Hascovir Control

Package Leaflet: Information for the Patient

Hascovir control

200 mg, tablets

Aciclovir

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

This medicine should always be taken exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 5 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

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

The active substance of Hascovir control is acyclovir, which inhibits the multiplication of pathogenic viruses for humans in the Herpesgroup.
Hascovir control is used to treat:

• recurrent herpes labialis and facial herpes caused by the herpes simplex virus in adults;
• recurrent genital herpes caused by the herpes simplex virus in adults.

In the case of recurrent infections, it is especially important to start treatment during the prodromal period, such as itching, burning, or a feeling of tension.
Hascovir control can only be used in patients who have been previously diagnosed with herpes simplex virus infection by a doctor.
If after 5 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking Hascovir control

When not to take Hascovir control

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

Warnings and precautions

Before starting Hascovir control, the patient should discuss it with their doctor or pharmacist.
Hascovir control should not be taken without prior consultation with a doctor:

• in patients with renal impairment;
• in patients taking other medicines that may damage the kidneys;
• in elderly patients (over 65 years of age);
• in pregnant or breastfeeding women;
• in individuals with impaired immune function (e.g., after bone marrow transplantation, HIV-infected). Patients with impaired immune function should consult their doctor about treatment for any infection;
• in patients with severe recurrent herpes labialis;
• in patients with severe recurrent genital herpes;
• in case of frequent (> 6 per year) and prolonged (after 5 days of therapy, no positive treatment effects) recurrences of herpes, with more severe clinical symptoms (including when new foci of infection occur after 3-4 days of therapy). This may indicate an immune deficiency or absorption disorders requiring diagnosis and a different dosage of the medicine.

Children and adolescents

Hascovir control should not be used in children and adolescents under 18 years of age.

Hascovir control 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, especially:

• probenecid - a medicine used in gout;
• cimetidine - a medicine used mainly in gastric and duodenal ulcer disease;
• mycophenolate mofetil - a medicine used after organ transplants.

Taking Hascovir control with food and drink

Concomitant food intake does not affect the absorption of Hascovir control. Hascovir control can be taken with or without food.
During treatment, the patient should drink plenty of fluids to avoid kidney damage.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or are planning to have a baby, they should consult their doctor before taking this medicine.
Hascovir control should be avoided during pregnancy, unless the doctor considers that the benefit to the mother outweighs the potential risk to the fetus.
The medicine passes into breast milk, so caution should be exercised when taking it during breastfeeding. The medicine can only be used after consulting a doctor.

Driving and using machines

There is no data on the effect of the medicine on the ability to drive and use machines.
However, the patient should consider the possibility of side effects of acyclovir, such as dizziness, disorientation, seizures.

Hascovir control contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is considered "sodium-free".

3. How to take Hascovir control

This medicine should always be taken exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.

Adults

Hascovir control should be taken orally in a dose of 200 mg five times a day, every 4 hours (with a night break), for 5 days.
In the case of recurrent infections, it is especially important to start treatment during the prodromal period, such as itching, burning, or a feeling of tension, or immediately after the first changes appear.

Dosage in patients with renal impairment

During treatment with Hascovir control, patients with renal impairment should drink plenty of fluids (see also section 2 "Warnings and precautions").
In patients with severe renal impairment, with a creatinine clearance of less than 10 ml/min, the dosage of acyclovir should be determined by the doctor. In such patients, the doctor may recommend reducing the dose of the medicine to 1 tablet (200 mg) taken twice a day, every 12 hours.

Dosage in elderly patients

In elderly patients, the possibility of renal impairment should be considered.
In patients with severe renal impairment, with a creatinine clearance of less than 10 ml/min, the dosage of acyclovir should be determined by the doctor, who will adjust the dose of the medicine accordingly (see: Dosage in patients with renal impairment).
During treatment, the patient should drink plenty of fluids.

Taking a higher dose of Hascovir control than recommended

A single dose of acyclovir up to 20 g usually does not cause symptoms of poisoning.
Accidental, repeated overdose of acyclovir taken orally for several days is associated with gastrointestinal symptoms (nausea, vomiting) and neurological symptoms (headache, confusion).
In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Hascovir control

The missed dose should be taken as soon as possible.
A double dose should not be taken to make up for the missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Hascovir control can cause side effects, although not everybody gets them.

The patient should immediately contact their doctor or go to the nearest hospital emergency department if they experience:

• anaphylactic reaction (a life-threatening allergic reaction with symptoms such as itching, hives, shortness of breath, low blood pressure, rapid heartbeat) - rare (affects 1 to 10 people in 10,000);
• angioedema (swelling of the soft tissues of the face, lips, tongue, and sometimes with concurrent swelling of the larynx, which can make breathing difficult) - rare (affects 1 to 10 people in 10,000).

Frequently(affects 1 to 10 patients in 100):

• headache, dizziness;
• nausea, vomiting, diarrhea, abdominal pain;
• itching, rash (also occurring after exposure to sunlight);
• fatigue, fever.

Less frequently(affects 1 to 10 patients in 1,000):

• skin reactions: hives, hair loss.

Rarely(affects 1 to 10 patients in 10,000):

• shortness of breath;
• increased levels of urea and creatinine in the blood, transient increase in bilirubin and liver enzyme activity in the blood.

Very rarely(affects less than 1 patient in 10,000):

• anemia, decreased white blood cell count, thrombocytopenia (low platelet count);
• agitation, disorientation, tremors, ataxia, speech disorders, hallucinations, psychotic symptoms, seizures, somnolence, encephalopathy (brain damage), coma;
• hepatitis, jaundice;
• acute kidney failure.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their 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, phone: +48 22 49 21 301, fax: +48 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, more information can be collected on the safety of the medicine.

5. How to store Hascovir control

The medicine should be stored out of 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 stated.
There are no special precautions for storage.
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. Contents of the pack and other information

What Hascovir control contains

• -The active substance of Hascovir control is acyclovir. One tablet contains 200 mg of acyclovir.
• -The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), potato starch, magnesium stearate.

What Hascovir control looks like and contents of the pack

White, biconvex, round tablets, uncoated, with a smooth surface.
One pack of Hascovir control contains 25 or 30 tablets.

Marketing authorization holder and manufacturer

PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK S.A., 51-131 Wrocław, ul. Żmigrodzka 242 E

Medicine information

phone: 22 742 00 22
e-mail: [email protected]

Date of last revision of the leaflet: