Verapamil 40mg tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Verapamil hydrochloride
Available from:
Mawdsley-Brooks & Company Ltd
ATC code:
C08DA01
INN (International Name):
Verapamil hydrochloride
Dosage:
40mg
Pharmaceutical form:
Tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02060200

Package leaflet:Information for the user

Verapamil 40 mg, 80 mg and

120 mg Tablets

verapamil hydrochloride

Read all of this leaflet carefully before you start

taking 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. This includes any possible side

effects not listed in this leaflet. See section 4.

1. What Verapamil is and what it is used for

2. What you need to know before you take

Verapamil

3. How to take Verapamil

4. Possible side effects

5. How to store Verapamil

6. Contents of the pack and other information

What Verapamil is and what it is used for

Verapamil is a calcium channel blocker, which

expands your blood vessels to allow more blood

to flow through them. It also acts on the nerve

signals passing through the heart muscle, which

can help to correct certain types of abnormal

heart rhythm.

Verapamil is used:

to prevent or treat angina (chest pain) and

certain abnormal heart rhythms

to treat high blood pressure.

What you need to know before you take

Verapamil

Do not take Verapamil

if you are allergic to Verapamil or any of the

other ingredients of this medicine (listed in

section 6).

if you have a very slow heart-beat of less than

50 beats per minute.

if you suffer from heart problems including sick

sinus syndrome (causing a slow heart rate).

if you suffer Lown-Ganong-Levine or

Wolff-Parkinson-White syndrome (causing

palpitations).

if you have had a heart attack which has been

followed by a slow heart rate, low blood

pressure or breathlessness.

if you have very low blood pressure due to

heart problems.

if you have a weak heart (causing

breathlessness and tiredness).

if you have problems of conduction in the heart

such as sino atrial block and 2nd or 3rd degree

atrioventricular block.

if you suffer from porphyria (a rare inherited

disease affecting the blood).

if you have been given a muscle relaxant called

dantrolene by injection.

if you have been given a type of medicine

called a Beta-blocker by injection.

if you drink grapefruit juice.

if you are already taking a medicine containing

ivabradine for the treatment of certain heart

diseases.

This medicine is not suitable for anyone under the

age of 18 years old.

Talk to your doctor before taking this product if

any of the above apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking

Verapamil

if you have liver problems.

if you have a heart condition.

if you are pregnant or breast-feeding.

if you have any kidney problems.

if you have low blood pressure.

if you have myasthenia gravis, Lambert-Eaton

syndrome or Duchenne muscular dystrophy

(nervous conditions which cause muscle

weakness).

if you are taking medicine for high blood

cholesterol (a “statin”, such as simvastatin or

atorvastatin).

Children and adolescents

There are no data on the use of verapamil tablets

in children and adolescents.

Other precautions you should take

If you are to have an operation requiring an

anaesthetic (including treatment at the dentist),

tell the doctor, surgeon or dentist that you are

taking Verapamil tablets.

Other medicines and Verapamil

Tell your doctor or pharmacist if you are taking,

have recently taken or might take any other

medicines.

It is important that you talk to your doctor if you

are taking or have recently taken beta blockers,

such as propranolol, or other drugs which

lower blood pressure, as this may result in very

low blood pressure or heart failure.

You should also talk to your doctor if you are

taking or have recently taken any of the following:

Alpha blockers e.g. prazosin and terazosin used

to treat high blood pressure and heart

conditions.

Diuretics (also called “water tablets”).

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, disopyramide, flecainide, digoxin

and digitoxin.

medicines used to treat depression (including the

herbal product, St John’s Wort), anxiety or

psychosis e.g. 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.

doxorubicin, an anti-cancer medicine.

cimetidine, used to treat indigestion or stomach

ulcers.

dabigatran, an anticoagulant medicine that

helps prevent blood clots.

carbamazepine, phenytoin or phenobarbital,

(phenobarbitone). These medicines are used as

anti-convulsants.

rifampicin, used to treat tuberculosis and other

types of infection.

ritonavir, used to treat HIV.

erythromycin and telithromycin, used to treat

certain types of infection.

colchicine or sulfinpyrazone, used to treat gout.

dantrolene, used in multiple sclerosis to relax

muscles.

Tell your surgeon or dentist that you are taking

Verapamil if surgery is planned as it may affect

the anaesthetic used.

Please tell your doctor or pharmacist if you are

taking or have recently taken any other

medicines, including medicines obtained without

a prescription.

Verapamil with food, drink and alcohol

Do not drink excessive amounts of alcohol whilst

you are taking Verapamil, as the effects of alcohol

may be exaggerated. Verapamil slows the

elimination of alcohol from the body.

Do not drink grapefruit juice whilst you are being

treated with Verapamil.

Pregnancy, breast-feeding and fertility

Verapamil is not recommended if you are

pregnant, planning to become pregnant or are

breast-feeding. Ask your doctor or pharmacist for

advice before taking any medicine.

Driving and using machines

Verapamil may enhance and prolong the effects

of alcohol. The ability to drive or operate

machinery or work under hazardous conditions

may be impaired. This is particularly true in the

initial stages of treatment, when the dose is

increased or when changing from one drug to

another. If affected do not drive or operate

machinery.

Verapamil contains Lactose

Patients who are intolerant to lactose should note

that Verapamil tablets contain a small amount of

lactose. If you have been told by your doctor that

you have an intolerance to some sugars, contact

your doctor before taking this medicinal product.

