Hascovir

Patient Information Leaflet

You should read the contents of the leaflet before using the medicine.
You should keep this leaflet, so you can read it again if you need to.
You should consult a doctor or pharmacist if you need advice or additional information.
This text has been written specifically for the person it has been prescribed to and should not be passed on to others, as it may harm them, even if their symptoms are the same.

HASCOVIR

(Aciclovir)
200 mg, 400 mg, tablets

Composition: HASCOVIR, 200 mg tablets

1 tablet contains:
Active substance:
Aciclovir 200 mg
Excipients: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), potato starch, magnesium stearate.
Available packs contain 30 tablets in 2 blisters of 15 pieces each.
HASCOVIR, 400 mg tablets
1 tablet contains:
Active substance:
Aciclovir 400 mg
Excipients: lactose monohydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), potato starch, magnesium stearate.
Available packs contain 30 tablets in 2 blisters of 15 pieces each.
Responsible entity
"HASCO-LEK" Pharmaceutical Production Company S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Table of Contents of the Leaflet:

1. What is HASCOVIR and what is it used for
2. How to use HASCOVIR
3. How to take HASCOVIR
4. Possible side effects
5. Storage of HASCOVIR

What is HASCOVIR and what is it used for

The active substance of HASCOVIR is aciclovir, which has the ability to inhibit the multiplication of pathogenic viruses for humans, including the Herpesgroup.
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HASCOVIR is used for:

- treatment of skin and mucous membrane infections caused by the herpes simplex virus (Herpes simplex), including genital herpes (primary and recurrent infections);
- prevention of recurrent herpes simplex in patients with normal immunity;
- prevention of herpes simplex virus infections in patients with reduced immunity;
- treatment of infections caused by the varicella-zoster virus (Varicella-zoster).

2. Before using HASCOVIR

You should not use the medicine if you are hypersensitive to aciclovir, valaciclovir, or any other component of the medicine.
You should consult a doctor, even if the following warnings apply to past situations.
Using HASCOVIR with food and drink
Concurrent food intake does not affect the absorption of HASCOVIR.
Using HASCOVIR in patients with kidney and/or liver function disorders
The medicine should be used with caution in patients with kidney failure, especially dehydrated patients and those treated with high doses of aciclovir or receiving other medicines that may damage the kidneys. When administering high doses of aciclovir, you should consume a large amount of fluids to avoid the risk of kidney damage.
Pregnancy
You should consult a doctor before using the medicine.
The medicine may be used during pregnancy only in cases where the benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding
You should consult a doctor before using the medicine.
The medicine passes into breast milk, so it may be used with caution, only after consulting a doctor.
Driving vehicles and operating machinery
There are no data available.

Important information about some components of HASCOVIR

The medicine contains lactose. If you have previously been diagnosed with intolerance to some sugars, you should inform your doctor before taking the medicine.

3. How to use HASCOVIR

Although the symptoms may worsen at the beginning of treatment, you should continue using the medicine as recommended by your doctor.
Using HASCOVIR for skin infections
Adults and children over 12 years: usually 5 times a day, every 4 hours, for 5 days. In the case of genital herpes, 2 times a day, every 12 hours, for 5 days.
Children under 12 years: the dosage is determined by the doctor.

4. Possible side effects

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

1. Common (may occur in less than 1 in 10 patients):

• Nausea
• Vomiting
• Diarrhea
• Headache
• Dizziness

2. Uncommon (may occur in less than 1 in 100 patients):

• Rash
• Itching
• Fatigue

3. Rare (may occur in less than 1 in 1000 patients):

• Allergic reactions, such as hives, angioedema
• Kidney function disorders
• Neurological disorders (e.g., seizures, confusion, hallucinations) - especially in patients with kidney function disorders, the elderly, or children

If you experience any side effects, you should stop using the medicine and consult a doctor.

5. Storage of HASCOVIR

Store in room temperature (up to 25°C), in the original packaging, out of reach and sight of children.

Adults:

• treatment of infections caused by the herpes simplex virus (Herpes simplex):

200 mg 5 times a day, every 4 hours (with a night break), for 5 days. In the case of severe infections, the treatment may be extended. The administration of the medicine should be started as soon as possible after the infection has been diagnosed.

• prevention of recurrent herpes simplex in patients with normal immunity:

200 mg 4 times a day, every 6 hours (with a night break), or 400 mg 2 times a day, every 12 hours.

• prevention of herpes simplex virus infections in patients with reduced immunity:

200 mg 4 times a day, every 6 hours. The dose may be increased to 400 mg in patients with significantly reduced immunity.

• treatment of infections caused by the varicella-zoster virus (Varicella-zoster):

800 mg 5 times a day, every 4 hours (with a night break). The medicine should be used for 7 days.

