Active ingredients: Atenolol
TENORMIN 100 mg tablets
Indications Why is Tenormin used? What is it for?
Tenormin contains atenolol. Atenolol belongs to a group of medicines called beta-blockers, which work by slowing the heartbeat.
Tenormin is indicated in adults for:
- treat high blood pressure (high blood pressure)
- treating attacks of angina pectoris (heart disease manifesting as chest pain)
- treat irregular heartbeat (arrhythmias)
- help prevent the onset of another heart attack (acute myocardial infarction).
Talk to your doctor if you don't feel better or if you feel worse.
Contraindications When Tenormin should not be used
Do not take Tenormin
- if you are allergic to atenolol or any of the other ingredients of this medicine
- if you have heart disease, including heart failure not controlled by adequate therapy or heart block
- if you suffer from reduced or irregular heartbeats, very low blood pressure, severe circulatory problems
- in case of shock (heart disorder that occurs when the blood is not adequately oxygenated)
- if your doctor has diagnosed you with blood acid levels that are above normal (metabolic acidosis)
- if you have a cancer called 'pheochromocytoma' that is not being treated (usually this cancer develops near a kidney and can cause high blood pressure)
If you find yourself in any of the above situations, please tell your doctor
Precautions for use What you need to know before taking Tenormin
Talk to your doctor or pharmacist before taking Tenormin:
- if you have kidney problems
- if you suffer from thyroid problems (a gland found in the neck)
- if you have diabetes (a disease characterized by an excess of sugar in the blood)
- if you suffer from heart problems or blood circulation problems even if controlled by adequate therapy
- if you have breathing problems or asthma
- if you suffer from a type of chest pain called "Prinzmetal's angina"
- if you are pregnant or want 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 on verapamil or diltiazem therapy
Reduced heart rate (number of heart beats per minute)
During treatment with Tenormin you may experience a reduction in your heart rate (see section "Possible side effects"). This effect is normal, but if you are concerned about it, consult your doctor.
Diabetes or hypoglycemia (low blood sugar levels)
If you have diabetes and are being treated with antidiabetics (medicines to treat diabetes), this medicine can raise your blood sugar levels. This generally causes an increase in heart rate.
Anesthesia
If you need to be hospitalized, you must inform the medical staff about your treatment with Tenormin and, in particular, the anesthetist (the doctor who deals with anesthesia) in case of surgery.
For those who carry out sporting activities
The use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.
Children and adolescents
Tenormin should not be given to children and adolescents under the age of 18
Interactions Which drugs or foods can modify the effect of 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:
- For the treatment of high blood pressure or chest pain (particularly verapamil, diltiazem, clonidine, or nifedipine). Before starting treatment with Tenormin it is necessary that at least 48 hours have passed since the suspension of any previous therapy with verapamil or diltiazem, or vice versa.
- Medicines to treat irregular heartbeats (disopyramide or amiodarone)
- medicine to treat heart failure (digoxin, a medicine used for heart disorders)
- nasal decongestants or other medicines (which contain for example pseudoephedrine) to treat colds.
- Pain relievers such as indomethacin or ibuprofen
- clonidine (medicine to treat high blood pressure or to prevent migraines). If you are taking clonidine and Tenormin together do not stop taking clonidine or Tenormin without first consulting your doctor.
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Babies born to mothers who have taken Tenormin before giving birth or while breastfeeding may be at risk for hypoglycaemia (low blood sugar) or bradycardia (reduced heart beats per minute).
Driving and using machines
Taking Tenormin is unlikely to affect your ability to drive and use machines.
However, dizziness and fatigue can sometimes occur; in case of these symptoms it is advisable not to carry out these activities.
Dose, Method and Time of Administration How to use Tenormin: Posology
Always take this medicine exactly as your doctor or pharmacist has told you.
If in doubt, consult your doctor or pharmacist. Your doctor will tell you how many tablets to take each day and when according to your disease.
The tablets should be taken whole with a little water, preferably always at the same time.
Adults
High blood pressure (high blood pressure)
The recommended dose is one tablet a day. Usually the desired blood pressure lowering effect is achieved after one or two weeks of therapy.
Angina pectoris
Most patients respond to administration of one tablet per day.
Irregular heartbeat (arrhythmias)
The recommended dose as maintenance therapy is half or one tablet per day.
