Aciclovir hikma

Package leaflet: Information for the patient

Aciclovir Hikma, 250 mg, powder for solution for infusion
Aciclovir Hikma, 500 mg, powder for solution for infusion
Aciclovirum
Please read the entire leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Table of contents

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

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

Aciclovir Hikma contains the active substance called aciclovir. It belongs to a group of medicines known as antiviral agents. Its mechanism of action involves killing viruses or inhibiting their growth.
Aciclovir Hikma may be used for:

• treatment of infections caused by varicella-zoster virus (chickenpox and shingles);
• treatment of severe cases of genital herpes;
• prevention and treatment of infections caused by herpes simplex virus (cold sores and genital herpes) in individuals with weakened immunity, meaning their bodies are less able to fight infections;
• treatment of herpes simplex virus infections in children up to 3 months of age. Such infections may, in rare cases, be caused by the virus responsible for cold sores and genital herpes;
• treatment of herpes simplex encephalitis (this type of infection may, in rare cases, be caused by the virus responsible for cold sores and genital herpes).

2. Important information before using Aciclovir Hikma

When not to use Aciclovir Hikma:

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

Warnings and precautions
Before starting treatment with Aciclovir Hikma, discuss this with your doctor or nurse.
You should consult your doctor or nurse before using Aciclovir Hikma if:

• the patient has impaired kidney function,
• the patient is over 65 years of age.

If you are unsure whether any of the above apply to the patient, speak to your doctor or nurse before using Aciclovir Hikma.

Aciclovir Hikma and other medicines
Tell your doctor about all medicines the patient is currently using, has recently used, or plans to use.
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 rejection of transplanted organs;
• lithium, used in the treatment of manic-depressive disorders;
• theophylline, used in the treatment of certain breathing disorders.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine.

Driving and operating machinery
Studies on the effect of aciclovir on the ability to drive vehicles or operate machinery have not been conducted.

Aciclovir Hikma contains sodium

Aciclovir Hikma 250 mg
This medicine contains 26.2 mg of sodium (the main component of table salt) per vial. This corresponds to 1.31% of the maximum recommended daily dietary intake of sodium for adults.

Aciclovir Hikma 500 mg
This medicine contains 52.2 mg of sodium (the main component of table salt) per vial. This corresponds to 2.61% of the maximum recommended daily dietary intake of sodium for adults.

3. How to use Aciclovir Hikma

The patient must never self-administer this medicine. It is always administered by a person appropriately trained to do so.
Before administration, the medicine will be diluted.
Aciclovir Hikma is given as a continuous intravenous infusion. This medicine is administered slowly by intravenous infusion over 1 hour.
Aciclovir Hikma is usually administered every 8 hours.
The patient may receive fluids to prevent dehydration.
The dose administered, frequency of administration, and duration of treatment will depend on:

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

The doctor may adjust the dose of Aciclovir Hikma if:

• the patient has impaired kidney function. If the patient has kidney problems, it is important to drink plenty of fluids during treatment with Aciclovir Hikma;
• the patient is overweight or obese;
• the patient is elderly. If any of the above apply to the patient, medical advice must be sought before administering Aciclovir Hikma.

Use in children
The dose of Aciclovir Hikma administered:

• to neonates and children up to 12 years of age is calculated based on body weight. If the child has kidney problems, the dose may be reduced.

Overdose of Aciclovir Hikma
If an overdose of Aciclovir Hikma is suspected, a doctor or nurse must be informed immediately.
If the patient has received an overdose of Aciclovir Hikma, they may:

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur when using this medicine:
Allergic reactions (in no more than 1 in 10,000 people)
If a patient experiences an allergic reaction, treatment with Aciclovir Hikma should be discontinued immediately and the patient should seek medical advice without delay. Symptoms may include:

• skin rash, itching or hives;
• swelling of the face, lips, tongue or other parts of the body;
• shortness of breath, wheezing or difficulty breathing;
• fever (high body temperature) of unknown cause and a feeling of fainting, especially when standing.

Other adverse reactions include:
Common (in no more than 1 in 10 people)

• nausea or vomiting;
• itchy rash resembling hives;
• skin reaction upon exposure to light (photosensitivity);
• itching;
• swelling, redness and tenderness at the site of administration.

Uncommon (in no more than 1 in 100 people)

• more frequent than usual nosebleeds and bruising.

Very rare (in no more than 1 in 10,000 people)

• headache or dizziness;
• diarrhoea or abdominal pain;
• feeling of fatigue;
• fever;
• effects on certain blood and urine test results;
• weakness;
• agitation or confusion;
• chills or tremors;
• hallucinations (seeing or hearing things that are not real);
• seizures;
• unusual drowsiness;
• loss of balance while walking and lack of motor coordination;
• difficulty speaking;
• inability to think logically or assess situations;
• loss of consciousness (coma);
• paralysis of part or all of the body;
• disturbances in behaviour, speech or eye movement;
• neck stiffness and photophobia (sensitivity to light);
• hepatitis (liver inflammation);
• yellowing of the skin and whites of the eyes (jaundice);
• kidney problems associated with passing small amounts of urine or complete inability to pass urine;
• pain in the lower back, in the kidney area or over the hip (kidney pain).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Aciclovir Hikma

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Prepare the medicine immediately before use. Any unused medicine should be discarded.
Do not use this medicine after the expiry date stated on the label and carton after:
Expiry date (EXP). The expiry date refers to the last day of the stated month.

