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ADALAT LA 60MG TABLETS

Active substance(s): NIFEDIPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
®

ADALAT LA 60MG TABLETS
(nifedipine)

Your medicine is available using the name Adalat LA 60mg
Tablets but will be referred to as Adalat LA throughout this
leaflet.

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.
2.
3.
4.
5.
6.

What Adalat LA is and what it is used for
What you need to know before you take Adalat LA
How to take Adalat LA
Possible side effects
How to store Adalat LA
Contents of the pack and other information

1. What Adalat LA is and what it is used for
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. What you need to know 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 nifedipine, any other similar
medicines (known as dihydropyridines) or any of the
other ingredients of this medicine (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 that 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.

Warnings and precautions

Talk to your doctor before taking Adalat LA

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 need to take Adalat
LA, you should stop breast-feeding before you start to
take this medicine.

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.

If your liver is not working properly. Your doctor
may need to do some blood tests. You may also be
given a lower dose of 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.

One tablet of Adalat LA 60mg contains 48mg salt (sodium
chloride).
Tell your doctor if you are on a low-salt diet.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are
planning to have a baby, ask your doctor for advice
before taking this medicine.
You may be able to use Adalat LA but only after special
consideration and agreement by your doctor.
Do not take Adalat LA if you are breast-feeding. If you
need to take Adalat LA, you should stop breast-feeding
before you start taking this medicine.

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 LA is specially formulated so that you only have to
take one dose each day.
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
Monday
Viernes
Friday

Martes
Tuesday
Sábado
Saturday

Miércoles
Wednesday
Domingo
Sunday

Jueves
Thursday

Tell your doctor if you are taking, have recently taken or
might take any other medicines.

Always take this medicine exactly as your doctor has told
you. Check with your doctor if you are not sure.

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.

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.

Some medicines may affect the way Adalat LA works.
Tell your doctor if you are taking:

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

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
















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 (antifungal 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).

Adalat LA with food and drink

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.

Page 1 of 2

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.

Use in children and adolescents: 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.

If you take more Adalat LA than you should



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 Adalat LA

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 a forgotten dose.
If you have any further questions on the use of this
medicine, ask your doctor.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.

Serious side effects
If you notice:











severe, sudden generalised allergic reaction including
very rarely life-threatening shock (e.g. difficulty in
breathing, drop of blood pressure, fast pulse), swelling
(including potentially life-threatening swelling of the
airway)
other allergic reactions causing swelling under the skin
(possibly severe and including swelling of the larynx
that may result in a life-threatening outcome)
fast heart beat (tachycardia)
shortness of breath or difficulty breathing
mild to moderate allergic reactions
itching (possibly severe), a rash or hives
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.

If you develop:


a skin reaction or blistering/peeling of the skin and/or
mucosal reactions (in the mouth/nose or at the
penis/vagina) (Toxic Epidermal Necrolysis)



Contact your doctor immediately before you
continue treatment as these may be signs of a severe
reaction.

Less serious side effects

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

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

Other side effects

(Frequency not known: frequency cannot be estimated from
the available data)

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

a reduction in the number of white blood cells
(leucopenia)

a more severe decrease in a specific class of white
blood cell (agranulocytosis)

increased blood sugar (hyperglycaemia)

decreased skin sensitivity (hypoaesthesia)

drowsiness (somnolence)

eye pain

chest pain (angina pectoris)

heartburn or indigestion (gastroesophageal sphincter
insufficiency)

yellowing of the whites of the eyes or skin (jaundice)

sensitivity to light (photosensitivity allergic reaction)

small, raised areas of bleeding in the skin (palpable
purpura)

joint pain

muscle pain
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 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 Adalat LA












Store in the original container. The tablets should be
protected from strong light, so only remove the tablet
from the container or blister strip when you are about
to take it.
Do not store above 30°C.
KEEP OUT OF THE SIGHT AND REACH OF
CHILDREN.
Do not use the tablets after the expiry date which is
marked on both the outer carton and on each blister
strip of tablets.
If your doctor decides to stop the treatment, return any
leftover tablets to the pharmacist. Only keep then if
your doctor tells you to.
If the tablets appear discoloured or show any other
signs of deterioration, take them to your pharmacist
who will advise you.
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.

6. Contents of the pack and other
information
What Adalat LA contains

Each prolonged release tablet contains 60mg nifedipine in a
modified release formulation.
Adalat LA also contains polyethylene oxide, hypromellose,
magnesium stearate (salt), propylene glycol, macrogol 3350,
hydroxypropylcellulose, titanium dioxide (E171),
red iron oxide (E172), black iron oxide (E172) and
cellulose acetate.
Each tablet also contains 48mg of sodium chloride (salt).

What Adalat LA looks like and contents of the pack

Adalat LA are prolonged release, pink, circular convex tablets
with 'Adalat 60' marked on one side.
Adalat LA comes in calendar packs of 28 tablets.

Manufacturer

Manufactured by: Bayer Pharma AG, D-51368 Leverkusen,
Germany.
Procured within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
Page 2 of 2

PL No: 08929/0090

POM

Leaflet revision and issue date (Ref): 02.11.15
Adalat® is a registered trademark of Bayer AG.

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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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