ACICLOVIR SALA 250 mg POWDER FOR SOLUTION FOR INFUSION

Introduction

Patient Information Leaflet

Aciclovir Sala 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 doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

In this leaflet:

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

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

Aciclovir Sala is a medicine that contains the active substance called aciclovir. Aciclovir belongs to a group of medicines called antivirals, which are active against herpes viruses. It works by eliminating or stopping the growth of viruses.

This medicine is indicated for:

• Treatment of herpes simplex virus infections.

• Prevention of herpes simplex virus infections in patients whose immune system is not working well, which means their bodies are less able to fight off infections.
• Initial and recurrent treatment of varicella-zoster virus infections in patients whose immune system is not working well.

• Treatment of immunocompetent patients with zoster, especially in progressive or disseminated cutaneous infections.
• Treatment of herpetic encephalitis (inflammation of the brain, which can rarely be caused by the virus responsible for labial and genital herpes).

• Treatment of herpes simplex virus infections in newborns and children up to 3 months.

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

Do not use Aciclovir Sala:

• If you are allergic to aciclovir, valaciclovir, ganciclovir, or any of the excipients (listed in section 6).

Warnings and precautions

Be especially careful with Aciclovir Sala:

Consult your doctor or nurse before starting to use aciclovir:

• If you have any kidney disease or are over 65 years old, your doctor may use a lower dose. Also, you should drink enough liquid during treatment to maintain adequate hydration.

• If you have had a kidney transplant, your doctor should monitor your kidney function, as a slight increase in creatinine or serum urea may occur, which could be confused with a rejection reaction.
• If you have a weakened immune system.

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

Other medicines and Aciclovir Sala

Tell your doctor, pharmacist, or nurse if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.

It is especially important that you talk to 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 plan to become pregnant, consult your doctor before using this medicine.

The safety of this medicine in pregnant women has not been established, and it will only be used in cases where the benefit-risk assessment by your doctor advises its use.

Aciclovir is excreted in breast milk, and breastfeeding is not recommended during treatment.

Driving and using machines

No data are available to limit this activity.

Important information about some of the ingredients of Aciclovir:

This medicine contains 26 mg of sodium per vial (main component of table/cooking salt). This is equivalent to 1.3% of the maximum recommended daily intake of sodium for an adult.

3. How to use Aciclovir Sala

You should never administer the medicine yourself. The medicine will always be administered by a trained person. Aciclovir will be given to you as a continuous infusion into a vein. This is where the medicine is administered slowly over 1 hour.

Aciclovir is usually administered every 8 hours.

You may receive fluids 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 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 over 65 years old.

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:

• children between 3 months and 12 years of age is calculated based on body surface area.
• newborns and children up to 3 months of age is calculated based on body weight.

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

Use in elderly

The dose should be reduced in patients with renal impairment.

Your doctor will indicate the dose and duration of your treatment with intravenous aciclovir. In acute herpes simplex virus infections, 5 days of treatment is usually sufficient, but the duration of treatment will depend on the severity of the infection, the patient's condition, and response to treatment. The treatment of herpetic encephalitis and neonatal herpes simplex usually lasts 10 days. The duration of prophylactic administration of intravenous aciclovir will be determined by the duration of the risk period.

If you use more Aciclovir Sala than you should:If you think you have received too much aciclovir, talk to your doctor or nurse immediately.

If you have received too much aciclovir, you may: feel confused or agitated, have hallucinations (see or hear things that do not exist), have convulsions, 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.

If you forget to use Aciclovir Sala

Do not administer a double dose to make up for forgotten doses.

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;

• skin rash with itching and appearance of hives;

• skin reaction after exposure to light (photosensitivity);

• itching;

• swelling, redness, and sensitivity at the injection site.
• Increased liver enzymes

Uncommon(affect less than 1 in 100 people)

• Decrease in red blood cell count (anemia)
• Decrease in white blood cell count (leukopenia)
• Decrease in platelet count (thrombocytopenia, which can lead to more frequent nosebleeds and bruising)

Rare(affect less than 1 in 1,000 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 sleepiness or drowsiness;

• difficulty 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;

• behavioral, speech, and eye movement changes;

• 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 (little or no urine output);

• lower back pain, the area of the kidneys in your back, or just above the hips (kidney pain).

Reporting of side effects

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

5. Storage of Aciclovir Sala

Keep Aciclovir Sala out of the sight and reach of children.

This medicine does not require special storage conditions.

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

The solutions obtained after reconstituting the vial with 10 ml of water for injection maintain their stability for 12 hours at 25°C or for 24 hours at 2°C-8°C.

From a microbiological point of view, the solution should be used immediately after preparation. If not used immediately, the time and conditions of storage before use are the responsibility of the user.

Do not use this medicine if you observe any visible turbidity or crystallization in the solution.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aciclovir Sala

• The active substance is aciclovir
• Each vial contains 250 mg of aciclovir as sodium salt.
• The other excipients are: sodium hydroxide.

Appearance of the product and pack contents

Aciclovir Sala is presented in glass vials containing a white or almost white sponge-like tablet, closed with a rubber stopper and sealed with a closure cap.

The 250 mg dose is available in 10 ml vials, in packs of 5 and 50 vials.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Laboratorio Reig Jofré, S.A.

Gran Capitán, 10 - 08970 Sant Joan Despí - Barcelona - Spain

Date of last revision of this leaflet: February 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals

The solution should be administered only by intravenous route and in a continuous but very slow manner, so that it is administered over a period of not less than one hour.

Reconstitution and/or dilution is recommended immediately before use. The vial does not contain any preservative, so the unused solution should be discarded. If visible turbidity or crystallization appears before or during infusion, the solution should be rejected. The diluted solution should not be stored in the refrigerator.

Reconstitution of the lyophilized product:

The vial of intravenous aciclovir, which contains 250 mg of lyophilized aciclovir, should be reconstituted by adding 10 ml of water for injection or sodium chloride (0.9%) solution for intravenous infusion. The concentration of the reconstituted solution is 25 mg/ml.

Method of administration

Intravenous direct:

The reconstituted solution is administered using a controlled-rate infusion pump over a period of not less than one hour.

Intravenous infusion:

The reconstituted solution can be diluted for administration by infusion. The dilution is made totally or partially, depending on the required dose, by adding and mixing it with at least 100 ml of infusion solution, to obtain a solution with a maximum concentration of 0.5% (250 mg/50 ml). The contents of 2 vials (500 mg of aciclovir) can be added to 100 ml of infusion solution, and if the required dose is higher than 500 mg, a second volume of infusion solution can be used.

Aciclovir intravenous is compatible with the following infusion solutions:

• Sodium chloride (0.45%, 0.9% p/v).
• Sodium chloride (0.18% p/v) and glucose (4% p/v).
• Sodium chloride (0.45% p/v) and glucose (2.5% p/v)
• Sodium lactate (Hartmann solution)

Aciclovir intravenous, once added to the infusion solution, should be shaken vigorously to ensure perfect mixing.

After accidental infusion of intravenous aciclovir, severe inflammation of the extravascular tissue may occur, sometimes followed by ulcers. Infusion using mechanical pumps poses greater risks than gravity infusion. Phlebitis and inflammation at the infusion site may occur.

Expiry date

Do not use Aciclovir Sala 250 mg powder for solution for infusion after the expiry date stated on the packaging.

Date of last revision of this leaflet: February 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/