Verapamil contains Sodium

This medicine contains less than 1 mmol sodium

(23 mg) per tablet, that is to say essentially

‘sodium-free’.

How to take Verapamil

Always take this medicine exactly as your doctor

or pharmacist has told you. Check with your

doctor or pharmacist if you are not sure.

The tablets should be swallowed preferably with

a glass of water.

The recommended dose is:

Angina

Adults:

Between 80 mg and 120 mg, taken three times

daily.

Abnormal Heart Rhythms

Adults:

Between 40 mg and 120 mg, taken three times

daily.

Children:

For children of up to two years, the usual

dosage is half a 40 mg tablet, taken two to

three times daily.

For children 2 years and above the usual dose

is one to three 40 mg tablets taken two to three

times a day according to age and effectiveness.

High Blood Pressure

Adults:

Between 120 mg and 160 mg, taken twice daily.

Your doctor may increase this up to a

maximum of 480 mg per day.

Children:

Your doctor will calculate the appropriate dose

of Verapamil for your child based on your

child’s body weight and severity of the disease.

The Elderly

In the case of elderly patients, your doctor may

prescribe a reduced dosage if you suffer from

liver problems or kidney problems or certain

heart conditions.

If you take more Verapamil than you should

If you (or someone else) swallow a lot of the

tablets all together, or if you think a child has

swallowed any of the tablets contact your nearest

hospital casualty department or your doctor

immediately. An overdose is likely to cause low

blood pressure, shock, heart problems, cardiac

arrest or slow heart beat. Please take this leaflet,

any remaining tablets and the container with you

to the hospital or doctor so that they know which

tablets were consumed.

If you forget to take Verapamil

If you forget to take a tablet, take one as soon as

you remember, unless it is nearly time to take the

next one. Do not take a double dose to make up

for a forgotten dose.

If you stop taking Verapamil

Do not stop taking your medicine without talking

to your doctor first even if you feel better.

If you have any further questions on the use of

this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side

effects, although not everybody gets them.

If the following happens, stop taking the tablets

and tell your doctor immediately or go to the

casualty department at your nearest hospital:

an allergic reaction (swelling of the lips, face or

neck leading to unexpected wheezing, severe

difficulty in breathing, skin rash or hives).

Stevens-Johnson syndrome, a serious illness

with blistering of the skin, mouth, eyes and

genitals.

These are very serious but rare side effects. You

may need urgent medical attention or

hospitalisation.

Tell your doctor immediately if you experience

any of the following side effects:

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.

Palpitations, chest pains for the first time or

chest pains becoming more frequent, swollen

ankles, hot and painful hands or feet.

Swelling of the limbs.

The following side effects have been reported at

the approximate frequencies shown:

Common (affecting fewer than one person in 10

but more than one person in 100):

abdominal pain/discomfort

numbness

tremor

movement disorders

muscle weakness

joint or muscle pain

tinnitus (ringing or buzzing in the ears)

tickling or prickling feeling on the skin

redness or burning sensation in the hands or

feet

there may be changes to some blood test results.

Uncommon (affecting fewer than one person in

100 but more than one person in 1,000):

mild constipation

flushing.

Rare (affecting fewer than one person in 1,000 but

more than one person in 10,000):

headaches

nausea (feeling sick), vomiting (being sick)

soreness of the gums

ankle swelling

fatigue, dizziness

impotence (inability to get or maintain an

erection)

increased concentrations of the hormone

prolactin in the blood.

Very rare (affecting fewer than one person in

10,000):

problems with your liver, but any such effects

are reversible

hair loss

skin reactions.

The below side effects may occur if Verapamil is

taken for a long time but resolve when you stop

taking the tablets. Tell your doctor if:

you develop swollen gums which start to

spread over your teeth (gingival hyperplasia)

the development of the breasts in men

(gynaecomastia) which is reversible

production of milk in men or women who are

not breast-feeding (galactorrhoea).

Reporting of side effects

If you get any side effects, talk to your doctor or

pharmacist. 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 or search for MHRA

Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide

more information on the safety of this medicine.

How to store Verapamil

Keep this medicine out of the sight and reach of

children.

Keep the tablets in the pack and do not store

above 25°C.

Do not use this medicine after the expiry date

which is stated on the carton and blister pack. The

expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater

or household waste. Ask your pharmacist how to

throw away medicines no longer use. These

measures will help protect the environment.

Contents of the pack and other

information

What Verapamil tablets contains

The active substance is verapamil hydrochloride.

The tablets contain either 40, 80 or 120 mg of

the active substance.

The other ingredients are lactose monohydrate,

maize starch, microcrystalline cellulose (E460),

sodium starch glycolate (Type A) (E576),

povidone (E1201), silica anhydrous colloidal,

magnesium stearate (E572), hypromellose

(E464), polyethylene glycol 400 and 4000 and

the colourings quinolone yellow (E104),

titanium dioxide (E171), iron oxide (E172),

carnauba wax and water, purified.

What Verapamil tablets look like and contents of

the pack

Verapamil 40 mg are biconvex, film-coated tablets

engraved 1T1 or 40/0234 and plain on the reverse.

Verapamil 80 mg are biconvex, film-coated tablets

engraved 2T1 or 80/0235 and plain on the reverse.

Verapamil 120 mg are biconvex, film coated tablets

engraved 3T1 or 120/0241 and plain on the reverse.

