Package leaflet: Information for the patient

Hevipoint, 200 mg, tablets
Aciclovirum
Please read the entire 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 patient leaflet or as directed by
the physician or pharmacist.

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

Table of contents

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

1. What Hevipoint is and what it is used for

Hevipoint 200 mg tablets contain an active substance called aciclovir—a synthetic antiviral agent that inhibits the replication of viruses from the Herpes group.
Hevipoint 200 mg tablets are indicated for the treatment of recurrent herpes labialis and facial herpes caused by the herpes simplex virus (Herpes simplex) in adults.
Hevipoint 200 mg tablets may only be used in patients who have previously been diagnosed with herpes simplex virus infection.
If there is no improvement after 5 days or if your condition worsens, consult your doctor.

2. Important information before taking Hevipoint

When not to take Hevipoint:

if the patient is allergic to acyclovir or to any of the other components of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Hevipoint, discuss it with your doctor or pharmacist.
Do not take Hevipoint without prior consultation with a doctor:

if the patient has impaired kidney function,
if the patient is taking other medicines that may damage the kidneys,
if the patient has a weakened immune system (e.g. after bone marrow transplantation, HIV infection). Patients with reduced immunity should consult a doctor regarding treatment of any infection,
if the patient is 65 years of age or older,
in pregnant or breastfeeding women,
if severe recurrent herpes labialis has occurred,
if frequent (>6 per year) and prolonged recurrences of herpes (lack of positive treatment effects after 5 days of therapy) are observed, with more severe clinical symptoms (e.g. when new lesions appear after 3–4 days of treatment). This may indicate immunodeficiency or absorption disorders requiring diagnosis and possible adjustment of dosing.

If in doubt whether the above conditions apply to the patient, consult a doctor before starting
treatment with Hevipoint.
Hydration status
If the patient is taking acyclovir, they should drink plenty of fluids to maintain proper hydration.
Children and adolescents
Hevipoint should not be used in children and adolescents under 18 years of age.
Hevipoint and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines the patient plans to take.
Particularly inform your doctor or pharmacist if the patient is taking any of the following medicines:

probenecid (used in the treatment of gout);
cimetidine (used in peptic ulcer disease);
tacrolimus, cyclosporine, or mycophenolate mofetil (used in organ transplant recipients);
theophylline (used in the treatment of asthma and other respiratory disorders). Pregnancy and breastfeeding If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. The use of this medicine during pregnancy should be avoided unless the doctor considers that the benefits to the mother outweigh the potential risks to the fetus. Caution should be exercised when using this medicine in breastfeeding women due to the passage of acyclovir into breast milk. During breastfeeding, the medicine may be used only after consultation with a doctor.

Driving and operating machinery
The effect of acyclovir on the ability to drive vehicles and operate machinery has not been studied. However, the possibility of adverse effects of acyclovir such as dizziness, confusion, and seizures should be taken into account.
Hevipoint contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Hevipoint

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Adults
Hevipoint 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 tingling, burning, or tightness—or immediately after the first skin lesions appear.

Dosage in elderly patients
In elderly patients, impaired kidney function should be taken into consideration.
In patients with severe renal impairment, with a creatinine clearance of less than 10 ml/min, dosage adjustment of acyclovir must be determined exclusively by a physician (see: Dosage in patients with renal impairment).
During treatment, patients should drink plenty of fluids.

Use in patients with renal impairment
Caution should be exercised when administering Hevipoint to patients with impaired kidney function.
Patients with renal impairment should drink large amounts of fluids during treatment with Hevipoint (see also section 2 "Warnings and precautions").

In patients with severe renal impairment (creatinine clearance less than 10 ml/min), dosage adjustment of acyclovir must be determined exclusively by a physician. In such patients, the physician may recommend reducing the dose to 1 tablet (200 mg) twice daily, approximately 12 hours apart.

Taking more Hevipoint than recommended
Acyclovir is generally not harmful unless excessively high doses are taken over several days.
A single intake of up to 20 g of acyclovir in an adult usually does not cause symptoms of poisoning. However, unintentional, repeated oral overdosage over several days has been associated with gastrointestinal symptoms (nausea, vomiting) and neurological symptoms (headache, confusion).

If an excessive dose of Hevipoint is taken, inform your doctor or pharmacist immediately or contact the nearest hospital emergency department for further advice.

Missed dose of Hevipoint
If a dose is missed, it should be taken as soon as remembered, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.

If you have any further doubts 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 everybody will experience them.

Common adverse reactions (may affect up to 1 in 10 people):

headaches, dizziness,
nausea, vomiting, diarrhoea, abdominal pain,
itching, skin rash (including photosensitivity),
fatigue, fever (high body temperature).

Uncommon adverse reactions (may affect up to 1 in 100 people):

urticaria,
cases of accelerated, generalized hair loss (this may be associated with various diseases and with the use of many drugs; its relationship to acyclovir is uncertain).

Rare adverse reactions (may affect up to 1 in 1,000 people):

severe, life-threatening allergic reaction (anaphylactic reaction),
angioedema (most commonly occurs in the face, mainly around the lips and eyelids, but may also affect the tongue, glottis or larynx, thus potentially posing an immediate threat to life),
shortness of breath,
transient increase in blood levels of bilirubin and liver enzymes,
increased blood urea and creatinine levels.

Very rare adverse reactions (may affect up to 1 in 10,000 people):

decreased number of red blood cells (anaemia), white blood cells (leukopenia), and platelets (thrombocytopenia),
agitation, disorientation, tremors, ataxia, speech disorders, hallucinations, psychotic symptoms, seizures, somnolence, brain damage (encephalopathy), coma; these events are usually transient and generally observed in patients with impaired renal function or other predisposing factors (see section 2),
hepatitis, jaundice,
acute kidney failure, kidney pain.

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:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 provide more information on the safety of the medicine.

5. How to store Hevipoint

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 specified month.
No special storage instructions apply for 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. Such measures help protect the environment.

6. Contents of the pack and other information

What Hevipoint contains

The active substance is aciclovir. Each tablet contains 200 mg of aciclovir.
The other ingredients are: microcrystalline cellulose, povidone K30, sodium carboxymethyl starch (type A), magnesium stearate.

What Hevipoint looks like and contents of the pack
White or almost white, round, biconvex tablets, with the imprint "ACL" on one side.
Hevipoint is available in blisters made of PVC/Aluminium in a cardboard carton.
The pack contains 30 tablets.
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Manufacturer
Adamed Pharma S.A.
ul. Marszałka J. Piłsudskiego 5
95-200 Pabianice