OMERIA 6.25 мг Таблетка

Содержание инструкции

1. Omeria 6.25 mg tablets
   1. What Omeria is and what it is used for
   2. What you need to know before taking Omeria
   3. How to take Omeria
   4. Possible side effects
   5. How to store Omeria
   6. Contents of the pack and other information

Omeria 6.25 mg tablets

Omeria 25 mg tablets
Carvedilol
Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Omeria is and what it is used for

Omeria contains the active substance carvedilol, which belongs to the class of medicines called
“alpha and beta-adrenergic receptor blockers”.
Carvedilol is a non-selective beta-blocker. Beta-blockers exert their action at the
cardiac level, where they reduce the force of contraction and the heart rate, decreasing the
work done by the heart and preventing an excessive acceleration of the heartbeat; furthermore
they act on the “renin-angiotensin-aldosterone” system, promoting the reduction of fluid and salt retention
in the body, and consequently the reduction of blood volume with an
effect of dilation and distension of blood vessels.
Omeria is used in the treatment of:

• high blood pressure (essential arterial hypertension), alone or in combination with other antihypertensive medicines, in particular with thiazide diuretics, drugs that help the elimination of fluids;
• chest pain, caused by an insufficient supply of oxygen to the heart muscle due to a temporary decrease in blood flow in the coronary arteries of the heart (angina pectoris);
• heart failure, which occurs when the heart is no longer able to pump blood adequately throughout the body.

2. What you need to know before taking Omeria

Do not take Omeriaif:

• you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• you have a decrease in heart activity such that the amount of blood pumped by the heart at rest is less than normal (unstable/decompensated heart failure);
• you suffer from a type of heart failure classified as Class IV NYHA (New York Health Association), which requires the administration of specific inotropic medicines (medicines with an action on the contractility of the heart muscle) intravenously to facilitate heart function;
• you have severe liver problems;
• you suffer from disorders of the heart's electrical conduction system, such as:
• a condition in which the structure that generates the heart's electrical impulses is malfunctioning (sick sinus syndrome, including sinoatrial block);
• a condition in which there is a defect in the conduction of the cardiac impulse between atrium and ventricle (atrioventricular block of 2nd and 3rd degree) (unless you have a permanent pacemaker);
• you have a very slow heart rate (less than 50 beats per minute) (severe bradycardia);
• you suffer from very low blood pressure (severe hypotension, present if the systolic blood pressure, i.e. the first value obtained when measuring blood pressure, is less than 85 mmHg);
• you have a decrease in blood flow reaching the organs and tissues of the body, due to a decrease in heart activity (cardiogenic shock);
• you suffer from bronchial asthma (narrowing and inflammation of the bronchi) or other respiratory diseases with a bronchospastic component (e.g. patients with chronic obstructive pulmonary disease (COPD), a disease that makes it difficult to empty the air from the lungs, who are not taking medicines orally or by inhalation);
• you suffer from a tumor that affects the medulla of the adrenal gland (pheochromocytoma), not controlled under treatment with alpha-blocking medicines;
• you suffer from an accumulation of acids in the body, due to metabolic disorders (metabolic acidosis);
• you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”);
• if you are being treated with medicines used to treat high blood pressure or heart rhythm disturbances such as verapamil or diltiazem intravenously (see section “Other medicines and Omeria”)

Warnings and precautions
Talk to your doctor or pharmacist before taking Omeria if:

