called antivirals, which are active against herpes viruses. It works by killing the viruses or stopping their growth.

This medicine is indicated in adults, adolescents, and children over 3 months of age for:

• Treatment of herpes simplex virus (HSV) infections in immunocompromised patients and initial severe genital herpes in immunocompetent patients.
• Prophylaxis of herpes simplex virus (HSV) infections in immunocompromised patients.
• Treatment of immunocompromised patients with varicella-zoster virus (VZV) infections and treatment of immunocompetent patients with zoster, especially in progressive or disseminated cutaneous infections.
• Treatment of herpetic encephalitis

This medicine is also indicated for the treatment of herpes simplex virus (HSV) infections in newborns and children under 3 months.

2. What you need to know before you take Aciclovir Accord

Do not use Aciclovir Accord:

if you are allergic to aciclovir or valaciclovir or any of the excipients listed in section 6.

Warnings and Precautions

Talk to your doctor, pharmacist, or nurse before you start using aciclovir:

• If you have any kidney disease or are elderly (over 65 years), your doctor may use a lower dose. Also, you should drink plenty of fluids during treatment to maintain adequate hydration.

Other Medicines and Aciclovir Accord

Tell your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

It is especially important that you talk to 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 transplant rejection);
• lithium (used to treat manic-depressive disorders)
• theophylline (used to treat certain respiratory disorders)

Pregnancy and Breastfeeding

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

The safety of this medicine in pregnant women has not been established, it will only be used in cases where the benefit-risk assessment by your doctor advises its use.

Aciclovir is excreted in breast milk, breastfeeding is not recommended during treatment.

Driving and Using Machines

No studies have been conducted to investigate the effect of intravenous aciclovir on the ability to drive and use machines.

3. How to Use Aciclovir Accord

Never administer the medicine to yourself. The medicine will always be administered by a trained person.

Aciclovir Accord will be administered to you as a continuous infusion into a vein, slowly over 1 hour.

Aciclovir is usually administered every 8 hours. You may receive fluids to ensure you do not become dehydrated. The dose, frequency, and duration of treatment will depend on:

• the type of infection you have,
• your weight,
• your age.

Adults and adolescents over 12 years

Patients with herpes simplex virus (except for herpetic encephalitis) or varicella-zoster virus infections: dose of 5 mg/kg every 8 hours.

Immunocompromised patients with varicella-zoster virus infections or herpetic encephalitis: dose of 10 mg/kg every 8 hours.

Your doctor may adjust the dose of aciclovir if you have kidney problems. If you have kidney problems, it is important that you receive plenty of fluids while being treated with aciclovir.

Children between 3 months and 12 years

The dose of intravenous aciclovir for children between 3 months and 12 years is calculated based on body surface area. The doctor will adjust the dose for children with kidney problems.

Children with herpes simplex virus (except for herpetic encephalitis) or immunocompetent children with zoster: 250 mg/m2 of body surface area every 8 hours.

Immunocompromised children with varicella-zoster virus infections or children with herpetic encephalitis: dose of 500 mg/m2 of body surface area every 8 hours.

Newborns and infants up to 3 months of age

The dose of intravenous aciclovir in newborns and infants up to 3 months of age is calculated based on body weight. The doctor will adjust the dose for newborns and infants with kidney problems.

Known or suspected neonatal herpes: dose of 20 mg/kg every 8 hours for 21 days for disseminated disease and central nervous system disease, or for 14 days for disease limited to the skin and mucous membranes.

Patients with Renal Impairment

If you have kidney problems, your doctor may adjust the dose of Aciclovir Accord. It is important that you drink plenty of water while being treated with this medicine to ensure you do not become dehydrated.

Patients over 65 years of age

If you are elderly, your doctor may adjust the dose of aciclovir to avoid possible kidney problems. It is important that you drink plenty of water to ensure you do not become dehydrated.

If you are given more Aciclovir Accord than you should

If you think you have been given too much Aciclovir Accord, tell your doctor or nurse immediately. You may:

• Feel confused or agitated.
• Have hallucinations (see or hear things that do not exist).
• Have seizures.
• Lose consciousness (coma).

If you have any other questions about the use of this medicine, ask your doctor or nurse.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount received.

