ADALAT LA 60 MG PROLONGED-RELEASE TABLETS

Active substance: NIFEDIPINE

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Package leaflet - information for the user

Your doctor will take special care:

0 Adalat



®

LA 60 mg

Prolonged-release tablets
Nifedipine

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 What Adalat LA is
2

Before you take Adalat LA

3
4
5
6

How to take Adalat LA



these apply to you.

Possible side effects
ef

Tell your doctor:

How to store Adalat LA



Further information

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

Befor
Before you take Adalat LA

Do not take Adalat LA:















2013

 Talk to your doctor before you take Adalat LA if any of



1

November

If you have low blood pressure and you
were prescribed Adalat LA for your angina.
REVISED
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 breastfeeding. If you need to take Adalat LA,
you should stop breastfeeding 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.

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.




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
egnancy
cause a severe fall in blood pressure).
Erythromycin (an antibiotic).
Ketoconazole, itraconazole or fluconazole (anti-fungal
medicines).
Indinavir
Indinavir, nelfinavir, ritonavir, saquinavir or amprenavir
(to treat HIV).
Fluoxetine or nefazodone (to treat depression).
T
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.

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

4

Possible side effects
ef

Like all medicines, Adalat LA can have side effects, although not
everybody gets them.

Serious side effects

Pregnancy and breastfeeding

If you notice:

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 breastfeeding. If you need
to take Adalat LA, you should stop breastfeeding 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.

3

How to take Adalat LA

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







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
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Other side effects
(Frequency unknown)
ess
• 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.

If you get side effects

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

5

How to store Adalat LA
stor

Keep this medicine out of the reach and sight of children.
Do not store above 30°C.
Store your medicine in its original container. Protect from strong 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.
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

Further information

What Adalat LA contains
Adalat LA tablets contain the active ingredient, nifedipine.
Adalat LA tablets also contain propylene glycol, cellulose acetate,
hypromellose, hydroxypropylcellulose, polyethylene oxide,
macrogol, magnesium stearate, shellac, titanium dioxide (E171) and
iron oxide (E172).
Each 60 mg tablet also contains 48mg of sodium chloride (salt) to
be taken into consideration by patients on a controlled sodium diet.

What’s in the pack
Each prolonged-release tablet contains 60 mg of nifedipine. Each
tablet is pink and round with a laser hole on one side and marked
‘Adalat 60’.
Each pack contains 28 tablets. Each tablet has the day of the
week printed next to it to remind you when to take it.
Marketing authorisation holder:
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA
Manufacturer:
Bayer Pharma AG, Leverkusen, Germany
This leaflet was last revised: November 2013
Product licence number: PL 00010/0175

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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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