Prevention of another heart attack
The recommended dose as maintenance therapy is one tablet per day.
Senior citizens
If you are elderly your doctor may decide to prescribe a lower dose of Tenormin.
If you have severe kidney problems
If you have severe kidney problems your doctor may decide to prescribe a lower dose of Tenormin.
Use in children and adolescents
Tenormin should not be given to children and adolescents under the age of 18.
Overdose What to do if you have taken too much Tenormin
If you use more TENORMIN than you should
In case of accidental ingestion / intake of an overdose of Tenormin, notify your doctor immediately or go to the nearest hospital.
If you forget to use TENORMIN
Do not take a double dose to make up for a forgotten tablet.
In case you forget to take a dose, it should be taken as soon as possible. Two doses should not be taken at the same time.
If you stop taking TENORMIN
Improving your health should not lead to stopping treatment, unless requested by your doctor.
Discontinuation of treatment should take place gradually.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist
Side Effects What are the side effects of Tenormin
Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment with TENORMIN, as with any drug, the following side effects may occur at the following frequency:
Common (may affect up to 1 in 10 patients):
- slow heartbeats
- cold fingers and toes
- gastrointestinal disturbances (e.g. nausea, diarrhea)
- changes in blood tests related to liver function (transaminases)
- tiredness
Uncommon (may affect up to 1 in 100 patients):
- sleep disorders
Rare (may affect up to 1 in 1000 patients):
- worsening of heart function up to heart block (a condition which can cause abnormal heart beat, dizziness, tiredness or fainting), difficulty in breathing and / or swollen ankles if you have heart failure
- sudden drop in blood pressure when standing with the possibility of unconsciousness, worsening of intermittent claudication (difficulty walking which subsides with rest), numbness and cramping of 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 unexplained things), aggravation of nervous diseases with mental depression, catatonia (apathy and reduced motor activity) and memory disturbances
- dry mouth
- liver toxicity including intrahepatic cholestasis (reduced flow of bile to the duodenum due to an "internal obstruction in the liver) which can lead to yellowing 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), redness of the skin and worsening of skin pigment loss in people with vitiligo (skin disease with white patches)
- dry eyes, visual disturbances
- impotence (inability to get an "erection)
- worsening of breathing difficulties if you have asthma or have suffered from asthma problems
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 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 safety. of this medicine.
Expiry and Retention
- Do not store above 25 ° C. Store in the original package to protect 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 carton after EXP. The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
What Tenormin contains
- the active ingredient is: atenolol 100 mg
- the other components are: heavy magnesium carbonate, corn starch, sodium lauryl sulfate, gelatin, magnesium stearate.
What Tenormin looks like and contents of the pack
Tablets packed in blister packs of 14 tablets and 42 tablets.
Not all pack sizes may be marketed
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
TENORMIN 100 MG TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains: atenolol 100 mg.
For excipients see section 6.1.
03.0 PHARMACEUTICAL FORM
Tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Arterial hypertension, including that of renal origin.
Angina pectoris.
Arrhythmias.
Early intervention in acute myocardial infarction.
04.2 Posology and method of administration
Adults
Arterial hypertension, including that of renal origin
One tablet (100 mg) per day. The full antihypertensive effect is usually achieved after one or two weeks of therapy. If necessary, a further reduction in blood pressure can be achieved by combining Tenormin with other antihypertensive drugs.
In particular, the simultaneous administration of Tenormin with a diuretic causes an antihypertensive effect higher than that produced by the single drugs.
Angina pectoris
Most patients respond to administration of one tablet (100 mg) per day.
Increasing the dosage generally does not provide additional benefit.
Arrhythmias
After controlling for arrhythmias with Tenormin solution for infusion, an oral maintenance dose of 50-100 mg / day is recommended.
Early intervention in acute myocardial infarction
Treatment with Tenormin 5 mg / 10 ml solution for infusion should be started within 12 hours of the onset of precordial pain in acute myocardial infarction. 15 minutes after bolus injection, administer Tenormin 50 mg (½ tablet) orally followed by another 50 mg 12 hours after injection. Subsequently, oral maintenance therapy is recommended at a dose of 100 mg / day which should be started after another 12 hours.
If bradycardia and / or hypotension (of such a magnitude as to require therapeutic intervention) or other serious side effects appear, Tenormin should be discontinued.
