NEBIVOLOL 5 mg tablets

CONFIDENTIAL 1.8.2 Risk Management Plan, ver. 1

 Undesirable events un Section 4.8 Respiratory, thoracic and mediastinal disorders: Common: dyspnoea Uncommon: bronchospasm

 Prescription only medicine Missing information  Information on recommendation in Not applicable on use in paediatric section 4.2 population Children and adolescents No studies have been conducted in children and adolescents. Therefore, use in children and adolescents is not recommended

VI.2 Elements for a Public Summary

VI.2.1 Overview of disease epidemiology

Not applicable for generic application.

VI.2.2 Summary of treatment benefits

Based on the available data from clinical studies and clinical experience of several years, nebivolol represents an effective drug in the treatment of hypertension and chronic heart failure in adult patients.

If administered as indicated in the Summary of Product Characteristics and taking into account the Part VI: Summary of activities in the risk management plan, nebivolol can be considered effective in the approved indications and generally well tolerated.

VI.2.3 Unknowns relating to treatment benefits

The safety and efficacy of nebivolol have not been studied in children and adolescents and are therefore unknown. Use of nebivolol in paediatric population is indicated as important missing information (see section VI.2.4). Nebilenin is not recommended for use in this patient age group.

VI.2.4 Summary of safety concerns

Important identified risks

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NEBIVOLOL 5 mg tablets

CONFIDENTIAL 1.8.2 Risk Management Plan, ver. 1

Risk What is known Preventability Problem with heart and vessels Cardiovascular disorders are the The patient should inform his/her (Cardiovascular disorders) problems of your heart and blood doctor about problems with heart vessels. These could include such or vessels. conditions as abnormally slow Nebivolol must not be prescribed heartbeat (bradycardia), low to patients with conditions such blood pressure, worsening of as low blood pressure, serious problems with peripheral circulation problems in arms and circulation. legs, very slow heartbeat and certain other heart rhythm problems, and recently experienced heart failure. A special care should be taken when taking nebivolol while developing health problems such as abnormally slow heartbeat, untreated chronic heart failure or poor circulation in arms and legs. You will be regularly monitored at the beginning of your treatment for chronic heart failure by an experienced physician Patients should inform physician about any unusual heart symptoms. Patients should not use other for controlling the blood pressure or medicines for heart problems (such as , , cibenzoline, clonidine, digoxin, , , , , guanfacin, hydroquinidine, lacidipine, , methyldopa, , moxonidine, , , , , , , rilmenidine, ). Patients should also not use Medicines for depression e.g. , paroxetine, .

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NEBIVOLOL 5 mg tablets

CONFIDENTIAL 1.8.2 Risk Management Plan, ver. 1

Masking of symptoms of low Patient with low blood sugar Nebilenin should be taken with blood sugar level level and overactive thyroid special care in patient with (hypoglycaemia) and overactive gland could experience diabetes and overactive thyroid thyroid gland symptoms such fast heartbeat or gland. (hyperthyroidism) palpitation which normally are a Patients should inform physician warning signal. This warning about any problems with blood signal could be masked by intake sugar level or thyroid gland. of nebivolol. Nebilenin has no effect on blood sugar level or thyroid gland. Aggravation of airways Nebivolol could strengthen Nebilenin should not be contraction in patients with contraction of airways in patients prescribed patients with asthma asthma or wheezing (or chronic with long term lung disorders and wheezing symptoms. obstructive pulmonary (now or in the past) that are disorders) presented with airways contraction.

Important missing information

Risk What is known No information on use in children Since no clinical trials with nebivolol have been conducted in this and adolescents patient group use of Nebilenin in children and adolescents is not recommended.

VI.2.5 Summary of risk minimisation measures by safety concern

No additional risk minimisation measures are proposed.

VI.2.6 Planned post authorisation development plan

Not applicable.

VI.2.7 Summary of changes to the Risk Management Plan over time

Not applicable. This is the first RMP version.

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