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ADALAT LA 30 MG PROLONGED-RELEASE TABLETS

Active substance(s): NIFEDIPINE

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Package leaflet: Information for the user

0 Adalat

®

LA 30 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.

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






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 What Adalat LA is and what it is used for



3
4
5
6

How to take Adalat LA

1

REVISED

Talk to your doctor before taking Adalat LA



What you need to know before you take Adalat LA

2015

Warnings and precautions

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

2

April

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.

Possible side effects
ef
How to store Adalat LA

Tell your doctor:

Contents of the pack and other information



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).





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:

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.





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

2

What you need to know before you
befor
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 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).
egnancy
• Magnesium sulphate injections during pregnancy (may
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).

Adalat LA with food and drink
You can take Adalat LA with or without food.

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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 30 mg contains 24 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

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)

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.

 Contact your doctor immediately before you continue

This may be more likely when you first start treatment, if you
change tablets, or if you have drunk alcohol.

Less serious side effects

3

How to take Adalat LA

treatment as these may be signs of a severe reaction.

Apart from the side effects listed above, these are the other side
effects of Adalat LA, starting with the more common ones:

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

Common side effects

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.

Uncommon side effects

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.

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

(These may affect up to 1 in 10 people)
• headache
• flushing
• general feeling of being unwell
• constipation
• swelling, particularly of the ankles and legs
(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

Possible side effects
ef

Like all medicines, this medicine can cause side effects, although
not everybody gets them.
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Other side effects
(Frequency not known: frequency cannot be estimated from the
available data)

6

Contents of the pack and other
information



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

What Adalat LA contains







difficulty swallowing

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








increased blood sugar (hyperglycaemia)







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

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)
decreased skin sensitivity (hypoaesthesia)
drowsiness (somnolence)
eye pain
chest pain (angina pectoris)
heartburn or indigestion (gastroesophageal sphincter
insufficiency)
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

Adalat LA tablets contain the active ingredient, nifedipine.

Each 30 mg tablet also contains 24 mg of sodium chloride (salt) to
be taken into consideration by patients on a controlled sodium diet.

What Adalat LA looks like and contents of the
pack
Each prolonged-release tablet contains 30 mg of nifedipine. Each
tablet is pink and round with a laser hole on one side and marked
‘Adalat 30’.
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 and
Manufacturer
Marketing authorisation holder:
Bayer plc, Bayer House, Strawberry Hill, Newbury, Berkshire RG14 1JA
Manufacturer:
Bayer Pharma AG, Leverkusen, Germany
This leaflet was last revised in April 2015.
Product licence number: PL 00010/0174

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 (see details below). By reporting
side effects you can help provide more information on the safety
of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal

5

How to store Adalat LA
stor

Keep this medicine out of the sight and reach 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 this medicine after the expiry date which is stated on
both the outer carton and on each blister strip of tablets after EXP.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

U

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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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