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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Package leaflet contents:

1. What Aciclovir Accord is and what it is used for
2. What you need to know 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 Aciclovir Accord is and what it is used for

Aciclovir Accord is a medicine that contains the active substance aciclovir. Aciclovir belongs to a group of medicines called antivirals, which are active against herpesviruses. It works by eliminating 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 of severe initial genital herpes in immunocompetent patients.
• Prophylaxis of herpes simplex virus (HSV) infections in immunocompromised patients.
• Treatment of varicella-zoster virus (VZV) infections in immunocompromised patients and treatment of herpes zoster in immunocompetent patients, particularly in cases of progressive or disseminated skin infections.
• Treatment of herpes encephalitis.

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

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

Do not use Aciclovir Accord:

if you are allergic to aciclovir or valaciclovir, or to any of the excipients listed 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 elderly (over 65 years of age), your doctor may use a lower dose. You should also drink an adequate amount of fluid during treatment to maintain proper hydration.

Other medicines and Aciclovir Accord

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

It is especially important that you speak with 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, ciclosporin, or mycophenolate mofetil (used to prevent rejection of transplanted organs);
• lithium (used to treat manic-depressive disorders);
• theophylline (used to treat certain types of respiratory disorders)

Pregnancy and lactation

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 demonstrated; it will only be used if, in the opinion of your doctor, the benefit-risk assessment justifies its use.

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

Driving and operating machinery

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

3. How to use Aciclovir Accord

You must never administer the medicine to yourself. The medicine will always be administered by a trained person.

Aciclovir Accord will be given to you as a continuous intravenous infusion, slowly over 1 hour.

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

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

Adults and adolescents over 12 years of age

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

Immunocompromised patients with varicella zoster virus infections or with herpes encephalitis: 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 important that you receive plenty of fluids during aciclovir treatment.

Children between 3 months and 12 years of age

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

Children with herpes simplex virus infections (except for herpes encephalitis) 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 herpes encephalitis: 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 for newborns and infants up to 3 months of age is calculated based on body weight. The physician will adjust the dose in newborns and infants with kidney problems.

Suspected or confirmed neonatal herpes: dose of 20 mg/kg every 8 hours for 21 days in disseminated disease and central nervous system disease, or for 14 days in 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 to drink plenty of water during treatment with this medicine to ensure that you do not become dehydrated.

Elderly patients (over 65 years of age)

If you are elderly, your doctor may adjust your aciclovir dose 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 receive

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 (seeing or hearing things that are not real).
• 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at: 91 562 04 20, stating the medication and the amount taken.

4. Possible adverse effects

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

Listed below are the adverse effects that may occur 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 contact your doctor immediately. Signs may include:

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

Other adverse effects:

Frequent (affect less than 1 in 10 people)

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

Uncommon (affect less than 1 in 100 people)

• reduction in the number of red blood cells (anaemia)
• reduction in the number of white blood cells (leucopenia)
• reduction in the number of platelets (thrombocytopenia which may lead to nosebleeds and bruising more easily than usual)

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

• diarrhoea;
• stomach pain;
• headache;
• dizziness;
• fatigue;
• fever;
• feeling agitated or confused;
• spasms or tremors;
• hallucinations (seeing or hearing things that are not real);
• seizures;
• unusual drowsiness or sleepiness;
• unsteadiness when walking and lack of coordination;
• difficulty speaking;
• inability to think or judge clearly;
• loss of consciousness (coma);
• brain dysfunction (encephalopathy);
• local inflammatory reactions;
• increased bilirubin
• inflammation of the liver;
• yellowing of the skin and whites of the eyes;
• kidney problems;
• back pain in the area of the kidneys or just above the hips.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aciclovir Accord

Keep out of the sight and reach of children.

Store below 25 ºC.

Do not use Aciclovir Accord after the expiry date stated on the packaging after EXP/EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6.

Composition of Aciclovir Accord:

• The active substance is aciclovir. Each vial contains 250 mg of aciclovir (as sodium aciclovir).
• It contains no excipients.

Appearance of the product and contents of the pack

Aciclovir Accord is available in cardboard packs containing 5 glass vials and in hospital packs containing 50 vials.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party

Accord Healthcare, S.L.U.

World Trade Center

c/ Moll de Barcelona, s/n

Ed. Est, 6th floor

08039 Barcelona

Spain

Manufacturing Responsible Party:

Laboratorio Reig Jofré, S.A.

Gran Capitán, 10 - Sant Joan Despí

08970 Barcelona

Spain

Date of most recent review of this leaflet: June 2024

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

This information is intended exclusively for physicians or healthcare professionals:

In all cases, the dose must be administered very slowly, over a period of no less than one hour. Aciclovir Accord must be administered intravenously only after reconstitution of the lyophilized powder as described below:

Each vial of injectable aciclovir must be reconstituted by adding 10 ml of Water for Injections or 0.9% Sodium Chloride Solution for Intravenous Infusion to the vial; thus, the resulting solution contains 25 mg of aciclovir per ml.

Once reconstituted, Aciclovir Accord may be injected directly into a vein over a period of no less than one hour using a controlled-rate infusion pump, or it may be further diluted for administration by infusion.

For intravenous administration using a controlled-rate infusion pump, aciclovir solutions of 25 mg/ml should be used. For intravenous infusion, each vial of injectable aciclovir must be reconstituted appropriately and then diluted either totally or partially, depending on the required dose, by adding and mixing it with at least 50 ml of infusion fluid. The contents of 2 vials (500 mg of aciclovir) may be added to 100 ml of infusion fluid, and if the required dose exceeds 500 mg, a second volume of infusion fluid may be used.

Aciclovir Accord, when diluted according to the appropriate instructions to obtain a concentration not exceeding 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's solution).

After adding Aciclovir Accord to the infusion fluid, the mixture must be shaken vigorously to ensure thorough mixing.

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

Reconstitution or dissolution must be performed immediately before use. Since the product contains no preservative, any unused solution must be discarded.

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