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KENZEM 120MG SR CAPSULES

Active substance(s): DILTIAZEM HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

CP.DIL.JNT.SRC.CH.V4P1

KENZEM 60mg, 90mg AND 120mg SR CAPSULES
(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 further questions, please ask your doctor or your pharmacist.
• 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 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 Kenzem is and what it is used for
2. What you need to know before you take Kenzem
3. How to take Kenzem
4. Possible side effects
5. How to store Kenzem
6. Contents of the pack and other information

1.

WHAT KENZEM IS AND WHAT IT IS USED FOR

Kenzem 60mg, 90mg and 120mg SR Capsules are one of a group of
medicines called “calcium channel blockers” which are used to treat high
blood pressure or to help control angina (chest pain).

2.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE KENZEM

DO NOT take Kenzem and tell your doctor if you:
• have had an allergic reaction (rash, itching, shortness of breath) to a
medicine containing diltiazem or any of the ingredients listed in
section 6, Contents of the pack and other information
• are pregnant, trying to become pregnant or are breast-feeding
• are suffering from serious problems with your heart rhythm (e.g. slow
pulse rate, palpitations, slow heart beat - less than 50 beats per
minute) or heart failure. This includes having an uneven heart beat
(unless you have a pacemaker)
• are being treated with dantrolene injection (for severe muscle spasm)
Take special care and tell your doctor if you:
• are elderly
• are diabetic
• suffer from a kidney or liver disorder
• are suffering from mild problems with your heart rhythm or reduced
heart function
• are going to have an operation
• are predisposed to mood changes or are depressed
• are at risk of developing intestinal obstruction

Pregnancy, breast-feeding and Fertility
DO NOT take this medicine if you:
• are pregnant or planning to become pregnant
• are breast-feeding or planning to start breast-feeding
Always speak to your doctor before taking any medicine.
Driving and using machines
You may feel dizzy while taking this medicine. Do not drive or operate any
tools or machines if you feel dizzy.
Important information about some of the ingredients in your
medicine
This product contains sucrose. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before
taking this medicinal product.

3.

HOW TO TAKE KENZEM

Always take your medicine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
Kenzem 60mg, 90mg and 120mg SR Capsules are sustained release
capsules, which means the drug is released over a longer period of time.
DOSAGE
Adults
Angina: The usual dose is one 90mg or one 120mg capsule twice a day.
Your doctor may increase your dose up to two 120mg capsules twice a
day.

Other medicines and Kenzem
Tell your doctor or pharmacist if you are taking, or have recently taken any
other medicines even those not prescribed by a doctor. In particular tell
your doctor if you are taking any of the following:
• Dantrolene infusion (used as a muscle relaxant)
• Anti-hypertensive agents (medicines used to reduce your blood
pressure), such as beta blockers (e.g. propranolol) or alpha blockers
(e.g. prazosin), diuretics (water tablets) or ACE inhibitors (e.g. captopril,
ramipril)
• Carbamazepine (used to treat epilepsy)
• Theophylline (for asthma or breathing difficulties)
• Ciclosporin (used after organ transplant to prevent rejection or used to
treat psoriasis)
• Digoxin (to treat palpitations or irregular heart beat)
• Cimetidine or ranitidine (used to treat stomach ulcers or acid reflux
disorders)
• Anaesthetic agents at the doctor’s or dentist’s
• Antiarrhythmic drugs (medicines used to treat abnormal heart rhythms
e.g. adenosine, amiodarone)
• Lithium (used to treat depression)
• Rifampicin (used to treat bacterial infections including tuberculosis)
• Medicines for lowering cholesterol - statins (e.g. atorvastatin,
fluvastatin or simvastatin)
• Nitrate derivatives (used to treat heart problems e.g. glyceryl trinitrate)
• Midazolam or triazolam (used as sedatives for conditions such as panic
disorders, anxiety, insomnia, alcohol withdrawal and in some cases for
epileptic seizures)
• Methylprednisolone (used as an anti-inflammatory to relieve pain)

High blood pressure: The usual dose is one 90mg or one 120mg
capsule twice a day.
Your doctor may increase your dose to one 120mg capsule three times a
day.

Taking Kenzem SR Capsules with food and drink
Do not take Kenzem SR Capsules at the same time as taking an alcoholic
drink.

If you stop taking Kenzem
Take this medicine for as long as your doctor tells you to, as you may
become unwell if you stop.
If you have any further questions on the use of Kenzem, ask your
doctor or pharmacist.

Customer: CH

Originated by: TC (AWG)

Colours

Product: Kenzem 60mg, 90mg and 120mg SR Capsules
Dimensions: 210mm x 297mm
Item Code: CP.DIL.JNT.SRC.CH.V4P1
Proof No and Date: 1

12/07/2016

Revision:
ARTWORK FOR SUBMISSION
Supersedes: n/a

Pantone Blue
280 C

Adults with liver or kidney problems and elderly patients
Angina and high blood pressure: The usual dose is one 60mg capsule
twice a day.
Your doctor may increase your dose to one 90mg or one 120mg capsule
twice a day. This will depend on your heart rate.
Use in children
Kenzem 60mg, 90mg and 120mg SR Capsules are not recommended for
use in children.
Swallow the capsule whole with a drink of water. Do not suck or chew the
capsule. Try to take your capsules at the same time each day.
If you forget to take Kenzem
If you forget to take a dose, take it as soon as you remember, unless it is
more than six hours since your last dose was due. Do not take a double
dose to make up for the dose you have missed.
If you take more Kenzem than you should
If you take too many capsules, or you think a child has accidentally
swallowed any, contact your nearest hospital casualty department or
doctor immediately. Take this leaflet and any remaining capsules with you
to show the doctor.

4.

POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
STOP taking your medicine and tell your doctor immediately, or go
to your nearest hospital casualty department if you experience:
• an allergic reaction. The symptoms may include a rash, problems with
swallowing or breathing, swelling of the lips, face, throat or tongue
• severe blistering rash where layers of skin peel off leaving scalded
skin. You may also have a fever. This could be an illness called ‘toxic
epidermal necrolysis’.
• a skin rash with dark circles and pale centres, red patches, blistering or
peeling. You may also have a fever. This could be an illness called
‘erythema multiforme’ or ‘Stevens-Johnson syndrome’.
• heart problems or heart failure. The signs could be shortness of breath,
flushing, feeling of tiredness along with swollen ankles and legs
• a severe slowing of the heart (which may cause either fainting or
dizziness)
• hepatitis (symptoms include high temperature, nausea, muscle aches,
tiredness, loss of appetite and diarrhoea). A disturbance in liver enzyme
level is often detectable by a blood test.
Tell your doctor if you notice any of the following side effects:
Very common: may affect more than 1 in 10 people
• Swelling of the lower legs
Common: may affect up to 1 in 10 people
• Headache, dizziness
• Very fast, uneven or forceful heartbeat (palpitations)
• Flushing (feeling of warmth)
• Constipation, stomach pain, feeling sick, indigestion
• Skin redness
• Feeling unwell

6.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Kenzem SR Capsules contain
Kenzem 60mg, 90mg or 120mg SR Capsules contain the active
ingredient diltiazem hydrochloride.
The other inactive ingredients include sugar spheres (sucrose and maize
starch), povidone, methacrylic acid copolymer, ethylcellulose, talc and
diethyl phthalate. The capsule is made of gelatin and contains titanium
dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).
What Kenzem SR Capsules look like and contents of the pack
Kenzem 60mg SR Capsules are opaque pink and white capsules.
Kenzem 90mg SR Capsules are opaque pink and yellow capsules.
Kenzem 120mg SR Capsules are opaque pink and orange capsules.
Each pack contains 56 capsules.
Manufacturer
Ethypharm, Z.I. Saint Arnoult, 28170 Chateunauf-en-Thymerais, France.
Marketing Authorisation Holder
Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland.
Distributor
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.
PL 30464/0143, PL 30464/0144 and PL 30464/0145
This leaflet was last revised August 2014.

Uncommon: may affect up to 1 in 100 people
• Nervousness
• Difficulty sleeping
• Slow or uneven heartbeat
• Sudden increase in blood pressure
• Vomiting (getting sick)
• Diarrhoea
Rare: may affect 1 in 1,000 people
• Dry mouth
• Itchy, lumpy rash (called urticaria)
Not known: frequency cannot be estimated from the available data
• Bruising or bleeding under the skin, which may be caused by a
reduction in blood platelets
• Mood changes, depression
• Abnormal or jerky movements
• Skin rash caused by narrow or blocked blood vessels (called vasculitis)
• Swollen gums
• Sensitivity of skin to light. You may get sunburnt easier than someone
not taking this medicine. It is advisable to use sun protection while
taking this medicine.
• Breast enlargement in men
• High blood sugar levels
Blood tests
Kenzem can change the levels of liver enzymes, which may show up in
blood tests. This can mean that your liver is not working properly.
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.
By reporting side effects you can help provide more information on the
safety of this medicine.

5.

HOW TO STORE KENZEM

Do not use after the expiry date stated on the pack. The expiry date refers
to the last day of that month.
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF
CHILDREN.
Store below 25°C in a dry place away from heat and moisture.
Return any leftover capsules to your pharmacist. Only keep them if your
doctor tells you to. 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.
CP.DIL.JNT.SRC.CH.V4P1

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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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