Tolvaptan Accord 7.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Tolvaptan Accord 7.5 mg tablets

tolvaptan

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because 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.

Leaflet contents:

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

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

Tolvaptán Accord, which contains the active substance tolvaptán, belongs to a group of medicines called vasopressin antagonists. Vasopressin is a hormone that helps prevent water loss from the body by reducing urine production. An antagonist blocks vasopressin from exerting its water-retaining effect, thereby reducing the amount of water in the body by increasing urine production, resulting in an increase in blood sodium levels.

Tolvaptán Accord is used to treat low serum sodium levels in adults. You have been prescribed this medicine because you have low sodium levels in your blood as a result of a condition called "syndrome of inappropriate antidiuretic hormone secretion (SIADH)", in which the kidneys retain too much water. This condition leads to an inappropriate production of the hormone vasopressin, causing your blood sodium levels to become too low (hyponatremia). This may cause difficulties with concentration and memory or with maintaining balance.

2. What you need to know before taking Tolvaptan Accord

Do not take Tolvaptan Accord

• if you are allergic to tolvaptan or to any of the other ingredients of this medicine (listed in section 6), or if you are allergic to benzazepine or benzazepine derivatives (e.g., benazepril, conivaptan, fenoldopam mesylate, or mirtazapine)
• if your kidneys do not work (no urine production)
• if you have any condition that increases blood salt levels (“hypernatremia”)
• if you have any condition associated with very low blood volume
• if you do not feel thirsty
• if you are pregnant
• if you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting Tolvaptan Accord:

• if you are unable to drink enough water or if you have fluid restrictions
• if you have difficulty urinating or have an enlarged prostate
• if you have liver disease
• if you have previously experienced an allergic reaction to benzazepine, tolvaptan, or other benzazepine derivatives (e.g., benazepril, conivaptan, fenoldopam mesylate, or mirtazapine), or to any of the other ingredients of this medicine (listed in section 6)
• if you have a kidney disease called autosomal dominant polycystic kidney disease (ADPKD)
• if you have diabetes.

Adequate water intake

Tolvaptan Accord causes water loss because it increases urine production. This water loss may lead to adverse effects such as dry mouth and thirst, and even more serious adverse effects such as kidney problems (see section 4). Therefore, it is important that you have access to water and are able to drink sufficient amounts whenever you feel thirsty.

Children and adolescents

Tolvaptan Accord must not be used in the treatment of children and adolescents (under 18 years of age).

Other medicines and Tolvaptan Accord

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

The following medicines may increase the effects of this medicine:

• ketoconazole (for fungal infections);
• macrolide antibiotics;
• diltiazem (used for high blood pressure and chest pain);
• other products that increase blood salt concentration or contain large amounts of salt.

The following medicines may decrease the effects of this medicine:

• barbiturates (used to treat epilepsy/seizures and certain sleep disorders);
• rifampicin (for tuberculosis);
• St. John’s wort, a herbal medicine used to treat depression.

This medicine may increase the effects of the following medicines:

• digoxin (used to treat heart rhythm irregularities and heart failure);
• dabigatran etexilate (used as a blood anticoagulant);
• metformin (for the treatment of diabetes);
• sulfasalazine (used to treat inflammatory bowel disease or rheumatoid arthritis).

This medicine may decrease the effects of the following medicine:

• desmopressin (used to increase blood clotting factors).

It may be appropriate for you to take these medicines at the same time as your treatment with Tolvaptan Accord. Your doctor will decide what is suitable for you.

Taking Tolvaptan Accord with food and drinks

Avoid drinking grapefruit juice when taking Tolvaptan Accord.

Pregnancy and breastfeeding

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

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

Appropriate contraceptive measures should be used during treatment with this medicine.

Driving and using machines

It is unlikely that Tolvaptan Accord will negatively affect your ability to drive or operate machinery. However, you may occasionally feel dizzy, weak, or may briefly faint.

