ADALAT RETARD 20MG TABLETS

Active substance: NIFEDIPINE

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CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Adalat Retard 20mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/0093E

DATE OF PROOF:

03/08/12

DATE:

PROOF HISTORY:
v.2 - waymade - 03/08/12

DATE:

Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED NOVEMBER 2011

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Pg 4

6. Further information
Your medicine is called Adalat Retard 20mg tablets. Each tablet contains 20mg of the active ingredient,
nifedipine, in a pink-grey lacquered tablet marked with Bayer logo and ‘1U’ on the reverse.
Adalat Retard 20mg tablets also contain the following ingredients:
Lactose, microcrystalline cellulose, maize starch, polysorbate 80, magnesium stearate, hypromellose,
macrogol 4000, titanium dioxide (E171) and red iron oxide (E172).
Adalat Retard 20mg tablets are available as blister packs of 56 tablets.
POM

PL No: 6464/0093

This product is manufactured by Bayer AG, Leverkusen, Germany and 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.) 3.8.2012
Adalat is a registered trademark of BAYER AG

ADALAT® RETARD 20mg TABLETS
(nifedipine)
Patient Information Leaflet
This product is known as the above name but will be referred to as Adalat Retard 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 Retard is
2. Before you take Adalat Retard
3. How you take Adalat Retard
4. Possible side effects
5. How to store Adalat Retard
6. Further information

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

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

If you get a sudden angina attack. Adalat Retard 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 Retard are listed in
section 6.

If you are pregnant.

If you are breastfeeding. If you need to take Adalat Retard, you should stop breastfeeding before
you start to take this medicine.

If you are taking rifampicin, an antibiotic.

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

If you have been told to avoid lactose, that you have a hereditary condition called Lapp lactase
deficiency or glucose-galactose malabsorption.
Tell your doctor and do not take Adalat Retard if any of these apply to you.
Your doctor will take special care:

If you have low blood pressure and you were prescribed Adalat Retard 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 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 Retard.

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 Retard.

Talk to your doctor before you take Adalat Retard 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 Retard.

If you have chest pains after taking your first dose of Adalat Retard. 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 Retard may interfere with the results of certain urine
tests.

If you are a man who has been unable to father a child by in vitro fertilisation. Drugs like Adalat
Retard have been shown to impair sperm function.

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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.

PRE-PRESS NO.:

02-1808

PRODUCT:

Adalat Retard 20mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/0093E

DATE OF PROOF:

03/08/12

DATE:

PROOF HISTORY:
v.2 - waymade - 03/08/12

DATE:

CUSTOMER: Waymade

Leaflet Flat Size = 296 x 317

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

UK PIL DATED NOVEMBER 2011

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

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Some medicines may affect the way Adalat Retard 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 Retard
You can take Adalat Retard either with or without food.
Do not drink grapefruit juice or eat grapefruit while taking Adalat Retard.
Do not start taking Adalat Retard 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 Retard. Grapefruit juice is known to increase the blood levels of the active ingredient,
nifedipine. This effect can last for at least 3 days.
Pregnancy and breastfeeding
Do not take Adalat Retard if you are pregnant. If you are pregnant, think you might be pregnant or are
planning a family, tell your doctor before taking Adalat Retard.
You may be able to use Adalat Retard after week 20 of your pregnancy, but only after special consideration
and agreement by your doctor.
Do not take Adalat Retard if you are breastfeeding. If you need to take Adalat Retard, you should stop
breastfeeding before you start taking the tablets.
Driving and using machines
Adalat Retard 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 you take Adalat Retard
Take the tablets as prescribed by your doctor.








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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.

To start with, you may be given a lower strength (10 mg) tablet called Adalat Retard 10. This
allows your doctor to monitor how you are responding so that the best long-term dose can be
identified.
The usual maintenance dose of Adalat Retard (20 mg strength) is 1 tablet, every 12 hours (i.e.
twice per day), but your doctor may increase or decrease the dose depending on how well your
blood pressure or angina is being controlled. The maximum dose is 2 tablets (40 mg) every 12
hours.
Lower doses may be prescribed for elderly patients.
If you have problems with your liver you are likely to be given Adalat Retard 10, at least to begin
with.
Swallow the tablets whole with a little water.
Continue to take the tablets for as long as your doctor has told you to.

Do not take them with grapefruit juice.
You can take Adalat Retard either with or without food.
Use in children: Adalat Retard 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 as prescribed, waiting 12 hours before
taking your next dose.
Do not take a double dose to make up for the missed dose.

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 Retard, 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 unknown)

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 Retard 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.

4. Possible side effects
Like all medicines, Adalat Retard 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

5. How to store Adalat Retard
Adalat Retard 20mg tablets should not be stored above 25°C. Store in the manufacturer’s original container,
protected from strong light. Only remove a tablet from the box or blister strip when you are ready to take it.
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 consult your pharmacist
who will advise you what to do.
Do not dispose of medicines in household rubbish. Any unused Adalat Retard tablets should be returned to a
pharmacist (chemist) who will dispose of them properly. This helps the environment.

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

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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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