SECTRAL 400 mg Coated Tablets

Содержание инструкции

1. Sectral 400 mg film-coated tablets
   1. What Sectral is and what it is used for
   2. What you need to know before taking Sectral
   3. How to take Sectral
   4. Possible side effects
   5. How to store Sectral
   6. Contents of the pack and other information

Sectral 400 mg film-coated tablets

acebutolol

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

1. What Sectral is and what it is used for

Sectral contains the active ingredient acebutolol, which belongs to a class of medicines called
“Selective Beta-blockers”, it works by lowering blood pressure (antihypertensive medicine).
Sectral is indicated for the treatment:

• of high blood pressure (arterial hypertension) of any type and severity,
• of severe chest pain called “angina pectoris”,
• of increased heart rate (supraventricular tachyarrhythmias: sinus tachycardia, fibrillation, extrasystolic arrhythmias, atrial flutter; ventricular tachycardia),
• of some alterations in heart rate (arrhythmias due to hyperdigitation, rhythm disturbances due to adrenergic overstimulation).

2. What you need to know before taking Sectral

Do not take Sectral

• if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6),
• if you have severe heart problems (cardiogenic shock, second and third degree A-V block, sinoatrial node syndrome, sinoatrial block, decompensated heart failure),
• if you have very low blood pressure (especially if the maximum pressure is equal to or lower than 100 mmHg and the minimum is equal to or lower than 60mmHg),
• if you have a severe slowing of the heartbeat (pronounced bradycardia <45-50 bpm),
• if you have an alteration in the amount of acid in the blood (metabolic acidosis),
• if you have severe circulatory disorders of the limbs (peripheral arteriopathy and Raynaud's phenomenon),
• if you have a tumor called “pheochromocytoma” not treated with medicines,
• if you have bronchial hyperreactivity, for example in bronchial asthma or severe chronic obstructive pulmonary diseases.

Warnings and precautions
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts consult your doctor or pharmacist.

• If you have kidney problems (renal insufficiency) Sectral will be prescribed to you with attention to the dose (the frequency of administration must not exceed the single daily dose and the dose will be reduced according to kidney function).
• If you suffer from liver problems and especially if you have severe impairment of liver and kidney function (concomitant severe hepatic and renal insufficiency) you must be very careful when using Sectral due to the possible accumulation of this medicine in the blood.
• Sectral, like all medicines of the same class (beta-blockers) can lead to a slowing of the heartbeat (bradycardia), in this case your doctor will reduce the recommended dose.
• Take Sectral and all medicines of the same class (beta-blockers) with great care if you suffer from some heart diseases (compensated heart failure, Prinzmetal's angina). Discontinuation of treatment with beta-blockers must be done by a gradual reduction of the dosage.
• If you suffer from circulatory disorders of the limbs (peripheral circulatory disorders) be careful to use Sectral and all medicines of the same class (beta-blockers), because they can worsen these disorders.
• Sectral and medicines of the same class (beta-blockers) can mask the disorders of severe alterations of the thyroid gland (thyrotoxicosis).
• Take Sectral with particular caution if you suffer from diabetes with strong fluctuations in blood sugar levels (glycemia), if you are fasting and doing strenuous exercise, because you may experience a strong drop in blood sugar levels (severe hypoglycemia). The signs of reduced blood sugar (particularly the increased heartbeat) may be masked during treatment with Sectral.

If you suffer from a type of tumor called “pheochromocytoma” your doctor will give you Sectral only if you are
taking “alpha-adrenergic” medicines at the same time.

• If you suffer from a severe skin disease called “psoriasis”, your doctor will prescribe Sectral and medicines of the same class (beta-blockers) only after careful evaluation because psoriasis may worsen.
• Sectral and medicines of the same class (beta-blockers) can increase the sensitivity to substances that cause allergy (allergens) and the severity of allergic reactions (anaphylactic). If you have had severe allergic reactions (hypersensitivity) and are undergoing treatment for allergies (desensitizing treatment), your doctor will prescribe Sectral only if strictly necessary.
• Beta-blockers cause an attenuation of the reflex tachycardia and an increase in the risk of hypotension (low blood pressure). If your doctor decides to interrupt the treatment with Sectral before you undergo surgery, the therapy will be suspended for at least 24 hours. Continuing the therapy reduces the risk of heart rhythm disturbances (arrhythmias), heart ischemia and exacerbations of hypertension, but increases the risk of low blood pressure (hypotension). If the doctor decides to continue the treatment, the anesthesiologist must be informed that you are taking Sectral.
• If you suffer from respiratory disorders (obstructive airway disease), your doctor will prescribe Sectral only if strictly necessary.
• When you have to stop Sectral, your doctor will gradually reduce the dose, especially if you suffer from severe heart diseases (ischemic heart disease).
• During treatment with Sectral you may have blood diseases that manifest with reddish spots on the skin (thrombocytopenic and non-thrombocytopenic purpura); if you experience these disorders, inform your doctor.
• Use Sectral with caution if you wear contact lenses because you may have dry eyes.
• In elderly patients Sectral has been used without the need for dose adjustment. However, your doctor may prescribe you lower maintenance doses.

