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MEZATIL CAPSULES SR 60 MG

Active substance(s): DILTIAZEM HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Mezatil 60mg, 90mg and 120mg Sustained Release Capsules
(Diltiazem 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.
What is in this leaflet:
1. What Mezatil is and what it is used for
2. What you need to know before you take Mezatil
3. How to take Mezatil
4. Possible side effects
5. How to store Mezatil
6. Contents of the pack and other information
1. What Mezatil is and what it is used for
The active ingredient in this medicine is diltiazem hydrochloride. It belongs to a group of medicines
called calcium channel blockers. These work by making your blood vessels wider. This helps to lower
your blood pressure. It also makes it easier for your heart to pump blood around the body.
Your medicine is used for the following:

To treat mild to moderate high blood pressure (hypertension)

To prevent attacks of chest pain (angina)
2. What you need to know before you take Mezatil
Do not take Mezatil:

If you are allergic to diltiazem or any of the other ingredients of this medicine (listed in section 6)

If you are pregnant, planning to become pregnant, could become pregnant or you are breastfeeding (see “Pregnancy and breast-feeding” section)

If you have heart problems, such as:
o Very slow heartbeat (severe bradycardia with less than 40 beats per minute)
o Second or third degree heart block, unless you have a pacemaker fitted
o Sick sinus syndrome, unless you have a pacemaker fitted
o Heart failure after a heart attack
o Left ventricular failure with lung congestion
o A narrowing of the aortic valve in the heart, restricting the blood flow (severe aortic stenosis)
o Weakened heart unable to pump blood around the body (cardiogenic shock)
o Severely low blood pressure (hypotension)

If you are being treated with dantrolene infusion (see “Other medicines and Mezatil” section )

If you suffer from porphyria (a rare disease of the blood pigment)

If you are taking ivabradine (see “Other medicines and Mezatil” section)
Warnings and precautions
Talk to your doctor before taking Mezatil if:

You are diabetic as your doctor may need to change the dosage of your diabetic medication

You have liver or kidney problems or you are elderly. You should be closely monitored by your
doctor, in particular your heart rate, at the beginning of treatment

You have problems with your heart such as:
o Reduced left ventricular function
o Slow heartbeat (mild bradycardia), as it may become worse
o First degree heart block (symptoms may include skipped beats)
o Prolonged PR interval (detected on an electrocardiogram ECG).

You are due to have a general anaesthetic as you must tell the anaesthetist that you are taking
Mezatil



You are at risk of developing a blockage of the bowel,

Other medicines and Mezatil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those obtained without prescription. This includes herbal medicines.
Mezatil should not be taken with the following:

Dantrolene infusion, used to relieve muscle spasm for conditions such as cerebral palsy, multiple
sclerosis or spinal cord injury

Ivabradine, used to treat chest pain (angina) and heart failure
Other medicines which may interact with or be affected by Mezatil include:

Medicines used to treat high blood pressure or chest pain (angina), such as nifedipine, beta
blockers such as propranalol, ACE inhibitors (e.g. enalapril), alpha blockers (e.g. doxazosin) and
diuretics (e.g. bendrofluazide)

Medicines used for the treatment of irregular heartbeat such as amiodarone or heart failure such
as digoxin (antiarrhythmics). Particular care is needed if you are elderly or you are taking a high
dose

Medicines used to treat stomach ulcers such as cimetidine or ranitidine (H2 antagonists). You
should be carefully monitored when starting or stopping treatment with such medicines and your
dose of Mezatil may need to be adjusted

Medicines to treat epilepsy such as phenytoin, carbamazepine, phenobarbital or primidone
(antiepileptics)

Medicines to prevent rejection of transplant organs such as ciclosporin, tacrolimus or sirolimus

Theophylline, used to treat bronchial asthma

Warfarin, used to thin the blood (anti−coagulant)

Lithium, used to treat depression or mania

Rifampicin, an antibiotic used to treat various infections. You should be carefully monitored when
starting or stopping treatment with rifampicin

