Aciclovir Noridem

Leaflet accompanying the packaging: patient information

Aciclovir Noridem, 250 mg, powder for solution for infusion

Aciclovir Noridem, 500 mg, powder for solution for infusion

Aciclovir

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Aciclovir Noridem and what is it used for
• 2. Important information before taking Aciclovir Noridem
• 3. How to take Aciclovir Noridem
• 4. Possible side effects
• 5. How to store Aciclovir Noridem
• 6. Contents of the packaging and other information

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

Aciclovir Noridem contains the active substance aciclovir. This medicine has a direct antiviral effect (destroys or stops the development of the virus that causes herpes or shingles). It is used to treat certain herpes virus infections and certain forms of chickenpox and shingles (a viral disease characterized by a painful rash, for example, on the eye).

2. Important information before taking Aciclovir Noridem

When not to take Aciclovir Noridem

• If the patient is allergic to aciclovir or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Aciclovir Noridem, the patient should discuss it with their doctor, pharmacist, or nurse.

• If the patient has kidney disease (kidney dysfunction).
• If the patient experiences back pain in the kidney area, which may be a sign of kidney disease (kidney dysfunction); treatment may need to be discontinued.
• If the patient is taking aciclovir intravenously or taking high doses of aciclovir orally, they should maintain adequate hydration.

Aciclovir Noridem and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

• If Aciclovir Noridem is used simultaneously with other medicines that have a toxic effect on the kidneys, it may increase the risk of kidney dysfunction. Caution should be exercised when administering aciclovir intravenously in combination with other nephrotoxic medicines.
• Concomitant intravenous administration (administration of multiple medicines at the same time through the same infusion set and also mixing them in one infusion) should not be used. The medicine may crystallize when mixed with certain other medicines.
• If the patient is taking lithium (a medicine used to treat mood disorders) simultaneously with high doses of aciclovir administered intravenously, they should be closely monitored for lithium toxicity.
• If the patient is taking aciclovir simultaneously with theophylline (a medicine used to treat asthma and certain respiratory diseases), the doctor may order tests to determine theophylline levels in the blood.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. The medicine should not be taken during pregnancy, unless explicitly recommended by a doctor. If the patient becomes pregnant during treatment, they should inform their doctor, as only the doctor can decide whether to continue treatment. The patient should not breastfeed while taking aciclovir, as it may pass into human milk.

Driving and using machines

The doctor will assess the patient's ability to drive and use machines based on their health and certain side effects, especially those related to the nervous system, that may occur during treatment (see section 4: Possible side effects).

Aciclovir Noridem contains sodium

Vial 250 mg

This medicine contains 26.1 mg of sodium (the main component of table salt) per vial. This corresponds to 1.3% of the maximum recommended daily sodium intake in the diet for adults.

Vial 500 mg

This medicine contains 52.2 mg of sodium (the main component of table salt) per vial. This corresponds to 2.6% of the maximum recommended daily sodium intake in the diet for adults.

3. How to take Aciclovir Noridem

The patient will never take this medicine on their own. The medicine will always be administered to the patient by a person properly trained to do so.

Dose

The dose is determined based on the patient's health, age, and weight.

• Adults:5 to 10 mg/kg body weight every 8 hours.
• Children over 3 months:the dose will be calculated based on body weight, from 10 to 20 mg/kg body weight every 8 hours, with a maximum dose of 400 mg to 800 mg every 8 hours.
• Newborns:20 mg/kg body weight every 8 hours.

Patients with kidney dysfunction

Caution should be exercised when administering aciclovir to patients with kidney dysfunction.

• If the patient has kidney dysfunction, the doctor will adjust the dose of the medicine.
• If the patient is elderly, the doctor will adjust the dose, as kidney function may be reduced in older people.
• In the case of patients with obesity, especially those with kidney dysfunction and the elderly, the dose should be adjusted.
• In the case of infants and children with kidney dysfunction, the dose should be adjusted according to the severity of kidney dysfunction.
• In all cases, adequate hydration should be maintained during treatment to reduce the risk of kidney dysfunction.

During treatment, to reduce the risk of kidney dysfunction.