• you suffer from chronic congestive heart failure (a condition in which the heart is unable to pump blood efficiently) as worsening of heart failure or fluid retention may occur. If your condition worsens during therapy, your doctor will evaluate a dose reduction or alternative therapy;
• you have reduced and worsening kidney function, resulting from heart failure with low blood pressure, thickening of blood vessels and insufficient blood supply to the heart (ischemic heart disease), and/or underlying kidney failure, as carvedilol treatment may worsen kidney function;
• you suffer from left ventricular dysfunction (a portion of the heart is unable to contract effectively or fill adequately) after acute myocardial infarction (death of heart cells due to prolonged lack of oxygen supply), as in this case you must receive appropriate therapy to return to a stable clinical condition before taking Omeria;
• you suffer from diabetes and are being treated with medicines that lower blood sugar (blood sugar levels), as taking Omeria may be associated with worsening blood sugar control, or the initial signs and symptoms of acute hypoglycemia (sudden drop in blood sugar), such as tachycardia (fast heartbeat), blurred vision, dizziness, sweating, restlessness, may be masked or attenuated. Regular monitoring of blood sugar is necessary during treatment to adjust dosages of medicines;
• you have problems with the peripheral blood vessels (vessels in areas outside the heart and brain) that are blocked (peripheral vascular disease) as they may worsen with carvedilol treatment;
• you suffer from a rare disease that affects the arteries, characterized by brief episodes of narrowing of the blood vessels, and which manifests predominantly on the fingertips and toes, with sensations of pain, numbness or tingling, and a change in skin color to pale and cyanotic (Raynaud's disease);
• you have an excess of hormones produced by the thyroid gland in the body (thyrotoxicosis) as taking Omeria may mask its symptoms (e.g. tachycardia). Do not suddenly stop treatment with Omeria as it may alter thyroid function;
• you are to undergo general surgery requiring the use of anesthetics (medicines that induce sedation, reduce sensitivity to pain and muscle relaxation) as carvedilol may increase the effect of muscle contractility;
• you have a reduced heart rate (bradycardia), with values less than 55 beats per minute;
• you have had a severe hypersensitivity reaction (allergy) in the past or are currently undergoing desensitization therapy (taking progressively increasing doses of a drug to which you are hypersensitive, in order to be able to take it at effective and safe doses), as you may be more sensitive to some medicines (such as epinephrine) used to treat allergic reactions (anaphylactic);
• you suffer from an inflammatory skin disease characterized by thickened and reddened patches, covered with gray-colored scales (psoriasis);
• you are affected by a pheochromocytoma (a tumor that causes high blood pressure), as your doctor will only prescribe Omeria after making a risk/benefit assessment;
• you suffer from a form of angina pectoris known as “Prinzmetal's angina”, also called “variant angina” because taking Omeria may increase it;
• you wear contact lenses, as treatment with Omeria may reduce tear production;
• you have rapidly fluctuating blood pressure (labile hypertension) or suffer from high blood pressure caused by an underlying medical condition (secondary hypertension);
• You have a first-degree heart block (an alteration of the heartbeat) because carvedilol can reduce the speed of conduction of the electrical impulse of the heart.

During treatment with Omeria, very rare cases of severe skin and mucous membrane reactions have been reported, such as toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS) (see section 4 “Possible side effects”). In such cases, contact your doctor immediately because taking Omeria will have to be stopped.

Children and adolescents
The tolerability and efficacy of Omeria in patients under the age of 18 have not been established.

Other medicines and Omeria
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Pay particular attention and tell your doctor if you are taking:

• digoxin and other digitalis medicines, which stimulate the action of the heart, maintaining its functionality at an appropriate level;
• insulin or other antidiabetic medicines taken orally;
• rifampicin, a bactericidal antibiotic;
• cimetidine, a medicine used to treat heartburn and stomach ulcers;
• reserpine, a substance used to treat high blood pressure and some forms of psychosis;
• medicines that block the monoamine oxidase enzyme (MAOIs) used to treat depression;
• cyclosporine and tacrolimus, medicines used to prevent organ rejection after transplantation;
• verapamil, diltiazem, amiodarone or other medicines used to treat heart rhythm disorders (arrhythmias);
• clonidine, a medicine mainly used to treat high blood pressure but also for other medical conditions;
• calcium antagonists used to treat high blood pressure;
• any other medicine used to treat high blood pressure, such as diuretics or ACE inhibitors;
• fluoxetine and paroxetine, medicines used to treat severe depression or obsessive-compulsive disorders;
• medicines called NSAIDs (non-steroidal anti-inflammatory drugs) used to treat pain and inflammation;
• bronchodilator beta-agonists, used to treat asthma and obstructive bronchial diseases with an asthmatic basis.
• anesthetics and neuromuscular blocking agents, medicines that induce sedation, reduce sensitivity to pain and muscle relaxation. Tell your doctor if you are to undergo surgery requiring anesthesia.
• adrenaline (epinephrine) used to treat severe allergic reactions.

