ACICLOVIR ALTAN 250 mg POWDER FOR SOLUTION FOR INFUSION

2. What you need to know before you use Aciclovir Altan 250 mg Powder for Solution for Infusion

Do not use Aciclovir

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Aciclovir Altan if:

• you have kidney problems
• you are over 65 years old.

If you are unsure whether any of the above applies to you, talk to your doctor or pharmacist before using Aciclovir Altan.

It is important to drink plenty of water while using Aciclovir Altan.

Other medicines and Aciclovir Altan

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

This includes medicines obtained without a prescription, including herbal medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• probenecid, used to treat gout
• cimetidine, used to treat ulcers
• tacrolimus, cyclosporin, or mycophenolate mofetil, used to prevent your body from rejecting transplanted organs

• theophylline, used for respiratory problems
• lithium, used to treat mental health problems.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Aciclovir Altan should not be prescribed without prior consultation with your doctor, who will assess the benefit versus the risk to the baby of taking Aciclovir Altan powder for solution for infusion during pregnancy.

Aciclovir may pass into breast milk. If you are breastfeeding, check with your doctor before using Aciclovir Altan

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed.

Aciclovir Altan 250 mg Powder for Solution for Infusion EFGcontains:

This medicine contains 23.55 mg of sodium (a major component of cooking/table salt) in each vial. This is equivalent to 1.17% of the maximum recommended daily intake of sodium for an adult.

3. How to use Aciclovir Altan 250 mg Powder for Solution for Infusion

Aciclovir Altan will be administered to you by a doctor or nurse via intravenous injection.

Before administration, the medicine must be diluted.

Aciclovir Altan will be administered via continuous intravenous infusion over a period of at least 1 hour.

Your doctor will decide the correct dose to be administered to you; the 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 Altan if:

• you have kidney problems. If you have kidney problems, it is essential that you receive plenty of fluids while being treated with Aciclovir Altan.

Talk to your doctor before using Aciclovir Altan if you notice any of the above circumstances.

If you use more Aciclovir Altan than you should

If you think you have been given too much Aciclovir Altan, contact your doctor or nurse immediately.

If you are given too much Aciclovir Altan, you may experience changes in your laboratory tests (increased urea and creatinine in the blood) with corresponding changes in kidney function (renal insufficiency).

Additionally, you may:

• feel confused or agitated
• have hallucinations (see or hear things that are not there)
• have seizures
• 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.

If you experience any allergic reaction, stop taking Aciclovir Altan and contact your doctor immediately.

You may experience the following side effects with this medicine:

Common (may affect up to 1 in 10 people)

• inflammation and redness at the infusion site (phlebitis)
• nausea, vomiting
• itching, hives
• rash, including skin reaction after exposure to sunlight (photosensitivity)
• changes in some laboratory tests (increased urea in the blood, creatinine, and some liver enzymes)

Uncommon (may affect up to 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 in the blood (thrombocytopenia).

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

• severe allergic reaction (anaphylaxis)
• inflammation of the lips, face, neck, and throat that causes difficulty breathing (angioedema)
• breathing difficulties (dyspnea)
• headache (cephalalgia)
• dizziness
• feeling confused or agitated
• tremors
• unsteadiness when walking and lack of coordination (ataxia)
• slow and difficult speech (dysarthria)
• seeing or hearing things that are not there (hallucinations)
• thought and perception disorders related to a psychiatric disorder (psychotic symptoms)
• seizures
• sleepiness
• brain damage (encephalopathy)
• loss of consciousness (coma)
• diarrhea
• abdominal pain
• yellowing of the whites of the eyes or skin (jaundice)
• inflammation of the liver (hepatitis)
• reduced kidney function (renal insufficiency, acute kidney failure)
• back pain, in the area corresponding to the kidneys (kidney pain)
• fatigue
• fever
• local inflammatory reactions
• abnormal laboratory tests (increased bilirubin)

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national pharmacovigilance system for human medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Aciclovir Altan 250 mg Powder for Solution for Infusion

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

This medicine does not require any special storage conditions.

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

Expiry date of the reconstituted product

Once the vial is reconstituted with 10 ml of water for injections, the stability of the solutions is maintained for 12 hours at 25°C.

6. Container Content and Additional Information

Composition of Aciclovir Altan

• The active ingredient is aciclovir. Each vial contains 250 mg of aciclovir (sodium).
• The other components (excipients) are: sodium hydroxide.

Appearance of Aciclovir and Container Content

Aciclovir Altan 250 mg powder for solution for infusion is supplied in packs of 5 and 50 vials.

Marketing Authorization Holder:

Altan Pharmaceuticals, S.A.

C/ Cólquide, 6. Portal 2. 1ª planta. Oficina F.

Edificio Prisma

28230 Las Rozas. Madrid

Spain

Manufacturer:

Altan Pharmaceuticals, S.A.

