TENOFOVIR DISOPROXIL VIATRIS 245 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Tenofovir Disoproxil Mylan 245 mg Film-Coated Tablets EFG

tenofovir disoproxil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Tenofovir Disoproxil Mylan is and what it is used for
2. What you need to know before you take Tenofovir Disoproxil Mylan
3. How to take Tenofovir Disoproxil Mylan
4. Possible side effects
5. Storage of Tenofovir Disoproxil Mylan
6. Contents of the pack and other information

If this medicine has been prescribed to your child, note that all the information in this leaflet is intended for your child (in this case, read “your child” instead of “you”).

1. What Tenofovir Disoproxil Mylan is and what it is used for

Tenofovir Disoproxil Mylan contains the active substance tenofovir disoproxil. This active substance is an antiretroviral or antiviral medicine used to treat HIV or HBV, or both. Tenofovir is a nucleotide reverse transcriptase inhibitor, also known as NtRTI, which works by interfering with the normal function of enzymes (in the case of HIV, reverse transcriptase, and in hepatitis B, DNA polymerase) that are essential for the viruses to reproduce. For the treatment of HIV infection, Tenofovir Disoproxil Mylan must always be used in combination with other medicines.

Tenofovir Disoproxil Mylan is a medicine used to treatHIV (Human Immunodeficiency Virus) infection. The tablets are suitable for:

• Adults.
• Adolescents between 12 and less than 18 years who have already been treatedwith other HIV medicines which are no longer fully effective due to the development of resistance, or which have caused side effects.

Tenofovir Disoproxil Mylan is also used to treat chronic hepatitis B, an infection caused by the HBV(hepatitis B virus). The tablets are suitable for:

• Adults.

• Adolescents between 12 and less than 18 years.

You do not need to have HIV to be treated with Tenofovir Disoproxil Mylan for HBV.

This medicine is not a cure for HIV infection. While you are taking Tenofovir Disoproxil Mylan, you may still develop infections or other illnesses associated with HIV. You may also continue to transmit HBV to others. Therefore, it is important that you take precautions to avoid infecting others.

2. What you need to know before you take Tenofovir Disoproxil Mylan

Do not take Tenofovir Disoproxil Mylan

• to tenofovir, tenofovir disoproxil, or any of the other ingredients of this medicine (listed in section 6).

If this is the case, tell your doctor immediately and do not take Tenofovir Disoproxil Mylan.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Tenofovir Disoproxil Mylan.

• Tenofovir Disoproxil Mylan does not reduce the risk of transmission of HBV through sexual contact or blood contamination. You must continue to take precautions to avoid this.

• If you have had kidney disease or if your blood tests have shown kidney problems, talk to your doctor or pharmacist.Tenofovir Disoproxil Mylan should not be given to adolescents with existing kidney problems. Before starting treatment, your doctor may ask you to have blood tests to check your kidney function. Tenofovir Disoproxil Mylan can affect your kidneys during treatment. Your doctor may ask you to have blood tests during treatment to check your kidney function. If you are an adult, your doctor may advise you to take the tablets less frequently. Do not reduce the dose prescribed by your doctor unless your doctor has told you to.

Tenofovir Disoproxil Mylan is not normally taken with other medicines that can damage your kidneys (see Other medicines and Tenofovir Disoproxil Mylan). If this is unavoidable, your doctor will monitor your kidney function once a week.

• Bone problems.Some adult patients with HIV who are taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by lack of blood supply to the bone). Among the many risk factors for developing this disease are the duration of combination antiretroviral therapy, the use of corticosteroids, alcohol consumption, severe immunosuppression, and high body mass index. The symptoms of osteonecrosis are: stiffness in the joints, pain, and discomfort (especially in the hip, knee, and shoulder), and difficulty moving. If you notice any of these symptoms, tell your doctor.

