ACICLOVIR ACCORD 25 mg/ml CONCENTRATE FOR INFUSION SOLUTION

Contents of the Package Leaflet

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

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

This medicine contains aciclovir as the active substance. Aciclovir is an antiviral medicine (antiviral means against viruses) and prevents the multiplication of viruses.

Aciclovir is indicated for:

• Treatment and prevention of infections caused by a virus called herpes simplex. Aciclovir is mainly used in patients with decreased immune response due to bone marrow transplantation or treatment for acute leukemia.
• Treatment of shingles or herpes zoster in patients with decreased resistance and treatment of severe shingles or herpes zoster in patients with normal resistance. Shingles or herpes zoster is caused by a virus called varicella zoster.
• Treatment of severe genital infections caused by a virus called genital herpes
• Treatment of meningitis (encephalitis) caused by a virus called herpes simplex.
• Treatment of infections in newborns caused by a virus called neonatal herpes

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

Do not use Aciclovir Accord

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

If any of the above applies to you, do not use Aciclovir Accord. If you are not sure, consult your doctor or pharmacist before using this medicine.

Warnings and Precautions

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

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

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking Aciclovir Accord.

It is important to drink plenty of water while using aciclovir.

Using Aciclovir Accord with Other Medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and 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 stomach ulcers
• Tacrolimus, cyclosporin or mycophenolate mofetil, used to prevent organ rejection after transplantation
• Lithium
• Theophylline

Pregnancy, Breast-feeding and Fertility

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

Driving and Using Machines

Aciclovir Accord is usually used in hospitalized patients. Therefore, information on driving and using machines is not applicable.

Aciclovir Accord Contains Sodium

This medicine contains 26.7 mg of sodium (main component of table/cooking salt) in each 10 ml vial. This is equivalent to 1.41% of the maximum recommended daily intake of sodium for an adult. This medicine contains 53.4 mg of sodium (main component of table/cooking salt) in each 20 ml vial. This is equivalent to 2.82% of the maximum recommended daily intake of sodium for an adult. This medicine contains 106.8 mg of sodium (main component of table/cooking salt) in each 40 ml vial. This is equivalent to 5.65% of the maximum recommended daily intake of sodium for an adult.

3. How to Use Aciclovir Accord

How this medicine is administered

Never consider administering this medicine yourself. It will always be administered by a person who is properly qualified to do so.

Before the medicine is administered to you, it must be diluted.

Aciclovir will be administered to you as a continuous infusion into your vein. This means that the medicine is administered slowly over a period of time.

The dose that will be administered to you, the frequency and duration of treatment will depend on:

• The type of infection you have
• Your weight
• Your age

The usual dose of Aciclovir Accord in adults is between 5 and 10 mg per kg of body weight administered every 8 hours.

In children between 3 months and 12 years of age, the doctor will calculate the dose of Aciclovir Accord based on body surface area.

In the case of newborns being treated for neonatal herpes infection, the usual dose is 20 mg per kg of body weight administered every 8 hours for 14-21 days.

In elderly patients and in patients with decreased renal function, the doctor may reduce the dose by less frequent infusions.

Your doctor may adjust the dose of Aciclovir Accord if:

• You have kidney problems. If you have kidney problems, it is important that you receive plenty of fluids while being treated with aciclovir.

If any of the above applies to you, talk to your doctor before Aciclovir Accord is administered to you.

If you have been administered more Aciclovir Accord than you should

If you think you have been administered more aciclovir than you should, talk to your doctor or nurse immediately.

If you have been administered too much aciclovir 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.

Allergic Reactions(may affect up to 1 in 10,000 people)

If you experience an allergic reaction, stop taking aciclovir and seek medical attention immediately. The signs may include:

• rash, itching or hives on the skin
• swelling of the face, lips, tongue or other parts of the body
• difficulty breathing, wheezing or breathing problems
• unexplained high temperature (fever) and feeling dizzy, especially when standing up.

