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DILTIAZEM HYDROCHLORIDE 60MG MODIFIED RELEASE TABLETS

Active substance(s): DILTIAZEM HYDROCHLORIDE

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PIL MOCKUP DILTIAZEM :DILTIAZEM 00590416/03........... 185 X 297mm

4/7/16

1:13 PM

Page 1

PATIENT INFORMATION LEAFLET

DILTIAZEM HYDROCHLORIDE 60MG
MODIFIED RELEASE TABLETS

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.
In this leaflet:
1. What Diltiazem Hydrochloride is and what it is used for
2. What you need to know before you take Diltiazem
Hydrochloride
3. How to take Diltiazem Hydrochloride
4. Possible side effects
5. How to store Diltiazem Hydrochloride
6. Contents of the pack and other information

• dantrolene given as an infusion for severe muscle spasms or

severe fever

• medicines used to treat high blood pressure such as










1. What is diltiazem hydrochloride and what it is
used for






pectoris (a heart problem) and to treat mild to moderate
hypertension
• It works by reducing the amount of oxygen used by the
heart muscle and increasing the ability to exercise



• Diltiazem Hydrochloride is one of a group of medicines

called calcium antagonists

• This medicine is for the prevention and treatment of angina

2. What you need to know before you take diltiazem
hydrochloride

Do not take this medicine if you:
• are hypersensitive (allergic) to Diltiazem Hydrochloride or
any of the other ingredients of this medicine (listed in
section 6)
• have marked bradycardia (a very slow heart rate)
• have sick sinus syndrome (a disorder of the heartbeat)
• have left ventricular failure (heart failure)
• have severe hypotension (low blood pressure)
• have second or third degree heart block (unless you have a
working pacemaker fitted). If you have heart block, certain
parts of the heart may beat at the wrong rate and, therefore,
the heart does not pump the blood around your body well
• are being treated with dantrolene infusion (for severe
muscle spasm)
• have an inherited disorder of the red blood pigment
haemoglobin, causing skin blisters, abdominal pain and
nervous system disorders (porphyria)
• are pregnant or are a woman of child bearing age
• are breast-feeding or planning to breast-feed
Warnings and precautions
Talk to your doctor or pharmacist before taking these
tablets if you have:
• impaired liver function
• impaired kidney function
• at risk of mood changes, including depression
• are likely to have surgery which requires a general
anaesthetic
• problems with your stomach or intestines
• heart problems apart from angina or the conditions
described in the previous section
• diabetes: The treatment for your diabetes may need to be
adjusted, as Diltiazem Hydrochloride tablets may impair
glucose tolerance

Other medicines and Diltiazem Hydrochloride
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, especially if you are
already taking:








prazosin, hydralazine, minoxidil, nitroprusside, doxazosin,
tamsulosin, atenolol, propanolol or acebutolol
diuretics (water tablets, used in the treatment of
hypertension, heart failure and liver or renal failure)
antiarrhythmic drugs such as digoxin and amiodarone (used
to treat an irregular heart beat)
medicines such as ivabradine, glyceryl trinitrate or
isosorbide trinitrate used to treat angina
phenobarbital, phenytoin, primidone and carbamazepine (to
treat epilepsy)
ciclosporin, sirolimus and tacrolimus (used to suppress
immune system)
theophylline (used in breathing problems)
lithium (used for mental health problems)
midazolam or triazolam (used for sedation and anaesthesia)
imipramine and other tricyclic antidepressants (used for
depression)
antipsychotics
rifampicin (to treat tuberculosis)
ranitidine and cimetidine used to treat stomach ulcers
statins such as simvastatin, fluvastatin and atorvastatin
(used to treat high cholesterol)
methylprednisolone used to treat inflammation and allergic
reactions
levodopa to treat Parkinsons disease
dutasteride used to treat an enlarged prostate gland
baclofen and tizanidine used as muscle relaxants
oestrogens used in hormone replacement therapy
corticosteroids (to treat inflammation)
carbenoxolone (to treat oesophageal ulceration and
inflammation)

Your doctor will be able to tell you which drugs you can take
together.
If you are about to have an operation, tell the hospital staff that
you are taking this medicine.
Treatment has been continued without problems in patients
who have undergone an anaesthetic.
Pregnancy and breast-feeding
Do not take Diltiazem Hydrochloride tablets if you are
pregnant, planning to become pregnant, are a woman of child
bearing age or if you are breast feeding. Speak to your doctor
before taking any medicine.
Driving and using machines
Diltiazem tablets may cause dizziness or tiredness, therefore
make sure you are not affected before driving or operating
machinery.

Diltiazem Hydrochloride contains lactose and castor oil
Lactose - If a doctor has told you that you have an intolerance
to some sugars, contact your doctor before taking this
medicine, as it contains lactose.
Castor oil – may cause stomach upset and diarrhoea

Tests
If you have impaired kidney or liver function, your doctor may
want to monitor you by carrying out blood tests.

3. How to take diltiazem hydrochloride

Always take this medicine exactly as described in this leaflet
or as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.

The tablets should be swallowed whole with a glass of water.
The exact dosage should be as directed by your doctor.
Generally, the dose is one tablet three times daily.

For the elderly with liver or kidney problems, a dose of 60mg
twice daily with monitoring of heart rate is recommended.
If necessary your doctor may increase the dose to:

PIL MOCKUP DILTIAZEM :DILTIAZEM 00590416/03........... 185 X 297mm

• Two tablets (120mg) three times a day (360mg)
• Two tablets (120mg) four times a day (480mg)

Keep taking your medicine until your doctor tells you to stop.
This product is not recommended for children.

Your doctor may want to do regular checks on your blood,
heart, liver and kidneys while taking this medicine.
If you take more tablets than you should
If you or anyone else has taken too many tablets, contact your
nearest hospital casualty department or tell your doctor
immediately. Take the container and any remaining tablets
with you. An overdose may lead to severe low blood pressure
leading to collapse, and a slow heart beat which may be
accompanied by changes in heart rhythm and conduction.

If you forget to take Diltiazem Hydrochloride tablets
If you forget to take a dose, take the missed dose as soon as
you remember and then go on as before. Do not take two doses
at the same time to make up for a forgotten dose.
If you stop taking these tablets
If you suddenly stop taking this medicine it may cause the
symptoms to come back so always follow your doctor’s
instructions carefully.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Diltiazem Hydrochloride 60mg Modified
Release Tablets may cause side effects, although not
everybody gets them.
Stop taking this medicine and contact your doctor or
pharmacist immediately if:
• You have an allergic reaction. The signs include rash,
swallowing or breathing problems, swelling of your lips,
face, throat, or tongue.
• You get blistering or peeling of the skin around the lips,
eyes, mouth, nose and genitals, “flu-like” symptoms and
fever. This could be an illness called “Stevens-Johnson
syndrome”.
• You get a severe blistering rash where large areas of skin
peel away leaving exposed areas of raw skin over the body.
You may feel generally unwell and have a fever, chills and
aching muscles. This could be an illness called “toxic
epidermal necrolysis”.
• You have a skin rash or lesions with a pink/red ring and a
pale centre which may be itchy, scaly or filled with fluid.
This may appear on the palms or on soles of the feet. This
could be a sign of a condition called “erythema multiforme”

Tell your doctor straight away if you experience any of the
following as you may need urgent medical treatment:
Common (may affect up to 1 in 10 people):
• slow or uneven heartbeat
• very fast, uneven or forcefull heartbeat (palpitations)
Not known (frequency cannot be estimated from the available
data):
• skin rash caused by narrow or blocked blood vessels
(vasculitis)
• shortness of breath, feeling tired with swollen legs and
ankles, this could be a sign of heart failure
• unusual movements of the tongue, muscle spasms of the
face, rolling eyes, and trembling
• high temperature, feeling tired, loss of appetite, stomach
pain, feeling sick. These can be signs of inflammation of
the liver (hepatitis)
• passing large amounts of urine, excessive thirst and having
a dry mouth or skin. These may be signs of high blood
sugar (hyperglycemia)
• breast enlargement in men

Tell your doctor as soon as possible if you notice any of the
following side effects:
Very common (may affect more than 1 in 10 people):
• swelling of the lower limbs
Common (may affect up to 1 in 10 people):
• indigestion, stomach pain, constipation, diarrhoea

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Uncommon (may affect up to 1 in 100 people):
• feeling dizzy, light-headed or faint when standing or sitting
up quickly (low blood pressure)
Rare (may affect up to 1 in 1,000 people):
• dry mouth
• itchy, lumpy rash (urticaria)
Not known (frequency cannot be estimated from the available
data):
• swollen gums

Other side effects below have been reported. Tell your
doctor or pharmacist if any of the following side effects get
serious:
Common (may affect up to 1 in 10 people):
• headache
• flushing
• feeling sick (nausea) or being sick (vomiting)
• general feeling of being unwell
• weakness or tiredness
• feeling dizzy
• skin redness
Uncommon (may affect up to 1 in 100 people):
• difficulty sleeping
Frequency unknown (frequency cannot be estimated from the
available data):
• mood changes
• bleeding or bruising under the skin
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 to store diltiazem hydrochloride

• Keep all medicines out of the sight and reach of children.
• Do not use any medicine after the expiry date printed after

“EXP” on the carton and blister pack. The expiry date
refers to the last day of that month.
• Keep your medicine below 25°C in a dry place.

Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to
protect the environment.

6. Contents of the pack and other information

What Diltiazem Hydrochloride contains
• The active substance is diltiazem hydrochloride. Each tablet
contains 60mg of Diltiazem Hydrochloride in a modified
release formulation.
• The other ingredients are: lactose monohydrate,
hydrogenated castor oil, polyethylene glycol 6000,
magnesium stearate. See end of section 2 for further
information on lactose and castor oil.

What Diltiazem Hydrochloride look like and contents of
the pack
• Diltiazem Hydrochloride tablets are off-white, engraved
‘DTZ 60’ on one side and ‘PV’ on the reverse.
• Pack sizes of the tablets are 28, 30, 56, 60, 84, 100 or 500
tablets in blister packs. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Pharmvit Ltd, 177 Bilton Road, Perivale,
Greenford, Middlesex UB6 7HQ.
Telephone: 0208 997 5444
Fax:
0208 997 5433

To request a copy of this leaflet in large print or audio
format or for additional copies, please contact the licence
holder at the address (or telephone, fax) above.
Product licence number: PL 04556/0059
Reference: 00590416/03

POM

This leaflet was last revised in April 2016

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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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