Aciclovir Stada 800 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Aciclovir Stada 800 mg tablets EFG
Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet. 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Aciclovir Stada is and what it is used for
- What you need to know before taking Aciclovir Stada
- How to take Aciclovir Stada
- Possible adverse effects
- How to store Aciclovir Stada
- Contents of the pack and other information
1. What Aciclovir Stada is and what it is used for
Aciclovir Stada belongs to a class of drugs effective against viral infections (antivirals).
Aciclovir Stada is used
- for the treatment of varicella zoster virus (herpes) affecting the skin and mucous membranes in immunocompetent patients in whom a severe course of the disease may be anticipated.
2. What you need to know before starting Aciclovir Stada
Do not take Aciclovir Stada
- If you are allergic to aciclovir, valaciclovir, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before taking Aciclovir Stada.
- if you have impaired kidney function or are an elderly person. The dose must then be adjusted, and you should also drink an adequate amount of fluid during treatment (see also section 3 “How to take Aciclovir Stada”).
- if you have a neurological disorder.
Taking Aciclovir Stada with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
In particular, inform your doctor if you are taking any of the following medicines:
- interferon (a medicine used in the treatment of multiple sclerosis), which may increase the effects of both medicines.
- zidovudine (a medicine used in the treatment of AIDS), which may lead to disorders of the nervous system (neuropathies), seizures, and lethargy.
- theophylline (used for asthma and other respiratory problems).
- cimetidine (used to treat peptic ulcers) and probenecid (used to treat gout), as they increase aciclovir concentration.
- mycophenolate mofetil (a medicine used in transplant patients). Caution is required if taking high doses of aciclovir, as blood levels of both medicines may be increased.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
There is still insufficient information available on the consequences of using aciclovir during pregnancy. You should consult your doctor or pharmacist if you are pregnant.
Breastfeeding
Aciclovir is excreted in breast milk. Likewise, there is insufficient knowledge about its consequences. Therefore, consult your doctor or pharmacist if you are breastfeeding.
Driving and using machines
It is currently unknown whether aciclovir affects the ability to drive or use machines. Although the properties of aciclovir make such an effect unlikely, fatigue, headache, and effects on the nervous system have occasionally been reported. You should take this into account if you intend to drive or use machines during treatment with aciclovir.
Aciclovir Stada contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.
3. How to take Aciclovir Stada
The dose will be determined by your doctor individually for each patient.
Always take this medicine exactly as your doctor has instructed you. In some cases, the dose may differ from the recommended dose. Consult your doctor if you are unsure.
Recommended dose:
One 800 mg aciclovir tablet, five times daily, every 4 hours. The nighttime dose should be omitted. Treatment should be initiated within 48 hours after the onset of infection. The duration of treatment should be 7 days.
Use in children
For the treatment of herpes zoster in children, there are no available data regarding dosing.
Patients with reduced renal function
Caution is recommended if renal function is impaired.
The dose should be reduced to one 800 mg aciclovir tablet three times daily at approximately 8-hour intervals in patients with moderate renal impairment (creatinine clearance in the range of 10–25 mL/min). In patients with severe renal impairment (creatinine clearance less than 10 mL/min), a dose of one 800 mg aciclovir tablet twice daily at 12-hour intervals is recommended.
Elderly patients
In principle, dose adjustment is not required in elderly patients. However, if renal impairment is present, the doctor may decide to adjust the dose.
Method of administration
Take the tablets with half a glass of water or another liquid.
Patients with renal impairment or elderly patients should ensure they drink plenty of fluids during treatment with aciclovir. It is also important that patients receiving high doses of aciclovir take sufficient fluids.
If you take more Aciclovir Stada than you should
Contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone: 915 62 04 20, indicating the medication and the amount ingested.
Symptoms of overdose include gastrointestinal effects such as nausea or vomiting, and central nervous system effects such as headache and confusion.
If you forget to take Aciclovir Stada
If you have just remembered that you missed a dose, you may still take it. However, if a considerable time has passed since the scheduled dose, you should skip the missed dose. Wait for the next scheduled dose and continue with your normal dosing schedule. Do not take a double dose to make up for a missed dose.
If you stop taking Aciclovir Stada
Your doctor has advised you on how long you should continue taking aciclovir. Do not stop treatment earlier than prescribed without first consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. These adverse effects usually disappear once treatment has ended. Below is a list of possible adverse effects.
Frequent: may affect up to 1 in 10 people
- Confusion
- Hallucinations
- Headache, dizziness, somnolence
- The generally reversible adverse effects mentioned above usually occurred in patients with renal function disorders and in cases of overdose, as well as with other predisposing factors, but cannot be entirely attributed to these characteristics.
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Itching
- Skin rash (including photosensitivity)
- Fatigue
- Fever
- Tiredness
Uncommon: may affect up to 1 in 100 people
- Sleeplessness
- Urticaria
- Diffuse hair loss (its relationship with treatment is unclear)
Rare: may affect up to 1 in 1,000 people
- Severe allergic reaction (anaphylaxis)
- Breathing difficulty (dyspnea)
- Reversible increases in bilirubin and liver enzymes
- Angioedema
- Increased blood urea and creatinine
Very rare: may affect up to 1 in 10,000 people
Blood count changes (anaemia, leucopenia, thrombocytopenia)
- Feelings of depersonalization (reversible upon discontinuation of treatment), agitation, psychotic symptoms
- Tremor, ataxia, dysarthria, seizures, encephalopathy, disturbances of consciousness up to coma
- The generally reversible adverse effects mentioned above usually occurred in patients with renal function disorders or other predisposing factors, but cannot be entirely attributed to these characteristics.
- Hepatitis, jaundice
- Acute renal failure, kidney pain
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them through the Spanish Pharmacovigilance System for Human Medicines: https:/www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Aciclovir Stada
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container, following "Do not use after" or "EXP".
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.
6. Contents of the pack and other information
- The active substance in Aciclovir Stada is aciclovir. One tablet contains 800 mg of aciclovir.
- The other components are: microcrystalline cellulose, sodium carboxymethylstarch (type A) (derived from potato starch), copovidone, magnesium stearate and colloidal anhydrous silica.
What Aciclovir Stada looks like and contents of the pack
Aciclovir Stada 800 mg tablets are oblong, white tablets, scored on both sides.
Each pack of Aciclovir Stada 800 mg tablets contains 35, 50 or 500 tablets in blister strips. The blister strips contain 5 tablets each.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern
(Barcelona) Spain
[email protected]
Manufacturer
STADA Arzneimittel AG,
Stadastrasse 2-18
61118 Bad Vilbel (Germany)
or
LAMP San Prospero S.p.A
Via della Pace 25/A
41030 San Prospero, Modena
(Italy)
or
Centrafarm Services, B.V
Van de Reijtstraat 31-E
4814 NE Breda
(The Netherlands)
or
Sanico NV
Veedijk 59
2300 Turnhout
Belgium
This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
Belgium: Aciclovir EG
Denmark: Aciclodan 800 mg
Finland: Acyclostad 800 mg tabletti
The Netherlands: Aciclovir CF 800 mg tabletten
Portugal: Aciclovir Ciclum 800 mg comprimidos
Spain: Aciclovir Stada 800 mg comprimidos EFG
Sweden: Aciclovir STADA 800 mg
Date of the most recent revision of this leaflet: February 2021
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/