ADALAT LA 20MG PROLONGED-RELEASE TABLETS

Active substance: NIFEDIPINE

View full screen / Print PDF » Download PDF ⇩

Transcript
S0382-28-GR-PIL-20.02.2013

Also tell your doctor:

PATIENT INFORMATION LEAFLET

Adalat® LA 20mg Prolonged-release
tablets
(nifedipine)
The name of your medicine is Adalat LA 20mg Prolonged-release
tablets but will be referred to as Adalat LA throughout the
remainder of 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 get 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 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.
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 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.

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.

 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 20mg contains 21mg salt (sodium chloride).
Tell your doctor if you are on a low-salt diet.

Pregnancy and breast-feeding
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.
You may be able to use Adalat LA after week 20 of your pregnancy,
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.

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.










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.

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








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 lifethreatening 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

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

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 package.
Protect from light and only remove the tablet from the blister strip
when you are about to take it.
 Do not use after the expiry date which is marked on both the outer
carton and on each blister strip of tablets.
 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.
 If the tablets become discoloured or show any signs of deterioration,
you should seek the advice of your pharmacist.

6. FURTHER INFORMATION
What Adalat LA contains:
Each tablet contains 20mg of the active ingredient, nifedipine.
Adalat LA tablets also contain polyethylene oxide, magnesium
stearate, sodium chloride, red iron oxide E172, cellulose acetate,
macrogol 3350, hydroxypropylcellulose, titanium dioxide E172,
hypromellose and propylene glycol.
Each 20mg tablet also contains 21mg of sodium chloride (salt) to be
taken into consideration by patients on a controlled sodium diet.

What’s in the pack
Adalat LA are pink, circular convex prolonged-release tablets with a
laser hole on one side and marked with ‘Adalat 20’ in black ink on the
other side.
Each pack contains 28 tablets. Each tablet has the day of the week
printed next to it to remind you when to take it.

Manufacturer
Bayer Pharma AG
Leverkusen, Germany

Procured from within the EU and repackaged by: Amimed
Direct Ltd, Hendon London, NW9 6AQ.
Product Licence holder: Sam Pharma Ltd, Unit 20 Garrick
Industrial Estate, Irving Way, Hendon, London, NW9 6AQ.
POM

PL No: 33902/0382

Leaflet revision date: 20/02/2013
Adalat® is a registered trademark of Bayer Aktiengesellschaft.
S0382-28-GR-PIL-20.02.2013

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.

Hide
(web1)