SELES 100 mg Tablets

Зміст інструкції

1. Seles Beta 100 mg tablets
   1. What is Seles Beta and what is it used for
   2. What you need to know before you take 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

Seles Beta 100 mg tablets

atenolol

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 their symptoms are the same as yours, as it could 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 Seles Beta is and what it is used for
• 2. What you need to know before you take 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 is Seles Beta and what is it used for

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

• of high blood pressure (arterial hypertension), including that of renal origin
• of heart attacks (angina pectoris)

2. What you need to know before you take 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 serious 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 higher than normal levels of acid in your blood (metabolic acidosis).
• If you suffer from severe peripheral arterial circulatory disorders or are affected by a severe form of a rare disease characterized by brief episodes of narrowing of the arteries, the blood vessels that carry blood from the heart to the rest of the body (Raynaud's syndrome).
• If you have a heart rhythm disorder called “sick sinus syndrome” or “second or third degree atrioventricular block”.
• If you have a tumor of the adrenal gland, called “pheochromocytoma” that has not been treated.
• If your heart function is insufficient and is not controlled by adequate therapy (manifest and uncontrolled heart failure).
• If you are being treated with medicines, injected directly into a vein, called calcium antagonists, for example 1/6

verapamil (used for the treatment of high blood pressure) or diltiazem (used for the
treatment of high blood pressure, angina pectoris, and other heart disorders), or medicines
used to normalize the heart rhythm, such as disopyramide;

• If you are taking medicines used for the treatment of depression (MAO inhibitors except MAO-B inhibitors);
• If you suffer from severe asthma and severe chronic obstructive pulmonary diseases;
• 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 can increase the number and duration of angina attacks.
• If you suffer from peripheral arterial circulatory disorders (see also section 2 “Do not take Seles Beta”) but of a modest nature because Seles Beta may worsen these disorders.
• If you have a heart rhythm disorder called first-degree atrioventricular block because Seles Beta may worsen this condition.
• If you suffer from hypoglycemia or diabetes; this medicine may mask the symptoms that indicate that blood sugar (glycemia) levels have dropped too low (hypoglycemia) such as increased heart rate, palpitations and excessive sweating.
• If you have problems with your thyroid gland (thyrotoxicosis). The medicine may hide the symptoms of thyrotoxicosis such as a fast heartbeat, tremor or excessive sweating.
• If you have an excessive reduction in heart rate. In such cases, the doctor may consider reducing the dosage 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 epinephrine therapy. Seles Beta can also cause angioedema and urticaria.
• If you suffer from sudden spasms of the airways (bronchospasm), such as asthma. In such cases, the doctor may consider adjusting the dosage of the medicine.
• If you are being treated for a type of tumor called pheochromocytoma; in this case, blood pressure must be closely monitored during treatment.
• If you are being treated with ophthalmic beta-blockers as the effects of Seles Beta may be potentiated.
• If you develop symptoms such as a skin rash and joint pain, which may be indicative of a disease called “systemic lupus erythematosus”, the doctor may decide to stop treatment (see section 4 “undesirable effects”).
• If you suffer from kidney problems.
• If you are pregnant or planning to become pregnant or if you are breastfeeding (See section “Pregnancy and Breastfeeding” and section “Do not take Seles Beta”)
• if you have a predisposition to a skin disease called psoriasis.

If you are going to have surgery, tell 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
ischemic heart disease. If you need to stop or suspend therapy with Seles Beta after prolonged
use, the reduction must always be done gradually with a gradual decrease, as a
sudden suspension may lead to a reduced supply of oxygenated blood to a more or less
extensive area of the heart (myocardial ischemia) with exacerbation of angina pectoris (heart
disease that manifests with chest pain), or myocardial infarction, or may cause an exacerbation
of hypertension.

Doping tests
For those who engage in sports: the use of this medicine without therapeutic necessity constitutes doping and
may still result in positive doping tests.

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

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, tell 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 with action on the nervous system.
• Cardiac glycosides such as digitalis, used to treat heart failure.
• Antiarrhythmic medicines (e.g. disopyramide or amiodarone), used for the treatment of irregular heartbeats.
• Sympathomimetic medicines such as epinephrine used to stimulate heart activity.
• Non-steroidal anti-inflammatory drugs (e.g. ibuprofen, indometacin) used for pain and inflammation control.
• Oral antidiabetic drugs or insulin administered for the treatment of diabetes.
• Medicines used for the treatment of 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 convulsions (barbiturates);
• Medicines used to treat mental disorders, such as psychoses (phenothiazines);
• Other medicines for the control of blood pressure (vasodilators, antihypertensives, diuretics).
• Medicines used to induce anesthesia or to relax muscles (peripheral muscle relaxants).

