ADALAT LA 20 TABLETS

Active substance: NIFEDIPINE

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592 LEAFLET Adalat 20131108

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.

PACKAGE LEAFLET: INFORMATION FOR THE USER

ADALAT LA 20 TABLETS
(nifedipine)



If you notice increased breathlessness.

Your medicine is known as Adalat LA 20 Tablets but will be referred
to as Adalat LA throughout the following patient information leaflet.



If you notice swelling of the ankles.

Read all of this leaflet carefully because you start taking this
medicine.

Also tell your doctor:

Keep this leaflet. You may need to read it again.
If you have more questions, ask your doctor or pharmacist.

→ Tell your doctor before you take the next dose if any of
these apply to you.


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.

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 is Adalat LA
2. Before you take Adalat LA
3. How to take Adalat LA

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).

1. WHAT IS ADALAT LA



Quinupristin/dalfopristin (a combination antibiotic).

Adalat LA contains nifedipine, which belongs to a group of
medicines called calcium antagonists.



Phenytoin, carbamazepine or valproic acid (to treat
epilepsy).

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.

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).

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.



Ketoconazole, itraconazole or fluconazole (anti-fungal
medicines).



Indinavir, nelfinavir, ritonavir, saquinavir or amprenavir (to
treat HIV).

2. BEFORE YOU TAKE ADALAT LA



Fluoxetine or nefazodone (to treat depression).

Do not take Adalat LA:



Tacrolimus (to prevent the rejection of transplanted organs).



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



Phenobarbital (usually used to treat insomnia or anxiety).



If you get a sudden angina attack. Adalat LA will not help
relieve symptoms of angina quickly.

Food and drink with Adalat LA



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.

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

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.



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 taking rifampicin, an antibiotic.

Tell your doctor if you are on a low-salt diet.



If you have a liver disease that prevents your liver from
working properly.

Pregnancy and breastfeeding



If you have inflammation of the bowel or intestines, such as
Crohn’s disease.

Do not take Adalat LA if you are pregnant. If you are pregnant,
think you might be pregnant or are planning a family, tell your
doctor before taking Adalat LA.



If you have an obstruction or narrowing in your intestines,
or have had this in the past.

You may be able to use Adalat LA after week 20 of your pregnancy,
but only after special consideration and agreement by your doctor.



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).

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



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).

One tablet of Adalat LA 20 contains 21mg salt (sodium chloride).

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.

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



Dose for high blood pressure: the usual dose is 1 tablet, once
a day.

Your doctor will take special care:



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.



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 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.

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

Take your dose at the same time each day, preferably in the
morning.

To help you the blister pack may be printed with the days of the
week:



increase in the need to pass water (urinate)

∆ε /Lunes/LUN = MONDAY,



painful or difficult urination



inability to achieve or maintain an erection (impotence)



blurred vision

Tρ/Martes/MAR = TUESDAY,

Tε/Miércoles/MER = WEDNESDAY, Πε/Jueves/GIO = THURSDAY,
Πα/Viernes/VEN = FRIDAY,

Σα

/Sábado/SAB = SATURDAY,

K‫/ ט‬Domingo/DOM = SUNDAY.
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.

 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

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



chest pain (angina pectoris)

4. POSSIBLE SIDE EFFECTS



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

heartburn or indigestion (gastroesophageal sphincter
insufficiency)



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



sensitivity to light (photosensitivity allergic reaction)

If you notice:



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





joint pain



muscle pain

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.

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)

All of these symptoms usually go away when treatment with Adalat
LA is stopped.
If you get side effects



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)

→ Tell your doctor if any side effect gets serious, or if you get
any effects not listed in this leaflet.



shortness of breath or difficulty breathing

Reporting of side effects



mild to moderate allergic reactions

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.

 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)

By reporting side effects, you can help provide more information on
the safety of this medicine.
5. HOW TO STORE ADALAT LA


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C



Store in the original container to protect from moisture. Only
remove a tablet from the box or blister strip when you are about
to take it.

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



Protect from strong light.



Do not use after the expiry date printed on the carton label or
blister strip.

(These may affect up to 1 in 10 people)



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.

→ Contact your doctor immediately before you continue
treatment as these may be signs of a severe reaction
Less serious side effects



headache



flushing



general feeling of being unwell



constipation

 swelling, particularly of the ankles and legs
Uncommon side effects

6. FURTHER INFORMATION

(These may affect up to 1 in 100 people)



Each tablet contains 20mg of the active ingredient, nifedipine, in
a modified release formulation. Each tablet contains 21mg of
sodium chloride.



Adalat LA also contains 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.

What Adalat LA contains



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

What Adalat LA looks like and contents of the pack



irregular heartbeat (palpitations)





dry mouth

Adalat LA is a round, pink, biconvex tablet marked ‘Adalat 20’
on one side.



indigestion or upset stomach





wind (flatulence)



Adalat LA are available as calendar blister packs of 14, 28 or 56
tablets. Each tablet has the day of the week printed next to it to
remind you when to take it.

feeling sick (nausea)



muscle cramps

Product Licence holder



joint swelling



sleep disorders



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

anxiety or nervousness



reddening of the skin

Manufacturer



nose bleeds



nasal congestion



Adalat LA is manufactured by Bayer AG, Leverkusen, Germany and
Bayer HealthCare Manufacturing S.r.I. – via delle Groane 126,
Garbagnate Milanese, Italy.

sensation of spinning or whirling motion (vertigo)



migraine



Leaflet revision date: 08 November 2013

dizziness



Adalat is a registered trade mark of Bayer AG, Germany.

trembling

Adalat LA also contains hypromellose.

POM

PL 08747/0592

592 LEAFLET Adalat 20131108

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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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