Other medicines and Sectral
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Sectral can be affected by or affect the following medicines.

• Do not use Sectral in association with verapamil (used for high blood pressure) and wait a few days after the end of verapamil therapy before starting Sectral therapy (and vice versa). Use Sectral with great care together with other medicines of the same class as verapamil (calcium antagonists), in particular diltiazem. An increased risk of depression has been reported when beta-blockers are administered together with diltiazem (see “Undesirable effects”).
• Use particular caution if you take Sectral together with medicines that serve to regulate the heartbeat (antiarrhythmics with cardio-depressive action, for example quinidine), or anesthetics, or morphine (used for pain), if you suffer from diabetes and are taking medicines that serve to lower blood sugar levels (hypoglycemic agents).
• Medicines that serve to regulate the heartbeat (class I antiarrhythmics), such as disopyramide and amiodarone, can lead to effects on the heart (increasing atrial conduction time and inducing negative inotropic effects) if administered simultaneously with medicines of the same class as Sectral (beta-blockers).
• If you take Sectral (or medicines of the same class as Sectral) simultaneously with clonidine (used for high blood pressure), continue the therapy with clonidine for several days even after you have stopped taking Sectral. An abrupt discontinuation of clonidine during treatment with Sectral can cause an excessive increase in blood pressure.
• The concomitant treatment of Sectral and medicines that act on the heart (cardiac glycosides), reserpine (used for high blood pressure and some mental illnesses), alpha-methyldopa, guanethidine and guanfacine (used for high blood pressure) can lead to a severe slowing of the heartbeat or other heart problems (conduction delays).
• The use of fingolimod (used for multiple sclerosis) with Sectral and medicines of the same class (beta-blockers) is not recommended, because this association can increase the effects of slowing the heartbeat (bradycardic effects) of fingolimod. If the doctor considers this co-administration necessary, you will be carefully monitored at the beginning of treatment and for at least the following morning.
• The concomitant use of Sectral and medicines called “calcium antagonists”, used for high blood pressure, for example nifedipine, can also cause a greater drop in blood pressure and,

occasionally, the appearance of severe heart problems (bradycardia, hypotension and heart failure).

• Sectral and medicines of the same class (beta-blockers) can increase the effect of decreasing blood sugar levels (hypoglycemic) of insulin and oral antidiabetic medicines. If you suffer from diabetes (labile diabetes and insulin-dependent) your doctor may deem it necessary to reduce the dose of substances that serve to lower blood sugar levels (such as insulin and oral antidiabetic medicines). However, medicines of the same class as Sectral are also known to decrease the effect of glibenclamide (used to decrease blood sugar levels).
• Sectral can eliminate the action of medicines that serve to dilate the bronchi (sympathomimetic and xanthine bronchodilators).
• The simultaneous use of digoxin (used for heart problems) and medicines similar to Sectral (beta-blockers) can sometimes lead to a severe slowing of the heartbeat (bradycardia).
• Anti-inflammatory medicines, for example non-steroidal anti-inflammatory agents (NSAIDs) and Indometacin, can decrease the action of Sectral.
• The simultaneous administration of Sectral together with medicines for depression (tricyclic antidepressants), barbiturates and phenothiazines (used for mental illnesses), as well as other medicines for high blood pressure (antihypertensive agents) can increase the effect of lowering blood pressure of Sectral and medicines of the same class (beta-blockers).
• There is a risk that the simultaneous administration of some medicines used for depression (monoamine oxidase inhibitors MAOIs) and high doses of Sectral and medicines belonging to the same class (beta-blockers) may cause an increase in blood pressure (hypertension).
• If you are to undergo general anesthesia, the anesthesiologist must be informed, because the use of anesthetic agents such as ether, cyclopropane and trichloroethylene can cause heart problems.
• Avoid the association of Sectral with “rauwolfia alkaloids” and their derivatives (used for high blood pressure).
• Sectral can alter the values of some tests (determination of 17-ketosteroids in urine and methoxylated catecholamine derivatives in urine).
• The use in association of Sectral and pain medicines (narcotics) can cause a greater drop in blood pressure.
• A harmful increase in blood pressure may occur during the simultaneous administration of Sectral with “noradrenaline” or “adrenaline”.
• Medicines known to induce heart rhythm disturbances: the concomitant use with beta-blockers, such as Sectral, can induce arrest in the conduction of the heart's electrical signal.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not use Sectral during the first three months of pregnancy, unless your doctor considers it essential.
In these cases, your doctor will prescribe the lowest possible dose.
Do not use Sectral in the last months of pregnancy, because medicines of the same class as Sectral (beta-blockers) administered in the last months of pregnancy can cause a decrease in the heartbeat (bradycardia), a decrease in blood sugar (hypoglycemia) and lung or heart complications in the fetus/newborn.
Medicines of the same class as Sectral (beta-blockers) can reduce the amount of blood (perfusion) to the placenta, which can cause fetal death in the womb, premature birth and premature babies.
If the doctor decides to continue the treatment with Sectral because it is necessary for your health, it
must be stopped at least 48-72 hours before the expected birth, because otherwise there is a
possibility of a decrease in the heartbeat (bradycardia), a decrease in blood pressure
(hypotension), a decrease in blood sugar (hypoglycemia) and respiratory depression (neonatal asphyxia) in the newborn.
If the treatment with Sectral cannot be interrupted before birth, the newborn will be carefully
monitored during the first 48-72 hours of life.