Atazanivir, efavirenz, amprenavir or ritonavir, used to treat HIV infection and AIDS (antiretrovirals)

Midazolam or triazolam, used to produce sleepiness or drowsiness before an operation, during
minor surgery or as a premedication (benzodiazepines)

Buspirone, used to treat anxiety

Dutasteride, used to treat men with an enlarged prostate

Imipramine, used to treat the symptoms of depression (tricyclic antidepressant)

Eplerenone, used to control blood pressure and heart function

Atorvastatin or simvastatin, used to lower lipids known as cholesterol and triglycerides in the
blood (statins). You should be closely monitored

Alfentanil, a short-acting painkiller used for surgical procedures

Cilostazol, used to treat cramping pain in the leg when walking, due to poor circulation
(intermittent claudication)

Methylprednisolone, used for inflammation and allergic reactions (corticosteroids). You should be
monitored when starting treatment with methylprednisolone as your dose may need to be
adjusted
Pregnancy and breast−feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor for advice before taking this medicine.
Pregnancy
You must not take this medicine if you are pregnant, might become pregnant or think you may be
pregnant. If it is at all possible that you could become pregnant, you must only take this medicine if
you are using effective contraception.
Breast-feeding
As the active ingredient diltiazem passes into breast milk, you must not breast-feed whilst taking this
medicine.
Driving and using machines

You may feel dizzy or generally unwell (malaise). If affected you should not drive or operate
machinery.
Mezatil contains sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicine.
3 How to take Mezatil
Always take Mezatil exactly as your doctor has told you. Check with your doctor or pharmacist
if you are not sure.
Your medicine comes in a sustained-release capsule which means the drug is released over a longer
period of time.




These capsules are to be taken orally
The capsules should be swallowed whole
Do not suck or chew the capsules

Adults
 The usual initial dose is normally 90mg taken twice a day.
 Your doctor may decide to increase this to 180mg twice a day if required.
Elderly and patients with liver or kidney problems
 The initial dose should be 60mg taken twice a day.
 Your doctor may increase the dose slowly to achieve the required level of control.
 The daily dose should not exceed 90mg twice a day.
Use in children
Children should not take this medicine.
If you take more Mezatil than you should
If you accidentally take too many capsules, contact your doctor or nearest hospital emergency
department immediately for advice. Remember to take this leaflet or any remaining capsules with you.
Symptoms of overdose include: low blood pressure (hypotension), slow heartbeat (bradycardia)
and/or an irregular heartbeat, heart attack. It may also cause an increase in blood sugar levels
(hyperglycaemia).
If you forget to take your Mezatil
Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do
not take a double dose to make up for a forgotten dose.
If you stop taking Mezatil
It is important that you keep taking Mezatil for as long as your doctor has told you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, Mezatil can cause side effects, although not everybody gets them.
Seek medical advice immediately if you develop the following:

Allergic reaction: swelling of the face, throat or tongue, difficulty breathing or dizziness

Swelling of the deeper layers of the skin caused by a build-up of fluid (angioneurotic oedema)
 Fever, general ill feeling, itching, joint aches, multiple skin lesions (erythema multiforme)
 Severe blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome) or severe
blistering of the skin (toxic epidermal necrolysis)
 Wheezing, breathlessness, abdominal pain, diarrhoea, fever, cough and rashes due to an
increase in a certain type of white blood cells (eosinophilia)
Very common side effects (may affect more than 1 in 10 people)

Swelling of the ankles (peripheral oedema)

Common side effects (may affect up to 1 in 10 people)

Headache

Dizziness

AV heart block (first, second or third)

Feeling your heartbeat (palpitations)

Flushing

Minor stomach problems such as, indigestion (dyspepsia), stomach pain, feeling sick (nausea),
constipation

Skin rashes (erythema)

General feeling of not being well (malaise)
Uncommon side effects (may affect up to 1 in 100 people)
 Nervousness
 Difficulty sleeping (insomnia)

Slower heartbeat (bradycardia)

