ACICLOVIR HIKMA 250 mg POWDER FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Aciclovir Hikma 250 mg Powder for Solution for Infusion EFG

Read all of this leaflet carefully before you start using 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 nurse.
• If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Aciclovir Hikma and what is it used for
2. What you need to know before you use Aciclovir Hikma
3. How to use Aciclovir Hikma
4. Possible side effects
5. Storage of Aciclovir Hikma
6. Contents of the pack and further information

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

Aciclovir Hikma contains a medicine called aciclovir. Aciclovir belongs to a group of medicines called antivirals. It works by killing or stopping the growth of viruses.

Aciclovir can be used to:

• treat chickenpox (varicella) virus infections.
• treat severe genital herpes.
• prevent and treat herpes simplex virus infections (cold sores and genital herpes) in people whose immune system is not working properly, which means their bodies are less able to fight off infections.
• treat herpes simplex virus infections in children up to 3 months of age. This is rarely caused by the virus responsible for cold sores and genital herpes.
• treat herpes simplex encephalitis (inflammation of the brain). This is rarely caused by the virus responsible for cold sores and genital herpes.

2. What you need to know before you use Aciclovir Hikma

Do not use Aciclovir Hikma:

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

Warnings and precautions

Talk to your doctor or nurse before you start using aciclovir.

Talk to your doctor or nurse before using aciclovir if:

• you have kidney problems.

• you are over 65 years of age.

If you are not sure about the above circumstances, talk to your doctor or nurse before using aciclovir.

Using Aciclovir Hikma with other medicines

Tell your doctor if you are taking, have recently taken or might take any other medicines.

It is especially important that you tell your doctor or pharmacist if you are taking any of the following medicines:

• probenecid, used to treat gout;
• cimetidine, used to treat stomach ulcers;
• tacrolimus, cyclosporin or mycophenolate mofetil, used to prevent the body from rejecting transplanted organs;
• lithium, used to treat manic-depressive disorders;
• theophylline, used to treat some respiratory disorders.

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 using this medicine.

Driving and using machines

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

Aciclovir Hikma contains sodium

This medicine contains 26.2 mg of sodium per dose (main component of cooking/table salt) in each vial. This is equivalent to 1.31% of the maximum recommended daily intake of sodium for an adult.

3. How to use Aciclovir Hikma

You should never give yourself the medicine. The medicine will always be given by a person trained to do so.

Before administration, the medicine will be diluted.

Aciclovir will be given to you as a continuous infusion into a vein. This is where the medicine is given slowly over 1 hour.

Aciclovir is usually given every 8 hours.

You may be given fluids to make sure you do not become dehydrated.

The dose, frequency and duration of the dose will depend on:

• the type of infection you have,
• your weight,
• your age.

Your doctor may adjust the dose of aciclovir if:

• you have kidney problems. If you have kidney problems, it is important that you receive plenty of fluids while being treated with aciclovir.
• you are overweight.
• you are an elderly person.

Talk to your doctor before undergoing aciclovir if any of the above conditions apply to you.

Use in children

The dose of aciclovir given to newborns and children up to 12 years of age is calculated based on body weight.

If a child has kidney problems, the dose of the medicine may be reduced.

If you use more Aciclovir Hikma than you should

If you think you have received too much aciclovir, talk to your doctor or nurse immediately.

If you have been given too much aciclovir, it is possible:

• to feel confused or agitated,
• to have hallucinations (see or hear things that do not exist),
• to have seizures,

to lose consciousness (coma).

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

This medicine can cause the following side effects:

Allergic reactions(affect less than 1 in 10,000 people)

If you have an allergic reaction, stop taking aciclovir and talk to your doctor immediately. The signs may include:

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

Other side effects include:

Common(affect less than 1 in 10 people)

• nausea and vomiting;
• itching, skin rash in the form of a hive;
• skin reaction after exposure to light (photosensitivity);
• itching;
• swelling, redness and sensitivity at the injection site.

Uncommon(affect less than 1 in 100 people)

• nosebleeds and bruising more often than usual.

Rare(affect up to 1 in 10,000 people)

• headache or feeling dizzy;
• diarrhea or stomach pain;
• fatigue;
• fever;
• effects on some blood and urine tests;
• feeling weak;
• feeling agitated or confused;
• spasms or tremors;
• hallucinations (seeing or hearing things that do not exist);
• seizures;
• feeling unusually sleepy or drowsy;
• unsteadiness when walking and lack of coordination;
• difficulty speaking;
• inability to think or judge clearly;
• loss of consciousness (coma);
• paralysis of part or all of your body;
• changes in behavior, speech and eye movements;
• stiffness of the neck and sensitivity to light;
• inflammation of the liver (hepatitis);
• yellowing of the skin and the white part of the eyes (jaundice);
• kidney problems (urine comes out very little or not at all);
• back pain, in the area of the kidneys in your back or just above the hip (kidney pain).

