TENORMIN 100 mg Coated Tablet

Зміст інструкції

1. TENORMIN 100 MG COMPRESSE
   1. What is Tenormin and what is it 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

TENORMIN 100 MG COMPRESSE

Atenolol

Read this leaflet carefully before you start 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 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 Tenormin is and what it is used for
• 2. What you need to know before you take 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 is Tenormin and what is it used for

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

• treating high blood pressure (arterial hypertension)
• treating angina pectoris attacks (heart disease that manifests with chest pain) If your condition does not improve or worsens, please consult your doctor.

2. What you need to know before taking Tenormin

Do not take Tenormin

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

If you are in any of the above situations, tell 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 disease characterized by excess sugar in the blood) and hypoglycemia (a disease characterized by a low level of sugar in the blood) because it may mask changes in heart rate (tachycardia)
• if you have heart problems or blood circulation problems even if controlled by adequate therapy
• if you have respiratory problems or asthma
• if you suffer from a type of chest pain called “Prinzmetal's angina”
• if you are pregnant or planning to become pregnant or if you are breastfeeding (See section “Pregnancy and Breastfeeding”)
• if you have ever had allergic reactions in the past (for example, from insect bites)
• if you are taking verapamil or diltiazem.
• do not suddenly stop taking Tenormin, especially if you suffer from insufficient oxygenation of the heart (ischemic heart disease). If you need to stop or discontinue therapy with Tenormin after prolonged use, the reduction must always be done gradually with a step-down decrease, as sudden discontinuation can lead to reduced blood supply to a more or less extensive area of the heart (myocardial ischemia) with exacerbation of angina pectoris (heart disease that manifests with chest pain), or myocardial infarction, or may cause an exacerbation of hypertension.
• if you suffer from severe impaired renal 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, the therapy with Tenormin should be stopped at least 24 hours before the surgery, as there is an increased risk of decreased 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 decrease in heart rate (see section “Possible side effects”). This effect is normal, but if it becomes a cause for concern, consult your doctor.

Diabetes or hypoglycemia (low blood sugar levels)
If you have diabetes and are being treated with antidiabetic drugs (medicines to treat diabetes), this medicine
may increase blood sugar levels. This generally causes an increase in heart rate.

Anesthesia
If you are to be hospitalized, you must inform the medical staff of the ongoing treatment with
Tenormin and, in particular, the anesthesiologist (the doctor responsible for anesthesia) in case of surgery.

For those who play sports
The use of the drug without a therapeutic need constitutes doping and may still
result in positive doping tests.

Children and adolescents
Tenormin should notbe given to children and adolescents under the age of 18 years.

Sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose of Tenormin, meaning
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, tell your doctor if you are taking any of the following medicines:

• medicines for the treatment of high blood pressure or chest pain (especially verapamil, diltiazem, clonidine, or nifedipine), as concomitant use with these medicines can lead to a worsening of the conditions described above, especially in patients with impaired cardiac function. This can cause a severe drop in blood pressure (severe hypotension), a heart rate below 60 beats per minute (bradycardia), and heart failure. At least 48 hours must have elapsed since the discontinuation of any previous intravenous therapy with verapamil or diltiazem before starting treatment with Tenormin, or vice versa.
• medicines for the treatment of irregular heartbeats (disopyramide or amiodarone)
• medicine for the treatment of heart failure (digoxin, a medicine used for heart disorders)
• nasal decongestants or other drugs (containing, for example, pseudoephedrine) for the treatment of colds
• pain relievers such as indometacin or ibuprofen
• clonidine (medicine for the treatment of 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. Consult your doctor also if you need to replace clonidine with Tenormin.
• Insulin or drugs that lower blood glucose levels (hypoglycemic drugs).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding with breast
milk, 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 (decreased 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 vehicles and operate
machinery.
However, dizziness and fatigue may sometimes occur; if you experience these symptoms, it is
advisable not to engage in these activities.

3. How to take Tenormin

Take this medicine following exactly the instructions of 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 initial dose, especially in the elderly, is the lowest possible dose in
order to promptly recognize the onset of symptoms of heart failure (the heart's inability to provide blood in an adequate quantity compared to the body's actual needs), bradycardia
(a reduction in heart rate below 60 beats per minute) and bronchial symptoms.
The tablets must be swallowed whole with some water, preferably always at the same time.
The tablets must not be chewed and must be taken with a sufficient amount of liquid
to aid swallowing.

Adults

High blood pressure (arterial hypertension)
The recommended initial dose is ½ tablet per day.
Usually, the desired blood pressure lowering effect is achieved after one or two weeks of
therapy. If you do not obtain a satisfactory effect, take one tablet per day during the second
week.
If necessary, a further reduction in blood pressure can be obtained by taking Tenormin
with other drugs used to control high blood pressure (antihypertensive drugs).

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

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

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

Use in children and adolescents
Tenormin must notbe administered to children and adolescents under the age of 18 years.

If you use more Tenormin than you should
In case of accidental ingestion/intake of an excessive dose of Tenormin, immediately inform your
doctor or go to the nearest hospital.

If you forget to use Tenormin
Do not take a double dose to make up for the forgotten 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
Improvement in your health condition should not lead to discontinuation of treatment unless
requested by your doctor.
Discontinuation of treatment should occur gradually.
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.
During treatment with Tenormin, as with any medicine, the following side effects may occur with the following frequency:

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

• slowed heartbeat
• cold hands and feet
• gastrointestinal disorders (e.g. nausea, vomiting, diarrhea, abdominal pain)
• alterations of blood tests related to liver function (transaminases)
• fatigue

Uncommon (may affect up to 1 in 100 people):

• sleep disturbances

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

• worsening of heart function up to heart block (a condition that can cause an abnormal heartbeat, dizziness, fatigue or fainting), difficulty breathing and/or swelling of the ankles if you have heart failure
• sudden drop in blood pressure when standing up with the possibility of loss of consciousness, worsening of intermittent claudication (difficulty walking 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
• changes in mood, nightmares, confusion, psychosis (mental disorders), hallucinations (seeing inexplicable things), worsening of nervous system diseases with mental depression, catatonia (apathy and reduction of motor activity) and memory disorders
• dry mouth
• liver toxicity including intrahepatic cholestasis (reduction of bile flow to the duodenum due to an internal obstruction in the liver) which can lead to a yellowish discoloration of the skin and eyes
• purpura (purple spots on the skin), thrombocytopenia (reduction in the number of platelets in the blood)
• hair loss, skin rashes including worsening of psoriasis (chronic skin inflammation), skin redness and worsening of skin pigment loss in subjects affected by vitiligo (skin disease with the appearance of white patches)
• dry eyes, visual disturbances
• impotence (inability to obtain an erection)
• bronchospasm (worsening of breathing difficulties) if you have asthma or have suffered from asthma problems

Frequency not known (the frequency cannot be estimated from 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 considered normal)
• dyspnea (difficulty breathing)
• depression

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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 Tenormin

• Do not store at a temperature above 25°C. Store in the original packaging to protect the medicine from light and moisture.
• 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 pack after EXP. 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 Tenormin contains

• the active ingredient is: atenolol 100 mg
• the other ingredients are :heavy magnesium carbonate, corn starch, sodium lauryl sulfate, gelatin, magnesium stearate.

Description of the appearance of Tenormin and contents of the pack
Tablets packaged in blisters of 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.tv, DK-2300, København S, Denmark

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