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VERAPAMIL HYDROCHLORIDE 2.5 MG/ML SOLUTION FOR INJECTION

Active substance(s): VERAPAMIL HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

2700
13.09.16[6]

Securon® IV
(verapamil hydrochloride)
IMPORTANT INFORMATION
Read all of this leaflet carefully before you receive Securon IV
 Keep this leaflet as you may need to read it again
 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
Your medicine is available using the above name but will be referred to
as Securon IV throughout this leaflet.
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 stored?
6. Further information about Securon IV
1. What is Securon IV and what is it used for?
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.

The following information is intended for healthcare professional
only:

Securon® IV
(verapamil hydrochloride)
The following information is intended for healthcare professionals only:
This is an extract from the Summary of Product Characteristics (SmPC)
to assist in the administration of Securon IV for intravenous injection.
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: http://www.medicines.org.uk/emc/.
The Patient Information Leaflet provided (see other half of this leaflet)
should be given to the patient.
1. Trade Name of the Medicinal Product
Securon IV
2. Qualitative and Quantitative Composition
Verapamil Hydrochloride 2.5 mg/ml
3. Pharmaceutical Form
Aqueous solution for intravenous injection.
4. Clinical Particulars
4.1. Therapeutic Indications
Securon IV is indicated for the treatment of paroxysmal supraventricular
tachycardia and the reduction of ventricular rate in atrial flutter/fibrillation.
4.2. Posology and Method of Administration
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 5mg may be given after 5 to 10 minutes.
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 effect.
Elderly: The dosage should be administered over 3 minutes to minimise
the risk of adverse effects.
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.
For use with beta-blocker therapy, see ‘Contra-indications’ and ‘Special
Warnings and Precautions for Use’.
4.3. Contra-indications
Hypersensitivity to the active substance or to any of the excipients.
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.

2. What should you know before receiving Securon IV?
If the answer to any of the following questions is ‘YES’ please tell your
doctor or pharmacist BEFORE receiving Securon IV:
 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 breast-feeding?
 Do you have kidney problems?
 Do you have very low blood pressure?
 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 Wolff-Parkinson-White
syndrome?
 Are you currently receiving intravenous beta-blockers, e.g. atenolol,
propranolol?
 Do you have a condition where the nerve to muscle transmission is
affected e.g. myasthenia gravis, Lambert-Eaton syndrome, advanced
Duchenne muscular dystrophy?
 Are you being treated with ivabradine (for heart condition)?

 Dabigatran (medicine to prevent the formation of blood clots)
 Medicines containing ivabradine for the treatment of certain heart

Your doctor will monitor you closely if:
 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 anaesthetic




You MUST tell your doctor if you are taking any medicines with or
without a prescription or have recently taken any of the following
medicines:
 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
digitoxin

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 maybe
precipitated.
Combination with ivabradine (see section Interactions with other
medicinal products and other forms of interaction).
4.4. Special Warnings and Precautions for Use
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
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.
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.
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.
Use with caution in the presence of diseases in which neuromuscular
transmission is affected (myasthenia gravis, Lambert-Eaton syndrome,
advanced Duchenne muscular dystrophy)
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.
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.
4.8. Undesirable Effects
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.
System Organ
Class
Nervous system
disorders

Frequency

Undesirable
Effects

common

- dizziness
- headache

common

- bradycardia
- hypotension
- tachycardia

Cardiac disorders/
vascular disorders

uncommon
Gastrointestinal
disorders
uncommon

- nausea
- abdominal pain

diseases

 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 anti-inflammatory painkiller (NSAID) used to
relieve pain and reduce fever
Almotriptan, used to treat migraine
Midazolam, used as a sedative or anaesthetic
Theophylline, used to treat asthma
Cimetidine, used to treat indigestion or stomach ulcers
Rifampicin, used to treat tuberculosis and other types of infection
Carbamazepine, phenytoin or phenobarbital (phenobarbitone). These
medicines are used as anti-convulsants
Ritonavir, used to treat HIV
Erythromycin, clarithromycin and telithromycin, used to treat types of
infection
Colchicines or sulfinpyrazone, used to treat gout

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

Cases of seizures during verapamil hydrochloride injection have been
reported.
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.
Nervous system disorders: somnolence and extrapyramidal syndrome.
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.
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.
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 longterm verapamil treatment; this was fully reversible in all cases when the
drug was discontinued.
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 reaction.
4.9. Overdose
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.
Treatment of overdosage depends on the type and severity of symptoms.
The specific antidote is calcium, e.g. 10-20ml of 10% calcium gluconate
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, or ciprenaline, 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 administered.
In the case of hypotension, after appropriately positioning the patient,
dopamine, dobutamine or noradrenaline may be given.
6.4. Special Precautions for Storage
Do not store above 30°C. Protect from light.
Administrative Data
7. Product Licence Holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1
1XD.
The product is available in 2 ml clear glass ampoules containing a
colourless solution, each containing 5 mg of verapamil hydrochloride.
Pack size: 5x2ml
Leaflet revision and issue date (Ref.) 13.09.16[6]
Securon is a trademark of Abbott GmbH & Co.

3. How will you receive Securon IV?
Securon IV is given to you by injection into a vein (Intravenously). This
will be carried out by a doctor.
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 follows
Adults:
5-10 mg by slow intravenous injection over a period of 2 minutes.
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.
Children:
0-1 Year: 0.1 to 0.2 mg per kg bodyweight
1-15 years: 0.1 to 0.3 mg per kg bodyweight
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
treatment.
If you experience any of the following rare side effects tell your
doctor IMMEDIATELY:
 Changes in heart rhythm, chest pains for the first time or chest pains
becoming frequent
 Swollen ankles
 Unexpected wheezing, difficulty breathing, swelling of the mouth, lips
or tongue, itching or a severe skin rash
 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
Other side effects with verapamil include flushing of the face or neck,
sweating, headaches, tiredness, seizures, dizziness, vertigo,
nervousness, movement disorders, abnormal discomfort, nausea,
abdominal pain or vomiting.

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.
If you experience any other unusual symptoms after you have
received Securon IV, tell your doctor, nurse or pharmacist.
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:
www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. How should Securon IV be stored?
Do not store above 30°C. Protect from light.
The doctor or nurse will check that the expiry date on the label has not
passed before you are given the injection. It should NOT be used after
the expiry date printed on the label.
If your doctor decides to stop your treatment, return any left over
medicine to your pharmacist.
Only keep the medicine if your doctor tells you to. Do not dispose of left
over medicine carelessly (e.g. down the toilet or in with your general
rubbish).
If your medicine becomes discoloured or shows any other signs of
deterioration, consult your doctor or pharmacist who will tell you what to
do.

6. Further Information about 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 adjuster.
What Securon IV looks like:
The product is available in 2 ml clear glass ampoules containing a
colourless solution, each containing 5 mg of verapamil hydrochloride.
Pack size: 5x2ml
Manufacturer and Product Licence Holder
Manufactured by Famar Health Care Services Madrid S.A.U., Avda. de
Leganés, 62 28923 Alcorcón-Madrid, Spain. Procured from the EU by
Product Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close,
Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2700

Leaflet revision and issue date (Ref.) 13.09.16[6]
Securon is a trademark of Abbott GmbH & Co. KG

PATIENT INFORMATION LEAFLET

2700
13.09.16[6]

Verapamil Hydrochloride 2.5 mg/ml solution
for injection
IMPORTANT INFORMATION
Read all of this leaflet carefully before you receive Verapamil
Hydrochloride
 Keep this leaflet as you may need to read it again
 This leaflet provides a summary of the information currently available
on Verapamil Hydrochloride
 For further information or advice ask your doctor or pharmacist
 Tell your doctor or pharmacist if you experience any side effects
Your medicine is available using the above name but will be referred to
as Verapamil Hydrochloride throughout this leaflet.
Leaflet contents:
1. What is Verapamil Hydrochloride and what is it used for?
2. What should you know before receiving Verapamil Hydrochloride?
3. How will you receive Verapamil Hydrochloride?
4. Possible side effects
5. How should Verapamil Hydrochloride be stored?
6. Further information about Verapamil Hydrochloride
1. What is Verapamil Hydrochloride and what is it used for?
Verapamil Hydrochloride belongs to a group of medicines called calcium
channel blockers; its active ingredient is verapamil hydrochloride.
Verapamil hydrochloride is used to treat abnormal heart rhythms such as
an irregular or rapid heart rate.

The following information is intended for healthcare professional
only:

Verapamil Hydrochloride 2.5 mg/ml solution
for injection

2. What should you know before receiving Verapamil
Hydrochloride?
If the answer to any of the following questions is ‘YES’ please tell your
doctor or pharmacist BEFORE receiving Verapamil Hydrochloride:
 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 breast-feeding?
 Do you have kidney problems?
 Do you have very low blood pressure?
 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 Wolff-Parkinson-White
syndrome?
 Are you currently receiving intravenous beta-blockers, e.g. atenolol,
propranolol?
 Do you have a condition where the nerve to muscle transmission is
affected e.g. myasthenia gravis, Lambert-Eaton syndrome, advanced
Duchenne muscular dystrophy?
 Are you being treated with ivabradine (for heart condition)?
Your doctor will monitor you closely if:
 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 anaesthetic
You MUST tell your doctor if you are taking any medicines with or
without a prescription or have recently taken any of the following
medicines:
 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
digitoxin

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

The following information is intended for healthcare professionals only:
This is an extract from the Summary of Product Characteristics (SmPC)
to assist in the administration of Verapamil Hydrochloride for intravenous
injection.
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: http://www.medicines.org.uk/emc/.
The Patient Information Leaflet provided (see other half of this leaflet)
should be given to the patient.
1. Trade Name of the Medicinal Product
Verapamil Hydrochloride 2.5 mg/ml solution for injection
2. Qualitative and Quantitative Composition
Verapamil Hydrochloride 2.5 mg/ml
3. Pharmaceutical Form
Aqueous solution for intravenous injection.
4. Clinical Particulars
4.1. Therapeutic Indications
Verapamil Hydrochloride is indicated for the treatment of paroxysmal
supraventricular tachycardia and the reduction of ventricular rate in atrial
flutter/fibrillation.
4.2. Posology and Method of Administration
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 5mg may be given after 5 to 10 minutes.
Children: Verapamil Hydrochloride must always be administered under
ECG monitoring in young patients.
0-1 year: 0.1-0.2 mg/kg body weight (usual single dose range: 0.75-2mg).
1-15 years: 0.1-0.3 mg/kg body weight (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 effect.
Elderly: The dosage should be administered over 3 minutes to minimise
the risk of adverse effects.
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.
For use with beta-blocker therapy, see ‘Contra-indications’ and ‘Special
Warnings and Precautions for Use’.
4.3. Contra-indications
Hypersensitivity to the active substance or to any of the excipients.
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 than50 beats/minute;
hypotension of less than 90 mmHg systolic; simultaneous administration
of intravenous beta-blockers.

4.4. Special Warnings and Precautions for Use
Verapamil may affect impulse conduction. For this reason, Verapamil
Hydrochloride should be used with caution in patients with bradycardia or
first degree AV block. Verapamil may affect left ventricular contractility;
this effect is small and normally not important but cardiac failure may be
precipitated or aggravated. In patients with poor ventricular function,
therefore, Verapamil Hydrochloride should only be given after cardiac
failure has been controlled with appropriate therapy, e.g. digitalis.
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.
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.
Use with caution in the presence of diseases in which neuromuscular
transmission is affected (myastheniagravis, Lambert-Eaton syndrome,
advanced Duchenne muscular dystrophy)
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. 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 breast feeding. 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.
4.8. Undesirable Effects
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.
System Organ
Class
Nervous system
disorders

Frequency

Undesirable
Effects

common

- dizziness
- headache

common

- bradycardia
- hypotension
- tachycardia

Cardiac disorders/
vascular disorders

uncommon
Gastrointestinal
disorders
uncommon

- nausea
- abdominal pain

 Dabigatran (medicine to prevent the formation of blood clots)
 Medicines containing ivabradine for the treatment of certain heart
diseases

 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 anti-inflammatory painkiller (NSAID) used to
relieve pain and reduce fever
Almotriptan, used to treat migraine
Midazolam, used as a sedative or anaesthetic
Theophylline, used to treat asthma
Cimetidine, used to treat indigestion or stomach ulcers
Rifampicin, used to treat tuberculosis and other types of infection
Carbamazepine, phenytoin or phenobarbital (phenobarbitone). These
medicines are used as anti-convulsants
Ritonavir, used to treat HIV
Erythromycin, clarithromycin and telithromycin, used to treat types of
infection
Colchicines or sulfinpyrazone, used to treat gout

Driving and using machinery
Verapamil may affect your ability to drive or operate machinery, you
MUST check with your doctor before you do so.
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 feeding.
Other important information
Do NOT drink grapefruit juice whilst taking Verapamil Hydrochloride as it
can effect the absorption of this medicine. This does not occur with other
fruit juices such as orange, apple or tomato juice.

Cases of seizures during verapamil hydrochloride injection have been
reported.
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.
Nervous system disorders: somnolence and extrapyramidal syndrome.
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.
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.
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 longterm verapamil treatment; this was fully reversible in all cases when the
drug was discontinued.
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 reaction.
4.9. Overdose
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.
Treatment of overdosage depends on the type and severity of symptoms.
The specific antidote is calcium, e.g. 10-20ml of 10% calcium gluconate
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, or ciprenaline, 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 administered.
In the case of hypotension, after appropriately positioning the patient,
dopamine, dobutamine or noradrenaline may be given.
6.4. Special Precautions for Storage
Do not store above 30°C. Protect from light.
Administrative Data
7. Product Licence Holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1
1XD.
The product is available in 2 ml clear glass ampoules containing a
colourless solution, each containing 5 mg of verapamil hydrochloride.
Pack size: 5x2ml
Leaflet revision and issue date (Ref.) 13.09.16[6]

3. How will you receive Verapamil Hydrochloride?
Verapamil Hydrochloride is given to you by injection into a vein
(Intravenously). This will be carried out by a doctor.
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 follows
Adults:
5-10 mg by slow intravenous injection over a period of 2 minutes.
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.
Children:
0-1 Year: 0.1 to 0.2 mg per kg bodyweight
1-15 years: 0.1 to 0.3 mg per kg bodyweight
The injection may be repeated after 30 minutes, if necessary.
4. Possible side effects
As with all medicines, Verapamil Hydrochloride can cause side effects.
Verapamil Hydrochloride 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
treatment.
If you experience any of the following rare side effects tell your
doctor IMMEDIATELY:
 Changes in heart rhythm, chest pains for the first time or chest pains
becoming frequent
 Swollen ankles
 Unexpected wheezing, difficulty breathing, swelling of the mouth, lips
or tongue, itching or a severe skin rash
 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
Other side effects with verapamil include flushing of the face or neck,
sweating, headaches, tiredness, seizures, dizziness, vertigo,
nervousness, movement disorders, abnormal discomfort, nausea,
abdominal pain or vomiting.

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.
If you experience any other unusual symptoms after you have
received Verapamil Hydrochloride, tell your doctor, nurse or
pharmacist.
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:
www.mhra.gov.uk/yellowcard. By reporting side effects, you can help
provide more information on the safety of this medicine.
5. How should Verapamil Hydrochloride be stored?
Do not store above 30°C. Protect from light.
The doctor or nurse will check that the expiry date on the label has not
passed before you are given the injection. It should NOT be used after
the expiry date printed on the label.
If your doctor decides to stop your treatment, return any left over
medicine to your pharmacist.
Only keep the medicine if your doctor tells you to. Do not dispose of left
over medicine carelessly (e.g. down the toilet or in with your general
rubbish).
If your medicine becomes discoloured or shows any other signs of
deterioration, consult your doctor or pharmacist who will tell you what to
do.

6. Further Information about Verapamil Hydrochloride
What Verapamil Hydrochloride 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 adjuster.
What Verapamil Hydrochloride looks like:
The product is available in 2 ml clear glass ampoules containing a
colourless solution, each containing 5 mg of verapamil hydrochloride.
Pack size: 5x2ml
Manufacturer and Product Licence Holder
Manufactured by Famar Health Care Services Madrid S.A.U., Avda. de
Leganés, 62 28923 Alcorcón-Madrid, Spain. Procured from the EU by
Product Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close,
Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2700

Leaflet revision and issue date (Ref.) 13.09.16[6]

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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