SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
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SUMMARY OF PRODUCT CHARACTERISTICS
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1. NAME OF THE MEDICINAL PRODUCT
Betaxolol Hydrochloride 20 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 20 mg betaxolol hydrochloride (equivalent to 17.88 mg betaxolol).
Excipient with known effect Each film-coated tablet contains 100.00 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet
White, round, biconvex film-coated tablets with a break-line on one face.
The tablet can be divided into equal doses.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Betaxolol Hydrochloride is indicated in adults for: Treatment of essential hypertension. Chronic, stable angina pectoris.
4.2 Posology and method of administration
Posology
Adults Essential hypertension The initial dose is 10 mg once daily. In case of insufficient effect this dosage can be increased to 20 mg per day. In moderate hypertension the standard dose is 20 mg once daily. In certain cases it could be necessary to increase the daily dose to 40 mg.
Stable angina pectoris The dosage should be adjusted individually. The starting dose is 10 mg a day, which can be increased to the usual dose of 20 mg once daily. In certain cases it could be necessary to increase the daily dose to 40 mg.
Patients with impaired renal or liver function In patients with renal impairment (creatinine clearance up to 20 ml/minute) there is no need to adjust the daily dose, however, clinical monitoring at the beginning of the treatment until steady plasma levels of the medicinal product are attained (over 4 days on average) is recommended.
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In patients with severe renal impairment (creatinine clearance below 20 ml/minute) and in patients with haemo- or peritoneal dialysis the dose of 10 mg/day should not be exceeded. In patients on dialysis the daily dose can be given independent of the time of dialysis.
In patients with liver failure there is no need to adjust the dose. Careful clinical monitoring is recommended at the beginning of the treatment.
Elderly patients The treatment of elderly patients should be started cautiously with low doses and under close monitoring (see section 4.4).
Paediatric population The safety and efficacy of betaxolol in children has not yet been established. Betaxolol hydrochloride should not be used in children (see section 4.4).
Method of administration Oral use.
Betaxolol Hydrochloride should always be taken at the same time of the day, preferably in the early morning. The tablets may be taken with or without food.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Severe forms of bronchial asthma and chronic obstructive pulmonary disease Decompensated heart failure Cardiogenic shock Second and third degree atrioventricular block, unless a pacemaker is inserted Prinzmetal's variant angina pectoris (pure form and with monotherapy) Sick-sinus syndrome, including sinoatrial block Bradycardia (less than 45-50 beats/min) Severe forms of Raynaud's phenomenon and peripheral arterial disorders Untreated pheochromocytoma Hypotension History of anaphylactic reaction Metabolic acidosis Concurrent administration with floctafenine or sultopride (see section 4.5)
4.4 Special warnings and precautions for use
The treatment must not be discontinued suddenly in patients with stable angina pectoris: this could result in serious heart rhythm disorders, myocardial infarction or sudden death. Discontinuation of treatment The treatment should not be discontinued suddenly, especially in patients with ischaemic heart disease. The doses should be reduced gradually, within a one to two-week period. If necessary, with simultaneous introduction of replacement therapy to prevent any aggravation of angina pectoris. Asthma and chronic obstructive lung disease Beta-blockers may be administered only in mild forms of the disease, cardio selective beta-blockers at the lowest possible doses should be preferably used and it is recommended to carry out pulmonary function tests before and after the start of beta-blocker treatment.
During an asthma attack beta2-agonist bronchodilators may be used.
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Heart failure In patients with compensated heart failure, betaxolol can be administered in gradually increasing doses, if necessary. At the start of treatment very low doses should be administered. Close monitoring of the patient's condition is required.
Bradycardia Beta-blockers may induce bradycardia. The dosage of betaxolol hydrochloride must be decreased, if the resting heart rate of the patient drops below 50-55 beats per minute and symptoms of bradycardia appear.
First degree atrioventricular block With respect to the negative dromotropic effect of beta-blockers, betaxolol should be administered with caution to patients with first-degree atrioventricular block.
