TENSIBLOCK 100 mg Tablets

Зміст інструкції

1. TENSIBLOCK 100 mg tablets
   1. What is TENSIBLOCK and what is it used for
   2. What you need to know before taking TENSIBLOCK
   3. How to take TENSIBLOCK
   4. Possible side effects
   5. How to store TENSIBLOCK
   6. Contents of the pack and other information

TENSIBLOCK 100 mg tablets

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

1. What is TENSIBLOCK and what is it used for

This medicine contains the active ingredient atenolol, belonging to a group of medicines
called beta-blockers, which work by slowing the heartbeat and causing the heart to
beat with less force.
TENSIBLOCK is indicated for:

• the treatment of high blood pressure (hypertension), including that of renal origin;
• the treatment of chest pain caused by heart problems (angina pectoris);
• the treatment of some types of heart rhythm disturbances (arrhythmia);
• the early treatment of a heart attack (myocardial infarction).

2. What you need to know before taking TENSIBLOCK

Do not take TENSIBLOCK

• if you are allergic to atenolol or 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 your body;
• if you have low blood pressure (hypotension);
• if your doctor has told you that the acidity level of your blood is higher than normal (metabolic acidosis);
• if you have severe blood circulation problems in the limbs (peripheral arterial circulation);
• if you have a heart conduction defect (atrioventricular block greater than first degree, sinus node disease);
• if you have an untreated tumor of the adrenal gland called pheochromocytoma;
• if your heart function is insufficient and is not controlled by adequate therapy (uncontrolled heart failure);
• if you are taking medicines containing verapamil (used to treat high blood pressure) or diltiazem (used to treat high blood pressure, angina pectoris, and other heart disorders).

Warnings and precautions
Talk to your doctor or pharmacist before taking TENSIBLOCK.
Pay particular attention and consult your doctor before taking this medicine:

• if your heart function is insufficient (heart failure) and is kept under control by adequate therapy;
• if you suffer from chest pain called Prinzmetal's angina, as this medicine may increase the number and duration of angina attacks;
• if you have heart problems (first-degree atrioventricular block);
• if your heart's ability to increase the amount of blood it pumps to the body is poor (poor cardiac reserve);
• if you have diabetes or low blood sugar levels (hypoglycemia). Atenolol may mask the signs and symptoms of acute hypoglycemia such as increased heart rate (tachycardia) and blood pressure;
• if you have problems with your thyroid gland (thyrotoxicosis), because atenolol may hide its symptoms;
• if you have had severe allergic reactions (anaphylactic reactions) in the past. If you develop an allergic reaction, the doses of adrenaline normally used may not be sufficient;
• if you suffer from respiratory diseases or asthma, in the latter case TENSIBLOCK may worsen your breathing difficulties.

During treatment with this medicine, your heart rate will decrease, however
if this effect is excessive, consult your doctor who will intervene by reducing the dosage.
If you participate in sports: the use of this medicine without a therapeutic need constitutes doping
and may still result in a positive doping test.

Children
The use of TENSIBLOCK is contraindicated in children.

Other medicines and TENSIBLOCK
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Do not take this medicine if you have been given medicines containing verapamil or
diltiazem, used to treat high blood pressure. At least 48
hours must have passed since stopping treatment with verapamil or diltiazem before starting therapy with
TENSIBLOCK.
Pay particular attention and consult your doctor if you are taking:

• medicines used to treat heart rhythm disturbances (Class I antiarrhythmics such as disopyramide, digitalis glycosides);
• clonidine, a medicine used to treat high blood pressure. If TENSIBLOCK therapy is to replace clonidine therapy, stop clonidine therapy several days before starting treatment with this medicine. If the two drugs are administered simultaneously, clonidine must be discontinued several days after stopping this medicine;
• medicines used to treat high blood pressure belonging to the dihydropyridine group (e.g. nifedipine);
• medicines used in case of inflammation and to relieve pain (e.g. ibuprofen, indometacin);
• medicines used to induce anesthesia;
• medicines that stimulate the heart belonging to the sympathomimetic group, such as adrenaline.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Since the possibility of harm to the fetus cannot be excluded, the use of this
medicine if you are pregnant or planning a pregnancy requires a careful assessment
of the risks, especially during the first six months of pregnancy.
Use this medicine with great caution during breastfeeding because atenolol is
excreted in breast milk.

Driving and operating machinery
This medicine does not impair the ability to drive vehicles and operate machinery. However, if
you experience dizziness or fatigue, do not drive vehicles and do not use machinery.

3. How to take TENSIBLOCK

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Treatment of high blood pressure (hypertension)
The recommended dose is half a tablet (50 mg) or 1 tablet (100 mg) daily. The maximum
blood pressure lowering effect is obtained after 1 or 2 weeks of therapy. To
further lower your blood pressure, depending on your health conditions, your
doctor may prescribe you to take atenolol in combination with another medicine for
high blood pressure (such as a diuretic).

