Hypoloc 5mg tablets

Main information

  • Trade name:
  • Hypoloc 5mg tablets
  • Dosage:
  • 5mg
  • Pharmaceutical form:
  • Tablet
  • Administration route:
  • Oral
  • Class:
  • No Controlled Drug Status
  • Prescription type:
  • Valid as a prescribable product
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Hypoloc 5mg tablets
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Product summary:
  • BNF: 02040000; GTIN: 5038227000263

Status

  • Source:
  • eMC
  • Authorization number:
  • PL 16239/0019
  • Last update:
  • 22-07-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Package leaflet: Information for the user

HYPOLOC

5 mg tablets

Nebivolol

Read all of this leaflet carefully before you start using 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 or nurse. This includes any

possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

What Hypoloc is and what it is used for

What you need to know before you take Hypoloc

How to take Hypoloc

Possible side effects

How to store Hypoloc

Contents of the pack and other information

1.

What Hypoloc is and what it is used for

Hypoloc contains nebivolol, a cardiovascular drug belonging to the group of selective beta-

blocking agents (i.e. with a selective action on the cardiovascular system). It prevents increased

heart rate, controls heart pumping strength. It also exerts a dilating action on blood vessels, which

contributes as well to lower blood pressure.

It is used to treat raised blood pressure (hypertension).

Hypoloc is also used to treat mild and moderate chronic heart failure in patients aged 70 or over,

in addition to other therapies.

2.

What you need to know before you take Hypoloc

Do not take Hypoloc

if you are allergic to nebivolol or any of the other ingredients of this medicine (listed in

section 6).

if you have one or more of the following disorders:

low blood pressure

serious circulation problems in the arms or legs

very slow heartbeat (less than 60 beats per minute)

certain other serious heart rhythm problems (e.g. 2

and 3

degree atrioventricular block,

heart conduction disorders).

heart failure, which has just occurred or which has recently become worse, or you are

receiving treatment for circulatory shock due to acute heart failure by intravenous drip

feed to help your heart work

asthma or wheezing (now or in the past)

untreated phaeochromocytoma, a tumour located on top of the kidneys (in the adrenal

glands)

liver function disorder

a metabolic disorder (metabolic acidosis), for example, diabetic ketoacidosis.

Warnings and precautions

Talk to your doctor or pharmacist before taking Hypoloc.

Inform your doctor if you have or develop one of the following problems:

abnormally slow heartbeat

a type of chest pain due to spontaneously occurring heart cramp called Prinzmetal angina

untreated chronic heart failure

degree heart block (a kind of light heart conduction disorder that affects heart rhythm)

poor circulation in the arms or legs, e.g. Raynaud’s disease or syndrome, cramp-like pains

when walking

prolonged breathing problems

diabetes: This medicine has no effect on blood sugar, but it could conceal the warning signs

of a low sugar level (e.g. palpitations, fast heartbeat).

overactive thyroid gland: This medicine may mask the signs of an abnormally fast heart rate

due to this condition

allergy: This medicine may intensify your reaction to pollen or other substances you are

allergic to

psoriasis (a skin disease - scaly pink patches)

or if you have ever had psoriasis

if you have to have surgery, always inform your anaesthetist that you are on Hypoloc before

being anaesthetised.

If you have serious kidney problems do not take Hypoloc for heart failure and tell your doctor.

You will be regularly monitored at the beginning of your treatment for chronic heart failure by an

experienced physician (see section 3).

This treatment should not be stopped abruptly unless clearly indicated and evaluated by your

doctor (see section 3).

Children and adolescents

Because of the lack of data on the use of the product in children and adolescents, Hypoloc is

not

recommended for use in them.

Other medicines and Hypoloc

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines.

Always tell your doctor if you are using or receiving any of the following medicines in addition

to Hypoloc:

Medicines for controlling the blood pressure or medicines for heart problems (such as

amiodarone,

amlodipine,

cibenzoline,

clonidine,

digoxin,

diltiazem,

disopyramide,

felodipine,

flecainide,

guanfacin,

hydroquinidine,

lacidipine,

lidocaine,

methyldopa,

mexiletine, moxonidine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone,

quinidine, rilmenidine, verapamil).

Sedatives and therapies for psychosis (a mental illness) e.g. barbiturates (also used for

epilepsy), phenothiazine (also used for vomiting and nausea) and thioridazine.

Medicines for depression e.g. amitriptyline, paroxetine, fluoxetine.

Medicines used for anaesthesia during an operation

.

Medicines for asthma, blocked nose or certain eye disorders such as glaucoma (increased

pressure in the eye) or dilation (widening) of the pupil.

Baclofen (an antispasmodic drug); Amifostine (a protective medicine used during cancer

treatment)

All these drugs as well as nebivolol may influence the blood pressure and/or heart function.

Medicines

for treating excessive stomach acid or ulcers (antacid drug): you should take

Hypoloc during a meal and the antacid drug between meals.

Hypoloc with food and drink

Please refer to section 3.

Pregnancy and breast-feeding

Hypoloc should not be used during pregnancy, unless clearly necessary.

It is not recommended for use while 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.

Driving and using machines

This medicine may cause dizziness or fatigue. If affected,

do not

drive or operate machinery.

Hypoloc contains lactose

This product 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.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-

free’.

3.

How to take Hypoloc

Always take this medicine exactly as your doctor has told you. Check with your doctor or

pharmacist if you are not sure.

Hypoloc may be taken before, during or after the meal, but, alternatively, you can take it

independently of meals. The tablet is best taken with some water.

Treatment of raised blood pressure (hypertension)

The usual dose is 1 tablet per day.

The dose should be taken preferably at the same time of

the day.

Elderly patients and patients with a kidney disorder will usually start with ½ (half) tablet

daily.

The therapeutic effect on blood pressure becomes evident after 1-2 weeks of treatment.

Occasionally, the optimal effect is reached only after 4 weeks.

Treatment of chronic heart failure

Your treatment will be started and closely supervised by an experienced physician.

Your doctor will start your treatment with ¼ (quarter) tablet per day. This may be increased

after 1-2 weeks to ½ (half) tablet per day, then to 1 tablet per day and then to 2 tablets per day

until the correct dose is reached for you. Your doctor will prescribe the dose that is right for

you at each step and you should closely follow his/her instructions.

The maximum recommended dose is 2 tablets (10mg) a day.

You will need to be under the close supervision for 2 hours by an experienced physician

when you start treatment and every time your dose is increased

Your doctor may reduce your dose if necessary

You should

not stop

treatment

abruptly

as this can make your heart failure worse.

Patients with serious kidney problems should not take this medicine.

Take your medicine once daily, preferably at about the same time of day.

If you have been told by your doctor to take ¼ (quarter) or ½ (half) tablet daily, please refer to

the instructions below on how to break Hypoloc 5 mg cross-scored tablets.

Place the tablets onto a flat, hard surface (e.g. a table or worktop), with the cross score facing

Break the tablet by pushing it with the index fingers of both hands placed along one

breakmark (Diagrams 1 and 2).

Tablet quarters are obtained by breaking the halves in the same way (Diagrams 3 and 4).

Diagrams 1 and 2: Easy breaking of the Nebivolol 5 mg cross-scored tablet in half.

Diagrams 3 and 4: Easy breaking of half of the Nebivolol 5 mg cross-scored tablet into quarters.

Your doctor may decide to combine Hypoloc tablets with other medicines to treat your

condition.

Do not use in children or adolescents.

If you take more Hypoloc than you should

accidentally

take

overdose

this

medicine,

tell

your

doctor

pharmacist

immediately

. The most frequent symptoms and signs of a Hypoloc overdose are very slow heart

beat (bradycardia), low blood pressure with possible fainting (hypotension), breathlessness such

as in asthma (bronchospasm), and acute heart failure.

You can take activated charcoal (which is available at your pharmacy) while you wait for the

arrival of the doctor.

If you forget to take Hypoloc

If you forget a dose of Hypoloc, but remember a little later on that you should have taken it, take

that day’s dose as usual. However, if a long delay has occurred (e.g. several hours), so that the

next due dose is near, skip the forgotten dose and take the next, scheduled,

normal dose

at the

usual time. Do not take a double dose. Repeated skipping, however, should be avoided.

If you stop taking Hypoloc

You should always consult with your doctor before stopping Hypoloc treatment, whether you are

taking it for high blood pressure or chronic heart failure.

You should not stop Hypoloc treatment abruptly as this can temporarily make your heart failure

worse.

If it is necessary to stop Hypoloc treatment

for chronic heart failure, the daily dose should

be decreased gradually

,

by halving the dose, at weekly intervals.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

When Hypoloc is

used for the treatment of raised blood pressure

, the possible side effects are:

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

headache

dizziness

tiredness

an unusual itching or tingling feeling

diarrhoea

constipation

nausea

shortness of breath

swollen hands or feet.

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

slow heartbeat or other heart complaints

low blood pressure

cramp-like leg pains on walking

abnormal vision

impotence

feelings of depression

digestive difficulties (dyspepsia),

gas in stomach or bowel

,

vomiting

skin rash, itchiness

breathlessness such as in asthma, due to sudden cramps in the muscles around the airways

(bronchospasm)

nightmares.

Very rare side effects

(may affect up to 1 in 10,000 people):

fainting

worsening of psoriasis (a skin disease - scaly pink patches).

The following side effects have been reported only in some isolated cases during Hypoloc

treatment:

whole-body allergic reactions, with generalised skin eruption (hypersensitivity reactions);

rapid-onset swelling, especially around the lips, eyes, or of the tongue with possible sudden

difficulty breathing (angioedema);

kind of skin rash notable for pale red, raised, itchy bumps of allergic or non allergic causes

(urticaria).

In a clinical study for

chronic heart failure,

the following side effects were seen

:

Very common side effects (may affect more than 1 in 10 people):

slow heart beat

dizziness

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

worsening of heart failure

low blood pressure (such as feeling faint when getting up quickly)

inability to tolerate this medicine

a kind of light heart conduction disorder that affects heart rhythm (1

degree AV-block)

swelling of the lower limbs

(such as swollen ankles).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card

Scheme. Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide

more information on the safety of this medicine.

5.

How to store Hypoloc

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions. Do not use this medicine

after the expiry date which is stated on the carton label and blister foil after EXP. The expiry date

refers to the last day of that month.

Do not throw any medicine via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help to protect the environment.

6.

Contents of the pack and other information

What Hypoloc contains

active

substance

nebivolol.

Each

tablet

contains

nebivolol

nebivolol

hydrochloride):

2.5 mg of d-nebivolol and 2.5 mg of l-nebivolol.

The other ingredients are: lactose monohydrate, polysorbate 80 (E433), hypromellose (E464),

maize

starch,

croscarmellose

sodium

(E468),

microcrystalline

cellulose

(E460),

silica

colloidal anhydrous (E551), magnesium stearate (E572).

What Hypoloc looks like and contents of the pack

Hypoloc is available as white, round, cross-scored tablets in packs of 7, 14, 28, 30, 50, 56, 90,

100, 500 tablets. Tablets are provided in blister packs (PVC/aluminium blister).

(Not all pack sizes may be marketed)

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Menarini International Operations Luxembourg S.A.

1, Avenue de la Gare L-1611 Luxembourg

Luxembourg

Manufacturer

Berlin-Chemie AG

Glienicker Weg 125, 12489 Berlin, Germany

Menarini - von Heyden GmbH

Leipziger Strasse 7-13, 01097 – Dresden, Germany

Qualiphar N.V.

Rijksweg 9, 2880 Bornem, Belgium

Marketed by

A. Menarini Farmaceutica Internazionale SRL

This medicinal product is authorised in the Member States of the EEA under the following

names:

Austria: Hypoloc

Belgium: Nobiten

Cyprus: Lobivon

Denmark: Hypoloc

Finland: Hypoloc

France: Temerit

Germany: Nebilet

Greece: Lobivon

Ireland: Hypoloc

Italy: Nebilox

Iceland: Hypoloc

Luxembourg: Nobiten

Norway: Hypoloc

Portugal: Nebilet

Spain: Lobivon

Sweden: Hypoloc

The Netherlands: Nebilet

United Kingdom: Hypoloc

This leaflet was last revised in 06/2018.