ACICLOVIR TEDEC 25 mg/ml SOLUTION FOR INFUSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Aciclovir TEDEC 25 mg/ml solution for infusion EFG

Read all of this 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 further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Aciclovir belongs to the pharmacotherapeutic group of antivirals active against herpes virus.

This medicine is indicated in:

• Treatment of infections caused by herpes simplex virus.
• Prevention of infections caused by herpes simplex virus in immunocompromised patients.

• Treatment of immunodepressed patients with herpes zoster, especially in progressive or disseminated cutaneous infections.

• Treatment of infections caused by herpes simplex virus in neonates.

2. What you need to know before you use Aciclovir Tedec

Do not use Aciclovir Tedec:

• If you are allergic to aciclovir, valaciclovir, ganciclovir, or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use aciclovir:

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

• If it is used in patients who have undergone kidney transplants, your doctor should monitor kidney function, as a slight increase in creatinine or serum urea may occur, which could be confused with a rejection reaction.

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

Other medicines and Aciclovir Tedec

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy, breastfeeding, and fertility

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, and it will only be used in cases where the benefit-risk assessment by your doctor advises its use.

Aciclovir is excreted in breast milk.

Driving and using machines

No data are available to restrict this activity.

Aciclovir Tedec contains sodium and sodium metabisulfite

This medicine contains 39.3 mg of sodium (main component of table/cooking salt) per ampoule. This is equivalent to 1.965% of the maximum recommended daily sodium intake for an adult.

This medicine may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sodium metabisulfite.

3. How to use Aciclovir Tedec

Follow exactly the administration instructions of this medicine indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to use your medicine.

This medicine and its administration method have been prescribed exclusively for you. You should never give it to others or use it for other types of disorders.

Your doctor will indicate the dose and duration of your treatment with intravenous aciclovir. In acute infections caused by herpes simplex virus, 5 days of treatment are usually sufficient, but the duration of treatment will depend on the severity of the infection, the patient's condition, and response to treatment. The treatment of herpetic encephalitis and neonatal herpes simplex usually lasts 10 days. The duration of prophylactic administration of intravenous aciclovir will be determined by the duration of the risk period.

The recommended dose is:

Adults

Normal renal function

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

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

Impaired renal function

The administration of intravenous aciclovir in patients with impaired renal function should be performed with caution.

The following modifications are recommended in case of renal dysfunction:

Use in children and adolescents

The dose of intravenous aciclovir for children between 3 months and 12 years is calculated based on body surface area.

Children with infections caused by herpes simplex virus or varicella-zoster virus: dose of 250 mg/m2 of body surface area, every 8 hours.

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

Children with impaired renal function require appropriate modifications according to the degree of impairment.

The dose of aciclovir in neonates (herpes simplex): 10 mg/kg every 8 hours.

Use in elderly patients

The dose should be reduced in patients with renal insufficiency.

If you think the action of aciclovir is too strong or too weak, tell your doctor.

If you use more Aciclovir Tedec than you should

If you have used a higher dose than you should, consult your doctor or pharmacist immediately. In the administration of single doses up to 80 mg/kg, no side effects have been observed. Intravenous aciclovir is dialyzable.

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 ingested. Bring this leaflet with you.

If you forget to use Aciclovir Tedec

Do not administer a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some patients treated with intravenous aciclovir have presented the following symptoms: increased liver enzymes, decreased hematological indices, rash, and fever, nausea, and vomiting.

Disorders of the nervous system: agitation, confusion, tremor, difficulty moving, difficulty speaking, confusion or imagining things (hallucinations), convulsions, somnolence, encephalopathy (brain disorder), coma. These effects are generally reversible and usually appeared in patients with renal impairment or predisposing factors.

In some patients, a rapid and reversible increase in blood urea or creatinine levels was observed, which is believed to be due to high plasma levels of the drug and the patients' hydration status. Therefore, it is essential that the hydration level is adequate.

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 them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aciclovir Tedec

Keep this medicine out of the sight and reach of children.

Before dilution: No special storage conditions are required.

After dilution: The validity period of this medicine after dilution is 8 hours at 25°C and 24 hours at 2-8°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

6. Contents of the pack and further information

Composition of Aciclovir Tedec

The active substance is aciclovir. Each ampoule contains 250 mg of aciclovir.

The other components (excipients) are: sodium metabisulfite (E-223), sodium hydroxide, sodium citrate (E-331), hydrochloric acid, water for injectable preparations, and nitrogen.

Appearance of the product and pack contents

Aciclovir Tedec 25 mg/ml is a solution for infusion. It is presented in white glass ampoules. The solution is a clear, colorless, or pale yellow liquid. Each pack contains 5 ampoules. It is also presented in a clinical pack of 50 ampoules.

Marketing authorization holder and manufacturer

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid (Spain)

Date of the last revision of this leaflet: May 2021

Other sources of information

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

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This information is intended only for healthcare professionals

The solution should be administered only by intravenous route and continuously but very slowly, so that it is administered over a period of not less than one hour.

If necessary, it is recommended to dilute immediately before use. The unused solution should be discarded. If visible turbidity or crystallization appears before or during infusion, the solution should be rejected.

Method of administration

Undiluted intravenous infusion:

The solution is administered using a controlled-rate infusion pump over a period of not less than one hour.

Infusion with dilution:

The solution can be diluted for administration by infusion. The dilution is made totally or partially, according to the necessary dose, adding and mixing it with at least 50 ml of infusion solution, to obtain a solution with a maximum concentration of 0.5% (250 mg/50 ml). The contents of 2 ampoules (500 mg of aciclovir) can be added to 100 ml of infusion solution, and if the required dose is higher than 500 mg, a second volume of infusion solution can be used.

This medicine is compatible with the following solutions:

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

It should be shaken vigorously to ensure perfect mixing.

After accidental intravenous injection of aciclovir, severe inflammation may appear in the extravascular tissue, sometimes followed by ulcers. Infusion using mechanical pumps poses greater risks than gravity infusion. Phlebitis and inflammation at the infusion site may occur.