Hascovir

Patient Leaflet

Read the leaflet carefully before taking the medicine.
Keep this leaflet, you may need to read it again.
Ask your doctor or pharmacist if you need advice or more information.
This text has been written specifically for the person it is prescribed to and should not be given 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.
Marketing Authorization Holder
“HASCO-LEK” Pharmaceutical Company S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

Table of Contents:

1. What is HASCOVIR and what is it used for
2. How to take HASCOVIR
3. How to use 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 replication of pathogenic viruses of the Herpesgroup in humans.
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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 (chickenpox and shingles).

2. Before taking HASCOVIR

Do not take the medicine if you are hypersensitive to aciclovir, valaciclovir, or any other component of the medicine.
Consult your doctor, even if the following warnings refer to past situations.
Taking HASCOVIR with food and drink
Eating food at the same time does not affect the absorption of HASCOVIR.

Taking HASCOVIR in patients with kidney and/or liver function disorders

The medicine should be used with caution in patients with kidney failure, especially those who are dehydrated and taking high doses of aciclovir or other medicines that may damage the kidneys. When taking high doses of aciclovir, you should drink plenty of fluids to avoid the risk of kidney damage.

Pregnancy

Consult your doctor before taking the medicine.
The medicine can be used during pregnancy only if the doctor considers that the benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding

Consult your doctor before taking the medicine.
The medicine passes into breast milk, so it can be used with caution, but only after consulting a doctor.

Driving and operating machinery

No data available.

Important information about some components of HASCOVIR

Sugar content. If you have been diagnosed with intolerance to some sugars, inform your doctor before taking the medicine.

Taking HASCOVIR

Even if the symptoms of the viral infection disappear temporarily, you should follow the doctor's recommendations regarding the dose and duration of treatment.

3. How to take HASCOVIR

Take only as directed by your doctor.
The dose and frequency of administration are determined by the doctor individually, depending on the type and severity of the infection and the patient's condition.

4. Possible side effects

Like all medicines, HASCOVIR can cause side effects, although not everybody gets them.
Rarely, allergic reactions may occur, such as: itching, hives, angioedema, and in severe cases, anaphylactic shock.

5. Storage of HASCOVIR

Store at 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 case of severe infections, the treatment can be extended. The administration of the preparation should be started as soon as possible after the infection is 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 can be increased to 400 mg in patients with significantly reduced immunity.

• treatment of infections caused by the varicella-zoster virus (chickenpox and shingles):

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

Children:

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

from 2 years of age and older – as recommended for adults

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

below 2 years of age – 200 mg 4 times a day
from 2 to 5 years of age – 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.

• Dosing in patients with kidney function disorders

When taking the medicine in patients with kidney function disorders, great caution should be exercised.

• treatment of infections caused by the herpes simplex virus:

in severe infections – 200 mg every 4 hours (with a night break) for 10 days

• prevention of recurrent herpes simplex:

200 mg 2 times a day every 12 hours.
In patients with kidney failure with creatinine clearance less than 10 ml/min, the dose should be reduced by half.

Overdose:

In case of overdose, stop the treatment and consult a doctor immediately. There is no data on aciclovir overdose in humans. Symptoms of overdose may include nausea, vomiting, diarrhea, agitation, seizures, and kidney failure.

Indications: The medicine is indicated for the treatment of the following infections caused by the herpes simplex virus and varicella-zoster virus:

• herpes labialis
• genital herpes
• chickenpox
• shingles

The medicine can be used to treat and prevent herpes simplex virus infections in patients with reduced immunity.

4. Possible side effects

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

• mild skin reactions, such as hives, hair loss.

Rare side effects (occurring in 1 to 10 out of 10,000 patients taking 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.

Very rare side effects (occurring in less than 1 out of 10,000 patients taking the medicine):

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

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

5. Procedure in case of overdose

In case of taking a higher dose of the medicine 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 symptoms of toxicity. 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).
Procedure after overdose: In case of overdose, the patient should be monitored. Hemodialysis may be necessary.
In case of taking a higher dose of the medicine than recommended, consult a doctor or pharmacist immediately.

6. Pharmacodynamics

Aciclovir is an antiviral medicine. It works by inhibiting the replication of the herpes virus, including the varicella-zoster virus and the herpes simplex virus. Aciclovir is phosphorylated in virus-infected cells to aciclovir monophosphate, and then to aciclovir triphosphate, which inhibits viral DNA polymerase.
Aciclovir shows selectivity towards viral DNA polymerase, as it is a substrate for this enzyme much stronger than for the host cell polymerase.

7. Pharmacokinetics

Absorption: After oral administration, aciclovir is poorly absorbed (15-30%) and in a non-proportional manner to the dose. Absorption is not significantly affected by food.
Metabolism and distribution: Aciclovir undergoes minimal metabolism in the liver to an inactive product.
Excretion: Aciclovir and its metabolites are excreted mainly in the urine. In patients with kidney failure, the excretion of aciclovir is reduced.
The half-life of aciclovir in the blood is approximately 2.5-3 hours in patients with normal kidney function.