Tolvaptan Accord contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Tolvaptán Accord

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

• Treatment with Tolvaptán Accord will be initiated in the hospital.
• For the treatment of low sodium levels (hyponatremia), your doctor will instruct you to start with a dose of 15 mg, which may then be increased up to a maximum of 60 mg to achieve the desired serum sodium level. To monitor the effects of Tolvaptán Accord, your doctor will request periodic blood tests. In some cases, to achieve the desired serum sodium level, your doctor may prescribe a dose of 7.5 mg.
• Swallow the tablet without chewing, with a glass of water.
• Take the tablets once daily, preferably in the morning, with or without food.

If you take more Tolvaptán Accord than you should

If you take more tablets than prescribed, drink large amounts of water and contact your doctor or the nearest hospital immediately. Remember to bring the medicine package with you so it is clear what you have taken.

If you forget to take Tolvaptán Accord

If you forget to take your dose, take it as soon as you remember on the same day. If you miss a tablet one day, take your usual dose the next day. DO NOT take a double dose to make up for the missed dose.

If you stop taking Tolvaptán Accord

If you stop taking Tolvaptán Accord, your low sodium levels may return. Therefore, you should only stop taking Tolvaptán Accord if you experience adverse effects requiring urgent medical attention (see section 4) or if your doctor instructs you to do so.

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

4. Possible adverse effects

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

If you notice any of the following adverse effects, you may need urgent medical attention. Stop taking Tolvaptán Accord and contact a doctor immediately or go to the nearest hospital if you:

• have difficulty urinating
• notice swelling of the face, lips or tongue, itching, widespread rash, wheezing or shortness of breath (symptoms of an allergic reaction).

Consult your doctor if you experience symptoms of fatigue, loss of appetite, discomfort in the upper right part of the abdomen, dark urine or jaundice (yellowing of the skin or eyes).

Other adverse effects

Very common (may affect more than 1 in 10 people)

• feeling unwell
• thirst
• rapid increase in sodium levels.

Common (may affect up to 1 in 10 people)

• drinking too much water
• water loss
• high levels of sodium, potassium, creatinine, uric acid and blood sugar
• decreased blood sugar levels
• decreased appetite
• fainting
• headache
• dizziness
• low blood pressure upon standing
• constipation
• diarrhoea
• dry mouth
• irregular bleeding into the skin
• increased need to urinate or urinating more frequently
• tiredness, general weakness
• fever
• general feeling of being unwell
• blood in the urine
• increased levels of liver enzymes in the blood
• increased levels of creatinine in the blood.

Uncommon (may affect up to 1 in 100 people)

• altered sense of taste
• kidney problems.

Frequency not known (cannot be estimated from available data)

• allergic reactions (see above)
• liver problems
• acute liver failure (ALF)
• increase in liver enzymes.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system detailed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Tolvaptan Accord

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP or CAD. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tolvaptan Accord

• The active substance is tolvaptan.

Tolvaptan Accord 7.5 mg tablets: each tablet contains 7.5 mg of tolvaptan.

• The other components are monohydrate lactose, corn starch, microcrystalline cellulose, magnesium stearate, sodium croscarmellose, hydroxypropylcellulose and indigo carmine aluminium lake (E 132).

Appearance of the product and contents of the pack

Tolvaptan Accord 7.5 mg: uncoated tablets, sky blue to blue in colour, round, biconvex, approximately 5.0 mm in diameter, engraved with "MT" on one side and "18" on the other.

Tolvaptan Accord 7.5 mg tablets are available in single-dose PVC/Alu blisters of 7x1, 10x1, 28x1, 30x1 tablets in a cardboard pack.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est, 6a Planta,

08039 Barcelona,

Spain

Manufacturer

Accord Healthcare Polska Sp. z.o.o.

ul. Lutomierska 50,

95-200, Pabianice, Poland

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park,

Paola PLA 3000, Malta

Accord Healthcare B.V.

Winthontlaan 200,

3526 KV Utrecht, The Netherlands

Date of the most recent revision of this leaflet: March

Other sources of information

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