6. Contents of the pack and other information

What Aciclovir Hikma contains

• The active substance is aciclovir. Each vial contains 250 mg of aciclovir in the form of sodium salt. Each vial contains 500 mg of aciclovir in the form of sodium salt.
• The other ingredient is sodium hydroxide.

What Aciclovir Hikma looks like and contents of the pack
Aciclovir Hikma is available as a white powder in type I glass vials, closed with a bromobutyl rubber stopper and an aluminium cap.
The 250 mg strength is supplied in 10 ml vials, in cartons containing 5 or 10 vials.
The 500 mg strength is supplied in 20 ml vials, in cartons containing 5 or 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, 8, 8A e 8B – Fervença
2705-906 Terrugem SNT
Portugal
[email protected]

Manufacturer
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, 8, 8A e 8B – Fervença
2705-906 Terrugem SNT
Portugal

Hikma Italia S.p.A.
Viale Certosa, 10
27100 Pavia
Italy

This medicinal product is authorised in the European Economic Area under the following names:
France: Aciclovir Hikma 250mg et 500 mg Poudre pour solution pour perfusion
Germany: Aciclovir Hikma 250 mg und 500 mg, Pulver zur Herstellung einer Infusionslösung
Italy: Aciclovir Hikma 250 mg e 500 mg Polvere per soluzione per infusione
Portugal: Aciclovir Hikma, 250 mg e 500 mg, Pó para solução para perfusão
Poland: Aciclovir Hikma 250 mg i 500 mg proszek do sporządzania roztworu do infuzji
Spain: Aciclovir Hikma 250 mg Polvo para solución para perfusión
United Kingdom: Aciclovir 250mg and 500 mg Powder for solution for infusion
Belgium: Aciclovir Hikma 250 et 500 mg poudre pour solution pour perfusion
Austria: Aciclovir Hikma 250 mg und 500 mg Pulver zur Herstellung einer Infusionslösung
Netherlands: Aciclovir Hikma 250 mg en 500 mg poeder voor oplossing voor infusie

Information intended exclusively for medical professionals:

Stability of the solution after reconstitution and dilution
From a chemical and physical standpoint, the solution remains stable for 12 hours at a temperature of 15°C to 25°C.
From a microbiological point of view, the medicinal product should be used immediately. If it is not used immediately, the responsibility for the storage conditions and duration prior to use lies with the user.

Special precautions for disposal and preparation of the medicinal product for use
Reconstitution:
Aciclovir Hikma solution containing 25 mg acyclovir per ml should be prepared by adding the volumes of water for injection or 0.9% sodium chloride solution for infusion (0.9%) indicated below:

| Medicinal product form | Reconstitution volume | |------------------------|------------------------| | Vial containing 250 mg | 10 ml | | Vial containing 500 mg | 20 ml |

Based on the calculated dose, the appropriate number and size of vials required for use should be determined. To reconstitute the contents of each vial, add the recommended volume of infusion solution to each vial and gently shake the vial until the contents are completely dissolved.

Administration method:
The required dose of Aciclovir Hikma should be administered as a slow intravenous infusion lasting at least one hour.
After reconstitution, Aciclovir Hikma can be administered using an infusion pump with controlled infusion rate.

Additionally, the reconstituted solution may be further diluted for intravenous infusion of acyclovir at a concentration not exceeding 5 mg/ml (0.5% w/v).
The required volume of reconstituted solution should be added to the selected infusion solution according to the recommendations below, and the mixture should be shaken vigorously to ensure complete mixing.

In children and neonates, when the smallest possible volume of infusion solution is indicated, dilution is recommended such that 4 ml of reconstituted solution (100 mg acyclovir) is added to 20 ml of infusion solution.

For adults, infusion bags containing 100 ml of infusion solution are recommended, even if this results in an acyclovir concentration significantly below 5 mg/ml (0.5% w/v). Thus, one 100 ml infusion bag may be used for any dose between 250 mg and 500 mg acyclovir (10 ml to 20 ml of reconstituted solution), whereas for doses from 500 mg to 1000 mg, a second bag must be used.

When diluted according to the recommended scheme, Aciclovir Hikma is pharmaceutically compatible with the following infusion solutions and remains stable for up to 12 hours at room temperature (15°C–25°C):

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

When diluted according to the above scheme, Aciclovir Hikma provides an acyclovir concentration not exceeding 5 mg/ml (0.5% w/v).

Due to the absence of antimicrobial preservatives, reconstitution and dilution must be performed under aseptic conditions immediately before use, and any unused solution must be discarded. Reconstituted and diluted solutions must not be stored in a refrigerator.

If any cloudiness or crystallization is observed in the solution before or during infusion, the solution must not be used.