Senior citizens
Dosage may need to be reduced, particularly in patients with impaired renal function.
Children
There is no clinical experience relating to the pediatric use of Tenormin; therefore its administration to children is not recommended.
Insufficiency renal
As Tenormin is excreted via the kidney, the dosage must be reduced in patients with severe renal impairment. There is no significant accumulation of Tenormin in patients who have a creatinine clearance greater than 35 ml / min / 1.73 m2 (the normal limit is 100-150 ml / min / 1.73 m2). In patients with creatinine clearance of 15-35 ml / min / 1.73 m 2 (equivalent to 3.4-6.8 mg% of serum creatinine) the dosage should be 50 mg per day or 100 mg every other day.
For patients with creatinine clearance 2 (equivalent to 6.8 mg% serum creatinine) the posology should be 50 mg every other day or 100 mg every 4 days.
In hemodialysis patients Tenormin should be administered orally at a dose of 50 mg after each session; Administration should be performed in a hospital setting as marked reductions in blood pressure may occur.
04.3 Contraindications
Like other beta-blockers, Tenormin must not be administered to patients with: hypersensitivity to the active substance or to any of the excipients; bradycardia; cardiogenic shock; hypotension; metabolic acidosis; severe disorders of peripheral arterial circulation; 2nd and 3rd degree atrioventricular block; diseases of the sinus node; untreated pheochromocytoma; heart failure not controlled by adequate therapy.
Tenormin should not be combined with verapamil or diltiazem therapy.
04.4 Special warnings and appropriate precautions for use
Although Tenormin is contraindicated in heart failure not controlled by adequate therapy (see section 4.3) it can be administered to patients with controlled signs of heart failure and, with due caution, to patients with poor cardiac reserve.
In patients with Prinzmetal's angina, Tenormin may increase the number and duration of anginal seizures through alpha receptor mediated coronary arterial vasoconstriction. However, its use in these patients may be considered with extreme caution, as Tenormin is a selective beta-blocker beta-1.
As already indicated in section 4.3, Tenormin must not be administered to patients with severe disorders of the peripheral arterial circulation. During its use, in patients suffering from peripheral vascular disorders of modest entity, an aggravation of these disorders may also occur.
Particular caution should be exercised when administering Tenormin to patients with 1st degree atrioventricular block due to its negative effect on conduction time.
Tenormin can modify hypoglycaemia-induced tachycardia. Tenormin can mask the signs of thyrotoxicosis.
Reduction of heart rate is a pharmacological action induced by Tenormin. Dosage reduction should be considered in the rare cases where symptoms attributable to excessive reduction in heart rate appear.
It is important not to abruptly stop treatment with Tenormin, especially in patients with ischemic heart disease.
In patients treated with Tenormin and with a history of anaphylactic reactions to various allergens, an aggravation of allergic reactions may occur on the occasion of repeated stimuli by the allergen.
These patients may not respond adequately to the doses of adrenaline commonly used in the treatment of allergic reactions.
In asthmatic patients Tenormin can induce an increase in respiratory tract resistance; however, its use in these patients may be considered with extreme caution, as Tenormin is a selective beta-blocker beta-1. In the event of increased respiratory tract resistance, administration of Tenormin should be discontinued and, if necessary, therapy with bronchodilator preparations (such as salbutamol) initiated.
04.5 Interactions with other medicinal products and other forms of interaction
Tenormin must not be administered to patients receiving calcium channel blockers with a negative inotropic effect (eg verapamil, diltiazem); it is necessary that at least 48 hours have passed since the discontinuation of one of these drugs before starting the other therapy.
Concomitant use with dihydropyridines (eg nifedipine) may increase the risk of hypotension and cases of heart failure may occur in patients with latent heart failure.
Glycoside-digitalis drugs, associated with beta-blockers, can cause an increase in atrioventricular conduction time.
Beta-blockers can aggravate the sharp rise in blood pressure that can occur after discontinuation of clonidine. If the two drugs are administered at the same time, the beta-blocker must be discontinued several days before stopping the clonidine therapy. If beta-blocker therapy is to replace clonidine therapy, initiation of beta-blocker therapy should occur several days after stopping clonidine therapy.
Class I antiarrhythmic drugs (eg disopyramide) and amiodarone can potentiate the effect on atrial conduction time and induce a negative inotropic effect.
