Diltiazem Hydrochloride Tablets 60mg
PACKAGE LEAFLET: INFORMATION FORTHE USER
Read all ofthis 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 or nurse.
• 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 any of the side effects gets serious, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Diltiazem Hydrochloride Tablets 60mg are and what they are used for
2. What you need to know before you take Diltiazem Hydrochloride Tablets 60mg
3. How to take Diltiazem Hydrochloride Tablets 60mg
4. Possible side effects
5. How to store Diltiazem Hydrochloride Tablets 60mg
6. Contents of the pack and other information
1. WHAT DILTIAZEM HYDROCHLORIDE
TABLETS 60MG ARE AND WHAT THEY ARE USED FOR
Diltiazem Hydrochloride Tablets 60mg contain a medicine called diltiazem hydrochloride. It belongs to a group of medicines called calcium channel blockers and is used to prevent and treat angina pectoris.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DILTIAZEM HYDROCHLORIDE TABLETS 60MG
Do not take this medicine ifyou:
• Are hypersensitive (allergic) to diltiazem hydrochloride or any of the other ingredients in this medicine (listed in section 6)
• Are pregnant or are a woman of child bearing age
• Are taking a medicine called dantrolene used for severe muscle spasms or severe fever (see taking other medicines section)
• Have a heart condition such as; a severe slow heart beat (bradycardia), disturbances in heart rhythm causing palpitations or fainting (sick sinus syndrome) not requiring a pacemaker, heart failure with reduced blood flow, congestive heart failure, second or third degree heart block without a functioning pacemaker, narrowing of the opening of the aortic valve in the heart (aortic stenosis), shock caused by heart problems (cardiogenic shock)
• Have very low blood pressure.
Warnings and precautions:
Talk to your doctor, or pharmacist or nurse before taking Diltiazem Hydrochloride Tablets 60mg ifyou:
• Suffer from kidney or liver problems
• Have been told by your doctor that you have an intolerance to some sugars (see section Diltiazem Hydrochloride Tablets 60mg contain lactose)
• Have any other problems with your heart, apart from angina or the conditions described in the previous section
• Are going to have an operation and may require an anaesthetic
• Are at risk of mood changes, including depression
• Are at risk from stomach or intestine problems.
Ifyou are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine.
Other medicines and Diltiazem Hydrochloride Tablets 60mg:
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
In particular tell your doctor if you are taking any of the following:
• Dantrolene given as an infusion for severe muscle spasms or severe fever
• Medicines for high blood pressure such as doxazosin, tamsulosin, atenolol, propranolol or acebutolol
• Medicines such as digoxin and amiodarone used to treat an uneven heartbeat
• Medicines such as glyceryl trinitrate or isosorbide trinitrate used to treat angina
• Medicines such as simvastatin, fluvastatin and atorvastatin used to treat high cholesterol
• Ciclosporin, sirolimus and tacrolimus used after organ transplants
• Phenobarbital, phenytoin, primidone and carbamazepine used to treat epilepsy
• Theophylline used to treat asthma and breathing problems
• Lithium used to treat mental illness including depression
• Triazolam and midazolam used to treat sleeplessness and anxiety
• Methylprednisolone used to treat inflammation and allergic reactions
• Rifampicin used to treat tuberculosis
• Ranitidine and cimetidine used to treat stomach ulcers
• Imipramine and other tricyclic antidepressants (used for depression)
• Diuretics (water tablets)
• Levodopa to treat Parkinson's disease
• Dutasteride used to treat an enlarged prostate gland
• Baclofen and tizanidine used as muscle relaxants
• Oestrogens used in hormone replacement therapy (HRT).
If you are currently receiving treatment for diabetes it may need to be adjusted as Diltiazem Hydrochloride Tablets 60mg may impair glucose tolerance.
Ifyou are going to have an anaesthetic tell the doctor or dentist that you are taking this medicine.
Pregnancy and breast-feeding:
Do not take Diltiazem Hydrochloride Tablets 60mg 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:
These tablets may make you feel dizzy or tired. If you feel dizzy or tired after taking this medicine do not drive, operate tools or machinery.
Diltiazem Hydrochloride Tablets 60mg contain lactose
If you have been told by your doctor that you have an intolerance to some sugars you should talk to your doctor before taking this medicine.
Diltiazem Hydrochloride Tablets 60mg contain hydrogenated castor oil
This may cause stomach upsets and diarrhoea.
