Carvedilol (Tablets) Instructions for Use

Instructions
Dosage forms

ATC Code

C07AG02 (Carvedilol)

Active Substance

Carvedilol (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Beta₁-, beta₂-adrenoblocker. Alpha₁-adrenoblocker

Pharmacotherapeutic Group

Beta-adrenergic blockers; alpha- and beta-adrenergic blockers

Pharmacological Action

An antihypertensive agent from the group of alpha- and beta-adrenergic blockers without intrinsic sympathomimetic activity. It blocks α₁-, β₁-, and β₂-adrenergic receptors.

As a result of β₁-adrenergic receptor blockade, it moderately reduces conduction, force, and frequency of heart contractions without causing a sharp bradycardia. As a result of α₁-adrenergic receptor blockade, it causes peripheral vasodilation.

As a result of β₂-adrenergic receptor blockade, it may somewhat increase bronchial tone, the tone of some microcirculatory vessels, as well as intestinal tone and peristalsis.

Pharmacokinetics

After oral administration, it is rapidly and almost completely absorbed from the gastrointestinal tract. C_max in blood plasma is reached within 1 hour. Bioavailability is 25%.

Plasma protein binding is 98-99%. V_d is about 2 L/kg. It crosses the placental barrier and is excreted in breast milk. It undergoes a significant first-pass effect through the liver. Metabolites have pronounced antioxidant and adrenoblocking action.

T_1/2 is 6-10 hours. Plasma clearance is 590 ml/min. It is excreted mainly with bile.

In patients with impaired liver function, bioavailability may increase to 80%.

Indications

Arterial hypertension.

Coronary artery disease: prevention of attacks of stable angina pectoris.

Chronic heart failure (as part of combination therapy).

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
I10	Essential [primary] hypertension
I20	Angina pectoris
I50.0	Congestive heart failure

ICD-11 code	Indication
BA00.Z	Essential hypertension, unspecified
BA40.Z	Angina pectoris, unspecified
BD10	Congestive heart failure

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Take orally, with food, to minimize the risk of orthostatic hypotension.

For arterial hypertension, initiate therapy at 12.5 mg once daily.

After two days, if tolerated, increase the dose to 25 mg once daily.

If further blood pressure control is required, increase the dose to 50 mg once daily after one to two weeks.

The maximum recommended daily dose is 50 mg.

For stable angina pectoris, initiate therapy at 12.5 mg twice daily.

After two days, if tolerated, increase the dose to 25 mg twice daily.

For chronic heart failure, therapy must be initiated under close medical supervision.

The initial dose is 3.125 mg twice daily for two weeks.

If this dose is tolerated, double the dose to 6.25 mg twice daily.

Subsequent doubling should occur at intervals of no less than two weeks.

The maximum recommended dose for heart failure is 25 mg twice daily for patients weighing less than 85 kg and 50 mg twice daily for patients weighing 85 kg or more.

In elderly patients, initiate therapy at the lowest possible dose and titrate cautiously.

Do not abruptly discontinue therapy; taper the dose gradually over one to two weeks.

For patients with severe renal impairment, no specific dosage adjustment is required.

Carvedilol is contraindicated in patients with severe hepatic impairment.

Adverse Reactions

From the cardiovascular system: at the beginning of treatment (first-dose effect) and when increasing the dose, episodes of excessive blood pressure reduction are possible (usually these phenomena resolve on their own and the patient’s condition stabilizes without special correction); with further use of carvedilol, bradycardia is also possible; less commonly, peripheral blood flow disorders, angina attacks, AV block, episodes of intermittent claudication are observed; in some cases – increased manifestations of heart failure.

From the central and peripheral nervous system: weakness, fatigue, headache are possible; in some cases – sleep disorders, mental depression, paresthesia.

From the digestive system: increased intestinal tone and motility; in some cases – changes in plasma transaminase activity.

Allergic reactions: rarely – allergic exanthema, itching.

Dermatological reactions: urticaria, reactions resembling lichen planus, appearance of psoriatic plaques or exacerbation of a pre-existing psoriatic process.