Breastfeeding
Sectral passes into breast milk.
Do not use Sectral during breastfeeding.

Driving and operating machinery
Sectral can occasionally cause dizziness and fatigue.
Keep this in mind if you have to drive vehicles or operate machinery.
Sectral contains lactose
If your doctor has diagnosed you with an intolerance to some sugars, contact him before taking this
medicine.

Sectral contains wheat starch
This medicine contains only a very small amount of gluten (from wheat starch).
This medicine is considered “gluten-free” and it is very unlikely to cause you problems if you
are celiac.
One Sectral tablet (400mg of acebutolol) contains no more than 4 micrograms of gluten.
If you are allergic to wheat (condition different from celiac disease) do not take this medicine.

For athletes:
The use of the medicine without therapeutic necessity constitutes doping and may still result in positive
doping tests.

3. How to take Sectral

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Swallow the tablets whole with a little liquid, preferably before meals.

For the treatment of high blood pressure (hypertension)
The recommended dose is:
Initially 400 mg per day orally, in a single dose or in two doses of 200 mg.
If the response is not adequate, your doctor may increase the dose to 800-1200 mg per day divided into
2-3 administrations.

For the treatment of angina pectoris
The recommended dose is:
Usually 400 mg per day orally, in 1-2 administrations.
In more severe forms, your doctor may increase the dose to 800 mg per day divided into 2-4
administrations.

For the treatment of heart rhythm disturbances (cardiac arrhythmias)
Your doctor will advise you to start oral therapy with a dose of 200 mg (half a tablet).
The oral administration of Sectral develops its full effect about three hours after taking it.
Usually 400 mg per day (2 doses of 200 mg) are sufficient, but some people may require a
dose of 600 mg per day (3 doses of 200 mg).

Patients with kidney and liver diseases (impaired renal and hepatic function):
Follow your doctor's prescription very carefully.

If you take more Sectral than you should
The disorders that may occur if you take more Sectral than you should depend particularly on the
condition of your heart.
If you suffer from severe heart problems (pronounced heart failure), even low doses can cause
damage to your heart condition. The main disorders that may manifest are: fatigue,
loss of consciousness, dilation of the pupils and occasionally convulsions. May also occur:
lowering of blood pressure (hypotension), slowing of the heartbeat (bradycardia)
up to severe heart rhythm disturbances (asystole) and other heart disorders (conduction disturbances:
ECG often shows escape rhythms supraventricular or ventricular or may manifest arrest in
the conduction of the electrical signal of the heart) with possible severe impairment of heart function
(heart failure) and shock, which may manifest with constriction of blood vessels (peripheral vasoconstriction) and constriction of the bronchi (bronchospasm).
Stop treatment if you take more Sectral than you should (overdose) or if you experience a sudden
slowing of the heartbeat or blood pressure and contact your doctor quickly.

