Package leaflet: Information for the patient

Tenofovir disoproxil Viatris 245 mg film-coated tablets

tenofovir disoproxil
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Tenofovir disoproxil Viatris is and what it is used for
What you need to know before taking Tenofovir disoproxil Viatris
How to take Tenofovir disoproxil Viatris
Possible side effects
How to store Tenofovir disoproxil Viatris
Contents of the pack and other information

If this medicine has been prescribed for a child, all information in this package leaflet refers to the child (in such case "the child" instead of "you").

1. What Tenofovir disoproxil Viatris is and what it is used for

Tenofovir disoproxil Viatris contains the active substance tenofovir disoproxil. This active substance is an antiretroviral or antiviral medicine used for the treatment of HIV or HBV infection, or both. Tenofovir is a nucleotide reverse transcriptase inhibitor (NRTI), which works by interfering with the normal activity of certain enzymes (reverse transcriptase in HIV; DNA polymerase in hepatitis B) that are essential for viruses to replicate. Tenofovir disoproxil Viatris must always be used in combination with other medicines when treating HIV infection.

Tenofovir disoproxil Viatris 245 mg tablets are a treatment for HIV infection (human immunodeficiency virus). The tablets are indicated for:

adults
adolescents aged 12 to less than 18 years who have previously been treated with other HIV medicines that are no longer fully effective due to the development of resistance, or that have caused undesirable effects.

Tenofovir disoproxil Viatris 245 mg tablets are also used for the treatment of chronic hepatitis B, a hepatitis B virus (HBV) infection. The tablets are indicated for:

adults
adolescents aged 12 to less than 18 years.

You do not need to have HIV infection to be treated with Tenofovir disoproxil Viatris for HBV.
This medicine is not a cure for HIV infection. While taking Tenofovir disoproxil Viatris, you may still develop infections or other diseases associated with HIV infection. You may also transmit HBV to others; therefore, it is important that you take precautions to avoid infecting other people.

2. What you should know before taking Tenofovir disoproxil Viatris

Do not take Tenofovir disoproxil Viatris

If you are allergic to tenofovir, tenofovir disoproxil, or to any of the other ingredients of this medicine (listed in section 6).

If this applies to you, inform your doctor immediately and do not take Tenofovir disoproxil Viatris.

Warnings and precautions

Tenofovir disoproxil Viatris does not reduce the risk of transmitting HBV to others through sexual contact or blood contamination. You must continue to take precautions to prevent transmission.
Talk to your doctor or pharmacist before taking Tenofovir disoproxil Viatris.

If you have had kidney disease, or if blood tests have shown kidney problems. Tenofovir disoproxil Viatris should not be administered to adolescents who already have kidney problems. Before starting treatment, your doctor may prescribe blood tests to assess kidney function. Tenofovir disoproxil Viatris may affect the kidneys during treatment. Your doctor may order blood tests during treatment to monitor kidney function. If you are an adult, your doctor may advise you to take the tablets less frequently. Do not reduce the prescribed dose unless instructed by your doctor.

Tenofovir disoproxil Viatris should not be taken with other medicines that may damage the kidneys (see Other medicines and Tenofovir disoproxil Viatris). If this is unavoidable, your doctor will monitor the child’s kidney function once a week.

If you have osteoporosis, have previously had bone fractures, or have bone problems.

Bone problems (manifesting as persistent or worsening bone pain, and sometimes resulting in fractures) may occur due to damage to the renal tubular cells (see section 4, Possible side effects). Inform your doctor if you experience bone pain or fractures.
Tenofovir disoproxil may also cause loss of bone mineral density. More pronounced bone loss has been observed in clinical studies where patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor.
In general, the long-term effects of tenofovir disoproxil on bone health and the risk of future fractures in adult and pediatric patients are uncertain.
Some adult HIV patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue due to reduced blood supply to the bone). Duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this condition. Signs of osteonecrosis include joint stiffness, discomfort, and pain (especially in the hips, knees, and shoulders), and difficulty moving. Contact your doctor if you notice any of these symptoms.

Inform your doctor if you have previously had liver problems, including hepatitis. Patients with liver problems, including chronic hepatitis B or C, treated with antiretrovirals have an increased risk of serious and potentially fatal liver complications. If you have hepatitis B, your doctor will carefully evaluate the most appropriate treatment regimen for you. If you have had liver disease or chronic hepatitis B, your doctor may request blood tests to monitor liver function.
Be cautious about infections. If you have advanced HIV (AIDS) and have an infection, you may develop symptoms of infection and inflammation or worsening of symptoms from an existing infection when starting treatment with Tenofovir disoproxil Viatris. These symptoms may indicate that your body's immune system is fighting the infection. Monitor for signs of inflammation or infection shortly after starting Tenofovir disoproxil Viatris. If you notice signs of inflammation or infection, inform your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after starting medicines for the treatment of HIV infection. Autoimmune disorders may occur several months after starting treatment. If you notice any signs of infection or other symptoms such as muscle weakness, initial weakness in hands and feet spreading toward the trunk, palpitations, tremor, or hyperactivity, inform your doctor immediately to receive necessary treatment.

Inform your doctor or pharmacist if you are over 65 years of age. Tenofovir disoproxil Viatris has not been studied in patients over 65 years of age. If you are over this age and have been prescribed Tenofovir disoproxil Viatris, your doctor will monitor you closely.

Children and adolescents
Tenofovir disoproxil Viatris 245 mg tablets are indicated for:

HIV-1 infected adolescents aged 12 to less than 18 years with body weight of at least 35 kg who have previously been treated with other HIV medicines that are no longer fully effective due to development of resistance, or that have caused side effects.
HBV infected adolescents aged 12 to less than 18 years with body weight of at least 35 kg.

Tenofovir disoproxil Viatris 245 mg tablets are not indicated for the following categories:

not indicated in children infected with HIV-1 under 12 years of age
not indicated in children infected with HBV under 12 years of age.

For dosage, see section 3, How to take Tenofovir disoproxil Viatris.

Other medicines and Tenofovir disoproxil Viatris
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
When starting therapy with Tenofovir disoproxil Viatris, do not stop taking any anti-HIV medicine prescribed by your doctor if you have both HBV and HIV infection.

Do not take Tenofovir disoproxil Viatris if you are already taking other medicines containing tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir disoproxil Viatris together with medicines containing adefovir dipivoxil (a medicine used to treat chronic hepatitis B).
It is particularly important to inform your doctor if you are taking other medicines that may damage your kidneys.

These include:

aminoglycosides, pentamidine, or vancomycin (for bacterial infection)
amphotericin B (for fungal infection)
foscarnet, ganciclovir, or cidofovir (for viral infection)
interleukin-2 (for cancer treatment)
adefovir dipivoxil (for HBV)
tacrolimus (for immunosuppression)
non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve bone or muscle pain)
Other medicines containing didanosine (for HIV infection): Taking Tenofovir disoproxil Viatris with other antiviral medicines containing didanosine may increase didanosine levels in the blood and may reduce CD4 cell count. When medicines containing tenofovir disoproxil and didanosina have been taken together, cases of pancreatitis and lactic acidosis (excess lactic acid in the blood) have rarely been reported, sometimes resulting in death. Your doctor must carefully consider whether to treat you with tenofovir and didanosine in combination.
It is also important to inform your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.

Tenofovir disoproxil Viatris with food and drink
Tenofovir disoproxil Viatris should be taken with food (e.g., a meal or a snack).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Try to avoid pregnancy during treatment with Tenofovir disoproxil Viatris. You should use an effective contraceptive method to avoid pregnancy.
If you have already taken Tenofovir disoproxil Viatris during pregnancy, your doctor may request regular blood tests and other diagnostic examinations to monitor the baby’s development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV has outweighed the risk of side effects.
If you are a mother with HBV and the newborn has received treatment to prevent transmission of hepatitis B at birth, you may be able to breastfeed the newborn, but you should discuss this with your doctor first to obtain further information.
Breastfeeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the child through breast milk. If you are breastfeeding or considering breastfeeding, you must discuss this with your doctor as soon as possible.

Driving and using machines
Tenofovir disoproxil Viatris may cause dizziness. If dizziness occurs while taking Tenofovir disoproxil Viatris, do not drive or ride a bicycle and do not use tools or machinery.

Tenofovir disoproxil Viatris contains lactose
Inform your doctor before taking Tenofovir disoproxil Viatris. If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Tenofovir disoproxil Viatris

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is:

Adults: 1 tablet once daily, taken with food (for example, a meal or a snack).
Adolescents aged 12 to less than 18 years with a body weight of at least 35 kg: 1 tablet once daily, taken with food (for example, a meal or a snack).

If you have particular difficulty swallowing, you may use the back of a spoon to crush the tablet. Then mix the powder in about 100 ml (half a glass) of water, orange juice, or grape juice and drink immediately.

Always take the dose prescribed by your doctor. This is important to ensure that the medicine remains fully effective and to reduce the risk of developing resistance to treatment. Do not change the dose unless instructed by your doctor.
If you are an adult and have kidney problems, your doctor may prescribe Tenofovir disoproxil Viatris less frequently.
If you have HBV, your doctor may recommend an HIV test to determine whether you have both HBV and HIV. Refer to the package leaflet of other antiretroviral medicines for guidance on how to take these medicines.
For patients with swallowing difficulties, other formulations of this medicine may be suitable; please consult your doctor or pharmacist.

If you take more Tenofovir disoproxil Viatris than you should
If you accidentally take too many tablets of Tenofovir disoproxil Viatris, your risk of experiencing possible side effects from this medicine may increase (see section 4, Possible side effects). Contact your doctor or the nearest emergency department. Bring the bottle of tablets with you so that you can easily describe what you have taken.

If you forget to take Tenofovir disoproxil Viatris
It is important not to miss any dose of Tenofovir disoproxil Viatris. If you forget a dose, consider how much time has passed since the usual dosing time.

If less than 12 hours have passed since the usual time, take the missed dose as soon as possible, then take the next dose at the regular time.
If more than 12 hours have passed since the usual time, do not take the missed dose. Wait and take the next dose at the regular time. Do not take a double dose to make up for the forgotten tablet.

If you vomit within 1 hour after taking Tenofovir disoproxil Viatris, take another tablet. You do not need to take another tablet if you vomit more than 1 hour after taking Tenofovir disoproxil Viatris.

If you stop taking Tenofovir disoproxil Viatris
Do not stop taking Tenofovir disoproxil Viatris without consulting your doctor. Stopping Tenofovir disoproxil Viatris may reduce the effectiveness of the treatment prescribed by your doctor.

If you have hepatitis B infection or both HIV and hepatitis B infection (co-infection), it is especially important not to stop treatment with Tenofovir disoproxil Viatris without first contacting your doctor. Some patients have experienced worsening of their hepatitis, as shown by symptoms or blood tests, after stopping tenofovir disoproxil. Blood tests may need to be repeated for several months after stopping treatment. In patients with advanced liver disease or cirrhosis, stopping treatment is not recommended, as it may lead to worsening of hepatitis in some patients.

Talk to your doctor before stopping Tenofovir disoproxil Viatris for any reason, especially if you have experienced a side effect or have another illness.
Inform your doctor immediately of any new or unusual symptoms observed after stopping treatment, particularly symptoms normally associated with hepatitis B infection.
Contact your doctor before restarting Tenofovir disoproxil Viatris tablets.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

During HIV therapy, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to the recovery of health status and lifestyle, and in the case of blood lipids, sometimes also to the HIV medications themselves. Your doctor will monitor these changes.

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Possible serious side effects: inform your doctor immediately

Lactic acidosis (excess lactic acid in the blood) is a rare (may affect up to 1 in 1,000 people) but serious side effect, which can be fatal. The following side effects may be signs of lactic acidosis:
- deep and rapid breathing
- drowsiness
- feeling unwell (nausea, vomiting, and stomach pain)

If you think you have lactic acidosis, contact your doctor immediately.

Other possible serious side effects

The following side effects are not common (may affect up to 1 in 100 people):

stomach pain (abdominal) caused by inflammation of the pancreas
damage to certain kidney cells (tubular cells)

The following side effects are rare (may affect up to 1 in 1,000 people):

kidney inflammation, excessive urination and thirst
changes in urine and back pain due to kidney problems, including kidney failure
softening of the bones (with bone pain and sometimes fractures), which may occur due to damage to renal tubular cells
fatty liver

If you think you are experiencing any of these serious side effects, consult your doctor.

