Ictadi

Leaflet accompanying the packaging: information for the user

Ictady, 245 mg, coated tablets

Tenofovir disoproxil

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

If Ictady has been prescribed for a child, note that all the information contained in this leaflet refers to the child (in this case, the term "patient" means "child").

1. What is Ictady and what is it used for

Ictady contains the active substance tenofovir disoproxil in the form of fumarate. This active substance is an antiretroviralmedicine, i.e. an antiviral medicine used to treat HIV or HBV or both infections. Tenofovir is a nucleotide reverse transcriptase inhibitor. This substance is generally referred to as NRTI and works by disrupting the normal functioning of enzymes (reverse transcriptase in the case of HIV and DNA polymerase in the case of hepatitis B) that are crucial for the replication of viruses. In the case of HIV, Ictady should always be used in combination with other HIV treatments.

Ictady is intended for the treatment of HIV infection(human immunodeficiency virus).
The tablets are suitable for:

• adults
• adolescents aged 12 to less than 18 years, previously treatedwith other HIV medicines that are no longer fully effective due to the development of resistance or have caused side effects.

Ictady is also intended for the treatment of chronic hepatitis B,

infection caused by HBV(hepatitis B virus). The tablets are suitable for:

• adults
• adolescents aged 12 to less than 18 years.

The patient does not need to have HIV to be treated with Ictady for HBV infection.
This medicine will not cure HIV infection. People taking Ictady may still develop infections or other illnesses related to HIV infection. It is also possible to transmit HIV or HBV to others, so it is essential to take precautions to avoid infecting others.

2. Important information before taking Ictady

When not to take Ictady

• If the patient is allergicto tenofovir, tenofovir disoproxil in the form of fumarate, or any of the other ingredients of this medicine listed in section 6. The patient should immediately inform their doctor and not take Ictady.

Warnings and precautions

Before starting treatment with Ictady, the patient should discuss it with their doctor or pharmacist.

• Be careful not to infect others.The patient can still transmit the HIV virus to others while taking this medicine, although effective antiretroviral therapy reduces this risk. The patient should discuss with their doctor the precautions necessary to avoid infecting others. Ictady does not reduce the risk of transmitting HBV to others through sexual contact or contaminated blood. The patient should continue to take precautions to prevent this.
• If the patient has had kidney disease or if the tests indicate kidney disease, they should consult their doctor or pharmacist.Ictady should not be given to adolescents with kidney disease. Before starting treatment, the doctor may order blood tests to assess kidney function. Ictady may harm the kidneys during treatment. During treatment, the doctor may order blood tests to monitor kidney function. In adult patients, the doctor may recommend taking the tablets less frequently. The patient should not reduce the prescribed dose unless their doctor recommends it.

Ictady is not usually taken with other medicines that may harm the kidneys (see "Ictady and other medicines"). If this cannot be avoided, the doctor will check the patient's kidney function every week.

• Bone disorders.In some adult patients with HIV undergoing antiretroviral therapy, a bone disease called osteonecrosis (death of bone tissue due to lack of blood supply to the bone) may develop. The duration of antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, and increased body mass index may be some of the many risk factors for the development of this disease. Symptoms of osteonecrosis are joint stiffness, pain (especially in the hip, knee, and shoulder), and difficulty moving. If the patient experiences any of these symptoms, they should tell their doctor.

Bone disorders (manifested as persistent or worsening bone pain, and sometimes leading to fractures) may also occur due to damage to the renal tubular cells (see section 4 "Possible side effects"). If the patient experiences bone pain or fractures, they should tell their doctor.
Tenofovir disoproxil may also cause a decrease in bone mass. The most significant bone loss was observed in clinical trials in which patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor.
Generally, the long-term effect of tenofovir disoproxil on bone health and the risk of fractures in the future in adult patients, as well as in children and adolescents, is not clear.
If the patient has osteoporosis, they should tell their doctor. Patients with osteoporosis are more prone to fractures.

• If the patient has had liver disease in the past, including hepatitis, they should consult their doctor.Patients with liver disease, including chronic hepatitis B or C, treated with antiretroviral medicines, are at increased risk of severe and potentially life-threatening side effects affecting the liver. In patients with hepatitis B, the doctor will determine the most appropriate treatment. If the patient has had liver disease in the past or chronic hepatitis B, the doctor may recommend regular blood tests to monitor liver function.

The patient should protect themselves from infections.In patients with advanced HIV infection (AIDS), when they become infected, after starting treatment with Ictady, symptoms of infection and inflammation or worsening of existing infection symptoms may occur. These symptoms may indicate that the immune system is strengthening and starting to fight the infection. After starting Ictady, the patient should be aware of symptoms of inflammation or infection. If symptoms of inflammation or infection occur, the patient should immediately inform their doctor.

• Patient over 65 years of age should consult their doctor or pharmacist.Ictady has not been studied in patients over 65 years of age. Patients over this age who have been prescribed Ictady will be closely monitored by their doctor.