From the respiratory system: in some cases – nasal congestion.

From the hematopoietic system: in some cases – thrombocytopenia, leukopenia.

Contraindications

AV block of II and III degree, severe bradycardia, heart failure in the stage of decompensation, shock, bronchial asthma, chronic lung diseases with broncho-obstructive syndrome in history, hepatic insufficiency, pregnancy, lactation, hypersensitivity to carvedilol.

Use in Pregnancy and Lactation

Carvedilol is contraindicated for use during pregnancy and during lactation (breastfeeding).

Although there is no direct evidence of embryo- or fetotoxic effects of carvedilol, it is known that it crosses the placental barrier and is excreted in breast milk. Blockade of alpha- and beta-adrenergic receptors in the fetus or newborn may induce perinatal or neonatal distress syndrome, manifested by bradycardia, respiratory depression, hypothermia, and hypoglycemia.

Use in Hepatic Impairment

Contraindicated in hepatic insufficiency.

Pediatric Use

There is no clinical experience with the use of carvedilol in pediatrics.

Geriatric Use

In elderly patients, a dose of 12.5 mg/day may be effective.

Special Precautions

Use with caution in patients with coronary artery disease and heart failure. Before starting treatment with carvedilol for heart failure, adequate therapy should be carried out to eliminate symptoms of decompensation.

When using carvedilol in patients with coronary artery disease, a decrease in myocardial oxygen demand is possible (due to blockade of β₁-adrenergic receptors). In this regard, withdrawal of carvedilol should be gradual to avoid the development of angina attacks.

In patients with endocrine disorders, Carvedilol may mask the symptoms of hyperthyroidism and early signs of acute hyperglycemia (which should be warned to patients with insulin-dependent diabetes mellitus).

Alcohol consumption is not recommended during treatment.

There is no clinical experience with the use of carvedilol in pediatrics.

Effect on the ability to drive vehicles and operate machinery

At the beginning of treatment, as well as when increasing the dose of carvedilol during treatment, one should refrain from driving a car and other activities that require high concentration and quick psychomotor reactions.

Drug Interactions

When used concomitantly with carvedilol, antiarrhythmic agents, anesthetic agents, antihypertensive drugs, antianginal drugs, other beta-adrenergic blockers (including in the form of eye drops), there is a risk of undesirable drug interaction.

When used concomitantly with inhibitors of the CYP2D6 isoenzyme, an enhancement of the effect of carvedilol is theoretically possible.

When used concomitantly with inducers of the CYP2D6 isoenzyme system, a decrease in the effect of carvedilol is possible.

When used concomitantly with verapamil, diltiazem for intravenous administration, the development of severe arterial hypotension is possible.

When used concomitantly with digoxin, an increase in the plasma concentration of digoxin and an increased risk of severe bradycardia and AV conduction disturbances are possible.

When used concomitantly with insulin, oral hypoglycemic drugs, an increased risk of hypoglycemia is possible.

When used concomitantly with clonidine, severe bradycardia, arterial hypotension, and conduction disturbances are possible. In case of sudden withdrawal of clonidine in patients receiving Carvedilol, a sharp increase in blood pressure is possible.

When used concomitantly with reserpine, MAO inhibitors, there is a risk of severe arterial hypotension and bradycardia.

When used concomitantly with rifampicin, the AUC and C_max of carvedilol in plasma decrease.

Fluoxetine inhibits the CYP2D6 isoenzyme, which leads to inhibition of carvedilol metabolism and its accumulation. This may enhance the cardiodepressant effect (including bradycardia). Fluoxetine and, mainly, its metabolites are characterized by a long T_1/2, so the likelihood of drug interaction persists even several days after discontinuation of fluoxetine.

When used concomitantly with cimetidine, the AUC of carvedilol increases without changing its C_max in plasma.

When used concomitantly with cyclosporine, an increase (from small to moderate) in the plasma concentration of cyclosporine is possible.

When used concomitantly with ergotamine derivatives, a deterioration in peripheral circulation is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Carvedilol Sandoz^® [Sandoz, d.d. (Slovenia)]
Tablets 3.125 mg: 10, 20, 30, 40, or 50 pcs.

Marketing Authorization Holder

Sandoz, d.d. (Slovenia)

Manufactured By

Salutas Pharma, GmbH (Germany)

Dosage Form

Carvedilol Sandoz^®

Tablets 3.125 mg: 10, 20, 30, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets light pink in color, round, biconvex, with a score on both sides and on the edges and with the inscription “C1” on one side.

	1 tab.
Carvedilol	3.125 mg

Excipients: iron oxide red, lactose monohydrate, microcrystalline cellulose, crospovidone, povidone K30, colloidal silicon dioxide, magnesium stearate.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.

Carvedilol Sandoz^® [Sandoz, d.d. (Slovenia)]
Tablets 6.25 mg: 30 pcs.

Marketing Authorization Holder

Sandoz, d.d. (Slovenia)

Manufactured By

Salutas Pharma, GmbH (Germany)

Dosage Form

Carvedilol Sandoz^®

Tablets 6.25 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Tablets yellow in color, round, biconvex, with a score on both sides and on the edges and with the inscription “C2” on one side.

	1 tab.
Carvedilol	6.25 mg

Excipients: iron oxide yellow, lactose monohydrate, microcrystalline cellulose, crospovidone, povidone K30, colloidal silicon dioxide, magnesium stearate.

10 pcs. – blisters (3) – cardboard packs.

Carvedilol Sandoz^® [Sandoz, d.d. (Slovenia)]
Tablets 12.5 mg: 10, 20, 30, 40, or 50 pcs.

Marketing Authorization Holder

Sandoz, d.d. (Slovenia)

Manufactured By

Salutas Pharma, GmbH (Germany)

Dosage Form

Carvedilol Sandoz^®

Tablets 12.5 mg: 10, 20, 30, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets pinkish-beige in color, round, biconvex, with a score on both sides and on the edges and with the inscription “C3” on one side.

	1 tab.
Carvedilol	12.5 mg

Excipients: iron oxide red, iron oxide yellow, lactose monohydrate, microcrystalline cellulose, crospovidone, povidone K30, colloidal silicon dioxide, magnesium stearate.

Carvedilol Sandoz^® [Sandoz, d.d. (Slovenia)]
Tablets 25 mg: 10, 20, 30, 40, or 50 pcs.

Marketing Authorization Holder

Sandoz, d.d. (Slovenia)

Manufactured By

Salutas Pharma, GmbH (Germany)

Dosage Form

Carvedilol Sandoz^®

Tablets 25 mg: 10, 20, 30, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white in color, round, biconvex, with a score on both sides and on the edges and with the inscription “C4” on one side.

	1 tab.
Carvedilol	25 mg

Excipients: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone K30, colloidal silicon dioxide, magnesium stearate.

Carvedilol Sandoz^® [Sandoz, d.d. (Slovenia)]
Tablets 50 mg: 10, 20, 30, 40, or 50 pcs.

Marketing Authorization Holder

Sandoz, d.d. (Slovenia)

Manufactured By

Salutas Pharma, GmbH (Germany)

Dosage Form

Carvedilol Sandoz^®

Tablets 50 mg: 10, 20, 30, 40, or 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white in color, round, biconvex, with a score on both sides and on the edges and with the inscription “C5” on one side.

	1 tab.
Carvedilol	50 mg

Excipients: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone K30, colloidal silicon dioxide, magnesium stearate.

Carvedilol Canon [Canonpharma Production, CJS (Russia)]
Tablets 6.25 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 50, 56, 60, 70, 80, 81, 90, or 100 pcs.
Tablets 12.5 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 50, 56, 60, 70, 80, 81, 90, or 100 pcs.
Tablets 25 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 50, 56, 60, 70, 80, 81, 90, or 100 pcs.

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Dosage Forms

	Carvedilol Canon	Tablets 6.25 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 50, 56, 60, 70, 80, 81, 90, or 100 pcs.
		Tablets 12.5 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 50, 56, 60, 70, 80, 81, 90, or 100 pcs.
		Tablets 25 mg: 7, 10, 14, 20, 21, 28, 30, 35, 40, 50, 56, 60, 70, 80, 81, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white in color, round, flat-cylindrical, with a bevel and a score; slight marbling is allowed.

	1 tab.
Carvedilol	6.25 mg

Excipients: calcium hydrogen phosphate dihydrate – 38.55 mg, hypromellose (hydroxypropyl cellulose) – 2.5 mg, croscarmellose sodium (primellose) – 2 mg, lactose monohydrate (milk sugar) – 50 mg, magnesium stearate 0.7 mg.

7 pcs. – contour cell packaging (aluminum/PVC) (1) – cardboard packs.
7 pcs. – contour cell packaging (aluminum/PVC) (2) – cardboard packs.
7 pcs. – contour cell packaging (aluminum/PVC) (3) – cardboard packs.
7 pcs. – contour cell packaging (aluminum/PVC) (4) – cardboard packs.
7 pcs. – contour cell packaging (aluminum/PVC) (5) – cardboard packs.
7 pcs. – contour cell packaging (aluminum/PVC) (8) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (1) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (2) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (3) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (4) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (5) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (6) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (7) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (8) – cardboard packs.
10 pcs. – contour cell packaging (aluminum/PVC) (10) – cardboard packs.
20 pcs. – contour cell packaging (aluminum/PVC) (1) – cardboard packs.
20 pcs. – contour cell packaging (aluminum/PVC) (2) – cardboard packs.
20 pcs. – contour cell packaging (aluminum/PVC) (3) – cardboard packs.
20 pcs. – contour cell packaging (aluminum/PVC) (4) – cardboard packs.
20 pcs. – contour cell packaging (aluminum/PVC) (5) – cardboard packs.
28 pcs. – contour cell packaging (aluminum/PVC) (1) – cardboard packs.
28 pcs. – contour cell packaging (aluminum/PVC) (2) – cardboard packs.
28 pcs. – contour cell packaging (aluminum/PVC) (3) – cardboard packs.
30 pcs. – contour cell packaging (aluminum/PVC) (1) – cardboard packs.
30 pcs. – contour cell packaging (aluminum/PVC) (2) – cardboard packs.
30 pcs. – contour cell packaging (aluminum/PVC) (3) – cardboard packs.

Tablets white or almost white, round, flat-cylindrical, with a bevel and a score; slight marbling is allowed.

	1 tab.
Carvedilol	12.5 mg

Excipients: calcium hydrogen phosphate dihydrate – 50 mg, hypromellose (hydroxypropyl cellulose) – 3.5 mg, croscarmellose sodium (primellose) – 3 mg, lactose monohydrate (milk sugar) – 70 mg, magnesium stearate – 1 mg.

7 pcs. – contour cell packs (aluminum/PVC) (1) – cardboard packs.
7 pcs. – contour cell packs (aluminum/PVC) (2) – cardboard packs.
7 pcs. – contour cell packs (aluminum/PVC) (3) – cardboard packs.
7 pcs. – contour cell packs (aluminum/PVC) (4) – cardboard packs.
7 pcs. – contour cell packs (aluminum/PVC) (5) – cardboard packs.
7 pcs. – contour cell packs (aluminum/PVC) (8) – cardboard packs.
10 pcs. – contour cell packs (aluminum/PVC) (1) – cardboard packs.
10 pcs. – contour cell packs (aluminum/PVC) (2) – cardboard packs.
10 pcs. – contour cell packs (aluminum/PVC) (3) – cardboard packs.
10 pcs. – contour cell packs (aluminum/PVC) (4) – cardboard packs.
10 pcs. – contour cell packs (aluminum/PVC) (5) – cardboard packs.
10 pcs. – contour cell packs (aluminum/PVC) (6) – cardboard packs.
10 pcs. – contour cell packs (aluminum/PVC) (7) – cardboard packs.
10 pcs. – contour cell packs (aluminum/PVC) (8) – cardboard packs.
10 pcs. – contour cell packs (aluminum/PVC) (10) – cardboard packs.
20 pcs. – contour cell packs (aluminum/PVC) (1) – cardboard packs.
20 pcs. – contour cell packs (aluminum/PVC) (2) – cardboard packs.
20 pcs. – contour cell packs (aluminum/PVC) (3) – cardboard packs.
20 pcs. – contour cell packs (aluminum/PVC) (4) – cardboard packs.
20 pcs. – contour cell packs (aluminum/PVC) (5) – cardboard packs.
28 pcs. – contour cell packs (aluminum/PVC) (1) – cardboard packs.
28 pcs. – contour cell packs (aluminum/PVC) (2) – cardboard packs.
28 pcs. – contour cell packs (aluminum/PVC) (3) – cardboard packs.
30 pcs. – contour cell packs (aluminum/PVC) (1) – cardboard packs.
30 pcs. – contour cell packs (aluminum/PVC) (2) – cardboard packs.
30 pcs. – contour cell packs (aluminum/PVC) (3) – cardboard packs.

Tablets white or almost white, round, flat-cylindrical, with a bevel and a score; slight marbling is allowed.

	1 tab.
Carvedilol	25 mg

Excipients: calcium hydrogen phosphate dihydrate – 70 mg, hypromellose (hydroxypropyl cellulose) – 5.3 mg, croscarmellose sodium (primellose) – 4.5 mg, lactose monohydrate (milk sugar) – 93.7 mg, magnesium stearate – 1.5 mg.

Tablets

	1 tab.
Carvedilol	12.5 mg

1 kg – bags – fiber drums – Not specified
1 kg – bags – plastic buckets – Not specified
10 pcs. – jars – cardboard packs (10 pcs.) – By prescription
10 pcs. – contour cell packs – cardboard packs (10 pcs.) – By prescription
10 pcs. – contour cell packs (10 pcs.) – In-Bulk
10 pcs. – contour cell packs (10 pcs.) – cardboard packs (100 pcs.) – By prescription
10 pcs. – contour cell packs (2 pcs.) – cardboard packs (20 pcs.) – By prescription
10 pcs. – contour cell packs (3 pcs.) – cardboard packs (30 pcs.) – By prescription
10 pcs. – contour cell packs (4 pcs.) – cardboard packs (40 pcs.) – By prescription
10 pcs. – contour cell packs (5 pcs.) – cardboard packs (50 pcs.) – By prescription
10 pcs. – contour cell packs (6 pcs.) – cardboard packs (60 pcs.) – By prescription
10 pcs. – contour cell packs (7 pcs.) – cardboard packs (70 pcs.) – By prescription
10 pcs. – contour cell packs (8 pcs.) – cardboard packs (80 pcs.) – By prescription
10 pcs. – contour cell packs (9 pcs.) – cardboard packs (90 pcs.) – By prescription
100 pcs. – jars – cardboard packs (100 pcs.) – By prescription
112 pcs. – jars – cardboard packs (112 pcs.) – By prescription
126 pcs. – jars – cardboard packs (126 pcs.) – By prescription
14 pcs. – jars – cardboard packs (14 pcs.) – By prescription
14 pcs. – contour cell packs – cardboard packs (14 pcs.) – By prescription
14 pcs. – contour cell packs (10 pcs.) – cardboard packs (140 pcs.) – By prescription
14 pcs. – contour cell packs (14 pcs.) – In-Bulk
14 pcs. – contour cell packs (2 pcs.) – cardboard packs (28 pcs.) – By prescription
14 pcs. – contour cell packs (3 pcs.) – cardboard packs (42 pcs.) – By prescription
14 pcs. – contour cell packs (4 pcs.) – cardboard packs (56 pcs.) – By prescription
14 pcs. – contour cell packs (5 pcs.) – cardboard packs (70 pcs.) – By prescription
14 pcs. – contour cell packs (6 pcs.) – cardboard packs (84 pcs.) – By prescription
14 pcs. – contour cell packs (7 pcs.) – cardboard packs (98 pcs.) – By prescription
14 pcs. – contour cell packs (8 pcs.) – cardboard packs (112 pcs.) – By prescription
14 pcs. – contour cell packs (9 pcs.) – cardboard packs (126 pcs.) – By prescription
140 pcs. – jars – cardboard packs (140 pcs.) – By prescription
2 kg – bags – fiber drums – Not specified
2 kg – bags – plastic buckets – Not specified
20 pcs. – jars – cardboard packs (20 pcs.) – By prescription
21 pcs. – jars – cardboard packs (21 pcs.) – By prescription
28 pcs. – jars – cardboard packs (28 pcs.) – By prescription
