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ADALAT LA 20 TABLETS

Active substance(s): NIFEDIPINE

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592 LEAFLET Adalat 20160112

PACKAGE LEAFLET: INFORMATION FOR THE USER

ADALAT LA 20 TABLETS
(nifedipine)
Your medicine is known as Adalat LA 20 Tablets but will be referred
to as Adalat LA throughout the following patient information 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.

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.

Do not pass it on to others. It may harm them, even if their signs of
illness are the same as yours.



If you are to have a barium contrast x-ray (barium meal).
These tablets may affect the results of the test.

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.



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.

This medicine has been prescribed for you only.

What is in this leaflet:
1. What Adalat LA is and what it is used for
2. What you need to know before you take Adalat
LA
3. How to take Adalat LA

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).

5. How to store Adalat LA



Cimetidine (to treat stomach ulcers).

6. Contents of the pack and other information



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).

4. Possible side effects

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.



Erythromycin (an antibiotic).

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.



Ketoconazole, itraconazole or fluconazole (anti-fungal
medicines).



Indinavir, nelfinavir, ritonavir, saquinavir or amprenavir (to
treat HIV).

2. What you need to know before you take Adalat LA



Fluoxetine or nefazodone (to treat depression).

Do not take Adalat LA:



Tacrolimus (to prevent the rejection of transplanted organs).



Phenobarbital (usually used to treat insomnia or anxiety).



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.

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.



If you have an obstruction or narrowing in your intestines,
or have had this in the past.

One tablet of Adalat LA 20mg contains 21mg salt (sodium chloride).
Tell your doctor if you are on a low-salt diet.



If you have ever had an obstruction in the gullet (the
oesophagus - the tube connecting the throat to the stomach).

Pregnancy and breast-feeding



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.

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.

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.



If you have a “Kock pouch” (a surgically constructed intestinal
reservoir with an opening through the abdominal wall) in your
gut.

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.



If your blood pressure continues to rise despite treatment
(malignant hypertension).

Driving and using machines

 Tell your doctor and do not take Adalat LA if any of these
apply to you.
Warnings and precautions

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.

Talk to your doctor before taking Adalat LA

3. How to take 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.

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



If you have a heart condition where your heart cannot cope
with increased strain (poor cardiac reserve).



If you are pregnant.



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.

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



Dose for angina: the dose depends on your individual
requirements. Your doctor will decide how much you should
take.



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.

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.



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.

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.



painful or difficult urination

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.



inability to achieve or maintain an erection (impotence)



blurred vision



temporary increase in certain liver enzymes

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.
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.

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

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.

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

If you notice:



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)

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
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)



joint pain



fast heart beat (tachycardia)



muscle pain



shortness of breath or difficulty breathing



mild to moderate allergic reactions

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

 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.

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 OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C



Store in the original container to protect from moisture. Only
remove a tablet from the box or blister strip when you are about
to take it.



Protect from strong light.



Do not use after the expiry date printed on the carton label or
blister strip.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

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

6.

CONTENTS OF THE PACK AND OTHER INFORMATION

What Adalat LA contains
Uncommon side effects



Each tablet contains 20mg of the active ingredient, nifedipine, in
a modified release formulation. Each tablet contains 21mg of
sodium chloride.



Adalat LA also contains the following: polyethylene oxide,
magnesium stearate, red iron oxide (E172), cellulose acetate,
polyethylene glycol, hydroxypropyl cellulose, titanium dioxide
(E171), propylene glycol and black printing ink.

(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)

Adalat LA also contains hypromellose.
What Adalat LA looks like and contents of the pack



fainting





irregular heartbeat (palpitations)

Adalat LA is a round, pink, biconvex tablet marked ‘Adalat 20’
on one side.



dry mouth





indigestion or upset stomach



Adalat LA tablets are available as calendar blister packs of 14,
28 tablets. Each tablet has the day of the week printed next to it
to remind you when to take it.

wind (flatulence)



feeling sick (nausea)

Product Licence holder



muscle cramps



joint swelling



Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, HA0 1DX.

sleep disorders



anxiety or nervousness



Manufacturer

reddening of the skin



nose bleeds

Adalat LA is manufactured by Bayer HealthCare Manufacturing
S.r.I. – via delle Groane 126, Garbagnate Milanese, Italy.



nasal congestion



sensation of spinning or whirling motion (vertigo)



migraine



dizziness

Leaflet revision date: 12 January 2016



trembling

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



increase in the need to pass water (urinate)

POM

PL 08747/0592

592 LEAFLET Adalat 20160112

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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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