Heviran
Ask a doctor about a prescription for Heviran
How to use Heviran
Package Leaflet: Information for the Patient
Heviran, 200 mg, Film-Coated Tablets
Heviran, 400 mg, Film-Coated Tablets
Heviran, 800 mg, Film-Coated Tablets
Aciclovir
Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
- Keep this package leaflet, you may need to read it again.
- In case of any doubts, consult a doctor or pharmacist.
- This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
- If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
Table of Contents of the Package Leaflet
- 1. What is Heviran and what is it used for
- 2. Important information before taking Heviran
- 3. How to take Heviran
- 4. Possible side effects
- 5. How to store Heviran
- 6. Contents of the pack and other information
1. What is Heviran and what is it used for
Heviran is an antiviral medicine.
It is used for:
- treatment of skin and mucous membrane infections caused by the herpes simplex virus, including primary and recurrent genital herpes;
- prevention of herpes simplex virus recurrences in patients with normal immunity;
- prevention of herpes simplex virus infections in patients with reduced immunity;
- treatment of infections caused by the chickenpox and shingles virus.
2. Important information before taking Heviran
When not to take Heviran
- if the patient is allergicto acyclovir, valacyclovir, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting treatment with Heviran, the patient should discuss it with their doctor if:
- the patient has kidney disease;
- the patient is taking other medicines that may damage the kidneys;
- the patient is dehydrated;
- the patient is elderly.
In case of doubts whether the above circumstances apply to the patient, they should consult their doctor before starting treatment with Heviran.
During treatment, the patient should drink plenty of fluids to avoid the risk of kidney damage and reduce the risk of side effects.
Heviran and other medicines
The patient should inform their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take, especially:
- probenecid - a medicine used for gout
- cimetidine - a medicine used mainly for stomach and duodenal ulcers
- mycophenolate mofetil - a medicine used after organ transplants
- theophylline - a medicine used for asthma and other respiratory diseases.
Heviran with food and drink
The medicine can be taken regardless of meals.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The medicine can be used during pregnancy only if the doctor believes that the expected benefit to the mother outweighs the risk to the fetus.
Acyclovir passes into breast milk. Due to the risk of side effects in the breastfed child, the patient should decide with their doctor whether to stop taking the medicine or stop breastfeeding while taking the medicine.
Driving and using machines
The medicine may cause side effects that affect the ability to drive or operate machines. The patient should not drive or operate machines unless they are sure they feel well.
Heviran contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".
3. How to take Heviran
This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The doses of the medicine may vary for different patients.
Treatment should be started as soon as possible after diagnosis.
During treatment, the patient should drink plenty of fluids to avoid the risk of kidney damage and reduce the likelihood of side effects.
The tablets should be swallowed with water.
Use in adults
Treatment of herpes simplex virus infections
The medicine should be taken in a dose of 200 mg five times a day (approximately every 4 hours) with a night break. The medicine is usually taken for 5 days, but in cases of severe primary infections, the doctor may extend the treatment.
For patients with significantly reduced immunity (e.g., after bone marrow transplantation), the doctor may double the dose to 400 mg.
Prevention of herpes simplex virus infections in patients with reduced immunity
To prevent herpes simplex virus infection in patients with reduced immunity, 200 mg is given four times a day, approximately every 6 hours.
For patients with significantly reduced immunity (e.g., after bone marrow transplantation), the doctor may decide to increase the dose to 400 mg.
Treatment of chickenpox and shingles virus infections
The medicine should be taken in a dose of 800 mg five times a day (approximately every 4 hours), with a night break. The medicine is usually taken for 7 days.
Treatment should be started as soon as possible after diagnosis. The best treatment results for both chickenpox and shingles are achieved when the medicine is given within 24 hours of the first skin changes - rash.
Use in children and adolescents
Treatment of herpes simplex virus infections and prevention of herpes simplex virus infections in patients with reduced immunity:
Children over 2 years of age
- dose as for adults. Children under 2 years of age
- half the adult dose.
Treatment of chickenpox virus infections:
Children over 6 years of age
- 800 mg four times a day. Children between 2 and 5 years of age
- 400 mg four times a day. Children under 2 years of age
- 200 mg four times a day.
The medicine is taken for 5 days.
The dose can also be determined more precisely by administering 20 mg/kg of body weight (up to a maximum dose of 800 mg) four times a day.
Use in elderly patients
In elderly patients, the doctor will consider the possibility of impaired kidney function and adjust the dose of the medicine accordingly (see: Use in patients with impaired kidney function).
During treatment, the patient should drink plenty of fluids.
Use in patients with impaired kidney function
Caution should be exercised when taking Heviran in patients with impaired kidney function.