Method of administration

This medicine is administered intravenously by medical personnel (only intravenous administration).

Duration of treatment

The treatment duration is usually 5 to 10 days. This period should be adjusted according to the patient's health and response to treatment. In the case of herpes in newborns and depending on the indication, this period may be 14 or 21 days.

Overdose of Aciclovir Noridem

The patient should immediately consult a doctor. In some situations (e.g., if the patient has kidney disease), neurological disorders may occur (see section 4: Possible side effects). If the patient has any further doubts about the use of this medicine, they should consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Aciclovir Noridem can cause side effects, although not everybody gets them. Side effects are listed in order from most common to rarest.

Frequent:(may occur in up to 1 in 10 patients)

• Gastrointestinal disorders:
• nausea,
• vomiting,
• diarrhea,
• abdominal pain.
• Liver function disorders:increased bilirubin levels and increased liver enzyme activity (substances produced by the liver) in serum. These symptoms usually disappear after treatment is discontinued.
• Skin reactions:
• itching,
• rash,
• hives (a rash that looks like one caused by nettles).
• Kidney function disorders:increased urea and creatinine levels in the blood (a sign of kidney dysfunction).
• General disorders:inflammatory skin changes or phlebitis (the formation of a blood clot in a vein) at the injection site, which can lead to necrosis (cell death) in rare cases of extravasation (when the medicine leaks from the vein into which it was injected) or insufficient dilution of the solution. Such inflammatory changes are related to the alkaline pH of this medicine.

Frequency not known:(cannot be estimated from the available data)

• Blood disorders:
• thrombocytopenia (reduced platelet count - cells that enable blood to clot)
• leukopenia (reduced white blood cell count).
• Nervous system disorders:
• headache, dizziness.
• balance disorders, ataxia (problems with walking and lack of coordination) and dysarthria (slow speech and pronunciation problems), which may occur together or separately and indicate cerebellar syndrome (a group of symptoms of fairly severe cerebellar damage, the part of the brain responsible for balance).

Nervous system disorders, in some cases severe, which may indicate encephalopathy (brain disease) and include disorientation, excitement, tremors, myoclonus (involuntary muscle contractions), seizures, hallucinations, psychosis (personality disorders), somnolence, and coma. Such neurological symptoms can usually be observed in patients with kidney dysfunction who have received a higher dose than recommended or in elderly patients (see "Warnings and precautions"). These symptoms usually disappear after treatment is discontinued. The occurrence of these symptoms may be a result of overdose; therefore, the patient should inform their doctor as soon as possible.

• Liver function disorders:acute liver damage.
• Respiratory system disorders:dyspnea (difficulty breathing).
• Immune system disorders:anaphylactic reaction (a generalized allergic reaction).
• Skin reactions:angioedema (sudden swelling of the face and neck).
• Kidney function disorders:acute kidney failure, especially in elderly patients or patients with kidney dysfunction who have received a higher dose than recommended, back pain in the kidney area, which may indicate kidney dysfunction (see also "Warnings and precautions"). The risk of acute kidney failure is due to overdose and/or dehydration, or concomitant use of medicines that have a toxic effect on the kidneys. Investigations for these predisposing factors should be carried out, regardless of the patient's age. The risk of kidney dysfunction can be avoided by using the correct dose, following the warnings for use (especially maintaining adequate hydration), and administering the medicine in a slow infusion.

Other side effects

Frequency not known:(cannot be estimated from the available data)

• fatigue,
• fever.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction 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, more information can be collected on the safety of the medicine.

5. How to store Aciclovir Noridem

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the vial and carton after "Expiry date (EXP)". The expiry date refers to the last day of the month stated. There are no special storage precautions for the medicine in terms of temperature. After reconstitution of 250 mgStability has been demonstrated for 24 hours at a temperature of 23°C to 27°C in artificial light and at a temperature of 2°C to 8°C, after dissolution in 10 mL of water for injections or in sodium chloride 9 mg/mL (0.9%) solution for injections.After reconstitution of 500 mgStability has been demonstrated for 24 hours at a temperature of 23°C to 27°C in artificial light and at a temperature of 2°C to 8°C, after dissolution in 20 mL of water for injections or in sodium chloride 9 mg/mL (0.9%) solution for injections.After dilution of 250 mgStability has been demonstrated for 12 hours at a temperature of 23°C to 27°C at an aciclovir concentration of 2.5 mg/mL after dilution with compatible solutions listed in the Information intended for healthcare professionals only, Preparation and procedure. After dilution of 500 mgStability has been demonstrated for 12 hours at a temperature of 23°C to 27°C at an aciclovir concentration of 5.0 mg/mL after dilution with compatible solutions listed in the Information intended for healthcare professionals only, Preparation and procedure. From a microbiological point of view, the medicine should be used immediately. If the medicine is not used immediately, the user is responsible for the storage conditions prior to administration, and these should not exceed 24 hours at a temperature of 2°C to 8°C or the times stated above for chemical and physical stability, depending on which is shorter, unless the opening/reconstitution/dilution method was performed under controlled and validated aseptic conditions. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Aciclovir Noridem contains

• The active substance of the medicine is aciclovir. Each 250 mg powder for solution for infusion contains 250 mg of aciclovir (in the form of aciclovir sodium). Each 500 mg powder for solution for infusion contains 500 mg of aciclovir (in the form of aciclovir sodium).
• The other ingredient is sodium hydroxide.

What Aciclovir Noridem looks like and contents of the packaging

Aciclovir Noridem powder for solution for infusion is supplied in vials of colorless glass (type I), with a capacity of 10 mL (for 250 mg) or 20 mL (for 500 mg), containing a white or off-white powder, closed with a bromobutyl rubber stopper, an aluminum seal, and a PP flip-off cap (250 mg: dark blue and 500 mg: yellow), in a cardboard box. Pack sizes: 1, 5, or 10 vials. Not all pack sizes may be marketed.

Marketing authorization holder

Noridem Enterprises Limited Evagorou & Makariou Mitsi Building 3, Office 115 Nikosia 1065 Cyprus

Manufacturer

Demo S.A. PHARMACEUTICAL INDUSTRY 21st km National Road Athens-Lamia 14568 Krioneri, Attiki, Greece, T: +30 210 8161802, F: +30 2108161587.

This medicine is authorized in the Member States of the European Economic Area under the following names:

Germany Aciclovir Noridem 250 mg Pulver zur Herstellung einer Infusionslösung Aciclovir Noridem 500 mg Pulver zur Herstellung einer Infusionslösung Romania Aciclovir Noridem 250 mg Pulbere pentru soluţie perfuzabilă Aciclovir Noridem 500 mg Pulbere pentru soluţie perfuzabilă Czech Republic Aciclovir Noridem Aciclovir Noridem Croatia Aciklovir Noridem 250 mg prašak za otopinu za infuziju Aciklovir Noridem 500 mg prašak za otopinu za infuziju Austria Aciclovir Noridem 250 mg Pulver zur Herstellung einer Infusionslösung Aciclovir Noridem 500 mg Pulver zur Herstellung einer Infusionslösung Italy Aciclovir Noridem Aciclovir Noridem Poland Aciclovir Noridem Aciclovir Noridem Slovakia Aciclovir Noridem 250 mg Prášok na infúzny roztok Aciclovir Noridem 500 mg Prášok na infúzny roztok Aciclovir Noridem 250 mg Poudre pour solution pour perfusion Aciclovir Noridem 500 mg Poudre pour solution pour perfusion Aciclovir Noridem 250 mg polvo para solución para perfusion Aciclovir Noridem 500 mg polvo para solución para perfusion Aciclovir Noridem Aciclovir Noridem Aciclovir Noridem 250 mg Poeder voor oplossing voor infusie Aciclovir Noridem 500 mg Poeder voor oplossing voor infusie Aciclovir Noridem 250 mg Por oldatos infúzióhoz Aciclovir Noridem 500 mg Por oldatos infúzióhoz Aciklovir Noridem 250 mg prašek za raztopino za infundiranje Aciklovir Noridem 500 mg prašek za raztopino za infundiranje France Spain Portugal Netherlands Hungary Slovenia

Date of last revision of the leaflet:

