InfoCons Consumer Protection informs you – Sibnayal – Package Leaflet

Before anything else

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Sibnayal is and what it is used for

Sibnayal contains two active substances, potassium citrate and potassium hydrogen carbonate (also known as potassium bicarbonate).

Sibnayal is an alkalising medicine that is used to control blood acidity caused by a kidney disease called distal renal tubular acidosis (dRTA).

It will help reduce the effect of dRTA on your everyday life. Sibnayal is used in adults, adolescents and children above 1 year.

⚠️ 2. What you need to know before you take Sibnayal

Do not take Sibnayal

• if you are allergic to potassium citrate or potassium bicarbonate or any of the other ingredients of this medicine (listed in section 6),
• if you have a severe kidney disease or kidney failure,
• if you have a high level of potassium in your blood (hyperkalaemia).

Warnings and precautions

Talk to your doctor before taking Sibnayal :

• if you have a disease or you take a medicine that can increase your blood potassium (see below “Other medicines and Sibnayal”),
• if you frequently have gastro- intestinal symptoms such as bloating, diarrhoea, nausea, vomiting,
• if you have chronic kidney disease.

Sibnayal prolonged- release granules are designed to release the active substances slowly after taking the granules. You may see remains of the granules in your stools. This is normal and does not reduce the effectiveness of the medicine.

You will need regular appointments with your doctor. From time to time, your doctor may need to do blood, urine or heart tests, to adjust the dose of Sibnayal. Your doctor will regularly check your kidney function if you are elderly and/or have worsening kidney function.

Children

Do not give this medicine to children below 1 year of age because of the risk of choking.

Other medicines and Sibnayal

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Some medicines may affect how Sibnayal works or make side effects more likely. These include:

• any medicine that increases the level of potassium in your blood such as:
• angiotensin -converting enzyme (ACE) inhibitors (used to treat high blood pressure, heart disease and kidney disease in patients suffering from type 1 diabetes),
• potassium -sparing diuretics (used to treat high blood pressure, fluid build- up in tissue (oedema) and heart conditions),
• potassium supplements (used to prevent or treat low potassium levels in the blood),
• ciclosporin (used to prevent or treat transplant rejection),
• heparin sodium (used to prevent or delay blood clotting),
• nonsteroidal anti -inflammatory drugs (NSAIDs) (used to reduce fever, pain and inflammation),
• any medicine that may be affected by a disturbance in the level of potassium in your blood such as :
• digitalis glycosides (such as digoxin, used to treat heart failure and certain heart rhythm disorders),
• corticosteroids (used to treat inflammation),
• any other medicine that could cause heart rhythm disorders such as:
• amiodarone and quinidine (used to control cardiac rhythm),
• chlorpromazine (used to treat certain mental illnesses),
• cisapride (used to treat heartburn),
• sparfloxacin (used to treat certain bacterial infections).

Some medicines may be affected by increased urine pH in relation with Sibnayal treatment such as :

• salicylates (used to treat pain and inflammation – aspirin -like medicines),
• tetracyclines (used to treat certain bacterial infections),
• barbiturates (sleep inducing medicines).

Sibnayal with food, drink and alcohol

Do not mix Sibnayal with hot food or hot liquids. Do not drink alcohol while you are taking Sibnayal.

Pregnancy, breast -feeding and fertility 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.

Driving and using machines

This medicine is not likely to affect your ability to drive or use machines.

Sibnayal contains potassium

32 Sibnayal 8 mEq contains 308 mg of potassium per sachet. This is to be taken into consideration if you have a reduced kidney function or if you are on a controlled potassium diet.

Sibnayal 24 mEq contains 924 mg of potassium per sachet. This is to be taken into consideration if you have a reduced kidney function or if you are on a controlled potassium diet.

💊 3. How to take Sibnayal

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

The amount of Sibnayal that people have to take depends on their age, weight and condition. Your doctor will tell you exactly the dose of this medicine to take. This will always be one or more whole sachets.

Your doctor may need to adjust your dose of Sibnayal. The use of this medicine requires medical supervision.

Dose The dose is adjusted by the doctor according to the level of bicarbonate in your blood.

How to use This medicine is for oral use (to be taken by mouth).

If you are not sure of how to use Sibnayal, contact your doctor or pharmacist.

1. Hold the sachet vertically with your fingers above the dotted line. Shake it from side to side to ensure the contents move to the bottom of the sachet.

2. Cut the sachet along the dotted line, using scissors if necessary.

3. Place all or part of the sachet contents directly into your mouth on your tongue.

4. Swallow the granules immediately with a large glass of water. Do not chew or crush the granules.

33 Repeat steps 1 to 4 as required until you have taken the full dose.

For patients who are unable to swallow granules 1. Mix Sibnayal with small amounts of soft and cold food (e.g. fruit puree or yoghurt) directly on the spoon. You must swallow the soft food mixture immediately. Do not store the mixture for use later.

2. Place the mixture directly into the mouth and swallow it without chewing. Make sure that Sibnayal does not remain in the mouth.

Repeat steps 1 and 2 as required until the full dose has been taken.

Do not mix the granules with liquid before taking them.

When to take Sibnayal Take Sibnayal in the morning and in the evening, during a meal. You must leave an interval of about 12 hours in between each dose to cover the whole night -and-day period.

If you vomit within two hours after intake, you should take another dose.

Dose adjustment Dose increases/decreases should be gradual, taking place over a few weeks. Your doctor will adjust the dose according to your condition.

Please consult your doctor in the event of any side effects, as he / she may have to adjust the dose of this medicine.

