DILTIAZEM HCL TABLETS 60 MG (MODIFIED RELEASE)

Active substance: DILTIAZEM HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Diltiazem Hydrochloride (Modified release) 60 mg Tablets
(Diltiazem Hydrochloride)
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
If any side effect gets serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor.
In this leaflet:
1.
What Diltiazem Hydrochloride is and what it is used for
2.
Before you take Diltiazem Hydrochloride
3.
How to take Diltiazem Hydrochloride
4.
Possible side effects
5.
How to store Diltiazem Hydrochloride
6.
Further information.
1.

WHAT DILTIAZEM HYDROCHLORIDE IS AND WHAT IT IS USED FOR

Diltiazem Hydrochloride belongs to a group of medicines called calcium channel blockers. Diltiazem
Hydrochloride works by relaxing the blood vessels and increasing the supply of blood and oxygen to
the heart while reducing its workload. Diltiazem Hydrochloride will reduce chest pains caused by
angina.
2.

BEFORE YOU TAKE DILTIAZEM HYDROCHLORIDE

Do not take Diltiazem Hydrochloride
-

if you are allergic (hypersensitive) to diltiazem hydrochloride or any of the other ingredients of
Diltiazem Hydrochloride
if you are going to have a general anaesthetic for an operation.
if you have been given an infusion of a drug called dantrolene.

Take special care with Diltiazem Hydrochloride
-

if you have a slow heartbeat, an irregular heartbeat or other heart condition

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription, or the following:
• medicine to treat a heart condition eg. digoxin
• carbamazepine, antiepileptic medicine
• ciclosporin, tacrolimus, sirolimus, usually used after an organ or bone marrow transplant
• simvastatin, used to lower blood cholesterol levels
• theophylline, to treat asthma
• lithium, to treat severe depression
• medicine to treat stomach ulcers or heartburn eg. cimetidine
• medicine to treat prostate problems or high blood pressure (alphablockers) e.g. prazosin
• medicine used to treat an infection e.g. rifampicin
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Pregnancy and breast-feeding
Do not take diltiazem hydrochloride if you are pregnant or planning to become pregnant. Talk to your
doctor first. Small amounts of diltiazem hydrochloride can pass into the breast milk of nursing
mothers. Ask your doctor or pharmacist for advice before taking any medicine.
Important information about some of the ingredients of Diltiazem Hydrochloride
Diltiazem Hydrochloride contains lactose. If your doctor has told you that you have an intolerance to
some sugars, such as lactose, contact your doctor before taking this medicine.
3.

HOW TO TAKE DILTIAZEM HYDROCHLORIDE

Always take Diltiazem Hydrochloride exactly as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.


Swallow the tablets whole with a glass of water. Do not crush or chew them.

The usual dose is:
Adults
The dose of Diltiazem Hydrochloride that your doctor prescribes for you will be adjusted to best treat
your condition. The usual dose is one tablet (60mg) three times daily. If necessary the dose may be
increased up to 6 tablets (360mg), divided up throughout the day. In some cases, such as in patients
suffering from unstable angina, total daily doses of up to 480mg (8 tablets) may be prescribed.
Elderly
Elderly patients or patients with a kidney problem may require a lower dose or the dose may be taken
less often.
Children
Diltiazem Hydrochloride should not be given to children.
If you take more Diltiazem Hydrochloride than you should
If you take more Diltiazem Hydrochloride than you should, contact your doctor or nearest hospital
emergency department immediately. Symptoms of overdose include severe low blood pressure leading
to collapse, slowing of the heartbeat and general heart problems. Take the container and any remaining
tablets with you.
If you forget to take Diltiazem Hydrochloride
If you forget to take Diltiazem Hydrochloride take the next dose as soon as you remember unless it is
almost time for your next dose. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.

POSSIBLE SIDE EFFECTS

Like all medicines, Diltiazem Hydrochloride can cause side effects, although not everybody gets them.
The most common side effects are:

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swelling of ankles
hot flushes
stomach upset

headache
feeling generally unwell
rash

The following side effects are rare but serious. Tell your doctor if you notice any of the following side
effects as you may need medical attention.
• liver problems, dark urine pale stools, yellowing of the skin or whites of the eyes
• heart rhythm changes
• depression
• Parkinsonian syndrome (trembling, muscle stiffness or spasms, slowing of movement).
• rash
• fever and red blister like spots on the skin
• overgrowth of the gums
If any side effect gets serious, or if you notice any side effect not listed in this leaflet, please tell your
doctor or pharmacist.
5.

HOW TO STORE DILTIAZEM HYDROCHLORIDE

Keep out of the reach and sight of children.
Do not use Diltiazem Hydrochloride after the expiry date, stated on the pack after EXP. The expiry
date refers to the last day of that month.
Store in a cool dry place. Protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
6.

FURTHER INFORMATION

What Diltiazem Hydrochloride tablets contain
-

The active substance is diltiazem hydrochloride 60 mg
The other ingredients are lactose, hydroxypropyl methylcellulose, povidone, ethylcellulose,
polyethylene glycol, hydrogenated vegetable oil, magnesium stearate, talc and purified water.

What Diltiazem Hydrochloride tablets look like and contents of the pack
Your medicine comes as a ‘modified release’ tablet, which is a white, convex and marked “DT/60” on
one side and “G” on the reverse.
Diltiazem Hydrochloride is available in blister packs or plastic bottles of 5, 7, 10, 14, 15, 20, 21, 25,
28, 30, 56, 60, 84, 90, 100, 112, 120, 168, or 180 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
This leaflet was last approved in 02/2008.

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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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