Leaflet: information for the user

Aciclovir Accord 25 mg/ml concentrate for infusion solution

aciclovir

Read this leaflet carefully before you start using 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 or pharmacist.
• 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, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

This medicine contains aciclovir as the active ingredient. 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 a decreased immune response due to a bone marrow transplant or treatment for acute leukemia.
• Treatment of shingles or herpes zoster in patients with a decreased immune response and treatment of shingles or herpes zoster in severe cases in patients with a normal immune response. Shingles or herpes zoster is caused by a virus called varicella zoster.
• Treatment of severe genital infections caused by a virus called herpes genital
• Treatment of meningitis (encephalitis) caused by a virus called herpes simplex.
• Treatment of infections in newborns caused by a virus called herpes neonatal

No use Aciclovir Accord

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

If the above applies to you, do not use Aciclovir Accord. If you have any doubts, consult your doctor or pharmacist before using this medication.

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 unsure whether any of the above points apply to you, consult your doctor or pharmacist before taking Aciclovir Accord.

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

Use of Aciclovir Accord with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes medications obtained without a prescription and herbal remedies.

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

• Probenecid, used to treat gout
• Cimetidine, used to treat stomach ulcers
• Tacrolimus, ciclosporin, or mycophenolate mofetil, used to prevent organ transplant rejection
• Lithium
• Theophylline

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Aciclovir Accord is generally used in hospitalized patients. Therefore, information on driving and operating machinery is not applicable.

Aciclovir Accord contains sodium

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

How to administer this medication

This medication should never be self-administered. It will always be administered by a qualified person.

The medicine must be diluted before administration.

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

The dose you will receive, the frequency, and the 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 your body surface area.

In the case of neonates 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 patients with reduced 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 essential that you receive a large amount of fluids while being treated with aciclovir.

If any of the above applies to you, speak with your doctor before aciclovir administration.

If you have been given more Aciclovir Accord than you should

If you believe you have been given more aciclovir than you should, speak with your doctor or nurse immediately.

If you have been given too much aciclovir, you may:

• Feel confused or agitated
• Have hallucinations (see or hear things that are not there)
• Have seizures
• Loss of 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.

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 symptoms may include:

• skin rash, itching, or hives
• inflammation in the face, lips, tongue, or other parts of the body
• shortness of breath, wheezing, or difficulty breathing
• unexplained fever (high temperature) and dizziness, especially when getting up.

Other side effects are:

Common(may affect up to 1 in 10 people)

• dizziness or feeling dizzy
• itching, such as urticaria
• skin reaction after exposure to light (photosensitivity)
• itching
• swelling, redness, and sensitivity at the injection site
• increase in liver enzymes

Uncommon(may affect up to 1 in 100 people)

• low levels of red blood cells in the blood (anemia)
• low levels of white blood cells in the blood (leucopenia)
• low levels of platelets (cells that help blood clot) (thrombocytopenia)

Very 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
• shaking
• hallucinations (seeing and hearing things that are not there)
• convulsions
• unusual feeling of numbness or drowsiness
• difficulty walking and lack of coordination
• difficulty speaking
• inability to think or judge clearly
• loss of consciousness (coma)
• paralysis of a part or the entire 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 white of the eyes (jaundice)
• kidney problems that result in little or no urine
• lower back pain, in the kidney area, back, or just above the hip (renal pain)

Reporting of side effects

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

Keep out of the sight and reach of children.

Store below 25 °C

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

Dispose of unused solution.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Aciclovir Accord:

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

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

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

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

The other components are sodium hydroxide and/or concentrated hydrochloric acid and water for injection preparations. Sodium hydroxide and concentrated hydrochloric acid are used to adjust the pH of the solution.

Appearance of the product and contents of the package

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

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

It is presented in packaging sizes of 1 vial, 5 vials or 10 vials.

Only some packaging sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare, S.L.U.

World Trade Center

c/ Moll de Barcelona, s/n,

Edifici Est, 6th floor

08039 Barcelona.

Spain

Responsible for manufacturing

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95-200 Pabianice, Poland

Date of the last review of this leaflet:February 2022

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 doctors or healthcare professionals:

For single use: Discard any unused solution.The disposal of unused medication 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 number of vials and their dose to be used.

Administration

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

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

Add the required volume of Aciclovir Accord to the chosen infusion solution as recommended below and shake well to ensure a correct mixture.

For children and neonates, in whom it is recommended to maintain the volume of infusion fluid 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 when this results in aciclovir concentrations substantially below 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 according to the recommended instructions, aciclovir is compatible with the following infusion fluids and remains 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

Lactate sodium (Hartmann's solution) for intravenous infusion

When aciclovir is diluted according to the instructions above, it should result in a concentration of aciclovir not exceeding 0.5% w/v.

Since no antimicrobial preservative is included, the dilution should be carried out in completely aseptic conditions, immediately before use and discard any unused solution.

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

Compatibility has been demonstrated with polypropylene (PP) syringes, intravenous administration equipment without PVC and infusion bags without PVC.