34 Switch from another alkalising medicine If you are switching from another alkalising medicines to Sibnayal, your doctor should closely supervise the switchover.

If you take more Sibnayal than you should

Talk to your doctor or pharmacist if you have taken more Sibnayal than you should have. You may feel nauseous, need to vomit and have diarrhoea.

If you have taken a large amount of this medicine , you may feel weak or get unexplained tightness of the muscles, spasms (muscular contraction), abnormal tingling or burning sensations, pins and needles or numbness, mental confusion or an abnormal heart rate.

If you forget to take Sibnayal

Do not take a double dose to make up for a forgotten dose. Take it as soon as you remember. However, if your next dose is in less than six hours, skip the missed dose. Do not take more than two doses a day.

Talk to your doctor if you forget to take one or more doses.

If you stop taking Sibnayal

This medicine is for long -term use. It will only be effective as long as you are using it.

Do not stop unless your doctor tells you to, even if you feel better, as your disease may get worse. If you want to stop treatment, first talk to your doctor.

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

❗ 4. Possible side effects

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

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

• abdominal pain (belly pain)

Common side effects (may affect up to 1 in 10 people)

• upper abdominal pain (upper belly pain),
• gastrointestinal pain and disorders (stomach and intestinal pain and disorders),
• dyspepsia (poor digestion),
• vomiting,
• diarrhoea
• feeling sick (nausea) when starting treatment.

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.

🌡️ 5. How to store Sibnayal

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

35 Do not use this medicine after the expiry date which is stated on the sachet and the carton after EXP.

The expiry date refers to the last day of that month.

Do not store above 25 °C.

After opening a sachet, discard any unused content.

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.

📦 6. Contents of the pack and other information

What Sibnayal contains

• The active substances are potassium citrate and potassium hydrogen carbonate (also known as potassium bicarbonate).
• The other ingredients are hypromellose (E464), microcrystalline cellulose (E460 (i)), glycerol dibehenate, magnesium stearate (E470b), silica colloidal anhydrous, magnesium oxide heavy (E530), ethylcellulose (E462), chlorophyllin (E140 (ii)), talc.

Each sachet of Sibnayal 8 mEq contains 282 mg of potassium citrate and 527 mg of potassium hydrogen carbonate.

Each sachet of Sibnayal 24 mEq contains 847 mg of potassium citrate and 1 582 mg of potassium hydrogen carbonate.

What Sibnayal looks like and contents of the pack

Sibnayal is a mixture of green and white prolonged- released granules supplied in sachets. Cartons contain 60 sachets.

Sibnayal is available in multipacks comprising 2, 3, 4, 5 and 6 cartons, each containing 60 sachets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

ADVICENNE 262 rue du Faubourg Saint Honoré 75008 Paris France For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien – Luxembourg/Luxemburg – Nederland TwinPharma BV Trasmolenlaan 5 3447 GZ Woerden Nederland Tél/Tel: +31 348 71 24 05 [email protected] Italia SPA Società Prodotti Antibiotici S.p.A.

Via Biella, 8 20143 Milano Italy Tel: +39 02 891391 [email protected] 36 България ExCEEd Orphan Distribution d.o.o.

Dužice 1, 10000 Zagreb Croatia Teл.: +359 888 918 090 [email protected] Magyarország ExCEEd Orphan Distribution d.o.o.

Dužice 1, 10000 Zagreb Croatia Tel.: +36 20 399 4269 [email protected] Česká republika ExCEEd Orphan s.r.o.

Bucharova 2657/12 Prague 5, 158 00 Czech republic Tel: +420 608 076 274 [email protected] Polska ExCEEd Orphan s.r.o.

Bucharova 2657/12 Prague 5, 158 00 Czech republic Tel.: +48 502 188 023 [email protected] Danmark – Norge – Suomi/Finland – Sverige – Deutschland -Malta- Ireland -Österreich – Ελλάδα – Κύπρος – Ísland Avanzanite Bioscience B.V.

Strawinskylaan 3051 1077 ZX Amsterdam Netherlands Tlf / Puh /Tel/ Τηλ/Simi: +31 20 808 6361 Portugal Prospa – Laboratórios Farmacêuticos, S.A.

Av.do Forte, nº3, Edifício Suécia IV, Piso 2 2790 -073 Carnaxide Portugal Tel: +351 214171747 [email protected] France ADVICENNE 262 rue du Faubourg Saint Honoré 75008 Paris France Tel : + 33 1 85 73 36 2 0 [email protected] România ExCEEd Orphan Distribution d.o.o.

Dužice 1, 10000 Zagreb Croatia Tel: +40 744 366 015 [email protected] España SPA Farma Ibérica Carrer de Roc Boronat, 147 08018 Barcelona Spain Tel: + 34 622 273 108 Slovenija ExCEEd Orphan Distribution d.o.o.

Dužice 1, 10000 Zagreb Croatia Tel: +386 30 210 050 [email protected] Hrvatska ExCEEd Orphan Distribution d.o.o.

Dužice 1, 10000 Zagreb Croatia Tel: +385 99 320 0330 [email protected] Eesti – Latvija – Lietuva ExCEEd Orphan Distribution d.o.o.

Dužice 1, 10000 Zagreb Croatia Tel: +370 661 663 99 [email protected] Slovenská republika ExCEEd Orphan s.r.o. Bucharova 2657/12, Prague 5, 158 00 Czech republic Tel: +420 608 076 274 [email protected] 37 This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Sibnayal (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/20/1517).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.