Label: Information for the Patient

Aciclovir Altan 250 mg Powder for Solution for Infusion EFG

Read this label carefully before starting to use this medication, as it contains important information for you

• Keep this label as you may need to read it again.

• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

1.What is Aciclovir Altan and how is it used

1. What you need to know before starting to use Aciclovir Altan
2. How to use Aciclovir Altan
3. Possible adverse effects
4. Storage of Aciclovir Altan
5. Contents of the package and additional information

Aciclovir Altan contains a medicine called aciclovir that belongs to a group of medicines called antivirals.

This medicine is indicated for:

• treatment of infections byHerpes simplexin immunocompromised patients (people with a weakened immune system, i.e., whose body has a lesser capacity to fight the infection).
• for the treatment of chickenpox and shingles (Infections by varicella-zoster) in immunocompromised patients (people with a weakened immune system).
• prevention of infectionsHerpes simplexin seriously immunocompromised patients (whose immune system functions with difficulty).
• for the treatment of recurrent varicella zoster and severe genital herpes in patients with a good functioning immune system.
• for the treatment of herpetic encephalitis (inflammation of the brain caused bythe herpes simplex virus).
• for the treatment of infections byHerpes simplexin newborns.

No use Aciclovir

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Aciclovir Altan if:

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

In case of doubt as to whether the above applies to you, consult your doctor or pharmacist before using Aciclovir Altan.

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

Other medications and Aciclovir Altan

Inform your doctor or pharmacist if you are using, have used recently, or may have to use any other medication.

This includes medications obtained without a prescription, including herbal remedies.

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

• Probenecid, used to treat gout
• Cimetidine, used to treat ulcers
• Tacrolimus, ciclosporin, or mycophenolate mofetil, used to prevent your body from rejecting transplanted organs

• Theophylline, used to treat 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

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

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

Driving and operating machinery

No studies have been conducted on the effects of aciclovir on driving and operating machinery.

Aciclovir Altan 250 mg powder for solution for infusion EFGcontains:

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

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

Before administering the medication, it must be diluted.

Aciclovir Altan will be administered to you through continuous intravenous infusion and slowly over a period of time not less than 1 hour.

The doctor will decide on the correct dose that will 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 ofAciclovir Altanif:

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

Consult with your doctor before usingAciclovir Altan, if you detect any of the above circumstances.

If you use moreAciclovir Altan than you should

If you consider that you have been administered an overdose ofAciclovir Altan, contact your doctor or nurse immediately.

If you are administered an overdose ofAciclovir Altan your laboratory tests (increase in blood urea and creatinine) may be altered with the respective alteration of renal function (renal insufficiency).

Additionally, you may:

• feel confused or agitated
• have hallucinations (see or hear things that are not happening)
• experience seizures
• lose 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 medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience any allergic reactionstop taking Aciclovir Altan and contact your doctor immediately.

You may experience the following side effects with this medicine:

Frequent (may affect1 in 10people)

• inflammation and redness at the infusion site (phlebitis)
• nausea, vomiting
• itching, urticaria
• eruption including skin reaction after exposure to sunlight (photosensitivity)
• alteration of some laboratory tests (elevated urea in the blood, creatinine, and some liver enzymes)

Rare(may affect1 in 100people)

• 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 affect1 in 10,000people)

• severe allergic reaction (anaphylaxis)
• inflammation of lips, face, neck, and throat causing difficulty breathing (angioedema)
• difficulty breathing (dyspnea)
• headache (cephalgia)
• dizziness
• feeling confused or agitated
• shaking
• instability while walking and lack of coordination (ataxia)
• speaking slowly and with difficulty (dysarthria)
• seeing or hearing things that are not there (hallucinations)
• psychiatric symptoms (psychotic symptoms)
• seizures
• drowsiness
• brain damage (encephalopathy)
• loss of consciousness (coma)
• diarrhea
• abdominal pain
• yellowing of the white part of the eyes or skin (jaundice)
• inflammation of the liver (hepatitis)
• reduced kidney function (renal insufficiency, acute renal failure)
• lower back pain, in the area corresponding to the kidneys (renal pain)
• fatigue
• fever
• local inflammatory reactions
• abnormal laboratory tests (elevated bilirubin)

Reporting of side effects

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

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

This medication does not require special conservation conditions.

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

Expiration date of the reconstituted product

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

Composition of Aciclovir Altan

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

Aspect of Aciclovir and packaging content

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

Marketing Authorization Holder:

Altan Pharmaceuticals, S.A.

C/ Cólquide, 6. Portal 2. 1st floor. Office F.

Edificio Prisma

28230 Las Rozas. Madrid

Spain

Responsible for manufacturing:

Altan Pharmaceuticals, S.A.

Avda. Constitución 198-199

Polígono Industrial Monte Boyal

45950 Casarrubios del Monte (Toledo)

Spain

Last review date of this leaflet:September 2022

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

Pharmaceutical form

Powder for solution for infusion.

Posology and administration method

Adults

In patients withHerpes simplex(except encephalitis herpética) or recurrent infections byVaricella zoster, the dose of Aciclovir Altan is 5 mg/kg of body weight every 8 hours, provided that renal function is not altered (see Posology in renal insufficiency).

In immunocompromised patients with infections byVaricella zosteror patients with encephalitis herpética, the dose to be administered of Aciclovir Altan is 10 mg/kg of body weight, every 8 hours, provided that renal function is not altered (see Posology in renal insufficiency).

In patients with obesity, the recommended dose for adults should be administered based on ideal body weight, not 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 aged 3 months or more with infections byHerpes simplex(except encephalitis herpética) or recurrent infections byVaricella zoster, the dose of Aciclovir Altan should be 250 mg/m2of body surface area every 8 hours if renal function is not altered.

In immunocompromised children with infections byVaricella zosteror children with encephalitis herpética, the dose of Aciclovir Altan should be 500 mg/m2of body surface area every 8hours, if renal function is not altered.

Neonates and infants up to 3 months of age

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

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

Newborns and children with renal impairment require a modified dose appropriately, according to the degree of impairment (see Posology in Renal Insufficiency).

Older adults

Consider the possibility of renal insufficiency in the elderly, and adjust the dose accordingly (see Posology in renal insufficiency).

Proper hydration should be maintained.

Renal insufficiency

Care should be taken when administering Aciclovir Altan to patients with renal insufficiency.

Proper hydration should be maintained.

The adjustment of the posology 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 m2for children under 13years of age. The following dose adjustments are suggested:

Table 1: Dose adjustment for intravenous aciclovir in adults and adolescents with renal insufficiency.

Table 2: Dose adjustment for intravenous aciclovir in neonates, infants, and children with renal insufficiency

Duration

The treatment with Aciclovir Altan generally lasts 5días, but should be adjusted according to the patient's condition and response to therapy. The treatment for encephalitis herpética usually lasts 10 days. The treatment for neonatal herpes infections usually lasts 14 days for mucocutaneous infections (skin - eyes - mouth) and 21 days for disseminated disease or that affects the central nervous system.

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

Administration method

The solution should be administered intravenously, continuously but very slowly, so that it is administered in a period of not less than one hour.

It is recommended to reconstitute and/or dilute 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

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

Administration route

IV direct:

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

IV infusion:

The reconstituted solution can be diluted for administration through infusion.The dilution is made totally or partially, as needed, by adding it 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 two vials (500 mg of aciclovir) can be added to 100 ml of infusion solution.

IV infusion:

The reconstituted solution can be diluted for administration through Infusion. The dilution is made totally or partially, as needed, by adding it 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 two vials (500 mg of aciclovir) can be added to 100 ml of infusion solution.

Aciclovir intravenous 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)
• Lactate sodium compound (Hartmann solution)

Once aciclovir intravenous is added to the infusion solution, it should be shaken well to ensure a suitable mixture.

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

The detailed and updated information on this medication is available on the website of theSpanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”