Verapamil is packed in Polypropylene or HDPE

containers with polyethylene or LDPE lids or child

resistant caps in packs of 100 and 250 tablets. Also

in PVdC coated PVC film with hard temper

aluminium foil blister strips in packs of 7, 10, 14, 21,

28, 30, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160,

168.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

TEVA UK Limited, Eastbourne, BN22 9AG

This leaflet was last revised in April 2020.

PL 00289/0271, PL 00289/0281-2 and PL 00289/0282

What is in this leaflet

1

2

Pharma code: 855

Version

REG0133133

Approved

Page 1 of 3

Read all of this leaflet carefully before you start

taking 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. This includes any possible side

effects not listed in this leaflet. See section 4.

1. What Verapamil is and what it is used for

2. What you need to know before you take

Verapamil

3. How to take Verapamil

4. Possible side effects

5. How to store Verapamil

6. Contents of the pack and other information

What Verapamil is and what it is used for

Verapamil is a calcium channel blocker, which

expands your blood vessels to allow more blood

to flow through them. It also acts on the nerve

signals passing through the heart muscle, which

can help to correct certain types of abnormal

heart rhythm.

Verapamil is used:

to prevent or treat angina (chest pain) and

certain abnormal heart rhythms

to treat high blood pressure.

What you need to know before you take

Verapamil

Do not take Verapamil

if you are allergic to Verapamil or any of the

other ingredients of this medicine (listed in

section 6).

if you have a very slow heart-beat of less than

50 beats per minute.

if you suffer from heart problems including sick

sinus syndrome (causing a slow heart rate).

if you suffer Lown-Ganong-Levine or

Wolff-Parkinson-White syndrome (causing

palpitations).

if you have had a heart attack which has been

followed by a slow heart rate, low blood

pressure or breathlessness.

if you have very low blood pressure due to

heart problems.

if you have a weak heart (causing

breathlessness and tiredness).

if you have problems of conduction in the heart

such as sino atrial block and 2nd or 3rd degree

atrioventricular block.

if you suffer from porphyria (a rare inherited

disease affecting the blood).

if you have been given a muscle relaxant called

dantrolene by injection.

if you have been given a type of medicine

called a Beta-blocker by injection.

if you drink grapefruit juice.

if you are already taking a medicine containing

ivabradine for the treatment of certain heart

diseases.

This medicine is not suitable for anyone under the

age of 18 years old.

Talk to your doctor before taking this product if

any of the above apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking

Verapamil

if you have liver problems.

if you have a heart condition.

if you are pregnant or breast-feeding.

if you have any kidney problems.

if you have low blood pressure.

if you have myasthenia gravis, Lambert-Eaton

syndrome or Duchenne muscular dystrophy

(nervous conditions which cause muscle

weakness).

if you are taking medicine for high blood

cholesterol (a “statin”, such as simvastatin or

atorvastatin).

Children and adolescents

There are no data on the use of verapamil tablets

in children and adolescents.

Other precautions you should take

If you are to have an operation requiring an

anaesthetic (including treatment at the dentist),

tell the doctor, surgeon or dentist that you are

taking Verapamil tablets.

Other medicines and Verapamil

Tell your doctor or pharmacist if you are taking,

have recently taken or might take any other

medicines.

It is important that you talk to your doctor if you

are taking or have recently taken beta blockers,

such as propranolol, or other drugs which

lower blood pressure, as this may result in very

low blood pressure or heart failure.

You should also talk to your doctor if you are

taking or have recently taken any of the following:

Alpha blockers e.g. prazosin and terazosin used

to treat high blood pressure and heart

conditions.

Diuretics (also called “water tablets”).

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, disopyramide, flecainide, digoxin

and digitoxin.

medicines used to treat depression (including the

herbal product, St John’s Wort), anxiety or

psychosis e.g. 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.

doxorubicin, an anti-cancer medicine.

cimetidine, used to treat indigestion or stomach

ulcers.

dabigatran, an anticoagulant medicine that

helps prevent blood clots.

carbamazepine, phenytoin or phenobarbital,

(phenobarbitone). These medicines are used as

anti-convulsants.

rifampicin, used to treat tuberculosis and other

types of infection.

ritonavir, used to treat HIV.

erythromycin and telithromycin, used to treat

certain types of infection.

colchicine or sulfinpyrazone, used to treat gout.

dantrolene, used in multiple sclerosis to relax

muscles.

Tell your surgeon or dentist that you are taking

Verapamil if surgery is planned as it may affect

the anaesthetic used.

Please tell your doctor or pharmacist if you are

taking or have recently taken any other

medicines, including medicines obtained without

a prescription.

Verapamil with food, drink and alcohol

Do not drink excessive amounts of alcohol whilst

you are taking Verapamil, as the effects of alcohol

may be exaggerated. Verapamil slows the

elimination of alcohol from the body.

Do not drink grapefruit juice whilst you are being

treated with Verapamil.

Pregnancy, breast-feeding and fertility

Verapamil is not recommended if you are

pregnant, planning to become pregnant or are

breast-feeding. Ask your doctor or pharmacist for

advice before taking any medicine.

Driving and using machines

Verapamil may enhance and prolong the effects

of alcohol. The ability to drive or operate

machinery or work under hazardous conditions

may be impaired. This is particularly true in the

initial stages of treatment, when the dose is

increased or when changing from one drug to

another. If affected do not drive or operate

machinery.

