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ZEMTARD 180 XL

Active substance(s): DILTIAZEM HYDROCHLORIDE

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
®

Uard 120XL,
180XL, 240XL
and 300XL
(Diltiazem Hydrochloride
Modified Release Capsules)

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 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 any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.
In this leaflet:
1. What Uard is and what it is used for
2. Before you take Uard
3. How to take Uard
4. Possible side effects
5. How to store Uard
6. Further 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. 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 50 beats per
minute (marked bradycardia)
- if you have a condition called sick sinus syndrome (an
abnormality of heart rate or heart rhythm)
- if you suffer from left-sided heart failure (left ventricular
failure), with symptoms such as shortness of breath and
swelling of the ankles
- 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 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.

- mefloquine (used for treating and preventing malaria)
- corticosteroids, sometimes simply referred to as steroids,
such as hydrocortisone or prednisolone (they may be
prescribed in many different illnesses but their main action
is in controlling inflammation)
- simvastatin, atorvastatin or lovastatin (medicines for
lowering cholesterol)
- nifedipine (used to treat high blood pressure and angina)
- 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.
It may still be safe for you to take Uard; your doctor or
pharmacist will be able to advise you further.

Take special care with Uard
- if you have any liver or kidney problems
- if you have a slow heart rate (mild 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 any of the above apply to you, it is important that you tell
your doctor or pharmacist before taking Uard and they will
decide what to do. It may still be safe for you to take Uard.

Taking Uard with food and drink
Taking Uard with food and drink does not affect the way the
product works.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any of the following medicines, including those
medicines obtained without a prescription:
- alpha-blockers, such as doxazosin or prazosin (medicines
used for high blood pressure or prostate enlargement in men)
- amiodarone (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 viral infections)
- sleeping tablets or sedatives
- 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 or tacrolimus (used to prevent rejection
of a transplanted organ)
- cilostazol (used to improve blood circulation to the legs)
- theophylline (used to treat breathing problems)
- general anaesthetics
- tricyclic antidepressants, such as imipramine
- antidepressants known as monoamine oxidase
inhibitors/MAOIs, such as moclobemide or phenelzine
- itraconazole (used to treat fungal infections)

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 or have
recently taken any other medicines, including medicines
obtained without a prescription.

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.

Important information for patients with an intolerance
to some sugars
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.

3. HOW TO TAKE UARD
Always take Uard exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
The usual 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.

PX2152/2

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.

Do not store your capsules above 25˚C. Store in the original
packaging in order to protect the capsules from light and
moisture.

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.

Do not use Uard if you notice that the packaging or any of the
capsules are damaged.

Uard 120XL, 180XL, 240XL and 300XL are packaged in
blister packs containing 28 capsules.

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.

Marketing Authorisation Holder
Galen Limited
Seagoe Industrial Estate
Craigavon, BT63 5UA
UK

5. HOW TO STORE UARD
Keep out of the reach and sight of children.
Do not use Uard after the expiry date which is stated on the
carton and blister foil. The expiry date refers to the last day of
that month.

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.
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 or pharmacist.

4. POSSIBLE SIDE EFFECTS

Manufacturer
Almac Pharma Services Limited
Almac House
20 Seagoe Industrial Estate
Craigavon, BT63 5QD
UK

6. FURTHER INFORMATION

Like all medicines, Uard can cause side effects, although not
everybody gets them.
If you notice:
- slowing of the heart rate (bradycardia)
- irregular heart rate
- severe skin rashes with skin flaking
Stop taking Uard and contact your doctor immediately.

What Uard contains
The active substance is diltiazem hydrochloride.
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 following side effects have also been reported:
- swelling of the legs, (this is - change in the way things taste
- feeling sick (nausea)
more common in elderly
patients and may be worse - loss of appetite
- being sick (vomiting)
with higher doses)
- constipation
- headache
- diarrhoea
- low blood pressure
- weight gain
- dizziness
- flushing (when your face, - skin rash
ears, neck and, occasionally, - sensitivity to sunlight
your upper chest, becomes - enlargement of breast
tissue in men
red in colour)
- jaundice (yellowing of the
- palpitations
skin and the whites of the
- tiredness/weakness
eyes)
- generally feeling unwell
- hepatitis (inflammation of
- depression
the liver)
- swollen gums

Distributed by
Ennogen Healthcare Limited
Unit G4, Riverside Industrial Estate
Riverside Way
Dartford, DA1 5BS
UK
This leaflet was last revised in 09/2015.

The beads in the capsule shells also contain other ingredients:
ammonio methacrylate copolymer types A and B, paraffin, talc,
sucrose and starch.

Uard is a trade mark.

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).

PX2152/2
01/09/15

The ink on the capsule shells contains shellac, black iron oxide
(E172) and propylene glycol.

If you consider any of the side effects to be serious, or if you
notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

PIL:

Uard 2152/1

Ink Colour:

Black

Fold Configuration:

2152/2
3

60mm

Folded

Folded Size: 155mm x 30mm
APPROVED BY:

155mm

4

155mm

Date:

100mm verification bar

30mm

Pharmacode: 21522
Supplied:

155mm

2

59.5mm

59.5mm

Dimensions: 238 x 155mm
PX No:

155mm

1

Finished dimensions: 155mm x 30mm

Expand view ⇕

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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