Tenormin

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

TENORMIN 100 MG TABLETS

Atenolol
Please read this leaflet carefully before taking 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Tenormin is and what it is used for

Tenormin contains atenolol. Atenolol belongs to a group of medicines called beta-blockers, which work by slowing down the heart rate.
Tenormin is indicated in adults for:

• treating high blood pressure (arterial hypertension)
• treating angina pectoris attacks (a heart condition characterized by chest pain)

Consult your doctor if you do not feel better or if you feel worse.

2. What you should know before taking Tenormin

Do not take Tenormin

• if you are allergic to atenolol or to any of the other ingredients of this medicine (listed in section 6)
• if you have heart diseases, including uncontrolled heart failure or heart block
• if you have slow or irregular heartbeats, very low blood pressure, or severe circulatory disorders
• in case of shock (a heart disorder occurring when blood is inadequately oxygenated)
• if your doctor has diagnosed you with abnormally high levels of acid in the blood (metabolic acidosis)
• if you have a tumor called "pheochromocytoma" that is not being treated (this tumor usually develops near a kidney and may cause high blood pressure)
• if you have a rare condition characterized by brief episodes of narrowing of the arteries, the blood vessels carrying blood from the heart to the rest of the body (Raynaud's syndrome)
• if you suffer from severe asthma or severe chronic obstructive pulmonary disease
• if you are being treated with intravenous verapamil or diltiazem
• if you are breastfeeding.

If you are in any of the above situations, inform your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tenormin:

• if you have kidney problems
• if you have thyroid problems (a gland located in the neck)
• if you have diabetes (a condition characterized by high blood sugar levels) or hypoglycemia (a condition characterized by low blood sugar levels), because it may mask changes in heart rate (tachycardia)
• if you have heart or circulatory problems, even if controlled by adequate therapy
• if you have respiratory problems or asthma
• if you have a type of chest pain called "Prinzmetal's angina"
• if you are pregnant, planning to become pregnant, or breastfeeding (See section "Pregnancy and Breastfeeding")
• if you have previously experienced allergic reactions (e.g., from insect stings)
• if you are being treated with verapamil or diltiazem.
• do not stop taking Tenormin abruptly, especially if you have inadequate oxygen supply to the heart (ischemic heart disease). If you need to stop or discontinue treatment with Tenormin after prolonged use, the dose should always be reduced gradually by stepwise tapering, as sudden discontinuation may lead to reduced oxygenated blood flow to a more or less extensive area of the heart (myocardial ischemia), worsening of angina pectoris (a heart disease characterized by chest pain), or even myocardial infarction, or may trigger worsening of hypertension.
• if you have severe impairment of kidney function, a dose adjustment is necessary because Tenormin is eliminated via the kidneys. Particular caution should be exercised when using anesthetic agents during treatment with Tenormin. If you are scheduled for surgery, Tenormin treatment should be discontinued at least 24 hours before the procedure, as there is an increased risk of low blood pressure (hypotension). Consult your doctor regarding the risk-benefit assessment of stopping Tenormin. Reduced heart rate (number of heartbeats per minute) During treatment with Tenormin, you may experience a reduced heart rate (see section "Possible side effects"). This effect is normal, but if it becomes a concern for you, consult your doctor.

Diabetes or hypoglycemia (low blood sugar levels)
If you have diabetes and are being treated with antidiabetic medicines (medicines for treating diabetes), this
medicine may increase blood sugar levels. This generally causes an increase in heart rate.
Anesthesia
If you are to be admitted to hospital, you must inform the medical staff about your ongoing treatment with
Tenormin, and particularly the anesthetist (the doctor responsible for anesthesia) in case of surgery.
For those engaged in sports activities
Using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.
Children and adolescents
Tenormin must not be given to children and adolescents under 18 years of age.
Sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose of Tenormin, i.e., essentially "sodium-free".
Other medicines and Tenormin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking any of the following medicines:

• medicines for treating high blood pressure or chest pain (especially verapamil, diltiazem, clonidine, or nifedipine), as concomitant use with these medicines may worsen the above-mentioned conditions, particularly in patients with impaired heart function. This may cause severe reduction in blood pressure (severe hypotension), heart rate below 60 beats per minute (bradycardia), and heart failure. At least 48 hours must elapse between stopping intravenous verapamil or diltiazem treatment and starting Tenormin, or vice versa.
• medicines for treating irregular heartbeats (disopyramide or amiodarone)
• a medicine used to treat heart failure (digoxin, a medicine used for heart disorders)
• nasal decongestants or other medicines (containing, for example, pseudoephedrine) used to treat colds
• painkillers such as indometacin or ibuprofen
• clonidine (a medicine used to treat high blood pressure or to prevent migraine). If you are taking clonidine and Tenormin together, do not stop treatment with clonidine or Tenormin without first consulting your doctor. Also consult your doctor if you need to switch from clonidine to Tenormin.
• insulin or medicines that lower blood glucose concentration (hypoglycemic agents).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, ask your
doctor or pharmacist for advice before taking this medicine.
Babies born to mothers who have taken Tenormin before delivery or during breastfeeding may be at risk of
hypoglycemia (low blood sugar) or bradycardia (reduced heart rate).
Atenolol accumulates in breast milk; therefore, its use is contraindicated during breastfeeding.
Driving and using machines
It is unlikely that taking Tenormin will affect your ability to drive or operate machinery.
However, dizziness and fatigue may occasionally occur; if you experience these symptoms, it is advisable not to perform such activities.

