Leaflet:information for the user

Tolvaptán Teva 15 mg EFG tablets

Tolvaptán Teva 30 mg EFG tablets

Tolvaptán Teva 15 mg + Tolvaptán Teva 45 mg EFG tablets

Tolvaptán Teva 30 mg + Tolvaptán Teva 60 mg EFG tablets

Tolvaptán Teva 30 mg + Tolvaptán Teva 90 mg EFG tablets

Read 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 yourdoctor orpharmacist.

-This medicine has been prescribedonlyfor you, and you should not give it to others even if they havethe same symptomsas you, as it may harm them.

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

1.What is Tolvaptán Teva and what it is used for

2.What you need to knowbeforestarting totake Tolvaptán Teva

3.How to take Tolvaptán Teva

4.Possible side effects

5Storage of Tolvaptán Teva

6.Contents of the pack and additional information

The active ingredient of this medication is tolvaptan, which blocks the effect of vasopressin, a hormone that participates in the formation of cysts in the kidneys of patients with ADPKD. By blocking the effect of vasopressin, tolvaptan slows down the development of renal cysts in patients with ADPKD, reduces the symptoms of the disease and increases urine production.

Tolvaptan is a medication used to treat a disease known as “autosomal dominant polycystic kidney disease” (ADPKD). This disease leads to the development of fluid-filled cysts in the kidneys, which causes pressure on the surrounding tissues and reduces renal function, even leading to renal insufficiency. Tolvaptan is used to treat ADPKD in adults with chronic kidney disease (CKD) in stages 1 to 4 with signs of rapid progression of the disease.

Do not take Tolvaptán Teva

• if you are allergic to tolvaptán or any of the other ingredients of this medicine (listed in section 6) or if you are allergic to benzazepine or benzazepine derivatives (for example, benazepril, conivaptán, mesilato de fenoldopam or mirtazapina).
• if you have been told that you have high levels of liver enzymes in your blood and that this prevents you from receiving treatment with tolvaptán.
• if your kidneys do not function (no urine production).
• if you have a condition associated with very low blood volume (for example, severe dehydration or hemorrhage).
• if you have a condition that increases the amount of sodium in your blood.
• if you do not feel thirsty.
• if you are pregnant.
• if you are breastfeeding.

Warnings and precautions

Consult your doctor before starting to take tolvaptán:

• if you have liver disease.
• if you cannot drink enough water (see “drink a sufficient amount of water” below) or if you have to limit your liquid intake.
• if you have difficulty urinating or prostate hypertrophy (for example, enlarged prostate).
• if you have high or low sodium levels in your blood.
• if you have had a past allergic reaction to benzazepine, tolvaptán or other benzazepine derivatives (for example, benazepril, conivaptán, mesilato de fenoldopam or mirtazapina), or to any of the other ingredients of this medicine (listed in section 6).
• if you have diabetes.
• if you have been told that you have high levels of uric acid in your blood (which may have caused gout).
• if you have advanced kidney disease.

This medicine may cause your liver not to function correctly. For this reason, please inform your doctor immediately if you experience signs that may indicate liver problems, such as:

• nausea
• vomiting
• fever
• fatigue
• loss of appetite
• abdominal pain
• dark urine
• jaundice (yellowing of the skin or eyes)
• itching (pruritus) in the skin
• pseudogripal syndrome (muscle and joint pain with fever)

During treatment with this medicine, your doctor will ask you to have monthly blood tests to monitor any changes in your liver function.

Drink a sufficient amount of water

This medicine causes water loss because it increases urine production. This water loss may cause side effects such as dry mouth and thirst, or even more serious side effects such as kidney problems (see section 4). Therefore, it is essential that you have access to water and can ingest sufficient amounts of liquid when you feel thirsty. Before going to bed, you should drink one or two glasses of water even if you do not feel thirsty, and also drink water after urinating at night. You should be particularly careful if you have a disease that reduces your ability to drink enough liquids or if you are at a higher risk of dehydration, for example if you have vomiting or diarrhea. Due to the increased urine production, it is also essential to always have a bathroom nearby.

