Nelet 5 mg Tablets
- Name:
Nelet 5 mg Tablets
- Company:
Gerard Laboratories
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 06/06/17
(Click to Download) Summary of Product Characteristics last updated on medicines.ie: 28/9/2015
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1. NAME OF THE MEDICINAL PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4. CLINICAL PARTICULARS
5. PHARMACOLOGICAL PROPERTIES
5. PHARMACOLOGICAL PROPERTIES
6. PHARMACEUTICAL PARTICULARS
6. PHARMACEUTICAL PARTICULARS
7. MARKETING AUTHORISATION HOLDER
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
10. DATE OF REVISION OF THE TEXT
Gerard Laboratories
Company Products
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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 6 June 2017 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change to name of medicinal product
Updated on 6 June 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 28 September 2015 SmPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - Contraindications
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 5.3 - Preclinical safety data
- Change to section 6.1 - List of excipients
- Change to section 9 - Date of renewal of authorisation
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 1: Formating only
Section 2: Each tablet contains 5.45 mg of nebivolol hydrochloride equivalent to 5.45 mg of nebivolol hydrochloride.
Excipient with known effect:
Each tablet contains 145.45 mg of lactose monohydrate/tablet.
Fora the full list of excipients, see section 6.1.
Section 3:
The tablet can be divided into 4 equal dosesquarters.
Section 4.1:
Hypertension
Treatment of Eessential hypertension.
Chronic heart failure (CHF)
Treatment of stable, mild to moderate chronic heart failure (CHF) in addition to standard therapies in elderly patients ≥ 70 years.
Section 4.2:
Method of administration:
For oral administration
The tablet or its parts should be swallowed with a sufficient amount of fluid (e.g. one glass of water). The tablet can be taken with or without food.
To date, an additional antihypertensive effect has been observed only when Nelet nebivolol 5 mg is combined with hydrochlorothiazide 12.5 - 25 mg.
Children and adolescents:
The efficacy and safety of nebivolol in children and adolescents aged below 18 years has not been established. No data are available. Therefore, use in children and adolescentsNelet is not recommended. for use in children below 18 years due to a lack of data on safety and efficacy
For those patients receiving cardiovascular drug therapy including diuretics and/or digoxin and/or ACE inhibitors and/or angiotensin II antagonists, dosing of these drugs should be stabilised during the past two weeks prior to initiation ofNelet nebivolol treatment.
Initiation of therapy and every dose increase should be done under the supervision of an experienced physician over a period of at least 2 hours to ensure that the clinical status (especially as regardswith respect to blood pressure, heart rate, conduction disturbances, signs of worsening of heart failure) remains stable.
Treatment of stable chronic heart failure with nebivolol is generally a long-term treatment.
It The treatment with nebivolol is not recommended that nebivolol treatment is to be stopped abruptly since this might lead to a transitory worsening of heart failure.
Children and adolescents:
The efficacy and safety of nebivolol in children and adolescents aged below 18 years has not been established. No data are available. Therefore, use in children and adolescentsNelet is not recommended. for use in children below 18 years due to a lack of data on safety and efficacy
Method of administration
For oral administration.
The tablet or its parts should be swallowed with a sufficient amount of fluid (e.g. one glass of water). The tablet can be taken with or without food.
Section 4.3:
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.the medicinal product.
• Liver insufficiency or liver function impairment.
• Acute heart failure, cardiogenic shock or episodes of heart failure decompensation requiring i.v. inotropic therapy.
• In addition, as with other beta-blocking agents, nebivolol is contraindicated in:
• sick sinus syndrome, including sino-atrial block;
• second and third degree heartatrioventricular block (without a pacemaker);
• history of bronchospasm andsevere bronchial asthma; or severe chronic obstructive pulmonary disease.
• untreated phaeochromocytoma;
• metabolic acidosis;
• bradycardia (heart rate < 60 bpm prior to starting therapy);
• hypotension (systolic blood pressure < 90 mmHg);
• severe peripheral circulatory disturbances.;
• combinations with floctafenine and sultopride (seealso section 4.5)
Section 4.4:
See also section 4.8 Undesirable effects.
Caution should be observed with certain anaesthetics that cause myocardial depression, such as cyclopropane, ether or trichlorethylene. The patient can be protected against vagal reactions by intravenous administration of atropine.
Cardiovascular:
In general, beta-adrenergic antagonists should not be used in patients with untreated congestive heart failure (CHF), unless their condition has been stabilised.
Combination of nebivolol with calcium channel antagonists of the verapamil and diltiazem type, with Class I antiarrhythmic drugs, and with centrally acting antihypertensive drugs is generally not recommended.For details please refer to (see section 4.5).
This medicinal product contains lactose. Patients with rare hereditary problems of
galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
The initiation of chronic heart failure treatment with nebivolol necessitates regular monitoring. For the posology and method of administration please refer to section 4.2. Treatment discontinuation should not be discontinued done abruptly unless clearly indicated. For further information please refer to section 4.2.
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Section 4.5:
Pharmacodynamic Iinteractions:
The following interactions apply to beta-adrenergic antagonists in general.
Combinations not recommended:
Class I antiarrhythmicsdrugs (quinidine, hydroquinidine, cibenzoline, flecainide, disopyramide, lidocaine, mexiletine, propafenone): effect on atrio-ventricular conduction time may be potentiated and negative inotropic effect increased (see section 4.4).
The anaesthesiologist should be informed when the patient is receivingNeletnebivolol.
Co-administration of cimetidine increased the plasma levels of nebivolol, without changing the clinical effect. Co-administration of ranitidine did not affect the pharmacokinetics of nebivolol. ProvidedNelet nebivolol is taken with a meal, and an antacid between meals, the two treatments can be co-prescribed.
Combining nebivolol with nicardipine slightly increased the plasma levels of both drugs, without changing the clinical effect. Co-administration of alcohol, furosemide or hydrochlorothiazide did not affect the pharmacokinetics of nebivolol. Nebivolol does not affect the pharmacokineticsor and pharmacodynamics of warfarin.
Section 4.6:
Use in pPregnancy
Nelet has pharmacological effects that may causecan be harmful effects onduring pregnancy
and/orfor the foetus/ new born. In general, beta-adrenoceptor blockers reduce placental perfusion, which has been associated with growth retardation, intrauterine death, abortion or early labour.
Use in lactationBreast-feeding
Section 4.7:
Some patients may experience adverse effects (see. section 4.8) which are mostly due to the reduction in blood pressure, such as When driving vehicles or operating machines it should be taken into account that dizziness and fatigue may occasionally occur.or fainting. Should these occur, one should refrain from driving and other activities requiring alertness.
These effects are more likely to occur after initiation of the treatment or after dose increases.
Section 4.8:
The frequency of adverse reactions listed below is defined with the following conventions:
Hypertension
The adverse reactions reported, which are in most of the cases of mild to moderate intensity, are tabulated below, classified by system organ class and ordered by frequency:
Side effects table updated.
The following adverse reactions have also been reported with some beta-adrenergic antagonists: hallucinations, psychoses, confusion, cold/cyanotic extremities, Raynaud phenomenon, dry eyes, and oculo-mucocutaneous toxicity of the practolol-type.
Chronic heart failure(CHF) 1
Data on adverse reactions in CHF patients are available from one placebo-controlled clinical trial involving 1067 patients taking nebivolol and 1061 patients taking placebo. In this study, a total of 449 nebivolol patients (42.1%) reported at least possibly causally-related adverse reactions compared to 334 placebo patients (31.5%). . The most commonly reported adverse reactions in nebivolol patients were bradycardia and dizziness, both occurring in approximately 11% of patients. The corresponding frequencies among placebo patients were approximately 2% and 7%, respectively.
The following incidences were reported for adverse reactions (at least possibly drug related) which are considered specifically relevant in the treatment of chronic heart failure:
- Aggravation of cardiac failure occurred in 5.8 % of nebivolol patients compared to 5.2% of placebo patients.
- Postural hypotension was reported in 2.1% of nebivolol patients compared to 1.0% of placebo patients.
- Drug intolerance occurred in 1.6% of nebivolol patients compared to 0.8% of placebo patients.
- First degree atrio-ventricular block occurred in 1.4% of nebivolol patients compared to 0.9% of placebo patients.
- Oedema of the lower limb were reported by 1.0% of nebivolol patients compared to 0.2% of placebo patients.
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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie.
Section 4.9:
No data are available on overdosage withNeletnebivolol.
Symptoms
Symptoms of overdosage with beta-blockers are: bradycardia, hypotension, bronchospasm and acute cardiac insufficiency.
Section 5.1:
In vitro and in vivo experiments in animals showed thatNelet nebivolol has no intrinsic sympathicomimetic activity.
Section 5.2:
Distribution
In plasma, both nebivolol enantiomers are predominantly bound to albumin. Plasma protein binding is 98.1% for SRRR-nebivolol and 97.9% for RSSS-nebivolol.
BiotransformationMetabolism
Nebivolol is extensively metabolised, partly to active hydroxy-metabolites. Nebivolol is metabolised via alicyclic and aromatic hydroxylation, N-dealkylation and glucuronidation; in addition, glucuronides of the hydroxy-metabolites are formed. The metabolism of nebivolol by aromatic hydroxylation is subject to the CYP2D6 dependent genetic oxidative polymorphism. The oral bioavailability of nebivolol averages 12% in fast metabolisers and is virtually complete in slow metabolisers. At steady state and at the same dose level, the peak plasma concentration of unchanged nebivolol is about 23 times higher in poor metabolisers than in extensive metabolisers. When unchanged drug plus active metabolites are considered, the difference in peak plasma concentrations is 1.3 to 1.4 fold. Because of the variation in rates of metabolism, the dose ofNelet nebivolol 5 mg should always be adjusted to the individual requirements of the patient: poor metabolisers therefore may require lower doses. Furthermore, the dose should be adjusted for patients over 65 years, patients with renal insufficiency and patients with hepatic insufficiency (see section 4.2).
Distribution
In plasma, both nebivolol enantiomers are predominantly bound to albumin. Plasma protein binding is 98.1% for SRRR-nebivolol and 97.9% for RSSS-nebivolol. The volume of distribution is between 10.1 and 39.4 l/kg.
Eliminationxcretion
One week after administration, 38% of the dose is excreted in the urine and 48% in the faeces. Urinary excretion of unchanged nebivolol is less than 0.5% of the dose.
Section 5.3:
Typo error corrected
Section 6.1:
Lactose monohydrate
Croscarmellose sodium
MaizeSstarch, maize
Polysorbate 80
HypromelloseHydroxypropyl methylcellulose
Microcrystalline cCellulose, microcrystalline
Silica, colloidal anhydrous
Magnesium stearate
Section 9:
Date of first authorisation: 5th June 2009
Date of last renewal: 15th July 2013
Section 2: Each tablet contains 5.45 mg of nebivolol hydrochloride equivalent to 5.
Excipient with known effect:
Each tablet contains 145.45 mg of lactose monohydrate
For
Section 3:
The tablet can be divided into 4 equal doses
Section 4.1:
Hypertension
Treatment of E
Chronic heart failure (CHF)
Treatment of stable, mild to moderate chronic heart failure (CHF) in addition to standard therapies in elderly patients ≥ 70 years.
Section 4.2:
For oral administration
The tablet or its parts should be swallowed with a sufficient amount of fluid (e.g. one glass of water). The tablet can be taken with or without food.
Children and adolescents:
The efficacy and safety of nebivolol in children and adolescents aged below 18 years has not been established. No data are available. Therefore, use in children and adolescents
For those patients receiving cardiovascular drug therapy including diuretics and/or digoxin and/or ACE inhibitors and/or angiotensin II antagonists, dosing of these drugs should be stabilised during the past two weeks prior to initiation of
Initiation of therapy and every dose increase should be done under the supervision of an experienced physician over a period of at least 2 hours to ensure that the clinical status (especially as regards
Treatment of stable chronic heart failure with nebivolol is generally a long-term treatment.
Children and adolescents:
The efficacy and safety of nebivolol in children and adolescents aged below 18 years has not been established. No data are available. Therefore, use in children and adolescents
Method of administration
For oral administration.
The tablet or its parts should be swallowed with a sufficient amount of fluid (e.g. one glass of water). The tablet can be taken with or without food.
Section 4.3:
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
• Liver insufficiency or liver function impairment.
• Acute heart failure, cardiogenic shock or episodes of heart failure decompensation requiring i.v. inotropic therapy.
• sick sinus syndrome, including sino-atrial block;
• second and third degree heart
• history of bronchospasm and
• metabolic acidosis;
• bradycardia (heart rate < 60 bpm prior to starting therapy);
• hypotension (systolic blood pressure < 90 mmHg);
• severe peripheral circulatory disturbances.;
• combinations with floctafenine and sultopride (see
Section 4.4:
See also section 4.8 Undesirable effects.
Caution should be observed with certain anaesthetics that cause myocardial depression
Cardiovascular:
In general, beta-adrenergic antagonists should not be used in patients with untreated congestive heart failure (CHF), unless their condition has been stabilised.
Combination of nebivolol with calcium channel antagonists of the verapamil and diltiazem type, with Class I antiarrhythmic drugs, and with centrally acting antihypertensive drugs is generally not recommended.
galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Section 4.5:
Pharmacodynamic I
The following interactions apply to beta-adrenergic antagonists in general.
Combinations not recommended:
Class I antiarrhythmics
The anaesthesiologist should be informed when the patient is receiving
Co-administration of cimetidine increased the plasma levels of nebivolol, without changing the clinical effect. Co-administration of ranitidine did not affect the pharmacokinetics of nebivolol. Provided
Combining nebivolol with nicardipine slightly increased the plasma levels of both drugs, without changing the clinical effect. Co-administration of alcohol, furosemide or hydrochlorothiazide did not affect the pharmacokinetics of nebivolol. Nebivolol does not affect the pharmacokinetics
Section 4.6:
Nelet has pharmacological effects that may cause
and/or
Section 4.7:
These effects are more likely to occur after initiation of the treatment or after dose increases.
Section 4.8:
The adverse reactions reported, which are in most of the cases of mild to moderate intensity, are tabulated below, classified by system organ class and ordered by frequency:
Side effects table updated.
The following adverse reactions have also been reported with some beta-adrenergic antagonists: hallucinations, psychoses, confusion, cold/cyanotic extremities, Raynaud phenomenon, dry eyes, and oculo-mucocutaneous toxicity of the practolol-type.
Chronic heart failure
The following incidences were reported for adverse reactions (at least possibly drug related) which are considered specifically relevant in the treatment of chronic heart failure:
- Aggravation of cardiac failure occurred in 5.8 % of nebivolol patients compared to 5.2% of placebo patients.
- Postural hypotension was reported in 2.1% of nebivolol patients compared to 1.0% of placebo patients.
- Drug intolerance occurred in 1.6% of nebivolol patients compared to 0.8% of placebo patients.
- First degree atrio-ventricular block occurred in 1.4% of nebivolol patients compared to 0.9% of placebo patients.
- Oedema of the lower limb were reported by 1.0% of nebivolol patients compared to 0.2% of placebo patients.
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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail:medsafety@hpra.ie.
Section 4.9:
No data are available on overdosage with
Symptoms
Symptoms of overdosage with beta-blockers are: bradycardia, hypotension, bronchospasm and acute cardiac insufficiency.
Section 5.1:
In vitro and in vivo experiments in animals showed that
Section 5.2:
Distribution
In plasma, both nebivolol enantiomers are predominantly bound to albumin. Plasma protein binding is 98.1% for SRRR-nebivolol and 97.9% for RSSS-nebivolol.
Biotransformation
Nebivolol is extensively metabolised, partly to active hydroxy-metabolites. Nebivolol is metabolised via alicyclic and aromatic hydroxylation, N-dealkylation and glucuronidation; in addition, glucuronides of the hydroxy-metabolites are formed. The metabolism of nebivolol by aromatic hydroxylation is subject to the CYP2D6 dependent genetic oxidative polymorphism. The oral bioavailability of nebivolol averages 12% in fast metabolisers and is virtually complete in slow metabolisers. At steady state and at the same dose level, the peak plasma concentration of unchanged nebivolol is about 23 times higher in poor metabolisers than in extensive metabolisers. When unchanged drug plus active metabolites are considered, the difference in peak plasma concentrations is 1.3 to 1.4 fold. Because of the variation in rates of metabolism, the dose of
Distribution
In plasma, both nebivolol enantiomers are predominantly bound to albumin. Plasma protein binding is 98.1% for SRRR-nebivolol and 97.9% for RSSS-nebivolol. The volume of distribution is between 10.1 and 39.4 l/kg.
One week after administration, 38% of the dose is excreted in the urine and 48% in the faeces. Urinary excretion of unchanged nebivolol is less than 0.5% of the dose.
Section 5.3:
Typo error corrected
Section 6.1:
Lactose monohydrate
Croscarmellose sodium
Maize
Hypromellose
Microcrystalline c
Silica, colloidal anhydrous
Magnesium stearate
Section 9:
Date of first authorisation: 5th June 2009
Date of last renewal: 15th July 2013
Updated on 28 September 2015 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 10 September 2015 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to storage instructions
- Change to side-effects
- Change to drug interactions
- Change to information about pregnancy or lactation
- Change to further information section
- Change to date of revision
- Change to dosage and administration
Updated on 15 September 2014 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
- Addition of manufacturer
Updated on 13 May 2011 PIL
Reasons for updating
- New PIL for medicines.ie
Updated on 10 May 2011 SmPC
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
In section 6.5 :
Aluminium-Aluminium perforated unit dose blisters in pack sizes of 28 x 1, 56 x 1, 100 x 1 tablets added
Updated on 21 March 2011 SmPC
Reasons for updating
- New SPC for medicines.ie
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
None provided