ADALAT CRONO 30 TABLETS

Active substance: NIFEDIPINE

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ADALAT® LA 30 TABLETS/ADALAT® CRONO 30 TABLETS
(nifedipine)
This product is available using any of the above names but will be referred
to as Adalat LA Tablets throughout the leaflet.
Patient Information Leaflet
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) How to take Adalat LA
4) Possible side effects
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.
 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.
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.
Talk to your doctor before you take Adalat LA if any of these apply to
you.

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.
 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 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).
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 30 contains 24mg 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
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.

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

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.

4) Possible side effects
Like all medicines, Adalat LA can have side effects, although not everybody
gets them.
Serious side effects
If you notice:
 Severe, sudden generalised allergic reaction including very rarely lifethreatening 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

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

5) How to store Adalat LA
 Do not use after the expiry date printed on the carton label or blister strip.
 Store in the original package to protect from moisture. The blisters should
be protected from strong light so only remove the tablet from the
container or blister strip when you are about to take it. Adalat LA Tablets
should not be stored above 30°C.
 Keep all medicines out of the sight and reach of children.
 If your doctor tells you to stop taking the tablets, please take them back to
the pharmacist for safe disposal. Only keep the tablets if your doctor tells
you to.
 If the tablets become discoloured or show any other signs of deterioration,
you should seek the advice of your pharmacist who will tell you what to
do.

6) Further information
What Adalat LA contains
Each tablet contains 30mg of the active ingredient, nifedipine in a prolonged
release formulation
Adalat LA Tablets also contain the following:
polyethylene oxide, hydroxypropylmethyl cellulose, magnesium stearate,
red iron oxide (E172), cellulose acetate, polyethylene glycol, hydroxypropyl
cellulose, titanium dioxide (E171) and propylene glycol.
Each tablet also contains 23.9mg 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
Adalat LA is a pink, round, coated tablet marked 'Adalat 30' in black ink on
one side and plain on the reverse.
Adalat LA 30 Tablets are available as calendar blister packs of 14 tablets.
Each tablet has the day of the week printed next to it to remind you when to
take it.
PL 10383/1493

Adalat LA 30 Tablets

POM

Who makes and repackages your medicine?
This product is manufactured by Bayer HealthCare Manufacturing S.r.l., via
delle Groane 126, Garbagnate Milanese (MI), Italy. Procured from within the
EU and repackaged by the Product Licence holder: Primecrown Ltd, 4/5
Northolt Trading Estate, Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 20.02.2014
Adalat® is a registered trademark of Bayer AG, Leverkusen, Germany.

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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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