Simtrend

Package Leaflet: Information for the User

Symtrend, 6.25 mg, film-coated tablets
Symtrend, 12.5 mg, film-coated tablets
Symtrend, 25 mg, film-coated tablets
Carvedilol

Read the package 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 you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Contents of the package leaflet:

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

1. What Symtrend is and what it is used for

Symtrend belongs to a group of medicines with alpha- and beta-adrenergic blocking activity. Symtrend is used to treat high blood pressure and angina pectoris. Symtrend is also used as an adjunctive treatment in heart failure, improving heart function.

2. Important information before taking Symtrend

When not to take Symtrend

• if you are allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6),
• if you have severe heart failure treated with certain intravenous medicines,
• if you have asthma or bronchospasm,
• if you have unstable heart failure or certain types of conduction disorders (such as second- or third-degree atrioventricular block, or sick sinus syndrome) - unless you have a pacemaker,
• if you have severe heart problems (cardiogenic shock),
• if you have very slow heart rate or very low blood pressure,
• if you have severe acid-base balance disorders (metabolic acidosis),
• if you have a rare type of angina pectoris called Prinzmetal's angina, caused by coronary artery spasm,
• if you have untreated pheochromocytoma (a type of adrenal gland tumor),
• if you have very poor blood circulation in your hands and feet, resulting in discoloration, pain, or intermittent claudication,
• if you have severe liver disease,
• if you are currently receiving intravenous medicines for high blood pressure or heart disease (verapamil or diltiazem),
• if you are breastfeeding.

Warnings and precautions

Before starting treatment with Symtrend, discuss it with your doctor.

• If you have heart failure and
• low blood pressure,
• coronary artery disease and/or peripheral artery disease,
• and/or kidney disease. In this case, kidney function should be monitored. It may be necessary to reduce the dose of the medicine.
• If you have diabetes. Taking Symtrend may mask the symptoms of low blood sugar. Therefore, you should regularly check your blood sugar levels.
• If you have congestive heart failure.
• If you have peripheral vascular disease.
• If you are scheduled for surgery.
• If you have a pheochromocytoma (a type of adrenal gland tumor).
• If you have coronary artery spasm, known as Prinzmetal's angina.
• If you have severe, untreated respiratory problems, Symtrend may worsen breathing difficulties.
• If you wear contact lenses. Symtrend may reduce tear production.
• If you have Raynaud's syndrome (initially blanching of the fingers or toes, then cyanosis, and finally redness with accompanying pain). Symtrend may worsen symptoms.
• If you have hyperthyroidism, with increased thyroid hormone production, Symtrend may mask symptoms of hyperthyroidism.
• If you are taking Symtrend and are scheduled for surgery requiring anesthesia, you should inform your anesthesiologist about taking Symtrend.
• If you have a very slow heart rate (less than 55 beats per minute).
• If you have ever had a severe allergic reaction (e.g., to insect bites or food) or if you are undergoing desensitization treatment or are about to undergo desensitization treatment, as Symtrend may reduce the effectiveness of medicines used to treat such allergic reactions.
• If you have psoriasis.

Symtrend with food, drink, and alcohol

Symtrend may enhance the effects of alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Symtrend should only be used during pregnancy if your doctor considers it essential. Therefore, you should always consult your doctor before taking Symtrend during pregnancy.
Breastfeeding
In animal studies during lactation, it was found that Symtrend passes into human milk, so it is not recommended to take the medicine while breastfeeding.

Driving and using machines

At the beginning of treatment or when treatment is changed, dizziness or fatigue may occur. If you experience dizziness or weakness while taking the tablets, you should avoid driving or operating machinery.

Symtrend contains lactose monohydrate and polydextrose

This medicine contains lactose monohydrate and polydextrose. If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Symtrend

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
In case of feeling that the effect of Symtrend is too strong or too weak, consult your doctor or pharmacist.
Swallow the film-coated tablets with a glass of water. The film-coated tablets can be taken with or without food. However, patients with heart failure should take the film-coated tablets with food to reduce the risk of dizziness when standing up quickly.

Symtrend tablets are available in the following strengths:

6.25 mg, 12.5 mg, and 25 mg

High blood pressure

The recommended dose is 1 tablet of Symtrend 12.5 mg (equivalent to 12.5 mg of carvedilol) for the first two days, and then 2 tablets of Symtrend 12.5 mg (equivalent to 25 mg of carvedilol) once daily. Other strengths of Symtrend are available for this dosing regimen.

