Symtrend

Patient Information Leaflet

Symtrend 6.25 mg, coated tablets
Symtrend 12.5 mg, coated tablets
Symtrend 25 mg, coated tablets
Carvedilolum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Symtrend is and what it is used for
2. What you need to know 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 called alpha- and beta-adrenolytics. Symtrend is used to treat high blood pressure and angina pectoris. Symtrend is also used as supportive treatment in heart failure, improving 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 medicines given intravenously (into a vein),
• if the patient has had asthma or bronchospasm,
• if the patient has unstable heart failure or certain types of heart conduction disorders (second- or third-degree atrioventricular block, or sick sinus syndrome) – unless a permanent pacemaker has been implanted,
• if the patient has been diagnosed with severe cardiac 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 an atypical form of angina pectoris called Prinzmetal's angina, caused by coronary artery spasm,
• if the patient has untreated adrenal gland overactivity (pheochromocytoma),
• if the patient has very poor blood circulation in 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 diseases (verapamil or diltiazem),
• if the patient is breastfeeding.

Warnings and precautions
Before starting treatment with Symtrend, discuss this with your doctor if the patient:

• has heart failure, and
• low blood pressure,
• impaired blood and oxygen supply to the heart (ischaemic heart disease) and arterial hardening (atherosclerosis),
• and/or kidney diseases. In such cases, kidney function should be monitored. Dose reduction may be necessary.
• has diabetes. Treatment with Symtrend may mask symptoms of low blood sugar. Therefore, blood glucose levels should be monitored regularly.
• has congestive heart failure.
• has peripheral vascular disease.
• is scheduled for surgery.
• has an adrenal gland tumour (called pheochromocytoma).
• has coronary artery spasm, known as Prinzmetal's angina.
• has severe, untreated respiratory disorders, as Symtrend may worsen breathing difficulties.
• wears contact lenses. Symtrend may reduce tear production.
• has Raynaud's syndrome (initially bluish discoloration of fingers or toes, followed by paleness and then redness, accompanied by pain). Symtrend may worsen symptoms.
• has hyperthyroidism, with increased thyroid hormone production, as Symtrend may mask symptoms of hyperthyroidism.
• is taking Symtrend and is scheduled for surgery requiring anaesthesia. Inform the anaesthesiologist in advance about taking Symtrend.
• has a very slow heart rate (less than 55 beats per minute).
• has ever experienced a severe allergic reaction (e.g. from insect stings or food) or is undergoing or scheduled for allergen immunotherapy, because Symtrend may reduce the effectiveness of medicines used to treat such allergic reactions.
• has psoriasis.

Symtrend and other medicines
Other medicines taken concurrently may interfere with the action of Symtrend, or their effects may be altered by Symtrend. Inform your doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines the patient plans to take.

It is especially important to inform the doctor about the use of the following medicines:

• digoxin (a medicine used in the treatment of heart failure),
• rifampicin (an antibiotic used to treat tuberculosis),
• cimetidine (a medicine used to treat gastric ulcers, heartburn and gastroesophageal reflux),
• ketoconazole (a medicine used to treat fungal infections),
• fluoxetine (a medicine used to treat depression),
• haloperidol (a medicine used to treat certain mental and/or psychiatric disorders),
• erythromycin (an antibiotic),
• cyclosporine (a medicine used to suppress immune system activity to prevent organ transplant rejection, also used in certain rheumatic or dermatological diseases),
• clonidine (a medicine used to lower blood pressure or treat migraine),
• verapamil, diltiazem, amiodarone (medicines used to treat irregular heart function),
• quinidine, disopyramide, mexiletine, propafenone, flecainide (medicines used to treat irregular heart function),
• other medicines that lower blood pressure. Carvedilol may enhance the effect of other concurrently used antihypertensive medicines (e.g. alpha-1 receptor antagonists) and medicines that lower blood pressure as an adverse effect, such as barbiturates (used to treat epilepsy), phenothiazines (used to treat psychosis), tricyclic antidepressants (used to treat depression), vasodilators, and alcohol,
• insulin or oral antidiabetic medicines (medicines that reduce blood sugar), as their blood sugar-lowering effect may be enhanced and symptoms of low blood sugar may be masked,
• inhaled anaesthetics (medicines used in anaesthesia),
• sympathomimetic medicines (medicines that increase sympathetic nervous system activity),
• certain bronchodilator medicines used in bronchial asthma or chronic obstructive pulmonary disease,
• dihydropyridines (medicines used to treat high blood pressure and heart diseases),
• nitrates (medicines used to treat heart diseases), as they may suddenly lower blood pressure,
• neuromuscular blocking agents (medicines that reduce muscle tension),
• ergotamine (an antimigraine medicine),
• certain painkillers (non-steroidal anti-inflammatory drugs, NSAIDs), estrogens (hormones), and corticosteroids (adrenal hormones), as they may in some cases weaken the blood pressure-lowering effect of carvedilol,
• medicines containing reserpine, guanethidine, methyldopa, guanfacine, and monoamine oxidase inhibitors (MAOIs), medicines used to treat depression, as they may further slow heart rate.

Symtrend with food, drink and alcohol
Symtrend may enhance the effects of alcohol.

Pregnancy and breastfeeding
During pregnancy, while breastfeeding, or if pregnancy is suspected or planned, consult a doctor before using this medicine.

Pregnancy
Symtrend may be used during pregnancy only if the doctor considers it necessary. Therefore, always consult a doctor before using Symtrend during pregnancy.

Breastfeeding
Animal studies during lactation have shown that Symtrend passes into human milk; therefore, taking this medicine during breastfeeding is not recommended.

Driving and operating machinery
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, driving or performing tasks requiring high concentration should be avoided.

Symtrend contains monohydrate lactose and polidextrose
This medicine contains monohydrate lactose and polidextrose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Symtrend

This medicine should always be taken exactly as directed by your doctor. If in doubt, consult
your doctor or pharmacist. If you feel that the effect of Symtrend is too strong or too weak,
consult your doctor or pharmacist.
The coated tablets should be swallowed with at least half a glass of water. The coated tablets
may be taken with or without food. However, patients with heart failure should take the
coated tablets with food to reduce the risk of dizziness upon sudden standing.
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 (corresponding to 12.5 mg of carvedilol)
for the first two days, followed by 2 tablets of Symtrend 12.5 mg (corresponding 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 (corresponding to 12.5 mg of carvedilol)
twice daily for two days, followed by 2 tablets of Symtrend 12.5 mg (corresponding to 25 mg of
carvedilol) twice daily. Other strengths of Symtrend are available for this dosing regimen.
Heart failure
The usual initial dose is half a tablet of Symtrend 6.25 mg (corresponding 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 regimen.
Taking more Symtrend than recommended
If you take more Symtrend than recommended, or if the medicine is accidentally swallowed
by a child, contact your doctor, go to hospital, or call emergency services for advice on the risk
and further management.
Symptoms of overdose may include feeling faint due to excessive lowering of blood pressure,
slowing of the heartbeat, and in severe cases, rarely, cardiac arrest. Breathing difficulties,
bronchoconstriction, malaise, disturbances of consciousness, and seizures may occur.
If you miss a dose of Symtrend
If you forget to take a dose (or doses), take the next dose at your usual time.
Do not take a double dose to make up for a missed dose.
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 they do not occur in everyone.
The frequency of possible adverse reactions is presented in the table below:

Most adverse reactions are dose-dependent and resolve after dose reduction or discontinuation of treatment. Some adverse reactions may occur at the beginning of treatment and resolve spontaneously during continued therapy.

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

Common
Bronchitis, pneumonia, upper respiratory tract infection, urinary tract infection, anaemia, weight gain, increased cholesterol concentration, disturbances in blood glucose control, depression, low mood, visual disturbances, dry eyes, eye irritation, slowed heart function, oedema (swelling affecting more than one part of the body), hypervolaemia, fluid overload, dizziness upon rapid standing, cold hands and feet, dyspnoea, pulmonary oedema, asthma in susceptible patients, nausea, diarrhoea, vomiting, indigestion, abdominal pain, pain in arms or legs, difficulty in urinating, pain. Renal failure and renal function disorders in patients with arteriosclerosis and (or) worsening renal function.

Uncommon
Sleep disorders, pre-syncope, syncope, paraesthesia, cardiac conduction disorders, angina pectoris, some skin reactions (e.g. allergic dermatitis, urticaria, pruritus and inflammatory skin conditions), psoriasis, impotence.

Rare
Thrombocytopenia, nasal congestion.

Very rare
Leukopenia, hypersensitivity reactions, increased liver enzyme activity (AlAT, AspAT, GGTP), urinary incontinence in women, severe skin adverse reactions (e.g. erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).

If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult your doctor or pharmacist.

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 also be reported directly to:
Department of Monitoring of Adverse Drug Reactions
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 to provide more information on the safety of the medicine.

5. How to store Symtrend

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the specified month.
Blister packs: Do not store above 30°C.
Keep in the original packaging to protect from light.
HDPE bottles: Do not store above 25°C.
Keep in the original packaging to protect from light.
Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What the medicine Symtrend contains
The active substance is carvedilol.
Each 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 with the following composition:
HPMC 2910/Hypromellose 3 cP
HPMC 2910/Hypromellose 6 cP
HPMC 2910/Hypromellose 50 cP
Titanium dioxide (E 171)
Triethyl citrate
Polyethylene glycol 8000
Polysorbate Fcc.

What Symtrend looks like and contents of the pack
6.25 mg, coated tablets: white, oval, with a division line on both sides and marked "6.25" on one side.
12.5 mg, coated tablets: white, oval, with a division line on both sides and marked "12.5" on one side.
25 mg, coated tablets: white, oval, with a division line on both sides and marked "25" on one side.
The tablets can be divided into two equal parts.
Pack sizes: 30 and 60 coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Symphar Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
Poland

Manufacturer
Dragenopharm Apotheker Püschl GmbH
Göllstraße 1
84529 Tittmoning
Germany

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