3. How to take Tenormin

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Your doctor will tell you how many tablets to take each day and when, depending on your condition.
The recommended starting dose, especially in elderly patients, is the lowest possible dose in order
to promptly detect the onset of symptoms of heart failure (the heart's inability to supply adequate blood to meet the body's needs), bradycardia
(reduction in heart rate below 60 beats per minute), and bronchial symptoms.
The tablets should be swallowed whole with a little water, preferably always at the same time each day.
The tablets must not be chewed and should be taken with sufficient liquid to aid swallowing.

Adults
High blood pressure (arterial hypertension)
The recommended starting dose is ½ tablet per day.
The desired blood pressure-lowering effect is usually achieved after one or two weeks of treatment. If this does not produce a satisfactory effect, take one tablet per day during the second week.
If necessary, further reduction in blood pressure may be achieved by taking Tenormin together with other medicines used to control high blood pressure (antihypertensive agents).

Angina pectoris
Most patients respond to the administration of one tablet per day.

Elderly
If you are elderly, your doctor may decide to prescribe a lower dose of Tenormin.

If you have severe kidney problems
If you suffer from severe kidney problems, your doctor may decide to prescribe a lower dose of Tenormin.

Use in children and adolescents
Tenormin must not be given to children and adolescents under 18 years of age.

If you take more Tenormin than you should
In case of accidental ingestion or overdose of Tenormin, inform your doctor immediately or go to the nearest hospital.

If you forget to take Tenormin
Do not take a double dose to make up for the missed tablet.
If you forget to take a dose, it is advisable to take it as soon as possible. Two doses must not be taken at the same time.

If you stop taking Tenormin
Do not stop treatment just because you feel better, unless instructed by your doctor.
Discontinuation of treatment must be done gradually.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

During treatment with Tenormin, as with any medicine, the following side effects may occur, according to the frequency categories listed below:

Common (may affect up to 1 in 10 people):

• Slowed heart rate
• Cold fingers and toes
• Gastrointestinal disturbances (e.g. nausea, vomiting, diarrhoea, abdominal pain)
• Changes in liver function blood tests (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 heart function up to heart block (a condition that may cause abnormal heartbeat, dizziness, fatigue or fainting), breathing difficulties and/or swelling of the ankles in patients with heart failure
• Sudden drop in blood pressure when standing, possibly leading to loss of consciousness; worsening of intermittent claudication (walking difficulty that improves with rest); numbness and cramps in the fingers followed by a sensation of heat and pain (Raynaud's phenomenon)
• Dizziness, headache, tingling in the hands or feet
• Mood changes, nightmares, confusion, psychosis (mental disorders), hallucinations (seeing things that cannot be explained), worsening of neurological diseases with mental depression, catatonia (apathy and reduced motor activity), and memory disturbances
• Dry mouth
• Liver toxicity, including intrahepatic cholestasis (reduced bile flow to the duodenum due to obstruction within the liver), which may lead to yellowing of the skin and eyes
• Purpura (purple skin spots), thrombocytopenia (reduced number of platelets in the blood)
• Hair loss, skin rashes including worsening of psoriasis (chronic skin inflammation), skin redness, and worsening loss of skin pigment in patients with vitiligo (a skin condition characterized by white patches)
• Dry eyes, visual disturbances
• Impotence (inability to achieve an erection)
• Bronchospasm (worsening of breathing difficulties) in patients with asthma or a history of asthma-related problems

Frequency not known (cannot be estimated from the available data):

• Lupus-like syndrome (a disease in which the immune system produces antibodies that primarily attack the skin and joints)
• Hypotension (a condition in which blood pressure is much lower than normal values)
• Dyspnoea (difficulty breathing)
• Depression

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website: 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 Tenormin

• Do not store above 25°C. Keep the medicine in the original packaging to protect it from light and moisture.
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month. Do not dispose of medicines 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 Tenormin contains

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

Description of the appearance of Tenormin and the contents of the pack
Tablets packed in blisters containing 14 tablets and 42 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers

Atnahs Pharma Netherlands B.V.
Copenhagen Towers,
Ørestands Boulevard 108,
5.th, DK-2300,
København S,
Denmark

Manufacturers
Corden Pharma GmbH
Otto-Hahn-Strasse
68723 Plankstadt
Germany
AstraZeneca AB
Gärtunavägen
SE-151 85 Södertälje
Sweden