Verapamil contains Lactose

Patients who are intolerant to lactose should note

that Verapamil tablets contain a small amount of

lactose. If you have been told by your doctor that

you have an intolerance to some sugars, contact

your doctor before taking this medicinal product.

Verapamil contains Sodium

This medicine contains less than 1 mmol sodium

(23 mg) per tablet, that is to say essentially

‘sodium-free’.

How to take Verapamil

Always take this medicine exactly as your doctor

or pharmacist has told you. Check with your

doctor or pharmacist if you are not sure.

The tablets should be swallowed preferably with

a glass of water.

The recommended dose is:

Angina

Adults:

Between 80 mg and 120 mg, taken three times

daily.

Abnormal Heart Rhythms

Adults:

Between 40 mg and 120 mg, taken three times

daily.

Children:

For children of up to two years, the usual

dosage is half a 40 mg tablet, taken two to

three times daily.

For children 2 years and above the usual dose

is one to three 40 mg tablets taken two to three

times a day according to age and effectiveness.

High Blood Pressure

Adults:

Between 120 mg and 160 mg, taken twice daily.

Your doctor may increase this up to a

maximum of 480 mg per day.

Children:

Your doctor will calculate the appropriate dose

of Verapamil for your child based on your

child’s body weight and severity of the disease.

The Elderly

In the case of elderly patients, your doctor may

prescribe a reduced dosage if you suffer from

liver problems or kidney problems or certain

heart conditions.

If you take more Verapamil than you should

If you (or someone else) swallow a lot of the

tablets all together, or if you think a child has

swallowed any of the tablets contact your nearest

hospital casualty department or your doctor

immediately. An overdose is likely to cause low

blood pressure, shock, heart problems, cardiac

arrest or slow heart beat. Please take this leaflet,

any remaining tablets and the container with you

to the hospital or doctor so that they know which

tablets were consumed.

If you forget to take Verapamil

If you forget to take a tablet, take one as soon as

you remember, unless it is nearly time to take the

next one. Do not take a double dose to make up

for a forgotten dose.

If you stop taking Verapamil

Do not stop taking your medicine without talking

to your doctor first even if you feel better.

If you have any further questions on the use of

this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side

effects, although not everybody gets them.

If the following happens, stop taking the tablets

and tell your doctor immediately or go to the

casualty department at your nearest hospital:

an allergic reaction (swelling of the lips, face or

neck leading to unexpected wheezing, severe

difficulty in breathing, skin rash or hives).

Stevens-Johnson syndrome, a serious illness

with blistering of the skin, mouth, eyes and

genitals.

These are very serious but rare side effects. You

may need urgent medical attention or

hospitalisation.

Tell your doctor immediately if you experience

any of the following side effects:

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.

Palpitations, chest pains for the first time or

chest pains becoming more frequent, swollen

ankles, hot and painful hands or feet.

Swelling of the limbs.

The following side effects have been reported at

the approximate frequencies shown:

Common (affecting fewer than one person in 10

but more than one person in 100):

abdominal pain/discomfort

numbness

tremor

movement disorders

muscle weakness

joint or muscle pain

tinnitus (ringing or buzzing in the ears)

tickling or prickling feeling on the skin

redness or burning sensation in the hands or

feet

there may be changes to some blood test results.

Uncommon (affecting fewer than one person in

100 but more than one person in 1,000):

mild constipation

flushing.

Rare (affecting fewer than one person in 1,000 but

more than one person in 10,000):

headaches

nausea (feeling sick), vomiting (being sick)

soreness of the gums

ankle swelling

fatigue, dizziness

impotence (inability to get or maintain an

erection)

increased concentrations of the hormone

prolactin in the blood.

Very rare (affecting fewer than one person in

10,000):

problems with your liver, but any such effects

are reversible

hair loss

skin reactions.

The below side effects may occur if Verapamil is

taken for a long time but resolve when you stop

taking the tablets. Tell your doctor if:

you develop swollen gums which start to

spread over your teeth (gingival hyperplasia)

the development of the breasts in men

(gynaecomastia) which is reversible

production of milk in men or women who are

not breast-feeding (galactorrhoea).

Reporting of side effects

If you get any side effects, talk to your doctor or

pharmacist. 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 or search for MHRA

Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide

more information on the safety of this medicine.

How to store Verapamil

Keep this medicine out of the sight and reach of

children.

Keep the tablets in the pack and do not store

above 25°C.

Do not use this medicine after the expiry date

which is stated on the carton and blister pack. The

expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater

or household waste. Ask your pharmacist how to

throw away medicines no longer use. These

measures will help protect the environment.

Contents of the pack and other

information

What Verapamil tablets contains

The active substance is verapamil hydrochloride.

The tablets contain either 40, 80 or 120 mg of

the active substance.

The other ingredients are lactose monohydrate,

maize starch, microcrystalline cellulose (E460),

sodium starch glycolate (Type A) (E576),

povidone (E1201), silica anhydrous colloidal,

magnesium stearate (E572), hypromellose

(E464), polyethylene glycol 400 and 4000 and

the colourings quinolone yellow (E104),

titanium dioxide (E171), iron oxide (E172),

carnauba wax and water, purified.

What Verapamil tablets look like and contents of

the pack

Verapamil 40 mg are biconvex, film-coated tablets

engraved 1T1 or 40/0234 and plain on the reverse.

Verapamil 80 mg are biconvex, film-coated tablets

engraved 2T1 or 80/0235 and plain on the reverse.

Verapamil 120 mg are biconvex, film coated tablets

engraved 3T1 or 120/0241 and plain on the reverse.

Verapamil is packed in Polypropylene or HDPE

containers with polyethylene or LDPE lids or child

resistant caps in packs of 100 and 250 tablets. Also

in PVdC coated PVC film with hard temper

aluminium foil blister strips in packs of 7, 10, 14, 21,

28, 30, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160,

168.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

TEVA UK Limited, Eastbourne, BN22 9AG

This leaflet was last revised in April 2020.

PL 00289/0271, PL 00289/0281-2 and PL 00289/0282

EAS4668a

50112-G

323 x 160

4

5

6

3

Version

REG0133133

Approved

Page 2 of 3

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

VERAPAMIL TABLETS BP 40mg

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 40mg Verapamil Hydrochloride PhEur.

Excipient with known effect

Sunset yellow aluminium lake (E110)

For the full list of excipients, see section 6.1

3

PHARMACEUTICAL FORM

Yellow film-coated tablets.

Yellow, circular, biconvex film-coated tablets, impressed “C” on one face and the

identifying letters “VR” on the reverse. Tablet diameter: 6.18-6.82mm.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

1) The management of mild to moderate hypertension and renal hypertension, used alone or

in combination with other antihypertensive therapy (see section 4.3 for warning regarding

concomitant administration with beta-blockers).

2) For the management and prophylaxis of angina pectoris (including variant angina).

3) The treatment and prophylaxis of paroxysmal supraventricular tachycardia and the

reduction of the ventricular rate in atrial fibrillation/flutter. Verapamil should not be used

for atrial fibrillation/flutter in patients with Wolff-Parkinson-White syndrome (see section

4.4).

4.2

Posology and method of administration

Posology

Adults:

Hypertension: 240mg verapamil daily. For patients new to verapamil therapy, the physician

should consider halving the initial dose to 120mg. Most patients respond to 240mg daily

given as a single dose. If control is not achieved after a period of at least one week, the

dosage may be increased to a maximum of 480mg (in divided doses of 240mg in the

morning and 240mg in the evening, at an interval of about twelve hours). A further

reduction in blood pressure may be acheived by combining verapamil with other

antihypertensive agents, in particular diuretics. 120mg may be used for dose titration

purposes.

Angina pectoris: 120mg twice daily. A small number of patients respond to a lower dose

and where indictaed, adjustment down to 120mg daily could be made. 120mg may be used

for dose titration purposes.

Supraventricular tachycardias: 40-120mg three times daily depending on the severity of the

condition.

Elderly: The adult dose is recommended unless renal or hepatic function is impaired (see

section 4.4, Special Warnings and Precautions for Use).

Paediatric population:

Verapamil tablets are not recommended for children.

Liver impairment

In patients with impaired liver function, metabolism of the drug is delayed to a greater or

lesser extent depending on the severity of hepatic dysfunction, thus potentiating and

prolonging the effects of verapamil hydrochloride. Therefore the dosage needs to be

adjusted with special caution in patients with impaired liver function and low doses should

be given initially (see Special Warnings and Precautions for Use).

Method of Administration

For oral use only.

Verapamil tablets should be taken without sucking or chewing, with sufficient liquid,

preferably with or shortly after meals.

4.3

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Hypotension (of less than 90mmHg systolic)

Second or third degree atrioventricular block; sick sinus syndrome (except in patients

with a functioning artifical pacemaker); uncompensated heart failure; marked

bradycardia (less than 50 beats/minute).

Combination with beta-blockers is contraindicated in patients with poor ventricular

function.

Wolff-Parkinson-White syndrome.

Concomitant ingestion of grapefruit juice is contraindicated.

Acute myocardial infarction complicated by bradycardia, marked hypotension or left

ventricular failure.

Combination with ivabradine (see section 4.5)

4.4.

Special Warnings and Precautions for Use

Since verapamil is extensively metabolised in the liver, careful dose titration is required in patients

with liver disease. 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.

Verapamil may affect impulse conduction and should therefore 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 pateints

with incipient cardiac failure, therefore, verapamil should be given only after such cardiac failure has

been controlled with appropriate therapy, e.g. digitalis.

When treating hypertension with verapamil, monitoring of the patient's blood pressure at regular

intervals is required.

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).

Verapamil tablets contain sunset yellow aluminium lake (E110) which may cause allergic reactions.

4.5.

Interaction with other medicinal products and other forms of Interaction

In vitro metabolic studies indicate that verapamil hydrochloride is metabolised by

cytochrome P450 CYP3A4, CYP1A2, CYP2C8, CYP2C9 and CYP2C18. Verapamil has

been shown to be an inhibitor of CYP3A4 enzymes and P-glycoprotein (P-gp). Clinically

significant interactions have been reported with inhibitors of CYP3A4 causing elevation of

plasma levels of verapamil hydrochloride while inducers of CYP3A4 have caused a

lowering of plasma levels of verapamil hydrochloride, therefore, patients should be

monitored for drug interactions.

The following are potential drug interactions associated with verapamil.

Acetylsalicylic acid

Concomitant use of verapamil with aspirin may increase the risk of bleeding.

Alcohol:

Increase in blood alcohol has been reported.