There may also be bone problems (which appear as persistent or worsening bone pain and sometimes end in fractures) due to damage to the kidney tubule cells (see section 4, Possible side effects). Tell the child’s doctor if the child has bone pain or fractures.

Tenofovir disoproxil can also cause bone loss. The most pronounced bone loss was observed in clinical studies when patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor.

In general, the effects of tenofovir disoproxil on long-term bone health and future fracture risk in adult and pediatric patients are unclear.

Tell the child’s doctor if the child has osteoporosis. Patients with osteoporosis have a higher risk of fractures.

• Tell your doctor if you have a history of liver disease, including hepatitis.Patients with liver disease, including chronic hepatitis B or C, who are treated with antiretrovirals have a higher risk of serious and potentially life-threatening liver complications. If you have hepatitis B infection, your doctor will carefully consider the best treatment for you. If you have a history of liver disease or chronic hepatitis B infection, your doctor may perform blood tests to check your liver function.

• Infections.If you have advanced HIV infection (AIDS) and you have an infection, you may develop symptoms of infection or inflammation, or worsening of the symptoms of an existing infection when you start treatment with Tenofovir Disoproxil Mylan. These symptoms may indicate that your immune system is improving and starting to fight the infection. Be aware of signs of inflammation or infection after you start taking Tenofovir Disoproxil Mylan. If you notice signs of inflammation or infection, tell your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you have started taking medicines for the treatment of your HIV infection. Autoimmune disorders can occur many months after the start of treatment. If you observe any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and moving up towards the trunk of the body, palpitations, tremor, or hyperactivity, tell your doctor immediately to receive the necessary treatment.

• If you are over 65 years of age, tell your doctor or pharmacist.Tenofovir Disoproxil Mylan has not been studied in patients over 65 years of age. If you are over this age and have been prescribed Tenofovir Disoproxil Mylan, your doctor will monitor you closely.

Children and adolescents

Tenofovir Disoproxil Mylan is suitablefor:

• Adolescents infected with HIV-1 between 12 and less than 18 years who weigh at least 35 kg and who have already been treatedwith other HIV medicines which are no longer fully effective due to the development of resistance, or which have caused side effects.
• Adolescents infected with HBV between 12 and less than 18 years who weigh at least 35 kg.

Tenofovir Disoproxil Mylan is notsuitable for the following groups:

• Not for children infected with HIV-1under 12 years of age.
• Not for children infected with HBVunder 12 years of age.

For dosing information, see section 3, How to take Tenofovir Disoproxil Mylan.

Other medicines and Tenofovir Disoproxil Mylan

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not stop taking any anti-HIV medicinesprescribed by your doctor when you start treatment with Tenofovir Disoproxil Mylan if you have HBV and HIV.

• Do not take Tenofovir Disoproxil Mylanif you are using medicines that already contain tenofovir disoproxil or tenofovir alafenamide. Do not take Tenofovir Disoproxil Mylan with medicines that contain adefovir dipivoxil (a medicine used to treat chronic hepatitis B).

• It is very important that you tell your doctorif you are taking other medicines that can damage your kidneys.

These medicines include:

• aminoglycosides, pentamidine, or vancomycin (used to treat bacterial infections),
• amphotericin B (used to treat fungal infections),
• foscarnet, ganciclovir, or cidofovir (used to treat viral infections),
• interleukin-2 (used to treat cancer),
• adefovir dipivoxil (used to treat HBV infection),
• tacrolimus (used to produce immune system suppression),
• non-steroidal anti-inflammatory drugs (NSAIDs, to relieve bone or muscle pain).

• Other medicines that contain didanosine (for HIV infection):Taking Tenofovir Disoproxil Mylan with other antiviral medicines that contain didanosine may increase the levels of didanosine in your blood and may reduce the CD4 cell count. When medicines containing tenofovir disoproxil and didanosine are taken together, rare cases of pancreatitis and lactic acidosis (excess of lactic acid in the blood) have been reported, sometimes fatal. Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine.

• It is also important that you tell your doctorif you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C virus infection.

Taking Tenofovir Disoproxil Mylan with food and drinks

Take Tenofovir Disoproxil Mylan with food (for example, a meal or a snack).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Avoid becoming pregnantwhile taking Tenofovir Disoproxil Mylan. You must use an effective method of contraception to avoid becoming pregnant.

• If you have taken Tenofovir Disoproxil Mylanduring your pregnancy, your doctor may ask you to have regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV was greater than the risk of side effects.

• If you are a mother and have HBV infection, and your baby has been treated to prevent transmission of hepatitis B at birth, it may be possible for you to breastfeed your infant, but first talk to your doctor for more information.

• It is not recommendedthat women with HIV breastfeed their babies because HIV infection can be transmitted to the baby through breast milk. If you are breastfeeding or think you might want to breastfeed, consult your doctor as soon as possible.

Driving and using machines

Tenofovir disoproxil may cause dizziness. If you feel dizzy while taking Tenofovir Disoproxil Mylan, do not drive or ride a bicycleor use tools or machines.

Tenofovir Disoproxil Mylan contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Tenofovir Disoproxil Mylan

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The recommended dose is:

• Adults:1 tablet a day with food (for example, a meal or a snack).
• Adolescents between 12 and less than 18 years who weigh at least 35 kg:1 tablet a day with food (for example, a meal or a snack).

If you have difficulty swallowing, you can use the tip of a spoon to crush the tablet. Then, mix the powder with approximately 100 ml of water (half a glass), orange juice, or grape juice, and drink it immediately.

• Always take the dose recommended by your doctor.This is to ensure that your medicine is completely effective and to reduce the risk of developing resistance to treatment. Do not change the dose unless your doctor tells you to.

• If you are an adult and have kidney problems,your doctor may advise you to take Tenofovir Disoproxil Mylan less frequently.

• If you have HBV, your doctor may offer you an HIV test to see if you have HBV and HIV. Check the package leaflets of the other antiretrovirals to find out how to take these medicines.

• It may be possible that other forms of this medicine are more suitable for patients who have difficulty swallowing; ask your doctor or pharmacist.

If you take more Tenofovir Disoproxil Mylan than you should

If you accidentally took too many Tenofovir Disoproxil Mylan tablets, you may have a higher risk of experiencing possible side effects with this medicine (see section 4, Possible side effects). Talk to your doctor or go to the nearest emergency department. Take the pack of tablets with you so that you can easily describe what you have taken.

If you forget to take Tenofovir Disoproxil Mylan

It is important that you do not miss a dose of Tenofovir Disoproxil Mylan. If you miss a dose, determine how long ago you should have taken it.

• If it is less than 12 hourssince you were supposed to take it, take it as soon as you can, and then take your next dose at the usual time.

• If it is more than 12 hourssince you were supposed to take it, do not take the missed dose. Wait and take the next dose at the usual time. Do not take a double dose to make up for missed doses.

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

If you stop taking Tenofovir Disoproxil Mylan

Do not stop taking Tenofovir Disoproxil Mylan without talking to your doctor. Stopping treatment with Tenofovir Disoproxil Mylan may reduce the effectiveness of the treatment recommended by your doctor.

If you have hepatitis B, or HIV and hepatitis B (co-infection),it is very important that you do not stop taking Tenofovir Disoproxil Mylan without first talking to your doctor. After stopping treatment with tenofovir disoproxil, some patients have had blood tests or symptoms indicating that their hepatitis had worsened. You may need to have blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, it is not recommended to stop treatment as this may lead to worsening of hepatitis.

• Talk to your doctor before stopping Tenofovir Disoproxil Mylan for any reason, particularly if you are experiencing any side effects or if you have another illness.

• Talk to your doctor immediately if you experience any new or unusual symptoms after stopping treatment, particularly those symptoms that you think may be related to hepatitis B virus infection.

• Contact your doctor before restarting Tenofovir Disoproxil Mylan tablets.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

During HIV treatment, there may be an increase in weight and glucose and lipid levels in the blood. This may be partly related to the recovery of health and lifestyle, and in the case of blood lipids, sometimes to HIV medications themselves. Your doctor will monitor these changes.

Like all medications, this medication can cause adverse effects, although not all people suffer from them.

Possible Serious Adverse Effects: Inform Your Doctor Immediately

• Lactic Acidosis(excess lactic acid in the blood) is a rare(may affect up to 1 in 1,000 patients) but serious adverse effect that can be fatal. The following adverse effects may be signs of lactic acidosis:
• deep and rapid breathing
• drowsiness
• nausea, vomiting, and stomach pain

If you think you may have Lactic Acidosis, contact your doctor immediately.

Other Possible Serious Adverse Effects

The following adverse effects are uncommon(may affect up to 1 in 100 patients):

• Abdominal Pain(stomach pain) caused by pancreas inflammation
• damage to renal tubular cells

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

• kidney inflammation, increased urine volume, and thirst
• changes inyour urineand back paindue to kidney problems, including kidney failure
• weakening of bones (with bone painand sometimes resulting in fractures), which may occur due to damage to renal tubular cells.
• Fatty Liver

If you think you may have any of these serious adverse effects, consult your doctor.

More Frequent Adverse Effects

The following adverse effects are very common(may affect at least 10 out of 100 patients):

• diarrhea, vomiting, nausea, dizziness, rash, feeling weak

Lab tests may also show:

• decreased blood phosphate levels

Other Possible Adverse Effects

The following adverse effects are common(may affect up to 10 out of 100 patients):

• headache, stomach pain, feeling tired, feeling bloated, flatulence

Lab tests may also show:

• liver problems

The following adverse effects are uncommon(may affect up to 1 in 100 patients):

• muscle rupture, muscle pain or weakness

Lab tests may also show:

• decreased blood potassium levels
• increased blood creatinine levels
• pancreas problems

Muscle rupture, weakening of bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness, and decreased blood potassium or phosphate levels may occur due to damage to renal tubular cells.

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

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

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tenofovir Disoproxil Mylan

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the bottle and carton after {EXP}. The expiration date is the last day of the month indicated.

Do not store above 25°C. Store in the original packaging to protect from light and moisture.

In the case of bottles, after opening the bottle for the first time, use the product within 90 days.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Tenofovir Disoproxil Mylan Composition

• The active ingredient is tenofovir disoproxil. Each Tenofovir Disoproxil Mylan tablet contains 245 mg of tenofovir disoproxil.
• The other ingredients are microcrystalline cellulose, lactose monohydrate (see section 2, Tenofovir Disoproxil Mylan contains lactose), hydroxypropylcellulose, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E171), triacetin, aluminum lake of carmine (E132).

Product Appearance and Package Contents

Tenofovir Disoproxil Mylan 245 mg film-coated tablets are light blue, round, biconvex, marked with 'TN245' on one side and 'M' on the other.

This medication is available in plastic bottles with a child-resistant cap containing 30 film-coated tablets and in multiple packs of 90 film-coated tablets, which contain 3 bottles of 30 film-coated tablets. The bottles also include a desiccant. Do not ingest the desiccant.

The tablets are also available in blisters of 10, 30, or 30 x 1 (single dose) film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Mylan Pharmaceuticals 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,

Komárom, H-2900,

Hungary

Mylan Germany GmbH

Zweigniederlassung Bad Homburg v. d. Hoehe,

Benzstrasse 1,

Bad Homburg v. d. Hoehe,

Hessen, 61352,

Germany

You can request more information about this medication from the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:{MM/YYYY}

Detailed information on this medication is available on the European Medicines Agency website: http://www.ema.europa.eu