ATRAM 6.25 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
   1. You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
2. What is Atram and what is it used for
3. Important information before taking Atram
   1. When not to take Atram:
   2. Warnings and precautions
   3. Children and adolescents
   4. Atram and other medicines
   5. Taking Atram with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Atram contains lactose, sucrose, and sodium
4. How to take Atram
   1. Treatment of high blood pressure
   2. Treatment of angina pectoris
   3. Treatment of heart failure
   4. Taking a higher dose of Atram than recommended
   5. Missing a dose of Atram
   6. Stopping treatment with Atram
5. Possible side effects
   1. Very common (may affect at least 1 in 10 people):
   2. Common (may affect up to 1 in 10 people):
   3. Uncommon (may affect up to 1 in 100 people):
   4. Rare (may affect up to 1 in 1,000 people):
   5. Very rare (may affect up to 1 in 10,000 people):
   6. Reporting side effects
6. How to store Atram
7. Contents of the packaging and other information
   1. What Atram contains
   2. What Atram looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. For more information, please contact the local representative of the marketing authorization holder:
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: information for the user

ATRAM 6.25;6.25 mg, tablets
ATRAM 12.5;12.5 mg, tablets
ATRAM 25;25 mg, tablets
Carvedilol

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you specifically. Do not pass it on 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 any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Atram and what is it used for

Atram contains the active substance carvedilol, which belongs to a group of medicines called beta-adrenergic blockers and to a group of medicines with vasodilating action.
This medicine is used to treat high blood pressure, chronic, stable angina pectoris (exertional chest pain) and stable, chronic heart failure. Atram is used to treat adults.

2. Important information before taking Atram

When not to take Atram:

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 or fluid retention requiring intravenous administration of medicines that support heart function;
if the patient has severe liver disease;
if the patient has bronchial asthma;
if the patient has certain types of conduction disorders (so-called second and third degree atrioventricular block, sick sinus syndrome or sinoatrial block);
if the patient has a very slow heart rate (less than 50 heartbeats per minute);
if the patient has severe heart function disorders (cardiogenic shock);
if the patient has very low blood pressure (systolic blood pressure below 85 mmHg).

Warnings and precautions

Before starting treatment with Atram, you should discuss it with your doctor or pharmacist:
if the patient has heart failure and is being treated with digoxin, diuretics and/or ACE inhibitors (digoxin and carvedilol slow down heart conduction).
if the patient has diabetes. Treatment with Atram may mask the symptoms of low blood sugar and worsen blood sugar control, so blood sugar levels should be regularly monitored.
if the patient has severe respiratory disorders (chronic obstructive pulmonary disease) that are not being treated with oral or inhaled medications. Atram may exacerbate breathing difficulties.

• if the patient has chronic heart failure with:
• low blood pressure (systolic blood pressure below 100 mmHg),
• disorders of blood and oxygen supply to the heart (ischemic heart disease) and vascular disease (atherosclerosis),
• kidney disease - in this case, the doctor will recommend monitoring kidney function, and it may also be necessary to reduce the dose.
• if the patient wears contact lenses - Atram may reduce tear production.
• if the patient has recently had a heart attack.
• if the patient has chronic lower limb ischemia (reduced blood and oxygen supply to the legs) or peripheral circulation disorders (such as Raynaud's syndrome) - Atram may exacerbate these symptoms.
• if the patient has hyperthyroidism (thyrotoxicosis) with increased thyroid hormone production - Atram may mask the symptoms.
• if the patient has had a severe allergic reaction (e.g., due to an insect sting or food consumption) or if the patient is undergoing or is about to undergo desensitization treatment, as Atram may reduce the effectiveness of medications used to treat such allergic reactions.
• if the patient has psoriasis.
• if the patient has a very slow heart rate (less than 55 heartbeats per minute).
• if the patient is currently being treated with calcium channel blockers or other antiarrhythmic medications - ECG and blood pressure monitoring are necessary.
• if the patient has severe skin reactions, such as toxic epidermal necrolysis and Stevens-Johnson syndrome.
• if the patient has a pheochromocytoma.
• if the patient has Prinzmetal's angina or is suspected of having this disease.
• if the patient has depression or myasthenia gravis.

Do not stop taking this medicine suddenly, and do not take it if you are pregnant or breastfeeding.

Children and adolescents

The safety and efficacy of Atram in children and adolescents under 18 years of age have not been established, so it should not be used in this age group.

