Heviran comfort max
Poland
Table of Contents
Patient Information Leaflet
Heviran Comfort MAX, 400 mg, tablets
Aciclovirum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as
instructed by the doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, please consult your pharmacist.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement after one month, or if you feel worse, contact your doctor.
Table of Contents
- What Heviran Comfort is and what it is used for
- Important information before taking Heviran Comfort
- How to take Heviran Comfort
- Possible side effects
- How to store Heviran Comfort
- Contents of the pack and other information
1. What Heviran Comfort is and what it is used for
Heviran Comfort is an antiviral medicine.
The active substance in Heviran Comfort is aciclovir, which inhibits the replication of human pathogenic viruses from the Herpes group.
Heviran Comfort is used for the prevention of:
- recurrent herpes simplex in immunocompetent adults.
Heviran Comfort may only be used in patients who have previously been diagnosed with herpes simplex virus infection.
If there is no improvement after one month, or if you feel worse, consult your doctor.
2. Important information before using Heviran Comfort
When not to use Heviran Comfort
- if the patient is allergic to aciclovir, valaciclovir, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting treatment with Heviran Comfort, discuss it with your doctor or
pharmacist.
Do not use Heviran Comfort without prior consultation with a doctor:
- in patients with impaired kidney function
- in patients taking other medicines that may damage the kidneys
- in elderly patients (aged 65 years or older)
- in pregnant or breastfeeding women (see section "Pregnancy, breastfeeding and fertility")
- in patients who have experienced particularly severe recurrent herpes labialis
- in patients who have experienced particularly severe recurrent genital herpes
- if frequent (more than 6 per year) and longer-lasting recurrences of herpes occur (no positive treatment effects after 5 days of therapy) than previously observed, with more severe clinical symptoms (e.g. new infection sites developing after 3–4 days of treatment). This may indicate immunodeficiency or absorption disorders requiring diagnosis and a different dosage regimen.
Patients who develop herpes while taking Heviran Comfort prophylactically should consult a doctor.
Do not use Heviran Comfort in patients with weakened immune systems (e.g. after bone marrow transplantation, or HIV-infected individuals). Patients with weakened immunity should consult a doctor regarding treatment of any infection.
During treatment, drink plenty of fluids to avoid kidney damage.
Children and adolescents
Heviran Comfort should not be used in children and adolescents under 18 years of age.
Heviran Comfort and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to use, particularly:
- probenecid – a medicine used in gout
- cimetidine – a medicine mainly used in peptic ulcer disease
- mycophenolate mofetil – a medicine used after organ transplantation
- theophylline – a medicine used in the treatment of asthma and other respiratory disorders.
Heviran Comfort with food and drink
This medicine can be taken independently of meals.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor before using this medicine.
Avoid using this medicine during pregnancy. The medicine may be used during pregnancy only if, in the opinion of the doctor, the expected benefit to the mother outweighs the risk to the fetus.
Aciclovir passes into breast milk. Due to the risk of adverse effects in the breastfed infant, a decision should be made in consultation with a doctor whether to discontinue the medicine or to stop breastfeeding during treatment.
Driving and operating machinery
There are no data on the effect of this medicine on the ability to drive or operate machinery.
However, the possibility of adverse effects of aciclovir such as dizziness, confusion, or seizures should be considered. Do not drive or operate machinery unless the patient is certain that he or she feels well.
Heviran Comfort contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".
3. How to use Heviran Comfort
This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
It is recommended to drink plenty of fluids while taking this medicine to avoid the risk of kidney damage and to reduce the likelihood of adverse effects.
Tablets should be swallowed with water.
Adults
The recommended dose is 1 tablet (400 mg) taken orally twice daily, every 12 hours.
Heviran Comfort may be used without medical consultation for up to 1 month, particularly during periods of exposure to factors that trigger herpes recurrences (e.g. increased exposure to sunlight, stress, fever).
Use in patients with renal impairment
Patients with impaired kidney function should drink large amounts of fluids while taking Heviran Comfort (see also section 2 "Warnings and precautions").
In patients with severe renal impairment, with creatinine clearance less than 10 ml/min, dosage adjustment of acyclovir must be determined exclusively by a physician.
Use in elderly patients
In elderly patients, impaired kidney function should be considered.
In patients with severe renal impairment, with creatinine clearance less than 10 ml/min, the dosage regimen of acyclovir must be determined solely by a physician, who will adjust the dose accordingly (see above: "Dosage in patients with renal impairment"). Adequate fluid intake is recommended during treatment.
Taking more Heviran Comfort than recommended
It is unlikely that accidental overdose would cause serious problems. Single oral doses of acyclovir up to 20 g have generally not caused toxic symptoms. However, unintentional, repeated oral overdosage over several days has been associated with gastrointestinal symptoms (nausea, vomiting) and neurological symptoms (headache, confusion).
In case of overdose, inform your doctor or pharmacist or contact the nearest hospital emergency department for further advice.
Missed dose of Heviran Comfort
If a dose is missed, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following rare (occurring in no more than 1 in
1,000 patients) symptoms occur, contact a doctor immediately:
- shortness of breath, angioedema (e.g. swelling of the face, tongue, and airway causing breathing difficulties)
- anaphylactic reaction (often manifesting as itching, urticaria, shortness of breath, drop in blood pressure, rapid heartbeat).
The following adverse reactions may also occur during treatment with this medicine:
Common (occurring in no more than 1 in 10 patients)
- headache, dizziness
- nausea, vomiting, diarrhoea, abdominal pain
- itching, rash (including photosensitivity)
- fatigue, fever.
Uncommon (occurring in no more than 1 in 100 patients)
- urticaria
- diffuse, accelerated hair loss. Since diffuse, accelerated hair loss may be associated with many diseases and with the use of many drugs, its relationship to the action of acyclovir is uncertain.
Very rare (occurring in no more than 1 in 10,000 patients)
- agitation, tremor
- movement coordination disorders (ataxia)
- speech disorders
- disorientation, hallucinations
- psychotic symptoms
- brain damage (encephalopathy)
- seizures, somnolence, coma
- hepatitis and jaundice
- acute kidney failure, kidney pain. Kidney pain may be associated with kidney (renal) failure. Renal function disorders usually resolve quickly after fluid supplementation in the patient and (or) after dose reduction or discontinuation of the medicine.
Heviran Comfort may cause changes in blood parameters, therefore the doctor may recommend
periodic blood tests. During treatment with the medicine, the following may occur:
Rare
- increased blood creatinine and urea levels (substances indicating kidney function)
- transient increase in liver enzyme activity and serum bilirubin (substances indicating liver function).
Very rare
- decreased platelet count, which may affect blood clotting. If unexplained bruising or red or purple spots appear on the skin, inform the doctor.
- decreased white blood cell count or anaemia.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor or pharmacist. Adverse reactions can be
reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Faks: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of the medicine.
5. How to store Heviran Comfort
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
Store in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the pack and other information
What Heviran Comfort contains
- The active substance is acyclovir. Each tablet contains 400 mg of acyclovir.
- Other components: microcrystalline cellulose, povidone, sodium carboxymethyl starch (type A), magnesium stearate.
What Heviran Comfort looks like and contents of the pack
400 mg tablets are white, round, and biconvex.
The pack contains 30 or 60 tablets.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01