3 kg – bags – fiber drums – Not specified
3 kg – bags – plastic buckets – Not specified
30 pcs. – jars – cardboard packs (30 pcs.) – By prescription
35 pcs. – jars – cardboard packs (35 pcs.) – By prescription
4 kg – bags – fiber drums – Not specified
4 kg – bags – plastic buckets – Not specified
40 pcs. – jars – cardboard packs (40 pcs.) – By prescription
42 pcs. – jars – cardboard packs (42 pcs.) – By prescription
49 pcs. – jars – cardboard packs (49 pcs.) – By prescription
5 kg – bags – fiber drums – Not specified
5 kg – bags – plastic buckets – Not specified
50 pcs. – jars – cardboard packs (50 pcs.) – By prescription
56 pcs. – jars – cardboard packs (56 pcs.) – By prescription
60 pcs. – jars – cardboard packs (60 pcs.) – By prescription
63 pcs. – jars – cardboard packs (63 pcs.) – By prescription
7 pcs. – contour cell packs – cardboard packs (7 pcs.) – By prescription
7 pcs. – contour cell packs (10 pcs.) – cardboard packs (70 pcs.) – By prescription
7 pcs. – contour cell packs (2 pcs.) – cardboard packs (14 pcs.) – By prescription
7 pcs. – contour cell packs (3 pcs.) – cardboard packs (21 pcs.) – By prescription
7 pcs. – contour cell packs (4 pcs.) – cardboard packs (28 pcs.) – By prescription
7 pcs. – contour cell packs (5 pcs.) – cardboard packs (35 pcs.) – By prescription
7 pcs. – contour cell packs (6 pcs.) – cardboard packs (42 pcs.) – By prescription
7 pcs. – contour cell packs (7 pcs.) – In-Bulk
7 pcs. – contour cell packs (7 pcs.) – cardboard packs (49 pcs.) – By prescription
7 pcs. – contour cell packs (8 pcs.) – cardboard packs (56 pcs.) – By prescription
7 pcs. – contour cell packs (9 pcs.) – cardboard packs (63 pcs.) – By prescription
70 pcs. – jars – cardboard packs (70 pcs.) – By prescription
80 pcs. – jars – cardboard packs (80 pcs.) – By prescription
84 pcs. – jars – cardboard packs (84 pcs.) – By prescription
90 pcs. – jars – cardboard packs (90 pcs.) – By prescription
98 pcs. – jars – cardboard packs (98 pcs.) – By prescription

Tablets

	1 tab.
Carvedilol	25 mg

Carvedilol-AKOS [Sintez PJSC (Russia)]
Tablets 6.25 mg: 10, 20, or 30 pcs.
Tablets 12.5 mg: 10, 20, or 30 pcs.
Tablets 25 mg: 10, 20, or 30 pcs.

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Forms

	Carvedilol-AKOS	Tablets 6.25 mg: 10, 20, or 30 pcs.
		Tablets 12.5 mg: 10, 20, or 30 pcs.
		Tablets 25 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel, marbling is allowed.

	1 tab.
Carvedilol	6.25 mg

Excipients: microcrystalline cellulose M102, calcium stearate, crospovidone, talc, lactose monohydrate.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.

Tablets white or almost white, round, flat-cylindrical, with a bevel, marbling is allowed.

	1 tab.
Carvedilol	12.5 mg

Excipients: microcrystalline cellulose M102, calcium stearate, crospovidone, talc, lactose monohydrate.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.