If you forget to take Sectral
Do not take a double dose to make up for a missed dose.
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 everyone will experience them.
The most common side effects of Sectral relate to the heart, the nervous system, blood vessels
(blockage of beta-adrenergic activity), as well as fatigue, stomach and intestinal disorders.
More serious side effects are heart changes (heart failure, atrioventricular block) and constriction of the bronchi (bronchospasm).
As with all medicines in the same class as Sectral (beta-blockers), abruptly stopping treatment can worsen chest pain (angina pectoris). Pay particular attention if you have a
heart condition called “ischemic heart disease”.

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

• positivity to a blood test called “anti-nuclear antibody”,
• fatigue,
• stomach and intestinal disorders.

Common side effects (may affect up to 1 in 10 people)

• depression,
• nightmares,
• dizziness,
• headache,
• blurred vision,
• difficulty breathing (dyspnea),
• nausea,
• diarrhea,
• redness (rash),
• itching,
• sweating.

Uncommon side effects (may affect up to 1 in 100 people)

• inflammations and changes of the skin (lupus-like syndrome),
• changes in heartbeat (palpitations),
• loss of consciousness (syncope),

Rare side effects (may affect up to 1 in 1000 people)

• alteration of the heartbeat (arrhythmia),
• dry mouth,
• loss of appetite (anorexia),
• changes in some liver blood tests (increased alkaline phosphatase, hyperbilirubinemia, increased SGOT and SGPT),
• skin disease called “psoriasis”, redness on the skin that resembles those that occur in “psoriasis”, worsening of psoriasis,
• impotence,
• decreased sexual desire (decreased libido),
• decreased potassium levels in the blood (hypokalemia),
• diabetes (precipitated or aggravated diabetes mellitus),
• increased fats in the blood (hyperlipidemia),
• decreased cholesterol (reduced HDL),
• decreased blood sugar (hypoglycemia).

Side effects with unknown frequency (frequency cannot be established based on available data)

• psychological disorders (psychosis),
• hallucinations,
• confusion,
• loss of sexual desire (loss of libido),
• sleep disorders,
• alteration of sensitivity of some areas of the body (paresthesia),
• disorders of the Nervous System (Central Nervous System),
• changes in movement, emotions and behavior (catatonia),
• changes in memory,
• dry eye
• heart disorders (heart failure, first-degree atrioventricular block, worsening of an existing atrioventricular block),
• decreased heart rate (bradycardia), the heartbeat becomes very slow or stops beating. You may experience dizziness and feel unusually tired and short of breath. This condition can occur especially in people over 65 years of age or people with other heart rhythm problems,
• difficulty walking (intermittent claudication),
• blood vessel disease called “Raynaud's syndrome”,
• bluish discoloration of the limbs (peripheral cyanosis) and cold limbs,
• low blood pressure (hypotension),
• pneumonia, even severe,
• presence in the lungs of cells belonging to different organs (pulmonary infiltration),
• narrowing of the volume of the bronchi (bronchospasm),
• worsening of asthma,
• vomiting,
• liver damage (hepatic damage, primarily hepatocellular),
• increased some liver blood tests (increased liver enzymes),
• disorders due to discontinuation of treatment (withdrawal syndrome),
• blood disease called “thrombocytopenic purpura”,
• decrease in some white blood cells (granulocytopenia),
• weakness (asthenia),
• severe muscle weakness (myasthenia),
• muscle cramps.

If you experience constriction of the bronchi (bronchospasm), a blood disease called “thrombocytopenic purpura”, alteration of some white blood cells (granulocytopenia), redness on the
skin (skin rash), the doctor will stop the treatment and administer appropriate treatment.

Reporting side effects
If you experience any side effects, including those not listed in this leaflet, tell 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 help provide more information on the safety of
this medicine.

5. How to store Sectral

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date that is stated on the pack after “Scad”. The expiry date refers to the last day of that month.
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 Sectral contains

• The active ingredient is acebutolol. One tablet contains 443.4 mg acebutolol hydrochloride equivalent to 400 mg acebutolol.
• The other ingredients are: wheat starch, povidone, anhydrous colloidal silica, talc, magnesium stearate, macrogols, hypromellose, lactose.

Description of the appearance of Sectral and contents of the pack
Sectral is presented in the form of film-coated tablets .

• pack of 30 tablets

Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Manufacturer
Sanofi-aventis, S.A. - Ctra. C-35 (La Batllòria-Hostalric) Km. 63.09 - 17404 Riells i Viabrea (Girona) - Spain