Aciclovir Hikma 250 mg powder for solution for infusion EFG
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Aciclovir Hikma 250 mg powder for solution for infusion EFG
Read the entire 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 nurse.
- If you experience any adverse reactions, consult your doctor or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Aciclovir Hikma is and what it is used for
- What you need to know before using Aciclovir Hikma
- How to use Aciclovir Hikma
- Possible side effects
- How to store Aciclovir Hikma
- 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. Aciclovir belongs to a group of medicines known as antivirals. It works by killing or stopping the growth of viruses.
Aciclovir can be used to:
- treat varicella zoster virus infections (chickenpox).
- treat severe cases of genital herpes.
- prevent and treat herpes simplex virus infections (cold sores and genital herpes) in people whose immune system is not working properly, meaning their bodies are less able to fight infections.
- treat herpes simplex virus infections in children up to 3 months of age. This is rarely caused by the virus responsible for cold sore and genital herpes infections.
- treat herpes encephalitis (inflammation of the brain). This is rarely caused by the virus responsible for cold sore 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
Consult your doctor or nurse before starting to use aciclovir.
Consult your doctor or nurse before using aciclovir if:
-
you have kidney problems.
-
you are over 65 years of age.
If you are unsure whether the above circumstances apply to you, consult your doctor or nurse before using aciclovir.
Using Aciclovir Hikma with other medicines
Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.
It is especially important that you talk to your doctor or pharmacist if you are taking any of the following medicines:
- probenecid, used for the treatment of gout;
- cimetidine, used for the treatment of stomach ulcers;
- tacrolimus, cyclosporine, or mycophenolate mofetil, used to prevent rejection of transplanted organs;
- lithium, used to treat manic-depressive disorders;
- theophylline, used to treat certain respiratory disorders.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
Driving and using machines
No studies have been conducted to investigate the effect of aciclovir on the ability to drive and use machines.
Aciclovir Hikma contains sodium
This medicine contains 26.2 mg of sodium per dose (main component of table/cooking salt) in each vial. This corresponds to 1.31% of the maximum daily recommended sodium intake for an adult.
3. How to use Aciclovir Hikma
You must never administer the medicine yourself. The medicine will always be administered by a trained person.
Before administration, the medicine will be diluted.
Aciclovir will be given to you as a continuous intravenous infusion. This means that the medicine is administered slowly over a period of 1 hour.
Aciclovir is usually administered every 8 hours.
You may receive fluids to ensure that you do not become dehydrated.
The dose, frequency, and duration of treatment will depend on:
- the type of infection you have,
- body weight,
- age.
Your doctor may adjust the aciclovir dose if:
- you have kidney problems. If you have kidney problems, it is important that you receive plenty of fluids during treatment with aciclovir.
- you are overweight.
- you are an elderly person.
Talk to your doctor before receiving aciclovir if any of the above conditions apply to you.
Use in children
The dose of aciclovir given to newborns and children up to 12 years 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, speak to your doctor or nurse immediately.
If you have been given too much aciclovir, you may:
- feel confused or agitated,
- have hallucinations (seeing or hearing things that do not exist),
- have seizures,
lose consciousness (coma).
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
This medicine may cause the following adverse effects:
Allergic reactions (affect fewer than 1 in 10,000 people)
If you have an allergic reaction, stop taking aciclovir and speak to your doctor immediately. Signs may include:
- skin rash, itching or hives;
- swelling of the face, lips, tongue or other parts of the body;
- shortness of breath, wheezing or difficulty breathing;
- fever of unknown origin (high temperature) and feeling faint, especially when standing up.
Other adverse effects include:
Common (affect fewer than 1 in 10 people)
- nausea and vomiting;
- itching, hive-like skin rash;
- skin reaction after exposure to light (photosensitivity);
- itching;
- swelling, redness and sensitivity at the injection site.
Uncommon (affect fewer than 1 in 100 people)
- nosebleeds and bruising more easily than usual.
Very rare (affect up to 1 in 10,000 people)
- headache or dizziness;
- diarrhoea or stomach pain;
- fatigue;
- fever;
- effects on certain blood and urine tests;
- feeling of weakness;
- feeling restless or confused;
- spasms or tremors;
- hallucinations (seeing or hearing things that do not exist);
- seizures;
- unusual drowsiness or sleepiness;
- unsteadiness when walking and lack of coordination;
- difficulty speaking;
- inability to think or judge clearly;
- unconsciousness (coma);
- paralysis of part or all of your body;
- changes in behaviour, speech and eye movements;
- neck stiffness and sensitivity to light;
- inflammation of the liver (hepatitis);
- yellowing of the skin and whites of the eyes (jaundice);
- kidney problems (little or no urine output);
- lower back pain, in the kidney area of your back or just above the hips (renal pain).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Aciclovir Hikma
Keep this medicine out of the sight and reach of children.
Store below 25°C.
