Simtrend

Package Leaflet: Information for the User

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

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

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

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

2. Important information before taking Symtrend

When not to take Symtrend

• if the patient is allergic to carvedilol or any of the other ingredients of this medicine (listed in section 6),
• if the patient has severe heart failure treated with certain intravenous medicines (into a vein),
• if the patient has had asthma or bronchospasm,
• if the patient has unstable heart failure or certain types of conduction disorders (so-called atrioventricular block of second or third degree, or so-called sick sinus syndrome) - unless a pacemaker has been implanted,
• if the patient has severe heart dysfunction (cardiogenic shock),
• if the patient has very slow heart rate or very low blood pressure,
• if the patient has severe acid-base balance disorders (metabolic acidosis, acidosis),
• if the patient has a rare form of angina pectoris called Prinzmetal's angina caused by coronary artery spasm,
• if the patient has untreated pheochromocytoma (a tumor of the adrenal gland),
• if the patient has very poor blood circulation in the hands and feet, resulting in coldness, pain, or intermittent claudication,
• if the patient has severe liver disease,
• if the patient is currently receiving intravenous medicines used to treat high blood pressure or heart disease (verapamil or diltiazem),
• if the patient is breastfeeding.

Warnings and precautions

Before starting to take Symtrend, the doctor should be consulted.

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

Symtrend with food, drink, and alcohol

Symtrend may enhance the effect of alcohol.

Pregnancy and breastfeeding

In pregnancy and during breastfeeding, or if pregnancy is suspected or planned, the doctor should be consulted before taking this medicine.
Pregnancy
Symtrend can be used during pregnancy only if the doctor considers it necessary. Therefore, before taking Symtrend during pregnancy, the doctor should be consulted.
Breastfeeding
In animal studies during lactation, it has been found that Symtrend passes into human milk, so it is not recommended to take the medicine during breastfeeding.

Driving and using machines

At the beginning of treatment or when treatment is changed, dizziness and fatigue may occur. If the patient experiences dizziness or weakness while taking the tablets, they should avoid driving or performing tasks that require high concentration.

Symtrend contains lactose monohydrate and polydextrose

This medicine contains lactose monohydrate and polydextrose. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Symtrend

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the doctor or pharmacist should be consulted. If the patient feels that the effect of Symtrend is too strong or too weak, they should consult their doctor or pharmacist.
The coated tablets should be swallowed with at least half a glass of water. The coated tablets can be taken with or without food. However, patients with heart failure should take the 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 Symtrend tablet of 12.5 mg (equivalent to 12.5 mg of carvedilol) for the first two days, and then 2 Symtrend tablets of 12.5 mg (equivalent to 25 mg of carvedilol) once a day. Other strengths of Symtrend are available for this dosing.

Angina pectoris

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

Heart failure

The usual initial dose is half a Symtrend tablet of 6.25 mg (equivalent to 3.125 mg of carvedilol) twice a day 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. The doctor will provide information on the appropriate dosing.

Taking a higher dose of Symtrend than recommended

In case of taking a higher dose of Symtrend than recommended or if the medicine is accidentally swallowed by a child, the doctor should be contacted, or the patient should go to the hospital or call for emergency assistance to obtain an opinion on the risk and advice on further action.
Symptoms of overdose may include feeling faint 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.

Missing a dose of Symtrend

If the patient forgets to take a dose (or doses), they should take the next dose at the usual time. A double dose should not be taken to make up for the missed dose.
In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

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 resolve 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, low mood, vision disturbances, dry eyes, eye irritation, slow heart rate, edema (swelling occurring in more than one part of the body), hyperolemia, fluid overload, dizziness when standing up quickly, cold hands and feet, shortness of breath, pulmonary edema, asthma in susceptible patients, nausea, diarrhea, vomiting, indigestion, abdominal pain, pain in the arms or legs, difficulty urinating, pain. Renal failure and renal dysfunction in patients with arteriosclerosis 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 any side effects occur, including those not listed in the leaflet, the doctor or pharmacist should be consulted.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to:
Department of 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.

Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Symtrend

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the carton. The expiry date refers to the last day of the 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. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Symtrend contains

The active substance of Symtrend is carvedilol.
One tablet contains 6.25 mg, 12.5 mg, or 25 mg of carvedilol.
The other ingredients of the medicine are:
Microcrystalline cellulose
Lactose monohydrate
Crospovidone CL
Povidone K 30
Colloidal anhydrous silica
Magnesium stearate
Coating – Opadry II White
YS-22-18096 with the composition:
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, coated tablets: white, oval, with a dividing line on both sides and the marking "6.25" on one side.
12.5 mg, coated tablets: white, oval, with a dividing line on both sides and the marking "12.5" on one side.
25 mg, coated tablets: white, oval, with a dividing 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 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Symphar Sp. z o.o.
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