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ZEMTARD 180 XL

Active substance(s): DILTIAZEM HYDROCHLORIDE / DILTIAZEM HYDROCHLORIDE / DILTIAZEM HYDROCHLORIDE

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Package Leaflet:
Information for the User
®

• if you are due to have an operation where you might be given a muscle relaxant
called dantrolene (most likely to be administered in hospital under general
anaesthesia)
• if you are already taking a medicine containing ivabradine for the treatment of
certain heart diseases
Talk to your doctor before taking this product if any of the above apply to you.

(Diltiazem Hydrochloride
Modified Release Capsules)

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Uard:
• if you have any liver or kidney problems
• if you are an elderly patient
• if you have a slow heart rate (bradycardia)
• if you have any heart problems such as heart failure or first degree heart block (a
problem with the electrical impulses of the heart)
• if you experience mood changes, including depression
• if you are at risk of developing a blockage of the bowel.

Uard 120XL, 180XL,
240XL and 300XL
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. 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, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Uard is and what it is used for
2. What you need to know before you take Uard
3. How to take Uard
4. Possible side effects
5. How to store Uard
6. Contents of the pack and other information
1. What Uard is and what it is used for
Uard contains diltiazem hydrochloride as the active substance. Diltiazem
hydrochloride belongs to a group of medicines known as calcium channel blockers.
Uard is used to treat high blood pressure (hypertension). It can also be used to
prevent and treat a certain type of chest pain known as angina. Uard works by
opening up blood vessels so that blood passes through them more easily, and so
reduces blood pressure and chest pain in angina.
2. What you need to know before you take Uard
Uard is not suitable for use in children.
Do not take Uard
• if you are allergic (hypersensitive) to diltiazem hydrochloride or any of the other
ingredients of Uard (see Section 6 for a full list of ingredients)
• if you are pregnant or could become pregnant
• if you are breast-feeding
• if you have a very slow heart rate, less than 40 beats per minute (severe bradycardia)
• if you have a condition called sick sinus syndrome (an abnormality of heart rate or
heart rhythm) or if you suffer from second or third degree heart block (this is a
problem with the electrical impulses of the heart), unless you have a working
pacemaker fitted
• if you suffer from left-sided heart failure (left ventricular failure), with symptoms
such as shortness of breath and swelling of the ankles

• tricyclic antidepressants, such as imipramine
• antidepressants known as monoamine oxidase inhibitors/MAOIs, such as
moclobemide or phenelzine
• itraconazole (used to treat fungal infections)
• mefloquine (used for treating and preventing malaria)
• corticosteroids, sometimes simply referred to as steroids, such as hydrocortisone,
prednisolone or methylprednisolone (they may be prescribed in many different
illnesses but their main action is in controlling inflammation)
• simvastatin, atorvastatin or lovastatin (medicines for lowering cholesterol)
• lithium (used in cases of marked mood changes or mania)
• nitrate medicines, such as glyceryl trinitrate or isosorbide mononitrate (used to
treat angina)
• ulcer-healing medicines, such as cimetidine and ranitidine.
It may still be safe for you to take Uard; your doctor or pharmacist will be able to
advise you further.

If any of the above apply to you, it is important that you tell your doctor, pharmacist
or nurse before taking Uard and they will decide what to do. It may still be safe for
you to take Uard.
• prior to general anaesthesia; if you know that you are going to have a general
anaesthetic please tell your anaesthetist that you are taking Uard.

Uard with food and drink
Taking Uard with food and drink does not affect the way the product works.
Pregnancy and breast-feeding
Do not take Uard if you are pregnant, trying to become pregnant or if you are
breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine
during pregnancy or while breast-feeding.

Other medicines and Uard
You must tell your doctor or pharmacist if you are being treated with dantrolene or
ivabradine because you should not take Uard (see section 2 ‘Do not take Uard….’).

Driving and using machines
It is safe to drive while taking this medicine, however it may make you feel faint or
dizzy. If you find that you are affected you should not drive or operate machinery.

Please tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including those medicines obtained without a prescription.

Uard contains sucrose
These capsules contain sucrose. If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor before taking this medicine.

In particular, you should inform your doctor or pharmacist if you are taking any of the
following medicines:
• alpha-blockers, such as doxazosin or prazosin (medicines used for high blood
pressure or prostate enlargement in men)
• amiodarone and other ‘antiarrhythmic’ medicines (used to treat abnormal heart
rhythms)
• rifampicin (used to treat bacterial infections)
• carbamazepine, phenytoin or primidone (used in epilepsy)
• atazanavir or ritonavir (used to treat HIV infection)
• sleeping tablets or sedatives, including midazolam or triazolam which belong to a
group of medicines called benzodiazepines, and barbiturates (which can also be
used to treat epilepsy)
• other calcium channel blockers (such as nifedipine) and other medicines used to
treat high blood pressure
• beta-blockers, such as propranolol or atenolol (medicines used to treat high blood
pressure or other heart conditions)
• digoxin (used to treat heart failure and abnormal heart rhythms)
• ciclosporin, sirolimus, tacrolimus or everolimus (used to prevent rejection of a
transplanted organ or for the treatment of other immune system disorders)
• cilostazol (used to improve blood circulation to the legs)
• theophylline (used to treat breathing problems)
• general anaesthetics