More frequent side effects

The following side effects are very common (may affect more than 1 in 10 people):

diarrhoea, feeling unwell (vomiting, nausea), dizziness, rash, feeling weak

Laboratory tests have also shown:

reduced phosphate levels in the blood

Other possible side effects

The following side effects are common (may affect up to 1 in 10 people):

headache, stomach pain, fatigue, feeling of fullness, intestinal gas (flatulence), loss of bone mass

Laboratory tests have also shown:

liver problems

The following side effects are uncommon (may affect up to 1 in 100 people):

muscle breakdown, muscle pain or muscle weakness

Laboratory tests have also shown:

reduced potassium levels in the blood
increased creatinine levels in the blood
pancreas problems

Muscle breakdown, softening of the bones (with bone pain and sometimes fractures), muscle pain, muscle weakness, and reduced potassium or phosphate levels in the blood may occur due to damage to renal tubular cells.

The following side effects are rare (may affect up to 1 in 1,000 people):

stomach pain (abdominal) caused by liver inflammation
swelling of the face, lips, tongue or throat

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system referred to in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tenofovir disoproxil Viatris

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and carton after
{Exp.}. The expiry date refers to the last day of that month.
Do not store above 25 °C. Keep in the original packaging to protect the medicine from light and moisture.
For bottles: use within 90 days after first opening of the bottle.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tenofovir disoproxil Viatris contains

The active substance is tenofovir disoproxil. Each tablet of Tenofovir disoproxil Viatris contains 245 mg of tenofovir disoproxil (as maleate).
The other ingredients are microcrystalline cellulose, lactose monohydrate (see section 2, Tenofovir disoproxil Viatris contains lactose), hydroxypropylcellulose, anhydrous colloidal silica, magnesium stearate, hypromellose, titanium dioxide (E171), triacetin, and indigo carmine aluminium lake (E132).

Description of the appearance of Tenofovir disoproxil Viatris and contents of the pack
Tenofovir disoproxil Viatris 245 mg film-coated tablets are blue, round, biconvex, film-coated tablets, imprinted with “TN245” on one side and “M” on the other.
This medicinal product is available in plastic bottles with child-resistant caps and desiccant packs containing 30 film-coated tablets, and in multipacks of 90 film-coated tablets comprising 3 bottles, each containing 30 film-coated tablets. The bottles also contain desiccant. Do not ingest the desiccant.
The tablets are also available in packaging containing blisters of 10, 30, or 30 x 1 (unit dose) tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Viatris Limited
Damastown Industrial Park,
Mulhuddart, Dublin 15,
DUBLIN
Ireland

Manufacturer
McDermott Laboratories Limited T/A Gerard Laboratories T/A Mylan Dublin
Unit 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland
Mylan Hungary Kft
Mylan utca 1,
Komarom, H-2900,
Hungary
Mylan Germany GmbH
Zweigniederlassung Bad Homburg v. d. Hoehe,
Benzstrasse 1, Bad Homburg v. d. Hoehe,
Hessen, 61352,
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: + 370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел.: + 359 2 44 55 400 Tél/Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: + 420 222 004 400 Tel.: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: + 45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: + 49 800 0700 800 Tel: + 31 (0)20 426 3300

Eesti Norge
Viatris OÜ Viatris AS
Tel: + 372 6363 052 Tlf: + 47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ: + 30 2100 100 002 Tel: + 43 1 86390

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00

France Portugal
Viatris Santé Mylan, Lda.
Tél: + 33 4 37 25 75 00 Tel: + 351 214 127 200

Hrvatska România
Viatris Hrvatska d.o.o BGP Products SRL
Tel: + 385 1 23 50 599 Tel: + 40 372 579 000

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: + 353 1 8711600 Tel: + 386 1 23 63 180

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: + 354 540 8000 Tel: + 421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: + 39 02 612 46921 Puh/Tel: + 358 20 720 9555

Κύπρος Sverige
GPA Pharmaceuticals Ltd. Viatris AB
Τηλ: + 357 22863100 Tel: + 46 (0)8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: + 371 676 055 80 Tel: + 353 18711600

More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu