Aciclovir Altan

Package Leaflet: Information for the User

Aciclovir Altan, 250 mg, Powder for Solution for Infusion

Aciclovir

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

• 1. What Aciclovir Altan is and what it is used for
• 2. Before you take Aciclovir Altan
• 3. How to take 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 antivirals.

This medicine is used for:

• treatment of herpes simplex virus infections in patients with impaired immune systems (in people whose immune system does not work properly, making it harder for the body to fight off infections)
• treatment of varicella-zoster virus infections in patients with impaired immune systems (in people whose immune system does not work properly)
• prevention of herpes simplex virus infections in patients with severely impaired immune systems (in people whose immune system works very poorly)
• treatment of recurrent varicella-zoster virus infections and primary genital herpes in patients without impaired immune systems, whose immune system works properly
• treatment of herpes simplex encephalitis (infection caused by the herpes simplex virus)
• treatment of herpes simplex virus infections in newborns

2. Before you take Aciclovir Altan

Do not take Aciclovir Altan:

• if you are allergic to aciclovir or valaciclovir, or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Before taking Aciclovir Altan, talk to your doctor, pharmacist, or nurse if:

• you have kidney problems
• you are over 65 years old

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Aciclovir Altan.

It is important to drink plenty of water while taking Aciclovir Altan.

Aciclovir Altan with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those obtained without a prescription, including herbal medicines.

In particular, tell your doctor or pharmacist if you are taking:

• probenecid used for gout
• cimetidine used for stomach ulcers
• tacrolimus, cyclosporin, or mycophenolate mofetil used to prevent organ rejection
• theophylline used for breathing problems
• lithium used for mental health problems

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Aciclovir Altan can be used during pregnancy only if the potential benefit to the mother outweighs the risk to the fetus.

Aciclovir may pass into breast milk. If you are breastfeeding, consult your doctor before taking Aciclovir Altan.

Driving and using machines

No studies have been conducted to assess the effect of aciclovir on the ability to drive and use machines.

Aciclovir Altan contains sodium

Aciclovir Altan contains 23.55 mg of sodium (main component of common salt) per vial, which is 1.17% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Aciclovir Altan

Aciclovir Altan will be given to you by a doctor or nurse.

Before administration, the medicine will be diluted.

Aciclovir Altan will be given as a continuous infusion into a vein, slowly over one hour.

The dose will be decided by your doctor, and the frequency and duration of administration will depend on:

• the type of infection you have
• your body weight
• your age

Your doctor may change the dose of Aciclovir Altan if:

• you have kidney problems. If you have kidney disease, it is essential to drink plenty of fluids during treatment with Aciclovir Altan.

If the above applies to you, consult your doctor before taking Aciclovir Altan.

Overdose

If you think you have taken too much Aciclovir Altan, tell your doctor or nurse immediately.

In case of overdose, changes in laboratory test results (increased levels of urea and creatinine in the blood) with resulting kidney problems (kidney failure) may occur.

Additionally, you may:

• feel confused or agitated
• have hallucinations (see or hear things that do not exist)
• have seizures
• lose consciousness (coma)

4. Possible side effects

Like all medicines, Aciclovir Altan can cause side effects, although not everybody gets them.

If you experience an allergic reaction, stop taking Aciclovir Altan and contact your doctor immediately.

The following side effects may occur:

Common(in up to 1 in 10 people)

• swelling and redness at the injection site (phlebitis)
• nausea, vomiting
• itching, hives
• rash, including photosensitivity reaction (sensitivity to light)
• changes in some laboratory test results (increased levels of urea, creatinine, and liver enzymes in the blood)

Uncommon(in up to 1 in 100 people)

• decreased red blood cell count (anemia)
• decreased white blood cell count (leukopenia)
• decreased platelet count (thrombocytopenia)

Rare(in up to 1 in 1,000 people)

• severe allergic reactions (anaphylaxis)
• swelling of the lips, face, neck, and throat, causing difficulty breathing (angioedema)
• breathing difficulties (dyspnea)
• headache
• dizziness
• agitation or confusion
• tremors
• balance problems while walking and lack of coordination (ataxia)
• speech difficulties (dysarthria)
• seeing or hearing things that do not exist (hallucinations)
• inability to think logically or assess situations (psychotic symptoms)
• seizures
• drowsiness
• brain damage (encephalopathy)
• loss of consciousness (coma)
• diarrhea
• abdominal pain
• yellowing of the skin and whites of the eyes (jaundice)
• liver inflammation
• kidney problems (kidney impairment, acute kidney failure)
• back pain in the kidney area (kidney pain)
• fatigue
• fever
• local allergic reactions
• abnormal laboratory test results (increased bilirubin levels)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181C 02-222 Warsaw

tel: +48 22 49 21 301

fax: +48 22 49 21 309

website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aciclovir Altan

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

No special storage precautions are required.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP.

The expiry date refers to the last day of that month.

Shelf-life after reconstitution

The reconstituted solution is 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.

This will help protect the environment.

6. Contents of the pack and other information

What Aciclovir Altan contains

• The active substance is aciclovir. Each vial contains 250 mg of aciclovir as sodium salt.
• The other ingredients 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 authorization holder

Altan Pharma Limited

The Lennox Building

50 Richmond Street South

Dublin 2

Co. Dublin

D02 FK02

Ireland

[email protected]

Manufacturer

Altan Pharmaceuticals S.A.

Avda. Constitución 198-199

Polígono Industrial Monte Boyal

45950 Casarrubios del Monte, Toledo

Spain

Date of last revision of the leaflet

Information intended for healthcare professionals only:

DOSAGE AND ADMINISTRATION

Detailed information on the use of this medicinal product is available in the Summary of Product Characteristics (SmPC).

Pharmaceutical form

Powder for solution for infusion.

Dosage and administration

Adults

Patients with herpes simplex virus infections (except for patients with herpes simplex encephalitis) or recurrent varicella-zoster virus infections should receive Aciclovir Altan at a dose of 5 mg/kg every 8 hours, provided that they do not have impaired kidney function (see "Patients with impaired kidney function").

Patients with impaired immune systems and varicella-zoster virus infections or herpes simplex encephalitis should receive Aciclovir Altan at a dose of 10 mg/kg every 8 hours, provided that they do not have impaired kidney function (see "Patients with impaired kidney function").

Obese patients should receive the recommended adult dose based on ideal body weight, not actual body weight.

Children and adolescents:

The dose of Aciclovir Altan for infants and children from 3 months to 12 years should be calculated based on body surface area.

Infants and children over 3 months with herpes simplex virus infections (except for herpes simplex encephalitis) or recurrent varicella-zoster virus infections should receive Aciclovir Altan at a dose of 250 mg/m2 every 8 hours, provided that they do not have impaired kidney function.

Children with impaired immune systems and varicella-zoster virus infections or herpes simplex encephalitis should receive Aciclovir Altan at a dose of 500 mg/m2 every 8 hours, provided that they do not have impaired kidney function.

Newborns and infants up to 3 months:

The dose of Aciclovir Altan for newborns and infants up to 3 months should be calculated based on body weight.

The recommended dosing regimen for neonates being treated for known or suspected neonatal herpes is 20 mg/kg every 8 hours for 21 days for disseminated or central nervous system disease or 14 days for disease limited to the skin and mucous membranes.

For neonates and children with impaired kidney function, dose modification is required based on the degree of kidney impairment (see "Patients with impaired kidney function").

Elderly patients

In elderly patients, consider the possibility of impaired kidney function and adjust the dose accordingly (see "Patients with impaired kidney function").

Ensure adequate hydration of the patient.

Patients with impaired kidney function

Caution is required when administering Aciclovir Altan to patients with impaired kidney function.

Ensure adequate hydration of the patient.

Dose adjustment in patients with impaired kidney function 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.

The following dose adjustments are recommended:

Table 1: Dose adjustment of intravenous aciclovir in adults and adolescents with impaired kidney function

Table 2: Dose adjustment of intravenous aciclovir in newborns, infants, and children with impaired kidney function

Duration of treatment

Treatment with Aciclovir Altan usually lasts for 5 days, but this may be changed depending on the patient's condition and response to treatment.

Treatment for herpes simplex encephalitis usually lasts for 10 days.

Treatment for neonatal herpes simplex virus infections usually lasts for 14 days for skin and mucous membrane lesions and 21 days for disseminated or central nervous system disease.

The duration of prophylactic treatment with Aciclovir Altan depends on the duration of the risk period.

Administration

The solution is administered intravenously, continuously, but very slowly, over at least one hour.

Reconstitution and/or dilution should be performed immediately before use.

Due to the lack of preservatives, any unused solution should be discarded.

If the solution becomes cloudy or crystals form during or after reconstitution, the solution should be discarded.

Reconstituted or diluted solutions should not be stored in the refrigerator.

Preparation of the solution

The vial of Aciclovir Altan for intravenous administration containing 250 mg of lyophilized aciclovir should be reconstituted by adding 10 ml of water for injection or 0.9% sodium chloride solution for infusion.

After reconstitution, a solution with a concentration of 25 mg/ml is obtained.

Route of administration

Intravenous administration

After reconstitution, the solution is administered using an infusion pump with controlled infusion rate over at least one hour.

Infusion

The reconstituted solution can be further diluted for infusion.

Dilution, total or partial, depending on the dose, should be performed by adding or mixing with at least 50 ml of infusion solution, to obtain 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.

If a dose greater than 500 mg is required, a second infusion solution can be used.

Aciclovir is compatible with the following infusion solutions:

sodium chloride 4.5 mg/ml (0.45%) solution

sodium chloride 9 mg/ml (0.9%) solution

sodium chloride 1.8 mg/ml (0.18%) and glucose (4% w/v) solution

sodium chloride 4.5 mg/ml (0.45%) and glucose (2.5% w/v) solution

multi-electrolyte solution (Hartmann's solution)

After adding aciclovir to the infusion solution, it should be shaken well to ensure complete mixing of the contents.

After incorrect administration of intravenous aciclovir, severe swelling of the tissue around the vein may occur, which may be followed by ulceration.

Infusion using a mechanical pump is associated with a higher risk than gravity infusion.

Phlebitis and swelling at the injection site may occur.