invirum

Package Leaflet: Information for the Patient

inVirum, 200 mg, tablets
Aciclovir

Read the package 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 package leaflet or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 5 days, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Invirum and what is it used for
• 2. Important information before taking Invirum
• 3. How to take Invirum
• 4. Possible side effects
• 5. How to store Invirum
• 6. Contents of the pack and other information

1. What is Invirum and what is it used for

The active substance of Invirum is acyclovir, which inhibits the multiplication of pathogenic viruses for humans in the Herpesgroup.
Invirum is used to treat:

• recurrent herpes labialis and facial herpes caused by the herpes simplex virus in adults;
• recurrent genital herpes caused by the herpes simplex virus in adults.

In the case of recurrent infections, it is especially important to start treatment during the prodromal period, such as itching, burning, or tension.
Invirum should only be used in patients who have been previously diagnosed with herpes simplex virus infection by a doctor.
If there is no improvement or the patient feels worse after 5 days, they should consult their 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 taking Invirum, the patient should discuss it with their doctor or pharmacist.
Invirum should not be taken without prior consultation with a doctor if:

• the patient has kidney function disorders;
• the patient is taking other medicines that may damage the kidneys;
• the patient is elderly (over 65 years old);
• the patient has impaired immunity (e.g., after bone marrow transplantation, HIV infection). Patients with impaired immunity should consult their doctor about treatment for any infection;
• the patient has experienced severe recurrent herpes labialis;
• the patient has experienced severe recurrent genital herpes;
• the patient observes frequent (more than 6 times a year) and longer-lasting (after 5 days of therapy without positive treatment effects) recurrences of herpes, with more severe clinical symptoms (e.g., when new foci of infection appear after 3-4 days of therapy). This may indicate immunodeficiency or absorption disorders requiring diagnosis and a different dosing regimen.

In pregnant or breastfeeding women, Invirum should not be used 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 and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should inform their doctor especially if they are taking any of the following medicines:

• probenecid(used to treat gout);
• cimetidine(used to treat stomach ulcers);
• tacrolimus, cyclosporin, or mycophenolate mofetil(used in patients after organ transplantation);
• theophylline(used to treat asthma and other respiratory diseases).

Taking Invirum with food and drink

During treatment, it is recommended to drink plenty of fluids to avoid the risk of kidney damage and reduce the likelihood of side effects.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Invirum should be avoided during pregnancy, unless the doctor considers that the benefit to the mother outweighs the potential risk to the fetus.
The medicine passes into breast milk, so caution should be exercised when taking it during breastfeeding. The medicine should only be used after consulting a doctor.

Driving and using machines

There is no data on the effect of the medicine on the ability to drive and use machines.
However, the patient should consider the possibility of side effects of acyclovir, such as dizziness, disorientation, seizures.

Invirum contains lactose and sodium

Lactose

The medicine contains 213.6 mg of lactose monohydrate in one tablet.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their 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, which means it is considered "sodium-free".

3. How to take Invirum

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

Adults

The recommended dose is: 1 tablet (200 mg) five times a day, every 4 hours (with a night break), for 5 days.
In the case of recurrent infections, it is especially important to start treatment during the prodromal period, such as itching, burning, or tension, or immediately after the appearance of the first changes.

Use in patients with kidney function disorders

During treatment with Invirum, patients with kidney function disorders should drink plenty of fluids (see also section 2 "Warnings and precautions").
In patients with severe kidney function disorders, with a creatinine clearance of less than 10 ml/min, the dosing regimen should be determined by the doctor. In such patients, the doctor may recommend reducing the dose of the medicine to 1 tablet (200 mg) twice a day, every 12 hours.

Use in elderly patients

In elderly patients, the possibility of kidney function disorders should be considered.
In patients with severe kidney function disorders, with a creatinine clearance of less than 10 ml/min, the dosing regimen should be determined by the doctor, who may recommend reducing the dose of the medicine (see above: "Use in patients with kidney function disorders").
During treatment, the patient should drink plenty of fluids.

Taking a higher dose of Invirum than recommended

Taking a single dose of acyclovir up to 20 g usually does not cause symptoms of poisoning.
Accidental, repeated overdose of orally administered acyclovir over several days is associated with symptoms from the gastrointestinal tract (nausea, vomiting) and neurological symptoms (headache, confusion - disorder of thought, disorientation).
In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Invirum

The missed dose should be taken as soon as possible.
A double dose should not be taken to make up for the missed dose.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should immediately inform their doctor or go to the nearest hospital if they experience:

• anaphylactic reaction (a life-threatening allergic reaction with symptoms such as itching, hives, shortness of breath, low blood pressure, rapid heartbeat) - occurs rarely(in 1 to 10 people per 10,000);
• angioedema (swelling of soft tissues of the face, lips, tongue, and possibly swelling of the larynx, which can make breathing difficult) - occurs rarely(in 1 to 10 people per 10,000).

Possible side effects

Common(occurring in 1 to 10 people per 100):

• headache and dizziness;
• nausea, vomiting, diarrhea, abdominal pain;
• itching, rash (also occurring after exposure to sunlight);
• fatigue, fever.

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

• hives, accelerated, diffuse hair loss.

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

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

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

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Invirum

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
The medicine should not be used after the expiry date stated on the blister pack and carton. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Invirum contains

• The active substance of Invirum is acyclovir. One tablet contains 200 mg of acyclovir.
• The other ingredients of the medicine are: lactose monohydrate, microcrystalline cellulose, povidone K30, sodium carboxymethylcellulose (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.
The pack contains 30 tablets.

Marketing authorization 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
Date of last revision of the leaflet:06.09.2022