Sympathomimetic drugs, such as adrenaline, can counteract the effect of beta-blockers when used concurrently.
The concomitant use of prostaglandin synthetase inhibitors (ibuprofen, indomethacin) may reduce the hypotensive effects of beta-blockers.
Particular caution should be exercised in the use of anesthetic agents in patients treated with Tenormin.
The anesthetist should be informed of such therapy and, in this case, an anesthetic agent with minimal negative inotropic activity should be used. risk of hypotension. The use of anesthetic agents that cause myocardial depression should be avoided.
04.6 Pregnancy and lactation
Pregnancy
Tenormin crosses the placental barrier and blood levels have been found in the umbilical cord.
No studies on the use of Tenormin in the 1st trimester of pregnancy have been performed and therefore the possibility of fetal harm cannot be ruled out. Tenormin has been used under close medical supervision for the treatment of hypertension in the 3rd trimester. The use of Tenormin in pregnant women for the treatment of mild to moderate hypertension has been associated with intra-uterine growth retardation. The use of Tenormin, in women who are pregnant or who may start it, requires a careful evaluation of the benefits induced by the therapy compared to the possible risks, particularly in the 1st and 2nd trimester of gestation.
Feeding time
There is a significant accumulation of Tenormin in breast milk. Caution should be exercised when Tenormin is administered to breastfeeding women.
Babies born to mothers who have taken Tenormin shortly before giving birth or while breastfeeding may be at risk of hypoglycaemia and bradycardia. Care should be taken when Tenormin is taken during pregnancy or breastfeeding.
04.7 Effects on ability to drive and use machines
Tenormin is unlikely to affect the ability to drive and use machines. However, it should be taken into account that dizziness or fatigue may occasionally occur.
04.8 Undesirable effects
In clinical studies, the undesirable events reported are generally attributable to the pharmacological actions of atenolol.
The following undesirable effects, listed by body system, have been reported with the following frequencies: very common (≥10%), common (1-9.9%), uncommon (0.1-0.9%), rare (0.01-0.09%), very rare (
Disorders cardiac
Common: bradycardia.
Rare: deterioration of heart function, development of heart block.
Disorders vascular
Common: cold in the extremities.
Rare: postural hypotension which may be associated with syncope, aggravation of intermittent claudication, in sensitive patients Raynaud's phenomenon.
Disorders of the system nervous
Rare: dizziness, headache, paraesthesia.
Disorders psychiatric
Uncommon: sleep disturbances similar to those reported by other beta-blockers.
Rare: mood changes, nightmares; psychosis or hallucinations, aggravation of nerve syndromes with mental depression, catatonia, confusion and memory disturbances.
Disorders gastrointestinal
Common: gastrointestinal disturbances. Rare: dry mouth.
Exams from laboratory
Common: increases in transaminase levels
Very rare: An increase in antinuclear antibodies has been observed, however the clinical relevance is unclear.
Disorders hepatobiliary
Rare: hepatic toxicity, including intrahepatic cholestasis.
Disorders of the blood And system lymphatic
Rare: purpura, thrombocytopenia.
Disorders of the skin And of the tissue subcutaneous
Rare: alopecia, psoriatic-type skin reactions, worsening of psoriasis, skin rash, in addition, atenolol can exacerbate depigmentation in subjects suffering from vitiligo.
Disorders eyepieces
Rare: dry eyes, visual disturbances.
Disorders of the system reproducer And of the breast
Rare: impotence.
Disorders respirators, thoracic And of the mediastinum
Rare: Bronchospasm may occur in patients with bronchial asthma or a history of asthma problems.
Disorders generic And to the site from administration
Common: fatigue.
If, according to clinical judgment, the patient's quality of life is negatively affected by the presence of any of the undesirable effects listed above, discontinuation of treatment should be considered.
04.9 Overdose
Symptoms of overdose can manifest as bradycardia, hypotension, acute heart failure and bronchospasm.
General supportive measures should include: close medical surveillance, hospitalization in the intensive care unit, gastric lavage, use of activated charcoal and a laxative to prevent absorption of any drug still present in the gastrointestinal tract, use of plasma or blood products to treat hypotension and shock.
The possibility of using hemodialysis or hemoperfusion should be considered.
