Hascovir

Package Leaflet: Information for the Patient

HASCOVIR

400 mg/5 ml, Oral Suspension

Aciclovir

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Hascovir and what is it 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 is Hascovir and what is it used for

The active substance of Hascovir is acyclovir, which inhibits the multiplication of pathogenic viruses for humans, including the Herpesgroup.
Indications for use
Hascovir oral suspension 400 mg/5 ml is indicated:

• for the treatment of skin and mucous membrane infections caused by the herpes simplex virus, including primary and recurrent genital herpes (except for herpes simplex virus infections in newborns and severe herpes simplex virus infections in children with significantly reduced immunity);
• for the prevention of recurrent herpes simplex virus infections in patients with normal immunity;
• for the prevention of herpes simplex virus infections in patients with reduced immunity;
• for the treatment of infections caused by the varicella-zoster virus.

2. Important information before taking Hascovir

When not to take Hascovir

• if you are allergic to acyclovir or valacyclovir or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Hascovir, discuss it with your doctor, especially if you:

• have kidney problems,
• are taking other medicines that may harm your kidneys,
• have significantly reduced immunity,
• are 65 years of age or older.

1/7
Hydration status
Patient taking high doses of acyclovir (e.g., for the treatment of shingles and administration of 4 g of acyclovir per day) should drink plenty of fluids to maintain proper hydration.

Hascovir and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
In particular, inform your doctor if you are taking any of the following medicines:

• probenecid (used to treat gout),
• cimetidine (used to treat stomach ulcers),
• tacrolimus, cyclosporin, or mycophenolate mofetil (used in transplant patients),
• theophylline (used to treat asthma and other respiratory diseases).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Acyclovir should be avoided during pregnancy unless the doctor considers that the benefits of taking the medicine outweigh the risks to the fetus.
Breastfeeding
Caution should be exercised when taking the medicine in breastfeeding women due to the passage of the medicine into human milk.

Driving and using machines

The effect of acyclovir on the ability to drive and use machines has not been studied. However, you should consider the possibility of side effects of acyclovir, such as dizziness, disorientation, and seizures.

Hascovir contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate

Due to the presence of methyl parahydroxybenzoate and propyl parahydroxybenzoate, this medicine may cause allergic reactions (possible late reactions).

Hascovir contains sorbitol (E 420)

The medicine contains 450 mg of sorbitol per 1 ml. Sorbitol is a source of fructose. If you have been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disease in which the patient's body does not break down fructose, you should contact your doctor before taking the medicine or giving it to your child.

Hascovir contains propylene glycol (E 1520) – a component of banana flavor

The medicine contains 2.7 mg of propylene glycol per 5 ml. Before administering the medicine to a child under 4 weeks of age, consult your doctor or pharmacist, especially if the child is taking other medicines containing propylene glycol or alcohol.

Hascovir contains ethanol – a component of banana flavor

The medicine contains 1.4 mg of ethanol per 5 ml. The amount of ethanol in 5 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of ethanol in this medicine will not cause noticeable effects.

Hascovir contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 5 ml, which means the medicine is considered "sodium-free".
2/7

3. How to take Hascovir

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Method of administration
The medicine is taken orally.
Before use, shake the bottle well.
The dose of the medicine prescribed by the doctor is measured using the oral syringe provided with the packaging. The syringe has a capacity of 5 milliliters, and the scale of the syringe allows for measuring the volume of the dose with an accuracy of ¼ (a quarter) milliliter (i.e., 20 mg of acyclovir).
Hascovir oral suspension contains 400 mg of acyclovir per 5 ml, which means 1 ml of suspension corresponds to 80 mg of acyclovir.

Recommended dose for adults Treatment of herpes simplex virus infections

The recommended dose is 200 mg of acyclovir (which corresponds to 2.5 ml of suspension with a strength of 400 mg/5 ml) five times a day, approximately every 4 hours, with a night break.
Treatment lasts for 5 consecutive days, but in severe primary infections, the doctor may recommend extending the treatment.
In patients with significantly reduced immunity (e.g., after bone marrow transplantation) or with impaired absorption from the gastrointestinal tract, the doctor may decide to double the dose of acyclovir to 400 mg (i.e., to 5 ml of suspension with a strength of 400 mg/5 ml) or administer acyclovir intravenously.
Treatment should be started as soon as possible after diagnosis. In recurrent infections, it is especially important to start treatment during the prodromal period or immediately after the appearance of the first lesions.
Prevention of recurrent herpes simplex virus infections in patients with normal immunity
In patients with normal immunity, the recommended dose is 200 mg of acyclovir (which corresponds to 2.5 ml of suspension with a strength of 400 mg/5 ml) four times a day, approximately every 6 hours.
In many patients, effective and more convenient may be the administration of a twice larger dose of acyclovir - 400 mg (i.e., 5 ml of suspension with a strength of 400 mg/5 ml) twice a day, every 12 hours.
Preventively, a dose of acyclovir reduced gradually to 200 mg (i.e., to 2.5 ml of suspension with a strength of 400 mg/5 ml) administered three times a day, approximately every 8 hours, or even twice a day, approximately every 12 hours, may also be effective.
In some patients, the response to preventive administration of the medicine occurs after the application of a total daily dose of 800 mg of acyclovir (i.e., 10 ml of suspension with a strength of 400 mg/5 ml).
The doctor will decide to discontinue the medicine every 6 to 12 months to observe possible changes in the course of the disease.
Prevention of herpes simplex virus infections in patients with reduced immunity

To prevent herpes simplex virus infection in patients with reduced immunity, it is recommended to administer 200 mg of acyclovir (which corresponds to 2.5 ml of suspension with a strength of 400 mg/5 ml) four times a day, approximately every 6 hours.
In patients with significantly reduced immunity (e.g., after bone marrow transplantation) or with impaired absorption from the gastrointestinal tract, the doctor may decide to double the dose to 400 mg of acyclovir (i.e., to 5 ml of suspension with a strength of 400 mg/5 ml) or administer acyclovir intravenously.
The period of preventive administration of the medicine will be determined by the doctor, taking into account the duration of the risk of infection.
Treatment of varicella-zoster virus and shingles infections
The recommended dose is 800 mg of acyclovir (i.e., 10 ml of suspension with a strength of 400 mg/5 ml) five times a day, approximately every 4 hours, with a night break.
The medicine is taken for 7 days.
The doctor may decide to administer the medicine intravenously in patients with significantly reduced immunity (e.g., after bone marrow transplantation) or with impaired absorption from the gastrointestinal tract.
Treatment should be started immediately after diagnosis. The best treatment results for both varicella and shingles are achieved when the medicine is administered within 24 hours after the appearance of the first skin lesions - rash.

Recommended dose for children Treatment of herpes simplex virus infections and prevention of herpes simplex virus infections in patients with reduced immunity

Children over 2 years of age: the dosage is the same as recommended for adults.
Children under 2 years of age: should be given half the dose recommended for adults.
Treatment of varicella-zoster virus infections
Children over 6 years of age: it is recommended to administer 800 mg of acyclovir (which corresponds to 10 ml of suspension with a strength of 400 mg/5 ml) four times a day.
Children from 2 to 5 years of age: it is recommended to administer 400 mg of acyclovir (which corresponds to 5 ml of suspension with a strength of 400 mg/5 ml) four times a day.
Children under 2 years of age: it is recommended to administer 200 mg of acyclovir (which corresponds to 2.5 ml of suspension with a strength of 400 mg/5 ml) four times a day.
The medicine is taken for 5 days.
The doctor may also determine the dose more precisely and recommend administering 20 mg of acyclovir/kg of body weight (up to a maximum dose of 800 mg of acyclovir - i.e., up to 10 ml of suspension with a strength of 400 mg/5 ml) four times a day.
There is a lack of detailed data on the recommended dosage of acyclovir for the prevention of recurrent herpes simplex virus infections and the treatment of shingles in children with normal immunity.

Use in elderly patients

In elderly patients, the doctor will take into account the possibility of impaired renal function and adjust the dose of the medicine accordingly (see: Use in patients with impaired renal function).
During treatment, you should drink plenty of fluids.