Other side effects are:

Common(may affect up to 1 in 10 people)

• dizziness or feeling dizzy
• itching, like hives
• skin reaction after exposure to light (photosensitivity)
• itching
• swelling, redness and sensitivity at the injection site
• increased liver enzymes

Uncommon(may affect up to 1 in 100 people)

• reduced red blood cell count (anemia)
• reduced white blood cell count (leukopenia)
• reduced platelet count (thrombocytopenia)

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

• headache or feeling dizzy
• diarrhea or stomach pain
• feeling tired
• fever
• effects on some blood and urine tests
• feeling weak
• agitation or confusion
• tremors
• hallucinations (seeing and hearing things that do not exist)
• seizures
• unusual feeling of numbness or drowsiness
• unsteadiness when walking and lack of coordination
• difficulty speaking
• inability to think or judge clearly
• loss of consciousness (coma)
• paralysis of a part or all of the body
• changes 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 whites of the eyes (jaundice)
• kidney problems where little or no urine is produced
• back pain, in the kidney area, in the back or just above the hip (kidney pain)

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

5. Storage of Aciclovir Accord

Keep out of the sight and reach of children.

Store below 25°C

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.

Discard any unused 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 Accord:

The active substance is aciclovir. Each ml contains aciclovir sodium equivalent to 25 mg of aciclovir.

Each 10 ml vial of concentrate contains aciclovir sodium equivalent to 250 mg of aciclovir.

Each 20 ml vial of concentrate contains aciclovir sodium equivalent to 500 mg of aciclovir.

Each 40 ml vial of concentrate contains aciclovir sodium equivalent to 1 g of aciclovir.

The other ingredients are sodium hydroxide and/or hydrochloric acid and water for injections. Sodium hydroxide and hydrochloric acid are used to adjust the pH of the solution.

Appearance of the Product and Contents of the Pack

This medicine is a concentrate for solution for infusion. It comes in a glass vial containing a clear or almost clear colorless solution. It is a concentrated solution that is diluted to produce the infusion solution. The pH value is between 10.7 and 11.7.

Transparent glass vials of 10, 20 or 50 ml (containing 10, 20 and 40 ml respectively), rubber stopper and tear-off aluminum seal.

It is available in pack sizes of 1 vial, 5 vials or 10 vials.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare, S.L.U.

World Trade Center

c/ Moll de Barcelona, s/n,

Edifici Est, 6ª planta

08039 Barcelona.

Spain

Manufacturer

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

Date of Last Revision of this Leaflet:February 2022

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:

For single use: Discard any unused solution. Disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.

From the calculated dose, determine the appropriate number of vials and their dose to be used.

Administration

The required dose of aciclovir should be administered by slow intravenous infusion over a period of more than one hour. Aciclovir Accord can be administered using a controlled-rate infusion pump.

Alternatively, Aciclovir Accord can be further diluted to achieve a concentration of no more than 5 mg/ml (0.5% w/v) for infusion.

Add the required volume of Aciclovir Accord to the chosen infusion solution as recommended below and shake well to ensure proper mixing.

For children and newborns, where it is recommended to keep the infusion fluid volume to a minimum, it is recommended that the dilution be based on 4 ml of solution (100 mg of aciclovir) added to 20 ml of infusion fluid.

For adults, it is recommended to use infusion bags containing 100 ml of infusion fluid, even if this results in aciclovir concentrations substantially lower than 0.5% w/v. Therefore, a 100 ml infusion bag can be used for any dose between 250 mg and 500 mg of aciclovir (10 and 20 ml of solution), but a second bag must be used for doses between 500 mg and 1000 mg.

When diluted as recommended, aciclovir is compatible with the following infusion fluids and stable for 24 hours at room temperature (below 25°C):

Sodium chloride (0.45% and 0.9% w/v) for intravenous infusion

Sodium chloride (0.18% w/v) and glucose (4% w/v) for intravenous infusion

Sodium chloride (0.45% w/v) and glucose (2.5% w/v) for intravenous infusion

Sodium lactate (Hartmann solution) for intravenous infusion

When aciclovir is diluted as recommended above, it should result in an aciclovir concentration of no more than 0.5% w/v.

Since no antimicrobial preservative is included, the dilution should be carried out under totally aseptic conditions, immediately before use, and any unused solution should be discarded.

The solution should be discarded if turbidity or crystallization is observed before or during infusion.

Compatibility has been demonstrated with polypropylene syringes, PVC-free IV administration sets, and PVC-free infusion bags.