Treatment of chest pain caused by heart problems (angina pectoris)
The recommended dose is 1 tablet (100 mg) daily. Do not take a higher dose because
this will not give you any benefit.

Treatment of certain types of heart rhythm disturbances (arrhythmias)
The recommended dose in maintenance therapy is half a tablet (50 mg) or 1 tablet
(100 mg) daily.

Early treatment of a heart attack (myocardial infarction)
If you experience typical heart attack pains, you should be injected with atenolol in liquid form
(injectable formulation) within 12 hours of the onset of pain. After 15 minutes from the injection in
large volume (bolus) into a vein, take half a tablet (50 mg) of TENSIBLOCK orally
followed by another half tablet (50 mg) after 12 hours from the injection. Subsequently, the recommended dose
for maintenance therapy is 1 tablet (100 mg) daily, which should be
started after another 12 hours.
If you experience symptoms such as slowing of the heartbeat (bradycardia) and/or severe
lowering of blood pressure (hypotension) or other serious side effects, treatment with
TENSIBLOCK must be stopped.

Use in the elderly
It may be necessary to reduce the dose, particularly if kidney function is impaired.

Use in children
There is no experience with the use of atenolol in children, therefore TENSIBLOCK is not
recommended in children.

Use in patients with impaired kidney function
If you suffer from severe impairment of kidney function, your doctor will reduce the dose according to your
health conditions.

Use in patients undergoing hemodialysis
The recommended dose is half a tablet (50 mg) after each blood filtration
(hemodialysis) session; administration must be carried out in hospital, as serious
reductions in blood pressure may occur.

If you take more TENSIBLOCK than you should
In case of ingestion/taking of an excessive amount of this medicine, contact
immediately your doctor or the Emergency Room of the nearest hospital.
In case of taking an excessive dose of this medicine, the symptoms you may experience
are: slowing of the heartbeat (bradycardia), decrease in blood pressure
(hypotension), impaired heart function (acute heart failure) and difficulty
breathing (bronchospasm).

If you forget to take TENSIBLOCK
Do not take a double dose to make up for the missed tablet.
Take the forgotten tablet as soon as possible, unless it is almost time to take
the next one.

If you stop taking TENSIBLOCK
Do not stop treatment with this medicine without consulting your doctor.
It is necessary that the interruption of treatment with this medicine occurs gradually,
especially if you suffer from disorders of the heart blood circulation (ischemic heart disease).
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.
The following side effects may occur:

Common(may affect up to 1 in 10 people)

• decrease in heart rate (bradycardia);
• feeling of coldness in the hands and feet;
• stomach/intestinal disorders;
• alteration of some liver parameters (increased transaminases);
• fatigue.

Uncommon(may affect up to 1 in 100 people)

• sleep disorders.

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

• worsening of a heart conduction defect known as cardiac block;
• feeling of dizziness when getting up due to a rapid drop in blood pressure (postural hypotension), which may be associated with fainting;
• difficulty in walking (intermittent claudication);
• numbness and pain in the fingers, followed by a sensation of warmth and pain (Raynaud's phenomenon);
• dizziness;
• headache;
• tingling in the hands and feet (paresthesia);
• mood changes;
• nightmares;
• mental disorders (psychosis and visual hallucinations);
• worsening of nervous syndromes with mental depression, movement and behavior disorders (catatonia), confusion, memory problems;
• dry mouth;
• liver damage (including intrahepatic cholestasis);
• skin disease manifested by the appearance of blisters that tend to bleed (purpura);
• reduction in the number of platelets (thrombocytopenia);
• dry eyes;
• vision problems;
• difficulty having or maintaining an erection (impotence);
• worsening of breathing difficulties (bronchospasm) in patients who suffer or have suffered from asthma;
• hair loss (alopecia);
• irritation and inflammation of the skin, including worsening of psoriasis, rash, decreased skin color (worsening of vitiligo).

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

• increase in antinuclear antibodies, a type of autoantibody that the body produces against itself. If any of these side effects occur and there is no explanation for these effects, consult your doctor and stop treatment.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store TENSIBLOCK

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 packaging after “Exp.”.
The expiry date refers to the last day of that month.
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 TENSIBLOCK contains

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

Description of the appearance of TENSIBLOCK and contents of the pack
Pack of 42 divisible tablets.

Marketing Authorisation Holder
JAKINMED S.r.l. - Via Roberto Lepetit 8/10, 20124, MILANO (MI)

Manufacturer
Laboratorio Farmaceutico CT, Via Dante Alighieri 71, 18038, Sanremo (IM)