Alpha blockers:

Verapamil may increase the plasma concentrations of prazosin and terazosin which may

have an additive hypotensive effect.

Antiarrhythmics:

Verapamil may slightly decrease the plasma clearance of flecainide whereas flecainide has

no effect on the verapamil plasma clearance.

Verapamil may increase the plasma concentrations of quinidine. Pulmonary oedema may

occur in patients with hypertrophic cardiomyopathy.

The combination of verapamil and antiarrhythmic agents may lead to additive

cardiovascular effects (e.g. AV block, bradycardia, hypotension, heart failure).

Anticonvulsants:

Verapamil may increase the plasma concentrations of carbamazepine. This may produce

side effects such as diplopia, headache, ataxia or dizziness. Verapamil may also increase the

plasma concentrations of phenytoin.

Antidepressants:

Verapamil may increase the plasma concentrations of imipramine.

Antidiabetics:

Varapamil may increase the plasma concentrations of glibenclamide (glyburide).

Antihypertensives, diuretics, vasodilators:

Potentiation of the hypotensive effect.

Anti-infectives

Rifampicin may reduce the plasma concentrations of verapamil which may produce a

reduced blood pressure lowering effect. Erythromycin, clarithromycin and telithromycin

may increase the plasma concentrations of verapamil.

Antineoplastics:

Verapamil may increase the plasma concentrations of doxorubicin.

Barbiturates:

Phenobarbital may reduce the plasma concentrations of verapamil.

Benzodiazepines and other anxiolytics:

Verapamil may increase the plasma concentrations of buspirone and midazolam.

Beta blockers:

Verapamil may increase the plasma concentrations of metoprolol and propranolol which

may lead to additive cardiovascular effects (e.g. AV block, bradycardia, hypotension, heart

failure).

Intravenous beta-blockers should not be given to patients under treatment with verapamil

Cardiac glycosides:

Verapamil may increase the plasma concentrations of digitoxin and digoxin. Verapamil has

been shown to increase the serum concentration of digoxin and caution should be exercised

with regard to digitalis toxicity. The digitalis level should be determined and the glycoside

dose reduced, if required.

Colchicine

Colchicine is a substrate for both CYP3A and the efflux transporter, P-glycoprotein (P-gp).

Verapamil is known to inhibit CYP3A and P-gp. When verapamil and colchicine are

administered together, inhibition of P-gp and/or CYP3A by verapamil may lead to increased

exposure to colchicine. Combined use is not recommended.

H

2

Receptor antagonists

Cimetidine may increase the plasma concentrations of verapamil.

HIV antiviral agents:

Due to the metabolic inhibitory potential of some of the HIV antiviral agents, such as

ritonavir, plasma concentrations of verapamil may increase. Caution should be used or dose

of verapamil may be decreased.

Immunosuppressants

Verapamil may increase the plasma concentrations of ciclosporin, everolimus, sirolimus and

tacrolimus.

Inhaled anaesthetics:

When used concomitantly, inhalation anaesthetics and calcium antagonists, such as

verapamil hydrochloride, should each be titrated carefully to avoid additive cardiovascular

effects (e.g. AV block, bradycardia, hypotension, heart failure).

Lipid lowering agents:

Verapamil may increase the plasma concentrations atorvastatin, lovastatin and simvastatin.

Treatment with HMG CoA reductase inhibitors (e.g., simvastatin, atorvastatin or lovastatin)

in a patient taking verapamil should be started at the lowest possible dose 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), consider a reduction in the

statin dose and retitrate against serum cholesterol concentrations.

Atorvastatin has been shown to increase verapamil levels. Although there is no direct in vivo

clinical evidence, there is strong potential for verapamil to significantly affect atorvastatin

pharmacokinetics in a similar manner to simvastatin or lovastatin. Consider using caution

when atorvastatin and verapamil are concomitantly administered.

Fluvastatin, pravastatin and rosuvastatin are not metabolized by CYP3A4 and are less likely

to interact with verapamil.

Lithium:

Serum levels of lithium may be reduced. However, there may be increased sensitivity to

lithium causing enhanced neurotoxicity.

Neuromuscular blocking agents employed in anaesthesia:

The effects may be potentiated.

Serotonin receptor agonists:

Verapamil may increase the plasma concentrations of almotriptan.

Theophylline:

Verapamil may increase the plasma concentrations of theophylline.

Uricosurics:

Sulfinpyrazone may reduce the plasma concentrations of verapamil which may produce a

reduced blood pressure lowering effect.

Anticoagulants:

When oral verapamil was co-administered with dabigatran etexilate (150mg), a P-gp

substrate, the Cmax and AUC of dabigatran were increased but magnitude of this change

differs depending on time between administration and the formulation of verapamil. Co-

administration of verapamil 240mg extended-release at the same time as dabigatran etexilate

resulted in increased dabigatran exposure (increase of Cmax by about 90% and AUC by

about 70%).

Close clinical surveillance is recommended when verapamil is combined with dabigatran

etexilate and particularly in the occurrence of bleeding, notably in patients having a mild to

moderate renal impairment.

Other cardiac therapy:

Concomitant use with ivabradine is contraindicated due to the additional heart rate lowering

effect of verapamil to ivabradine (see section 4.3).

Other:

St. John’s Wort may reduce the plasma concentrations of verapamil, whereas grapefruit

juice may increase the plasma concentrations of verapamil .

4.6.

Fertility, 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 clinicians judgement, it is

essential for the welfare of the patient.

Verapamil hydrochloride 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. 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.

4.7.

Effects on Ability to Drive and Use Machines

Depending on individual susceptibility, the patient’s ability to drive or operate machines

may be impaired due to feelings of drowsiness. This is particularly true in the initial stages

of treatment, or when changing over from another drug. Verapamil has been shown to

increase the blood levels of alcohol and slow its elimination. Therefore, the effects of

alcohol may be exaggerated.

4.8

Undesirable effects

Immune system disorders: allergic reactions (e.g. erythema, pruritus, urticaria) are very

rarely seen.

Nervous system disorders: headaches occur rarely, dizziness, paraesthesia, tremor,

extrapyramidal syndrome (e.g. parkinsonism), dystonia.

Ear and labyrinth disorders: vertigo, tinnitus.

Cardiac disorders: bradycardic arrhythmias such as sinus bradycardia, sinus arrest with

asystole, 2nd and 3rd degree AV block, bradyarrhythmia in atrial fibrillation, palpitations,

tachycardia, development or aggravation of heart failure, hypotension.

Vascular disorders: flushing, peripheral oedema.

Gastrointestinal disorders: nausea, vomiting, constipation is not uncommon, ileus and

abdominal pain/discomfort. Gingival hyperplasia may very rarely occur when the drug is

administered over prolonged periods. This is fully reversible when the drug is discontinued.

Skin and subcutaneous tissue disorders: alopecia, ankle oedema, Quincke's oedema,

Steven-Johnson syndrome, erythema multiforme, erythromelalgia, purpura.

Musculoskeletal and connective tissue disorders: muscular weakness, myalgia and

arthralgia.

Reproductive system and breast disorders: impotence (erectile dysfunction) has been

rarely reported and isolated cases of galactorrhoea. Gynaecomastia was observed on very

rare occasions in elderly male patients under longer term verapamil treatment which was

fully reversible in all cases when the drug was discontinued.

General disorders and administration site conditions: fatigue.

Investigations: On very rare occasions, a reversible impairment of liver function

characterised by an increase in transaminases and/or alkaline phosphatase, may occur during

verapamil treatment and is most probably a hypersensitivity reaction.

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 the

Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow

Card in the Google Play or Apple App Store.

4.9.

Overdose

The course of symptoms in verapamil intoxication depends on the amount taken, the point in

time at which detoxification measures are taken and myocardial contractility (age-related).

The main symptoms are as follows: blood pressure fall (at times to values not detectable),

shock symptoms, loss of consciousness, 1st and 2nd 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.

The therapeutic measures to be taken depend on the point in time at which verapamil was

taken and the type and severity of intoxication symptoms. In intoxications with large

amounts of slow-release preparations, it should be noted that the release of the active drug

and the absorption in the intestine may take more than 48 hours. Verapamil hydrochloride

cannot be removed by haemodialysis. Depending on the time of ingestion, it should be taken

into account that there may be some lumps of incompletely dissolved tablets along the entire

length of the gastrointestinal tract, which function as active drug depots.

General measures to be taken: Gastric lavage with the usual precautions, even later than 12

hours after ingestion, if no gastrointestinal motility (peristaltic sounds) is detectable. Where

intoxication by a modified release preparation is suspected, extensive elimination measures

are indicated, such as induced vomiting, removal of the contents of the stomach and the

small intestine under endoscopy, intestinal lavage, laxative, high enemas. The usual

intensive resuscitation measures apply, such as extrathoracic heart massage, respiration,

defibrillation and/or pacemaker therapy.

Specific measures to be taken: Elimination of cardiodepressive effects, hypotension or

bradycardia. The specific antidote is calcium, e.g. 10 - 20ml of a 10% calcium gluconate

solution administered intravenously (2.25 - 4.5mmol), repeated if necessary or given as a

continuous drip infusion (e.g. 5mmol/hour).

The following measures may also be necessary: In case of 2nd or 3rd degree AV block,

sinus bradycardia, asystole - atropine, isoprenaline, orciprenaline or pacemaker therapy. In

case of hypotension - dopamine, dobutamine, noradrenaline (norepinephrine). If there are

signs of continuing myocardial failure - dopamine, dobutamine, if necessary repeated

calcium injections.

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Selective calcium channel blockers with direct cardiac effects,

phenylalkylamine derivatives.

ATC code: C08 DA01

Verapamil, a phenylalkylamine calcium antagonist, has a balanced profile of cardiac and

peripheral effects. It lowers heart rate, increases myocardial perfusion and reduces coronary

spasm. In a clinical study in patients after myocardial infarction, verapamil reduced total

mortality, sudden cardiac death and reinfarction rate.

Verapamil reduces total peripheral resistance and lowers high blood pressure by

vasodilation, without reflex tachycardia. Because of its use-dependent action on the voltage-

operated calcium channel, the effects of verapamil are more pronounced on high than on

normal blood pressure.

As early as day one of treatment, blood pressure falls; the effect is found to persist also in

long-term therapy.

Verapamil is suitable for the treatment of all types of hypertension: for monotherapy in mild

to moderate hypertension; combined with other antihypertensives (in particular with

diuretics and, according to more recent findings, with ACE inhibitors) in more severe types

of hypertension. In hypertensive diabetic patients with nephropathy, verapamil in

combination with ACE inhibitors led to a marked reduction of albuminuria and to an

improvement of creatinine clearance.

