Tenofovir disoproxil Glenmark 245 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tenofovir Disoproxil Glenmark 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, as 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, and you should not give it to other people, even if they have the same symptoms as you. It may harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

If tenofovir has been prescribed for your child, please note that all the information in this leaflet applies to your child (in this case, read "your child" instead of "you").

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

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

Tenofovir is a medicine used to treat HIV infection (Human Immunodeficiency Virus).

The tablets are suitable 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 adverse effects.

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

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

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

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

2. What you need to know before taking Tenofovir Disoproxil Glenmark

Do not take Tenofovir Disoproxil Glenmark:

• 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.

Warnings and precautions

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

Consult your doctor or pharmacist before starting to take tenofovir.

• If you have had kidney disease or if your blood tests have shown kidney problems. Tenofovir should not be given to adolescents with pre-existing kidney problems. Before starting treatment, your doctor may request blood tests to assess how well your kidneys are functioning. Tenofovir may affect your kidneys during treatment. Your doctor may request periodic 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 your doctor has instructed you to do so.

Tenofovir is generally not taken together with other medicines that may damage your kidneys (see Taking Tenofovir Disoproxil Glenmark with other medicines). If this is unavoidable, your doctor will monitor your kidney function once a week.

• If you have osteoporosis, a history of bone fractures, or bone problems

Bone problems (manifesting as persistent or worsening bone pain and sometimes leading to fractures) may also occur due to damage to renal tubule 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. The most pronounced bone loss was observed in clinical studies when patients were treated with tenofovir disoproxil in combination with a boosted protease inhibitor.

Overall, the long-term effects of tenofovir disoproxil on bone health and the future risk of fractures in adult and pediatric patients are uncertain.

Some adult HIV patients receiving combination antiretroviral therapy may develop a bone disease called osteonecrosis (bone tissue death caused by reduced blood supply to the bone). Risk factors for developing this condition include duration of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, and high body mass index. Symptoms of osteonecrosis include joint stiffness, pain, and discomfort (especially in the hip, knee, or shoulder), and difficulty moving. If you notice any of these symptoms, inform your doctor.

• Talk to your doctor if you have a history of liver disease, including hepatitis.

Patients with liver disease, including chronic hepatitis B or C, treated with antiretrovirals, have an increased risk of serious and potentially fatal liver complications. If you have hepatitis 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 monitor your liver function.

• Infections. If you have advanced HIV infection (AIDS) and have another type of infection, you may develop symptoms of infection and inflammation or worsening of symptoms from an existing infection when you start treatment with tenofovir. These symptoms may indicate that your improved immune system is fighting the infection. Be alert for signs of inflammation or infection after starting tenofovir. 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 you have started taking medicines for HIV infection. Autoimmune disorders may appear many months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and moving upward toward the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive necessary treatment.

• If you are over 65 years old, inform your doctor or pharmacist. Tenofovir has not been studied in patients over 65 years of age. If you are older than this and have been prescribed tenofovir, your doctor will monitor you closely.

Children and adolescents

Tenofovir is suitable for:

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

Tenofovir is not suitable for the following groups:

• not for children infected with HIV-1 under 12 years of age.
• not for children infected with HBV under 12 years of age.

For dosage information, see section 3, How to take Tenofovir Disoproxil Glenmark.

Other medicines and Tenofovir Disoproxil Glenmark

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

• Do not stop taking any anti-HIV medicines prescribed by your doctor when starting tenofovir treatment if you have both HBV and HIV.

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

• It is very important that you tell your doctor if you are taking other medicines that may 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 suppress the immune system),

• non-steroidal anti-inflammatory drugs (NSAIDs, used to relieve bone or muscle pain).

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

• It is also important to inform your doctor if you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir for the treatment of hepatitis C virus infection.

Taking Tenofovir Disoproxil Glenmark with food and drink

Take Tenofovir with food (e.g., a meal or a snack).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

• .

• If you have taken tenofovir during pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took tenofovir during pregnancy, the benefit of protection against HIV outweighed the risk of adverse effects.

• If you are a mother with HBV and your baby received treatment to prevent hepatitis B transmission at birth, you may be able to breastfeed your baby, but you must speak with your doctor first to obtain further information.

• If you are a woman with HIV infection, do not breastfeed your child to avoid transmitting the virus through breast milk.

For adolescent/pediatric patients:

• If the girl has HBV and her baby is receiving treatment to prevent hepatitis B transmission at birth, she may be able to breastfeed her infant, but she should first speak with her doctor for more information.

Breastfeeding is not recommended for women living with HIV because HIV can be transmitted to the baby through breast milk. If you are breastfeeding or considering breastfeeding, you should consult your doctor as soon as possible.

Driving and using machines

Tenofovir may cause dizziness. If you experience dizziness during treatment with tenofovir, do not drive or ride a bicycle and do not operate tools or machinery.

Tenofovir Disoproxil Glenmark contains lactose

Inform your doctor before taking tenofovir disoproxil. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Tenofovir Disoproxil Glenmark contains phosphates

This medicine contains 46 mg of phosphates per tablet.

If you have severe damage to the cornea (the transparent layer at the front of the eye), treatment with phosphates may, in very rare cases, cause blurred vision due to calcium accumulation.

