Symibace

Package leaflet: Information for the user

Symibace, 2.5 mg, film-coated tablets
Symibace, 5 mg, film-coated tablets
Cilazaprilum
Please read all of this leaflet carefully before 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, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

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

1. What Symibace is and what it is used for
Symibace belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors.
Symibace is used in adults to treat:

• high blood pressure (hypertension),
• chronic (long-term) heart failure.

The medicine works by relaxing and widening blood vessels. This helps lower blood pressure and makes it easier for the heart to pump blood in patients with chronic heart failure.
Your doctor may also prescribe other medicines to be used together with Symibace.

2. Important information before taking Symibace

Do not take Symibace:

• if you are allergic to cilazapril or any of the other ingredients of this medicine (listed in section 6);
• if you have had an allergic reaction to other ACE inhibitors. These include: enalapril, lisinopril, and ramipril;
• if you have previously experienced a serious side effect called angioedema (a type of swelling) after taking other ACE inhibitors, or if you have hereditary angioedema or angioedema of unknown cause. Symptoms include swelling of the face, lips, mouth, or tongue;
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren;
• if you are currently taking or have taken sacubitril with valsartan, a medicine used to treat certain types of chronic (long-term) heart failure in adults, because this increases the risk of angioedema (rapid swelling of tissues under the skin, such as in the throat);
• after the third month of pregnancy (it is also better to avoid using Symibace early in pregnancy – see section 2 “Pregnancy and breastfeeding”).

Warnings and precautions
Before taking Symibace, talk to your doctor or pharmacist if:

• you have a heart condition. Symibace should not be used by patients with certain heart diseases;
• you have had a stroke or have problems with blood flow to the brain;
• you have kidney disease or reduced blood flow to the kidneys (renal artery stenosis);
• you have severe liver disease or jaundice;
• you have high levels of potassium in your blood;
• you are undergoing dialysis;
• you have recently had vomiting or diarrhoea;
• you are on a low-salt (low-sodium) diet;
• you are undergoing desensitisation treatment for bee or wasp venom;
• you are scheduled for surgery (including dental surgery). Some anaesthetics may lower blood pressure, causing it to drop too much;
• you have fluid in the abdominal cavity (ascites);
• you have diabetes;
• you have a collagen vascular disease;
• you are undergoing low-density lipoprotein (LDL) apheresis using dextran sulfate;
• you are taking any of the following medicines for high blood pressure:
  • an angiotensin II receptor antagonist (Angiotensin Receptor Blockers, ARB), also known as sartans (e.g. valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes;
  • aliskiren.

Your doctor may need to monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section “Do not take Symibace”.
If any of the above situations apply to you, or if you have any doubts, please speak to your doctor or pharmacist before taking Symibace.
Inform your doctor if you suspect (or are planning) pregnancy. Use of Symibace is not recommended early in pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child (see section 2 “Pregnancy and breastfeeding”).

Children and adolescents
Symibace is not recommended for children under 18 years of age.

Symibace with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription and herbal medicines. This is because Symibace may affect the action of other medicines, and some medicines may affect the action of Symibace.
The risk of angioedema may be increased if you are taking any of the following medicines:

• racecadotril, used to treat diarrhoea;
• medicines used to prevent organ transplant rejection or to treat cancer (e.g. temsirolimus, sirolimus, everolimus);
• vildagliptin, used to treat diabetes.

In particular, inform your doctor or pharmacist if you are currently taking, have taken in the past, or plan to take:

• diuretics – see the section “High blood pressure (hypertension)” in section 3 “How to take Symibace”;
• non-steroidal anti-inflammatory drugs (NSAIDs), such as acetylsalicylic acid, indomethacin, and ibuprofen;
• insulin or other medicines used to treat diabetes;
• lithium (used to treat depression);
• steroid medicines (such as hydrocortisone, prednisolone, and dexamethasone) or other medicines that suppress the immune system;
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that increase blood potassium levels (e.g. trimethoprim and co-trimoxazole, used for bacterial infections; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots);
• aldosterone antagonists;
• sympathomimetics;
• anaesthetics, opioids;
• tricyclic antidepressants, antipsychotics;
• gold compounds (used to treat rheumatoid arthritis).

Your doctor may need to adjust your dose and/or take other precautions. This may be necessary if you are taking an angiotensin II receptor antagonist (ARB) or aliskiren (see also information under “Do not take Symibace” and “Warnings and precautions”).

Taking Symibace with food and drink
Inform your doctor or pharmacist if you are taking potassium-containing supplements.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Your doctor will usually advise you to stop taking Symibace before planning a pregnancy or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Symibace is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child.

Breast-feeding
Symibace is not recommended during breast-feeding. Your doctor may choose an alternative treatment if you wish to breast-feed, especially if your baby is a newborn or premature.

Driving and using machines
Dizziness may occur while taking Symibace. This is more likely at the start of treatment. If you feel dizzy, do not drive, use tools, or operate machinery.

Symibace contains lactose monohydrate and sodium
Symibace contains lactose monohydrate, a type of sugar. If you have been previously diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
Symibace contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered “sodium-free”.

3. How to use Symibace

This medicine should always be taken exactly as your doctor has instructed. If you are unsure,
contact your doctor or pharmacist.
Recommended dose:

• Take one tablet of Symibace every day.
• Swallow the tablet with water.
• The time of day when Symibace is taken does not matter. However, the tablet should be taken at the same time each day.
• Symibace may be taken before or after food.