Prinzmetal variant of angina Beta-blockers may increase the number and duration of angina attacks in patients suffering from the Prinzmetal’s variant angina pectoris (see section 4.3). Cardioselective beta-blockers may be used in minor and mixed forms, provided that a vasodilator is co-administered.
Peripheral arterial disorders In patients with peripheral arterial disorders (Raynaud's syndrome or disease, arteritis, or chronic occlusive arterial disease of the lower limbs), beta-blockers should be used with great caution as they may result in an aggravation of the condition. In severe forms of Raynaud’s phenomenon and peripheral arterial circulatory disorders, beta-blockers are contraindicated (see section 4.3).
Pheochromocytoma The use of beta-blockers in the treatment of hypertension caused by treated pheochromocytoma requires close monitoring of the patient's blood pressure (see section 4.3).Beta blockers should only be used after prior administration if alpha inhibitors
Paediatric population The safety and efficacy of betaxolol has not yet been established, therefore betaxolol is not recommended in children and adolescents.
Elderly patients In elderly patients, the treatment should be initiated at low doses and the patient´s clinical condition must be closely monitored (see section 4.2).
Patients with renal impairment In patients with renal impairment, the dosage should be adjusted according to the serum creatinine levels or creatinine clearance (see section 4.2).
Diabetic patients Beta-blockers may mask some signs of hypoglycaemia, particularly tachycardia, palpitations and sweats (see section 4.5 and 4.8).
The patient must be informed about the necessity of blood glucose monitoring at shorter intervals, in particular at the start of treatment.
Psoriasis The benefit of beta-blockers in patients with a personal or family history of psoriasis should be carefully weighed, as it has been reported that psoriasis has been aggravated in patients treated with beta-blockers (see section 4.8).
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Allergic reactions In patients liable to have a severe anaphylactic reaction, irrespective of its cause, especially after the administration of iodine-containing contrast media or floctafenine (see sections 4.3 and 4.5) or during desensitising therapy, beta-blocker treatment may result in an aggravated allergic reaction and resistance to treatment by the usual doses of adrenaline.
General anaesthesia Beta-blockers attenuate reflex tachycardia and increase the risk of hypotension. Continuation of beta- blocker therapy reduces the risk of arrhythmias, myocardial ischemia and hypertensive crisis. Anaesthetists should be informed that the patient is being treated with a beta-blocker.
Anaesthetics with the least possible myocardial depressant effects should be used.
It is necessary to take into account the probability of anaphylaxis.
If discontinuation of the treatment is necessary, a 48-hour period is considered sufficient to restore the normal sensitivity to the catecholamines.
In some cases, beta-blocker therapy should not be interrupted: in patients with coronary insufficiency, due to a risk associated with an abrupt beta-blocker withdrawal, it is advisable to continue the treatment until the surgery in emergency or in cases when discontinuation is impossible, the patient must be protected from parasympathetic predominance by a sufficient premedication with atropine, repeated as needed
Ophthalmology Beta-adrenergic blockade reduces intraocular pressure and may hamper the glaucoma screening. The ophthalmologist should be informed that the patient is being treated with betaxolol. Patients with general and ocular beta-blocker therapy should be monitored due to a potential additive effect.
Thyrotoxicosis Beta-blockers can mask the cardiovascular signs of thyrotoxicosis.
Hypoglycaemia There is an increased susceptibility to hypoglycaemia, for example during prolonged fasting or heavy physical exertion.
Excipients Betaxolol hydrochloride contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
Contraindicated combinations
Floctafenine In the event of shock or hypotension caused by floctafenine, beta-blockers reduce the compensation reaction.
Sultopride Disorders of cardiac automatism (excessive bradycardia) due to their common bradycardic effect.
Not recommended combinations
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Amiodarone Concomitant use of beta-blockers with amiodarone can cause disturbances of contractility, cardiac automatism and conduction (suppression of sympathetic compensatory mechanisms).
Verapamil Betaxolol should not be used during treatment with verapamil or within a few days after treatment with verapamil (and vice versa).
Digitalis glycosides Concomitant use of betaxolol with these medicinal products can prolong atrioventricular conduction time and cause severe bradycardia.
Fingolimod Treatment with fingolimod should not be initiated in patients taking beta blockers because of the increased bradycardiac effect. If treatment with fingolimod is necessary, appropriate monitoring is recommended at the start of treatment, lasting at least overnight.
Monoamine oxidase inhibitors (except MAO-B inhibitors)
Combinations requiring precautions
Antiarrhythmics (propafenone and group Ia drugs: quinidine, hydroquinidine and disopyramide) Disturbances of contractility, cardiac automatism and conduction (suppression of sympathetic compensatory mechanisms). Electrocardiographic monitoring is recommended.
Baclofen Increased risk of hypotension.
Blood pressure should be monitored and if necessary, the antihypertensive agent dose should be adjusted.
Insulin and hypoglycaemic sulfonamides (see section 4.4) All beta-blockers mask certain symptoms of hypoglycaemia, such as palpitations and tachycardia. The patient must be informed thereof as well as of the necessity of blood glucose monitoring at shorter intervals, in particular at the start of treatment.
Anaesthetics Concomitant administration of betaxolol and anaesthetics can result in an increased lowering of the blood pressure. The negative inotropic effects (i.e. reduction in cardiovascular compensatory reactions) of anaesthetics and betaxolol can be additive (the beta-blockade during the intervention may be compensated by a beta-mimetic). In general, betaxolol should not be discontinued under general anaesthesia or before application of peripheral muscle relaxants. Sudden discontinuation should be avoided in all cases (see section 4.4).The anaesthetist should be informed of the treatment with beta-blocker. A discontinuation of betaxolol, if deemed necessary, should occur 48 hours before anaesthesia to restore the normal sensitivity to the action of catecholamines (see section 4.4).
Calcium channel blockers (bepridil, diltiazem and mibefradil) Disturbances of cardiac automatism (excessive bradycardia, sinus arrest), disturbances of sinoatrial and atrioventricular conduction and heart failure (synergistic effects).
These combinations should only be used under strict electrocardiographic monitoring, in particular in the elderly or at the start of treatment.
Lidocaine
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Interactions with propranolol, metoprolol and nadolol have been described.
Increased lidocaine plasma concentrations with a possible augmentation of undesirable neurological and cardiac effects (decreased lidocaine metabolism in the liver).
Dosage of lidocaine should be adjusted. Clinical and ECG monitoring and monitoring of lidocaine plasma concentrations during the beta-blocker therapy and after its discontinuation is recommended.
Iodine-containing contrast media In the event of shock or hypotension caused by iodine-containing contrast media, beta-blockers decrease the cardiovascular compensation reactions.
Whenever possible, beta-blocker therapy should be discontinued prior to radiological examination using contrast media. If it is necessary to continue beta-blocker therapy, the examination should be performed only if admission to intensive care unit is possible.
Cimetidine, hydralazine and alcohol These drugs induce increased plasma concentrations of beta-blockers with hepatic metabolism.
Combinations to be taken into consideration
Calcium channel blockers: dihydropyridines such as nifedipine Hypotension and heart failure in patients with latent or uncontrolled heart failure (negative inotropic effect of dihydropyridines in vitro, varying according to the product concerned and probably additive to the negative inotropic effect of beta-blockers). Beta-blocker therapy may minimize the reflex sympathetic reaction after an excessive haemodynamic stress.
Non-steroidal anti-inflammatory drugs (NSAIDs) Decreased anti -hypertensive effect (inhibition of vasodilative prostaglandins by NSAIDs and water and sodium retention with NSAID-pyrazolone derivatives).
Sympathomimetic agents Risk of decreased effect of beta-blockers.
Tricyclic antidepressants related to imipramine and neuroleptics Increased antihypertensive effect and risk of orthostatic hypotension (additive effect).
Corticosteroids and tetracosactides Decreased antihypertensive effect (water and sodium retention).
Mefloquine Risk of bradycardia (additive bradycardic effect).
Clonidine After abrupt discontinuation of clonidine while taking betaxolol the blood pressure could increase excessively (rebound hypertension). Therefore clonidine should only be discontinued when a few days earlier betaxolol has been discontinued first. Clonidine can then be gradually discontinued.
4.6 Fertility, pregnancy and lactation
Pregnancy There are insufficient data on the use of betaxolol in pregnant women to assess its potential harmfulness. Animal studies have not shown evidence of teratogenicity or other direct or indirect harmful effects at therapeutic doses (see section 5.3). On the basis of its pharmacodynamic properties,
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adverse effects may occur in the foetus and newborn infanrt (especially hypoglycaemia, hypotension, bradycardia and resporatory distress). Due to lack of experience, the use of betaxolol during pregnancy is not recommended unless the potential benefits of the treatment outweigh the risks.
Breast-feeding Betaxolol is excreted in breast milk. The quantities in milk may be high enough to cause pharmacological effects, such as bradycardia and hypoglycaemia, in the child. Therefore lactation is not recommended during adminstration of Betaxolol Hydrochloride.
Fertility No adverse effects on fertility known.
4.7 Effects on ability to drive and use machines
There are no studies evaluating the effect of betaxolol on the ability to drive. When driving vehicles or operating machines, an occasional occurrence of dizziness and fatigue should be taken into account.
4.8 Undesirable effects
In order to characterise the frequency of undesirable effects, the following terminology will be used: Frequency estimate: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000) Not known (cannot be estimated from the available data).
System Organ Class Adverse drug reaction
Metabolism and nutrition disorders Very rare Hypoglycaemia, hyperglycaemia. Psychiatric disorders Common Asthenia, insomnia
Rare Depression
Very rare Hallucinations, confusion, nightmares Nervous system disorders Common Especially in early treatment phase fatigue, dizziness, headache and sweating
Very rare Distal paraesthesia
Not known lethargy
Eye disorders Very rare Impaired vision
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System Organ Class Adverse drug reaction
Cardiac disorders Common Bradycardia, possibly severe bradycardia
Rare Heart failure, drop in blood pressure, atrioventricular conduction time shortened, or aggravation of existing atrioventricular block Vascular disorders Common Cold extremities
Rare Raynaud's syndrome, aggravation of existing intermittent claudication Respiratory, thoracic and mediastinal disorders Rare Bronchospasm Gastrointestinal disorders Common Gastralgia, diarrhoea, nausea and vomiting Skin and subcutaneous tissue disorders Common Allergic skin reactions (redness, itching, rash), alopecia
Rare Psoriasis aggravation
Not known Urticaria Reproductive system and breast disorders Common Impotence
Investigations: Rarely an occurrence of antinuclear antibodies has been observed: these have been associated only with clinical signs such as systemic lupus erythematosus in exceptional cases and they have resolved after the treatment discontinuation.
During betaxolol treatment lipid metabolism disorders may occur (decrease in HDL-cholesterol, increased triglycerides).
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via [To be completed nationally].
4.9 Overdose
Symptoms Symptoms of overdose: severe hypotension, bradycardia up to cardiac arrest, acute cardiac failure, cardiogenic shock, bronchospasm and occasionally generalised seizures.
Management
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In the event of life threatening bradycardia or an excessive drop in blood pressure, the following medicines could be administered: atropine glucagon sympatheticomimetics depending on weight and effect: dopamine, dobutamine, orciprenaline and adrenaline
In case of bronchospasm, beta2-agonists as an aerosol (in case of insufficient effect also intravenously) or aminophylline i.v. could be administered.
In case of generalised seizures slow intravenous administration of diazepam i.v. is recommended.
In haemodialysis or peritoneal dialysis betaxolol and its metabolites could be eliminated only to a little extent. In the event of cardiac decompensation in the newborn of a mother treated with beta-blockers: glucagon hospitalisation in a neonatal intensive care unit isoprenaline and dobutamine: prolonged treatment usually with high doses requiring specialised monitoring
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Beta blocking agents, selective, ATC code: C07AB05.
Betaxolol is a cardioselective beta1-adrenoceptor blocking agent with a long duration of action. The blocking activity is measurable for 24 hours after oral administration of 20 mg betaxolol. Following administration of therapeutic doses of betaxolol, a significant decrease in arterial blood pressure, heart rate and stroke volume are observed.
Betaxolol is characterised by a low membrane stabilising effect and no intrinsic sympathomimetic activity (ISA). Betaxolol does not reduce the renal excretion of sodium. Betaxolol reduces the plasma renin activity.
The known effects of beta blockers on blood lipids are less pronounced for betaxolol.
5.2 Pharmacokinetic properties
Absorption After oral administration, the active ingredient is completely and rapidly absorbed with minimal first- pass hepatic metabolism in the liver and a high bioavailability of approximately 85%, leading to a small inter and intra-individual variability in blood levels during chronic treatment.
Distribution About 50% betaxolol is bound to plasma proteins. The volume of distribution is about 6 L/kg.
Biotransformation Betaxolol is metabolised primarily to inactive metabolites, of which 10-15% is excreted unchanged in the urine
Elimination
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Betaxolol has a half-life of 15-20 hours.
5.3 Preclinical safety data
Non-clinical data revealed no special hazards for humans based on conventional studies on safety, pharmacology, repeated dose toxicity, genotoxicity and carcinogenicity.
In reproductive toxicity studies in rats and rabbits orally administered betaxolol hydrochloride was associated with adverse effects only at dosages well above the therapeutic dosage (presumably because of the pharmacodynamic effects of high systemic exposure). Teratogenic effects were not observed.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Core Cellulose, microcrystalline (E460) Lactose monohydrate Sodium starch glycolate Silica, colloidal anhydrous (E551) Magnesium stearate (E470b)
Film-coating Hypromellose (E464) Titanium dioxide (E171) Macrogol 400 (E1521)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5 Nature and contents of container
PVC/Aluminium blisters in cartons. 28, 30 90, 98 and 100 tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements for disposal.
7. MARKETING AUTHORISATION HOLDER
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[To be completed nationally]
8. MARKETING AUTHORISATION NUMBER(S)
[To be completed nationally]
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: Date of latest renewal:
[To be completed nationally]
10. DATE OF REVISION OF THE TEXT
[To be completed nationally]
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LABELLING
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PARTICULARS TO APPEAR ON THE OUTER PACKAGING
CARTON
1. NAME OF THE MEDICINAL PRODUCT
Betaxolol Hydrochloride 20 mg film-coated tablets betaxolol hydrochloride
2. STATEMENT OF ACTIVE SUBSTANCE
Each film-coated tablet contains 20 mg betaxolol hydrochloride (equivalent to 17.88 mg betaxolol).
3. LIST OF EXCIPIENTS
Also contains lactose. See leaflet for further information.
4. PHARMACEUTICAL FORM AND CONTENTS
Film-coated tablet
28 film-coated tablets 30 film-coated tablets 90 film-coated tablets 98 film-coated tablets 100 film-coated tablets
5. METHOD AND ROUTE OF ADMINISTRATION
Oral use. Read the package leaflet before use.
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
-
8. EXPIRY DATE
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EXP:
9. SPECIAL STORAGE CONDITIONS
-
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
-
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
[To be completed nationally]
12. MARKETING AUTHORISATION NUMBER(S)
[To be completed nationally]
13. BATCH NUMBER
LOT:
14. GENERAL CLASSIFICATION FOR SUPPLY
[To be completed nationally]
15. INSTRUCTIONS ON USE
[To be completed nationally]
16. INFORMATION IN BRAILLE
Betaxolol Hydrochloride
17. UNIQUE IDENTIFIER – 2D BARCODE
2D barcode carrying the unique identifier included.
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA
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PC: SN: NN:
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MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
BLISTER
1. NAME OF THE MEDICINAL PRODUCT
Betaxolol Hydrochloride 20 mg film-coated tablets betaxolol hydrochloride
2. NAME OF THE MARKETING AUTHORISATION HOLDER
[To be completed nationally]
3. EXPIRY DATE
EXP:
4. BATCH NUMBER
LOT:
5. OTHER
-
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PACKAGE LEAFLET
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Package leaflet: Information for the patient
Betaxolol Hydrochloride 20 mg film-coated tablets
betaxolol hydrochloride
Read all of 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 further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet 1. What Betaxolol hydrochloride is and what it is used for 2. What you need to know before you take Betaxolol hydrochloride 3. How to take Betaxolol hydrochloride 4. Possible side effects 5. How to store Betaxolol hydrochloride 6. Contents of the pack and other information
1. What Betaxolol hydrochloride is and what it is used for
Betaxolol hydrochloride belongs to a group of medicines called beta-blockers. These medicines lower blood pressure, slow heart rate and reduce the heart oxygen consumption.
Betaxolol hydrochloride is used for the treatment of high blood pressure (hypertension) in adults, of mild to moderate forms.
It is also used for long-term treatment of attacks of stable angina pectoris (chest pain resulting from insufficient blood supply to the heart muscle due to exertion or stress) in adults.
2. What you need to know before you take Betaxolol hydrochloride
Do not take Betaxolol hydrochloride if you: are allergic to betaxolol or any of the other ingredients of this medicine (listed in section 6) have severe asthma and another serious breathing problem called chronic obstructive lung disease (COPD), which makes you breathless when active with a cough with phlegm and suffer from frequent chest infections have severe heart failure have cardiogenic shock (failure of the heart to pump effectively) have heart conduction disturbances which prevent your heart from beating normally (second and third degree atrioventricular block, unless you have a pacemaker) have Prinzmetal's variant angina pectoris (chest pain while resting) have sick-sinus syndrome, including sinoatrial block (missed heart beats) have significantly slow heart rate have a severe form of Raynaud's syndrome and peripheral arterial disorder (causing poor circulation in arms and legs) have untreated adrenal gland tumour (pheochromocytoma) have low blood pressure
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have a history of severe allergic reactions which cause difficulty breathing with swelling of the nose, lips and eyelids (anaphylactic reaction) have higher than normal levels of acid in your blood (metabolic acidosis) are taking floctafenine (a medicine used for mild to moderate pain relief) or sultopride (a medicine used to treat schizophrenia)
Warnings and precautions Talk to your doctor or pharmacist before taking Betaxolol hydrochloride if you: have less severe forms of chronic obstructive lung disease and asthma. Examination of your lung function is recommended before the start of treatment have kidney problems have heart failure and are also being treated with medicines to help this condition, have other heart conduction disturbances (first degree aventricular block) have less severe forms of Raynaud’s Syndrome, infammation of the blood vessels walls or blockage (reducing blood flow) of the blood vessels are receiving treatment for a tumour of the adrenal glands called pheochromocytoma, which causes high blood pressure. Treatment of high blood pressure (hypertension) requires special measures, and your doctor will regularly test your blood pressure have diabetes and are prone to hypoglycemia (low blood sugar). This medicine may mask warning signs of low blood sugar such as fast uneven heartbeat and sweating. Patients with diabetes should monitor their blood sugar at more frequent intervals, especially at the start of treatment have glaucoma (increased pressure in the eye). Before any eye examination, tell your eye doctor or optician that you are taking this medicine have a family or personal history of psoriasis have thyrotoxicosis (a condition caused by an overactive thyroid gland). This medicine may hide symptoms
During treatment Talk to your doctor or pharmacist before you receive treatment for an allergy (known as desensitisation therapy), because betaxolol may increase your risk of having an allergic reaction and may also reduce the effectiveness of some medicines used to treat allergic reactions.
When taking this medicine, if you notice a large reduction in heart rate (less than 50-55 beats per minute), talk to your doctor.
If you are fasting/dieting, or are exercising heavily this medicine may increase the risk of developing low blood sugar. This medicine may also mask warning signs of low blood sugar. If you are concerned, talk to your doctor or pharmacist.
If you are due to have medical scans or X-rays, where you are to be injected with a dye beforehand, tell your doctor or hospital staff that you are taking this medicine. Your doctor may need to stop this medicine.
If you are to be given general anesthesia during surgery, tell the anesthetist or hospital staff that you are taking this medicine.
Children and adolescents Do not give this medicine to children and adolescents as safety and efficacy have not been established.
Other medicines and Betaxolol Hydrochloride
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Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The product must not be taken if you are taking floctafenine, a medicine used to reduce pain and swelling or sultopride, a medicine used in the treatment of schizophrenia.
Betaxolol hydrochloride is not recommended for use with the following: amiodarone and digoxin (medicines to treat heart rhythm problems) fingolimod, (a medicine used for treating multiple sclerosis) verapamil (used in the treatment of high blood pressure (hypertension) and heart problems) some medicines used to treat depression (known as MAOI-As, e.g. moclobemide)
Your doctor may carry out regular tests and checks in order to make sure that your medicine is working and that your heart is not affected by the combination of the medicines, if you are taking any of the following: calcium channel blockers (medicines used to treat high blood pressure (hypertension), e.g. bepridil, diltiazem, mibefradil) medicines used in heart rhythm disorders e.g. propafenone, quinidine, hydroquinidine, disopyramide baclofen (a drug reducing muscle tension) lidocaine (a local anaesthetic) iodine-containing contrast media (a dye which may be injected into the body before some medical scans e.g. MR scans, CT scans and X-rays to improve the pictures of inside the body) anti-diabetes medication e.g. insulin, glimepiride, as you may not notice that your blood sugar is low (hypoglycaemia) because this medicine may mask warning signs such as fast uneven heartbeat and sweating. You will need to measure your blood sugar levels more often especially at the start of treatment some general anaesthetics used in surgery; you should tell your anaesthetist or hospital staff that you are taking this medicine cimetidine (for stomach problems) hydralazine (used for high blood pressure (hypertension))
If you take any of the following medicines, talk to your doctor, because taking these medicines may affect the way that this medicine works. medicines used in the treatment of pain and inflammation, known as non-steroidal anti- inflammatory drugs (NSAIDS) medicines that help relax the blood vessels (also known as calcium channel blockers) used for high blood pressure or some circulation problems, e.g. nifedipine, amlodipine some medicines used to treat depression and mental health conditions e.g. imipramine corticosteroids and tetracosactides (a type of hormonal treatment) mefloquine (a medicine to treat malaria) sympathomimetics (medicines that may increase heart rate, e.g. phenylephrine)
If you have been taking a medicine called clonidine at the same time as this medicine, and you need to stop taking clonidine, your doctor may stop you taking betaxolol for a few days before you stop treatment with clonidine.
Betaxolol hydrochloride with alcohol You should not drink alcohol while taking this medicine.
Pregnancy and breast-feeding 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.
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There is a risk that betaxolol treatment during pregnancy may harm the baby. Tell your doctor if you are pregnant or planning to become pregnant. Your doctor will decide whether you can take betaxolol during pregnancy.
Betaxolol is present in breast milk, therefore its use is not recommended during breast-feeding.
Driving and using machines Due to its possible side effects (fatigue, dizziness), especially at the start of treatment, the product may adversely affect activities requiring alertness, coordination and quick decision-making (e.g. driving, operating machinery, working at heights, etc.). In such case you should perform these activities only with the approval of your doctor.
Betaxolol hydrochloride contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Betaxolol hydrochloride
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults Your doctor will decide how much Betaxolol you should take.
In mild hypertension the recommended initial dose is 10 mg (1/2 tablet) once daily usually in the morning. In case of insufficient effect, this dose can be increased to 20 mg (1 tablet) per day.
In moderate hypertension the recommended dose is 20 mg once daily, however the doctor may increase the dosage to 40 mg (2 tablets) per day.
The recommended daily dose in stable angina pectoris is one tablet. Your doctor may adjust the dosage from 10 to 40 mg (1/2 to 2 tablets) per day.
Patients with kidney problems If you have mild kidney problems, your doctor may give you the recommended dose. If you have more severe kidney problems, your doctor may lower your dose. If you are on dialysis, the recommended dose is 10 mg (1/2 tablet) per day, regardless of the timing of dialysis.
Patients with liver problems If you have liver problems, your doctor will give you the recommended dose, but may carry out tests to make sure that your liver is working properly especially at the start of the treatment
Elderly patients Your doctor may start you on a lower dose.
