PATIENT INFORMATION LEAFLET

Aaciclovir TEDEC 25 mg/ml Infusion Solution

Read this leaflet carefully before you start using this medicinebecause it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for youonlyand should not be given to others, even if they have the same symptomsas you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before using Aciclovir Tedec

3. How to use Aciclovir Tedec

4. Possible side effects

5. Storage of Aciclovir Tedec

6. Contents of the pack and additional information

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

This medication is indicated for:

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

• Treatment of immunocompromised patients with shingles, especially in progressive or disseminated skin infections.

• Treatment of herpes simplex virus infections in newborns.

Do not use Aciclovir Tedec :

• If you are allergic to aciclovir, valaciclovir, ganciclovir, or any of the other components of this medication (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 must drink enough liquid during treatment to maintain adequate hydration.

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

Consult your doctor, even if any of the circumstances mentioned above have occurred at any time.

Other medications and Aciclovir Tedec

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

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

This medication has not been proven safe for pregnant women, and it will only be used in cases where your doctor assesses the benefit/risk and recommends its use.

Aciclovir is excreted in breast milk.

Driving and operating machines

No data are available to limit this activity.

Aciclovir Tedeccontains sodium and sodium metabisulfite

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

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Remember to use your medication.

This medication and its administration method have been prescribed exclusively to you. Do not give it to anyone else or use it for other types of disorders.

Your doctor will indicate the dose and duration of your treatment with intravenous aciclovir. For acute infections caused by simple herpes virus, 5 days of treatment is usually sufficient, although 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 intravenous aciclovir prophylactic administration will be determined by the duration of the risk period.

The recommended dose is:

Adults

Normal renal function

Patients with simple herpes virus infections (except herpetic encephalitis) or varicella zoster virus infections: 5 mg/kg, every 8 hours.

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

Altered renal function

The administration of intravenous aciclovir in patients with altered 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 simple herpes virus infections or varicella zoster virus infections: 250 mg/m2of body surface area, every 8 hours.

Immunocompromised children with varicella zoster virus infections or children with herpetic encephalitis: 500 mg/m2of body surface area, every 8 hours.

Children with altered renal function require appropriate modifications according to the degree of alteration.

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 estimate that the action of aciclovir is too strong or too weak, inform your doctor.

If you use more Aciclovir Tedec than you should

If you have used a higher dose than prescribed, consult your doctor or pharmacist immediately. In the administration of single doses of 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 medication and the amount ingested. Bring this leaflet with you.

If you forgot to useAciclovir Tedec

Do not administer a double dose to compensate for the missed doses.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Nervous system disorders: agitation, confusion, tremor, difficulty moving, difficulty speaking, confusion or imagination of things (hallucinations), convulsions, drowsiness, encephalopathy (brain alteration), coma. These effects are generally reversible and normally appeared in patients with renal alterations or predisposing factors.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Before dilution: No special storage conditions are required.

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

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Composition of Aciclovir Tedec

The active principle is aciclovir. Each vial contains 250 mg of aciclovir.

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

Appearance of the product and contents of the package

Aciclovir Tedec 25 mg/ml is a perfusion solution. It is presented in white glass vials. The solution is a transparent, colorless or pale yellow liquid. Each package contains 5 vials. It is also presented in a clinical package of 50 vials.

Holder of the marketing authorization and responsible for manufacturing

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94

28802 Alcalá de Henares, Madrid (Spain)

Last review date of this leaflet: May 2021

Other sources of information

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

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This information is intended solely for healthcare professionals

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

If applicable, it is recommended to dilute immediately before use. Unused solution should be discarded. In case of visible turbidity or crystallization before or during infusion, the solution should be rejected.

Administration form

Intravenous perfusion without dilution:

The solutionis administered through a controlled rate infusion pump, over a period of not less than one hour.

Perfusion with dilution:

The solutioncan be diluted for administration through perfusion. The dilution is made totally or partially, as necessary, by 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 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.

This medication 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's solution)

It should be shaken vigorously to ensure a perfect mixture.

Following accidental intravenous injection of aciclovir, severe extravascular inflammation may occur, sometimes followed by ulcerations. Perfusion through mechanical pumps poses a higher risk than gravity perfusion. It may cause phlebitis and inflammation at the infusion site.