ADALAT LA 60MG TABLETS

Active substance: 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.

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.
2.
3.
4.
5.
6.

What Adalat LA is
Before you take Adalat LA
How to take Adalat LA
Possible side effects
How to store Adalat LA
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 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.

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 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.

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 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 might be pregnant or are planning
a family, tell your doctor before taking Adalat LA.
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 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.
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3. How to take Adalat LA
Adalat 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

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.
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.

Use in children: 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 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.

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 heartbeat (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 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
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

5. How to store Adalat LA
Store in the original container. The tablets should be
protected from strong light and moisture, 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. Further Information
What Adalat LA contains

Each 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.
PL No: 08929/0090

POM

Leaflet revision and issue date (Ref): 12.03.14
Adalat® is a registered trademark of Bayer AG.

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

If you get side effects
Tell your doctor if any side effects gets serious, or if
you get any effects not listed in this leaflet.

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.

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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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