Label:information for the patient

Tenofovir disoproxil Cipla 245 mg film-coated tablets EFG

Tenofovir disoproxil fumarate

Read this label carefully before starting to take this medication,because it contains important information for you.

-Keep this label, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medication has been prescribedonlyto you, and you should not give it to other people even iftheyhavethe same symptomsas you,as it may harm them.

-If you experience any adverse effects,consult your doctor or pharmacist,eveniftheyare not listed in this label. See section 4.

1.What isTenofovir disoproxil Ciplaand what is it used for

2.What you need to knowbeforestarting totakeTenofovir disoproxil Cipla

3.How to takeTenofovir disoproxil Cipla

4.Possible adverse effects

5Storage ofTenofovir disoproxil Cipla

6.Contents of the package and additional information

If tenofovir has been prescribed to your child, note that all the information in this labelis directed at your child (in this case, read “your child” instead of “you”).

Tenofovir contains the active ingredienttenofovir disoproxilo. This active ingredient is anantiretroviralor antiviral medicationused to treat HIV infection, or HBV, or both.Tenofovir isaninhibitor of the reverse transcriptase analog nucleotide,commonly knownasITIAN and acts by interfering with the normal function of certain enzymes (in the case of HIV thereverse transcriptaseand in hepatitis B theDNA polymerase) essential for the viruses toreplicate. Forthe treatment of HIV infection, tenofovir must be used always in combination withother medications.

Tenofovir is a medication used to treat HIV(Human Immunodeficiency Virus) infection. The tablets are suitable for:

-adults,

-adolescents between 12 and less than 18 years who have already been treatedwithothermedications against HIV that are no longer fully effective due to the developmentofresistances, or that have causedadverse effects.

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

-adults,

-adolescents between 12 and less than 18 years.

No HIV infection is required to be treated with tenofovir for HBV.

This medication is not a cure for HIV infection. While taking tenofoviryou maycontinue to have infections or other diseases associated with HIV infection. You may alsocontinue to transmit HBV to others. Therefore, it is essential to take precautionstoavoid infecting others.

Do not takeTenofovir disoproxil Cipla

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

If this is the case,inform your doctor immediately and do not takethis medication.

Warnings andprecautions

Consult your doctor or pharmacist before starting to takeTenofovir disoproxil Cipla.

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

-If you have had kidney disease or if your tests have shown kidney problems, consultyour doctor or pharmacist.You should not administer tenofovir to adolescents with existing kidney problems. Before starting treatment, your doctor may request that you have blood tests to evaluate the function of your kidneys. Tenofovir may affect your kidneys during treatment. Your doctor may request that you have blood tests during treatment to control the function of your kidneys. 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 usually not taken with other medications that may damage yourkidneys(seeTaking Tenofovir disoproxil Cipla with other medications). If this is unavoidable, your doctor will monitor the function of your kidneys once aweek.

-Bone problems.Some adult patients with HIV who receive antiretroviral combination treatment may develop a bone disease called osteonecrosis (bone tissue death caused by a lack of blood supply to the bone). Among the numerous risk factors for developing this disease are the duration of antiretroviral combination treatment, the use of corticosteroids, alcohol consumption, severe immunodepression, 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, inform your doctor.

You may also experience bone problems (which manifest as persistent bone pain or worsening and sometimes ending in fractures) due to damage to renal tubular cells (see section 4,Adverse reactions).

Inform your doctor or your child's doctor if you have bone pain or fractures.

Tenofovir disoproxil may 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 the future risk of fractures in adult and pediatric patients are imprecise.

Inform your doctor or your child's doctor if you know you have osteoporosis, a history of bone fractures, or if you have bone problems.

-Consult 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 severe and potentially fatal 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 monitor your liver function.

-Be aware of infections.If you have advanced HIV infection (AIDS) and present 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 improved immune system is fighting the infection. Be aware if you develop signs of inflammation or infection after starting to take tenofovir. If you notice signs of inflammation or infection, inform your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also appear after you start taking medications for the treatment of your HIV infection. Autoimmune disorders may appear 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 ascending to the trunk of the body, palpitations, tremors, or hyperactivity, inform your doctor immediately to receive the necessary treatment.

-If you are over 65 years old, inform 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 carefully.

