Aciclovir altan

Package leaflet: Information for the patient

Aciclovir Altan, 250 mg, powder for solution for infusion
Aciclovirum
Please read all of this leaflet carefully before use, as it contains important information for you.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor, nurse, or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, nurse, or pharmacist. See section 4.

Table of contents

1. What Aciclovir Altan is and what it is used for
2. Important information before using Aciclovir Altan
3. How to use Aciclovir Altan
4. Possible side effects
5. How to store Aciclovir Altan
6. Contents of the pack and other information

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

Aciclovir Altan 250 mg powder for solution for infusion contains the active substance aciclovir, which belongs to a group of medicines called antiviral agents.
This medicine is indicated for:

• Treatment of herpes simplex virus infections in immunocompromised patients (patients with weakened immune systems, meaning their bodies have a reduced ability to fight infections).
• Treatment of varicella-zoster virus infections in immunocompromised patients (patients with weakened immune systems).
• Prevention of herpes simplex virus infections in immunocompromised patients (patients with weakened immune systems).
• Treatment of recurrent varicella-zoster infections and treatment of primary genital herpes infections in patients without immune deficiency, whose immune systems function normally.
• Treatment of herpes simplex encephalitis (infection caused by the Herpes simplex virus).
• Treatment of herpes simplex virus infections in newborns.

2. Important information before using Aciclovir Altan

When not to use Aciclovir Altan:

• if the patient is allergic to acyclovir or valacyclovir, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Aciclovir Altan, discuss with your doctor, pharmacist, or
nurse if:

• the patient has impaired kidney function,
• the patient is aged 65 years or older.

If it is not known whether the above apply to the patient, consult your doctor or pharmacist before using Aciclovir Altan.
It is important that the patient drinks plenty of fluids during treatment with Aciclovir Altan.

Aciclovir Altan and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
This includes medicines available without a prescription, including herbal medicines.
In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines:

• probenecid, used in the treatment of gout;
• cimetidine, used in the treatment of stomach ulcers;
• tacrolimus, cyclosporine, or mycophenolate mofetil, used to prevent organ transplant rejection;
• theophylline, used in the treatment of certain breathing disorders;
• lithium, used in the treatment of psychiatric disorders.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Aciclovir Altan should only be administered during pregnancy after consultation with a doctor, when, in the doctor's opinion, the expected benefits of using acyclovir outweigh the potential risks to the fetus.
Acyclovir may pass into breast milk.
If the patient is breastfeeding, she should consult her doctor before using Aciclovir Altan.

Driving and operating machinery
No studies have been conducted to assess the effect of acyclovir on the ability to drive or operate machinery.

Aciclovir Altan contains sodium
Aciclovir Altan contains 23.55 mg of sodium (the main component of table salt) in each vial.
This corresponds to 1.17% of the maximum recommended daily dietary intake of sodium for adults.

3. How to use Aciclovir Altan

Aciclovir Altan will be administered to the patient by a doctor or nurse as an intravenous infusion.
Before administration, the medicine will be diluted.
Aciclovir Altan will be given as a slow, continuous intravenous infusion over 1 hour.

The doctor will decide the dose to be administered, and the frequency and duration of treatment will depend on:

• the type of infection the patient has,
• the patient's body weight,
• the patient's age.

The doctor may adjust the dose of Aciclovir Altan if:

• the patient has impaired kidney function. If the patient has kidney problems, it is important that they drink plenty of fluids during treatment with Aciclovir Altan.

If any of the above apply, medical advice must be sought before administering Aciclovir Altan.
Administration of a higher than recommended dose of Aciclovir Altan
If the patient suspects they have received too high a dose of Aciclovir Altan, the doctor or nurse must be informed immediately.
In case of overdose with Aciclovir Altan, changes in laboratory test results (increased blood urea and creatinine levels) may occur, leading to kidney function disturbances (kidney failure).
Additionally, the patient may:

• experience confusion or agitation;
• have hallucinations (see or hear things that do not exist);
• have seizures;
• lose consciousness (coma).