Tablets white or almost white, round, flat-cylindrical, with a bevel, marbling is allowed.

	1 tab.
Carvedilol	25 mg

Excipients: microcrystalline cellulose M102, calcium stearate, crospovidone, talc, lactose monohydrate.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.

Carvedilol-Teva [Pliva Hrvatska, d.o.o. (Croatia)]
Tablets 3.125 mg: 28 or 30 pcs.
Tablets 6.25 mg: 28 or 30 pcs.
Tablets 12.5 mg: 28 or 30 pcs.
Tablets 25 mg: 28 or 30 pcs.

Marketing Authorization Holder

Pliva Hrvatska, d.o.o. (Croatia)

Manufactured By

Teva Operations Poland, Sp. z o.o. (Poland)

Dosage Forms

	Carvedilol-Teva	Tablets 3.125 mg: 28 or 30 pcs.
		Tablets 6.25 mg: 28 or 30 pcs.
		Tablets 12.5 mg: 28 or 30 pcs.
		Tablets 25 mg: 28 or 30 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, biconvex, with an engraving “CA3” on one side.

	1 tab.
Carvedilol	3.125 mg

Excipients: microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, corn starch, talc, colloidal silicon dioxide, magnesium stearate.

14 pcs. – blisters (2) – cardboard packs with first opening control.
15 pcs. – blisters (2) – cardboard packs with first opening control.

Tablets white or almost white, round, biconvex, with an engraving “CA6” on one side.

	1 tab.
Carvedilol	6.25 mg

Excipients: microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, corn starch, talc, colloidal silicon dioxide, magnesium stearate.

14 pcs. – blisters (2) – cardboard packs with first opening control.
15 pcs. – blisters (2) – cardboard packs with first opening control.

Tablets round, biconvex, white or almost white, with an engraving “CA12” on one side.

	1 tab.
Carvedilol	12.5 mg

Excipients: microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, corn starch, talc, colloidal silicon dioxide, magnesium stearate.

14 pcs. – blisters (2) – cardboard packs with first opening control.
15 pcs. – blisters (2) – cardboard packs with first opening control.

Tablets white or almost white, round, biconvex, with an engraving “CA25” on one side.

	1 tab.
Carvedilol	25 mg

Excipients: microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, corn starch, talc, colloidal silicon dioxide, magnesium stearate.

10 pcs. – blisters (3) – cardboard packs with first opening control.
14 pcs. – blisters (2) – cardboard packs with first opening control.

Carvedilol-Vertex [Vertex, JSC (Russia)]
Tablets 12.5 mg: 10, 20, 30, 60 or 120 pcs.
Tablets 25 mg: 10, 20, 30, 60 or 120 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Forms

	Carvedilol-Vertex	Tablets 12.5 mg: 10, 20, 30, 60 or 120 pcs.
		Tablets 25 mg: 10, 20, 30, 60 or 120 pcs.

Dosage Form, Packaging, and Composition

Tablets from white to white with a creamy tint, flat-cylindrical with a bevel; slight “marbling” is allowed.

	1 tab.
Carvedilol	12.5 mg

Excipients: microcrystalline cellulose, lactose monohydrate, crospovidone, sodium stearyl fumarate.

10 pcs. – contour cell pack (1) – cardboard packs.
10 pcs. – contour cell pack (2) – cardboard packs.
10 pcs. – contour cell pack (3) – cardboard packs.
15 pcs. – contour cell pack (2) – cardboard packs.
15 pcs. – contour cell pack (4) – cardboard packs.
20 pcs. – contour cell pack (3) – cardboard packs.
30 pcs. – contour cell pack (1) – cardboard packs.
30 pcs. – contour cell pack (2) – cardboard packs.
15 pcs. – contour cell pack (8) – cardboard packs (for hospitals).
30 pcs. – contour cell pack (4) – cardboard packs (for hospitals).

Tablets from white to white with a creamy tint, flat-cylindrical with a bevel; slight “marbling” is allowed.