Package leaflet: Information for the patient

inVirum, 200 mg, tablets
Aciclovirum
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient information leaflet or as directed by the
physician or pharmacist.

Keep this leaflet for future reference.
If advice or further information is needed, consult a pharmacist.
If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
If there is no improvement after 5 days, or if the patient feels worse, contact a doctor.

Table of contents

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

1. What is inVirum and what is it used for

The active substance in inVirum is aciclovir, which inhibits the replication of disease-causing human viruses of the Herpes group.
inVirum is used in the treatment of:

recurrent herpes labialis and facial herpes 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 at the onset of early symptoms such as itching, burning, or tingling.
inVirum may only be used in patients who have previously been diagnosed with herpes simplex virus infection by a physician.
If there is no improvement after 5 days, or if the patient feels worse, consult a doctor.

2. Important information before taking Invirum

When not to take Invirum:

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

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

the patient has impaired kidney function;
the patient is taking other medicines that may damage the kidneys;
the patient is elderly (over 65 years of age);
the patient has a weakened immune system (e.g. after bone marrow transplantation, or infected with HIV). Patients with a weakened immune system should consult a doctor regarding treatment of any infection;
the patient has experienced particularly severe recurrent herpes labialis;
the patient has experienced particularly severe recurrent genital herpes;
the patient observes frequent (more than 6 times per year) and longer-lasting (without positive treatment effects after 5 days of therapy) recurrences of herpes, with more severe clinical symptoms (including development of new infection sites after 3–4 days of treatment). This may indicate immunodeficiency or absorption disorders requiring diagnosis and a different dosing regimen.

Invirum should not be used in pregnant or breastfeeding women without prior consultation with a doctor (see section: "Pregnancy and breastfeeding").
Children and adolescents
Invirum should not be used in children and adolescents under 18 years of age.
Invirum with other medicines
Inform your doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines you plan to take.
Especially inform your doctor 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 patients);
theophylline (used in the treatment of asthma and other respiratory disorders).

Taking Invirum with food and drink
During treatment, it is recommended to drink plenty of fluids to avoid the risk of kidney damage and to reduce the likelihood of adverse effects.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
The use of this medicine during pregnancy should be avoided unless the doctor considers that the benefit to the mother outweighs the potential risk to the fetus.
The drug passes into breast milk; therefore, caution should be exercised when using it during breastfeeding. The medicine may only be used after consultation with a doctor.
Driving and operating machinery
There is no data available on the effect of the medicine on the ability to drive or operate machinery.
However, the possibility of acyclovir-related adverse effects such as dizziness, confusion, and seizures should be taken into account.
Invirum contains lactose and sodium
Lactose
The medicine contains 213.6 mg of monohydrate lactose per tablet.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
Sodium
One tablet contains between 1.12 mg and 1.68 mg of 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 the medicine inVirum

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
During treatment, it is recommended to drink plenty of fluids to avoid the risk of kidney damage and to reduce the likelihood of adverse effects.

Adults
The recommended dose is: 1 tablet (200 mg) five times daily, every 4 hours (with a night-time break), for 5 days.
In cases of recurrent infections, it is particularly important to start treatment during the prodromal phase (when early symptoms such as itching, burning, or tingling occur) or immediately after the first skin lesions appear.

Use in patients with renal function impairment
During treatment with inVirum, patients with impaired renal function should drink large amounts of fluids (see also section 2, "Warnings and precautions").
In patients with severe renal impairment, in whom creatinine clearance is less than 10 ml/min, dosage must be determined solely by a doctor. In such patients, the doctor may recommend reducing the dose to 1 tablet (200 mg) twice daily, approximately every 12 hours.

Use in elderly patients
In elderly patients, consider the possibility of impaired renal function.
In elderly patients with severe renal impairment (creatinine clearance less than 10 ml/min), dosage must be determined solely by a doctor, who may recommend a reduced dose (see above: "Use in patients with renal function impairment").
During treatment, patients should drink plenty of fluids.

Accidental overdose of inVirum
Single ingestion of up to 20 g of aciclovir usually does not cause symptoms of poisoning.
Accidental, repeated overdosage of orally administered aciclovir over several days has been associated with gastrointestinal symptoms (nausea, vomiting) and neurological symptoms (headache, confusion – disturbance of thought process, disorientation).
If an overdose is taken, consult a doctor or pharmacist immediately.

Missed dose of inVirum
Take the missed dose as soon as possible.
Do not take a double dose to make up for a missed dose.
If in doubt about any further aspects concerning the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should immediately inform your doctor or go to the nearest hospital if any of the following occur:

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

Possible adverse reactions
Common (occur in 1 to 10 people per 100):

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

Uncommon (occur in 1 to 10 people per 1,000):

urticaria, increased diffuse hair loss.

Rare (occur in 1 to 10 people per 10,000):

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

Very rare (occur in fewer than 1 person per 10,000):

anaemia, decreased white blood cell count, thrombocytopenia (decreased platelet count);
restlessness, disorientation, tremors, ataxia, speech disorders, hallucinations, psychotic symptoms, seizures, somnolence, encephalopathy (brain damage), coma;
hepatitis, jaundice (may manifest as yellowing of the skin and eyes);
acute kidney failure, kidney pain.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed
in this leaflet, you should inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions,
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C, 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 the medicine.

5. How to store the medicine Invirum

Keep the medicine out of the sight and reach of children.
There are no special requirements for storing this medicine.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What the medicine Invirum contains

The active substance is acyclovir. One tablet contains 200 mg of acyclovir.
Other components of the medicine are: lactose monohydrate, microcrystalline cellulose, povidone K30, sodium carboxymethyl starch (type A), magnesium stearate.

What Invirum looks like and contents of the pack
Invirum is a tablet. The tablets are round, 11 mm in diameter, biconvex, white in colour.
Pack contains 30 tablets.
Marketing Authorisation Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100
Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Szkolna 31
95-054 Ksawerów