Atenolol Almus

Package leaflet: Information for the patient

Atenolol Almus 100 mg tablets

Equivalent medicine
Please 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Atenololo Almus 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 heartbeat.
Atenololo Almus is indicated for:

• the treatment of high blood pressure (hypertension), including renal origin hypertension;
• the treatment of chest pain caused by heart problems (angina pectoris);
• the treatment of certain types of irregular heartbeat (arrhythmia);
• the treatment at the onset of a heart attack (myocardial infarction).

2. What you need to know before taking Atenololo Almus

Do not take Atenololo Almus

• 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 have low blood pressure (hypotension);
• if your doctor has told you that the acidity level in your blood is higher than normal (metabolic acidosis);
• if you have severe circulation problems in the limbs (peripheral arterial disease);
• if you have a heart conduction disorder (second- or third-degree atrioventricular block);
• 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, pharmacist, or nurse before taking Atenololo Almus.
Pay special attention and consult your doctor before taking this medicine:

• If you have inadequate heart function (heart failure) that is controlled by appropriate therapy.
• If your heart's ability to increase the amount of blood pumped to the body is poor (low cardiac reserve).
• 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 you have diabetes. Atenolol may alter your response to low blood sugar levels. You may not feel the usual rapid heartbeat. Atenolol may also increase the risk of severe hypoglycaemia when used together with certain types of antidiabetic medicines called sulphonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide).
• If you have thyroid problems (thyrotoxicosis), as atenolol may mask its symptoms.
• If you have previously experienced severe allergic reactions (anaphylactic reactions). If you experience an allergic reaction, standard doses of adrenaline may not be sufficient.
• If you have respiratory disorders or suffer from asthma, as Atenololo Almus may worsen your breathing difficulties.
• If you are undergoing surgery requiring anaesthetics. Inform your anaesthetist that you are taking Atenololo Almus.

During treatment with this medicine, your heart rate will decrease. However, if this effect is excessive, consult your doctor, who may reduce the dose.
For athletes: Using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Children
The use of Atenololo Almus is contraindicated in children.
Sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially 'sodium-free'.
Other medicines and Atenololo Almus
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, used to treat high blood pressure. At least 48 hours must pass after stopping verapamil before starting treatment with Atenololo Almus.
Take particular care and consult your doctor if you are taking:

• medicines used to treat irregular heartbeats (class I antiarrhythmics such as disopyramide, amiodarone, digitalis glycosides);
• clonidine, a medicine used to treat high blood pressure. If treatment with Atenololo Almus is to replace clonidine, stop clonidine several days before starting this medicine. If both medicines are used 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 that stimulate the heart belonging to the sympathomimetic group, such as adrenaline;
• medicines used for inflammation and pain relief (e.g. ibuprofen, indomethacin);
• medicines used to induce anaesthesia (see section Warnings and precautions);
• insulin or oral medicines for diabetes, such as sulphonylureas (e.g. gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide).

Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breast-feeding, consult your doctor or pharmacist before taking this medicine.
Since a risk to the unborn child cannot be excluded, the use of this medicine during pregnancy or when planning pregnancy requires careful evaluation by your doctor of the risks, especially during the first six months of pregnancy.
Inform your doctor if you are breast-feeding or planning to breast-feed, as using this medicine during breastfeeding requires caution because atenolol is excreted in breast milk.
Driving and using machines
This medicine is unlikely to affect your ability to drive or use machines.
However, if you experience dizziness or fatigue, do not drive or operate machinery.

3. How to take Atenololo Almus

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Take the tablets with water, preferably always at the same time and as a single daily dose.

Treatment of high blood pressure (hypertension)
The recommended dose is half a tablet or 1 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 1 tablet (100 mg) daily. Do not take a higher dose, as this will not provide additional benefit.

Treatment of certain types of heart rhythm disorders (arrhythmias)
The recommended dose is half a tablet or 1 tablet (100 mg) daily.

Treatment at the first signs of heart attack
If you experience typical symptoms of a heart attack, you should be given atenolol in liquid form (injectable formulation) within 12 hours of the onset of pain. After 15 minutes from the intravenous bolus injection, take half a tablet of Atenololo Almus orally, followed by another half tablet 12 hours after the injection. Subsequently, the recommended maintenance dose is 1 tablet daily, which should be started 12 hours after the previous dose.

If you experience symptoms such as slowing of the heartbeat (bradycardia) and/or severe drop in blood pressure (hypotension) or other serious side effects, treatment with Atenololo Almus must be discontinued.

Use in the elderly
Dose reduction may be necessary, particularly if kidney function is impaired.

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

Use in patients undergoing haemodialysis
The recommended dose is 50 mg after each blood filtration session (haemodialysis); administration must take place in hospital, as severe reductions in blood pressure may occur.

If you take more Atenololo Almus than you should
If you ingest or take an excessive amount of this medicine, contact your doctor or the nearest hospital emergency department immediately. Symptoms of overdose may include slowing of the heartbeat (bradycardia), low blood pressure (hypotension), inadequate heart function (acute heart failure), and breathing difficulties (bronchospasm).

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

If you stop taking Atenololo Almus
Do not stop treatment with this medicine without consulting your doctor.
Discontinuation of treatment with this medicine should be gradual, 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 everyone experiences them.
The following side effects may occur:
Common (may affect up to 1 in 10 people)

• slowing of the heartbeat (bradycardia);
• feeling of coldness in the hands and feet;
• nausea and diarrhoea;
• changes in liver function tests (increased transaminases);
• fatigue.

Uncommon (may affect up to 1 in 100 people)

• sleep disorders.

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

• breathing difficulties and/or swelling of the ankles if you have impaired heart function (heart failure);
• blockage of heart function (cardiac conduction block);
• sudden drop in blood pressure when standing upright (postural hypotension), possibly leading to loss of consciousness (syncope);
• worsening of movement difficulties (intermittent claudication);
• numbness and pain in the fingers followed by a sensation of heat and pain (Raynaud's phenomenon);
• dizziness and headache;
• tingling in the hands or feet (paraesthesiae);
• mood changes;
• nightmares, mental disturbances (psychosis or hallucinations);
• worsening of nervous syndromes with mental depression, movement and behavioural disorders (catatonia), confusion and memory disturbances;
• dry mouth;
• liver toxicity, including disturbances in bile flow (intrahepatic cholestasis);
• skin disease characterized by the appearance of blood-tinged blisters (purpura);
• reduced platelet count (thrombocytopenia);
• hair loss (alopecia);
• irritation and inflammation of the skin, including worsening of psoriasis, skin rash and redness of the skin;
• worsening of skin depigmentation in people suffering from a condition called vitiligo;
• visual disturbances, dry eyes;
• sexual impotence;
• worsening of breathing difficulties if you suffer from asthma or have had asthma in the past.

Not known (frequency cannot be estimated from available data)

• decrease or increase in blood sugar levels (hypoglycaemia, hyperglycaemia);
• changes in blood lipid levels (triglycerides and cholesterol);
• lupus-like syndrome (a disease in which the immune system produces antibodies that primarily attack the skin and joints).

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 via 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 Atenolol Almus

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 Atenololo Almus 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 Atenololo Almus and contents of the pack
Pack containing 42 divisible tablets.
Marketing Authorization Holder
Almus S.r.l.
Via Cesarea, 11/10
16121 Genoa
Manufacturer
Laboratorio Farmaceutico CT
Via Dante Alighieri 71
18038 Sanremo (IM)