Adalat LA 60 mg Prolonged-release Tablets

Ireland - English - HPRA (Health Products Regulatory Authority)

Buy It Now

Active ingredient:
Nifedipine
Available from:
PCO Manufacturing Ltd.
ATC code:
C08CA; C08CA05
INN (International Name):
Nifedipine
Dosage:
60 milligram(s)
Pharmaceutical form:
Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Dihydropyridine derivatives; nifedipine
Authorization status:
Authorised
Authorization number:
PPA0465/012/006
Authorization date:
2001-12-14

PACKAGE LEAFLET – INFORMATION FOR THE USER

Adalat

®

LA 60mg Prolonged

Release Tablet

Nifedipine

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 more 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 Adalat LA is

2.

Before you take Adalat LA

3.

How you take Adalat LA

4.

Possible side effects

5.

How to store Adalat LA

6.

Further information

1.

What Adalat LA is

Adalat LA contains nifedipine, which belongs to a group of medicines

called calcium antagonists.

Adalat LA is used to treat high blood pressure or angina (chest

pain).

For high blood pressure: Adalat LA works by relaxing and expanding the

blood vessels.

This makes the blood flow more easily and lowers blood pressure.

Lower blood pressure reduces the strain on your heart.

For angina: Adalat LA works by relaxing and expanding the arteries

supplying the heart. This allows more blood and oxygen to reach the

heart and decreases the strain on it. Your angina attacks will be less

severe and less frequent if there is less strain on the heart.

2.

Before you take Adalat LA

Do not take Adalat LA:

If you have had a heart attack within the last month.

If you get a sudden angina attack. Adalat LA will not help relieve

symptoms of angina quickly.

If you have unstable angina.

If you are allergic to the active ingredient (nifedipine), to any other

similar medicines (known as dihydropyridines) or to any of the other

ingredients. The ingredients of Adalat LA are listed in section 6.

If you are taking rifampicin, an antibiotic.

If you have a liver disease that prevents your liver from working

properly.

If you have inflammation of the bowel or intestines, such as

Crohn’s disease.

If you have an obstruction or narrowing in your intestines, or

have had this in the past.

If you have ever had an obstruction in the gullet (the

oesophagus - the tube connecting the throat to the stomach).

If you have been told you have a narrowing of the aortic heart

valve (stenosis).

If you have ever had a collapse caused by a heart problem

(cardiogenic shock), during which you became breathless, pale and

had a cold sweat and dry mouth.

If you have a ‘Kock pouch’ (a surgically constructed intestinal

reservoir with an opening through the abdominal wall) in your gut.

If your blood pressure continues to rise despite treatment

(malignant hypertension).

Tell your doctor and do not take Adalat LA if any of these

apply to you.

Your doctor will take special care:

If you have low blood pressure and you were prescribed Adalat

LA for your angina. Your blood pressure may be decreased further

by this treatment.

If you have a heart condition where your heart cannot cope with

increased strain (poor cardiac reserve).

If you are pregnant

If you are breastfeeding

If you are a diabetic. The treatment for your diabetes may need to

be adjusted. If you have any questions about this, ask your doctor.

If you are on kidney dialysis. If you have a very high blood

pressure and a low blood volume, you might experience a sudden

drop in blood pressure when you take Adalat LA.

Talk to your doctor before you take Adalat LA if any of these

apply to you.

Tell your doctor:

If your chest pain (angina) gets worse (comes on more often or

more severely) over a matter of hours or days. You may be advised

not to take Adalat LA.

If you have chest pains after taking your first dose of Adalat LA.

Your doctor may wish to change your treatment.

If you notice increased breathlessness.

If you notice swelling of the ankles.

Tell your doctor before you take the next dose if any of these apply

to you.

Also tell your doctor:

If you are giving a urine sample. Adalat LA may interfere with the

results of certain urine tests.

If you are to have a barium contrast x-ray (barium meal). These

tablets may affect the results of the test.

If you are a man who has been unable to father a child by in

vitro fertilisation. Drugs like Adalat LA have been shown to impair

sperm function.

Other medicines and Adalat LA

Tell your doctor about any other medicines that you are taking, or

took recently. This includes any products you bought without a

prescription. Some medicines may affect the way Adalat LA works.

Tell your doctor if you are taking:

Other medicines to treat high blood pressure.

Rifampicin (an antibiotic)

Cimetidine (to treat stomach ulcers).

Digoxin, diltiazem, quinidine or beta-blockers (to treat heart

conditions).

Quinupristin/dalfopristin (a combination antibiotic)

Phenytoin, carbamazepine or valproic acid (to treat epilepsy).

Cisapride (to treat reduced movements of the gullet and stomach).

Magnesium sulphate injections during pregnancy (may cause a

severe fall in blood pressure).

Erythromycin (an antibiotic).

Ketoconazole, itraconazole or fluconazole (anti-fungal

medicines).

Indinavir, nelfinavir, ritonavir, saquinavir or amprenavir (to treat

HIV)

Fluoxetine or nefazodone (to treat depression).

Tacrolimus (to prevent the rejection of transplanted organs).

Phenobarbital (usually used to treat insomnia or anxiety).

Food and drink with Adalat LA

You can take Adalat LA with or without food.

Do not drink grapefruit juice or eat grapefruit while taking

Adalat LA.

Do not start taking Adalat LA within 3 days of drinking grapefruit juice or

eating grapefruit. Tell your doctor if you have had grapefruit or grapefruit

juice in this time. Also, do not drink grapefruit juice or eat grapefruit

whilst taking Adalat LA. Grapefruit juice is known to increase the blood

levels of the active ingredient, nifedipine. This effect can last for at least

3 days.

One tablet of Adalat LA 60mg contains 18.3mg salt (sodium).

Tell your doctor if you are on a low-salt diet

Pregnancy and breastfeeding

If you are pregnant, think you might be pregnant or are planning a

family, tell your doctor before taking Adalat LA.

If you need to take Adalat LA while breastfeeding, tell your doctor

before taking the tablets.

Driving and using machines

Adalat LA may make you feel dizzy, faint, extremely tired or have visual

disturbances. Do not drive or operate machinery if you are affected in

this way. This may be more likely when you first start treatment, if you

change tablets, or if you have drunk alcohol.

3.

How to take Adalat LA

Adalat is specially formulated so that you only have to take one dose

each day.

Adalat LA is not recommended for use in children and adolescents

below 18 years of age, because there is only limited data on the safety

and efficacy in this population.

Take the tablets as prescribed by your doctor.

Dose for high blood pressure: the usual dose is 1 tablet, once a

day.

Dose for angina: the dose depends on your individual

requirements. Your doctor will decide how much you should take.

Lower doses may be prescribed for elderly patients.

Swallow the tablets whole. Do not bite, chew or break them – if

you do they will not work properly. If you have difficulty swallowing

tablets, consult your doctor as he or she may wish to change your

medicine.

Continue to take these tablets for as long as your doctor has told

you to. Take your dose at the same time each day, preferably in the

morning. Take your tablets with a glass of water. Do not take them

with grapefruit juice. You can take Adalat LA with or without food.

You may see what looks like a complete tablet in the toilet or in your

stools. This is normal – it’s the outer shell of the tablet which is not

digested by the body.

If you take too many tablets

Get medical help immediately. If possible, take your tablets or the

box with you to show the doctor. Taking too many tablets may

cause your blood pressure to become too low and your heartbeats

to speed up or slow down. It may also lead to an increase in your

blood sugar level or an increase in the acidity of your blood,

swelling in the lungs, low blood oxygen levels and disturbances in

consciousness, possibly leading to unconsciousness.

If you forget to take the tablets

Take your normal dose immediately and continue taking your tablets at

the usual time of day, waiting at least 12 hours before taking the next

dose. Do not take a double dose to make up for the missed dose.

4.

Possible side effects

Like all medicines, Adalat LA can have side effects, although not

everybody gets them.

If you notice:

hives on the body, lips, eyes or tongue

itching of the skin or rash

fast heart beat (tachycardia)

shortness of breath or difficulty breathing

Contact your doctor immediately and do not take the next

dose as these may be the first signs of allergic reaction which may

become severe.

Apart from the side effects listed above, these are the other side effects

of Adalat LA, starting with the more common ones:

Common side effects

(These may affect up to 1 in 10 people)

headache

flushing

general feeling of being unwell

constipation

swelling, particularly of the ankles and legs

Uncommon side effects

(These may affect up to 1 in 100 people)

stomach pain (abdominal pain)

unspecific pain

chills

low blood pressure when standing up (symptoms include fainting,

dizziness, light headedness, occasional palpitations, blurred vision

and sometimes confusion)

fainting

irregular heartbeat (palpitations)

dry mouth

indigestion or upset stomach

wind (flatulence)

feeling sick (nausea)

muscle cramps

joint swelling

sleep disorders

anxiety or nervousness

reddening of the skin

nose bleeds

nasal congestion

sensation of spinning or whirling motion (vertigo)

migraine

dizziness

trembling

increase in the need to pass water (urinate)

painful or difficult urination

inability to achieve or maintain an erection (impotence)

blurred vision

temporary increase in certain liver enzymes

Rare side effects

(These may affect up to 1 in 1,000 people)

pins and needles

unpleasant abnormal sensation

inflammation of the gums, tender or swollen gums, bleeding gums

Other side effects

(Frequency unknown)

stomach pain or distress caused by a mass of foreign material

found in the stomach which may require surgery for removal

difficulty swallowing

abdominal pain, caused by obstruction of the gut or ulcers in the

vomiting

eye pain

chest pain

lowered white blood cell count

high blood sugar level

reduction in skin sensitivity to pain or touch

drowsiness or sleepiness

acid reflux

yellow discolouration of the skin (jaundice)

life-threatening skin reaction (toxic epidermal necrolysis)

allergic reaction to sunlight

purplish-red spots which can be felt

muscle / joint pain.

shortness of breath

All of these symptoms usually go away when treatment with Adalat LA is

stopped.

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 HPRA Pharmacovigilance,Earlsfort

Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517,

Website: www.hpra.ie, e-mail: medsafety@hpra.ie

By reporting side effects you can help provide more information on the

safety of this medicine.

5.

How to store Adalat LA

Keep this medicine out of the sight and reach of children.

Do not store above 25° C. Store your medicine in its original container.

Protect from strong light and only remove the tablet from the blister strip

when you are about to take it. Do not use after the expiry date which is

marked on both the outer carton and on each blister strip of tablets.

Do not dispose of medicines in household rubbish. Any unused

Adalat LA tablets should be returned to a pharmacist (chemist) who will

dispose of them properly. This helps the environment.

6.

Further information

What Adalat LA 60 contains

Adalat LA tablets contain the active ingredient, nifedipine.

Adalat LA tablets also contain sodium chloride, propylene glycol,

cellulose acetate, hypromellose, hydroxypropylcellulose, polyethylene

oxide, macrogol, magnesium stearate, shellac, titanium dioxide (E171),

ferric oxide red (E172) and iron oxide black (E172).

Each tablet also contains 18.3mg of sodium (salt) to be taken into

consideration by patients on a controlled sodium diet.

What’s in the pack

Each prolonged release film coated tablet contains 60 mg of nifedipine.

Each tablet is pink, circular and marked ‘Adalat 60’ on one side. Each

pack contains 28 tablets.

Manufacturer: Bayer Schering Pharma AG or Bayer Pharma AG,

D-51368, Leverkusen, Germany or Bayer AG, Kaiser-Wilhelm-Allee,

51368 Leverkusen, Germany

Repackaged and Distributed by:

PCO Manufacturing, Unit 10, Ashbourne Business Park, Rath,

Ashbourne, Co. Meath.

Parallel Product Authorisation number: PPA 465/12/6

Adalat is a registered trademark of Bayer AG

Date of Leaflet Preparation by PCO Manufacturing: August 2017

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Adalat LA 60 mg Prolonged-release Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

One tablet contains 60 mg of nifedipine.

Excipients: Sodium

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Prolonged-release film-coated tablet

Product imported from The Netherlands, Greece and Spain;

Pink, lacquered tablets printed ‘Adalat 60’ in black on one side, plain on the other side.

4 CLINICAL PARTICULARS

As per PA 1410/025/007

5 PHARMACOLOGICAL PROPERTIES

As per PA 1410/025/007

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Excipients present in the product imported from The Netherlands:

Polyethylene oxide

Hypromellose

Magnesium stearate

Sodium chloride

Iron oxide red (E172)

Cellulose acetate

Macrogol

Hyprolose

Propylene glycol

Titanium dioxide (E171)

Printing ink (shellac, iron oxide black (E172))

Excipients present in the product imported from Greece:

Polyethylene oxide

Hypromellose

Magnesium stearate

Sodium chloride

Iron oxide red (E172)

Cellulose acetate

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

0

9

/

0

8

/

2

0

1

7

C

R

N

2

1

9

5

8

3

1

p

a

g

e

n

u

m

b

e

r

:

1

Macrogol 4000

Propylene glycol

Titanium dioxide (E171)

Excipients present in the product imported from Spain:

Polyethylene oxide

Hypromellose

Magnesium stearate

Sodium chloride

Iron oxide red (E172)

Cellulose acetate

Macrogol

Hyprolose

Propylene glycol

Titanium dioxide (E171)

Iron oxide black (E172)

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

The shelf-life expiry date of this product is the date shown on the container and outer package of the product on the

market in the country of origin.

6.4 Special precautions for storage

Do not store above 25°C. Store in the original container. The tablets should be protected from strong light.

6.5 Nature and contents of container

Blister packs containing 28 tablets.

6.6 Special precautions for disposal of a used medicinal product or waste materials derived from

such medicinal product and other handling of the product

No special requirements.

7 PARALLEL PRODUCT AUTHORISATION HOLDER

PCO Manufacturing

Unit 10, Ashbourne Business Park

Rath

Ashbourne

Co. Meath

Ireland

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA0465/012/006

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

0

9

/

0

8

/

2

0

1

7

C

R

N

2

1

9

5

8

3

1

p

a

g

e

n

u

m

b

e

r

:

2

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 14

December 2001

Date of last renewal: 14

December 2006

10 DATE OF REVISION OF THE TEXT

September 2016

H

e

a

l

t

h

P

r

o

d

u

c

t

s

R

e

g

u

l

a

t

o

r

y

A

u

t

h

o

r

i

t

y

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

_

D

a

t

e

P

r

i

n

t

e

d

0

9

/

0

8

/

2

0

1

7

C

R

N

2

1

9

5

8

3

1

p

a

g

e

n

u

m

b

e

r

:

3

Similar products

Search alerts related to this product

View documents history

Share this information