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aciclovir Hikma

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

Do not store above 25°C.

Preparation is made at the time. The unused solution must be discarded.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date is the last day of the month shown.

6. Contents of the pack and further information

Composition of Aciclovir Hikma

• The active substance is aciclovir.

Each vial contains 250 mg of aciclovir as sodium salt.

.

• The other ingredient is sodium hydroxide.

Appearance of the product and pack contents

Aciclovir Hikma is presented in glass vials containing a white powder, closed with a rubber stopper and sealed with a closing cap.

The 250 mg dose is available in 10 ml vials, in packs containing 5 or 10 vials.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Hikma Farmacêutica (Portugal), SA

Estrada do Rio da Mó, 8, 8A e 8B - Fervença

2705-906 Terrugem SNT

Portugal

Manufacturer

Hikma Farmacêutica (Portugal), S.A.

Estrada do Rio da Mó, 8, 8A e 8B – Fervença

2705-906 Terrugem SNT

Portugal

or

Hikma Italia S.p.A.

Viale Certosa, 10

27100 Pavia

Italy

You can ask for more information about this medicine to the local representative of the marketing authorisation holder:

Hikma España, S.L.U.

Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2

28108 - Alcobendas, Madrid

Spain

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

Germany: Aciclovir Hikma 250 mg and 500 mg, Powder for Solution for Infusion

Austria: Aciclovir Hikma 250 mg and 500 mg Powder for Solution for Infusion

Belgium: Aciclovir Hikma 250 and 500 mg powder for solution for infusion

Spain: Aciclovir Hikma 250 mg powder for solution for infusion EFG

France: Aciclovir Hikma 250mg and 500 mg Powder for Solution for Infusion

Italy: Aciclovir Hikma 250 mg and 500 mg Powder for Solution for Infusion

Netherlands: Aciclovir Hikma 250 mg and 500 mg powder for solution for infusion

Poland: Aciclovir Hikma 250 mg and 500 mg powder for solution for infusion

Portugal: Aciclovir Hikma, 250 mg and 500 mg, Powder for Solution for Infusion

United Kingdom: Aciclovir 250mg and 500 mg Powder for Solution for Infusion

Date of last revision of this leaflet:December 2024

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The following information is intended for healthcare professionals only:

Shelf life after reconstitution and dilution

After reconstitution, the chemical and physical stability of the preparation has been demonstrated for 12 hours at 15°C to 25°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage time and conditions are the responsibility of the user.

Special precautions for disposal and other handling

Reconstitution:

Aciclovir should be reconstituted using the following volumes of water for injection or sodium chloride injection, intravenous (0.9% p/v) to provide a solution containing 25 mg of aciclovir per ml:

Formulation Volume of liquid for reconstitution

250 mg vial 10 ml

500 mg vial 20 ml

Based on the calculated dose, the number and dose of vials to be used are determined. To reconstitute each vial, add the recommended volume of infusion fluid and gently shake until the contents of the vial have dissolved completely.

Administration

The required dose of aciclovir should be administered by slow intravenous infusion over a period of one hour.

After reconstitution, aciclovir can be administered using a controlled-rate infusion pump.

Alternatively, the reconstituted solution can be further diluted to give an aciclovir concentration not greater than 5 mg/ml (0.5% p/v) for infusion.

Add the required volume of reconstituted solution to the chosen infusion solution, as recommended below, and shake well to ensure adequate mixing.

For children and neonates, in whom it is recommended to keep the infusion fluid volume to a minimum, it is recommended that the dilution be based on 4 ml of reconstituted solution (100 mg of aciclovir) added to 20 ml of infusion fluid.

For adults, it is recommended that infusion bags containing 100 ml of infusion fluid be used, even if this results in an aciclovir concentration substantially below 0.5% p/v. Thus, a 100 ml infusion bag can be used for any dose between 250 mg and 500 mg of aciclovir (10 and 20 ml of reconstituted solution), but a second bag must be used for doses between 500 mg and 1000 mg.

When diluted as recommended, aciclovir is known to be compatible with the following infusion fluids and stable for up to 12 hours at room temperature (15°C to 25°C):

• Sodium chloride infusion, intravenous (0.45% and 0.9% p/v);
• Sodium chloride (0.18% p/v) and glucose (4% p/v) infusion, intravenous;
• Sodium chloride (0.45% p/v) and glucose (2.5% p/v) infusion, intravenous;
• Compound sodium lactate infusion, intravenous (Hartmann's solution).

Aciclovir, when diluted as described above, will give an aciclovir concentration not greater than 0.5% p/v.

Since no antimicrobial preservative is included, reconstitution and dilution must be carried out under complete aseptic conditions, immediately before use, and any unused solution must be discarded.

Reconstituted or diluted solutions should not be refrigerated.

If any turbidity or visible crystallization appears in the solution before or during infusion, the preparation must be discarded.