Simibace

Leaflet attached to the packaging: information for the user

Symibace, 2.5 mg, coated tablets
Symibace, 5 mg, coated tablets
Cilazapril

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Symibace and what is it 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 is Symibace and what is it used for

Symibace belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).
Symibace is used in adults to treat:

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

The action of the medicine is based on relaxing and widening blood vessels. This helps to lower blood pressure and makes it easier for the heart to pump blood in patients with chronic heart failure.
The doctor may also prescribe other medicines to be taken at the same time as Symibace.

2. Important information before taking Symibace

When not to take Symibace:

the risk of angioedema (rapid swelling of tissues under the skin, such as the throat) may increase;

• after the third month of pregnancy (it is also recommended to avoid taking Symibace in early pregnancy - see section 2 "Pregnancy and breastfeeding").

Warnings and precautions

Before taking Symibace, the patient should discuss the following with their doctor or pharmacist:

• angiotensin receptor blockers (ARBs) (e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes,
• aliskiren.

The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals. See also section "When not to take Symibace".
If any of the above situations apply to the patient or in case of any doubts before taking Symibace, the patient should contact their doctor or pharmacist.
The patient should inform their doctor if they suspect or plan to become pregnant. It is not recommended to take Symibace in early pregnancy and it should not be taken after 3 months of pregnancy, as it may seriously harm the baby (see section 2 "Pregnancy and breastfeeding").

Children and adolescents

Symibace is not recommended for use in children under 18 years of age.

Symibace and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines 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.
If the patient is taking any of the following medicines, the risk of angioedema may increase:

• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent transplant rejection and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• wildagliptin, a medicine used to treat diabetes.

In particular, the patient should inform their doctor or pharmacist if they are currently taking, have recently taken, or plan to take:

• diuretics - see section "High blood pressure (hypertension)" in section 3 "How to take Symibace";
• non-steroidal anti-inflammatory drugs (NSAIDs). These include: acetylsalicylic acid, indomethacin, and ibuprofen;
• insulin or other diabetes medicines;
• lithium (used to treat depression);
• corticosteroids (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 potassium levels in the blood (e.g., trimethoprim and co-trimoxazole, used to treat bacterial infections; cyclosporin, an immunosuppressant used to prevent transplant rejection, and heparin, a medicine used to thin the blood to prevent clots);
• aldosterone antagonists;
• sympathomimetics;
• anesthetics, opioids;
• tricyclic antidepressants, antipsychotics;
• gold compounds (used to treat rheumatoid arthritis).

The doctor may need to adjust the dose and/or take other precautions. If the patient is taking an angiotensin receptor blocker (ARB) or aliskiren (see also the information under the heading "When not to take Symibace" and "Warnings and precautions").

Taking Symibace with food and drink

The patient should inform their doctor or pharmacist if they are taking potassium supplements.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

The doctor will usually advise the patient to stop taking Symibace before planned pregnancy or as soon as pregnancy is confirmed, and to take a different medicine instead of Symibace. Symibace is not recommended in early pregnancy and should not be taken after 3 months of pregnancy, as it may seriously harm the baby.

Breastfeeding

Symibace is not recommended during breastfeeding, and the doctor may choose an alternative treatment if the patient wishes to start breastfeeding, especially in the case of newborns or premature babies.

Driving and using machines

While taking Symibace, the patient may experience dizziness. This is more likely to occur at the start of treatment. If the patient experiences dizziness, they should not drive, use tools, or operate machinery.

Symibace contains lactose and sodium

Symibace contains lactose monohydrate, a type of sugar. If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
Symibace contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Symibace

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
Recommended dose:

• The patient should take one Symibace tablet per day.
• The tablet should be swallowed with water.
• The time of taking Symibace does not matter. However, the patient should take the tablet at the same time every day.
• Symibace can be taken before or after a meal.

High blood pressure (hypertension):

• The usual initial dose is 1 mg per day.
• The doctor will increase the dose until blood pressure control is achieved - the usual maintenance dose is between 2.5 mg and 5 mg per day.
• The doctor may prescribe a lower dose for patients with kidney problems or in elderly patients.
• If the patient is taking diuretics, the doctor may advise them to stop taking them about 3 days before starting Symibace. The usual initial dose of Symibace is then 0.5 mg per day. The doctor will then increase the dose until blood pressure control is achieved.

