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

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 shingles or herpes). It is used to treat some 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 tell 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 at the same time as 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 several 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 after mixing with some medicines.
• If the patient is taking lithium (a medicine used to treat mood disorders) at the same time as high doses of aciclovir administered intravenously, they should be closely monitored for lithium toxicity.
• If the patient is taking aciclovir at the same time as theophylline (a medicine used to treat asthma and some respiratory diseases), the doctor may order tests to determine the level of theophylline 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

Cautions should be exercised in patients with kidney dysfunction when administering aciclovir by infusion.

• If the patient has kidney dysfunction, the doctor will adjust the dose of this medicine.
• If the patient is elderly, the doctor will adjust the dose, as kidney function may be decreased 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 of the body 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 their response to treatment. In the case of herpes in newborns and depending on the indication, this period may be 14 or 21 days.

Using a higher dose of Aciclovir Noridem than recommended

The patient should consult their doctor immediately. 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 their doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Aciclovir Noridem can cause side effects, although not everybody gets them. Side effects have been listed in order of frequency, from most common to least common. 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 levels of urea and creatinine 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 (death of cells) 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 (decreased platelet count - cells that enable blood to clot)
• leukopenia (decreased white blood cell count).
• Nervous system disorders:
• headache, dizziness.
• balance disorders, ataxia (problems with walking and lack of coordination) and dysarthria (slow speech and problems with pronunciation), which may occur together or

separately and indicate the presence of a cerebellar syndrome (a group of symptoms of fairly severe cerebellar damage, the part of the brain responsible for balance).

• Neurological disorders, in some cases severe, which may indicate encephalopathy (brain disease) and include disorientation, agitation, tremors, myoclonus (involuntary muscle contractions), seizures, hallucinations, psychosis (personality disorders), drowsiness, 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 doctor should be informed 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 the combination of medicines that have a toxic effect on the kidneys. Investigations for the aforementioned 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 side effects occur, including any not listed in this leaflet, the patient 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 gathered 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 precautions for storage of 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 handling. 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 handling. 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 use, and these should not normally exceed 24 hours at 2°C to 8°C or the times stated above for chemical and physical stability, depending on which is the 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, 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 powder for solution for infusion Aciclovir Noridem 500 mg powder for solution for infusion Romania Aciclovir Noridem 250 mg powder for solution for infusion Aciclovir Noridem 500 mg powder for solution for infusion Czech Republic Aciclovir Noridem Aciclovir Noridem Croatia Aciklovir Noridem 250 mg powder for solution for infusion Aciklovir Noridem 500 mg powder for solution for infusion Austria Aciclovir Noridem 250 mg powder for solution for infusion Aciclovir Noridem 500 mg powder for solution for infusion Italy Aciclovir Noridem Aciclovir Noridem Poland Aciclovir Noridem Aciclovir Noridem Slovakia Aciclovir Noridem 250 mg powder for solution for infusion Aciclovir Noridem 500 mg powder for solution for infusion Aciclovir Noridem 250 mg powder for solution for infusion Aciclovir Noridem 500 mg powder for solution for infusion Aciclovir Noridem 250 mg powder for solution for infusion Aciclovir Noridem 500 mg powder for solution for infusion Aciclovir Noridem Aciclovir Noridem Aciclovir Noridem 250 mg powder for solution for infusion Aciclovir Noridem 500 mg powder for solution for infusion Aciclovir Noridem 250 mg powder for solution for infusion Aciclovir Noridem 500 mg powder for solution for infusion France Spain Portugal Netherlands Hungary Slovenia

Date of last revision of the leaflet:

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

Preparation and handling

The medicine should be prepared immediately before use. Any unused solutions should be discarded. Reconstitution The reconstitution of Aciclovir Noridem should be performed using the stated volumes of water for injections or sodium chloride 9 mg/mL (0.9%) solution for injections, to 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 the 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 a 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 the 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 infusion volume is indicated, it is recommended to dilute in such a way that 4 mL of the reconstituted solution (100 mg of aciclovir) is added to 20 mL of the 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 the 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 multi-component sodium lactate solution (Hartmann's solution) for infusion. Aciclovir Noridem, after dilution according to the above scheme, 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 under aseptic conditions immediately before use, and any unused solutions should be discarded. Reconstituted and diluted solutions should not be stored in the refrigerator. If any visible precipitates 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.

Pharmaceutical 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 kidney dysfunction (see "Dosage in patients with kidney dysfunction"). To find out 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 months

• HSV or VZV infections (except for encephalitis and meningitis): 10 mg/kg body weight every 8 hours, maximum dose 400 mg every 8 hours.
• Encephalitis or meningitis caused by HSV or VZV in immunocompromised children: 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 proven or suspected herpes infection in newborns, the recommended dose is 20 mg/kg body weight intravenously 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 dysfunctionThe dose and frequency of administration should be adjusted based on the creatinine clearance expressed in mL/min in adults and adolescents over 12 years, 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, 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 frequency of administration 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 frequency of administration according to indication

  In infants and children over 3 months

  HSV or VZV infection (except for encephalitis and meningitis)

  Encephalitis or meningitis caused by VZV in immunocompromised patients

  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 disseminated or central nervous system herpes infection in infants. 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 handling".

  Overdose

  Objective and subjective symptoms Overdose of intravenously administered aciclovir causes increased serum creatinine levels, blood urea levels, and subsequent 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.