Children and adolescents

Ictady 245 mg is suitablefor:

• adolescents with HIV-1 infection aged 12 to less than 18 years, with a body weight of at least 35 kg and previously treatedwith other HIV medicines that are no longer fully effective due to the development of resistance or have caused side effects.
• adolescents with HBV infection aged 12 to less than 18 years, with a body weight of at least 35 kg.

Ictady 245 mg is notsuitable for the following groups:

• Not for HIV-1 infected childrenunder 12 years of age
• Not for HBV infected childrenunder 12 years of age.

Dosing, see section 3 "How to take Ictady".

Ictady 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.

• Do not stop taking HIV medicinesprescribed by the doctor while starting Ictady, if the patient has both HBV and HIV.
• Do not take Ictadyat the same time as other medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Ictady at the same time as medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
• It is very important to inform the doctor about taking other medicines that may harm the kidneys.

These include:
o
aminoglycosides, pentamidine, or vancomycin (in bacterial infections)
o
amphotericin B (in fungal infections)
o
foscarnet, ganciclovir, or cidofovir (in viral infections)
o
interleukin-2 (in cancer treatment)
o
adefovir dipivoxil (in HBV)
o
tacrolimus (to suppress the immune system)
o
non-steroidal anti-inflammatory drugs (NSAIDs, to reduce bone or muscle pain).

• Other medicines containing didanosine (against HIV):taking Ictady and other antiviral medicines that contain didanosine at the same time may increase the level of didanosine in the blood and may also decrease the number of CD4 cells. When taking medicines containing tenofovir disoproxil and didanosine, pancreatitis and lactic acidosis (excessive amount of lactic acid in the blood) have been rarely observed, sometimes leading to death. The doctor will carefully consider whether to use tenofovir with didanosine.
• It is also important to inform the doctorabout taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir for the treatment of hepatitis C virus infection.

Ictady with food and drink

Ictady should be taken with food(e.g. with a meal or snack).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

• Ictady should not be taken during pregnancywithout a detailed discussion with the doctor. Although there are limited clinical data on the use of Ictady in pregnant women, it is not usually used unless it is absolutely necessary.
• If the patient is pregnantor plans to become pregnant, they must contact their doctor to discuss the possible benefits and risks of antiretroviral therapy for them and their child.
• If the patient took Ictadyduring pregnancy, the doctor may order regular blood tests and other diagnostic tests to monitor the development of the child. In children whose mothers took medicines like Ictady (NRTI) during pregnancy, the benefit of reducing the possibility of HIV infection outweighed the risk of side effects.
• If the mother has HBVand her child has been given medicines to prevent the transmission of hepatitis B during birth, the patient may be able to breastfeed, but they should first discuss it with their doctor to get detailed information.
• If the mother has HIVshe should not breastfeed to avoid transmitting the virus to the child through breast milk.

Driving and using machines

Ictady may cause dizziness. If the patient experiences dizziness while taking Ictady, they should not drive or ride a bike, and should not use any tools or operate machinery.

Ictady contains lactose

If the patient has been diagnosed with lactose intolerance or intolerance to other sugars, they should consult their doctor before taking this medicine.

Ictady contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is essentially "sodium-free".

3. How to take Ictady

This medicine should always be taken as directed by the doctor or pharmacist.If the patient is unsure, they should consult their doctor or pharmacist.

Recommended dose:

• Adults:1 tablet once a day with food (e.g. with a meal or snack).
• Adolescents aged 12 to less than 18 years, with a body weight of at least 35 kg:1 tablet once a day with food (e.g. with a meal or snack).

If the patient has significant swallowing difficulties, the tablet can be crushed with the tip of a spoon.
The powder should be mixed with approximately 100 ml (half a glass) of water, orange juice, or grape juice and taken immediately.

• The patient should always take the dose prescribed by the doctor.This is to ensure the full effectiveness of the medicine and to limit the development of resistance to the medicine. The patient should not change the dose of the medicine unless their doctor recommends it.
• In adult patients with kidney problems,the doctor may recommend taking Ictady less frequently.
• If the patient has HBV infection, the doctor may offer an HIV test to check if the patient also has HBV and HIV infection.

The patient should read the patient information leaflets for the relevant antiretroviral medicines to learn about their use.

Taking a higher dose of Ictady than recommended

Accidentally taking too many Ictady tablets may increase the risk of possible side effects of this medicine (see section 4 "Possible side effects"). The patient should contact their doctor or the emergency department of the nearest hospital for advice. The patient should take the bottle of tablets with them to show the medicine they have taken.

Missing a dose of Ictady

It is essential not to miss any dose of Ictady. If the patient misses a dose, they should calculate how much time has passed since they were supposed to take it.

• If it has been less than 12 hourssince the usual time of taking the dose, the patient should take it as soon as possible, and then take the next dose at the usual time.
• If it has been more than 12 hourssince the time the dose was supposed to be taken, the patient should not take the missed dose. They should wait and take the next dose at the usual time. The patient should not take a double dose to make up for the missed tablet.

If the patient vomits within 1 hour of taking Ictady, they should take another tablet. The patient does not need to take another tablet if they vomit more than 1 hour after taking Ictady.