3. How to take Uard
Always take this medicine exactly as your doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
The recommended dose for adults is between 180mg and 300mg of diltiazem given
once a day. This dose may be reduced to 120mg once a day, for elderly patients, or
patients with kidney or liver disease.
The label on the carton will tell you how many capsules you should take and when.
This product should be taken orally (by mouth). Swallow the capsules whole with a
drink of water. Do not crush or chew the capsules.
If you take more Uard than you should
If you take too many capsules, contact your nearest hospital casualty department or
doctor immediately. Take this leaflet and any remaining capsules with you to show
the doctor.
If you forget to take Uard
If you miss a dose but remember within 12 hours of the usual time, take it when you
remember. If you remember more than 12 hours after your usual time, leave out this
dose completely and carry on with the next dose when it is due. Do not take a
double dose to make up for a forgotten dose.
PX2152/3

If you stop taking Uard
Do not stop taking Uard without consulting your doctor. Stopping suddenly might
make your angina worse.
If you have any further questions on the use of this product, ask your doctor,
pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets
them.
If you experience any of the following side effects, stop taking Uard and
contact your doctor immediately:
• Slowing of the heart rate (bradycardia)
• Irregular heart rate
• Severe skin rash or itching especially those covering your whole body, severe
flaking, blistering or peeling of the skin, with or without a fever
• Signs of an allergic reaction, such as a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue
Very common side effects (may affect more than 1 in 10 people)
• Swelling of the hands, ankles or feet
Common side effects (may affect up to 1 in 10 people)
• Headache
• Dizziness
• Irregular heart rate
• Flushing (when your face, ears, neck and, occasionally, your upper chest, becomes
red in colour) or redness of the skin
• Constipation, indigestion, stomach pain, feeling sick (nausea)
• Feeling generally unwell
Uncommon side effects (may affect up to 1 in 100 people)
• Nervousness
• Difficulty sleeping
• Feeling dizzy, light-headed or faint when you stand or sit up quickly (low blood
pressure)
• Loss of appetite, being sick (vomiting), diarrhoea, changes in the way things taste,
weight gain
• A worsening of liver function tests (seen on a blood test)
Rare side effects (may affect up to 1 in 1000 people)
• Dry mouth
• Hives
Other side effects have also been reported, but their exact frequency is
unknown:
• A reduction in platelets in the blood, which increases the risk of bleeding or
bruising (thrombocytopenia)
• Changes in mood, including depression
• Unusual movements of the tongue, muscles spasms in the face, rolling eyes or
trembling











Heart failure
Inflammation of blood vessels, often with a skin rash
Swollen gums
Hepatitis (inflammation of the liver)
Increased sensitivity to sunlight. You may get sunburnt more easily and more
severely than someone not taking Uard. You should use sun protection while
taking this medicine
Skin rash
Sweating
Enlargement of breast tissue in men
Tiredness/weakness.

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 Uard
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and
blister foil. The expiry date refers to the last day of that month.
Do not store your capsules above 25˚C. Store in the original packaging in order to
protect the capsules from light and moisture.
Do not use Uard if you notice that the packaging or any of the capsules are damaged.
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 Uard contains
The active substance is diltiazem hydrochloride.

What Uard capsules look like and the contents of the pack
• Uard 120XL are hard gelatin capsules, with a brownish-red cap and an orange
body, with “DIL 120” overprinted in black ink.
• Uard 180XL are hard gelatin capsules, with a pink cap and a grey body, with “DIL
180” overprinted in black ink.
• Uard 240XL are hard gelatin capsules, with a light blue cap and body, with “DIL
240” overprinted in black ink.
• Uard 300XL are hard gelatin capsules, with a light blue cap and a white body, with
“DIL 300” overprinted in black ink.
Uard 120XL, 180XL, 240XL and 300XL are packaged in blister packs containing 28
capsules.
Marketing Authorisation Holder
Galen Limited
Seagoe Industrial Estate
Craigavon
BT63 5UA
UK
Manufacturer
Almac Pharma Services Limited
Almac House
20 Seagoe Industrial Estate
Craigavon
BT63 5QD
UK
Distributed by
Ennogen Healthcare Limited
Unit G4, Riverside Industrial Estate
Riverside Way
Dartford, DA1 5BS
UK
This leaflet was last revised in 07/2016.

Uard comes in four different strengths of capsule:
• Uard 120XL which contains 120mg of diltiazem hydrochloride per capsule.
• Uard 180XL which contains 180mg of diltiazem hydrochloride per capsule.
• Uard 240XL which contains 240mg of diltiazem hydrochloride per capsule.
• Uard 300XL which contains 300mg of diltiazem hydrochloride per capsule.
The beads in the capsule shells also contain other ingredients: ammonio
methacrylate copolymer types A and B, paraffin, talc, sucrose and starch.
The capsule shells are made of gelatin and may contain, depending on the strength
of the capsule, the following colouring agents: erythrosine (E127), indigotine (E132),
titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172) and yellow
iron oxide (E172).
The ink on the capsule shells contains shellac, black iron oxide (E172) and propylene
glycol.

PX2152/3
28/06/16

Expand Transcript

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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