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URADRIEST 200 MG PROLONGED-RELEASE CAPSULES HARD

Active substance(s): DILTIAZEM HYDROCHLORIDE / DILTIAZEM HYDROCHLORIDE

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Package leaflet: Information for the user

Uradriest 200 mg prolonged-release capsules, hard and
Uradriest 300 mg prolonged-release capsules, hard
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 Uradriest is and what it is used for
2. What you need to know before you take Uradriest
3. How to take Uradriest
4. Possible side effects
5. How to store Uradriest
6. Contents of the pack and other information
1. What Uradriest is and what it is used for
Uradriest contains a medicine called diltiazem hydrochloride. This
belongs to a group of medicines called ‘calcium-channel blockers’.
Uradriest is used for:
• High blood pressure
• Angina (chest pain).
It works 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 your body. This helps to prevent the chest pain caused by
angina.
2. What you need to know before you take Uradriest
Do not take Uradriest:
• if you are allergic to diltiazem hydrochloride or any of the other
ingredients of this medicine (listed in Section 6). Signs of an
allergic reaction include: a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue
• if you are breast-feeding or planning to breast-feed (see Section
below: ‘Pregnancy and breast-feeding’)
• if you have a very slow heartbeat – less than 50 beats per minute
• if you have heart failure and problems with blood flow to your
lungs. With these illnesses, you may feel out of breath and have
swollen ankles
• if you are already taking a medicine containing ivabradine for the
treatment of certain heart diseases
• if you have any other serious problems with your heart. This
includes having an uneven heartbeat (unless you have a
pacemaker).
• if you are taking a medicine called dantrolene used for severe
muscle spasm or serious fever (called “malignant hyperthermia”).
(see Section below: ‘Taking other medicines’).
Do not take this medicine if any of the above apply to you. If you are
not sure, talk to your doctor or pharmacist before taking Uradriest.
Warnings and precautions
Talk to your doctor or pharmacist before taking Uradriest:
• if you have any other problem with your heart, apart from angina or
those described in the Section above ‘Do not take Uradriest’
• if you are going to have an operation
• if you are at risk of mood changes, including depression
• if you are at risk of gut problems.
Your doctor will check you more closely particularly when you first
start taking the capsules
• if you have liver problems
• if you have kidney problems
• if you are over 65 years old
• if you have diabetes
Other medicines and Uradriest
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. This includes medicines you buy
without a prescription, including herbal medicines. This is because
Uradriest can affect the way some other medicines work. Also some
medicines can affect the way Uradriest works.
In particular, do not take this medicine and tell your doctor if you
are taking:
• Dantrolene (an infusion) used for severe muscle spasms or serious
fever (called ‘malignant hyperthermia’).

Uradriest may increase the effect of the following medicines:
• For high blood pressure such as doxazosin, tamsulosin, atenolol,
propranolol or acebutolol
• Used for an uneven heartbeat such as amiodarone and digoxin.
• Used for angina such as glyceryl trinitrate or isosorbide trinitrate
• Used for high levels of cholesterol such as simvastatin, fluvastatin
and atorvastatin
• Used for sleeplessness and anxiety, such as triazolam and
midazolam
• Carbamazepine - used for epilepsy
• Theophylline - used for breathing problems
• Lithium - used for some types of mental illness
• Methylprednisolone - used for inflammation and allergic reactions
• Immunosuppressants (ciclosporine, tacrolimus, sirolimus,
everolimus) - used to stop the rejection of organs after a transplant.
• Phenytoin used for epilepsy
• Aspirin used for relieving pain and reducing fever
• Iodinated contrast media (used for tests involving X-rays)
Uradriest may make the following medicine work less well:
• Rifampicin - used for tuberculosis.
The following medicines can increase the effect of Uradriest
• For stomach ulcers such as cimetidine and ranitidine.
If any of the above apply to you (or you are not sure), talk to your
doctor or pharmacist before taking Uradriest.
Uradriest with food, drink and alcohol
It is advisable to limit the amount of grapefruit juice you drink while
taking diltiazem as it can increase the blood levels of diltiazem and
may increase your chances of getting side effects. If you are concerned
you should stop drinking grapefruit juice and consult your doctor.
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 or pharmacist for advice
before taking this medicine.
Pregnancy
You should not take Uradriest if you are pregnant, might become
pregnant or think you may be pregnant. This is because Uradriest can
bring problems for your baby. Talk to your doctor if you might be
pregnant.
Breast-feeding
Do not breast-feed if you are taking Uradriest. This is because small
amounts may pass into the mother’s milk. If you are breast-feeding or
planning to breast-feed, talk to your doctor or pharmacist before taking
any medicine.
Driving and using machines
You may feel dizzy while taking this medicine. If this happens, do not
drive or use any tools or machines.
3. How to take Uradriest
Always take this medicine exactly as your doctor has told you. Check
with your doctor or pharmacist if you are not sure.
How to take this medicine:
• Take this medicine by mouth.
• Do not break, crush or chew your capsules.
• Swallow the capsules whole with a drink of water.
• Take before or during a meal.
• If you feel the effect of your medicine is too weak or too strong, do
not change the dose yourself, but ask your doctor
Recommended dose:
Adults:
Angina and high blood pressure
• The usual start dose is one Uradriest 200 mg capsule a day.
If necessary, your doctor may increase your dose. Possible doses are:
• One Uradriest 300 mg capsule a day
• Two Uradriest 200 mg capsules a day
• One Uradriest 300 mg capsule and one Uradriest
200 mg capsule a day.
Over 65 years or adults with liver or kidney problems
Angina and high blood pressure
• Your doctor will check you more closely particularly when you
first start taking the capsules.
• The usual starting dose is one Uradriest 200 mg capsule a day.
If necessary, your doctor may increase this to:
• One Uradriest 300 mg capsule a day.

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Uradriest 200 mg and 300 mg
prolonged-release capsule, hard
UK

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Children and adolescents
Uradriest should not be given to children and adolescents.
Tests
Your doctor may do regular tests while you are taking this medicine.
These might include a check on your heart. It may also include blood
tests to check your liver and kidneys.
If you take more Uradriest than you should
If you take more capsules than you should, tell a doctor or go to a
hospital casualty department straight away. Take the medicine pack
with you. This is so the doctor knows what you have taken. The
following effects may happen: feeling dizzy or weak, blurred vision,
chest pain, being shortness of breath, fainting, an unusually fast or
slow heartbeat, coma and sudden death.
If, in an emergency situation, the patient is treated quickly sudden
death is a potential outcome.
If you forget to take Uradriest
If you forget a dose, take it as soon as you remember it. However, if
it is nearly time for the next dose, skip the missed dose. Do not take a
double dose to make up for a forgotten dose.
If you stop taking Uradriest
Keep taking Uradriest until your doctor tells you to stop. Do not stop
taking Uradriest just because you feel better. If you stop, your illness
may get worse.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everyone gets them.
Stop taking Uradriest and see a doctor or go to a hospital straight
away if:
It is not known how often these side effects happen
• You have an allergic reaction. The signs may include: a rash,
swallowing or breathing problems, swelling of your lips, face,
eyelids, throat or tongue
• You have a red or lumpy skin, swollen eyelids, face, lips, throat, or
tongue, difficulty breathing or swallowing.
• You get blistering or peeling of the skin around the lips, eyes,
mouth, nose or genitals, flu-like symptoms or fever. This could be
an illness called “Stevens-Johnson syndrome”
• You get a severe blistering rash in which layers of the skin may
peel off to leave large areas of raw exposed skin over the body. You
may feel generally unwell, have a fever, chills or aching muscles.
This could be an illness called “Toxic Epidermal Necrolysis”
• You have a skin rash or skin problems with a pink/red ring and a
pale centre which may be itchy, scaly, or filled with fluid. The rash
is most likely to happen on the palms or soles or your feet. These
could be signs of a serious allergy to the medicine called “erythema
multiforme”.
Tell your doctor straight away if you notice any of the following
serious side effects – you may need urgent medical treatment:
Common (may affect up to 1 in 10 people)
• Slow or uneven heartbeat
• Very fast, uneven or forceful heartbeat (palpitations).
It is not known how often these side effects happen
• Skin rash caused by narrow or blocked blood vessels (called
‘vasculitis’)
• Being short of breath, feeling tired along with swollen ankles or
legs. These could be signs of heart failure
• Unusual movements of the tongue, muscle spasms in your face,
rolling eyes or trembling
• High temperature, feeling tired, loss of appetite, stomach pain,
feeling sick. These can be signs of inflammation of the liver (called
‘hepatitis’)
• Getting sunburnt more easily and more severely than someone not
taking Uradriest. You should use sun protection whilst taking this
medicine
• Breast enlargement in men.
• Passing large amounts of urine, excessive thirst and having
a dry mouth or skin. These may be signs of high blood sugar
(hyperglycemia).
Tell your doctor as soon as possible if you have any of the
following side effects:
Very common (may affect up to 1 in 10 people)
• Swelling of the lower legs.
Common (may affect up to 1 in 10 people)
• Indigestion, stomach pain, constipation or diarrhoea.
Uncommon (may affect up to 1 in 100 people)
• Feeling dizzy, light-headed or faint when you stand or sit up
quickly (low blood pressure).
Rare (may affect up to 1 in 1,000 people)
• Dry mouth
• Itchy, lumpy rash (called ‘urticaria’).
It is not known how often these side effects happen
• Swollen gums.

Tell your doctor or pharmacist if any of the following side effects
get serious or last longer than a few days:
Common (may affect up to 1 in 10 people)
• Headache
• Flushing (feeling of warmth)
• Feeling sick (nausea) or being sick (vomiting)
• General feeling of being unwell
• Feeling weak or tired
• Feeling dizzy
• Skin redness.
Uncommon (may affect up to 1 in 100 people)
• Difficulty sleeping.
It is not known how often these side effects happen
• Mood changes, including depression
• Bleeding or bruising under the skin.
Blood tests
Uradriest can change the levels of liver enzymes shown 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, 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 Uradriest
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 after ‘EXP’. The expiry date refers to the last day of that month.
Store below 25°C in the original packaging.
Store in the original packaging.
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 protect the environment.
6. Contents of the pack and other information
What Uradriest contains
- The active substance is Diltiazem Hydrochloride.
- The other ingredients are (for Uradriest 200 mg) povidone, talc,
ethylcellulose, stearic acid, gelatine and titanium dioxide (E171).
- The other ingredients are (for Uradriest 300 mg) povidone, talc,
ethylcellulose, stearic acid, gelatine and titanium dioxide (E171),
quinoline yellow (E104) and indigotine carmine (E132).
What Uradriest 200 mg and Uradriest 300 mg look like and
contents of the pack
• Uradriest 200mg capsules are opaque capsules with a white body
and cap.
• Uradriest 300mg capsules are opaque capsules with a white body
and green cap.
• The capsules are provided in blister packs containing 7 or 28
capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B Draycott Avenue, Kenton, Middlesex, HA3 0BU
United Kingdom
Manufacturer 1:
Manufacturer 2:
Lamp San Prospero S.p.A.
FARMEA – ANGERS
Via della Pace 25/A,
10 rue Bouché Thomas
41030 San Prospero,
ZAC d’Orgemont
Modena
ANGERS, 49000
Italy
France
Manufacturer 3:
ELPEN PHARMACEUTICAL CO. INC
Marathonos Ave. 95,
Pikermi Attiki, 19009,
Greece
This medicinal product is authorised in the Member States of the EEA
under the following names:
Portugal Diltiazem HCl ADOH 200 mg, cápsulas duras de
libertação prolongada
Diltiazem HCl ADOH 300 mg, cápsulas duras de
libertação prolongada
Spain
Diltiazem HCl ADOH 200 mg, cápsulas de liberación
prolongada, duras
Diltiazem HCl ADOH 200 mg, cápsulas de liberación
prolongada, duras
This leaflet does not contain all the information about your medicine.
If you have any questions or are not sure about anything, ask your
doctor or pharmacist.
This leaflet was last revised in 04/2017

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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