Package leaflet: Information for the patient

Hascovir Control
200 mg, tablets
Aciclovir
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please contact your pharmacist.
If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.
If there is no improvement after 5 days, or if you feel worse, contact your doctor.

Contents of the leaflet

What Hascovir Control is and what it is used for
Important information before taking Hascovir Control
How to take Hascovir Control
Possible side effects
How to store Hascovir Control
Contents of the pack and other information

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

The active substance in Hascovir Control is aciclovir, which inhibits the replication of disease-causing human viruses from the Herpes group.
Hascovir Control is used to treat:

recurrent herpes labialis (cold sores) of the lips and face caused by herpes simplex virus (Herpes simplex) in adults;
recurrent external genital herpes caused by herpes simplex virus (Herpes simplex) in adults.

In recurrent infections, it is particularly important to start treatment during the early symptomatic phase, such as itching, burning, or tingling sensations.
Hascovir Control should only be used in patients who have previously been diagnosed with herpes simplex virus infection by a doctor.
If there is no improvement after 5 days, or if you feel worse, consult your doctor.

2. Important information before using Hascovir control

When not to use 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 treatment with Hascovir control, discuss it with your doctor or pharmacist.
Do not use Hascovir control without prior consultation with a doctor:

in patients with impaired kidney function;
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 weakened immunity (e.g. after bone marrow transplantation, HIV-infected). Individuals with weakened immunity should consult a doctor regarding treatment of any infection;
in patients who have experienced particularly severe recurrent herpes labialis;
in patients who have experienced particularly severe recurrent genital herpes;
if frequent recurrences (>6 per year) occur, lasting longer than before (no positive treatment effect after 5 days of therapy), with more severe clinical symptoms (e.g. when new infection sites develop after 3–4 days of treatment). This may indicate immunodeficiency or absorption disorders requiring diagnosis and a different dosage regimen.

Children and adolescents
Hascovir control must not be used in children and adolescents under 18 years of age.
Hascovir control and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, especially:

probenecid – a medicine used in gout;
cimetidine – a medicine mainly used in peptic ulcer disease;
mycophenolate mofetil – a medicine used after organ transplantation.

Taking Hascovir control with food and drink
Taking Hascovir control with food does not affect its absorption. Hascovir control may be taken with or without food. During treatment, drink plenty of fluids to avoid kidney damage.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor before using this medicine.
Avoid using this medicine during pregnancy unless the doctor considers the benefit to the mother to outweigh the potential risk to the fetus.
The medicine passes into breast milk; therefore, caution should be exercised when using it during breastfeeding. The medicine may be used only after consultation with a doctor.
Driving and operating machinery
There are no data on the effect of the medicine on the ability to drive or operate machinery.
However, the possibility of adverse effects of aciclovir such as dizziness, confusion, and seizures should be taken into account.
Hascovir control contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to use Hascovir Control

This medicine should always be taken exactly as described in the patient leaflet or as directed by
your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults
Hascovir Control should be taken orally at a dose of 200 mg five times daily, every 4 hours
(with a nighttime break), for 5 days.
In recurrent infections, it is particularly important to start treatment during the prodromal phase,
before the appearance of symptoms such as itching, burning, or tingling, or immediately after the
first skin lesions appear.
Dosage in patients with renal impairment
Patients with impaired kidney function should drink large amounts of fluids during treatment with
Hascovir Control (see also section 2 "Warnings and precautions").
In patients with severe renal impairment, with creatinine clearance less than 10 ml/min, dosage
regimen of acyclovir must be determined exclusively by a physician. In such patients, the doctor
may recommend reducing the dose to 1 tablet (200 mg) twice daily, approximately every 12 hours.
Dosage in elderly patients
In elderly patients, impaired renal function should be considered.
In patients with severe renal impairment, with creatinine clearance less than 10 ml/min, the dosage
regimen of acyclovir must be determined exclusively by a physician, who will adjust the dose
appropriately (see: Dosage in patients with renal impairment).
Adequate fluid intake is recommended during treatment.
Taking more Hascovir Control than recommended
Single ingestion of up to 20 g of acyclovir usually does not cause symptoms of poisoning.
Accidental, repeated overdosage of orally administered acyclovir over several days has been
associated with gastrointestinal symptoms (nausea, vomiting) and neurological symptoms
(headache, confusion - disturbance of thought process).
If an overdose of this medicine is taken, seek immediate advice from a doctor or pharmacist.
If you forget to take Hascovir Control
Take the missed dose as soon as possible.
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should contact your doctor immediately or go to the nearest hospital emergency department if you experience:

anaphylactic reaction (a potentially life-threatening allergic reaction, with symptoms such as: itching, urticaria, shortness of breath, drop in blood pressure, rapid heartbeat) – rare (in 1 to 10 people per 10,000);
angioedema (swelling of soft tissues of the face, lips, tongue, sometimes with concurrent laryngeal swelling, which may impair breathing) – rare (in 1 to 10 people per 10,000).

Common (in 1 to 10 patients per 100):

headache and dizziness;
nausea, vomiting, diarrhoea, abdominal pain;
itching, rash (which may also appear following exposure to sunlight);
fatigue, fever.

Uncommon (in 1 to 10 patients per 1,000):

skin reactions: urticaria, hair loss.

Rare (in 1 to 10 patients per 10,000):

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

Very rare (occurring in less than 1 patient per 10,000):

anaemia, decreased number of white blood cells, thrombocytopenia (low platelet count);
agitation, disorientation, tremor, 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
Jerozolimskie Avenue 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Hascovir Control

Keep this medicine 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 stated month.
No special storage instructions apply to this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Hascovir Control contains

The active substance is acyclovir. Each tablet contains 200 mg of acyclovir.
The other ingredients (excipients) are: monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch (type A), potato starch, magnesium stearate.

What Hascovir Control looks like and contents of the pack
White, biconvex, round, uncoated tablets with a uniform smooth surface.
One pack contains 25 or 30 tablets.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicinal product information
tel.: 22 742 00 22
e-mail: [email protected]