Hascovir

Package leaflet: Information for the patient

HASCOVIR
800 mg, tablets
( Aciclovirum )
Please read carefully this leaflet before using the medicine, because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm someone else, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Hascovir is and what it is used for
2. Important information before taking Hascovir
3. How to take Hascovir
4. Possible side effects
5. How to store Hascovir
6. Contents of the pack and other information

1. What Hascovir is and what it is used for

The active substance in Hascovir is aciclovir, which inhibits the replication of human pathogenic viruses from the Herpes group.
The indication for use of Hascovir 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 aciclovir, valaciclovir, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Hascovir should be used with caution in patients with renal impairment, especially those who are dehydrated and those receiving high doses of aciclovir or concomitant treatment with other medicines that may damage the kidneys.
When high doses of aciclovir are used, patients should drink plenty of fluids to reduce the risk of kidney damage.
Elderly patients and patients with renal impairment should use Hascovir with caution, as they belong to groups at increased risk of developing nervous system-related adverse reactions. Such symptoms reported so far usually resolved after discontinuation of the medicine (see section 4).
It has not been proven that aciclovir treatment reduces the risk of complications related to herpes zoster in immunocompetent patients.

Other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
No clinically significant interactions with other medicines have been observed.

Food and drink
Taking Hascovir with food does not affect its absorption.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Hascovir may be used during pregnancy only if, in the opinion of the physician, the benefit to the mother outweighs the potential risk to the fetus.
The medicine passes into human milk; therefore, it may be used during breastfeeding (with caution), but only after consultation with a doctor.

Driving and operating machinery
No data available.

The medicine contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Hascovir

This medicine should always be taken exactly as directed by your doctor. If you have any doubts, you should consult your doctor or pharmacist.
Oral administration.
The usual dose is:

• Adults: Treatment of infections caused by varicella-zoster virus (Varicella-zoster) – 800 mg (1 tablet) 5 times daily, every 4 hours (with a nighttime break). The medicine should be taken for 7 days.

Treatment should be started immediately after diagnosis. The best treatment outcomes, both in cases of chickenpox and shingles, are achieved when the medicine is administered within 24 hours of the appearance of the first skin lesions – rash.

• Children: Treatment of infections caused by varicella-zoster virus
  Children aged 6 years and older – 800 mg (1 tablet) 4 times daily.
  Children aged 2 to 5 years – 400 mg 4 times daily.
  Children under 2 years of age – 200 mg 4 times daily.

The doctor may determine the dose more precisely based on the patient's body weight: 20 mg/kg body weight (up to a maximum dose of 800 mg) 4 times daily.
Treatment should be continued for 5 days.
If a dose smaller than 800 mg (1 tablet) is required, formulations with a lower content of active substance are available.

• Patients with impaired kidney function If the patient has impaired kidney function, they should drink large amounts of fluids during treatment with Hascovir.

Patients with severe renal impairment – 800 mg (1 tablet) twice daily.
Patients with moderate renal impairment – 800 mg (1 tablet) 3 times daily.

• Elderly patients Treatment should be initiated with lower doses of the medicine. When high doses of acyclovir are used, the patient should drink large amounts of fluids. The medicine should be used with particular caution in elderly patients with renal impairment.

Taking more Hascovir than recommended
If you take more medicine than recommended, you should immediately contact your doctor or pharmacist.
Single ingestion of acyclovir doses up to 20 g usually does not cause toxic symptoms.
Accidental, repeated overdosage of orally administered acyclovir over a period of 7 days has been associated with gastrointestinal symptoms (nausea, vomiting) and nervous system symptoms (headache, confusion).

Missing a dose of Hascovir
If you miss a dose, take it as soon as possible.
If it is already time for the next dose, do not take a double dose to make up for the missed dose.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everyone experiences them.

Adverse reactions occurring frequently (in 1 to 10 patients out of 100):

• Headache and dizziness,
• Nausea, vomiting, diarrhoea, abdominal pain,
• Itching, rash (appearing as a result of exposure to sunlight),
• Fatigue, fever.

Adverse reactions occurring uncommonly (in 1 to 10 patients out of 1,000):

• Urticaria, diffuse hair loss.

Adverse reactions occurring rarely (in 1 to 10 patients out of 10,000):

• Anaphylactic reaction (a potentially life-threatening allergic reaction with symptoms such as: itching, urticaria, shortness of breath, drop in blood pressure, rapid heartbeat); if any of the above symptoms occur, contact your doctor immediately,
• Shortness of breath,
• Angioedema (swelling of soft tissues of the face, lips, tongue, sometimes with concurrent laryngeal swelling, which may impair breathing),
• Increased blood urea and creatinine levels, transient increase in bilirubin levels and liver enzyme activity in blood.

Adverse reactions occurring very rarely (less than 1 in 10,000 patients):

• Anaemia, decreased white blood cell count, thrombocytopenia,
• Restlessness, disorientation, tremors, ataxia, speech disorders, hallucinations, psychotic symptoms, seizures, somnolence, encephalopathy (brain damage), coma,
• Hepatitis, jaundice, acute kidney failure.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your 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 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
E-mail: [email protected]
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide 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.
Keep the medicine out of the 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 specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Hascovir contains

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

What Hascovir looks like and contents of the pack
Oval, biconvex, white, uncoated tablets with a uniform, smooth surface.
The pack contains 30 tablets.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Information on the medicine
tel. +48 (22) 742 00 22
e-mail: [email protected]