Use in patients with impaired renal function

Caution should be exercised when taking acyclovir in patients with impaired renal function.
During treatment, you should drink plenty of fluids.
During the treatment of herpes simplex virus infections or the prevention of these infections in patients with severe renal impairment (creatinine clearance less than 10 ml/min), the doctor may recommend reducing the dose to 200 mg of acyclovir (i.e., to 2.5 ml of suspension with a strength of 400 mg/5 ml) administered twice a day, approximately every 12 hours.
During the treatment of varicella-zoster virus and shingles infections in patients with moderate renal impairment (creatinine clearance 10-25 ml/min), the doctor may recommend reducing the dose to 800 mg of acyclovir (i.e., 10 ml of suspension with a strength of 400 mg/5 ml) administered three times a day, approximately every 8 hours, and in patients with severe renal impairment (creatinine clearance less than 10 ml/min) - reducing the dose to 800 mg of acyclovir (i.e., to 10 ml of suspension with a strength of 400 mg/5 ml) administered twice a day, approximately every 12 hours.

Overdose of Hascovir

It is unlikely that accidental ingestion of an excessive dose of acyclovir will cause serious problems.
Single ingestion of even a dose of up to 20 g of acyclovir by a patient usually does not cause symptoms of poisoning. Unintentional, repeated oral overdose of acyclovir over several days was associated with gastrointestinal symptoms (nausea, vomiting) and neurological symptoms (headache, confusion).
If you have taken too much of the medicine, tell your doctor or pharmacist or contact the nearest hospital emergency department for further advice.

Missed dose of Hascovir

If you miss a dose, take it as soon as you remember and continue treatment as before. However, if it is almost time for the next dose, skip the missed dose.
Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In most cases, there were no data available to estimate the frequency of side effects, which may also vary depending on the indications for treatment. Known side effects observed during the use of acyclovir include:

• Common side effects(may affect up to 1 in 10 people):
• headache, dizziness,
• nausea, vomiting, diarrhea, abdominal pain,
• fatigue, fever,
• itching, rash (including hypersensitivity to light).

Uncommon side effects(may affect up to 1 in 100 people):

• urticaria, cases of accelerated, widespread hair loss. Since accelerated, widespread hair loss can be associated with many diseases and the use of many medicines, its relationship to the action of acyclovir is not certain.

Rare side effects(may affect up to 1 in 1,000 people):

• angioedema (most commonly occurs in the face, mainly in the area of the lips and eyelids, may also affect the tongue, glottis, or larynx, and can be life-threatening),
• shortness of breath,
• transient increase in bilirubin and liver enzyme activity in the blood,
• anaphylactic reaction (immediate allergic reaction, can be life-threatening),
• increase in urea and creatinine levels in the blood.

Very rare side effects(may affect up to 1 in 10,000 people):

• decrease in the number of different types of blood cells (anemia, thrombocytopenia, decreased white blood cell count),
• excitement, disorientation, tremors, ataxia, speech disorders, hallucinations, psychotic symptoms, seizures, somnolence, brain damage (so-called encephalopathy), coma.

5/7
The above events are usually transient and are most commonly observed in patients with impaired renal function or other predisposing factors (see section 2), and may also include:

• jaundice, hepatitis,
• acute renal failure, kidney pain. Kidney pain may be associated with kidney failure. The patient should be given adequate amounts of fluids. Renal impairment usually resolves quickly after fluid supplementation in the patient and (or) after dose reduction or withdrawal of the medicine. However, in exceptional cases, acute renal failure may occur.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please inform your 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:
Aleje Jerozolimskie 181C, 02-222 Warsaw,
tel.: 22 49 21 301, fax: 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 to gather more information on the safety of this medicine.

5. How to store Hascovir

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Shelf-life after first opening of the immediate packaging: 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Hascovir contains

• The active substance of Hascovir is acyclovir. The medicine contains 400 mg of acyclovir per 5 ml, which means 1 ml contains 80 mg of acyclovir.
• The excipients are: liquid sorbitol, non-crystallizing (E 420), glycerol (E 422), microcrystalline cellulose, and sodium carmellose, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate, banana flavor AR0476 [contains, among others, eugenol, propylene glycol (E 1520), and ethanol], purified water.

What Hascovir looks like and contents of the pack

Hascovir is a white suspension with a banana flavor and smell.
A brown glass bottle, type III, containing 150 ml of oral suspension, closed with a PE cap with a cork and a guarantee ring, in a cardboard box.
An oral syringe with a capacity of 5 ml is attached to the packaging.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
6/7
Information about the medicine
tel.: 22 742 00 22
e-mail: [email protected]

Date of last revision of the leaflet:

7/7