--------------------------------------------------------------------------------------------------------------------------- Information intended for healthcare professionals only:

Preparation and procedure

The medicine should be prepared immediately before use. Any unused solutions should be discarded. Reconstitution Reconstitution of Aciclovir Noridem should be performed using the specified volumes of water for injections or sodium chloride 9 mg/mL (0.9%) solution for injectionsto obtain a solution containing 25 mg of aciclovir per mL: Volume of reconstitution solution Vial 250 mg 10 mL Vial 500 mg 20 mL Based on the calculated dose, determine the appropriate number and size of vials needed. To reconstitute the contents of the vials, add the recommended volume of reconstitution solution to each vial and gently shake the vial until the contents are completely dissolved. Method of administration The required dose of Aciclovir Noridem should be administered by slow intravenous infusion over at least one hour. After reconstitution, Aciclovir Noridem can be administered using an infusion pump with controlled infusion rate. Alternatively, the reconstituted solution can be further diluted to administer aciclovir in an intravenous infusion at a concentration not exceeding 5 mg/mL (0.5% w/v) for infusion. Add the required volume of reconstituted solution to the chosen infusion solution, according to the following recommendations, and shake vigorously to ensure complete mixing of the contents. In the case of children and newborns, when the smallest volume of infusion solution is indicated, it is recommended to dilute in such a way that 4 mL of reconstituted solution (100 mg of aciclovir) is added to 20 mL of infusion solution. In the case of adults, it is recommended to use infusion bags containing 100 mL of infusion solution, even if this results in an aciclovir concentration significantly below 5 mg/mL (0.5% w/v). Thus, one infusion bag of 100 mL can be used for any dose between 250 mg and 500 mg of aciclovir (10 mL to 20 mL of reconstituted solution), but for doses between 500 mg and 1000 mg, a second bag should be used. After dilution according to the recommended scheme, Aciclovir Noridem is compatible with the following infusion solutions:

• sodium chloride 9 mg/mL (0.9%) solution for injections
• sodium chloride (0.45% w/v) solution for infusion
• sodium chloride (0.18% w/v) and glucose (4% w/v) solution for infusion
• sodium chloride (0.45% w/v) and glucose (2.5% w/v) solution for infusion
• multicomponent sodium lactate solution (Hartmann's solution) for infusion

After dilution according to the above scheme, Aciclovir Noridem will provide an aciclovir concentration not exceeding 0.5% w/v. Due to the lack of antimicrobial preservatives, reconstitution and dilution of Aciclovir Noridem should be performed with aseptic precautions directly before use, and any unused solution should be discarded. Reconstituted and diluted solutions should not be stored in the refrigerator. If any visible precipitate or crystals appear in the solution before or during infusion, the solution should be discarded. Any unused product or waste materials should be disposed of in accordance with local regulations.

Incompatibilities

This medicinal product should not be mixed with other medicinal products except those mentioned in "Method of administration".

Dosage and method of administration

Dosage The dosage in patients with normal kidney function is given below. In patients with impaired kidney function, the dose must be adjusted according to the severity of the impairment (see "Patients with kidney dysfunction"). To find the recommended duration of treatment, see "Duration of treatment". Dosage in patients with normal kidney function Adults and adolescents (over 12 years)

• Varicella zoster virus (VZV) infections: 10 mg/kg body weight every 8 hours; 10 to 15 mg/kg body weight every 8 hours in pregnant women;
• Herpes simplex virus (HSV) infections (except for encephalitis and meningitis): 5 mg/kg body weight every 8 hours.
• Herpes simplex encephalitis and meningitis: 10 mg/kg body weight every 8 hours.

Patients with obesity should receive the recommended adult dose based on their ideal body weight, not their actual body weight. Children and adolescentsChildren over 3 monthsThe dose for children between 3 months and 12 years should be calculated based on body weight.