Low blood pressure causing dizziness or light-headedness when you stand or sit up (orthostatic
hypotension)

Being sick (vomiting)

Diarrhoea

Increase in liver enzymes (detected through blood tests)
Rare side effects (may affect up to 1 in 1,000 people)
 Dry mouth
 Skin rashes with the formation of wheals (urticaria)
Other side effects (frequency not known)
 Increased risk of bleeding or bruising due to a reduction in blood platelets (thrombocytopenia)
 Swollen or enlarged lymph nodes (lymphadenopathy)
 Mood changes including depression, seeing or hearing things that are not real (hallucinations) or
personality change
 Medicine-induced movements disorders (extrapyramidal syndrome)
 Fainting (syncope)
 Memory loss (amnesia)
 Tingling or numbness in the hands or feet (paraesthesia)
 Sleepiness (somnolence)
 Shaking (tremor)
 Heart block, heart failure, chest pain (angina), irregular heartbeat (arrhythmia), feeling your
heartbeat (palpitations)

Inflammation of blood vessels (vasculitis)

Low blood pressure (hypotension)

Enlarged, swollen gums (gingivitis)

Loss of appetite (anorexia)

Inflammation of the liver (hepatitis)

Increased sensitivity of the skin to sunlight (photosensitivity)

Rash

Sweating

Peeling of the skin over large areas of the body (exfoliative dermatitis)

Skin rashes (erythema) with or without fever

Broken blood vessels that form tiny pin-point red/purple spots on the skin (petechiae)

Severe itching (pruritus)

Boil-like inflammation of the skin (exanthematous pustulosis)

Enlargement of breasts in men (gynaecomastia)

Sexual problems

Unusual or uncontrollable movements when walking

Increase in weight

Increase in CK (Creatine Kinase) blood levels (detected through blood test)

Poor sight ('lazy eye') [amblyopia]

Ringing in the ears (tinnitus)








Breathlessness (dysponea)
Nosebleed (epistaxis)
Blocked nose
High blood sugar level (hyperglycaemia)
Need to urinate during the night or more often (nocturia, polyuria)
Muscle or joint pain

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 Mezatil
 Keep this medicine out of the sight and reach of children.
 Do not use Mezatil after the expiry date, which is stated on the carton after EXP. The expiry date
refers to the last day of that month.
 Do not store above 25°C.
 Medicines should not be disposed of 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 Mezatil contains:
Each sustained release capsule contains 60mg, 90mg or 120mg of diltiazem hydrochloride.
The other ingredients are: sucrose, corn starch, povidone, methacrylic acid copolymer,
ethylcellulose, talc and diethyl phthalate.The hard gelatin capsules contain: titanium oxide (E171), red
iron oxide (E172), yellow iron oxide (E172).
What Mezatil looks like and contents of the pack:
 Mezatil 60mg are opaque pink and white sustained release capsules containing diltiazem
hydrochloride in sustained release sugar beads
 Mezatil 90mg are opaque pink and yellow sustained release capsules containing diltiazem
hydrochloride in sustained release sugar beads
 Mezatil 120mg are opaque pink and orange sustained release capsules containing diltiazem
hydrochloride in sustained release sugar beads
Mezatil is available in:
Mezatil Capsules are available in blister packs containing 14, 28, 42, 56 or 84 capsules or containers
of 100 capsules.
Not all pack sizes or pack types may be marketed.
Product Licence Numbers:
Mezatil 60mg Capsules: PL 11311/0538
Mezatil 90mg Capsules: PL 11311/0539
Mezatil 120mg Capsules: PL 11311/0540
Marketing Authorisation Holder:
Tillomed Laboratories Ltd
3 Howard Road
Eaton Socon
St. Neots
Cambridgeshire
PE19 8ET
UK
Manufacturer:
Ethypharm Industries

Zone Industrielle de Saint Arnoult
28170
Châteauneuf−en−Thymerais
France
This leaflet was last revised in July 2016
Till-Ver.2s

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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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