ADALAT LA 20 TABLETS

Active substance: NIFEDIPINE

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CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Adalat LA 20 tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/0921E

DATE OF PROOF:

25/03/14

DATE:

DATE:

PROOF HISTORY:
v.2 - waymade - 25/03/14

Leaflet Flat Size = 296 x 317

TVT CHECKED

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED NOVEMBER 2013
REPORTING OF SIDE EFFECTS

Pg 1

Pg 4

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 20

Adalat LA 20 tablets should not be stored above 30°C. Store in the manufacturers original pack and
protected from strong light. Do not use after the expiry date printed on the carton, label or blister strip.
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.
Do not dispose of medicines in household rubbish. Any unused Adalat LA tablets should be returned to a
pharmacist (chemist) who will dispose of them properly. This helps the environment.

6. Further information
Your medicine is called Adalat LA 20 tablets. Each pink, round film-coated tablet contains 20mg of the
active ingredient, nifedipine, in a controlled release formulation, and is marked 'Adalat 20' on one side and
plain on the other side.
Adalat LA 20 tablets also contain the following inactive ingredients:
polyethylene oxide, hypromellose, magnesium stearate, sodium chloride, red iron oxide (E172), cellulose
acetate, polyethylene glycol, hydroxypropyl cellulose, titanium dioxide (E171), propylene glycol and black
printing ink.
These tablets each contain 21mg of sodium chloride (salt) to be taken into consideration by patients on a
controlled sodium diet.
Adalat LA 20 tablets are available as calendar blister packs of 14 or 28 tablets (blister strips of 7 tablets).
POM

PL No: 6464/0921

This product is manufactured by Bayer Healthcare Manufacturing S.r.l., via delle Groane 126, Garbagnate,
Milan, Italy and is procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 25.03.2014
Adalat® is a registered trademark of BAYER AG

ADALAT® LA 20 TABLETS
(Nifedipine)
Patient Information Leaflet
This product will be referred to as Adalat LA 20 throughout this 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 20 is
2. Before you take Adalat LA 20
3. How to take Adalat LA 20
4. Possible side effects
5. How to store Adalat LA 20
6. Further information

1. What Adalat LA 20 is
Adalat LA 20 contains nifedipine, which belongs to a group of medicines called calcium antagonists.
Adalat LA 20 is used to treat high blood pressure or angina (chest pain).
For high blood pressure: Adalat LA 20 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 20 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 20
Do not take Adalat LA 20:

If you have had a heart attack within the last month.

If you get a sudden angina attack. Adalat LA 20 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 20 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 20 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 20 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 20, 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 20.

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 20.
Talk to your doctor before you take Adalat LA 20 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 20.

If you have chest pains after taking your first dose of Adalat LA 20. 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.

Pg 2

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Adalat LA 20 tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/0921E

DATE OF PROOF:

25/03/14

DATE:

DATE:

PROOF HISTORY:
v.2 - waymade - 25/03/14

Leaflet Flat Size = 296 x 317

TVT CHECKED

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED NOVEMBER 2013
REPORTING OF SIDE EFFECTS

Pg 2

Also tell your doctor:

If you are giving a urine sample. Adalat LA 20 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 20 have been shown to impair sperm function.
Other medicines and Adalat LA 20
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 20 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).

Pg 3

4. Possible side effects
Like all medicines, Adalat LA 20 can have 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 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 20, starting with the
more common ones:

Food and drink with Adalat LA 20
You can take Adalat LA 20 with or without food.
Do not drink grapefruit juice or eat grapefruit while taking Adalat LA 20.
Do not start taking Adalat LA 20 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 20. 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 breastfeeding
If you are pregnant, think you might be pregnant or are planning a family, tell your doctor before taking
Adalat LA 20.
You may be able to use Adalat LA 20, but only after special consideration and agreement by your doctor.
Do not take Adalat LA 20 if you are breastfeeding. If you need to take Adalat LA 20, you should stop
breastfeeding before you start taking the tablets.
Driving and using machines
Adalat LA 20 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 20
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 20 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 20 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
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.

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 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 20 is stopped.

Do not take a double dose to make up for the missed dose.
Pg 3

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

Expand view ⇕

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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