Omeria with food, drinks and alcohol
Omeria can be taken with food.
It is recommended to avoid drinking grapefruit juice during treatment with carvedilol.
Alcohol can enhance the hypotensive effect of carvedilol (lowers blood pressure).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Omeria during pregnancy.
Omeria should not be used during breastfeeding (see section “Do not take Omeria”)

Driving and using machines
Studies have not been conducted on the effects of carvedilol on patients' ability to drive vehicles and use machinery.
Omeria may affect your ability to drive vehicles and use machinery due to variable individual reactions (e.g. dizziness, fatigue), especially at the beginning of treatment, after a dose increase, following a change of medicine used for therapy, and in combination with alcohol.
Therefore, exercise due caution.

For those who practice sports
The use of the medicine without a therapeutic need constitutes doping and may still result in a positive doping test.

Omeria contains lactose and sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Omeria

Take this medicine following the instructions of your doctor exactly. If you have any doubts,
consult your doctor or pharmacist.
Take the Omeria tablets with a sufficient amount of water; it is not necessary
to take the tablets with meals, however if you suffer from heart failure take the
Omeria tablets during meals, to slow down the absorption of the medicine and avoid a
possible excessive lowering of blood pressure.

Treatment of high blood pressure (essential hypertension)
The recommended initial dose is 12.5 mg once a day, for the first two days;
afterwards the recommended dose is 25 mg once a day.
If necessary, your doctor may increase the dose at intervals of at least two
weeks, up to a maximum dose of 50 mg per day, taken once a day, or divided into
two doses of 25 mg twice a day.

Treatment of angina pectoris
The recommended initial dose is 12.5 mg twice a day, for the first two days;
afterwards the recommended dose is 25 mg twice a day.
Do not exceed this recommended dose.

Treatment of heart failure
Your doctor will prescribe the most appropriate dosage of Omeria for you to take, and will follow
you carefully during the period of time necessary to achieve the dosage suitable
for you.
The recommended initial dose is 3.125 mg (i.e. half a 6.25 mg tablet), twice a day,
for at least two weeks; subsequently your doctor may increase the dose
progressively, at intervals of at least two weeks, bringing it to 6.25 mg twice a day, then to 12.5 mg twice a day, and up to a maximum of 25 mg twice a day.
The maximum recommended dose is:

• 25 mg twice a day: if you suffer from severe heart failure, or if you suffer from moderate or mild heart failure and have a body weight of less than 85 kg;
• 50 mg twice a day: if you suffer from moderate or mild heart failure and have a body weight of more than 85 kg.

Use in children and adolescents
The tolerability and efficacy of Omeria in patients under 18 years of age have not been
established.

Use in the elderly

Treatment of high blood pressure (essential hypertension)
The recommended initial dose is 12.5 mg once a day. If necessary, your doctor may
increase the dose at intervals of at least two weeks, up to a maximum dose of 50
mg, to be taken in two doses of 25 mg twice a day.

Treatment of angina pectoris
The recommended initial dose is 12.5 mg twice a day; after an interval of at least two
days, your doctor may increase the dose to 25 mg twice a day.
Do not exceed this recommended dose.

Treatment of heart failure
Same dosage as indicated for adults (see above).

If you take more Omeria than you should
In case of accidental ingestion/taking of an excessive dose of Omeria, immediately inform
your doctor or go to the nearest hospital.
In case of accidental ingestion/taking of an excessive dose of Omeria you may
experience: severe lowering of blood pressure (hypotension), reduced
heart rate (bradycardia), decreased heart activity (heart failure), decreased blood flow reaching the organs and tissues of the body due to
decreased heart activity (cardiogenic shock), sinus arrest; cessation of
heart function; furthermore, respiratory problems such as narrowing
of the bronchi (bronchospasm), vomiting, mental confusion, involuntary movements of the
musculature, responsible for agitation and body spasms (convulsions) may occur.

Treatment in case of ingestion of an excessive dose of Omeria
In case of accidental ingestion/taking of an excessive dose of Omeria, in hospital
you will receive the normal intervention protocols and the most appropriate treatment based on the effects
of overdose and symptoms you are experiencing.

If you forget to take Omeria
Do not take a double dose to make up for a missed dose.

If you stop taking Omeria
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
Omeria must be discontinued gradually, over a period of two weeks, and under the control of
your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following side effects have been observed with the use of Omeria:

Very common (may affect more than 1 in 10 people)

• dizziness, headache;
• decreased heart activity (heart failure);
• low blood pressure;
• fatigue (asthenia).

