Hascovir

Package Leaflet: Information for the Patient

HASCOVIR

200 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 aciclovir, which inhibits the replication of pathogenic viruses of the Herpes group in humans.
Indications for use
Hascovir oral suspension 200 mg/5 ml is indicated:

• for the treatment of skin and mucous membrane infections caused by the herpes simplex virus, including primary and recurrent herpes simplex genital infections (except for herpes simplex virus infections in newborns and severe herpes simplex virus infections in children with significantly reduced immunity);
• for the prevention of herpes simplex recurrences 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 aciclovir or valaciclovir or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Hascovir, you should 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.

Hydration status
Patient taking high doses of aciclovir (e.g., in the treatment of shingles and administration of 4 g of aciclovir per day) should drink plenty of fluids to maintain proper hydration of the body.

Hascovir and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to 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 plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Aciclovir should be avoided during pregnancy unless your doctor considers that the benefits of taking the medicine outweigh the risks to the fetus.
Breastfeeding
Caution should be exercised when taking the medicine during breastfeeding due to the passage of the medicine into human milk.

Driving and using machines

The effect of aciclovir on the ability to drive and use machines has not been studied. However, you should consider the possibility of side effects of aciclovir, 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 or your child have previously been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disease in which the 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, you should contact 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".

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 your 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 (one-quarter) milliliter or ½ (one-half) milliliter (i.e., 10 mg or 20 mg of aciclovir).
The Hascovir oral suspension contains 200 mg of aciclovir per 5 ml, which means 1 ml of the suspension corresponds to 40 mg of aciclovir.

Recommended dose for adults Treatment of herpes simplex virus infections

The recommended dose is 200 mg of aciclovir (which corresponds to 5 ml of the suspension with a strength of 200 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, your 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, your doctor may decide to double the dose of aciclovir to 400 mg (i.e., to 10 ml of the suspension with a strength of 200 mg/5 ml) or to administer aciclovir intravenously.
Treatment should be started as soon as possible after diagnosis of the infection. 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 herpes simplex recurrences in patients with normal immunity
In patients with normal immunity, the recommended dose is 200 mg of aciclovir (which corresponds to 5 ml of the suspension with a strength of 200 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 higher dose of aciclovir - 400 mg (i.e., 10 ml of the suspension with a strength of 200 mg/5 ml) twice a day, every 12 hours.
Preventively, a dose of aciclovir reduced gradually to 200 mg (i.e., to 5 ml of the suspension with a strength of 200 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 aciclovir (i.e., 20 ml of the suspension with a strength of 200 mg/5 ml).
Your doctor will decide to stop taking 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 aciclovir (which corresponds to 5 ml of the suspension with a strength of 200 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, your doctor may decide to double the dose to 400 mg of aciclovir (i.e., to 10 ml of the suspension with a strength of 200 mg/5 ml) or to administer aciclovir intravenously.
The duration of preventive treatment will be determined by your doctor, taking into account the duration of the risk of infection.
Treatment of varicella-zoster virus infections
The recommended dose is 800 mg of aciclovir (i.e., 20 ml of the suspension with a strength of 200 mg/5 ml) five times a day, approximately every 4 hours, with a night break.
The medicine is taken for 7 days.
Your 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 of the infection. The best treatment results for both varicella and zoster 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: half of the dose recommended for adults should be administered.
Treatment of varicella-zoster virus infections
Children over 6 years of age: it is recommended to administer 800 mg of aciclovir (which corresponds to 20 ml of the suspension with a strength of 200 mg/5 ml) four times a day.
Children from 2 to 5 years of age: it is recommended to administer 400 mg of aciclovir (which corresponds to 10 ml of the suspension with a strength of 200 mg/5 ml) four times a day.
Children under 2 years of age: it is recommended to administer 200 mg of aciclovir (which corresponds to 5 ml of the suspension with a strength of 200 mg/5 ml) four times a day.
The medicine is taken for 5 days.
Your doctor may also determine the dose more precisely and recommend administering 20 mg of aciclovir per kilogram of body weight (up to a maximum dose of 800 mg of aciclovir - i.e., up to 20 ml of the suspension with a strength of 200 mg/5 ml) four times a day.
There is a lack of detailed data on the recommended dosage of aciclovir for the prevention of herpes simplex virus recurrences and the treatment of zoster in children with normal immunity.

Use in elderly patients

In elderly patients, your 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 aciclovir 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), your doctor may recommend reducing the dose to 200 mg of aciclovir (i.e., to 5 ml of the suspension with a strength of 200 mg/5 ml) administered twice a day, approximately every 12 hours.
During the treatment of varicella-zoster virus infections in patients with moderate renal impairment (creatinine clearance 10-25 ml/min), your doctor may recommend reducing the dose to 800 mg of aciclovir (i.e., to 20 ml of the suspension with a strength of 200 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 aciclovir (i.e., to 20 ml of the suspension with a strength of 200 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 aciclovir will cause serious problems.
Single ingestion of even a dose of up to 20 g of aciclovir by a patient usually does not cause symptoms of poisoning. Unintentional, repeated oral overdose of aciclovir over several days was associated with gastrointestinal symptoms (nausea, vomiting) and neurological symptoms (headache, confusion).
If you have taken too much of the medicine, you should inform your doctor or pharmacist or contact the nearest hospital emergency department for further advice.

Missed dose of Hascovir

If you miss a dose, you should take it as soon as possible and continue treatment as before. However, if it is almost time for the next dose, you should skip the missed dose.
Do not take a double dose to make up for the missed dose.
If you have any further questions about taking this medicine, you should 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 aciclovir include:

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

Uncommon side effects(may occur in up to 1 in 100 patients):

• urticaria, cases of accelerated, widespread hair loss. Since accelerated, widespread hair loss may be associated with many diseases and the use of many medicines, its relationship to the action of aciclovir is uncertain.

Rare side effects(may occur in up to 1 in 1,000 patients):

• angioedema (most often 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 occur in less than 1 in 10,000 patients):

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

The above events are usually transient and are most often 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. You should drink plenty of fluids. Impaired renal function 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 side effects

If you experience any side effects, including those not listed in this leaflet, you should 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Hascovir

Keep the 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 aciclovir. The medicine contains 200 mg of aciclovir per 5 ml, which means 1 ml contains 40 mg of aciclovir.
• 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 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
Information about the medicine
tel.: 22 742 00 22
e-mail: [email protected]

Date of last revision of the leaflet: