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ADALAT LA 60 TABLETS

Active substance(s): NIFEDIPINE

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213 LEAFLET Adalat LA 20140515

Also tell your doctor:

PACKAGE LEAFLET: INFORMATION FOR USER



Adalat LA 60 Tablets
(nifedipine)

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



Your medicine is known as Adalat LA 60 Tablets but will be referred
to as Adalat LA throughout the following leaflet.

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.

Read all of this leaflet carefully before you start taking this
medicine.
Keep this leaflet. You may need to read it again.

Other medicines and Adalat LA

This medicine has been prescribed for you.

Tell your doctor about any other medicines that you are taking,
or took recently. This includes any products you bought without a
prescription.

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

Some medicines may affect the way Adalat LA works. Tell your
doctor if you are taking:

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.



Other medicines to treat high blood pressure.



Rifampicin (an antibiotic).

In this leaflet



Cimetidine (to treat stomach ulcers).

1. What Adalat LA is



Digoxin, diltiazem, quinidine or beta-blockers (to treat heart
conditions).

3. How to take Adalat LA



Quinupristin/dalfopristin (a combination antibiotic).

4. Possible side effects



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).

If you have more questions, ask your doctor or pharmacist.

2. Before you take Adalat LA

5. How to store Adalat LA
6. Further information
1. 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. 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 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.





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

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

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

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



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.

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

Take the tablets as prescribed by your doctor.

Your doctor will take special care:




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 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.

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

 Talk to your doctor before you take Adalat LA if any of
these apply to you.

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

Tell your 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



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.

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.

4. POSSIBLE SIDE EFFECTS



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

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



increased blood sugar (hyperglycaemia)



decreased skin sensitivity (hypoaesthesia)

If you notice:



drowsiness (somnolence)





eye pain



chest pain (angina pectoris)



other allergic reactions causing swelling under the skin
(possibly severe and including swelling of the larynx that may
result in a life-threatening outcome)

heartburn or indigestion (gastroesophageal sphincter
insufficiency)



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





sensitivity to light (photosensitivity allergic reaction)

fast heart beat (tachycardia)





small, raised areas of bleeding in the skin (palpable purpura)

shortness of breath or difficulty breathing





joint pain

mild to moderate allergic reactions



muscle pain



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)

 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

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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
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.

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

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

(These may affect up to 1 in 10 people)

5. HOW TO STORE ADALAT LA



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)



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



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



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.



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)

6. FURTHER INFORMATION



fainting

What Adalat LA contains



irregular heartbeat (palpitations)





dry mouth



indigestion or upset stomach

Each Adalat LA 60 Tablet contains 60mg of the active
ingredient, nifedipine, in a modified release formulation. Each
tablet contains 48mg of sodium chloride.



wind (flatulence)





feeling sick (nausea)



muscle cramps

Adalat LA Tablets also contain 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.



joint swelling





sleep disorders

Adalat LA 60 Tablets contains hydroxypropylmethyl cellulose
and shellac.



anxiety or nervousness



reddening of the skin



nose bleeds



nasal congestion



sensation of spinning or whirling motion (vertigo)



migraine



dizziness



trembling

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



increase in the need to pass water (urinate)

Manufacturer



painful or difficult urination

This product is manufactured by



inability to achieve or maintain an erection (impotence)



Bayer AG, Germany.



blurred vision



Bayer Schering Pharma AG, Leverkusen, Germany



Bayer Pharma AG, Leverkusen, Germany

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

What Adalat LA looks like and contents of the pack


Adalat LA is round, pink, biconvex tablet marked ‘Adalat 60’ on
one side.



Adalat LA Tablets are available as calendar blister packs of 28
or 56 tablets. Each tablet has the day of the week printed next
to it to remind you when to take it.

Product Licence holder

POM

PL No: 08747/0213



pins and needles

Leaflet revision date: 15 May 2014



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

Adalat LA is a registered trademark of Bayer AG.

Other side effects
(Frequency unknown)


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)

213 LEAFLET Adalat LA 20140515

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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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