Hascovir

Leaflet included in the packaging: patient information

HASCOVIR

800 mg, tablets

(Aciclovirum)
You should carefully read the contents of the leaflet before using the medicine, as it contains
important information for the patient.

• -You should keep this leaflet, so that you can read it again if necessary.
• -In case of any doubts, you should consult a doctor or pharmacist.
• -This medicine has been prescribed to you for a specific purpose. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• -If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Hascovir and what is it used for
• 2. Important information before using Hascovir
• 3. How to use Hascovir
• 4. Possible undesirable effects
• 5. How to store Hascovir
• 6. Package contents and other information

1. What is Hascovir and what is it used for

The active substance of Hascovir is acyclovir, which inhibits the growth of pathogenic viruses for humans in the Herpesgroup.
The indication for use of the medicine is:

• treatment of infections caused by the varicella-zoster virus ( Varicella-zoster).

2. Important information before using Hascovir

When not to use Hascovir

• If the patient is allergic to acyclovir, valacyclovir, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

The medicine should be used with caution in patients with renal impairment, especially those who are dehydrated and being treated with high doses of acyclovir or receiving other medicines that may damage the kidneys.
When using high doses of acyclovir, the patient should drink plenty of fluids to avoid the risk of kidney damage.
Elderly patients and patients with renal impairment should use Hascovir with caution, as they belong to groups with an increased risk of neurological adverse effects. The symptoms reported so far have usually disappeared after discontinuation of the medicine (see section 4).
It has not been confirmed that treatment with acyclovir reduces the risk of complications associated with shingles in patients with normal immunity.

Hascovir and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No clinically significant interactions with other medicines have been found.

Hascovir with food and drink

Concomitant food intake does not affect the absorption of Hascovir.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
The medicine may be used during pregnancy only in cases where the benefit to the mother outweighs the potential risk to the fetus.
The medicine passes into breast milk, so it may be used during breastfeeding (with caution), but only after consulting a doctor.

Driving and operating machinery

No data available.

The medicine contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to use Hascovir

This medicine should always be used in accordance with the doctor's recommendations. In case of doubts, the patient should consult their doctor or pharmacist.
Oral administration.
The usual dose is:

• Adults:Treatment of infections caused by the varicella-zoster virus ( Varicella-zoster) 800 mg (1 tablet) 5 times a day every 4 hours (with a night break). The medicine should be used for 7 days.

Treatment should be started immediately after diagnosis of the infection. The best treatment results, both for chickenpox and shingles, are achieved when the medicine is administered within 24 hours of the appearance of the first skin changes - rash.

• Children:Treatment of infections caused by the varicella-zoster virus Children aged 6 and over
• 800 mg (1 tablet) 4 times a day. Children aged 2 to 5
• 400 mg 4 times a day. Children under 2 years
• 200 mg 4 times a day.

The dose for a child may be precisely determined by the doctor based on the patient's body weight; 20 mg/kg body weight (up to a maximum dose of 800 mg) 4 times a day.
Treatment should be continued for 5 days.
If a dose smaller than 800 mg (1 tablet) is required, other forms of the medicine with a lower active substance content are available.

• Patients with renal impairmentIf the patient has renal impairment, they should drink plenty of fluids while using Hascovir.

Patient with severe renal impairment - 800 mg (1 tablet) 2 times a day.
Patient with moderate renal impairment - 800 mg (1 tablet) 3 times a day.

• Elderly patientsTreatment should be started with lower doses of the medicine. When using high doses of acyclovir, the patient should drink plenty of fluids. The medicine should be used with particular caution in elderly patients with renal impairment.

Using a higher dose of Hascovir than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.
Single ingestion of a dose of acyclovir up to 20 g usually does not cause toxic symptoms.
Accidental, repeated overdose of orally administered acyclovir over a period of 7 days is associated with the occurrence of symptoms from the gastrointestinal (nausea, vomiting) and nervous (headache, disorientation) systems.

Missing a dose of Hascovir

In case of missing a dose, the patient should take it as soon as possible.
If it is already time for the next dose, the patient should not take a double dose to make up for the missed dose.

4. Possible undesirable effects

Like all medicines, Hascovir can cause undesirable effects, although not everybody gets them.
Undesirable effects occurin10 or more patients out of 100:

• headache, dizziness,
• nausea, vomiting, diarrhea, abdominal pain,
• fatigue, fever.

Undesirable effects occurin less than 10 patients out of 100, but more than 1 patient out of 1,000:

• hives, accelerated, diffuse hair loss.

Undesirable effects occurin less than 1 patient out of 1,000, but more than 1 patient out of 10,000:

• anaphylactic reaction (a life-threatening allergic reaction with symptoms such as hives, itching, difficulty breathing, low blood pressure, rapid heartbeat); in case of the above symptoms, the patient should immediately consult their doctor,
• shortness of breath,
• angioedema (swelling of the skin and mucous membranes, sometimes with swelling of the larynx, which can make breathing difficult),
• increased levels of urea and creatinine in the blood, transient increase in bilirubin levels and liver enzyme activity in the blood.

Undesirable effects occurin less than 1 patient out of 10,000:

• anemia, decreased white blood cell count, thrombocytopenia,
• excitation, disorientation, tremors, ataxia, speech disorders, hallucinations, psychotic symptoms, seizures, somnolence, encephalopathy (brain damage), sleepiness,
• hepatitis, jaundice, acute renal failure.

Reporting undesirable effects

If any undesirable effects occur, including any undesirable effects not mentioned in the leaflet, the patient should inform their doctor or pharmacist. Undesirable effects can be reported directly to the Department for Monitoring of Adverse Reactions of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: +48 22 49 21 301, fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Undesirable effects can also be reported to the marketing authorization holder.
Reporting undesirable effects helps to gather more information on the safety of the medicine.

5. How to store Hascovir

Store at a temperature not exceeding 25°C. Store in the original packaging.
The medicine should be kept out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month stated.
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. Package contents and other information

What Hascovir contains

• The active substance of Hascovir is acyclovir. One tablet contains 800 mg of acyclovir.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), potato starch, magnesium stearate.

What Hascovir looks like and what the package contains

Oval, biconvex, white, uncoated tablets with a uniform, smooth surface.
The package contains 30 tablets.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information about the medicine
tel. +48 (22) 742 00 22
e-mail: informacjaoleku@hasco-lek.pl

Date of the last update of the leaflet: