Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - samsca

Document Subject

Generated Narrative: MedicinalProductDefinition mp20187f2efcc8af1ff62d82a63aba8a40

identifier: http://ema.europa.eu/identifier/EU/1/09/539/005 (10 tablets)

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Samsca 7.5 mg tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-20187f2efcc8af1ff62d82a63aba8a40

identifier: http://ema.europa.eu/identifier/EU/1/09/539/005 (10 tablets)

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - samsca

Attesters

What is in this leaflet

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

Samsca, which contains the active substance tolvaptan, belongs to a group of medicines called vasopressin antagonists. Vasopressin is a hormone that helps prevent the loss of water from the body by reducing urine output. Antagonist means that it prevents vasopressin having its effect on water retention. This leads to a reduction in the amount of water in the body by increasing urine production and as a result it increases the level or concentration of sodium in your blood.

Samsca is used to treat low serum sodium levels in adults. You have been prescribed this medicine because you have a lowered sodium level in your blood as a result of a disease called syndrome of inappropriate antidiuretic hormone secretion (SIADH) where the kidneys retain too much water. This disease causes an inappropriate production of the hormone vasopressin which has caused the sodium levels in your blood to get too low (hyponatremia). That can lead to difficulties in concentration and memory, or in keeping your balance.

Do not take Samsca

• if you are allergic to tolvaptan or 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 a condition which increases the salt in your blood ( hypernatremia )
• if you have a condition which is associated with a very low blood volume
• if you do not realise when you are thirsty
• if you are pregnant
• if you are breast-feeding.

Warnings and precautions Talk to your doctor or pharmacist before taking Samsca:

• if you cannot drink enough water or if you are fluid restricted
• if you have difficulties in urination or have an enlarged prostate
• if you suffer from liver disease
• if you had an allergic reaction in the past 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 suffer from a kidney disease called autosomal dominant polycystic kidney disease (ADPKD)
• if you have diabetes.

Drinking enough water Samsca causes water loss because it increases your urine production. This water loss may result in side effects such as dry mouth and thirst or even more severe side effects like kidney problems (see section 4). It is therefore important that you have access to water and that you are able to drink sufficient amounts when you feel thirsty.

Children and adolescents Samsca is not suitable for children and adolescents (under age 18).

Other medicines and Samsca Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes all medicines obtained without a prescription.

The following medicines may increase the effect of this medicine:

• ketoconazole (against fungal infections),
• macrolide antibiotics,
• diltiazem (treatment for high blood pressure and chest pain),
• other products which increase the salt in your blood or which contain large amounts of salt.

The following medicines may lower the effect of this medicine:

• barbiturates (used to treat epilepsy/seizures and some sleep disorders),
• rifampicin (against tuberculosis).

This medicine may increase the effect of the following medicines:

• digoxin (used for treatment of irregularities of heartbeat and heart failure),
• dabigatran etexilate (used to thin the blood),
• metformin (used to treat diabetes),
• sulfasalazine (used to treat inflammatory bowel disease or rheumatoid arthritis).

This medicine may lower the effect of the following medicines:

• desmopressin (used to increase blood clotting factors).

It may still be alright for you to take these medicines and Samsca together. Your doctor will be able to decide what is suitable for you.

Samsca with food and drink Avoid drinking grapefruit juice when taking Samsca.

Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take this medicine if you are pregnant or breast-feeding.

Adequate contraceptive measures must be used during use of this medicine.

Driving and using machines Samsca is unlikely to adversely affect your ability to drive or to operate machinery. However, you may occasionally feel dizzy or weak or you may faint for a short period.

Samsca contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• Treatment with Samsca will be initiated in hospital.
• For treatment of your low sodium (hyponatremia), your doctor will start with a dose of 15 mg and may then increase it to a maximum of 60 mg to achieve the desired level of serum sodium. To monitor the effects of Samsca your doctor will do regular blood tests. To achieve the desired level of serum sodium your doctor can give in some instances a lower dose of 7.5 mg.
• Swallow the tablet without chewing, with a glass of water.
• Take the tablets once a day preferably in the morning with or without food.

If you take more Samsca than you should If you have taken more tablets than your prescribed dose, drink plenty of water and contact your doctor or your local hospital immediately. Remember to take the medicine pack with you so that it is clear what you have taken.

If you forget to take Samsca If you forget to take your medicine, you have to take the dose as soon as you remember on the same day. If you do not take your tablet on one day, take your normal dose on the next day. Do not take a double dose to make up for a forgotten dose.

If you stop taking Samsca If you stop taking Samsca this may lead to reoccurrence of your low sodium. Therefore, you should only stop taking Samsca if you notice side effects requiring urgent medical attention (see section 4) or if your doctor tells you to.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• find it difficult to urinate
• find a swelling of the face, lips or tongue, itching, generalised rash, or severe wheezing or breathlessness (symptoms of an allergic reaction).

Consult your doctor if symptoms of fatigue, loss of appetite, right upper abdominal discomfort, dark
urine or jaundice (yellowing of skin or eyes) occur.

Other side effects

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

• feeling sick
• thirst
• rapid rise in level of sodium.

Common (may affect up to 1 in 10 people)

• excessive drinking of water
• water loss
• high levels of sodium, potassium, creatinine, uric acid and blood sugar
• decrease in level of blood sugar
• decreased appetite
• fainting
• headache
• dizziness
• low blood pressure when standing up
• constipation
• diarrhoea
• dry mouth
• patchy bleeding in the skin
• itching
• increased need to urinate, or to urinate more frequently
• tiredness, general weakness
• fever
• general feeling of being unwell
• blood in urine
• raised levels of liver enzymes in the blood
• raised levels of creatinine in the blood.

Uncommon (may affect up to 1 in 100 people)

• sense of taste altered
• kidney problems

Not known (cannot be estimated from the available data)

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

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light and moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Samsca contains

• The active substance is tolvaptan Each Samsca 7.5 mg tablet contains 7.5 mg tolvaptan. Each Samsca 15 mg tablet contains 15 mg tolvaptan. Each Samsca 30 mg tablet contains 30 mg tolvaptan.

• The other ingredients are lactose monohydrate, maize starch, microcrystalline cellulose, hydroxypropylcellulose, magnesium stearate, indigo carmine aluminium lake (E 132).

What Samsca looks like and contents of the pack Samsca 7.5 mg: Blue, rectangular, shallow-convex tablets with dimensions of 7.7 4.35 2.5 mm, debossed with OTSUKA and 7.5 on one side. Samsca 15 mg: Blue, triangular, shallow-convex tablets with dimensions of 6.58 6.2 2.7 mm, debossed with OTSUKA and 15 on one side. Samsca 30 mg: Blue, round, shallow-convex tablets with dimensions of 8 3.0 mm, debossed with OTSUKA and 30 on one side.

Samsca 7.5 mg tablets are available as 10 tablets in PP/Alu blisters 30 tablets in PP/Alu blisters 10 1 tablet in PVC/Alu perforated unit dose blisters 30 1 tablet in PVC/Alu perforated unit dose blisters

Samsca 15 mg and Samsca 30 mg tablets are available as 10 1 tablet in PVC/Alu perforated unit dose blisters 30 1 tablet in PVC/Alu perforated unit dose blisters

Not all pack sizes may be marketed.

Marketing Authorisation Holder Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 1101 CT, Amsterdam Netherlands

Manufacturer Millmount Healthcare Limited Block-7, City North Business Campus, Stamullen, Co. Meath, K32 YDIreland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Otsuka Pharmaceutical Netherlands B.V. T l/Tel: +31 (0) 20 85 46 Lietuva Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46
Otsuka Pharmaceutical Netherlands B.V. Te : +31 (0) 20 85 46 Luxembourg/Luxemburg Otsuka Pharmaceutical Netherlands B.V. Tel/ T l: +31 (0) 20 85 46 esk republika Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 Magyarorsz g Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 Danmark Otsuka Pharma Scandinavia AB Tlf: +46854 528 Malta Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 Deutschland Otsuka Pharma GmbH Tel: +49691 700 Nederland Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 Eesti Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 Norge Otsuka Pharma Scandinavia AB Tlf: +46854 528
Otsuka Pharmaceutical Netherlands B.V. Th : +31 (0) 20 85 46 sterreich Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 Espa a Otsuka Pharmaceutical S.A Tel: +3493 2081 Polska Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 France Otsuka Pharmaceutical France SAS T l: +33147 080 Portugal Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 Hrvatska Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 Rom nia Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 Ireland Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 Slovenija Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 sland Otsuka Pharma Scandinavia AB S mi: +46854 528 Slovensk republika Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 Italia Otsuka Pharmaceutical Italy S.r.l. Tel: +39 02 00 63 27 Suomi/Finland Otsuka Pharma Scandinavia AB Tel/ Puh: +46854 528
Otsuka Pharmaceutical Netherlands B.V. Th : +31 (0) 20 85 46 Sverige Otsuka Pharma Scandinavia AB Tel: +46854 528 Latvija Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 United Kingdom (Northern Ireland) Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 This leaflet was last revised in {MM/YYYY}

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: