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• Yellowing of the skin or eyes, a
fever or tenderness around the
middle. These are signs that your
liver may not be functioning as
well as usual

Patient Information Leaflet

5. How should Securon IV be

Securon® IV 2.5 mg/ml
aqueous solution for
intravenous injection

Do not store above 30°C and
protect from light. The doctor or
nurse will check that the expiry
date on the label has not passed
Other side effects with verapamil
include flushing of the face or neck, before you are given the injection.
It should NOT be used after the
sweating, headaches, tiredness,
expiry date printed on the label.
seizures, dizziness, vertigo,
nervousness, movement disorders,
abnormal discomfort, nausea,
6. Further information about
abdominal pain or vomiting.
Securon IV

Verapamil Hydrochloride

• Keep this leaflet as you may
need to read it again

Marketing Authorisation and
Manufacturer’s Details
Marketing Authorisation Holder:
BGP Products Ltd., Abbott House,
Vanwall Business Park, Vanwall
Road, Maidenhead, Berkshire,
SL6 4XE, United Kingdom.
28923 Alcorc6n-Madrid, Spain.

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 at:
By reporting side effects you can
help provide more information on
the safety of this medicine.

If the answer to any of the following
questions is ‘YES’ please tell your
doctor or pharmacist BEFORE
receiving Securon IV:

Read all of this leaflet carefully
before you receive Securon IV


What Securon IV looks like:
The product is available in 2 ml
ampoules, each containing 5 mg of
verapamil hydrochloride.

2. What should you know before
receiving Securon IV?


What Securon IV contains:
Each ampoule of injection
solution contains 2.5 mg per ml
verapamil hydrochloride in water
for injections and sodium chloride,
with hydrochloric acid as pH

If you experience any other
unusual symptoms after you
have received Securon IV,
tell your doctor, nurse or

Securon IV belongs to a group of
medicines called calcium channel
blockers; its active ingredient is
verapamil hydrochloride. Securon
IV is used to treat abnormal heart
rhythms such as an irregular or
rapid heart rate.

• Are you are sensitive (allergic) to
the active ingredient verapamil
hydrochloride or any of the other
ingredients in the medicine? (See
section 6)
• Are you pregnant, planning to
become pregnant or breastfeeding?
• Do you have kidney problems?
• Do you have very low blood
• Do you have an abnormally slow,
fast or irregular heartbeat?
• Do you have or have you ever
suffered from heart problems
such as heart failure, or the
heart condition called WolffParkinson-White syndrome?
• Are you currently receiving
intravenous beta-blockers, e.g.
atenolol, propranolol?

• This leaflet provides a summary
of the information currently
available on Securon IV
• For further information or advice
ask your doctor or pharmacist
• Tell your doctor or pharmacist if
you experience any side effects

Leaflet contents:
1. What is Securon IV and what is it
used for?
2. What should you know before
receiving Securon IV?
3. How will you receive Securon IV?
4. Possible side effects
5. How should Securon IV be
6. Further information about
Securon IV

This leaflet was last revised in
July 2016.



Other side effects may sometimes
occur with long-term verapamil
treatment. Tell your doctor if
you develop swollen gums which
spread over your teeth, or (in
males) if your breasts swell. These
effects are very rare and resolve on
stopping treatment.

1. What is Securon IV and what
is it used for?



Skin and subcutaneous tissue disorders:
Steven-Johnson syndrome, erythema
and hyperhidrosis.
Reproductive system and breast
disorders: On very rare occasions,
gynaecomastia has been observed in
elderly male patients under long-term
verapamil treatment; this was fully
reversible in all cases when the drug was

Do not store above 30°C. Protect from

4.9. Overdose

7. Marketing Authorisation Holder

The symptoms of overdosage
include hypotension, shock, loss of
consciousness, first and second degree
AV block (frequently as Wenckebach’s
phenomenon with or without escape
rhythms), total AV block with total AV
dissociation, escape rhythm, asystole,
bradycardia up to high degree AV block
and, sinus arrest, hyperglycaemia,
stupor and metabolic acidosis. Fatalities
have occurred as a result of overdose.

4.2. Posology and Method of
For slow intravenous injection.
Adults: 5-10 mg by slow intravenous
injection over a period of 2 minutes.
The patient should be observed
continuously, preferably under ECG and
blood pressure control. If necessary,
e.g. in paroxysmal tachycardia, a further
5 mg may be given after 5 to 10 minutes.

The prescriber should be familiar with
the full SmPC in order to determine
the appropriateness of the use of the
product in a particular patient. The full
SmPC can be found on the electronic
Medicines Compendium (eMC) website:
The Patient Information Leaflet provided
(see other half of this leaflet) should be
given to the patient.

Children: Securon IV must always be
administered under ECG monitoring in
young patients.
0-1 year: 0.1-0.2 mg/kg bodyweight
(usual single dose range: 0.75-2 mg).
1-15 years: 0.1-0.3 mg/kg bodyweight
(usual single dose range: 2-5 mg).
The dose may be repeated after 30
minutes if necessary. Many cases are
controlled by doses at the lower end
of the range. The injection should be
stopped at the onset of the desired

1. Trade Name of the Medicinal
Securon IV

8. Marketing Authorisation Number

2. Qualitative and Quantitative

PL 43900/0026

Elderly: The dosage should be
administered over 3 minutes to minimise
the risk of adverse effects.

Verapamil Hydrochloride BP 2.5 mg/ml


Dosage in impaired liver and renal
function: Significant hepatic and renal
impairment should not increase the
effects of a single intravenous dose but
may prolong its duration of action.

3. Pharmaceutical Form

This technical leaflet was last revised in
February 2016.

Aqueous solution for intravenous





Securon IV is indicated for the treatment
of paroxysmal supraventricular
tachycardia and the reduction of
ventricular rate in atrial flutter/fibrillation.

This is an extract from the Summary of
Product Characteristics (SmPC) to assist
in the administration of Securon IV 2.5
mg/ml aqueous solution for intravenous

BGP Products Ltd.
Abbott House, Vanwall Business Park,
Vanwall Road,
Maidenhead, Berkshire, SL6 4XE , UK.

Treatment of overdosage depends on
the type and severity of symptoms.
The specific antidote is calcium, e.g.
10-20 ml of 10% calcium gluconate

Securon® IV 2.5 mg/ml aqueous
solution for intravenous injection

4.1. Therapeutic Indications

The following information is intended for
healthcare professionals only:


6.4. Special Precautions for Storage

4. Clinical Particulars

Verapamil Hydrochloride BP

In the case of hypotension, after
appropriately positioning the patient,
dopamine, dobutamine or noradrenaline
may be given.

Investigations: A reversible impairment
of liver function characterized by an
increase of transaminase and/or alkaline
phosphatase may occur on very rare
occasions during verapamil treatment
and is most probably a hypersensitivity

The following information is intended
for healthcare professionals only:




solution i.v. (2.25-4.5 mmol) if necessary
by repeated injection or continuous
infusion (e.g. 5 mmol/hour). The
usual emergency measures for acute
cardiovascular collapse should be
applied and followed by intensive care.
Verapamil hydrochloride cannot be
removed by haemodialysis. Similarly,
in the case of second or third degree
AV block, atropine, orciprenaline,
isoprenaline and if required, pacemaker
therapy should be considered. If there
are signs of myocardial insufficiency,
dopamine, dobutamine, cardiac
glycosides or calcium gluconate
(10-20 ml of a 10% solution) can be

Gastrointestinal disorders: gingival
hyperplasia may occur very rarely when
the drug is administered over prolonged
periods, and is fully reversible when the
drug is discontinued. On rare occasions,
vomiting has also been reported.

• Do you have a condition where
the nerve to muscle transmission
is affected e.g. myasthenia
gravis, Lambert-Eaton syndrome,
advanced Duchenne muscular
• Are you being treated with
ivabradine (for heart condition)?

Driving and using machinery
Verapamil may affect
your ability to drive or
operate machinery,
you MUST check with
your doctor before you
do so.

• Dabigatran (medicine to prevent
the formation of blood clots)
• Medicines containing ivabradine
for the treatment of certain heart
• Medicines used to treat
depression (including the herbal
product St John’s Wort}, anxiety
or psychosis. These may include
imipramine, buspirone and lithium
• Medicines known as
immunosuppressants such as
ciclosporin, sirolimus, everolimus
and tacrolimus. These are used to
prevent organ transplant rejection
• Glibenclamide, used to treat
certain types of diabetes
• Aspirin, a non-steroidal antiinflammatory painkiller (NSAID)
used to relieve pain and reduce
• Almotriptan, used to treat
• Midazolam, used as a sedative or
• Theophylline, used to treat
• Cimetidine, used to treat
indigestion or stomach ulcers
• Rifampicin, used to treat
tuberculosis and other types of
• Carbamazepine, phenytoin or
phenobarbital (phenobarbitone).
These medicines are used as anticonvulsants
• Ritonavir, used to treat HIV
• Erythromycin, clarithromycin and
telithromycin, used to treat types
of infection
• Colchicines or sulfinpyrazone,
used to treat gout

Your doctor will monitor you closely
• You have any other heart
problems in addition to the one
you are being treated for
• You need any other medication to
treat your abnormal heart rhythm
• You need to be given an
You MUST tell your doctor if you
are taking any medicines with or
without a prescription or have
recently taken any of the following
• Beta-blockers used to treat
high blood pressure and heart
conditions (these include atenolol,
propranolol and metoprolol)
• Alpha blockers used to treat
high blood pressure and heart
conditions (these include prazosin
and terazosin)
• Medicines Known as ‘statins’
such as atorvastatin, lovastatin,
simvastatin used to lower
cholesterol levels
• Any other medicine for high
blood pressure or an abnormal
heart beat (arrhythmia) such
as quinidine, flecainide,
disopyramide, digoxin and

5-10 mg by slow intravenous
injection over a period of 2
In elderly patients, the injection
may be given at a slower rate.
If necessary, an extra 5 mg may be
injected after 5 to 10 minutes.

This is particularly
important if you have
had prolonged
intravenous therapy
or if you have
switched to oral
(tablet) treatment.
Pregnancy and breast feeding
Please discuss with your doctor
if you are pregnant, planning to
become pregnant or are breast

0-1 Year: 0.1 to 0.2 mg per kg
1-15 years: 0.1 to 0.3 mg per kg
The injection may be repeated after
30 minutes, if necessary.
4. Possible side effects
As with all medicines, Securon IV
can cause side effects. Securon IV
affects the rhythm of the heart, but
may also slow down the heart rate
and cause a drop in blood pressure
in some patients.
The medical team will therefore
monitor you closely during your

Other important information
Do NOT drink grapefruit juice whilst
taking Securon IV as it can effect
the absorption of this medicine. This
does not occur with other fruit juices
such as orange, apple or tomato
3. How will you receive Securon

If you experience any of the
following rare side effects tell
your doctor IMMEDIATELY:

Securon IV is given to you by
injection into a vein (Intravenously).
This will be carried out by a doctor.

• Changes in heart rhythm, chest
pains for the first time or chest
pains becoming frequent

The dose will vary according to your
condition this will be decided by
the doctor. The medical team in the
hospital may monitor your blood
pressure and ECG (The electrical
activity of the heart) throughout your
treatment. The usual doses are as


• Swollen ankles
• Unexpected wheezing, difficulty
breathing, swelling of the mouth,
lips or tongue, itching or a severe
skin rash



For use with beta-blocker therapy,
see ‘Contra-indications’ and ‘Special
Warnings and Precautions for Use’.

small and normally not important but
cardiac failure may be precipitated
or aggravated. In patients with poor
ventricular function, therefore, Securon
IV should only be given after cardiac
failure has been controlled with
appropriate therapy, e.g. digitalis.

4.3. Contra-indications
Hypersensitivity to the active substance
or to any of the excipients.

Although the pharmacokinetics
of verapamil in patients with renal
impairment are not affected, caution
should be exercised and careful patient
monitoring is recommended. Verapamil
is not removed during dialysis.

Cardiogenic shock; acute myocardial
infarction complicated by bradycardia,
marked hypotension or left ventricular
failure; second or third degree AV block
(except in patients with a functioning
artificial ventricular pacemaker); sinoatrial block; sick sinus syndrome (except
in patients with a functioning artificial
ventricular pacemaker); uncompensated
heart failure; bradycardia of less than
50 beats/minute; hypotension of less
than 90 mmHg systolic; simultaneous
administration of intravenous betablockers.

Caution should be exercised in treatment
with HMG CoA reductase inhibitors (e.g.,
simvastatin, atorvastatin or lovastatin)
for patients taking verapamil. These
patients should be started at the lowest
possible dose of verapamil and titrated
upwards. If verapamil treatment is to
be added to patients already taking
an HMG CoA reductase inhibitor (e.g.,
simvastatin, atorvastatin or lovastatin),
refer to advice in the respective statin
product information.

Patients with atrial flutter/fibrillation in
the presence of an accessory pathway
(e.g. WPW syndrome) may develop
increased conduction across the
anomalous pathway and ventricular
tachycardia may be precipitated.

4.4. Special Warnings and Precautions
for Use


Cases of seizures during verapamil
hydrochloride injection have been
In rare cases of hypersensitivity,
bronchospasm accompanied by pruritis
and urticaria has been reported.
Other Reactions from Postmarketing
Surveillance or Phase IV Clinical Trials
Other adverse events reported with
verapamil are listed below by system
organ class:
Psychiatric disorders: on rare occasions,
nervousness has been reported.

Adverse events observed in clinical
trials are depicted in the following
table. Within each system organ class,
the adverse drug reactions are ranked
under headings of frequency, using the
following convention: common (>1/100,
<1/10), uncommon (>1/1,000, <1/100),
rare (>1/10,000, <1/1,000), very rare
(<1/10,000), including isolated reports.

Nervous system disorders: somnolence
and extrapyramidal syndrome.

Frequency Undesirable
Organ Class
common - dizziness
- headache
common - bradycardia
- hypotension
uncommon - tachycardia

4.6. Pregnancy and Lactation
Although animal studies have not shown
any teratogenic effects, verapamil should
not be given during the first trimester
of pregnancy unless, in the clinician’s
judgement, it is essential for the welfare
of the patient. Verapamil crosses the
placental barrier and can be detected
in umbilical vein blood at delivery.

Verapamil may affect impulse
conduction. For this reason, Securon
IV should be used with caution in
patients with bradycardia or first degree
AV block. Verapamil may affect left
ventricular contractility; this effect is

Frequency Undesirable
Organ Class
uncommon - nausea
- abdominal

4.8. Undesirable Effects

Use with caution in the presence of
diseases in which neuromuscular
transmission is affected (myasthenia
gravis, Lambert-Eaton syndrome,
advanced Duchenne muscular

Combination with ivabradine (see
section Interactions with other medicinal
products and other forms of interaction).


Also, verapamil is excreted in human
breast milk. Limited human data from
oral administration has shown that the
infant relative dose of verapamil is low
(0.1-1% of the mother’s oral dose) and
that verapamil use may be compatible
with breastfeeding. However, there
are currently no reports of verapamil
injection or infusion use during
breastfeeding. Due to the potential for
serious adverse reactions in nursing
infants, verapamil should only be used
during lactation if it is essential for the
welfare of the mother.

Ear and labyrinth disorders: vertigo.
Cardiac disorders/vascular disorders:
decreased myocardial contractility has
been reported. On rare occasions, 2nd
and 3rd block may occur and in extreme
cases, this may lead to asystole. The
asystole is usually of short duration and
cardiac action returns spontaneously
after a few seconds, usually in the
form of sinus rhythm. If necessary,
the procedures for the treatment of
overdosage should be followed as
described below. On rare occasions,
flushing has been reported.





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