Patient Information Leaflet

Aciclovir Sala 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 doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist or nurse even if they are not listed in this leaflet. See section 4.

In this leaflet:

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

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

3.How to use Aciclovir Sala

4.Possible side effects

5.Storage of Aciclovir Sala

6.Contents of the pack and additional information.

Aciclovir Sandoz is a medicine that contains the active ingredient called aciclovir. Aciclovir belongs to a group of medicines called antivirals, active against herpesviruses. It works by eliminating or preventing the growth of viruses.

This medicine is indicated for:

• Treatment of infections caused by herpes simplex virus.

• Prevention of infections caused by herpes simplex virus in patients whose immune system is not functioning properly, meaning their bodies are less able to fight off infections.
• Treatment of initial and recurrent infections caused by varicella zoster virus in patients whose immune system is not functioning properly.

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

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

No 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 must drink enough liquid during treatment to maintain proper hydration.

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

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

Other Medicines and Aciclovir Sala

Inform your doctor, pharmacist, or nurse if you are taking, or have recently taken, any other medicine, including those purchased without a prescription.

It is especially important to 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, ciclosporin, or mycophenolate mofetil, used to prevent the body from rejecting transplanted organs;
• lithium, used to treat manic-depressive disorders;
• theophylline, used to treat certain respiratory disorders.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medicine.

This medicine has not been proven safe for pregnant women, and it will only be used in cases where your doctor advises its use based on the benefit/risk assessment.

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

Driving and Operating Machines

No data are available to limit this activity.

Important Information about some of the Components of Aciclovir:

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

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

Aciclovir is usually administered every 8 hours.

You may receive liquids to ensure that 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 essential that you receive plenty of liquids while you are being treated with aciclovir.
• you are overweight.
• you are over 65 years old.

Speak with your doctor before undergoing aciclovir treatment 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 medication dose may be reduced.

Use inseniors

The dose should be reduced in patients with renal insufficiency.

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

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

If you have received too much aciclovir, you may experience: feeling confused or agitated, having hallucinations (seeing or hearing things that do not exist), having seizures, losing 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 medication and the amount ingested.

If you forgot to use Aciclovir

Do not administer a double dose to compensate for missed doses.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

This medicine 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 on the skin;

• 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;

• 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

Infrequent(affect fewer than 1 in 100 people)

• Reduction in the number of red blood cells (anemia)
• Reduction in the number of white blood cells (leucopenia)
• Reduction in the number of platelets (thrombocytopenia that may lead to nasal bleeding and appearance of bruises more frequently than usual.)

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;

• Alucinations (seeing or hearing things that do not exist);

• Seizures;

• Unusual feeling of sleep or somnolence;

• Difficulty 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;

• 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);

• Renal problems (urine is produced little or not at all);

• Lower back pain, the area of the kidneys in your back or just above your hips (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 for 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 medicine.

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

This medication does not require special storage conditions.

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

Solutions obtained after reconstituting the vial with 10 ml of injection water, 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 must be used immediately after its preparation.If it is not used immediately, the time and storage conditions before its use are the responsibility of the user.

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

Medications should not be thrown into the drains or trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of Aciclovir Solution

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

Appearance of the product and contents of the package

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

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing:

Laboratorio Reig Jofré, S.A

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

Last review date of this leaflet: February 2023

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

This information is intended solely for healthcare professionals

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

It is recommended to reconstitute and/or dilute immediately before use. The vial does not contain any type of preservative, so the unused solution should be discarded. In case of visible turbidity or crystallization before or during infusion, the solution should be rejected. The diluted solution should not be stored in the refrigerator.

Reconstitution of the lyophilisate:

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

Administration form

Intravenous direct:

The reconstituted solution is administered through a controlled infusion pump, over a period of not less than one hour.

Intravenous perfusion:

The reconstituted solution can be diluted for administration through infusion. The dilution is made totally or partially, according to 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 in the case of a required dose greater 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's solution)

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

After accidental intravenous infusion of aciclovir, a severe inflammation in the extravascular tissue may appear, sometimes followed by ulcerations. Infusion through mechanical pumps poses greater risks than gravity infusion. It may cause phlebitis and inflammation at the infusion site.

Expiration date

Do not use Aciclovir Solution 250 mg powder for perfusion after the expiration date indicated on the packaging

Last review date of this leaflet: February 2023

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