Atram and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
Other medicines taken at the same time may affect the action of Atram, and Atram may affect the action of these medicines.
It is especially important to inform your doctor about taking the following medicines:
other antihypertensive medicines (e.g., alpha-adrenergic receptor antagonists) and medicines that may cause low blood pressure as a side effect, such as barbiturates (used to treat epilepsy);
verapamil, diltiazem, amiodarone (medicines used to treat heart rhythm disorders) - concurrent use may lead to conduction disorders and sometimes heart function disorders;
digoxin (a medicine used to treat heart failure) - an increase in digoxin levels in the blood may occur, so monitoring of digoxin levels in the blood is necessary;
clonidine (a medicine used to lower blood pressure or treat migraines) – if treatment is discontinued, Atram should be discontinued a few days before gradually reducing clonidine doses;
insulin or oral antidiabetic medicines (medicines that lower blood sugar levels) - their blood sugar-lowering action may be enhanced, and symptoms associated with low blood sugar may be masked (especially increased heart rate); therefore, blood sugar levels should be monitored in diabetic patients;
rifampicin (an antibiotic used to treat tuberculosis) - in patients taking rifampicin concurrently, carvedilol levels in the blood may be reduced, and its action may be weakened;
cimetidine (a medicine used to treat stomach ulcers, heartburn, and reflux) - carvedilol levels in the blood may be increased, and its action may be enhanced;
fluoxetine and paroxetine (medicines used to treat mental disorders) - carvedilol levels in the blood may increase;
anesthetics (medicines used for anesthesia) - during general anesthesia, the doctor will exercise caution, as both carvedilol and anesthetics can slow down heart rate and lower blood pressure;
cyclosporine or tacrolimus (a medicine used after transplantation, e.g., heart or kidney) - carvedilol increases cyclosporine levels in the blood, so cyclosporine levels and dosing should be monitored;
nonsteroidal anti-inflammatory medicines (NSAIDs) - concurrent use may lead to increased blood pressure;
beta-mimetics (medicines used to treat asthma and chronic obstructive pulmonary disease) - carvedilol may weaken the action of these medicines;
dihydropyridines (medicines used to treat high blood pressure and heart disease);
medicines that block nerve-muscle conduction (medicines that reduce muscle tension);
ergotamine (a medicine used to treat migraines);
estrogens (hormones) and corticosteroids (adrenal hormones), as they may weaken the blood pressure-lowering action of carvedilol in some cases;
medicines containing reserpine, guanethidine, methyldopa, guanfacine, and monoamine oxidase inhibitors (MAOIs) used to treat depression, as these medicines may cause further slowing of heart rate.

Taking Atram with food, drink, and alcohol

You should avoid taking carvedilol with grapefruit or grapefruit juice. Grapefruit or grapefruit juice may increase carvedilol levels in the blood and cause unpredictable side effects. Do not drink alcohol while taking carvedilol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Atram should not be taken during pregnancy unless the potential benefit outweighs the potential risk.
Breastfeeding
It is not known whether Atram passes into breast milk, so breastfeeding is not recommended while taking this medicine.

Driving and using machines

This medicine has a minor influence on the ability to drive and use machines. At the beginning of treatment or when changing treatment, dizziness and fatigue may occur. If dizziness or weakness occurs while taking the medicine, you should avoid driving or working with machines that require attention. You should avoid drinking alcohol, as it may enhance these symptoms.

Atram contains lactose, sucrose, and sodium

Each Atram 6.25 tablet contains 13.285 mg of sucrose and 85.687 mg of lactose (in the form of monohydrate).
Each Atram 12.5 tablet contains 12.500 mg of sucrose and 80.625 mg of lactose (in the form of monohydrate).
Each Atram 25 tablet contains 25.000 mg of sucrose and 161.251 mg of lactose (in the form of monohydrate).
Before taking Atram, you should contact your doctor if you have been diagnosed with intolerance to some sugars.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is considered "sodium-free".

3. How to take Atram

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
The patient must remain under constant medical supervision while increasing the dose of Atram.

Treatment of high blood pressure

It is recommended to take the medicine once a day.
Adults
The recommended dose of Atram is 12.5 mg for the first two days, and then 25 mg once a day.
If necessary, the dose can be gradually increased, at 2-week intervals, to a maximum recommended daily dose of 50 mg, taken once a day or in two divided doses.
Elderly
The recommended initial dose is 12.5 mg once a day, which is usually sufficient for some patients. If the treatment effect is not satisfactory, the dose can be gradually increased, at 2-week intervals, to a maximum recommended daily dose of 50 mg, taken in divided doses.

Treatment of angina pectoris

Adults
The recommended initial dose is 12.5 mg twice a day for the first two days. Then, the dose should be increased to 25 mg twice a day. If necessary, the dose can be gradually increased, at 2-week intervals, to a maximum daily dose of 100 mg, taken in two divided doses.
Elderly
In elderly patients, a dose of 50 mg per day, taken in two divided doses, is recommended.

Treatment of heart failure

Adults
The recommended initial dose of Atram is 3.125 mg twice a day for two weeks. If the patient tolerates this dose well, it can be gradually increased to 6.25 mg twice a day, with at least 2-week intervals, and then to 12.5 mg twice a day and finally to 25 mg twice a day. The dose can be increased to the maximum tolerated dose by the patient.
The maximum recommended daily dose in patients with severe heart failure and in patients with a body weight of less than 85 kg with mild to moderate heart failure is 25 mg twice a day. In patients with a body weight of more than 85 kg with mild to moderate heart failure, the dose is 50 mg twice a day.
Before each dose increase, the patient must be examined by a doctor. In case of transient worsening of heart failure symptoms or fluid retention (edema), the doctor will recommend increasing the dose of diuretics (i.e., medicines that increase urine production and excretion), and sometimes temporary discontinuation of Atram.
In case the treatment is interrupted for more than two weeks, it is recommended to start treatment with a dose of 3.125 mg twice a day, and then gradually increase the dose according to the above scheme. The exact procedure will be provided by the doctor.
Tablets should be taken with food, swallowed whole, and washed down with a sufficient amount of liquid.