Children and adolescents

Tenofovir isappropriatefor:

-adolescents infected with HIV-1 between 12 and less than 18 years old who weigh at least 35 kg and who have already been treatedwith 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 years old who weigh at least 35 kg.

Tenofoviris notappropriate for the following groups:

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

-not for children infected with HBVunder 12 years old.

To know the dose, see section 3,How to take Tenofovir disoproxil Cipla.

Taking Tenofovir disoproxil Cipla with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any othermedication.

-Do not stop taking any HIV medication prescribed by your doctor when starting treatment with tenofovir if you have HBV andVIH.

-Do not take tenofovirif you are using medications that already contain tenofovir disoproxil or tenofovir alafenamide. Do not take 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 medicationsthatmay damage yourkidneys.

Among these medications are:

-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 treatcancer),

-adefovir dipivoxil (used to treat HBV infection),

-tacrolimus (used to produce immunosuppression),

-nonsteroidal 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 the levels of didanosine in your blood and may reduce the CD4 cell count. When taken together, medications containing tenofovir disoproxil and didanosine have been reported in rare cases to cause inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), 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 inform your doctorif you are taking ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir to treat hepatitis C infection.

Taking Tenofovir disoproxil Cipla with food and drinks

Take tenofovir with food(for example, a meal or a snack).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using thismedication.

For adults:

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

-If you are a mother and have HBV infection, and your baby has been treated to prevent the transmission of hepatitis B at birth, it is possible that you may breastfeed your infant, but first speak with your doctor 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 plan to breastfeed, you mustconsult your doctor as soon as possible.

For adolescents:

• If your child has HBV, and your baby has been treated to prevent the transmission of hepatitis B at birth, it is possible that your child may breastfeed your infant, but first speak with your child's doctor 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 plan to breastfeed, you mustconsult your doctor as soon as possible.

Driving and operating machines

Tenofovir may cause dizziness. If you notice dizziness during treatment with tenofovir,do not drive orride a bikeor operatemachines.

Tenofovir disoproxil Cipla contains lactose

This medication contains lactose monohydrate. If your doctor has told you that you are intolerant to certain sugars, consult with him before taking this medication.

Tenofovir disoproxil Cipla contains sodium

This medication contains less than 1 mmol (23 mg) of sodium per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.Yourdoctor or pharmacist..In case of doubt, consult your doctor or pharmacist again.

The recommended doseis:

-Adults:1 tablet per day with food (for example, a meal or anappetizer).

-Adolescents between 12 and less than 18 years who weigh at least 35 kg:1 tablet perdaywith food (for example, a meal or asnack).

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 or grapefruit juice and drink it immediately.

-Always take the recommended dose prescribed by your doctor.This is to ensure thatyourmedicine is completely effective, and to reduce the risk of developing resistancetotreatment. 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 totaketenofovir lessfrequently.

-If you have VHB, your doctor may offer you to undergo a HIV test to see if you have VHBandVIH.

Consult the prospectuses of other antiretrovirals to know how to take thesemedicines.

If you take moreTenofovir disoproxilo Ciplathan youshould

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

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

Carry thecontainerof tablets with you so that you can easily describe what youhavetaken.

If you forgot to takeTenofovir Disoproxilo Cipla

It is very important not to forget a dose of tenofovir. If you forget a dose, determine how longagoyou shouldhavetaken it.

-If it is less than 12 hourssince when you normally take it, take it as soon aspossible,and then take your next dose at your usualtime.

-If it is more than 12 hourssince you should have taken it, do not take the missed dose. Wait and takethenext dose at your usual time. Do not take a double dose to compensate for the misseddoses.

If you vomit before 1 hour after taking tenofovir,take another tablet.You do not need to take another tablet if you vomited more than an hour after takingtenofovir.

If you interrupt the treatment withTenofovir disoproxilo Cipla

Do not stop taking tenofovir without your doctor's advice. Stopping treatment with tenofovirmayreduce the effectiveness of the treatment recommended by yourdoctor.

If you have hepatitis B, or HIV and hepatitis B (coinfection),it is very important not to interruptyourtreatment with tenofovir without first talking to your doctor. After stopping treatment withtenofovir,some patients have presented blood tests or symptoms indicating that their hepatitishadworsened. You may need to have blood tests for several months after stopping treatment. In patients with advanced liver disease or cirrhosis, it is notrecommendedto stop treatment as this may lead to a worsening of theirhepatitis.