Children and adolescents

Do not administer this medicine to children and adolescents (under 18 years) because it has not been studied in this population.

Other medicines and Tolvaptán Teva

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine, including over-the-counter medicines.

The following medicines may increase the effect of Tolvaptán Teva:

• amprenavir, atazanavir, darunavir/ritonavir, and fosamprenavir (used to treat HIV/AIDS),

• aprepitant (used to prevent nausea and vomiting during chemotherapy),

• crizotinib and imatinib (used to treat cancer),

• ketoconazole, fluconazole, or itraconazole (used to treat fungal infections),

• macrolide antibiotics such as erythromycin or clarithromycin,

• verapamil (used to treat heart disease and hypertension),

• ciprofloxacin (an antibiotic),

• diltiazem (used to treat hypertension and chest pain).

The following medicines may decrease the effect of Tolvaptán Teva:

• phenytoin or carbamazepine (used to treat epilepsy),

• rifampicin, rifabutin, or rifapentine (used to treat tuberculosis),

• St. John's Wort (a traditional herbal medicine for mild depression and anxiety).

Tolvaptán Teva may increase the effect of the following medicines:

• digoxin (used to treat irregular heart rhythm and heart failure),

• dabigatran (used as an anticoagulant),

• sulfasalazine (used to treat irritable bowel syndrome or rheumatoid arthritis),

• metformin (used to treat diabetes).

Tolvaptán Teva may decrease the effect of the following medicines:

• vasopressin analogues such as desmopressin (used to increase blood clotting factors or to control urine production or urinary incontinence).

These medicines may affect Tolvaptán Teva or be affected by it:

• diuretics (used to increase urine production). When taken at the same time as Tolvaptán Teva, these medicines may increase the risk of dehydration-related side effects or cause kidney problems.

• diuretics or other medicines for hypertension. When taken at the same time as Tolvaptán Teva, these medicines may increase the risk of low blood pressure when standing up or getting up.

• medicines that increase sodium levels in the blood or contain high amounts of salt (e.g., tablets that dissolve in water and those used to treat indigestion). These may increase the effects of Tolvaptán Teva. There is a risk of excessive sodium in your blood.

You may not need to worry about taking these medicines at the same time as Tolvaptán Teva. Your doctor will decide what is best for you.

Taking Tolvaptán Teva with food and drinks

Do not take grapefruit juice while taking this medicine.

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant or breastfeeding.

Women of childbearing age should use reliable contraceptive methods while being treated with this medicine.

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 medicine.

Use in athletes

This medicine contains tolvaptán, which may produce a positive result in doping control tests.

Driving and operating machinery

Some people may feel dizzy, weak, or tired after taking tolvaptán. If you experience these effects, do not drive or use tools or machinery.

Tolvaptán Teva contains lactose and sodium

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

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

.

Only specialized doctors in the treatment of PQRAD can prescribe tolvaptan.

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

Dosage

The daily dose of tolvaptan should be divided into two doses, one higher than the other. The higher dose should be taken in the morning upon waking, at least 30 minutes before breakfast, while the lower dose should be taken 8 hours later.

The dose combinations are:

45 mg + 15 mg

60 mg + 30 mg

90 mg + 30 mg

Normally, your treatment will start with a dose of 45 mg in the morning and 15 mg 8 hours later. Your doctor may gradually increase your dose to a maximum combination of 90 mg in the morning and 30 mg 8 hours later. To determine which is the best dose, your doctor will regularly check how you tolerate the prescribed dose. You should always take the highest tolerable dose combination prescribed by your doctor.

If you are taking other medications that may increase the effects of tolvaptan, you may receive lower doses. In this case, your doctor may prescribe tolvaptan tablets with 30 or 15 mg of tolvaptan, which you should take once a day in the morning.

Administration form

Swallow the tablets without chewing and accompanied by a glass of water.

Tolvaptan Teva 15 mg tablets

Tolvaptan Teva 15 mg + Tolvaptan Teva 45 mg tablets

The 15 mg tablet can be divided into equal doses.

The morning dose should be taken at least 30 minutes before breakfast. The second daily dose can be taken with or without food.

If you take more Tolvaptan Teva than you should

In case you have taken more tablets than the prescribed dose,drink plenty of water and immediately contact your doctor or the nearest hospital. Remember to carry the medication box with you so that it is clear what you have taken. If you take the highest dose too late, you may have to go to the bathroom more frequently at night.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Tolvaptan Teva

If you forget to take your medication, you should take the dose as soon as you remember it on the same day. If you have not taken the tablets for a day, take the normal dose the next day. Do not take a double dose to compensate for the individual doses missed.

If you interrupt the treatment with Tolvaptan Teva

If you interrupt the treatment with tolvaptan, the kidney cysts may grow as fast as before starting the treatment with this medication. Therefore, you should only stop taking tolvaptan if you notice emergency medical attention required side effects (see section 4) or if your doctor tells you to.

If you have any other doubts about the use of thismedication, ask your doctororpharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Severe side effects:

If you experience any of the following side effects, you may need urgent medical attention. Stop taking tolvaptan and contact your doctor immediately or go to the nearest hospital if:

• You have difficulty urinating.

• You experience swelling of the face, lips, or tongue, itching, a generalised skin rash, or wheezing or difficulty breathing (symptoms of an allergic reaction).

Tolvaptan may cause your liver not to function properly.

Consult your doctor if you experience symptoms of nausea, vomiting, fever, fatigue, loss of appetite, abdominal pain, dark urine, jaundice (yellowing of the skin or eyes), skin itching, or joint and muscle pain with fever.

Other side effects:

Very common: may affect more than 1 in 10 people

• Thirst (excessive need to drink water)
• Headache
• Dizziness
• Diarrhea
• Dry mouth
• Increased need to urinate, urinating at night, or urinating more frequently
• Fatigue

Common: may affect up to 1 in 10 people

• Dehydration
• High concentrations of sodium, uric acid, and sugar in the blood
• Decreased appetite
• Changes in taste
• Gout
• Difficulty falling asleep
• Fainting
• Palpitations
• Difficulty breathing
• Abdominal pain
• Feeling full, having a bloated stomach, or experiencing stomach discomfort
• Constipation
• Heartburn
• Abnormal liver function
• Dry skin
• Skin rash
• Itching
• Hives
• Joint pain
• Muscle spasms
• Muscle pain
• General weakness
• Increased concentrations of liver enzymes in the blood
• Weight loss
• Weight gain

Rare: may affect up to 1 in 100 people

• Increased concentration of bilirubin (a substance that can cause yellowing of the skin or eyes) in the blood

Unknown frequency: cannot be estimated from available data

• Allergic reactions (see above)
• Generalised rash
• Acute liver failure (ALF)

Reporting of 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 to the Spanish 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 medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthecontainer and the blisterafter CAD or EXP. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or trash. Dispose of containers and medications you no longer need at the SIGREpoint at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Tolvaptan Teva

• The active ingredient is tolvaptan.

Each Tolvaptan Teva 15 mg tablet contains 15 mg of tolvaptan.

Each Tolvaptan Teva 30 mg tablet contains 30 mg of tolvaptan.

Each Tolvaptan Teva 45 mg tablet contains 45 mg of tolvaptan.

Each Tolvaptan Teva 60 mg tablet contains 60 mg of tolvaptan.

Each Tolvaptan Teva 90 mg tablet contains 90 mg of tolvaptan.

• The other excipients are lactose monohydrate (see section 2), sodium lauryl sulfate, povidone, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Appearance of the product and packaging contents

The different doses of Tolvaptan Teva tablets have different shapes and markings:

15 mg tablet: round, uncoated tablets, white to off-white, with a notch, having a line of partition on both sides and marked with "A" and "3" on one side of the partition line. Diameter approximately 5.50 mm.