3. HOW TO TAKE DILTIAZEM
HYDROCHLORIDE TABLETS 60MG
Always take Diltiazem Hydrochloride Tablets 60mg exactly as your doctor has instructed you. You should check with your doctor or pharmacist ifyou are unsure.
Swallow the tablets whole with a glass ofwater. Adults:
The normal dose of diltiazem hydrochloride is 60mg (one tablet), 3 times a day.
If necessary your doctor may increase this to:
• Two tablets (120mg) three times a day (360mg)
• Two tablets (120mg) four times a day (480mg)
Tell your doctor as soon as possible if you have any of the following:
Very common (affects more than 1in10 people)
• Swelling of the lower legs.
Common (affects less than 1in10 people)
• Indigestion, stomach pain, constipation, diarrhoea.
Elderly and patients with liver or kidney problems:
If you are an elderly patient, or suffer from liver or kidney problems, your doctor may prescribe a smaller dose, such as 60mg (one tablet) twice a day.
Children:
This medicine should not be given to children.
Your doctor may want to do regular checks on your blood, heart, liver and kidneys while taking this medicine.
Ifyou take more ofthese tablets than you should:
If you have accidently taken too many tablets you may experience low blood pressure making you feel dizzy, tired or a slowed heart rate. If you do take more than the recommended dose, you should contact your doctor or hospital immediately.
Uncommon (affects less than 1 in 100 people)
• Feeling dizzy, light-headed or faint when standing or sitting up quickly (low blood pressure).
Rare (affects less than 1 in 1000 people)
• Dry mouth
• Itchy, lumpy rash (urticaria).
Frequency unknown
• Swollen gums.
Other side effects below have been reported. Tell your doctor or pharmacist if any of the following side effects gets serious:
Common (affects less than 1in10 people)
• Headache
• Flushing
• Feeling sick (nausea) or being sick (vomiting)
• General feeling of being unwell
• Feeling dizzy
• Skin redness.
Ifyou stop taking these tablets:
Ifyou suddenly stop taking this medicine it may cause the symptoms to come back so always follow your doctors instructions carefully.
Ifyou forget to take these tablets:
Ifyou have forgotten to take your medicine, take it when you remember, if your next dose is due within 2 hours, take a single dose now and skip the next dose. If you are concerned about forgetting to take your medicine consult your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking these tablets and see a doctor immediately if:
• You have an allergic reaction. The signs include a 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, 'flulike' 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 which develops into a bull eye/target lesions with dark red centre, surrounded by a paler pink ring with a bright red outer ring. This may appear on the palms or on soles of the feet. This could be signs of a condition called 'erythema multiforme'.
Tell your doctor straight away ifyou experience any of the following as you may need urgent medical treatment:
Common (less than 1in10 people)
• Slow or uneven heartbeat
• Very fast, uneven or forceful heartbeat (palpitations).
Frequency unknown:
• 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 ofthe tongue, muscle spasms ofthe 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)
• You should wear sun protection whilst taking this medicine
• Breast enlargement in men.
Uncommon (affects less than 1 in 100 people)
• Difficulty sleeping.
Frequency unknown
• Mood changes, including depression
• Bleedingorbruisingundertheskin
• Rash.
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: http://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 TABLETS 60MG
Check the expiry date printed on the label or side of the box. Do not use after the expiry date stated on the label.
Do not store above 25°C. Store in the original package.
In case of any visible signs of deterioration, you should discard the package.
Medicines should not be disposed ofvia waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.
Keep out of the sight and reach of children
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Diltiazem Hydrochloride Tablets 60mg contain:
Diltiazem Hydrochloride Tablets 60mg contain the active substance diltiazem hydrochloride 60mg in each tablet.
The other ingredients are: lactose, hydrogenated castor oil, polyethylene glycol and magnesium stearate.
What Diltiazem Hydrochloride Tablets 60mg look like and contents ofthe pack:
Diltiazem Hydrochloride Tablets 60mg are white, flat tablets with a scoreline on one side.
These tablets are available in packs of 28, 30, 50, 56, 60, 84, 90, 100, 112, 250 and 1,000.
Marketing Authorisation Holder:
Ennogen Pharma Limited,
Unit G4, Riverside Industrial Estate Riverside Way, Dartford, DA1 5BS, United Kingdom.
Manufacturer:
Regent GM Laboratories Ltd
Cunard Road, North Acton, London, NW10 6PN
This leaflet was last revised in April 2015