The tablet can be divided into equal doses.
If you take more Betaxolol hydrochloride than you should In case of overdose or accidental ingestion of the product by a child it is necessary to seek medical help immediately. You may feel faint, dizzy, feel your heart beating more slowly, with chest pain, breathing problems and occasionally fits.
If you forget to take Betaxolol hydrochloride
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In case of a missed morning dose you can take the medicine during the day and continue the prescribed dosage regimen the next day. Do not take a double dose to make up for a forgotten dose.
If you stop taking Betaxolol hydrochloride Always contact your doctor or pharmacist before you stop taking this medicine. Treatment with betaxolol hydrochloride should not be stopped abruptly. If treatment withdrawal is necessary, your doctor may reduce the dosage gradually.
If you have any further questions on 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.
If you notice the following, contact your doctor or go to the nearest hospital casualty department straight away.
You have chest pain, feel your heart beating very slowly, feel faint, are short of breath and dizzy, especially if you have been told by your doctor that you have a problem with the rate or rhythm of your heartbeat; this may be due to problems with the way your heart beats (slowed aventricular conduction or aggravation of pre-existing atrioventricular block) Feeling breathless, tired with swollen ankles (heart failure) Swelling of the joints, feeling exhausted with rash over the cheeks and nose (systemic lupus erythematous, a disease where the immune system attacks parts of the body, which may be confirmed by blood tests)
Other possible side effects
Common (may affect up to 1 in 10 people): fatigue, dizziness, headache, sweating weakness, trouble sleeping (insomnia) stomach pain, diarrhoea, feeling sick (nausea) and vomiting slow heart beat (bradycardia) feeling cold in extremities problems with getting and maintaining an erection (impotence) allergic skin reactions (redness, itching, rash) and hair loss
Rare (may affect up to 1 in 1,000 people): skin disease with thickened patches of red skin, often with silvery scales (psoriasis), worsening of the symptoms of an existing psoriasis or psoriasiform eruptions depression feeling dizzy, light headed, faint, unsteady with a feeling of loss of balance (low blood pressure) discoloration of fingers (Raynaud's syndrome), worsening of pain due to impaired blood circulation in the lower limbs breathing difficulties such as wheezing which may be due to narrowing of the airways
Very rare (may affect up to 1 in 10,000 people): visual problems seeing, feeling or hearing things that are not there (hallucinations), confusion, nightmares tingling of the hands and feet (distal parathesia) feeling hungry, dizzy, tired, confused, with trembling, sweating, blurred vision and pale skin, which may be due to low blood sugar (hypoglycaemia)
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feeling tired and thirsty with a dry mouth and needing to pass water more often, especially at night, which may be due to high blood sugar (hyperglycaemia)
Not known (cannot be estimated from the available data): fatigue urticaria (hives)
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 [To be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Betaxolol hydrochloride
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 and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Betaxolol hydrochloride contains
The active substance is betaxolol hydrochloride. Each tablet contains 20 mg betaxolol hydrochloride.
The other ingredients are: Core Microcrystalline cellulose [E460], lactose monohydrate (see section 2, “Betaxolol contains lactose”), sodium starch glycolate, silica, colloidal anhydrous [E551], magnesium stearate [E470b] Film-coating Hypromellose [E464], titanium dioxide [E171], macrogol 400 [E1521].
What Betaxolol Hydrochloride looks like and contents of the pack
Betaxolol hydrochloride 20 mg are white, round, biconvex film-coated tablets with a break-line on one face.
Betaxolol hydrochloride is available in blisters of 28, 30 90, 98 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
[To be completed nationally]
Manufacturer
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Delpharm Reims 10 Rue Colonel Charbonneaux 51100 Reims France
This medicinal product is authorised in the Member States of the EEA under the following names:
Czech Republic Betaxolol Mylan 20 mg, potahované tablety Poland Betaxomyl Slovak Republic Betaxolol Mylan 20 mg, filmom obalené tablety The Netherlands Betaxolol HCl Mylan 20 mg, filmomhulde tabletten
This leaflet was last revised in
[To be completed nationally]
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