Angina pectoris

The recommended dose is 1 tablet of Symtrend 12.5 mg (equivalent to 12.5 mg of carvedilol) twice daily for two days, and then 2 tablets of Symtrend 12.5 mg (equivalent to 25 mg of carvedilol) twice daily. Other strengths of Symtrend are available for this dosing regimen.

Heart failure

The usual starting dose is half a tablet of Symtrend 6.25 mg (equivalent to 3.125 mg of carvedilol) twice daily for two weeks. The dose may be gradually increased, usually at two-week intervals.
However, it may be necessary to increase or decrease the dose. Your doctor will inform you about the appropriate dosing.

Overdose of Symtrend

In case of overdose or accidental ingestion by a child, contact your doctor, go to the hospital, or call the emergency services for advice on the risk and further action.
Symptoms of overdose may include feeling of fainting due to excessive lowering of blood pressure, slowing of heart rate, and in severe cases, occasional cardiac arrest. There may be breathing difficulties, bronchospasm, malaise, disturbances of consciousness, and seizures.

Missed dose of Symtrend

If you forget to take a dose (or doses), take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Symtrend can cause side effects, although not everybody gets them.
The frequency of possible side effects is presented in the table below:
Most side effects are dose-dependent and disappear after dose reduction or discontinuation of treatment. Some side effects may occur at the beginning of treatment and disappear spontaneously during continued treatment.

Very common

Dizziness, headache, heart failure, low blood pressure, fatigue.

Common

Bronchitis, pneumonia, upper respiratory tract infection, urinary tract infection, anemia, weight gain, increased cholesterol levels, disturbances of glucose control, depression, mood changes, vision disturbances, dry eyes, eye irritation, slow heart rate, edema (swelling in more than one part of the body), fluid overload, dizziness when standing up quickly, cold hands and feet, shortness of breath, pulmonary edema, asthma in susceptible patients, nausea, diarrhea, vomiting, gastrointestinal disorders, abdominal pain, pain in arms or legs, urinary retention, pain. Renal failure and renal impairment in patients with atherosclerosis and/or impaired renal function.

Uncommon

Sleep disturbances, pre-syncopal state, syncope, paresthesia, conduction disorders, angina pectoris, certain skin reactions (e.g., allergic dermatitis, urticaria, pruritus, and skin inflammation), psoriasis, impotence.

Rare

Thrombocytopenia, nasal congestion.

Very rare

Leukopenia, allergic reactions, increased liver enzyme activity (ALT, AST, GGTP), urinary incontinence in women, severe skin reactions (e.g., erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +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, you can help provide more information on the safety of this medicine.

5. How to store Symtrend

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. The expiry date refers to the last day of that month.
Blisters: Do not store above 30°C.
Store in the original package to protect from light.
HDPE bottles: Do not store above 25°C.
Store in the original package to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Symtrend contains

The active substance is carvedilol.
One tablet contains 6.25 mg, 12.5 mg, or 25 mg of carvedilol.
The other ingredients are:
Microcrystalline cellulose
Lactose monohydrate
Crospovidone CL
Povidone K 30
Colloidal anhydrous silica
Magnesium stearate
Coating – Opadry II White
YS-22-18096 consisting of:
HPMC 2910/Hypromellose 3cP
HPMC 2910/Hypromellose 6cP
HPMC 2910/Hypromellose 50cP
Titanium dioxide (E 171)
Triethyl citrate
Macrogol 8000
Polydextrose Fcc.

What Symtrend looks like and contents of the pack

6.25 mg, film-coated tablets: white, oval, with a score line on both sides and the marking "6.25" on one side.
12.5 mg, film-coated tablets: white, oval, with a score line on both sides and the marking "12.5" on one side.
25 mg, film-coated tablets: white, oval, with a score line on both sides and the marking "25" on one side.
The tablets can be divided into two equal parts.
Pack sizes: 30 and 60 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

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

Manufacturer

Dragenopharm Apotheker Püschl GmbH
Göllstraße 1
84529 Tittmoning
Germany

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

PL: Symtrend
Date of last revision of the leaflet:January 2021