Severe bradycardia can be corrected with 1-2 mg of atropine administered intravenously and / or with a cardiac pacemaker. If necessary, this can be followed by a 10 mg intravenous bolus dose of glucagon, which may be repeated or followed by 1-10 mg / h intravenous glucagon depending on response. If there is no response to glucagon or if it is not available, a beta-adrenoceptor stimulant such as dobutamine is used at a dose of 2.5-10 mcg / kg / min for intravenous infusion. Dobutamine, due to its positive inotropic effects, could also be used to treat hypotension and acute heart failure. These doses are likely to be inadequate to counteract the cardiac effects induced by beta-blockade in the event of a large overdose. The Dobutamine dose should then be increased as needed to achieve the desired response based on the patient's clinical condition.
Bronchospasm can usually be resolved by administering bronchodilator preparations.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: beta-blockers, selective, unassociated.
ATC code: C07AB03.
Atenolol is a selective beta-blocker beta-1 (eg acts preferentially on cardiac beta-1 adrenergic receptors). Selectivity decreases with increasing dose.
Atenolol is devoid of intrinsic sympathomimetic activity and membrane stabilizing activity and, like other beta-blockers, has negative inotropic effects (it is therefore contraindicated in uncontrolled heart failure).
As with other beta-blockers, the mode of action of atenolol in the treatment of hypertension is unclear.
The efficacy of atenolol in eliminating or reducing symptoms in patients with angina is likely to be determined by the reduction in heart rate and contractility.
It is unlikely that any additional auxiliary properties possessed by S (-) atenolol, with respect to the racemic mixture, will give rise to different therapeutic effects. Tenormin is effective and well tolerated by most ethnicities, although a lower response may occur in black patients.
Tenormin is compatible with diuretics, other antihypertensive and antianginal drugs (see section 4.5).
05.2 Pharmacokinetic properties
After intravenous administration, blood levels of atenolol decline in a tri-exponential fashion with an elimination half-life of approximately 6 hours.
In the dose range of 5-10 mg intravenously the blood profile level responds to linear pharmacokinetics and beta-blockade is still measurable 24 hours after a 10 mg intravenous dose.
After oral administration, absorption of atenolol is consistent but incomplete (approximately 40-50%) with peak plasma concentrations 2-4 hours post dose.
Blood levels of atenolol are consistent and subject to slight variability.
There is no significant hepatic metabolism of atenolol and more than 90% of absorbed atenolol reaches the systemic circulation unaltered.
The plasma half-life is approximately 6 hours, but may increase in patients with severe renal insufficiency, as the kidney is the major route of elimination.
Atenolol poorly penetrates tissues due to its low lipid solubility and its concentration in brain tissues is low. The amount of atenolol bound to plasma proteins is minimal (about 3%).
Tenormin is effective for at least 24 hours after a single daily oral dose. The dosage simplicity facilitates compliance due to its acceptability by the patient.
05.3 Preclinical safety data
Extensive clinical experience was obtained with atenolol.
The various information regarding its administration are reported in the specific paragraphs.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Heavy magnesium carbonate, corn starch, sodium lauryl sulfate, gelatin, magnesium stearate.
06.2 Incompatibility
There are no known incompatibilities.
06.3 Period of validity
In intact packaging: 5 years.
06.4 Special precautions for storage
Store at a temperature not exceeding 25 ° C and protected from light and humidity.
06.5 Nature of the immediate packaging and contents of the package
PVC blister sealed on a semi-rigid aluminum support. Tenormin 100 mg tablets - 14 tablets
Tenormin 100 mg tablets - 42 tablets
06.6 Instructions for use and handling
No special precautions are required.
07.0 MARKETING AUTHORIZATION HOLDER
AstraZeneca S.p.A.
Volta Palace, Via F. Sforza - Basiglio (MI).
08.0 MARKETING AUTHORIZATION NUMBER
Tenormin 100 mg tablets - 14 tablets A.I.C. n. 024016014
Tenormin 100 mg tablets - 42 tablets A.I.C. n. 024016038
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Tenormin 100 mg tablets - 14 tablets Date A.I.C .: 20.04.1979 / Renewal: 01.06.2005.
Tenormin 100 mg tablets - 42 tablets Date A.I.C .: 05.10.1999 / Renewal: 01.06.2005
10.0 DATE OF REVISION OF THE TEXT
05 December 2007