3. How to take Tenofovir Disoproxil Glenmark

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

• Adults: 1 tablet daily with food (for example, a meal or a snack).
• Adolescents aged 12 to under 18 years who weigh at least 35 kg: 1 tablet daily with food (for example, a meal or a snack).

If you have particular difficulty swallowing, you may 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 prescribed by your doctor. This is to ensure that your medicine is fully effective and to reduce the risk of developing treatment resistance. Do not change the dose unless your doctor tells you to do so.

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

• If you have HBV, your doctor may offer you an HIV test to determine whether you have both HBV and HIV.

Refer to the package leaflets of other antiretrovirals to find out how to take those medicines.

If you take more Tenofovir Disoproxil Glenmark than you should

If you accidentally took too many tenofovir tablets, you may be at increased risk of experiencing possible adverse effects with this medicine (see section 4, Possible adverse effects). Contact your doctor or go to the nearest emergency department.

If you have taken more tenofovir than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount taken.

Take the tablet packaging with you so you can easily describe what you have taken.

If you forget to take Tenofovir Disoproxil Glenmark

It is important not to miss a dose of tenofovir. If you forget a dose, determine how long it has been since you were supposed to take it.

• If it is less than 12 hours since you usually take it, take it as soon as possible, and then take your next dose at the usual time.

• If it is more than 12 hours since you should have taken 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 after taking tenofovir, take another tablet. You do not need to take another tablet if you vomited more than one hour after taking tenofovir.

If you interrupt treatment with Tenofovir Disoproxil Glenmark

Do not stop taking tenofovir without being told to do so by your doctor. Stopping treatment with tenofovir may reduce the effectiveness of the treatment recommended by your doctor.

If you have hepatitis B, or HIV and hepatitis B (coinfection), it is very important not to interrupt your treatment with tenofovir without first talking to your doctor. After stopping treatment with tenofovir, some patients have experienced blood test results or symptoms indicating that their hepatitis has worsened. You may need to have blood tests for several months after stopping treatment. In patients with advanced liver disease or cirrhosis, stopping treatment is not recommended, as this may lead to a worsening of your hepatitis.

• Talk to your doctor before stopping tenofovir for any reason, especially if you experience any adverse effects or have another illness.
• Contact your doctor immediately if you experience any new or unusual symptoms after stopping your treatment, particularly symptoms you think may be related to hepatitis B virus infection.
• Contact your doctor before restarting tenofovir tablets.

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

4. Possible adverse effects

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

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Possible serious adverse effects: inform your doctor immediately

• Lactic acidosis (excess lactic acid in the blood) is a rare but serious adverse effect (may affect up to 1 in 1,000 patients) that can be life-threatening. The following adverse effects may be signs of lactic acidosis:

  • deep, 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 caused by inflammation of the pancreas,
• damage to cells in the renal tubule.

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

• inflammation of the kidney, increased urine volume and feeling thirsty,

• changes in your urine and back pain due to kidney problems, including kidney failure,

• weakening of the bones (with bone pain, sometimes leading to fractures), which may occur due to damage to cells in the renal tubule,

• fatty liver.

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

More frequent adverse effects

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

• diarrhoea, vomiting, nausea, dizziness, rash, feeling weak.

Blood tests may also show:

• decreased blood phosphate levels.

Other possible adverse effects

The following adverse effects are common (may affect up to 1 in 10 patients):

• headache, stomach pain, feeling tired, feeling bloated, flatulence, loss of bone mass.

Blood 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 muscle weakness.

Blood tests may also show:

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

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

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tenofovir Disoproxil Glenmark

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the bottle, packaging, or blister after EXP. The expiry date refers to the last day of the month indicated.

Store below 25°C.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to your pharmacy’s SIGRE collection point. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Tenofovir Disoproxil Glenmark

• The active substance is tenofovir. Each film-coated tablet contains tenofovir disoproxil fumarate equivalent to 245 mg of tenofovir disoproxil.
• The other components are: microcrystalline cellulose, sodium croscarmellose, stearic acid, lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin, and indigo carmine aluminium lake (indigo carmine) (E132).

Nature of the product and pack contents

Tenofovir Disoproxil Glenmark are blue, oval, biconvex, film-coated tablets, engraved with "T1" on one side and smooth on the other, approximately 16.7 x 9.3 mm in size.

Tenofovir Disoproxil Glenmark is available in plastic bottles. Each bottle contains two silica gel desiccant sachets. The desiccant sachets must be kept in the bottle to protect the tablets and must not be swallowed.

Available pack sizes are:

• Carton box containing 1 bottle of 30 film-coated tablets.
• Carton box containing 3 bottles of 30 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH
Industriestr. 31
82194 Gröbenzell
Germany

Manufacturer:

Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoké Mýto
Czech Republic

Pharmadox Healthcare Ltd
KW20A Kordin Industrial Estate, Paola,
PL 3000, Malta

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

Glenmark Farmacéutica, S.L.U.
C/ Retama 7, 7th floor
28045 Madrid
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

United Kingdom: Tenofovir Disoproxil Glenmark 245 mg Film-coated Tablets
Germany: Tenofovir Disoproxil Glenmark 245 mg Filmtabletten
Spain: Tenofovir Disoproxilo Glenmark 245 mg comprimidos recubiertos con película EFG
Netherlands: Tenofovir Disoproxil Glenmark 245 mg filmomhulde tabletten

Date of the most recent revision of this leaflet: July 2024

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)