Omeria

Patient information leaflet

Omeria 6.25 mg tablets, 25 mg tablets

Carvedilol
Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine because 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 a class of medicines called
"alpha and beta-adrenergic receptor blockers".
Carvedilol is a non-selective beta-blocker. Beta-blockers exert their effect on the heart, where they reduce the force of contraction and heart rate, thereby decreasing the workload of the heart and preventing excessive increase in heartbeat. Additionally, they act on the "renin-angiotensin-aldosterone" system, helping to reduce fluid and salt retention in the body, and consequently reducing blood volume, resulting in dilation and relaxation of blood vessels.

Omeria is used in the treatment of:

• high blood pressure (essential arterial hypertension), either alone or in combination with other antihypertensive medicines, particularly thiazide diuretics, which are drugs that help eliminate fluids;
• chest pain caused by insufficient oxygen supply to the heart muscle due to a temporary reduction in blood flow through 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 should know before taking Omeria

Do not take Omeria if:

• you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• you have reduced heart function causing a lower than normal amount of blood pumped by the heart at rest (unstable/compensated heart failure);
• you suffer from a type of heart failure classified as NYHA class IV (New York Heart Association), requiring intravenous administration of specific inotropic medicines (medicines affecting the contractility of the heart muscle) to support 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 generating the heart's electrical impulses is malfunctioning (sinoatrial node disease, including sinoatrial block);
• a condition involving impaired conduction of the cardiac impulse between atria and ventricles (second- or third-degree atrioventricular block) (unless you have a permanent pacemaker);
• you have a very low heart rate (less than 50 beats per minute) (severe bradycardia);
• you suffer from very low blood pressure (severe hypotension, present when systolic pressure, i.e. the first value measured, is below 85 mmHg);
• you have reduced blood flow reaching the body's organs and tissues due to decreased 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 making it difficult to expel air from the lungs, who are not receiving oral or inhaled medication);
• you suffer from a tumor affecting the adrenal medulla (pheochromocytoma), not controlled by 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”);
• you are being treated with medicines used to treat high blood pressure or heart rhythm disorders such as intravenous verapamil or diltiazem (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 cannot pump blood efficiently), as this may worsen heart failure or cause fluid retention. If your condition worsens during treatment, your doctor will consider reducing the dose or switching to an alternative therapy;
• you have reduced and worsening kidney function due to heart failure with low blood pressure, thickening of blood vessels, and inadequate blood supply to the heart (ischemic heart disease), and/or pre-existing kidney failure, as treatment with carvedilol may worsen kidney function;
• you suffer from left ventricular dysfunction (a part of the heart unable to contract effectively or fill properly) after acute myocardial infarction (death of heart cells due to prolonged lack of oxygen), as you should receive appropriate therapy to stabilize your clinical condition before starting Omeria;
• you have diabetes and are being treated with medicines that lower blood glucose (blood sugar levels), as taking Omeria may impair glucose control, or mask or reduce early signs and symptoms of acute hypoglycemia (sudden drop in blood sugar), such as tachycardia (rapid heartbeat), blurred vision, dizziness, sweating, restlessness;
• you have problems with peripheral blood vessels (vessels outside the heart and brain) that are obstructed (peripheral vascular disease), as treatment with carvedilol may worsen this condition;
• you suffer from a rare disease affecting the arteries, characterized by brief episodes of blood vessel narrowing, mainly affecting fingertips and toes, with pain, numbness, tingling, and skin color changes to pale or cyanotic (Raynaud's disease);
• you have excess thyroid hormones in the body (thyrotoxicosis), as Omeria may mask symptoms (e.g. tachycardia). Do not stop Omeria treatment suddenly, as this may affect thyroid function;
• you are scheduled for general surgery requiring anesthetics (medicines inducing sedation, reducing pain sensitivity and muscle relaxation), as carvedilol may enhance muscle relaxant effects;
• you have a reduced heart rate (bradycardia), with values below 55 beats per minute;
• you have previously experienced a severe hypersensitivity reaction (allergy) or are currently undergoing desensitization therapy (receiving gradually increasing doses of a medicine to which you are hypersensitive, to reach effective and safe doses), as sensitivity may increase. You may be less responsive to certain medicines (such as epinephrine) used to treat allergic (anaphylactic) reactions;
• you suffer from an inflammatory skin disease characterized by thickened, red patches covered with gray scales (psoriasis);
• you have pheochromocytoma (a tumor causing high blood pressure), as your doctor will prescribe Omeria only after assessing the risk/benefit ratio;
• you suffer from a form of angina known as “Prinzmetal's angina”, also called “variant angina”, as taking Omeria may increase its frequency;
• 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 first-degree heart block (an alteration in heart rhythm), as carvedilol may reduce the speed of electrical impulse conduction in the heart;
• you are elderly or have heart rhythm disorders such as bradycardia (slow heart rate), sinoatrial dysfunction, or atrioventricular block (types of arrhythmias), as sinus arrest (a temporary pause in heartbeat) may occur (see “Undesirable effects”).

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

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

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

• digoxin and other digitalis medicines, which stimulate heart action, maintaining its function at an appropriate level;
• insulin or other oral antidiabetic medicines;
• rifampicin, a bactericidal antibiotic;
• cimetidine, a medicine used to treat heartburn and gastric ulcers;
• reserpine, a substance used to treat high blood pressure and certain forms of psychosis;
• medicines that inhibit monoamine oxidase (MAOIs), used to treat depression;
• cyclosporine and tacrolimus, medicines used to prevent organ transplant rejection;
• 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 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;
• beta-agonist bronchodilators, used to treat asthma and bronchial obstructive diseases of asthmatic origin;
• anesthetics and neuromuscular blocking agents, medicines inducing sedation, reducing pain sensitivity and muscle relaxation. Inform your doctor if you are scheduled for 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 grapefruit juice during treatment with carvedilol.
Alcohol may enhance the blood pressure-lowering effect of carvedilol (reduces blood pressure).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Omeria during pregnancy.
Omeria must not be used during breastfeeding (see section “Do not take Omeria”).

Driving and using machines
No studies have been conducted on the effects of carvedilol on patients' ability to drive or operate machinery.
Omeria may affect your ability to drive and use machinery due to variable individual reactions (e.g. dizziness, fatigue), especially at the beginning of treatment, after a dose increase, when switching medications, or in combination with alcohol.
Therefore, exercise appropriate caution.

For those engaged in sports
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

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

3. How to take Omeria

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Take Omeria tablets with a sufficient amount of water. It is not necessary to take the tablets with food; however, if you have heart failure, take 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 arterial hypertension)
The recommended starting dose is 12.5 mg once daily for the first two days; thereafter, the recommended dose is 25 mg once daily.
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 daily or divided into two doses of 25 mg twice daily.

Treatment of angina pectoris
The recommended starting dose is 12.5 mg twice daily for the first two days; thereafter, the recommended dose is 25 mg twice daily.
Do not exceed this recommended dose.

Treatment of heart failure
Your doctor will prescribe the most appropriate dosage of Omeria for you and will monitor you closely during the period required to reach the dosage suitable for you.
The recommended starting dose is 3.125 mg (i.e. half a 6.25 mg tablet) twice daily for at least two weeks; thereafter, your doctor may progressively increase the dose at intervals of at least two weeks, to 6.25 mg twice daily, then to 12.5 mg twice daily, and up to a maximum of 25 mg twice daily.
The maximum recommended dose is:

• 25 mg twice daily: if you have severe heart failure, or if you have moderate or mild heart failure and your body weight is less than 85 kg;
• 50 mg twice daily: if you have moderate or mild heart failure and your body weight is more than 85 kg.

Use in children and adolescents
The safety 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 arterial hypertension)
The recommended starting dose is 12.5 mg once daily. If necessary, your doctor may increase the dose at intervals of at least two weeks, up to a maximum dose of 50 mg, taken as two doses of 25 mg twice daily.
Treatment of angina pectoris
The recommended starting dose is 12.5 mg twice daily; after an interval of at least two days, your doctor may increase the dose to 25 mg twice daily.
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
If you accidentally ingest/absorb an excessive dose of Omeria, contact your doctor immediately or go to the nearest hospital.
If you accidentally ingest/absorb an excessive dose of Omeria, you may experience: severe lowering of blood pressure (hypotension), reduced heart rate (bradycardia), reduced heart function (heart failure), reduced blood flow to the organs and tissues of the body due to decreased heart function (cardiogenic shock), sinus arrest, or cessation of heart function. Additionally, respiratory problems such as narrowing of the bronchi (bronchospasm), vomiting, confusion, involuntary muscle movements causing agitation and body spasms (convulsive seizures) may occur.

