Hascovir control Max

Package Leaflet: Information for the Patient

Hascovir control MAX

400 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 this package leaflet for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse, a doctor should be consulted.

Table of Contents of the Package 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 aciclovir, which inhibits the multiplication of pathogenic viruses for humans in the Herpesgroup.
Hascovir control is used in:

• preventing recurrent herpes simplex in adults with normal immunity. If after 1 month there is no improvement or the patient feels worse, a doctor should be consulted.
• treating recurrent herpes labialis or genital herpes caused by the herpes simplex virus (Herpes simplex) in adults. If after 5 days there is no improvement or the patient feels worse, a doctor should be consulted. In the case of recurrent infections, it is particularly important to start treatment during the prodromal period (warning signs) or immediately after the first changes appear.

Hascovir control can only be used in patients who have been previously diagnosed with a herpes simplex virus infection.

2. Important information before taking Hascovir control

When not to take Hascovir control

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

Warnings and precautions

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

• in patients with kidney function disorders;
• in patients taking other medicines that may damage the kidneys;
• in elderly patients (65 years or older);
• in pregnant or breastfeeding women;
• in patients with particularly severe recurrent herpes labialis or particularly severe recurrent genital herpes;
• in case of frequent (more than 6 per year) and longer-lasting (no positive treatment effects after 5 days) recurrences of herpes, with more severe clinical symptoms (e.g., when new foci of infection appear after 3-4 days of treatment). This may indicate an immune deficiency or absorption disorders requiring diagnosis and a different dosage of the medicine.

During treatment, a large amount of fluid should be consumed to avoid the risk of kidney damage.
Hascovir control should not be taken by people with reduced immunity (e.g., after bone marrow transplantation, HIV infection). People with reduced immunity should consult a doctor about the treatment of any infection.
Patients who develop herpes while taking Hascovir control prophylactically should consult a doctor.

Children and adolescents

Hascovir control should not be taken by children and adolescents under 18 years of age.

Hascovir control and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently taken by the patient, as well as any planned medicines, 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

Concurrent food consumption does not affect the absorption of Hascovir control.
Hascovir control can be taken with or without food.
A large amount of fluid should be consumed during treatment.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor before taking this medicine.
The medicine should not be taken 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 during breastfeeding. The medicine can only be taken 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 possibility of side effects of aciclovir, such as dizziness, disorientation, seizures, should be taken into account.

Hascovir control contains lactose and sodium

If the patient has previously been diagnosed with intolerance to some sugars, the doctor should be consulted 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 this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.

Adults

Hascovir control can only be taken by patients who have been previously diagnosed with a herpes simplex virus infection.
Preventing recurrent herpes simplex
The medicine should be taken orally in a dose of 400 mg (1 tablet) twice a day, every 12 hours.
Without consulting a doctor, the medicine can be taken for a maximum of 1 month, especially during periods of exposure to factors that trigger recurrences of herpes (e.g., increased sun exposure, stress, fever).
Treating recurrent herpes labialis or genital herpes
The medicine should be taken orally in a dose of 200 mg (half a tablet) five times a day, every 4 hours (with a night break), for 5 days.
In the case of recurrent infections, it is particularly important to start treatment during the prodromal period (warning signs) or immediately after the first changes appear.

Use in children and adolescents

Hascovir control should not be taken by children and adolescents under 18 years of age.

Use in patients with kidney function disorders

During treatment with Hascovir control, patients with kidney function disorders should drink large amounts of fluid (see also section 2 "Warnings and precautions").
In the case of patients with severe kidney function disorders, with a creatinine clearance of less than 10 ml/min, the dosage of aciclovir can only be determined by a doctor.

Use in elderly patients

In elderly patients, the possibility of kidney function disorders should be taken into account.
In the case of patients with severe kidney function disorders, with a creatinine clearance of less than 10 ml/min, the dosage of aciclovir can only be determined by a doctor, who will adjust the dose accordingly (see above: "Use in patients with kidney function disorders"). During treatment, a large amount of fluid should be consumed.

Taking a higher dose of Hascovir control than recommended

Aciclovir is only partially absorbed from the gastrointestinal tract. Single ingestion of a dose of aciclovir up to 20 g usually does not cause toxicity symptoms. Accidental, repeated overdose of orally administered aciclovir over a period of 7 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, a doctor or pharmacist should be consulted immediately.

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.
In case of any further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Seek immediate medical attention if the following occurs:

• anaphylactic reaction (life-threatening hypersensitivity reaction with symptoms such as itching, hives, shortness of breath, low blood pressure, rapid heartbeat) - occurs rarely(not more often than in 1 in 1000 people);
• angioedema (swelling of soft tissues of the face, lips, tongue, and sometimes with concurrent swelling of the larynx, which can make breathing difficult) - occurs rarely(not more often than in 1 in 1000 people).

During treatment with Hascovir control, other side effects may also occur:
Common(not more often than in 1 in 10 people):

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

Uncommon(not more often than in 1 in 100 people):

• skin reactions: hives, hair loss.

Rare(not more often than in 1 in 1000 people):

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

Very rare(less often than in 1 in 10,000 people):

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

Reporting side effects

If any side effects occur, including those not listed in this package leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Medicinal Product 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Hascovir control

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
There are no special precautions for storing the medicine.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of unused medicines. 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 aciclovir. One tablet contains 400 mg of aciclovir.
• -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 tablets in the shape of discs with a diameter of 12 mm, uncoated with a smooth surface and a dividing line on both sides.
The tablet can be divided into equal doses.
One pack of the medicine contains 30 or 60 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 package leaflet: