TENOFOVIR DISOPROXIL GLENMARK 245 mg FILM-COATED TABLETS

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

Do not takeTenofovir Disoproxil Glenmark:

• If you are allergicto tenofovir, tenofovir disoproxil, or any of the other components of this medication listed in section 6.

If this is the case, tell your doctor immediately and do not taketenofovir disoproxil.

Warnings andprecautions

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

Consult your doctor or pharmacist before starting to take tenofovir.

• If you have had kidney disease or if your tests have shown kidney problems. Tenofovir should not be administered to adolescents with existing kidney problems. Before starting treatment, your doctor may request that you have blood tests to evaluate your kidney function. Tenofovir may affect your kidneys during treatment. Your doctor may request that you have blood tests during treatment to monitor your 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 told you to.

Tenofovir is not usually taken with other medications that can harm your kidneys (see Taking Tenofovir Disoproxil Glenmark with other medications). 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 (which manifest as persistent or worsening bone pain and sometimes end in fractures) may also occur due to damage to the renal tubular cells (see section 4, Possible side effects). Tell your doctor if you have bone pain or fractures.

Tenofovir disoproxil may also cause bone mass loss. The most significant 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 the future risk of fractures in adult and pediatric patients are uncertain.

Some adult patients with HIV who receive combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by lack of blood flow 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: joint stiffness, pain, and discomfort (especially in the hip, knee, and shoulder), and difficulty moving. If you notice any of these symptoms, tell your doctor.

• Tell your doctor if you have a history of liver disease, includinghepatitis.

Patients with liver disease, including chronic hepatitis B or C, treated with antiretrovirals, have a higher risk of serious and potentially life-threatening liver complications. If you have a 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 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 the symptoms of an existing infection when you start treatment with tenofovir. These symptoms may indicate that your immune system is improving and fighting the infection. Be aware of the signs of inflammation or infection after starting to take tenofovir. 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 medications for the treatment of your HIV infection. Autoimmune disorders can occur many months after starting treatment. If you observe any symptoms of infection or other symptoms such as muscle weakness, weakness that starts in the hands and feet and moves up to the torso, palpitations, tremors, or hyperactivity, tell your doctor immediately to receive the necessary treatment.

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

Children andadolescents

Tenofovir is suitablefor:

• adolescents infected with HIV-1 between 12 and less than 18 yearswho weigh at least35 kgand who have already been treated with other HIV medications that are no longer fully effective due to the development of resistance, or that have caused side effects.
• adolescents infected with HBV between 12 and less than 18 yearswho weigh at least35 kg.

Tenofovir is notsuitable for the following groups:

• not for children infected with HIV-1under 12 years.
• not for children infected with HBVunder 12 years.

To know the dose, see section 3, How to take Tenofovir Disoproxil Glenmark.

Other medications andTenofovir Disoproxil Glenmark

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

• Do not stop taking any anti-HIV medicationprescribed by your doctor when you start treatment with tenofovir if you have HBV and HIV.

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

• It is very important that you tell your doctor if you are taking other medicationsthatcan harm yourkidneys.

These medications 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 medications that contain didanosine (for HIV infection):Taking tenofovir with other antiviral medications that contain didanosine may increase didanosine levels in your blood and may reduce the CD4 cell count. When medications containing tenofovir disoproxil and didanosine are taken together, pancreatitis and lactic acidosis (excess lactic acid in the blood) have been rarely reported, in some cases 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.

TakingTenofovir Disoproxil Glenmarkwith food anddrinks

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

Pregnancy andbreastfeeding

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

• .

• If you have been taking tenofovirduring your pregnancy, your doctor may request that you have periodic blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took NtRTIs during pregnancy, the benefit of protection against HIV was greater than the risk of adverse effects.

• if you are a mother and have HBV and your baby received treatment to prevent hepatitis B transmission at birth, you may be able to breastfeed your baby, but you should talk to your doctor first to get more information.

• If you are a woman and have HIV infection, do not breastfeed your child to avoid transmitting the virus to your child 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 talk to her doctor first to get more information.

It is not recommended that women living with HIV breastfeed because HIV infection can be transmitted to the baby through breast milk. If you are breastfeeding or thinking of breastfeeding, you should consult your doctor as soon as possible.

Driving and usingmachines

Tenofovir may cause dizziness. If you feel dizzy during treatment with tenofovir, do not driveorride a bicycleor operate tools or machines.

Tenofovir Disoproxil Glenmark contains lactose

Tell your doctor before taking tenofovirdisoproxil. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Tenofovir Disoproxil Glenmark contains phosphates

This medication contains 46 mg of phosphates in each tablet.

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

3. How to take Tenofovir Disoproxil Glenmark

Follow the instructions for taking this medication exactly as indicated by yourdoctor or pharmacist.If you are unsure, consult your doctor or pharmacist again.

The recommended doseis:

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

If you have special 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 medication 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 less frequently.

• If you have HBV, your doctor may offer you an HIV test to see if you have HBV and HIV.

Consult the leaflets of other antiretrovirals to know how to take those medications.

If you take moreTenofovir Disoproxil Glenmarkthan you should

If you accidentally took too many tenofovir tablets, you may be at a higher risk of experiencing possible side effects with this medication (see section 4, Possible side effects). Consult your doctor or go to the nearest emergency department.

If you have taken more tenofovir than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

Carry the tablet package with you so that you can easily describe what you have taken.

If you forget to takeTenofovir Disoproxil Glenmark

It is essential that you do not miss a dose of tenofovir. If you miss a dose, determine how long it has been since you should have taken it.

• If it is less than 12 hourssince you normally take it, take it as soon as possible, and then take your next dose at your usual time.

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

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

If you interrupt treatment withTenofovir Disoproxil Glenmark

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

• Talk to your doctor before stopping tenofovir for any reason, particularly if you experience any side effect or if you have another illness.
• Talk to your doctor immediately if you experience any new or unusual symptoms after stopping your treatment, particularly those symptoms that you relate to hepatitis B virus infection.
• Contact your doctor before restarting tenofovir tablets.

If you have any other questions about the use of this medication, 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 produce 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 feeling ofthirst,
• 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 more than 1 in 10 patients):

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

Lab tests may alsoshow:

• decrease in 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.

Lab tests may alsoshow:

• 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 alsoshow:

• decrease in blood potassium levels,
• increase in blood creatinine,
• pancreas problems.

Muscle rupture, weakening of bones (with bone pain and sometimes resulting in fractures), muscle pain, muscle weakness, and decrease in 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 prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tenofovir Disoproxil Glenmark

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the bottle, packaging, or blister pack after CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Tenofovir Disoproxil Glenmark

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

Appearance of the Product and Package Contents

Tenofovir Disoproxil Glenmark are film-coated tablets of blue color, oval, biconvex, 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 bags. The desiccant bags should be kept in the bottle to protect the tablets and should not be swallowed.

The available package sizes are:

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

Only some package 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

You can request more information about this medication by contacting the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medication 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 film-coated tablets EFG

Netherlands: Tenofovir Disoproxil Glenmark 245 mg filmomhulde tabletten

Date of the Last Revision of this Prospectus:July 2024

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