The preparation is made at the time of use. Any unused solution should be discarded.
Do not use this medicine after the expiry date which is stated on the label and on the carton after EXP. The expiry date refers to the last day of the month indicated.
6. Contents of the pack and other information
Composition of Aciclovir Hikma
- The active substance is aciclovir.
Each vial contains 250 mg of aciclovir as the sodium salt.
- The other component is sodium hydroxide.
Appearance of the product and contents of the container
Aciclovir Hikma is supplied as a glass vial containing a white powder, closed with a rubber stopper and sealed with a flip-off cap.
The 250 mg dose is available in 10 ml vials, in cartons containing 5 or 10 vials.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Hikma Farmacêutica (Portugal), SA
Estrada do Rio da Mó, 8, 8A and 8B - Fervença
2705-906 Terrugem SNT
Portugal
Manufacturer
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, 8, 8A and 8B – Fervença
2705-906 Terrugem SNT
Portugal
or
Hikma Italia S.p.A.
Viale Certosa, 10
27100 Pavia
Italy
For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
Hikma España, S.L.U.
Calle Anabel Segura nº11, Edificio A, planta 1ª, oficina 2
28108 - Alcobendas, Madrid
Spain
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Aciclovir Hikma 250 mg und 500 mg, Pulver zur Herstellung einer Infusionslösung
Austria: Aciclovir Hikma 250 mg und 500 mg Pulver zur Herstellung einer Infusionslösung
Belgium: Aciclovir Hikma 250 et 500 mg poudre pour solution pour perfusion
Spain: Aciclovir Hikma 250 mg powder for solution for perfusion EFG
France: Aciclovir Hikma 250mg et 500 mg Poudre pour solution pour perfusion
Italy: Aciclovir Hikma 250 mg e 500 mg Polvere per soluzione per infusione
Netherlands: Aciclovir Hikma 250 mg en 500 mg poeder voor oplossing voor infusie
Poland: Aciclovir Hikma 250 mg i 500 mg proszek do sporzadzania roztworu do infuzji
Portugal: Aciclovir Hikma, 250 mg e 500 mg, Pó para solução para perfusão
United Kingdom: Aciclovir 250mg and 500 mg Powder for solution for infusion
Date of latest revision of this leaflet: December 2024
The following information is intended for healthcare professionals only:
In-use stability period after reconstitution and dilution
After reconstitution, chemical and physical stability of the preparation has been demonstrated for 12 hours at 15°C to 25°C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration of storage in use and conditions prior to use are the responsibility of the user.
Special precautions for disposal and other handling
Reconstitution:
Aciclovir must be reconstituted using the following volumes of water for injections or sodium chloride 0.9% (w/v) for intravenous infusion to provide a solution containing 25 mg of aciclovir per ml:
Formulation | Volume of liquid for reconstitution
---|---
250 mg vial | 10 ml
500 mg vial | 20 ml
Based on the calculated dose, determine the appropriate number and strength of vials to be used. To reconstitute each vial, add the recommended volume of infusion fluid and gently shake until the contents are completely dissolved.
Administration:
The required dose of aciclovir should be administered by slow intravenous infusion over a period of one hour.
After reconstitution, aciclovir may be administered via an infusion pump at a controlled rate.
Alternatively, the reconstituted solution may be further diluted to give a concentration of aciclovir not exceeding 5 mg/ml (0.5% w/v) for administration by infusion.
Add the required volume of reconstituted solution to the chosen infusion solution as recommended below, and mix well to ensure adequate mixing.
For children and neonates, where it is advisable to keep the volume of infusion fluid to a minimum, dilution is recommended based on adding 4 ml of reconstituted solution (100 mg of aciclovir) 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 substantially below 0.5% w/v. Thus, a 100 ml infusion bag may be used for any dose between 250 mg and 500 mg of aciclovir (10 and 20 ml of reconstituted solution), but a second bag should be used for doses between 500 mg and 1000 mg.
When diluted according to the recommended schedules, aciclovir is known to be compatible with the following infusion fluids and remains stable for up to 12 hours at room temperature (15°C to 25°C):
- Sodium chloride 0.45% and 0.9% (w/v) intravenous infusion;
- Sodium chloride 0.18% (w/v) and glucose 4% (w/v) intravenous infusion;
- Sodium chloride 0.45% (w/v) and glucose 2.5% (w/v) intravenous infusion;
- Compound sodium lactate intravenous infusion (Hartmann's solution).
When diluted according to the above schedule, aciclovir will yield a concentration of aciclovir not exceeding 0.5% w/v.
As no antimicrobial preservative is included, reconstitution and dilution must be carried out under complete aseptic conditions, immediately before use, and any unused solution must be discarded.
Reconstituted or diluted solutions must not be refrigerated.
If any visible cloudiness or crystallization occurs in the solution before or during infusion, the preparation must be discarded.