Chronic heart failure:

• The usual initial dose is 0.5 mg once daily.
• In elderly patients, the doctor will probably start treatment with a dose of 0.5 mg per day.
• If the patient has kidney or liver disease, the doctor may start treatment with a lower dose than usual.
• The doctor will probably increase the dose to at least 1 mg per day, depending on the patient's response to treatment.
• The usual maximum dose is 5 mg once daily.

Taking a higher dose of Symibace than recommended

If the patient takes more Symibace than they should, they should contact their doctor or go to the nearest hospital immediately. They should take the medicine pack with them. The following symptoms may occur: dizziness or a feeling of "emptiness" in the head, shallow breathing, cold and sweaty skin, inability to move or speak, and slow heart rate.

Missing a dose of Symibace

If the patient forgets to take a dose, they should skip the missed dose. They should then take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose. They should take the next dose as usual.

Stopping treatment with Symibace

Treatment of high blood pressure and heart failure is long-term, and the patient should consult their doctor before stopping treatment. Stopping or ending treatment may cause blood pressure to increase or symptoms to return in the case of heart failure treatment.
If the patient has any further questions about taking Symibace, they should ask their doctor or pharmacist.

4. Possible side effects

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

Severe side effects:

If the patient experiences a severe reaction called angioedema, they should stop taking Symibace and contact their doctor or go to the emergency department of the nearest hospital immediately. Symptoms include:

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

Blood disorders reported during treatment with ACE inhibitors:

• low red blood cell count (anemia). Symptoms include: feeling tired, pale skin, fast or irregular heartbeat (palpitations), and shortness of breath;
• low white blood cell count. Symptoms include: increased risk of infection, for example, of the mouth, gums, throat, and lungs;
• low platelet count. Symptoms include: easy bruising and bleeding from the nose.

Other possible side effects:

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

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

Uncommon side effects(may affect up to 1 in 100 people):

• low blood pressure. This can cause weakness, dizziness, a feeling of "emptiness" in the head, which can lead to blurred vision and fainting. Excessive lowering of blood pressure in some patients may increase the risk of heart attack or stroke,
• fast heartbeat,
• feeling weak,
• chest pain, palpitations,
• breathing difficulties, including shortness of breath and tightness in the chest,
• runny or blocked nose and sneezing (rhinitis),
• dryness or swelling of the mouth,
• loss of appetite,
• change in taste,
• diarrhea and vomiting,
• skin rash (which can be severe),
• muscle cramps or muscle or joint pain,
• impotence,
• increased sweating,
• flushing,
• sleep disturbances.

Rare side effects(may affect up to 1 in 1,000 people):

• low red blood cell count, low white blood cell count, or low platelet count, found in blood tests (anemia, neutropenia, agranulocytosis, and thrombocytopenia),
• severe allergic reaction (anaphylaxis),
• brain hypoperfusion, transient ischemic attack, ischemic stroke (may occur if blood pressure is too low),
• myocardial infarction (may occur if blood pressure is too low),
• arrhythmias,
• interstitial lung disease,
• systemic lupus erythematosus-like reactions,
• tingling or numbness of the 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 disorders, such as hepatitis or liver damage,
• severe skin reactions, including blistering or peeling of the skin,
• increased sensitivity to light,
• hair loss (which may be temporary),
• loosening or separation of the nail from the nail bed,
• breast enlargement, also in men.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of this medicine.

5. How to store Symibace

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and outer packaging after: EXP. The expiry date refers to the last day of the month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Symibace contains

• The active substance of Symibace is cilazapril. One coated tablet contains 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, oval, coated tablets with a score line on one side.
5 mg:
brown, oval, coated tablets with a score line on one side, with the inscription "C5" on one side.
The tablets can be divided into two equal parts.

Packaging

Symibace, 2.5 mg is available in packs containing 28 coated tablets (4 blisters x 7 tablets)
Symibace, 5 mg is available in packs containing 28 coated tablets (4 blisters x 7 tablets)

Marketing authorization holder

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

Manufacturer

Symphar Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
DDSA Pharmaceuticals Limited
84 Pembroke Road
W8 6NX London
United Kingdom

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

PL:
Symibace
Date of last revision of the leaflet:December 2020