Seles Beta

Package leaflet: Information for the patient

Seles Beta 100 mg tablets

atenolol
Please read this leaflet carefully before 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 other people, 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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Seles Beta is and what it is used for

Seles Beta contains an active substance called atenolol.
Atenolol belongs to a group of medicines known as beta-blockers, which reduce heart rate and
blood pressure.
Seles Beta is indicated for the treatment:

• of high blood pressure (arterial hypertension), including that of renal origin
• of chest pain due to heart problems (angina pectoris)

2. What you should know before taking Seles Beta

Do not take Seles Beta

• If you are allergic to atenolol or to any of the other ingredients of this medicine (listed in section 6).
• If you have a very slow heartbeat (bradycardia).
• If you have a severe heart problem known as cardiogenic shock, which occurs when your heart does not pump enough blood throughout the body.
• If you suffer from very low blood pressure (hypotension).
• If your doctor has diagnosed you with abnormally high levels of acid in the blood (metabolic acidosis).
• If you suffer from severe peripheral arterial circulation disorders or have a severe form of a rare disease characterized by brief episodes of narrowing of the arteries, the blood vessels carrying blood from the heart to the rest of the body (Raynaud's syndrome).
• If you have a heart rhythm disorder called "sinoatrial disease" or "second- or third-degree atrioventricular block".
• If you have an untreated tumour of the adrenal gland called "pheochromocytoma".
• If your heart function is inadequate and not controlled by appropriate therapy (overt uncontrolled heart failure).
• If you are being treated with intravenous medicines called calcium antagonists, for example verapamil (used to treat high blood pressure) or diltiazem (used to treat high blood pressure, angina pectoris, and other heart conditions), or medicines used to normalize heart rhythm, such as disopyramide.
• If you are taking medicines used to treat depression (MAO inhibitors, except MAO-B inhibitors).
• If you suffer from severe asthma or severe chronic obstructive pulmonary disease.
• If you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Seles Beta:

• If you suffer from heart failure.
• If you have a heart condition called Prinzmetal's angina, because Seles Beta may increase the number and duration of angina attacks.
• If you have peripheral arterial circulation disorders (see also section 2 “Do not take Seles Beta”), even if mild, because Seles Beta may worsen these conditions.
• If you have a heart rhythm disorder called first-degree atrioventricular block, because Seles Beta may worsen this condition.
• If you suffer from hypoglycaemia or diabetes; this medicine may mask the symptoms indicating that blood sugar levels (glycaemia) have dropped too low (hypoglycaemia), such as increased heart rate, palpitations, and excessive sweating. Atenolol may also increase the risk of severe hypoglycaemia when used with certain types of antidiabetic medicines called sulfonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide).
• If you have thyroid problems (thyrotoxicosis). The medicine may mask symptoms of thyrotoxicosis such as rapid heartbeat, tremor, or excessive sweating.
• If you have excessive reduction in heart rate. In such cases, your doctor may consider reducing the dose of the medicine.
• If you have a history of severe allergic reactions (e.g. anaphylaxis); this medicine may worsen such allergic reactions and reduce the response to adrenaline therapy. Seles Beta may also cause angioedema and urticaria.
• If you suffer from sudden spasms of the airways (bronchospasm), such as asthma. In such cases, your doctor may adjust the dosage of the medicine.
• If you are being treated for a tumour called pheochromocytoma; in this case, blood pressure must be closely monitored during treatment.
• If you are using ophthalmic beta-blockers, as the effects of Seles Beta may be enhanced.
• If you develop symptoms such as skin rash and joint pain, which could indicate a disease called "systemic lupus erythematosus", your doctor may decide to discontinue treatment (see section 4 “Undesirable effects”).
• If you suffer from kidney problems.
• If you are pregnant, planning to become pregnant, or breastfeeding (see section “Pregnancy and Breastfeeding” and section “Do not take Seles Beta”).
• If you have a predisposition to a skin condition called psoriasis.

If you are undergoing surgery, inform your doctor or healthcare staff that you are taking Seles Beta.
It is important not to stop treatment with Seles Beta abruptly, especially in patients with ischaemic heart disease. If you need to stop or discontinue treatment with Seles Beta after prolonged use, the dose should always be reduced gradually by tapering, as sudden discontinuation may lead to reduced oxygenated blood supply to a more or less extensive area of the heart (myocardial ischaemia), resulting in worsening of angina pectoris (a heart condition characterized by chest pain), or myocardial infarction, or may cause worsening of hypertension.

Anti-doping tests
For athletes: the use of this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

Children and adolescents
The use of Seles Beta is not recommended in individuals under 18 years of age.

Other medicines and Seles Beta
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking any of the following medicines:

• Calcium antagonists (e.g. verapamil, diltiazem) or dihydropyridines (e.g. nifedipine) or clonidine used to treat high blood pressure.
• Baclofen, used as a muscle relaxant acting on the nervous system.
• Cardiac glycosides such as digoxin, used to treat heart failure.
• Antiarrhythmic medicines (e.g. disopyramide or amiodarone), used to treat irregular heartbeats.
• Sympathomimetic medicines such as adrenaline, used to stimulate heart activity.
• Non-steroidal anti-inflammatory drugs (e.g. ibuprofen, indometacin), used to control pain and inflammation.
• Insulin or oral antidiabetic medicines used to treat diabetes, such as sulfonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide).
• Medicines used to treat depression (MAO inhibitors, except MAO-B inhibitors).
• Medicines that stimulate the heart, such as epinephrine or norepinephrine.
• Medicines used to treat depression, such as tricyclic antidepressants.
• Medicines used to treat seizures (barbiturates).
• Medicines used to treat mental disorders, such as psychosis (phenothiazines).
• Other medicines used to control blood pressure (vasodilators, antihypertensives, diuretics).
• Medicines used to induce anaesthesia or to relax muscles (peripheral muscle relaxants).

If you are going to hospital for surgery, inform the anaesthetist or medical staff that you are taking Seles Beta. This is because low blood pressure (hypotension) may occur if certain types of anaesthetics are administered while you are taking this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Seles Beta is contraindicated in women who are breastfeeding (see section “Warnings and precautions”).

Driving and using machines
Seles Beta may cause dizziness and fatigue. If these symptoms occur, do not drive and do not operate machinery.

Seles Beta contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Seles Beta

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will tell you how many tablets to take each day and when, depending on your condition. The recommended starting
dose, especially in elderly patients, is the lowest possible dose in order to promptly identify
the onset of symptoms of heart failure (the heart's inability to supply adequate blood flow to meet the body's needs),
bradycardia (reduction in heart rate below 60 beats per minute), and bronchial symptoms.
Swallow the tablets whole with a glass of water, away from meals.

Adults

Treatment of high blood pressure (arterial hypertension), including that of renal origin
The recommended dose is half a tablet (50 mg) or one tablet (100 mg) daily.
Your doctor will prescribe the dose most suitable for your hypertension.
Usually, improvement becomes evident after one or two weeks of treatment.

Prevention of chest pain (angina pectoris)
The recommended dose is one tablet (100 mg) daily.

Elderly patients
If you are elderly (aged over 65 years), your doctor may decide to prescribe Seles Beta at lower doses,
especially if you have kidney problems.

Use in children and adolescents
Use of Seles Beta is not recommended in individuals under 18 years of age.

Patients with reduced kidney function (renal insufficiency)
If you have severe kidney problems, your doctor will prescribe the appropriate dose of Seles Beta based on the severity
of your renal insufficiency.
If you are undergoing haemodialysis, the recommended dose is half a tablet (50 mg) of Seles Beta after each dialysis session,
administered in hospital so that immediate intervention is possible should blood pressure drop excessively.

If you take more Seles Beta than you should
If you take more Seles Beta than prescribed, contact your doctor immediately or go to the nearest hospital emergency department.
Take the medicine pack with you so that the doctor knows what you have taken.
The following symptoms may occur: slow heartbeat, low blood pressure, problems with the heart's pumping function (acute heart failure) and breathing difficulties, as well as narrowing of the lower airways (bronchi) causing breathing difficulty (bronchospasm).

If you forget to take Seles Beta
If you forget to take a dose of Seles Beta, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose. Do not take a double dose to make up for the forgotten one.

If you stop taking Seles Beta
Do not stop taking Seles Beta without talking to your doctor.
It is necessary to stop treatment gradually.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Common (may affect up to 1 in 10 people)

• Cold hands and feet
• Slow heart rate (bradycardia)
• Gastrointestinal disorders (e.g. nausea, vomiting, diarrhoea, abdominal pain)
• Feeling of tiredness
• Liver function abnormalities (increased transaminases in blood)

Uncommon (may affect up to 1 in 100 people)

• Sleep disorders

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

• Skin rashes (purpura)
• Reduced number of blood cells called platelets
• Mood changes
• Nightmares
• Changes in personality (psychosis) or hallucinations
• Worsening of nervous disorders with mental depression
• Psychiatric syndrome characterised by motor abnormalities including inability to move (catatonia)
• Confusion and memory disturbances
• Dizziness
• Headache
• Tingling or numbness in hands or feet (paraesthesia)
• Dry eyes
• Dry mouth
• Visual disturbances
• Worsening of heart failure
• Alteration of electrical impulses that control the heartbeat (precipitation of heart block)
• Heart failure
• Slowing of atrioventricular conduction or worsening of an existing atrioventricular block
• Sudden drop in blood pressure upon changing position (postural hypotension), which may be associated with loss of consciousness (syncope)
• Increased leg pain during physical exertion (worsening of intermittent claudication)
• Numbness and spasms in fingers, accompanied by heat and pain (Raynaud's disease)
• Sudden narrowing of the airways causing breathing difficulty (bronchospasm), if you suffer or have suffered from asthma
• Dry mouth
• Liver damage (hepatic toxicity and possible bile accumulation in the liver (intrahepatic cholestasis))
• Hair loss
• Dry, scaly skin as in psoriasis, or worsening of psoriasis
• Skin rash
• Worsening of skin patches lacking pigment, if you suffer from vitiligo
• Inability to maintain an erection (impotence)

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

• Increase in antibodies produced by the body against itself, known as antinuclear antibodies (detected in blood tests). This has been observed, but its clinical significance is unknown.
• Immune system disorder called systemic lupus erythematosus (a disease causing skin rash and joint pain) and lupus-like syndrome.

Not known (frequency cannot be estimated from available data)

• Constipation (stool retention)
• Allergic reactions (hypersensitivity) to the medicine
• Swelling of the face, hands, feet (angioedema)
• Urticaria
• Dyspnoea (difficulty breathing)
• Hypotension

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via 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 Seles Beta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp".
The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Seles Beta contains

• The active substance is atenolol. Each tablet contains 100 mg of atenolol.
• The other components are magnesium carbonate, maize starch, sodium lauryl sulfate, gelatin, magnesium stearate.

Description of the appearance of Seles Beta and the pack contents
Seles Beta tablets are white, round, convex, with a break line on one side.
Seles Beta tablets are packaged in aluminum/PVC blisters and are available in packs containing 28 tablets.
Marketing Authorization Holder
Teofarma S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)
Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno, 48
Quinto de’ Stampi
20089 Rozzano (MI)
Italy