Stopping treatment with Ictady

The patient should not stop taking Ictady without consulting their doctor. Stopping treatment with Ictady may lead to a decrease in the effectiveness of the treatment prescribed by the doctor.

If the patient has hepatitis B or both HIV and hepatitis B infection

and hepatitis B infection, it is very important not to stop taking Ictady without consulting the doctor first. In some patients, after stopping Ictady, blood test results or symptoms indicated a worsening of hepatitis. For several months after stopping Ictady, it may be necessary to perform blood tests. In patients with advanced liver disease or liver cirrhosis, it is not recommended to stop treatment, as it may lead to a worsening of hepatitis in some patients.

• Before stopping Ictady for any reason, the patient should consult their doctor, especially if they have experienced any side effects or have another illness.
• The patient should immediately inform their doctorabout any new or unusual symptoms they notice after stopping treatment, especially those that are usually associated with hepatitis B virus infection.
• Before restarting Ictady, the patient should consult their doctor.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

During treatment for HIV infection, an increase in body weight and levels of lipids and glucose in the blood may occur. This is partly related to the improvement in health and lifestyle, and in the case of lipid levels in the blood, sometimes to the use of HIV medicines themselves. The doctor will order the necessary tests for these changes.
Like all medicines, Ictady can cause side effects, although not everybody gets them.

Possible serious side effects: the patient should immediately inform their doctor

• Lactic acidosis(excessive amount of lactic acid in the blood) is a rare(may affect less than 1 in 1,000 patients) but serious side effect that can be fatal. Side effects that may be signs of lactic acidosis are: o deep, rapid breathing o drowsiness o nausea, vomiting, and abdominal pain If the patient suspects they have lactic acidosis, they should immediately contact their doctor.

Other possible serious side effects

The following side effects occur uncommonly(may affect less than 1 in 100 patients):

• abdominal paincaused by pancreatitis
• damage to the renal tubular cells

The following side effects occur rarely(may affect less than 1 in 1,000 patients):

• kidney inflammation, excessive urination, and thirst
• changes in urine test resultsand back paincaused by kidney dysfunction, including kidney failure
• bone softening (manifested as bone painand sometimes leading to fractures), which may occur due to damage to the renal tubular cells
• fatty liver

In case of suspected serious side effects, the patient should contact their doctor.

Most common side effects

The following side effects occur very commonly(may affect more than 10 in 100 patients):

• diarrhea, vomiting, nausea, dizziness, rash, feeling weak Tests may also show:o decreased phosphate levels in the blood

Other possible side effects

The following side effects occur commonly(may affect less than 10 in 100 patients):

• headache, abdominal pain, feeling tired, feeling bloated, bloating Tests may also show:o liver function disorders

The following side effects occur uncommonly(may affect less than 1 in 100 patients):

• muscle breakdown, muscle pain, or muscle weakness Tests may also show:o decreased potassium levels in the blood o increased creatinine levels in the blood o pancreas disorders

Muscle breakdown, bone softening (manifested as bone pain and sometimes leading to fractures), muscle pain, muscle weakness, and decreased potassium or phosphate levels in the blood may occur due to damage to the renal tubular cells.
The following side effects occur rarely(may affect less than 1 in 1,000 patients):

• abdominal paincaused by liver inflammation
• swelling of the face, lips, tongue, or throat

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet,

they should tell their doctor or pharmacist.Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: ndl@urpl.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 Ictady

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after "EXP".
The expiry date refers to the last day of the month stated.
This medicine does not require special storage conditions.
Use within 30 days of first opening; store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ictady contains

• The active substance of Ictady istenofovir. Each Ictady tablet contains 245 mg of tenofovir disoproxil (in the form of fumarate).

Other ingredients are:

Core of the tablet: lactose, microcrystalline cellulose 112 (E 460), maize starch, croscarmellose sodium, and magnesium stearate (E 470b).
Coating of the tablet: Indigo carmine, lake (E 132), titanium dioxide (E 171), polyvinyl alcohol (E 1203), macrogol 4000 (E 1521), and talc (E 553b). See section 2 "Ictady contains lactose".

What Ictady looks like and contents of the pack

Ictady, 245 mg, coated tablets are light blue, almond-shaped tablets, approximately 17.0 mm x 10.5 mm in size.
Ictady, 245 mg, coated tablets are available in bottles containing 30 tablets. Each bottle contains a desiccant that must be kept in the bottle to protect the tablets. The desiccant is in a separate package and should not be swallowed.
The following pack size is available:
30 (1 x 30) coated tablets

Marketing authorization holder

Rivopharm Ltd.

17 Corrig Road, Sandyford
Dublin 18
Ireland

Manufacturer

Remedica Ltd
Aharnon Street, Limassol Industrial Estate
3056 Limassol
Cyprus

For more information about this medicine and its names in the Member States of the European Economic Area, the patient should contact the representative of the marketing authorization holder:

Actavis Export International Limited, BLB 016 Bulebel Industrial Estate, ZTN3000, Zejtun, Malta.
Contact in Poland: tel. (+48 22) 512 29 00.
Date of last revision of the leaflet:January 2021.