Aciclovir Hikma

Package leaflet: Information for the patient

Aciclovir Hikma,

250 mg and 500 mg
Powder for solution for infusion
Equivalent medicine
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask the nurse.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or nurse. See section 4.

Contents of this leaflet

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

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

Aciclovir Hikma contains a medicine called aciclovir. This belongs to a group of
medicines known as antivirals. It works by killing or inhibiting the growth of viruses.
Aciclovir Hikma can be used for:

• Treating Varicella Zoster infections (chickenpox).
• Treating severe cases of genital herpes.
• Preventing and treating Herpes Simplex infections (cold sores and genital herpes) in people whose immune system is weakened, meaning their body is less able to fight infections.
• Treating Herpes Simplex infections in children up to 3 months of age. This may rarely be caused by the virus responsible for cold sores and genital herpes infections.
• Treating Herpes encephalitis (inflammation of the brain). This may rarely be caused by the virus responsible for cold sores and genital herpes infections.

2. What you need to know before using Aciclovir Hikma

Do not use Aciclovir Hikma:

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

Warnings and precautions
Talk to your doctor or nurse before using Aciclovir Hikma.
Check with your doctor or nurse before taking Aciclovir Hikma if:

• You have kidney problems
• You are over 65 years of age. If you are unsure whether the above conditions apply to you, please speak to your doctor or nurse before using Aciclovir Hikma.

Other medicines and Aciclovir Hikma
Tell your doctor if you are taking, have recently taken, or might take any other
medicines.
In particular, inform 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 rejection in organ transplant patients;
• lithium, used to treat bipolar disorder;
• theophylline, used to treat certain respiratory disorders.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding,
please consult your doctor before taking this medicine.
Aciclovir Hikma contains sodium
Aciclovir Hikma contains 37.8 mg of sodium per dose. This should be taken into consideration in patients
following a low-sodium diet.

3. How to use Aciclovir Hikma

You must never take this medicine on your own. It will always be administered by a trained healthcare professional.
Before the medicine is given to you, it must be diluted.
Aciclovir Hikma will be administered to you as a continuous slow infusion into a vein over a period of 1 hour.
Aciclovir Hikma is generally administered every 8 hours.
You may be given fluids to prevent dehydration.
The dose you will receive, as well as the frequency and duration of treatment, will depend on:

• The type of infection you have,
• Your body weight,
• Your age.

Your doctor may adjust the dose of Aciclovir Hikma if:

• You have kidney problems. If you have impaired renal function, it is important that you receive an adequate amount of fluids during treatment with Aciclovir Hikma.
• You are overweight.
• You are elderly. Inform your doctor if any of the above conditions apply to you before receiving Aciclovir Hikma.

Use in children
The dose of Aciclovir Hikma administered to:

• Children between 3 months and 12 years of age is calculated based on body surface area.
• Neonates and infants up to 3 months of age is calculated based on body weight. If a child has kidney problems, the dose of the medicine may be reduced.

If you use more Aciclovir Hikma than you should
If you think you have been given too much Aciclovir Hikma, inform your doctor or nurse immediately.
If you have been given too much Aciclovir Hikma, you may:

• Feel confused or agitated,
• Experience hallucinations (seeing or hearing things that are not real),
• Have seizures,
• Lose consciousness (coma).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur with this medicine:

Allergic reactions (affecting less than 1 in 10,000 people)
If you have an allergic reaction, stop using Aciclovir Hikma and contact a doctor immediately. Symptoms may include:

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

Other side effects include:
Common (affecting less than 1 in 10 people)

• feeling unwell or general malaise;
• itching, blister-like rash;
• skin reaction after exposure to light (photosensitivity);
• itching;
• swelling, redness and pain at the injection site.

Uncommon (affecting less than 1 in 100 people)

• nosebleeds and bruising more easily than usual.