If you have to go to hospital for surgery, tell the anesthesiologist or medical staff that you are
taking Seles Beta. This is because a decrease in blood pressure (hypotension) may occur if you are given certain types of anesthetics while taking this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning to become pregnant, or if you are breastfeeding with breast
milk, ask 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 can cause dizziness and fatigue. If you experience these symptoms, do not drive and do not use
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 following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
The doctor will tell you how many tablets to take each day and when, depending on your condition; the initial
recommended dose, especially in the elderly, is the lowest possible dose in order to
promptly recognize the onset of symptoms of heart failure (the heart's inability to provide
blood in an adequate quantity compared to the body's actual needs), bradycardia (reduction of the
heart rate below a value of 60 beats per minute) and bronchial symptoms.

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) per day.
The doctor will prescribe the dose that is most suitable for your hypertension.
Usually, improvements are visible after one or two weeks of therapy.

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

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

Use in children and adolescents
The use of Seles Beta is not recommended in the population under the age of 18 years.

Patients with reduced kidney function (renal insufficiency)
If you have severe kidney problems, your doctor will prescribe Seles Beta at the correct dose for you based on the extent
of the renal insufficiency you suffer from.
If you are on hemodialysis, the recommended dose is half a tablet (50 mg) of Seles Beta after each session,
administered in hospital to be able to intervene immediately if the reduction in blood pressure is
excessive.

If you take more Seles Beta than you should
If you take more Seles Beta than prescribed by your doctor, contact your doctor immediately or go to the
nearest hospital emergency room.
Bring the package of the medicine 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 difficulty breathing, as well as narrowing of the
lower airways (bronchi) with difficulty breathing (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 the
time to take the next dose, skip the missed dose. Do not take a double dose to
make up for the forgotten dose.

If you stop taking Seles Beta
Do not stop taking Seles Beta without talking to your doctor.
It is necessary to stop taking it gradually.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Common (may affect up to 1 in 10 people)

• Cold hands and feet
• Slowed heartbeat (bradycardia)
• Gastrointestinal disorders (e.g. nausea, vomiting, diarrhoea, abdominal pain)
• Feeling tired
• Changes in liver function (increased transaminases in the blood)

Uncommon (may affect up to 1 in 100 people)

• Sleep disorders

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

• Skin spots (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 anomalies including inability to move (catatonia)
• Feeling of confusion and memory disorders
• Dizziness
• Headache
• Sensations of tingling or numbness in the hands or feet (paraesthesia)
• Dry eyes
• Dry mouth
• Visual disturbances
• Worsening of heart failure
• Alteration of the impulses that determine the heartbeat (precipitation of heart block)
• Heart failure
• Slowing of atrioventricular conduction or intensification of atrioventricular block
• Sudden drop in blood pressure following a sudden change in position (postural hypotension) which may be associated with loss of consciousness (syncope)
• Increased leg pain in association with physical exertion (worsening of intermittent claudication)
• Numbness and spasm in the fingers which is accompanied by warmth and pain (Raynaud's disease)
• Sudden narrowing of the airways causing difficulty breathing (bronchospasm) if you suffer from or have suffered from asthma
• Dry mouth
• Liver damage (hepatic toxicity and possible problems of bile stagnation in the liver (intrahepatic cholestasis))
• Hair loss
• Dry and scaly skin as in psoriasis, or worsening of psoriasis
• Skin rash
• Worsening of colourless patches on the skin 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 that the body produces against itself, called antinuclear antibodies (detected by blood tests). This has been observed, but its clinical significance is unknown.
• Disease of the immune system called systemic lupus erythematosus (a disease that causes a rash and joint pain) and lupus-like syndrome.

Not known (frequency cannot be estimated from available data)

• Constipation
• Allergic (hypersensitivity) reactions to the drug
• Swelling of the face, hands, feet (angioedema)
• Urticaria
• Dyspnea (difficulty breathing)
• Hypotension

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the system
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 which is stated on the pack after the wording Exp.
The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in waste water 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 Seles Beta contains

• The active ingredient is atenolol. Each tablet contains 100 mg of atenolol.
• The other ingredients are magnesium carbonate, corn starch, sodium lauryl sulfate, gelatin, magnesium stearate.

Description of the appearance of Seles Beta and contents of the pack
Seles Beta tablets are white, round, convex, with a fracture line on one side.
Seles Beta tablets are packaged in aluminum/PVC blisters and are available in packs
containing 28 tablets.

Marketing Authorisation 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