Common (may affect up to 1 in 10 people)

• inflammation of the bronchi and lungs (bronchitis and pneumonia), upper respiratory tract infections (outer nose and oral cavity; nasal cavities and paranasal sinuses; pharynx, larynx, cartilaginous tissue);
• urinary tract infections;
• decreased level of red blood cells in the blood (anemia);
• weight gain, increased cholesterol levels in the blood (hypercholesterolemia), increase or decrease in blood glucose levels (hyperglycemia and hypoglycemia) (in patients suffering from diabetes);
• depression, depressed mood;
• feeling of loss of consciousness, loss of consciousness (pre-syncope, syncope),
• vision problems, decreased tear production (dry eyes), eye irritation;
• decreased heart rate (bradycardia), fluid accumulation (edema) affecting the whole body, arms and legs, genitals, increased blood volume (hypervolemia), increased fluids;
• low blood pressure related to posture (orthostatic hypotension), problems with blood circulation in the peripheral areas of the body (cold hands and feet, problems with peripheral blood vessels, worsening of leg pain during physical exertion (intermittent claudication) and worsening of Raynaud's disease);
• high blood pressure (hypertension);
• difficulty breathing (dyspnea), fluid accumulation in the lungs (pulmonary edema), asthma (in patients predisposed to this condition);
• feeling unwell (nausea), diarrhea, vomiting, difficulty digesting food (dyspepsia), abdominal pain;
• pain in the hands and feet;
• decreased kidney function (renal insufficiency) and kidney problems (in patients with widespread vascular disorders and/or underlying renal insufficiency),
• pain.

Uncommon (may affect up to 1 in 100 people)

• sleep disturbances;
• confusion;
• numbness or tingling of the limbs, arms and legs (paresthesia);
• disorders in the conduction of the cardiac impulse between atrium and ventricle (atrioventricular block), severe chest pain (angina pectoris);
• constipation;
• skin reactions (such as: rash of pustules, blisters and bubbles (exanthem) of an allergic nature, skin inflammation (dermatitis), rash (urticaria), itching, thickened and reddened patches, covered with gray scales (psoriatic skin lesions), lesions of the mucous membranes and skin from lichen planus), hair loss (alopecia);
• inability to have an erection (erectile dysfunction).

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

• decreased level of platelets in the blood (thrombocytopenia);
• blocked nose (nasal congestion);
• dry mouth;
• urination disorders (retention of urine or difficulty in its emission)

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

• decreased level of white blood cells in the blood (leukopenia);
• allergic reaction (hypersensitivity);
• increased level of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and gamma-glutamyltransferase (GGT);
• severe skin adverse reactions such as a rash characterized by lesions with erythema and edema and sometimes with blisters (erythema multiforme), severe forms of peeling (Stevens-Johnson syndrome) and skin decomposition (toxic epidermal necrolysis);

Not known (frequency cannot be estimated based on available data)

• manifestation of diabetes symptoms with alteration of blood sugar levels (glycemia), worsening of diabetes, changes in blood glucose;
• sinus arrest (temporary cessation of heartbeat);
• hyperhidrosis (excessive sweating);
• urinary incontinence (difficulty retaining urine) in women that resolves with discontinuation of treatment;
• hallucinations (perception of things that do not exist in reality).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
consult your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side
effects you can contribute to providing more information on the safety of this
medicine.

5. How to store Omeria

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after the
words “Scad.”. The expiry date refers to the last day of that month.
Store at a temperature below 25°C.
Store in the original packaging to protect the medicine from light and moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Omeria contains
The active ingredient is carvedilol.
Each 6.25 mg tablet contains 6.25 mg of carvedilol.
The other ingredients are: sucrose, lactose monohydrate, povidone, colloidal anhydrous silica,
crospovidone, magnesium stearate, yellow iron oxide (E 172).
Each 25 mg tablet contains 25 mg of carvedilol.
The other ingredients are: sucrose, lactose monohydrate, povidone, colloidal anhydrous silica,
crospovidone, magnesium stearate.

Description of the appearance of Omeria and contents of the pack
Omeria is presented in the form of divisible tablets, contained in PVC and aluminum blisters.
Omeria 6.25 mg tablets is available in packs of 28 divisible tablets.
Omeria 25 mg tablets is available in packs of 30 divisible tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A.
Via San Giuseppe Cottolengo, 15
20143 Milan

Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo,1
03012 Anagni (FR)