High blood pressure (hypertension):

• The usual starting dose is 1 mg once daily.
• Your doctor will increase the dose until blood pressure is controlled – the usual maintenance dose is typically between 2.5 mg and 5 mg once daily.
• Your doctor may prescribe a lower dose for patients with impaired kidney function or elderly patients.
• If you are taking diuretics, your doctor may advise you to stop taking them about 3 days before starting Symibace. In such cases, the usual starting dose of Symibace is 0.5 mg once daily. Your doctor will then gradually increase the dose until blood pressure is controlled.

Chronic heart failure:

• The usual starting dose is 0.5 mg once daily.
• In elderly patients, your doctor will likely start treatment at a dose of 0.5 mg once daily.
• If you have kidney or liver disease, your doctor may start treatment at a dose lower than usual.
• Your doctor will likely increase the dose to at least 1 mg once daily, depending on your response to treatment.
• The usual maximum dose is 5 mg once daily.

Taking more Symibace than prescribed
If you take more Symibace than prescribed or if someone else takes the medicine, contact your doctor immediately or go to the nearest hospital. Take the medicine pack with you. The following symptoms may occur: dizziness or a feeling of "emptiness" in the head, shallow breathing, cold and clammy skin, inability to move or speak, and slow heart rate.

Missing a dose of Symibace
If you forget to take a dose, skip the missed dose. Take the next dose at your usual time. Do not take a double dose to make up for a missed dose. Continue taking the medicine according to your regular schedule.

Stopping treatment with Symibace
Treatment of high blood pressure and heart failure is long-term, and stopping treatment should be discussed with your doctor. Stopping or discontinuing treatment may lead to increased blood pressure or a recurrence of symptoms in the case of heart failure treatment.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions:
If a serious reaction called angioedema occurs, stop taking Symibace and contact your doctor immediately or go to the emergency department of the nearest hospital. Symptoms include:

• sudden swelling of the face, throat, lips, or mouth. This swelling may cause difficulty breathing or swallowing.

Blood disorders reported during treatment with ACE inhibitors:

• low number of red blood cells (anaemia). Symptoms include feeling tired, pale skin, fast or irregular heartbeat (palpitations), and shortness of breath;
• low number of all types of white blood cells. Symptoms include increased number of infections, for example in the mouth, gums, throat, and lungs;
• low number of platelets. Symptoms include easy bruising and nosebleeds.

Other possible adverse reactions:
Common adverse reactions (may occur in up to 1 in 10 patients):

• dizziness,
• cough,
• nausea,
• feeling tired,
• headache.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• low blood pressure. This may cause weakness, dizziness, feeling faint or "lightheaded", which may lead to blurred vision and fainting. Excessive lowering of blood pressure in some patients may increase the risk of heart attack or stroke,
• rapid heartbeat,
• feeling weak,
• chest pain, palpitations,
• difficulty breathing, including shortness of breath and chest tightness,
• nasal discharge or congestion and sneezing (rhinitis),
• dryness or swelling of the oral mucosa,
• loss of appetite,
• altered taste,
• diarrhoea and vomiting,
• skin rash (which may be severe),
• muscle cramps or muscle or joint pain,
• impotence,
• excessive sweating,
• facial flushing,
• sleep disturbances.

Rare adverse reactions (may occur in up to 1 in 1000 patients):

• decreased number of red blood cells, white blood cells, or platelets, detected in blood tests (anaemia, neutropenia, agranulocytosis, and thrombocytopenia),
• severe allergic reaction (anaphylaxis),
• cerebral ischaemia, transient ischaemic attack, ischaemic stroke (may occur if blood pressure is too low),
• myocardial infarction (may occur if blood pressure is too low),
• heart rhythm disorders,
• interstitial lung disease,
• disorders resembling systemic lupus erythematosus,
• tingling or numbness of hands or feet,
• wheezing,
• feeling of fullness or pulsating pain behind the nose, cheeks, and eyes (sinusitis),
• tongue pain,
• pancreatitis. Symptoms include severe abdominal pain radiating to the back,
• changes in kidney or liver function (shown in blood and urine tests),
• low sodium levels in the blood,
• high potassium levels in the blood,
• liver function disorders, such as liver inflammation or liver damage,
• severe skin reactions, including blisters or skin peeling,
• increased sensitivity to light,
• hair loss (which may be temporary),
• loosening or separation of the nail from the nail bed,
• breast enlargement, including in men.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Symibace

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and outer packaging following: EXP. The expiry date refers to the last day of the stated month.
Do not store above 25ºC.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Symibace contains

• The active substance is cilazapril. One coated tablet contains either 2.5 mg or 5 mg of cilazapril as cilazapril monohydrate.
• The other ingredients are:

Core: Lactose monohydrate, maize starch, hypromellose 3cp, talc, sodium stearyl fumarate.
Coating: Opadry brown 03B26857: hypromellose 6cp, talc, titanium dioxide (E171), macrogol 400,
iron oxide red (E172).

What Symibace looks like and contents of the pack

2.5 mg: brown, elongated film-coated tablets, with a score line on one side.
5 mg: brown, elongated film-coated tablets, with a score line on one side and engraved with the code "C5" on one side.
The tablets can be divided into two equal parts.

Packaging

Symibace 2.5 mg is available in packages containing 28 film-coated tablets (4 blisters x 7 tablets).
Symibace 5 mg is available in packages containing 28 film-coated tablets (4 blisters x 7 tablets).

Marketing Authorisation Holder

Symphar Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
Poland

Manufacturer

Symphar Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

DDSA Pharmaceuticals Limited
84 Pembroke Road
W8 6NX London
United Kingdom

This medicinal product is authorised in the European Economic Area under the following names:
PL: Symibace