Adalat LA 30mg Prolonged-Release Tablet

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Nifedipine
Available from:
Imbat Limited
ATC code:
C08CA; C08CA05
INN (International Name):
Nifedipine
Dosage:
30 milligram(s)
Pharmaceutical form:
Prolonged-release tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Therapeutic area:
Dihydropyridine derivatives; nifedipine
Authorization status:
Authorised
Authorization number:
PPA1151/047/002
Authorization date:
2009-06-19

Page 1 of 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

Adalat

®

LA 30mg Prolonged-Release Tablet

(nifedipine)

Your medicine is available using the name Adalat LA 30mg

Prolonged-Release Tablet but will be referred to as Adalat LA

throughout this leaflet.

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

What Adalat LA is

Before you take Adalat LA

How you take Adalat LA

Possible side effects

How to store Adalat LA

Contents of the pack and other 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 breast-feeding.

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 30mg contains 9.4mg salt (sodium).

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

Pregnancy and breast-feeding

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 breast-feeding, 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.

There is a memory aid on the blister packs for the daily

intake.

The translation of the days of the week is as follows:

Lunes

Martes

Miércoles

Jueves

Monday

Tuesday

Wednesday

Thursday

Viernes

Sábado

Domingo

Friday

Saturday

Sunday

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.

Page 2 of 2

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 gut

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, pharmacist or

nurse. 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 30°C.

Store in the original package in order to protect from

light and moisture.

Only remove the tablet from the blister strip when you

are about to take it.

Do not use this medicine after the expiry date (Exp)

which is marked on the carton and blister strips. This

refers to the last day of that month.

Do not use this medicine if you notice discoloration,

damage or any other signs of deterioration.

Do not throw away any medicines via wastewater or

household waste. Ask your pharmacist how to throw

away any medicines you no longer use. These measures

will help protect the environment.

6.

Contents of the pack and other

information

What Adalat LA contains

One tablet contains 30mg nifedipine.

The other ingredients are:

polyethylene oxide, hypromellose, magnesium stearate,

sodium chloride, red iron oxide (E172), cellulose acetate,

macrogol, hydroxypropylcellulose, propylene glycol,

titanium dioxide (E171) and black iron oxide (E172).

This medicinal product contains sodium chloride (salt).

This is to be taken into consideration by patients on a

controlled sodium diet.

What Adalat LA looks like and contents of the pack

Adalat LA are pink, circular, convex tablets with “Adalat 30”

marked on one side and plain on the reverse.

Adalat LA comes in calendar blister packs of 28 tablets.

Manufacturer

Manufactured by:

Bayer AG, D-51368 Leverkusen, Germany.

Procured from within the EU and repackaged by:

Doncaster Pharmaceuticals Group Ltd, Kirk Sandall,

Doncaster, DN3 1QR, UK.

PPA holder:

Imbat Ltd., Unit L2, North Ring Business Park, Santry,

Dublin 9.

Distributed by:

Eurodrug Ltd., Unit L2, North Ring Business Park, Santry,

Dublin 9.

PPA1151/047/002

Leaflet revision and issue date (ref): 25.06.18

Adalat

is a registered trademark of Bayer AG.

Summary of Product Characteristics

1 NAME OF THE MEDICINAL PRODUCT

Adalat LA 30mg Prolonged-Release Tablet

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

One tablet contains 30 mg nifedipine.

Excipient with known effect: Sodium

For a full list of excipients, see Section 6.1.

3 PHARMACEUTICAL FORM

Prolonged-release film-coated tablet.

Product imported from the UK, Romania and Spain:

Pink, circular, convex tablets with 'Adalat 30'

marked on one side and plain on the reverse.

4 CLINICAL PARTICULARS

As per PA1410/025/006

5 PHARMACOLOGICAL PROPERTIES

As per PA1410/025/006

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Product imported from the UK and Romania:

Polyethylene oxide

Hypromellose

Magnesium stearate

Sodium chloride

Cellulose acetate

Macrogol

Hydroxypropylcellulose

Propylene glycol

Titanium dioxide (E171)

Iron oxide (E172)

Shellac*

(* in product sourced from the UK only).

Product imported from Spain:

Polyethylene oxide

Hypromellose

Magnesium stearate

Sodium chloride

Red iron oxide (E172)

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Cellulose acetate

Macrogol

Hydroxypropylcellulose

Propylene glycol

Titanium dioxide (E171)

Black iron oxide (E172)

6.2 Incompatibilities

Not applicable

6.3 Shelf life

The shelf life expiry date of this product is the date shown on the blister strips and outer carton of the product as

marketed in the country of origin.

6.4 Special precautions for storage

Product sourced from Spain: Do not store above 30°C.

Store in the original package in order to protect from light and moisture.

Product sourced from Romania & UK: Do not store above 30°C.

Store in the original container. Protect from strong light.

6.5 Nature and contents of container

Over-labelled outer carton containing blister strips.

Pack size: 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

Imbat Limited

Unit L2

North Ring Business Park

Santry

Dublin 9

Ireland

8 PARALLEL PRODUCT AUTHORISATION NUMBER

PPA1151/047/002

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 19

June 2009

10 DATE OF REVISION OF THE TEXT

December 2016

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