5.2

Pharmacokinetic properties

Verapamil hydrochloride is a racemic mixture consisting of equal portions of the R-

enantiomer and the S-enantiomer. Verapamil is extensively metabolised. Norverapamil is

one of 12 metabolites identified in urine, has 10 to 20% of the pharmacologic activity of

verapamil and accounts for 6% of excreted drug. The steady-state plasma concentrations of

norverapamil and verapamil are similar. Steady state after multiple once daily dosing is

reached after three to four days.

Absorption

Greater than 90% of verapamil is rapidly absorbed from the small intestine after oral administration.

Mean systemic availability of the unchanged compound after a single dose of SR verapamil is

approximately 33%, owing to an extensive hepatic first-pass metabolism. Bioavailability is about

two times higher with repeated administration. Peak verapamil plasma levels are reached four to five

hours after SR administration. The peak plasma concentration of norverapamil is attained

approximately five hours after SR administration. The presence of food has no effect on the

bioavailability of verapamil.

Distribution

Verapamil is widely distributed throughout the body tissues, the volume of distribution ranging from

1.8-6.8 l/kg in healthy subjects. Plasma protein binding of verapamil is approximately 90%.

Biotransformation

Verapamil is extensively metabolised. In vitro metabolic studies indicate that verapamil is

metabolised by cytochrome P450, CYP3A4, CYP1A2, CYP2C8, CYP2C9 and CYP2C18. In healthy

men, orally administered verapamil hydrochloride undergoes extensive metabolism in the liver, with

12 metabolites having been identified, most in only trace amounts. The major metabolites have been

identified as various N and O-dealkylated products of verapamil. Of these metabolites, only

norverapamil has any appreciable pharmacological effect (approximately 20% that of the parent

compound), which was observed in a study with dogs.

Elimination

Following oral administration, the elimination half-life is three to seven hours. Approximately 50%

of an administered dose is eliminated renally within 24 hours, 70% within five days. Up to 16% of a

dose is excreted in the faeces. About 3% to 4% of renally excreted drug is excreted as unchanged

drug. The total clearance of verapamil is nearly as high as the hepatic blood flow, approximately 1

L/h/kg (range 0.7-1.3 L/h/kg).

Special Populations

Geriatric

Aging may affect the pharmacokinetics of verapamil given to hypertensive patients. Elimination

half-life may be prolonged in the elderly. The antihypertensive effect of verapamil was found not to

be age-related.

Renal insufficiency

Impaired renal function has no effect on verapamil pharmacokinetics, as shown by comparative

studies in patients with end-stage renal failure and subjects with healthy kidneys. Verapamil and

norverapamil are not significantly removed by haemodialysis.

Hepatic insufficiency

The half-life of verapamil is prolonged in patients with impaired liver function owing to lower oral

clearance and a higher volume of distribution.

5.3.

Preclinical Safety Data

Reproduction studies have been performed in rabbits and rats at oral verapamil doses up to

0.6 and 1.2 times respectively the maximum recommended human oral daily dose based on

a body surface area comparison (mg/m

) and have revealed no evidence of teratogenicity. In

the rat, however, a dose similar to the clinical dose was embryocidal and retarded foetal

growth and development. These effects occurred in the presence of maternal toxicity

(reflected by reduced food consumption and reduced weight gain of dams). This oral dose

has also been shown to cause hypotension in rats.

6.

PHARMACEUTICAL PARTICULARS

6.1.

List of Excipients

Also contains: croscarmellose sodium, magnesium stearate, maize starch, propylene glycol,

sunset yellow aluminium lake (E110), quinoline yellow aluminium lake (E104), titanium

dioxide

(E171),

microcrystalline

cellulose

(E460),

hydroxypropylcellulose

(E463),

methylhydroxypropylcellulose (E464), purified talc (E553).

6.2.

Incompatibilities

None known.

6.3

Shelf life

Three years from the date of manufacture.

6.4.

Special Precautions for Storage

Store below 25°C in a dry place.

6.5.

Nature and Contents of Container

product

containers

rigid

injection

moulded

polypropylene

injection

blow-

moulded

polyethylene

containers

snap-on

polyethylene

lids;

case

supply

difficulties should arise the alternative is amber glass containers with screw caps.

The product may also be supplied in blister packs and cartons:

a) Carton: Printed carton manufactured from white folding box board. b) Blister pack: (i)

m white rigid PVC. (ii) Surface printed 20

m hard temper aluminium foil with 5-

6g/M

PVC and PVdC compatible heat seal lacquer on the reverse side.

Pack size: 28s, 30s, 56s, 60s, 84s, 90s, 100s, 112s, 120s, 168s, 180s, 250s, 500s, 1000s.

Product may also be supplied in bulk packs, for reassembly purposes only, in polybags

contained in tins, skillets or polybuckets filled with suitable cushioning material. Bulk packs

are included for temporary storage of the finished product before final packaging into the

proposed marketing containers. Maximum size of bulk packs: 50,000.

6.6.

Instructions for Use, Handling and Disposal

Not applicable.

7

MARKETING AUTHORISATION HOLDER

Accord-UK Ltd

(Trading style: Accord)

Whiddon Valley

Barnstaple

Devon

EX32 8NS

8.

MARKETING AUTHORISATION NUMBER(S)

PL 0142/0281

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