Children:

• treatment of infections caused by the herpes simplex virus (Herpes simplex) and prevention of them in patients with reduced immunity:

from 2 years of age and above - as recommended for adults

• below 2 years - half of the recommended dose for adults
• treatment of infections caused by the varicella-zoster virus:

below 2 years - 200 mg 4 times a day
from 2 to 5 years - 400 mg 4 times a day
The dose can be precisely determined based on the patient's body weight; 20 mg/kg body weight (up to a maximum dose of 800 mg) 4 times a day. The treatment should be continued for 5 days.

• Dosage in patients with kidney function disorders

When using the medicine in patients with kidney function disorders, the dose should be delayed. The dose should be reduced.

• treatment of infections caused by the herpes simplex virus:

200 mg 4 times a day, every 6 hours. The dose may be increased to 400 mg in patients with significantly reduced immunity.

• prevention of recurrent herpes simplex:

200 mg 2 times a day, every 12 hours.

Important warnings and precautions Before starting to use the medicine, you should read the contents of the leaflet attached to the packaging.

The medicine should be used as recommended by your doctor.
You should avoid contact between the medicine and mucous membranes and eyes.
In the case of side effects, you should stop using the medicine and consult a doctor.
The medicine may cause side effects, such as dizziness, nausea, vomiting, and diarrhea.
The medicine may interact with other medicines. You should inform your doctor about all medicines you are taking.
The medicine should not be used by pregnant or breastfeeding women without consulting a doctor.
The medicine should be stored out of reach of children.
The medicine should be used with caution in patients with kidney function disorders.
The medicine may enhance the effect of other medicines that depress the central nervous system.
The medicine may cause drowsiness. You should be careful when driving vehicles and operating machinery.
The medicine should be used as recommended by your doctor.
In case of doubts, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, HASCOVIR can cause side effects.
– headaches and dizziness, nausea, vomiting, diarrhea, abdominal pain, itching, rash (which may also occur after exposure to sunlight), fatigue, fever.
Side effects that occur uncommonly (in 1 to 10 out of 1000 patients using the medicine):

• mild skin reactions, e.g., hives, hair loss.

Side effects that occur rarely (in 1 to 10 out of 10,000 patients using the medicine):

• anaphylactic reaction, shortness of breath, angioedema, increased levels of urea and creatinine in the blood, transient increase in bilirubin and liver enzymes in the blood.

Side effects that occur very rarely (less than 1 in 10,000 patients using the medicine):

• anemia, decreased white blood cell count, thrombocytopenia, agitation, confusion, tremors, ataxia, speech disorders, fainting, psychotic symptoms, seizures, somnolence, encephalopathy, coma, hepatitis, redness of kidney failure.

In some people, other side effects may occur during the use of the medicine, the frequency of which is not known.

5. Overdose procedure

In the case of taking a larger dose of the medicine than recommended:
Aciclovir is only partially absorbed from the gastrointestinal tract. A single dose of aciclovir up to 20 g usually does not cause symptoms of toxicity. Accidental, repeated overdose of orally administered aciclovir over a period of 7 days is associated with symptoms from the gastrointestinal tract (nausea, vomiting) and neurological symptoms (headache, confusion).
Procedure after overdose: In the event of an overdose, the patient should be monitored. Hemodialysis may be necessary.
In the event of taking a larger dose of the medicine than recommended, you should immediately consult a doctor or pharmacist.

6. Pharmacodynamics

Aciclovir is an antiviral medicine. The mechanism of action of aciclovir involves the inhibition of the replication of the herpes simplex virus (Herpes simplex virus - HSV) and the varicella-zoster virus (Varicella-zoster virus - VZV).
Aciclovir is phosphorylated in virus-infected cells to aciclovir monophosphate by viral thymidine kinase. Then, aciclovir monophosphate is converted to aciclovir triphosphate by cellular kinases. Aciclovir triphosphate inhibits viral DNA polymerase, causing the termination of the DNA chain and the inhibition of viral replication.
Aciclovir exhibits selective toxicity to virus-infected cells, as its phosphorylation depends on viral thymidine kinase.

7. Pharmacokinetics

Absorption: Aciclovir is poorly absorbed from the gastrointestinal tract. The bioavailability of aciclovir after oral administration is 15-30%. Absorption does not change significantly in the presence of food.
Metabolism and distribution: Aciclovir is metabolized in the liver to an inactive breakdown product.
Excretion: Aciclovir and its metabolites are excreted mainly in the urine. The half-life of aciclovir is approximately 2.5-3 hours in patients with normal kidney function.
In patients with kidney failure, the half-life of aciclovir is prolonged and requires dose adjustment.