-Talk to your doctor before stopping tenofovir for any reason, particularlyifyou experience any side effects or have anotherillness.

-Talk to your doctor immediately if you experience any new or unusual symptomsafterstopping treatment, particularly those symptoms related to the hepatitisBvirus infection.

-Contact your doctor before restarting the tablets oftenofovir.

If you have any other questions about the use of this medication, ask your doctor orpharmacist.

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

Like all medications, this medication may produce side effects, although not all people will experience them.

Severe possible side effects: inform your doctor immediatelyimmediately

-Lactic acidosis (excess lactic acid in the blood) is a rare but severe side effect (can affect up to 1 in 1,000 patients) that can be fatal. The following side 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 doctorimmediately.

Other possible severe side effectssevere

The following side effects areinfrequent(can affect up to 1 in 100 patients):

-Abdominal pain(due to pancreatitis inflammation),

-Kidney cell damage.

The following side effects arerare(can affect up to 1 in 1,000 patients):

-Kidney inflammation,increased urine volume and sensation ofthirst,

-Changes inyoururineandback paindue to kidney problems, including kidney failure,

-Weakness of the bones (withbone painand sometimes ending in fractures),whichmay occur due to kidney cell damage,

-Fatty liver.

If you think you may have any of these severe side effects, consult yourdoctor.

More frequent side effectsside effects

The following side effects arevery frequent(can affect more than 1 in 10 patients):

-Diarrhea, vomiting, nausea, dizziness, rash, feelingweak.

The tests may also show:

-Decreased phosphate levels in the blood.

Other possible side effectsside effects

The following side effects arecommon(can affect up to 1 in 10 patients):

-Headache, stomach pain, feeling tired, feeling bloated, flatulence, bone loss.

The tests may also show:

-Liver problems.

The following side effects areinfrequent(can affect up to 1 in 100 patients):

-Muscle rupture, muscle pain or weakness.

The tests may also show:

-Decreased potassium levels in the blood,

-Increased creatinine levels in the blood,

-Kidney problems.

Muscle rupture, weakness of the bones (with bone pain and sometimes ending in fractures), muscle pain, weakness, and decreased potassium or phosphate levels in the blood, may occur due to kidney cell damage.

The following side effects arerare(can affect up to 1 in 1,000 patients):

-Abdominal pain (due to liver inflammation),

-Swelling of the face, lips, tongue, orthroat.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe bottle, packaging or blister dafter CAD. The expiration date is the last day of the month indicated.

Blister packaging

Do not store above 25ºC.

Bottle packaging

Store below 30ºC.

Keep in the original bottle to protect from moisture.

Keep the bottle properly closed.

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Tenofovir Disoproxil Cipla Composition

-The active ingredientis tenofovir disoproxil. Each film-coated tablet contains 245 mg of tenofovir disoproxil (as fumarate).

-The other components are:

Tablet core:lactose monohydrate, sodium croscarmellose (E468), maize starch, polisorbate 80 (E433), microcrystalline cellulose (E460), and magnesium stearate (E572).

Tablet coating:lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin, aluminium lake blue #2 FD&C/indigo carmin Al (E132).

Appearance of the product and packaging contents

Tenofovir Cipla tablets are blue-coated, capsule-shaped, biconvex, 17.20 ±0.30mm in length, and 8.20 ±0.30mm in thickness, with the mark “TNV” on one face and smooth on the other.

High-density polyethylene (HDPE) bottle with a child-resistant polypropylene cap containing 30 film-coated tablets and a silica gel desiccant.

Smooth aluminium blister packaging with a 3-layer laminated aluminium foil.

The following packaging sizes are available: carton packs with a 30-tablet HDPE bottle and carton packs with 90 (3 x 30) film-coated tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Cipla Europe NV

De Keyserlei 58-60, Box-19,

2018 Antwerp

Belgium

Responsible manufacturer:

Cipla (EU) limited

Dixcart House,

Addlestone Road,

Bourne Business Park,

Addlestone,Surrey, KT15 2LE,

UK

Or

Cipla Europe NV

De Keyserlei 58-60,

Box-19, 2018 Antwerp,

Belgium

Or

S&D Pharma CZ, spol. S.r.o,

Theodor 28, 273 08 Pchery (Pharmos a.s. facility), Czech Republic

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet: November 2024

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).