4. Possible Side Effects

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

The following side effects may appear with this medicine:

Allergic Reactions(very rare: affect less than 1 in 10,000 people)

If you have an allergic reaction, stop taking aciclovir and talk to your doctor immediately. The signs may include:

• skin rash, itching, or hives;
• swelling of the face, lips, tongue, or other parts of your body;
• shortness of breath, wheezing, or difficulty breathing;
• fever of unknown origin (high temperature) and feeling of fainting, especially when standing up.

Other side effects:

Common(affect less than 1 in 10 people)

• nausea and vomiting
• skin rash with itching and hives
• skin reaction after exposure to light (photosensitivity);
• itching
• swelling, redness, and sensitivity at the injection site;
• increased liver enzymes
• increased urea and creatinine in blood

Uncommon(affect less than 1 in 100 people)

• Decrease in red blood cell count (anemia)
• Decrease in white blood cell count (leukopenia)
• Decrease in platelet count (thrombocytopenia that can lead to nosebleeds and bruising more frequently than usual.)

Rare(affect up to 1 in 10,000 people)

• diarrhea;
• stomach pain;
• headache;
• dizziness;
• fatigue;
• fever;
• feeling of agitation or confusion;
• seizures;
• hallucinations (seeing or hearing things that do not exist);
• loss of consciousness (coma);
• unusual feeling of sleepiness or drowsiness;
• unsteadiness when walking and lack of coordination;
• difficulty speaking;
• inability to think or judge clearly;
• loss of consciousness (coma);
• brain disorder (encephalopathy);
• local inflammatory reactions;
• increased bilirubin
• liver inflammation;
• yellowing of the skin and the white part of the eyes;
• kidney problems;
• back pain in the kidney area or just above the hips.

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website http://www.aemps.gob.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aciclovir Accord

Keep out of sight and reach of children.

Store below 25 ºC.

Do not use Aciclovir Accord after the expiry date which is stated on the carton after EXP/CAD. The expiry date is the last day of the month stated.

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.

Composition of Aciclovir Accord:

• The active substance is aciclovir. Each vial contains 250 mg of aciclovir (as aciclovir sodium).
• It does not contain excipients.

Appearance and Contents of the Pack

Aciclovir Accord is available in cardboard boxes with 5 glass vials and clinical boxes with 50 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Accord Healthcare, S.L.U.

World Trade Center

c/ Moll de Barcelona, s/n

Ed. Est, 6ª planta

08039 Barcelona

Spain

Manufacturer:

Laboratorio Reig Jofré, S.A

Gran Capitán, 10 - Sant Joan Despí

08970 Barcelona

Spain

Date of Last Revision of this Leaflet:June 2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

In all cases, the dose should be administered very slowly, over a period of not less than one hour.Aciclovir Accord should only be administered intravenously after reconstitution of the lyophilized form as indicated below:

Each vial of aciclovir for injection should be reconstituted by adding 10 ml of water for injections or sodium chloride solution for intravenous infusion (0.9%); this will result in a solution containing 25 mg of aciclovir per ml.

Aciclovir Accord Once reconstituted can be injected directly into a vein over a period of not less than one hour using a controlled-rate infusion pump, or can be diluted for administration by infusion.

For intravenous administration using a controlled-rate infusion pump, aciclovir solutions of 25 mg/ml will be used. For intravenous infusion, each vial of aciclovir for injection should be reconstituted as appropriate and then diluted, either totally or partially, depending on the required dose, by adding and mixing with at least 50 ml of infusion solution. The contents of 2 vials (500 mg of aciclovir) can be added to 100 ml of infusion solution, and if the required dose is greater than 500 mg, a second volume of infusion solution can be used.

Aciclovir Accord, when diluted according to the instructions to obtain a concentration not greater than 0.5% w/v, is compatible with the following infusion fluids:

• Sodium chloride (0.45%, 0.9% w/v).
• Sodium chloride (0.18% w/v) and dextrose (4% w/v).
• Sodium chloride (0.45% w/v) and dextrose (2.5% w/v)
• Sodium lactate (Hartmann solution)

Once Aciclovir Accord is added to the infusion solution, it should be shaken vigorously to ensure a perfect mix.

The reconstituted or diluted solutions should not be refrigerated. When reconstituted or diluted according to the recommended procedure, the solution is stable for 12 hours at 20 °C.

Reconstitution or dilution should be done immediately before use, and as it does not contain any preservative, the unused solution should be discarded.

The solution should also be rejected if visible turbidity or crystallization appears before or during infusion. This solution should not be stored in the refrigerator.