Very rare (affecting less than 1 in 10,000 people)

• headache or dizziness;
• diarrhoea or stomach pain;
• feeling tired;
• fever;
• effects on certain blood and urine tests;
• feeling weak;
• feeling restless or confused;
• agitation or tremors;
• hallucinations (seeing or hearing things that are not there);
• seizures;
• feeling unusually sleepy or apathetic;
• unsteadiness when walking and lack of coordination;
• difficulty speaking;
• inability to think or judge clearly;
• loss of consciousness (coma);
• paralysis of part or all of the body;
• disturbances in behaviour, speech and eye movements;
• stiff neck and sensitivity to light;
• inflammation of the liver (hepatitis);
• yellowing of the skin and whites of the eyes (jaundice);
• kidney problems resulting in little or no urine production;
• pain in the lower back, in the kidney area or just above the hip (kidney pain).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Aciclovir Hikma

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Prepare immediately before use. Unused solution must be discarded.
Do not use this medicine after the expiry date stated on the vial and carton after EXP. The expiry date refers to the last day of that month.

6. Package contents and other information

What Aciclovir Hikma contains

• The active substance is aciclovir.
• Each vial contains 250 mg of aciclovir as the sodium salt.
• Each vial contains 500 mg of aciclovir as the sodium salt.
• The other ingredient is sodium hydroxide.

Description of the appearance of Aciclovir Hikma and contents of the pack
Aciclovir Hikma is supplied in glass vials containing a white powder, closed with a rubber stopper and sealed with a flip-off cap.
The 250 mg dosage is available in 10 ml vials, in packs containing 5 and 10 vials.
The 500 mg dosage is available in 20 ml vials, in packs containing 5 and 10 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, 8, 8A and 8B – Fervença
2705-906 Terrugem SNT
Portugal

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Aciclovir Hikma 250 mg and 500 mg Powder for solution for infusion
Germany: Aciclovir Hikma 250 mg und 500 mg, Pulver zur Herstellung einer Infusionslösung
Portugal: Aciclovir Hikma, 250 mg e 500 mg, Pó para solução para perfusão

The following information is intended exclusively for healthcare professionals:

Duration of chemical and physical stability of the product after reconstitution and dilution
Chemical and physical stability in use has been demonstrated for 12 hours at 15°C – 25°C.
From a microbiological standpoint, the medicinal product should be used immediately. If not
used immediately, the storage times and conditions prior to use are the responsibility of the
user.

Special precautions for disposal and handling

Reconstitution:
Aciclovir Hikma must be reconstituted using the following volumes of either Water for Injections or Sodium Chloride for Intravenous Infusion (0.9% p/v) to obtain a solution containing 25 mg of aciclovir per ml:

| Formulation | Volume of fluid for reconstitution |
|------------|-----------------------------------|
| 250 mg vial | 10 ml |
| 500 mg vial | 20 ml |

Based on the calculated dose, determine the correct number and concentration of vials to be used. To reconstitute each vial, add the recommended volume of infusion fluid and gently shake until the contents of the vial are completely dissolved.

Administration:
The required dose of Aciclovir Hikma must be administered by slow intravenous infusion over a period of 1 hour.
After reconstitution, Aciclovir Hikma may be administered via an infusion pump at a controlled rate.

Alternatively, the reconstituted solution may be further diluted to achieve a concentration of aciclovir not exceeding 5 mg/ml (0.5% p/v) for administration by infusion.

Add the required volume of reconstituted solution to the chosen infusion solution, as recommended below, and mix thoroughly to ensure adequate homogeneity.

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

For adults, infusion bags containing 100 ml of infusion fluid are recommended, even when this results in an aciclovir concentration practically below 0.5% p/v. Thus, a 100 ml infusion bag can be used for each dose of aciclovir between 250 mg and 500 mg (10 and 20 ml of reconstituted solution), but a second bag must be used for doses between 500 mg and 1000 mg.

When diluted according to the recommended regimens, Aciclovir Hikma is known to be compatible with the following infusion fluids and stable for up to 12 hours at room temperature (15°C to 25°C):

• Sodium Chloride Intravenous Infusion (0.45% and 0.9% p/v)
• Sodium Chloride (0.18% p/v) and Glucose (4% p/v) Intravenous Infusion
• Sodium Chloride (0.45% p/v) and Glucose (2.5% p/v) Intravenous Infusion
• Lactated Ringer's Intravenous Infusion (Hartmann's Solution)

When diluted according to the above scheme, Aciclovir Hikma will yield a solution with aciclovir concentration not exceeding 0.5% p/v.

Since no antimicrobial preservative is present, reconstitution and dilution must be carried out under aseptic conditions immediately before use, and any unused solution must be discarded.

Reconstituted or diluted solutions must not be frozen.

If cloudiness or crystallization is observed in the solution before or during infusion, the preparation must be discarded.