Skip to Content

UK Edition. Click here for US version.

ADALAT LA 30MG PROLONGED-RELEASE TABLETS

Active substance(s): NIFEDIPINE / NIFEDIPINE / NIFEDIPINE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

FRONT PAGE
T06820

ADALAT® LA 30mg Prolonged-release Tablets
(nifedipine)

Your medicine is called ADALAT LA 30mg Prolonged-release Tablets but will be referred to as Adalat LA
throughout the leaflet.
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.
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
4. Possible side effects
5. How to store Adalat LA
6. Contents of the pack and other information

1. 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.

2. 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 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.
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 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 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 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.
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 function.
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 30 contains 24 mg 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 medicine.
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 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 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 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.

BACK PAGE
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 doctor.

4. 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 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 (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 data)
• 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 is stopped.
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
Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Store your medicine in its original container. Protect from strong light and only remove the tablet from
the blister strip when you are about to take it.
Do not use this medicine after the expiry date which is stated on both the outer carton and on each
blister strip of tablets after EXP.
The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Adalat LA contains
Adalat LA tablets contain 30 mg of the active ingredient, nifedipine.
Adalat LA tablets also contains:
Adalat LA tablets also contains:
Tablet Core

Coating

Polish and Print

Cellulose acetate
Macrogol (3350)
Hydroxypropylcellulose
Hypromellose 3 cps
Propylene glycol
Hypromellose 5 cps
Titanium dioxide (E171)
Ferric oxide, red (E172)

Polyethylene oxide
Hypromellose 5 cps
Magnesium stearate
Sodium chloride
Red Ferric oxide (E172)

Black ink for printing
Opacode S-1-17823
(Contains: iron oxide black
(E172)
and Shellac)

Each 30 mg tablet also contains 24 mg 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
Each prolonged-release tablet contains 30 mg of nifedipine. Each tablet is pink, round, convex
prolonged-release with a laser hole on one side and marked with ‘Adalat 30’ in black on the reverse.
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 and Product Licence Holder:
This product is manufactured by Bayer Pharma AG, D-51368 Leverkusen, Germany. It is procured from
within the EU by the Product Licence Holder: Swinghope Ltd, Commerce Way, Edenbridge TN8 6ED,
UK and repackaged by YMD Pharma Limited, Commerce Way, Edenbridge TN8 6ED, UK.
POM

PL 10380/1635

Adalat LA 30 mg Prolonged-release tablets

Leaflet revision date: 10/03/2017
Adalat® is a registered trademark of Bayer AG, Germany.

Blind or partially sighted?
Is this leaflet hard to see or read?
Call 02030969700 to obtain the leaflet in a format
suitable for you.
T06820

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.

Hide