Tensiblock

Package leaflet: Information for the patient

TENSIBLOCK 100 mg tablets

Atenolol
Generic medicine
Please read all of this leaflet carefully before you take 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, talk to 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 taking 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 TENSIBLOCK is and what it is used for

This medicinal product contains the active substance atenolol, which belongs to a group of medicines called beta-blockers, that work by slowing the heart rate and reducing the force of the heart's contractions.
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 certain types of irregular heartbeat (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 to any of the other ingredients of this medicine (listed in section 6);
• if you have a very slow heart rate (bradycardia);
• if you have a severe heart condition known as cardiogenic shock, which occurs when your heart does not pump enough blood throughout the 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 circulation problems in the limbs (peripheral arterial circulation disorders);
• if you have a heart conduction disorder (higher than first-degree atrioventricular block, sinoatrial node diseases);
• if you have an untreated tumour of the adrenal gland called phaeochromocytoma;
• if your heart function is inadequate and not controlled by appropriate 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 conditions).

Warnings and precautions
Talk to your doctor or pharmacist before taking TENSIBLOCK.
Be especially careful and consult your doctor before taking this medicine:

• if your heart function is inadequate (heart failure) but is being controlled by appropriate therapy;
• if you suffer from chest pain called Prinzmetal's angina, as this medicine may increase the frequency 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 pumped to the body is poor (poor cardiac reserve);
• if you have diabetes or low blood sugar levels (hypoglycaemia). Atenolol may mask the signs and symptoms of acute hypoglycaemia such as increased heart rate (tachycardia) and blood pressure; atenolol may also increase the risk of severe hypoglycaemia when used with certain types of antidiabetic medicines called sulphonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide);
• if you have thyroid problems (thyrotoxicosis), because atenolol may mask their symptoms;
• if you have previously experienced severe allergic reactions (anaphylactic reactions). If you have an allergic reaction, standard doses of adrenaline may not be sufficient;
• if you have respiratory disorders or suffer from 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 may reduce the dosage.
If you engage in sports: using this medicine without therapeutic need constitutes doping
and may result in a positive anti-doping test.

Children
The use of TENSIBLOCK is contraindicated in children.

Other medicines and TENSIBLOCK
Inform 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 administered medicines containing verapamil or
diltiazem, used to treat high blood pressure. At least 48 hours must have passed after stopping
treatment with verapamil or diltiazem before starting therapy with TENSIBLOCK.
Be especially careful and consult your doctor if you are taking:

• medicines used to treat irregular heartbeats (class I antiarrhythmics such as disopyramide, digitalis glycosides);
• clonidine, a medicine used to treat high blood pressure. If treatment with TENSIBLOCK is to replace clonidine therapy, stop clonidine several days before starting this medicine. If both medicines are to be administered together, clonidine should 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 for inflammation and pain relief (e.g. ibuprofen, indometacin);
• medicines used to induce anaesthesia;
• medicines that stimulate the heart belonging to the sympathomimetic group, such as adrenaline;
• medicines called sulphonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride or tolbutamide).

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Since a risk to the unborn baby cannot be excluded, the use of this medicine during pregnancy or when planning a pregnancy requires careful assessment of risks, especially during the first six months of pregnancy.
Use this medicine with caution during breastfeeding, as atenolol is excreted in breast milk.

Driving and using machines
This medicine does not affect the ability to drive or operate machinery. However, if you experience dizziness or fatigue, do not drive or operate machinery.

3. How to take TENSIBLOCK

Take this medicine exactly as directed by your doctor or pharmacist.
If you are unsure, consult your doctor or pharmacist.

Treatment of high blood pressure (hypertension)
The recommended dose is half a tablet (50 mg) or one tablet (100 mg) daily. The maximum blood pressure-lowering effect is achieved after 1 or 2 weeks of treatment. To further lower your blood pressure, depending on your health condition, your doctor may prescribe 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 one tablet (100 mg) daily. Do not take a higher dose, as this will not provide additional benefit.

Treatment of certain types of irregular heartbeat (arrhythmias)
The recommended maintenance dose is half a tablet (50 mg) or one tablet (100 mg) daily.

Early treatment of a heart attack (myocardial infarction)
If you experience typical symptoms of a heart attack, atenolol in liquid form (injectable formulation) must be administered to you within 12 hours of the onset of pain. Fifteen minutes after the intravenous bolus injection, take half a tablet (50 mg) of TENSIBLOCK orally, followed by another half tablet (50 mg) 12 hours after the injection. Subsequently, the recommended maintenance dose is one tablet (100 mg) daily, which should be started 12 hours later.

If you experience symptoms such as slow heartbeat (bradycardia) and/or severe drop in blood pressure (hypotension) or other serious adverse effects, treatment with TENSIBLOCK must be discontinued.

Use in the elderly
A dose reduction may be necessary, 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 for use in children.

Use in patients with impaired renal function
If you have severe impairment of kidney function, your doctor will adjust the dose according to your condition.

Use in patients undergoing haemodialysis
The recommended dose is half a tablet (50 mg) after each blood filtration session (haemodialysis). Administration should be performed in hospital, as severe drops in blood pressure may occur.

If you take more TENSIBLOCK than you should
In case of accidental ingestion or overdose of this medicine, contact your doctor or go immediately to the nearest hospital emergency department.
Symptoms of overdose may include: slow heartbeat (bradycardia), low blood pressure (hypotension), acute heart failure, and breathing difficulties (bronchospasm).

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

If you stop taking TENSIBLOCK
Do not stop treatment with this medicine without consulting your doctor.
Treatment with this medicine should be discontinued gradually, especially if you suffer from heart circulation disorders (ischaemic heart disease).

If you have any doubts about how to use this medicine, consult 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);
• sensation of coldness in hands and feet;
• stomach/intestinal disturbances;
• changes in some liver parameters (elevation of 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 disorder known as heart block;
• dizziness upon standing due to a rapid drop in blood pressure (postural hypotension), which may be associated with fainting;
• difficulty in movement (intermittent claudication);
• numbness and pain in the fingers, followed by a sensation of heat and pain (Raynaud's phenomenon);
• dizziness;
• headache;
• tingling in hands and feet (paraesthesia);
• mood changes;
• nightmares;
• mental disturbances (psychosis and visual hallucinations);
• worsening of neurological syndromes with mental depression, movement and behavioural disorders (catatonia), confusion, memory problems;
• dry mouth;
• liver damage (including intrahepatic cholestasis);
• skin disease characterized by the appearance of bleeding blisters (purpura);
• reduction in platelet count (thrombocytopenia);
• dry eyes;
• vision problems;
• difficulty in achieving or maintaining erection (impotence);
• worsening of breathing difficulty (bronchospasm) in patients who have or have had asthma;
• hair loss (alopecia);
• skin irritation and inflammation, including worsening of psoriasis, skin rash, loss of skin pigmentation (worsening of vitiligo).

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

• increase in antinuclear antibodies, a type of autoantibody produced by the body against itself. If any of these side effects occurs and there is no explanation for them, consult your doctor and discontinue treatment.

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 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 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 TENSIBLOCK contains

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

Description of the appearance of TENSIBLOCK and package contents
Pack containing 42 divisible tablets.
Marketing Authorization Holder
JAKINMED S.r.l. - Via Roberto Lepetit 8/10, 20124, MILAN (MI)
Manufacturer
Laboratorio Farmaceutico CT, Via Dante Alighieri 71, 18038, Sanremo (IM)