30 mg tablet: round, uncoated tablets, white to off-white, marked with "T5" on one face and flat on the other face, with a diameter of approximately 6.80 mm.

45 mg tablet: square, uncoated tablets, white to off-white, marked with "T8" on one face and flat on the other face, with dimensions of approximately 7.70 mm x 7.70 mm.

60 mg tablet: barrel-shaped, uncoated tablets, white to off-white, marked with "A0" on one face and flat on the other face, with dimensions of approximately 10.60 mm x 6.30 mm.

90 mg tablet: pentagonal, uncoated tablets, white to off-white, marked with "AT" on one face and flat on the other face, with dimensions of approximately 11.27 mm x 11.00 mm.

The following packaging sizes are available:

• Blister with PVC/Aclar/PVC forming film and PET/Aluminum foil backing.
• Blister with PVC/Aclar/PVC forming film and aluminum foil backing.
• Blister with OPA/Aluminum/PVC forming film and PET/Aluminum foil backing.

Tolvaptan Teva 15 mg tablets EFG:blister packs containing 7 or 28 tablets, and single-dose blister packs containing 7x1 tablets.

Tolvaptan Teva 30 mg tablets EFG:blister packs containing 7 or 28 tablets, and single-dose blister packs containing 7x1 tablets.

Tolvaptan Teva 15 mg + Tolvaptan Teva 45 mg tablets EFG:blister packs containing 14 tablets (7 high-dose tablets + 7 low-dose tablets), 28 tablets (14 high-dose tablets + 14 low-dose tablets), or 56 tablets (28 high-dose tablets + 28 low-dose tablets), and single-dose blister packs containing 56x1 tablets (28x1 high-dose tablets + 28x1 low-dose tablets).

Tolvaptan Teva 30 mg + Tolvaptan Teva 60 mg tablets EFG:blister packs containing 14 tablets (7 high-dose tablets + 7 low-dose tablets), 28 tablets (14 high-dose tablets + 14 low-dose tablets), or 56 tablets (28 high-dose tablets + 28 low-dose tablets), and single-dose blister packs containing 56x1 tablets (28x1 high-dose tablets + 28x1 low-dose tablets).

Tolvaptan Teva 30 mg + Tolvaptan Teva 90 mg tablets EFG:blister packs containing 14 tablets (7 high-dose tablets + 7 low-dose tablets), 28 tablets (14 high-dose tablets + 14 low-dose tablets), or 56 tablets (28 high-dose tablets + 28 low-dose tablets), and single-dose blister packs containing 56x1 tablets (28x1 high-dose tablets + 28x1 low-dose tablets).

Only some packaging sizes may be commercially available.

Marketing authorization holder

Teva B.V.

Swensweg 5,

2031GA Haarlem,

Netherlands

Manufacturer:

Teva Operations Poland Sp. z.o.o. (BS 2)

ul. Mogilska 80

PL-31-546 Kraków

Poland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta,

Alcobendas, 28108 – Madrid

Spain

Last review date of thisleaflet:April 2023.

Other sources of information

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet with your smartphone. You can also access this information on the following internet address:

Tolvaptan Teva 15 mg tablets EFG

https://cima.aemps.es/cima/publico/detalle.html?nregistro=84994

Tolvaptan Teva 30 mg tablets EFG

https://cima.aemps.es/cima/publico/detalle.html?nregistro=84992

Tolvaptan Teva 15 mg + Tolvaptan Teva 45 mg tablets EFG

https://cima.aemps.es/cima/publico/detalle.html?nregistro=84993

Tolvaptan Teva 30 mg + Tolvaptan Teva 60 mg tablets EFG

https://cima.aemps.es/cima/publico/detalle.html?nregistro=84991

Tolvaptan Teva 30 mg + Tolvaptan Teva 90 mg tablets EFG

https://cima.aemps.es/cima/publico/detalle.html?nregistro=84997

)