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Leaflet Details
Licence Number:

PLPI 15184/1633

Leaflet size:

210mm x 350mm, Portrait double sided - 2 columns on each side

Column width:


Text Free Border:

5mm (around edge & between columns)



Font Size:

Title = 15pt
Generic Name = 12pt
Main Section Headings = 10pt
Sub Headings = 8pt
Main Text = Font 8pt / Leading 9pt
Statement for Blind = 12pt


Black print on white paper

UK Leaflet:

Bayer, August 2016

Lexon Revision date:


Ref: 1633/171116/1/F & Ref: 1633/171116/1/B =
Adalat LA 20mg Prolonged-release tablets (Front & Back)

This is the final mock-up.

Ref: 1633/171116/1/F


Adalat LA 20mg Prolonged-release tablets
Patient Information 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 you have any further questions, ask your doctor or pharmacist.
* This medicine has been prescribed for you only.
* Do not pass it on to others. It may harm them, even if their signs of illness
are the same as yours.
* 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.
Your medicine is called Adalat LA 20mg Prolonged-release tablets, but will
be referred to as Adalat LA throughout this leaflet.
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
3 How to take Adalat LA

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
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

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


What you need to know 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 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
* 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
Tell your doctor and do not take Adalat LA if any of these apply to you.

Other medicines and 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:
* 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).
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 20 contains 21mg 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
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.

Warnings and precautions
Talk to your doctor before taking Adalat LA


If you have low blood pressure and you were prescribed Adalat LA for
your angina. Your blood pressure may be decreased further by this
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


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
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

Ref: 1633/171116/1/B


Adalat LA 20mg Prolonged-release tablets
Patient Information Leaflet (continued)
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


Possible side effects

Like all medicines, this medicine can cause side effects, although not
everybody gets them.
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
* other allergic reactions causing swelling under the skin (possibly severe
and including swelling of the larynx that may result in a life-threatening
* fast heart beat (tachycardia)
* shortness of breath (frequency not known) 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
Other side effects
(Frequency not known: frequency cannot be estimated from the available
* 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
* 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
Reporting of side effects
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: By reporting side effects you can help provide
more information on the safety of this medicine.

How to store Adalat LA

Do not store above 25°C.
Store in the original package in order to protect from light.
Do not take this medicine after the expiry date shown on the carton or blister
label. The expiry date refers to the last day of the month.
If your doctor tells you to stop taking the medicine, take any remaining
medicine back to the pharmacist for safe disposal. Only keep this medicine if
your doctor tells you to.
If your medicine becomes discoloured or shows any signs of deterioration,
ask your pharmacist who will advise you what to do.
Medicines should not be disposed of via water waste or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

Contents of the pack and other information

What Adalat LA contains:
The active substance in Adalat LA is nifedipine.
Each prolonged-release tablet contains 20mg of nifedipine.
Also contains hypromellose, polyethylene oxide (WSR N-80), polyethylene
oxide (coagulant), magnesium stearate, sodium chloride,
iron oxide red (E172), cellulose acetate, macrogol 3350,
hydroxypropylcellulose, propylene glycol and titanium dioxide (E171).
Each tablet also contains 21mg 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 are pink, round, convex tablet with a laser hole on one side and
Adalat 20 marked in black on the other side.
Adalat LA comes in blister packs containing 28 tablets.
Each tablet has the day of the week printed next to it to remind you when to
take it.
Manufacturer and Licence Holder
Manufactured by Bayer Pharma AG, Leverkusen Germany and is procured
from within the EU and repackaged by the Product Licence Holder: Lexon
(UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.


PL 15184/1633

Adalat LA 20mg Prolonged-release tablets

Adalat is a registered trademark of Bayer Aktiengesellschaft.
Revision date: 17/11/16

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414
for help.

Expand Transcript

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.