Product Information for the User

Aciclovir Accord 250 mg Powder for Injection and Infusion EFG

Read this entire product information carefully before starting to use this medicine, as it contains important information for you.

• Keep this product information, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed to you alone, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist or nurse even if they are not listed in this product information. See section 4.

Product Information Contents:

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

Aciclovir Accord is a medication that contains the active ingredient called aciclovir. Aciclovir belongs to a group of medicines called antivirals, active against herpesviruses. It acts by eliminating the viruses or stopping their growth.

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

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

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

Do not use Aciclovir Accord:

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

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use aciclovir:

• If you have any kidney disease or are over 65 years old, your doctor may use a lower dose. Also, you must drink enough liquid during treatment to maintain adequate hydration.

Other medicines and Aciclovir Accord

Inform your doctor, pharmacist or nurse if you are taking, have taken recently or may have to take any other medicine, including those bought without a prescription.

It is especially important to talk to your doctor or pharmacist if you are taking any of the following medicines:

• probenecid (used to treat gout);
• cimetidina (used to treat stomach ulcers);
• tacrólimus, ciclosporina or micofenolato de mofetilo (used to prevent organ transplant rejection);
• litio (used to treat manic-depressive disorders)
• teofilina (used to treat some types of respiratory disorders)

Pregnancy and breastfeeding

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

This medicine has not been proven to be safe for pregnant women, and it will only be used if your doctor advises it based on the benefit/risk assessment.

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

Driving and operating machines

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

You should never administer the medication to yourself. The medication 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 generally administered every 8 hours. You may receive liquids 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 infections (except encephalitis herpética) or varicella zoster virus infections: dose of 5 mg/kg every 8 hours.

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

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

Children between 3 months and 12 years

The intravenous aciclovir dose 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 infections (except encephalitis herpética) or immunocompetent children with herpes zoster: 250 mg/m2 of body surface area every 8 hours.

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

Newborns and infants up to 3 months of age

The intravenous aciclovir dose 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 diseases, or for 14 days for limited disease to the skin and mucous membranes.

Patients with renal insufficiency

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

Geriatric patients (over 65 years)

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

If you are administered more Aciclovir Accord than you should

If you think you have been administered too much Aciclovir Accord, inform your doctor or nurse immediately. You may experience:

• Confusion or agitation.
• Alucinations (seeing and hearing things that do not exist).
• Seizures.
• Loss of consciousness (coma).

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

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

Like all medicines, Aciclovir Accord may cause side effects, although not everyone will experience them.

The following side effects may appear with this medicine:

Allergic reactions(very rare: affect fewer 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;
• unknown fever (high temperature) and feeling of dizziness, especially when standing up.

Other side effects:

Common(affect fewer than 1 in 10 people)

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

Uncommon(affect fewer than 1 in 100 people)

• reduction in the number of red blood cells (anemia)
• reduction in the number of white blood cells (leucopenia)
• reduction in the number of platelets (thrombocytopenia that may lead to nasal bleeding and appearance of bruises more frequently than usual.)

Very rare(affect up to 1 in 10,000 people)

• diarrhea;
• stomach pain;
• headache;
• sensation of dizziness;
• fatigue;
• fever;
• sensation of agitation or confusion;
• spasms or tremors;
• hallucinations (seeing or hearing things that do not exist);
• convulsions;
• sensation of unusual sleep or somnolence;
• instability while walking and lack of coordination;
• difficulty speaking;
• inability to think or judge clearly;
• unconsciousness (coma);
• brain alteration (encephalopathy);
• local inflammatory reactions;
• increase in bilirubin
• inflammation of the liver;
• yellow discoloration 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Usewww.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

Store below 25 °C.

Do not use Aciclovir Accord after the expiry date shown on the packaging after EXP/CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via the drains or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Aciclovir Accord:

• The active ingredient is aciclovir. Each vial contains 250 mg of aciclovir (as aciclovir sodium).
• No contains excipients.

Appearance of the product and contents of the package

Aciclovir Accord is available in carton containers with 5 glass vials and clinical containers with 50 vials.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Accord Healthcare, S.L.U.

World Trade Center

c/ Moll de Barcelona, s/n

Ed. Est, 6th floor

08039 Barcelona

Spain

Responsible manufacturer:

Laboratorio Reig Jofré, S.A

Gran Capitán, 10 - Sant Joan Despí

08970 Barcelona

Spain

Last review date of this leaflet:June 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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This information is intended solely for doctors or healthcare professionals:

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

Each vial of injectable aciclovir should be reconstituted by adding 10 ml of water for injection or sodium chloride solution for intravenous infusion (0.9%); in this way, the solution contains 25 mg of aciclovir per ml.

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

For intravenous administration using a controlled infusion pump, solutions of aciclovir of 25 mg/ml will be used. For intravenous infusion, each vial of injectable aciclovir should be reconstituted in the most suitable way and then diluted either completely or partially, as needed, by adding it and mixing it 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 in the case of a required dose greater than 500 mg, a second volume of infusion solution can be used.

Aciclovir Accord, when diluted according to the appropriate instructions to obtain a concentration not greater than 0.5 per 100 ml, is compatible with the following infusion liquids:

• 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's solution)

Once Aciclovir Accord has been added to the infusion solution, it should be vigorously agitated to ensure a perfect mixture.

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.

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

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