Taking a higher dose of Atram than recommended

In case of taking a higher dose of Atram than recommended or accidental ingestion by a child, you should immediately seek medical help.
Symptoms of overdose may include dizziness due to low blood pressure, slow heart rate, and in severe cases, single heartbeats, heart failure, cardiogenic shock, and cardiac arrest. Breathing difficulties, bronchospasm, vomiting, disturbances of consciousness, and seizures may also occur.

Missing a dose of Atram

If the patient forgets to take a tablet, they should take it as soon as they remember. However, if it is close to the time for the next dose, they should skip the missed dose and take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Atram

Treatment with Atram is long-term. Do not stop taking the medicine suddenly or change the recommended dose without consulting your doctor first. If treatment needs to be discontinued, it should be done gradually to avoid side effects.
If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Atram can cause side effects, although not everybody gets them.
The following side effects have been reported during treatment with carvedilol (the active substance of Atram)

Very common (may affect at least 1 in 10 people):

• heart function disorders, which may cause shortness of breath or swelling of the ankles (heart failure);
• feeling weak or tired;
• dizziness;
• headache;
• low blood pressure.

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

• low red blood cell count;
• slow heart rate;
• fluid overload, increased blood volume in the body;
• vision disorders;
• reduced tear production (dry eye syndrome);
• eye irritation;
• nausea;
• diarrhea;
• vomiting;
• indigestion;
• abdominal pain;
• body or limb swelling;
• bronchitis, pneumonia, respiratory tract infections;
• urinary tract infections
• weight gain;
• increased cholesterol levels;
• worsening blood sugar control in patients with diabetes;
• pain (e.g., in the arms and legs);
• depression, low mood;
• acute kidney failure and worsening kidney function in patients with atherosclerosis and/or kidney function disorders;
• urination difficulties;
• shortness of breath;
• fluid accumulation in the lungs;
• breathing difficulties in patients with asthma or chronic obstructive pulmonary disease;
• low blood pressure when standing up, causing dizziness, feeling of "emptiness" in the head, or fainting;
• peripheral circulation disorders (cold hands and feet, intermittent claudication, worsening symptoms in patients with Raynaud's disease (initially bluish discoloration of fingers or toes, then pallor, and finally redness with pain) or intermittent claudication (leg pain that worsens during walking)).

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

• conduction disorders in the heart, angina pectoris (including chest pain);
• feeling faint, fainting;
• tingling or numbness in the hands or feet;
• sleeping difficulties;
• sexual impotence;
• allergic skin reactions (allergic rash, skin inflammation, hives, itching, psoriasis-like rash, lichen planus-like rash);
• sexual dysfunction;
• hair loss (alopecia).

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

• decreased platelet count, which increases the risk of bleeding or bruising;
• nasal congestion

Very rare (may affect up to 1 in 10,000 people):

• low white blood cell count;
• increased liver enzyme activity;
• involuntary urine leakage in women (urinary incontinence);
• allergic reactions;
• severe skin reactions (e.g., polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis).

Unknown(frequency cannot be estimated from available data)

• hallucinations;
• cardiac arrest (slow or abnormal heart rhythm);
• excessive sweating (hyperhidrosis)

Dizziness, fainting, headache, and fatigue usually have a mild intensity and are more likely to occur at the beginning of treatment.
Atram may also exacerbate diabetes symptoms or cause diabetes symptoms to appear in patients with very mild diabetes, known as "latent diabetes".

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of 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
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 Atram

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month.
Store in a temperature below 30°C. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Atram contains

The active substance is carvedilol.
Atram 6.25: Each tablet contains 6.25 mg of carvedilol
Atram 12.5: Each tablet contains 12.5 mg of carvedilol
Atram 25: Each tablet contains 25 mg of carvedilol.
The other ingredients are: sucrose, povidone 30, lactose monohydrate, colloidal silica anhydrous, sodium croscarmellose, magnesium stearate, yellow iron oxide (E 172),
Atram 12.5 and Atram 25: red iron oxide (E 172).

What Atram looks like and contents of the pack

Atram 6.25 is a yellow tablet, slightly speckled, with a dividing line on one side and "6" embossed on the other side. The tablet can be divided into equal doses.
Atram 12.5 is a yellow-brown tablet with a dividing line on one side and "12" embossed on the other side.
Atram 25 is a yellow-brown tablet with a dividing line on one side and "25" embossed on the other side.
The tablet can be divided into equal doses.
Atram 6.25, Atram 12.5: The pack contains 30 tablets.
Atram 25: The pack contains 30 or 90 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic.

For more information, please contact the local representative of the marketing authorization holder:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
tel.: +48 22 375 92 00

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

Czech Republic, PolandAtram
HungaryCarvedilol Zentiva
Date of last revision of the leaflet:December 2024