Treatment in case of overdose of Omeria
If you accidentally ingest/absorb an excessive dose of Omeria, you will receive standard emergency procedures and the most appropriate treatment in hospital, depending on the overdose effects and symptoms you are experiencing.

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

If you stop taking Omeria
If you have any questions about using this medicine, consult your doctor or pharmacist.
Omeria should be discontinued gradually over a two-week period and under medical supervision.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets 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;
• Reduced 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 pneumonitis), infections of the upper respiratory tract (external 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 (anaemia);
• Weight gain, increased blood cholesterol levels (hypercholesterolaemia), increased or decreased blood glucose levels (hyperglycaemia and hypoglycaemia) (in patients with diabetes);
• Depression, depressed mood;
• Feeling of losing consciousness, loss of consciousness (pre-syncope, syncope);
• Vision problems, reduced tear production (dry eyes), eye irritation;
• Reduced heart rate (bradycardia), fluid accumulation (oedema) affecting the whole body, arms and legs, genitals, increased circulating blood volume (hypervolaemia), increased fluid;
• Low blood pressure related to posture (orthostatic hypotension), circulation problems in peripheral areas of the body (cold hands and feet, peripheral vascular problems, worsening leg pain during physical activity (intermittent claudication), and worsening of Raynaud's disease);
• High blood pressure (hypertension);
• Breathing difficulties (dyspnoea), fluid accumulation in the lungs (pulmonary oedema), asthma (in patients predisposed to this condition);
• Feeling unwell (nausea), diarrhoea, vomiting, digestive problems (dyspepsia), abdominal pain;
• Pain in hands and feet;
• Reduced kidney function (renal failure) and kidney problems (in patients with widespread blood vessel disorders and/or pre-existing renal failure);
• Pain.

Uncommon (may affect up to 1 in 100 people)

• Sleep disorders;
• Confusion;
• Numbness or tingling of limbs, arms and legs (paraesthesia);
• Conduction disturbances of the cardiac impulse between atrium and ventricle (atrioventricular block), severe chest pain (angina pectoris);
• Constipation;
• Skin reactions (such as: pustular, blistering and bullous rash (exanthema) of allergic nature, skin inflammation (dermatitis), skin rash (urticaria), itching, thickened and red patches covered with grey scales (psoriasiform skin lesions), mucosal and skin lesions due to lichen planus), hair loss (alopecia);
• Inability to achieve an erection (erectile dysfunction).

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

• Decreased platelet levels in the blood (thrombocytopenia);
• Nasal congestion;
• Dry mouth;
• Urinary disorders (urine retention or difficulty in urination).

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

• Decreased white blood cell count (leucopenia);
• Allergic reaction (hypersensitivity);
• Increased levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT);
• Severe skin adverse reactions such as skin rash characterised by lesions with erythema and oedema, sometimes with blisters (erythema multiforme), severe forms of skin detachment (Stevens-Johnson syndrome), and skin decomposition (toxic epidermal necrolysis).

Not known (frequency cannot be estimated from the available data)

• Onset of diabetes symptoms with altered blood sugar levels (glycaemia), worsening of diabetes, changes in glycaemia;
• Sinus arrest (temporary pause in heartbeat);
• Hyperhidrosis (excessive sweating);
• Urinary incontinence (difficulty in holding urine) in women, which resolves upon discontinuation of treatment;
• Hallucinations (perception of things not existing in reality).

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

5. How to store Omeria

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

6. Package contents and other information

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

Description of the appearance of Omeria and contents of the pack
Omeria is available as scored tablets contained in PVC/aluminum blisters.
Omeria 6.25 mg tablets are available in packs of 28 scored tablets.
Omeria 25 mg tablets are available in packs of 30 scored tablets.

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

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