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ADALAT LA 20 MG PROLONGED-RELEASE TABLETS

Active substance(s): NIFEDIPINE

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Package leaflet: Information for the user



Adalat® LA 20 mg



Prolonged-release tablets
(nifedipine)



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.
The name of your medicine is Adalat LA 20mg Prolonged-release
tablets, but will be referred to as Adalat LA in this leaflet.

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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 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.

What is in this leaflet

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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.

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 if you are taking, have recently taken or might
take any other medicines.
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).

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.
One tablet of Adalat LA 20 contains 21 mg 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.
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.

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 and adolescents: Adalat LA is not recommended
for use in children and adolescents below 18 years of age,
because there are only limited data on the safety and efficacy in
this population.











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

If you take more Adalat LA than you should

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

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 lifethreatening 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 (frequency not known) 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)



















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
Keep this medicine out of the sight and reach of children.
Store your medicine in its original package. Do not store above
25°C. Protect from 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.
If your medicine gets discoloured or shows any other signs of
deterioration, seek the advice of your pharmacist.
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 Contents of the pack and other information
What Adalat LA contains

flushing

Each prolonged-release tablet contains 20 mg nifedipine as the
active ingredient.

general feeling of being unwell
constipation
swelling, particularly of the ankles and legs

(These may affect up to 1 in 100 people)



















difficulty swallowing

headache

Uncommon side effects









stomach pain or distress caused by a mass of foreign material
found in the stomach which may require surgery for removal

Adalat LA tablets also contain propylene glycol, cellulose acetate,
hypromellose, hyprolose, polyethylene oxide, macrogol 3350,
magnesium stearate, titanium dioxide (E171), red iron oxide
(E172).

stomach pain (abdominal pain)

Also contains 21 mg sodium chloride (salt). To be taken into
consideration by patients on a controlled sodium diet.

unspecific pain

What’s in the pack

chills

The prolonged-release tablets are pink and round, marked
‘Adalat 20’ in black ink on one side and plain on the other side.

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)

Each calendar blister pack contains 28 tablets. Each tablet has the
day of the week printed next to it to remind you when to take it.
Manufacturer:
Bayer Pharma AG, Leverkusen, Germany.
Procured from within the EU & repackaged by Product
Licence holder: Kosei Pharma UK Limited, 956 Buckingham
Avenue, Slough Trading Estate, SL1 4NL, UK.

muscle cramps

Adalat® LA 20 mg Prolonged-release Tablets,
PL: 39352/0006

joint swelling

Adalat® is a registered trade mark of Bayer AG, Germany.

sleep disorders

Leaflet date: 11/10/2016

feeling sick (nausea)

anxiety or nervousness
reddening of the skin
nose bleeds
nasal congestion

POM

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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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