During treatment, the patient should drink plenty of fluids.
During treatment of herpes simplex virus infections or prevention of these infections in patients with severe kidney impairment (creatinine clearance less than 10 ml/min), the doctor may recommend reducing the dose to 200 mg given twice a day, approximately every 12 hours.
During treatment of chickenpox and shingles virus infections in patients with moderate kidney impairment (creatinine clearance 10-25 ml/min), the doctor may recommend reducing the dose to 800 mg given three times a day, approximately every 8 hours, and in patients with severe kidney impairment (creatinine clearance less than 10 ml/min) - reducing the dose to
| Prevention of herpes simplex virus recurrences in patients with normal immunity | |
| The medicine should be taken in a dose of 200 mg four times a day (approximately every 6 hours). | |
| However, for some patients, the doctor may use a different dosing regimen: 400 mg twice a day (approximately every 12 hours) or even 800 mg once a day. | |
| A dose gradually reduced by the doctor to 200 mg three times a day (approximately every 8 hours) or even twice a day (approximately every 12 hours) may also be effective. | |
| The treating doctor will decide to discontinue treatment every 6 to 12 months to observe any changes in the course of the disease. | |
| The doctor will decide to discontinue treatment every 6 to 12 months to observe any changes in the course of the disease. | |
800 mg twice a day, approximately every 12 hours.
Overdose of Heviran
In case of taking too much of the medicine, the patient should inform their doctor or pharmacist or contact the nearest hospital emergency department for further advice.
Missing a dose of Heviran
If a dose of the medicine is missed, it should be taken as soon as possible. If it is already time for the next dose, the missed dose should not be taken. A double dose should not be taken to make up for a missed dose.
Stopping treatment with Heviran
The patient should not stop taking the medicine even if they feel well, unless their doctor advises them to do so.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.
4. Possible side effects
Like all medicines, Heviran can cause side effects, although not everybody gets them.
In case of the following rare (occurring in less than 1 in 1,000 patients)symptoms, the patient should immediately contact their doctor:
- shortness of breath, angioedema (e.g., swelling of the face, tongue, and larynx, causing breathing difficulties)
- allergic reaction (often manifested as skin rashes, blisters, and ulcers of the mouth and (or) eyes, sometimes with high fever).
The following side effects may also occur during treatment:
Common (occurring in less than 1 in 10 patients):
- headache, dizziness
- nausea, vomiting, diarrhea, abdominal pain
- itching, rash (including photosensitivity)
- fatigue, fever.
Uncommon (occurring in less than 1 in 100 patients):
- hives
- increased hair loss.
Very rare (occurring in less than 1 in 10,000 patients):
- excitement, tremors
- coordination disorders (ataxia)
- speech disorders
- disorientation, hallucinations
- psychotic symptoms
- brain damage (encephalopathy)
- seizures, drowsiness, coma
- hepatitis and jaundice
- acute kidney failure, kidney pain. Kidney pain may be related to kidney failure. The patient should be given adequate fluids. Kidney function disorders usually resolve quickly after fluid supplementation in the patient and (or) after reducing the dose or discontinuing the medicine.
There have been reports of acute kidney failure.
Heviran may cause changes in blood tests and therefore the doctor may recommend regular blood tests.
During treatment, the following may occur:
Rare (occurring in less than 1 in 1,000 patients):
- increased creatinine and urea levels in the blood (substances that indicate kidney function)
- increased liver enzyme activity and bilirubin in serum (substances that indicate liver function).
Very rare (occurring in less than 1 in 10,000 patients):
- decreased platelet count, which may affect blood clotting. If unexplained bruising, red or purple spots on the skin occur, the doctor should be informed.
- decreased white blood cell count or anemia.
Reporting side effects
If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.
5. How to store Heviran
The medicine should be stored out of sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect from light and moisture.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
6. Contents of the pack and other information
What Heviran contains
- The active substance of the medicine is acyclovir. Each tablet contains 200 mg, 400 mg, or 800 mg of acyclovir.
- The other ingredients are: tablet core:microcrystalline cellulose, povidone, sodium carboxymethylcellulose, magnesium stearate;tablet coating: hypromellose, macrogol 6000, titanium dioxide, triethyl citrate, talc.
The medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".
What Heviran looks like and contents of the pack
The 200 mg and 400 mg film-coated tablets are white, round, and biconvex.
The 800 mg film-coated tablets are white, oval, and biconvex, with a dividing line.
The tablet can be divided into equal doses.
The pack contains 30 tablets.
Marketing authorization holder and manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01
Date of last revision of the package leaflet:
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- ImporterZakłady Farmaceutyczne POLPHARMA S.A.
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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