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
If an allergic reaction occurs, stop using Aciclovir Altan immediately and contact your doctor without delay.
The following adverse effects may occur during treatment with this medicine:

Common (affects less than 1 in 10 people)

• Swelling and redness at the injection site (phlebitis);
• Nausea or vomiting;
• Itching, urticaria;
• Rash, skin reaction after exposure to light (photosensitivity);
• Changes in certain laboratory tests (increased blood urea, creatinine, and certain liver enzymes)

Uncommon (affects less than 1 in 100 people)

• Reduced number of red blood cells (anaemia);
• Reduced number of white blood cells (leukopenia);
• Reduced number of platelets (thrombocytopenia)

Very rare (affects less than 1 in 10,000 people)

• Severe hypersensitivity reactions (anaphylactic reactions);
• Swelling of lips, face, neck, and throat causing breathing difficulties (angioedema);
• Breathing difficulties (dyspnoea);
• Headache;
• Dizziness;
• Agitation or confusion;
• Tremor;
• Impaired balance while walking and lack of motor coordination (ataxia);
• Difficulty speaking (dysarthria);
• Seeing or hearing things that are not real (hallucinations);
• Inability to think logically or assess situations (psychotic symptoms);
• Seizures;
• Drowsiness;
• Brain damage (encephalopathy);
• Loss of consciousness (coma);
• Diarrhoea;
• Abdominal pain;
• Yellowing of the skin and whites of the eyes (jaundice);
• Inflammation of the liver (hepatitis);
• Reduced kidney function (renal function disorders, acute kidney failure);
• Pain in the lower back, in the kidney area (kidney pain);
• Fatigue;
• Fever;
• Local inflammatory reactions;
• Abnormal laboratory test results (elevated bilirubin).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Aciclovir Altan

Keep this medicine out of sight and reach of children.
There are no special requirements for storage of this medicinal product.
Do not use this medicine after the expiry date stated on the vial and outer carton after EXP.
The expiry date refers to the last day of the stated month.
Stability period after reconstitution
Solutions reconstituted with 10 ml of water for injections remain stable for 12 hours at 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Package contents and other information

What Aciclovir Altan contains

• The active substance is aciclovir. Each vial contains 250 mg of aciclovir in the form of sodium salt.
• The other ingredients (excipients) are: sodium hydroxide.

What Aciclovir Altan looks like and contents of the pack
Aciclovir Altan 250 mg powder for solution for infusion is available in packs of 5 and 50 vials.

Marketing Authorisation Holder
Altan Pharmaceuticals, S.A.
C/ Cólquide Nº 6, Portal 2, 1ª Planta, Oficina F. Edificio Prisma
Las Rozas, 28230 Madrid
Spain

Manufacturer
Altan Pharmaceuticals, S.A.
Avda. Constitución 198-199
Polígono Industrial Monte Boyal
45950 Casarrubios del Monte, Toledo
Spain

Altan Logo

Information intended exclusively for healthcare professionals:
DOSAGE AND GENERAL INFORMATION
Detailed information on the use of the medicinal product is provided in the Summary of Product Characteristics (SmPC).

Pharmaceutical form
Powder for solution for infusion.

Dosage and method of administration

Adults
Patients with infections caused by herpes simplex virus (with the exception of patients with herpes simplex encephalitis) or recurrent infections caused by varicella-zoster virus should receive Aciclovir Altan at a dose of 5 mg/kg body weight every 8 hours, provided that these patients do not have renal impairment (see "Patients with renal impairment").
Immunocompromised patients with infections caused by varicella-zoster virus and patients with herpes simplex encephalitis should receive Aciclovir Altan at a dose of 10 mg/kg body weight every 8 hours, provided that these patients do not have renal impairment (see section 4.2).
For obese patients, the recommended adult dose should be based on average body weight rather than actual body weight.

Children and adolescents:
The dose of Aciclovir Altan for infants and children aged 3 months to 12 years should be calculated based on body surface area.
Infants and children aged 3 months or older with infections caused by herpes simplex virus (excluding herpes simplex encephalitis) or recurrent infections caused by varicella-zoster virus should receive Aciclovir Altan at a dose of 250 mg/m² body surface area every 8 hours, provided that these patients do not have renal impairment.
Immunocompromised children with infections caused by varicella-zoster virus and children with herpes simplex encephalitis should receive Aciclovir Altan at a dose of 500 mg/m² body surface area every 8 hours, provided that these patients do not have renal impairment.