• Herpes simplex virus (HSV) infections (except for encephalitis and meningitis) or varicella zoster virus (VZV) infections: 10 mg/kg body weight every 8 hours, maximum dose 400 mg every 8 hours.
• Herpes simplex encephalitis and meningitis or varicella zoster virus (VZV) infections in immunocompromised patients: 20 mg/kg body weight every 8 hours, maximum dose 800 mg every 8 hours. NewbornsIn the case of newborns and infants up to 3 months, the dose should be calculated based on body weight.
  • In the case of suspected or confirmed herpes infection in newborns, the recommended dose is 20 mg/kg body weight every 8 hours for 21 days in the case of disseminated or central nervous system infection, or for 14 days in the case of disease limited to the skin and mucous membranes.

  Dosage in patients with kidney dysfunction

  The dose and dosing interval should be adjusted based on creatinine clearance expressed in mL/min in adults and adolescents and in mL/min/1.73 m2 body surface area in infants and children under 13 years. Caution should be exercised when administering aciclovir to patients with kidney dysfunction. In such patients, particular attention should be paid to adequate fluid intake. The following dose adjustments are proposed.

  Dose adjustment recommended in adults and adolescents over 12 years with kidney dysfunction

  Creatinine clearance Recommended dose and dosing interval according to indication

  HSV or VZV infection (except for encephalitis and meningitis)

  VZV infection in immunocompromised patients or herpes simplex encephalitis and meningitis

  25-50 mL/min

  5 mg/kg body weight every 12 hours 10 mg/kg body weight every 12 hours

  10-25 mL/min

  5 mg/kg body weight every 24 hours 10 mg/kg body weight every 24 hours

  0 (anuria) to 10 mL/min

  2.5 mg/kg body weight every 24 hours 5 mg/kg body weight every 24 hours

  Patients undergoing hemodialysis

  5 mg/kg body weight every 24 hours and after hemodialysis Dose adjustment in children under 12 years and infants with kidney dysfunction2.5 mg/kg body weight every 24 hours and after hemodialysis

  Recommended dose and dosing interval according to indication

  In infants and children over 3 months

  HSV or VZV infection (except for encephalitis and meningitis)

  VZV infection in immunocompromised patients or herpes simplex encephalitis and meningitis

  Creatinine clearance (mL/min/1.73 m2 body surface area)

  25-50 mL/min/1.73 m2 body surface area

  10 mg/kg body weight twice daily 20 mg/kg body weight twice daily

  10-25 mL/min/1.73 m2 body surface area

  5 mg/kg body weight twice daily 10 mg/kg body weight twice daily

  0 (anuria) to 10 mL/min/1.73 m2 body surface area

  2.5 mg/kg body weight twice daily 5 mg/kg body weight twice daily 2.5 mg/kg body weight twice daily, after hemodialysis 5 mg/kg body weight twice daily, after hemodialysis

  Patients undergoing hemodialysis

  Elderly patientsConsideration should be given to the possibility of impaired kidney function in elderly patients; the dose should be adjusted based on creatinine clearance (see "Dosage in patients with kidney dysfunction"). Adequate fluid intake should be ensured in patients.

  Duration of treatment

  The duration of treatment is usually 5 days but may be adjusted according to the patient's health and response to treatment. The duration is:

  • 8-10 days in the case of varicella zoster virus infection
  • 10 days in the case of herpes simplex encephalitis and meningitis; this period should be adjusted according to the patient's health and response to treatment
  • 5-10 days in the case of other herpes simplex virus infections
  • 14 days in the case of herpes infection in newborns involving skin and mucous membrane lesions (skin/eye/mouth)
  • 21 days in the case of herpes infection in infants with disseminated or central nervous system infection. The duration of prophylactic use of Aciclovir Noridem depends on the duration of the risk of infection.

  Method of administration

  Intravenous administration only

  Each dose should be administered slowly intravenously (using a pump or infusion) over at least one hour.Instructions for reconstitution of the medicine before administration, see "Preparation and procedure".

  Overdose

  Objective and subjective symptoms Overdose of intravenously administered aciclovir leads to increased creatinine levels in serum, urea in the blood, and consequently kidney dysfunction. After overdose, neurological symptoms such as confusion, hallucinations, agitation, seizures, and coma have been observed. Method of treatment The patient should be closely monitored for signs of toxicity. Hemodialysis significantly removes aciclovir from the blood and may be considered as a treatment method in case of overdose symptoms.