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ADALAT LA 30 TABLETS

Active substance(s): NIFEDIPINE

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324 LEAFLET Adalat LA 20151116

Tell your doctor:

PACKAGE LEAFLET: INFORMATION FOR USER
®

Adalat LA 30mg Tablets
(nifedipine)
Your medicine is known as Adalat LA 30mg Tablets but will be
referred to as Adalat LA throughout the following 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 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.

If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only.

Also tell your doctor:

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 giving a urine sample. Adalat LA may interfere with
the results of certain urine tests.

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 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.

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

Other medicines and Adalat LA

3. How to take 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:

4. Possible side effects
5. How to store Adalat LA
6. 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:



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).



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.



Fluoxetine or nefazodone (to treat depression).



Tacrolimus (to prevent the rejection of transplanted organs).



If you have unstable angina.



Phenobarbital (usually used to treat insomnia or anxiety).



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).

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 30 mg contains 24mg 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.

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

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.

Warnings and precautions

Driving and using machines

Talk to your doctor before taking Adalat LA

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.



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.

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.



dizziness



trembling

You can take Adalat LA with or without food.



increase in the need to pass water (urinate)



painful or difficult urination



inability to achieve or maintain an erection (impotence)



blurred vision

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.

• temporary increase in certain liver enzymes
Rare side effects
(These may affect up to 1 in 1,000 people)


pins and needles

 Get medical help immediately. If possible, take your tablets or
the box with you to show the doctor.



inflammation of the gums, tender or swollen gums, bleeding
gums

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.

Other side effects

If you take more Adalat LA than you should

(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)

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.

a more severe decrease in a specific class of white blood cell
(agranulocytosis)



increased blood sugar (hyperglycaemia)

4. Possible side effects



decreased skin sensitivity (hypoaesthesia)

Like all medicines, this medicine can cause side effects, although
not everybody gets them.



drowsiness (somnolence)



eye pain



chest pain (angina pectoris)



heartburn or indigestion (gastroesophageal sphincter
insufficiency)

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)



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)

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



muscle pain

Serious side effects
If you notice:






fast heart beat (tachycardia)

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



shortness of breath or difficulty breathing

Reporting of side effects



mild to moderate allergic reactions

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.

• 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.

By reporting side effects, you can help provide more information on
the safety of this medicine.

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)

5. HOW TO STORE ADALAT LA


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Adalat LA Tablets should be stored below 25°C in the
manufacturer’s original container and protected from strong
light. Only remove a tablet from the box or blister strip when you
are about to take it.

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:

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

 Contact your doctor immediately before you continue
treatment as these may be signs of a severe reaction.

Common side effects
(These may affect up to 1 in 10 people)


headache



flushing



general feeling of being unwell

6. FURTHER INFORMATION



constipation

What Adalat LA contains



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

Each Adalat LA contains 30mg of the active ingredient,
nifedipine, in a modified release formulation. Each tablet
contains 24mg of sodium chloride.



Adalat LA Tablets also contain the following: polyethylene
oxide, magnesium stearate, red iron oxide (E172), cellulose
acetate, polyethylene glycol, hydroxypropylmethyl cellulose,
titanium dioxide (E171), propylene glycol, hydroxypropyl
cellulose and black printing ink.
What Adalat LA looks like and contents of the pack


Adalat LA is round, pink, biconvex tablet marked ‘Adalat 30’ on
one side.



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



irregular heartbeat (palpitations)



dry mouth



indigestion or upset stomach



wind (flatulence)



feeling sick (nausea)



muscle cramps



joint swelling



sleep disorders



anxiety or nervousness

Leaflet revision date: 16 November 2015



reddening of the skin

Adalat LA is a registered trademark of Bayer AG, Germany.



nose bleeds



nasal congestion



sensation of spinning or whirling motion (vertigo)



migraine

Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, Middlesex, HA0 1DX, England.
Manufacturer
This product is manufactured by Bayer Pharma AG, Leverkusen,
Germany.
POM

PL 08747/0324

324 LEAFLET Adalat LA 20151116

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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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