Neonates and infants up to 3 months of age
The dose of Aciclovir Altan for neonates and infants up to 3 months of age should be calculated based on body weight.
The recommended dosing regimen for neonates and infants treated for confirmed or suspected herpes virus infection is aciclovir 20 mg/kg body weight administered intravenously every 8 hours for 21 days in cases of disseminated central nervous system infection, or for 14 days in cases of infection limited to skin and mucous membranes.
In neonates and children with renal impairment, dosage adjustment is required depending on the degree of renal impairment (see "Patients with renal impairment" below).

Elderly patients
In elderly patients, the possibility of renal impairment should be considered and dosage adjusted accordingly (see "Patients with renal impairment" below).
Adequate hydration of the patient should be ensured.

Patients with renal impairment
Caution is required when administering Aciclovir Altan to patients with renal impairment. Adequate hydration of the patient should be ensured.
Dosage adjustment in patients with renal impairment is based on creatinine clearance expressed in ml/min for adults and adolescents, and in ml/min/1.73 m² for infants and children under 13 years of age. The following dosage adjustments are recommended:
Table 1: Dosage adjustment of intravenous aciclovir in adults and adolescents with renal impairment

Table 2: Dosage adjustment of intravenous acyclovir in neonates, infants, and children
with impaired renal function

Duration of treatment
Treatment with the medicinal product Aciclovir Altan usually lasts 5 days, but this period may vary depending on the patient's condition and response to therapy. Treatment of herpes simplex encephalitis usually lasts 10 days. Treatment of herpes simplex virus infection in newborns usually lasts 14 days for skin and mucous membrane infections, and 21 days for disseminated disease or disease involving the central nervous system.
The duration of prophylactic use of the medicinal product Aciclovir Altan depends on the period of risk of infection.

Method of administration
The solution should be administered intravenously, continuously and very slowly, so that the infusion lasts no less than 1 hour.
Reconstitution and/or dilution should be performed immediately before use. Due to the absence of preservatives, any unused solution should be discarded. If cloudiness or crystals appear in the solution before or during infusion, the solution must be discarded. Reconstituted or diluted solutions must not be stored in a refrigerator.

Preparation of the solution
A vial of the medicinal product Aciclovir Altan for intravenous administration containing 250 mg of acyclovir lyophilisate should be reconstituted by adding 10 ml of water for injections or 0.9% sodium chloride solution. The reconstituted solution has a concentration of 25 mg/ml.

Dilution
Dilution, either complete or partial depending on the dose, should be performed by adding or mixing at least 50 ml of infusion solution to achieve a maximum concentration of 0.5% (250 mg/50 ml).
The contents of 2 vials (500 mg acyclovir) may be added to 100 ml of infusion solution. If a dose greater than 500 mg is required, a second volume of infusion solution may be used.

Route of administration
Intravenous administration
After reconstitution, the solution should be administered via an infusion pump as a slow, one-hour intravenous infusion.

Infusion
The prepared solution may be further diluted for infusion administration.
Dilution, either complete or partial depending on the dose, should be performed by adding or mixing at least 50 ml of infusion solution to achieve a maximum concentration of 0.5% (250 mg/50 ml).
The contents of 2 vials (500 mg acyclovir) may be added to 100 ml of infusion solution. If a dose greater than 500 mg is required, a second volume of infusion solution may be used.

Acyclovir is pharmaceutically compatible with the following infusion solutions:

• Sodium chloride solution 4.5 mg/ml (0.45%)
• Sodium chloride solution 9 mg/ml (0.9%)
• Sodium chloride solution 1.8 mg/ml (0.18% w/v) and glucose (4% w/v)
• Sodium chloride solution 4.5 mg/ml (0.45% w/v) and glucose (2.5% w/v)
• Multi-component sodium lactate solution (Hartmann's solution)

After adding acyclovir to the infusion solution, the mixture should be shaken vigorously to ensure complete mixing.

Following accidental intravenous extravasation of acyclovir, severe extravascular tissue swelling may occur, sometimes leading to ulceration. Infusion using a mechanical pump carries a higher risk than gravity-driven infusion. Phlebitis and swelling at the site of administration may occur.