Avda. Constitución 198-199

Polígono Industrial Monte Boyal

45950 Casarrubios del Monte (Toledo)

Spain

Date of Last Revision of this Prospectus:September 2022

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The following information is intended only for doctors or healthcare professionals:

DOSAGE AND ADMINISTRATION. FOR INFORMATION PURPOSES ONLY

Refer to the product's technical data sheet (TDS) for complete prescription information.

Pharmaceutical Form

Powder for solution for infusion.

Dosage and Administration

Adults

In patients with Simple Herpes(except for herpetic encephalitis) or recurrent Varicella Zosterinfections, the dose of Aciclovir Altan is 5 mg/kg of body weight every 8 hours, provided that renal function is not impaired (see Dosage in Renal Insufficiency).

In immunocompromised patients with Varicella Zosterinfections or patients with herpetic encephalitis, the dose of Aciclovir Altan to be administered is 10 mg/kg of body weight, every 8 hours, provided that renal function is not impaired (see Dosage in Renal Insufficiency).

In patients with obesity, the recommended dose for adults should be administered based on the ideal body weight and not the actual body weight.

Pediatric Population

The dose of Aciclovir Altan in infants and children between 3 months and 12 years of age is calculated based on body surface area.

In infants and children 3 months of age or older with Simple Herpes(except for herpetic encephalitis) or with recurrent Varicella Zosterinfections, the dose of Aciclovir Altan should be 250 mg/m2 of body surface area every 8 hours if renal function is not impaired.

In immunodepressed children with Varicella Zosterinfections or children with herpetic encephalitis, the dose of Aciclovir Altan should be 500 mg/m2 of body surface area every 8 hours, if renal function is not impaired.

Neonates and Infants up to 3 Months of Age

The dosage of Aciclovir Altan in neonates and infants up to 3 months of age is calculated based on body weight.

The recommended regimen for infants treated for known or suspected neonatal herpes is aciclovir 20 mg/kg of body weight intravenously, every 8 hours, for 21 days for disseminated disease and CNS disease, or for 14 days for disease limited to the skin and mucous membranes.

Neonates and children with impaired renal function require a modified dose, according to the degree of impairment (see Dosage in Renal Insufficiency).

Elderly

The possibility of renal insufficiency in the elderly should be taken into account, so the dose should be adjusted accordingly (see Dosage in Renal Insufficiency).

Adequate hydration should be maintained.

Renal Insufficiency

Caution should be exercised when administering Aciclovir Altan to patients with renal insufficiency.

Adequate hydration should be maintained.

The adjustment of the dosage in patients with renal insufficiency is based on creatinine clearance, determined in units of ml/min for adults and adolescents and in units of ml/min/1.73 m2 for children under 13 years of age. The following dosage adjustments are suggested:

Table 1: Dosage Adjustment for Intravenous Aciclovir in Adults and Adolescents with Renal Insufficiency.

Table 2: Dosage Adjustment for Intravenous Aciclovir in Neonates, Infants, and Children with Renal Insufficiency

Duration

Treatment with Aciclovir Altan usually lasts 5 days, but should be adjusted according to the patient's conditions and response to therapy. Treatment for herpetic encephalitis usually lasts 10 days. Treatment for neonatal herpes infections usually lasts 14 days for mucocutaneous infections (skin, eyes, mouth) and 21 days for disseminated disease or disease affecting the central nervous system.

The duration of prophylactic administration of Aciclovir Altan is determined according to the duration of the risk period.

Method of Administration

The solution should be administered intravenously, continuously but very slowly, 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 has no preservatives, so the unused solution should be discarded. In case of visible turbidity or crystallization before or during infusion, the solution should be discarded. The reconstituted or diluted solution should not be refrigerated.

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 injectable preparations or sodium chloride solution (0.9%) for intravenous infusion. The reconstituted solution is 25 mg/ml.

Route of Administration

IV direct:

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

IV infusion:

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

IV infusion:

The reconstituted solution can be diluted for administration by infusion. The dilution is made totally or partially, according to the necessary dose, adding and mixing it with at least 50 ml of infusion solution to obtain a solution with a maximum concentration of 0.5% (250 mg/50 ml). The contents of the two vials (500 mg of aciclovir) can be added to 100 ml of infusion solution.

Aciclovir intravenously is compatible with the following infusion solutions:

• Sodium chloride 4.5 mg/ml (0.45%)
• Sodium chloride 9 mg/ml (0.9%)
• Sodium chloride 1.8 mg/ml (0.18%) + Glucose (4% w/v)
• Sodium chloride 4.5 mg/ml (0.45%) + Glucose (2.5% w/v)
• Compound sodium lactate (Hartmann's solution)

Once aciclovir intravenously is added to the infusion solution, it should be shaken well to ensure adequate mixing.

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

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