Patient Information Leaflet

Aciclovir Hikma 250 mg Powder for Solution for Infusion EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your nurse.
• If you experience any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you start taking Aciclovir Hikma

3. How to use Aciclovir Hikma

4. Possible side effects

5. Storage of Aciclovir Hikma

6. Contents of the pack and additional information

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 may be used for:

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

Do not use Aciclovir Hikma:

- If you are allergic (hypersensitive) to aciclovir or valaciclovir or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or nurse before starting to use aciclovir.

Consult your doctor or nurse before using aciclovir if:

• You have kidney problems.

• You are over 65 years old.

If you are unsure about the above circumstances, consult your doctor or nurse before using aciclovir.

Using Aciclovir Hikma with other medications

Inform your doctor if you are taking, have taken recently, or may need to use any other medication.

It is especially important to talk to your doctor or pharmacist if you are taking any of the medications listed below:

• Probenecid, used for the treatment of gout;
• Cimetidine, used for the treatment of 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 intend to become pregnant, consult your doctor before using this medication.

Driving and operating machinery

No studies have been conducted to investigate the effect of aciclovir on the ability to drive and operate machinery.

Aciclovir Hikma contains sodium

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

You should never administer the medication yourself. The medication will always be administered by a trained person.

Before administration, the medication will be diluted.

Aciclovir will be administered to you as a continuous infusion in a vein. This is where the medication is administered slowly over 1 hour.

Aciclovir is generally administered every 8 hours.

You may receive liquids to ensure 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 aciclovir dose if:

• you have kidney problems. If you have kidney problems, it is essential that you receive plenty of liquids while undergoing treatment with aciclovir.
• you are overweight.
• you are an elderly person.

Speak with your doctor before undergoing aciclovir treatment if you can apply any of the above conditions.

Use in Children

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

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

If You Use More Aciclovir Hikma Than You Should

If you think you have received too much aciclovir, speak with your doctor or nurse immediately.

If you have been given too much aciclovir, you may experience:

• feeling confused or agitated,
• hallucinations (seeing or hearing things that do not exist),
• seizures,

loss of consciousness (coma).

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

This medication may cause the following side effects:

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

If you have an allergic reaction, stop taking aciclovir and talk to your doctor immediately. Symptoms 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;
• unknown fever (high temperature) and feeling of dizziness, especially when standing up.

Other side effects include:

Frequent(affect fewer than 1 in 10 people)

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

Rare(affect fewer than 1 in 100 people)

• nasal bleeding and frequent appearance of bruises.

Very rare(affect up to 1 in 10,000 people)

• headache or feeling of dizziness;
• diarrhea or stomach pain;
• fatigue;
• fever;
• effects on some blood and urine tests;
• feeling of weakness;
• feeling of agitation or confusion;
• spasms or tremors;
• hallucinations (seeing or hearing things that do not exist);
• convulsions;
• unusual feeling of sleep or drowsiness;
• instability while walking and lack of coordination;
• difficulty speaking;
• inability to think or judge clearly;
• unconsciousness (coma);
• paralysis of part or all of your body;
• alterations in behavior, speech, and eye movements;
• rigidity of the neck and sensitivity to light;
• inflammation of the liver (hepatitis);
• yellowing of the skin and white part of the eyes (jaundice);
• kidney problems (urine is passed little or not at all);
• lower back pain, in the area of the kidneys of your back or just above the hip (renal pain).

Reporting side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Store below 25°C.

The preparation is made at the time of use. Unused solution must be discarded.

Do not use this medication after the expiration date appearing on the label and the box after CAD. The expiration date is the last day of the month indicated.

Composition of Aciclovir Hikma

• The active ingredient is aciclovir.

Each vial contains 250 mg of aciclovir as sodium salt.

.

• The other component is sodium hydroxide.

Appearance of the product and contents of the package

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

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Hikma Farmacêutica (Portugal), SA

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

2705-906 Terrugem SNT

Portugal

Responsible 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

Further information on this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Hikma España, S.L.U.

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

28108 - Alcobendas, Madrid

Spain

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Germany:Aciclovir Hikma 250 mg und 500 mg, Powder for the preparation of an infusion solution

Austria:Aciclovir Hikma 250 mg und 500 mg Powder for the preparation of an infusion solution

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

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

France:Aciclovir Hikma 250mg et 500 mg Powder for solution for infusion

Italy:Aciclovir Hikma 250 mg e 500 mg Powder for solution for infusion

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

Poland:Aciclovir Hikma 250 mg i 500 mg powder for the preparation of a solution for infusion

Portugal:Aciclovir Hikma, 250 mg e 500 mg, Powder for solution for infusion

United Kingdom:Aciclovir 250mg and 500 mg Powder for solution for infusion

Last review date of this leaflet:December 2024

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The following information is intended only for healthcare professionals:

Stability period 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 storage period in use and the conditions before use will be the responsibility of the user.

Special precautions for disposal and other manipulations

Reconstitution:

Aciclovir must be reconstituted using the following volumes of water for injectable preparations or sodium chloride injection (0.9% w/v) to provide a solution containing 25 mg of aciclovir per ml:

FormulationVolume of liquid for reconstitution

250 mg vial10 ml

500 mg vial20 ml

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

Administration

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

After reconstitution, aciclovir may be administered by a controlled infusion pump.

Alternatively, the reconstituted solution may be further diluted to give a concentration of aciclovir not exceeding 5 mg/ml (0.5% w/v) for infusion.

Add the required volume of reconstituted solution to the chosen infusion solution, as recommended below, and agitate well to ensure a suitable mixture is produced.

For children and neonates, where it is recommended to maintain the volume of infusion fluid 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 when this results in a concentration of aciclovir substantially below 0.5% w/v. Thus, a 100 ml infusion bag may be used for any dose between 250 mg and 500 mg of aciclovir (10 and 20 ml of reconstituted solution), but a second bag should be used for doses between 500 mg and 1000 mg.

When diluted in accordance with the recommended schedules, aciclovir is known to be compatible with the following infusion fluids and stable for a maximum of 12 hours at room temperature (15°C to 25°C):

• Sodium chloride infusion solution (0.45% and 0.9% w/v);
• Sodium chloride (0.18% w/v) and glucose (4% w/v) infusion solution;
• Sodium chloride (0.45% w/v) and glucose (2.5% w/v) infusion solution;
• Sodium lactate compound for infusion solution (Hartmann's solution).

Aciclovir, when diluted in accordance with the above scheme, will give a concentration of aciclovir not exceeding 0.5% w/v.

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

The reconstituted or diluted solutions should not be refrigerated.

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