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NIFEDIPINE 5 MG SOFT CAPSULES
Active substance(s): NIFEDIPINE / NIFEDIPINE / NIFEDIPINE
Adalat® 5 mg Soft Capsules / Nifedipine 5 mg Soft Capsules
This product is available as any of the above names but will be referred to as Adalat
capsules throughout the remainder of this 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
What Adalat capsules are and what they are used for
What you need to know before you take Adalat capsules
How to take Adalat capsules
Possible side effects
How to store Adalat capsules
Contents of the pack and other information
1. What Adalat capsules are and what they are used for
Adalat capsules contain nifedipine, which belongs to a group of medicines called
Adalat capsules are used to treat high blood pressure, angina (chest pain) or a
condition called Raynaud’s phenomenon which causes discolouration (often
whitening) of the fingers and toes.
For high blood pressure: Adalat capsules work 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 capsules work 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
Adalat capsules can increase the risk of serious heart problems in patients with high
blood pressure or angina. Because of this, Adalat capsules are only used in these
patients if no other treatments are appropriate.
For Raynaud’s phenomenon: Adalat capsules work by relaxing and expanding the
blood vessels in the fingers and toes. This helps ensure a good blood supply.
2. What you need to know before you take Adalat capsules
Do not take Adalat capsules:
If you have had a heart attack within the last month.
If you get a sudden angina attack. Adalat capsules 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
If you are taking rifampicin, an antibiotic.
If you have been told that you have a narrowing of the aortic heart valve
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
→ Tell your doctor and do not take Adalat capsules if any of these apply to
Warnings and precautions
Talk to your doctor before taking Adalat capsules
If you have low blood pressure. 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 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 capsules.
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 capsules.
→ Talk to your doctor before you take Adalat capsules if any of these apply to
→ 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 capsules 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 capsules have been shown to impair sperm function.
Other medicines and Adalat capsules
Tell your doctor if you are taking, have recently taken or might take any other
Some medicines may affect the way Adalat capsules work. Tell your doctor if you are
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
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 capsules with food and drink
You can take Adalat capsules either with or without food.
Do not drink grapefruit juice or eat grapefruit while taking Adalat capsules.
Do not start taking Adalat capsules 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 capsules.
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 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 capsules, but only after special consideration and
agreement by your doctor.
Do not take Adalat capsules if you are breast-feeding. If you need to take Adalat
capsules while breast-feeding, tell your doctor before taking this medicine.
Driving and using machines
Adalat capsules 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.
Adalat capsules contains Yellow orange S (E110)
May cause allergic reactions.
3. How to take Adalat capsules
Always take this medicine exactly as your doctor has told you. Check with your doctor
if you are not sure.
The recommended starting dose is one 5 mg capsule every 8 hours. This allows
your doctor to monitor how you are responding so that the best long-term dose can
The dose can be increased to a maximum of 20 mg every 8 hours.
Lower doses may be prescribed for older patients or for patients who have liver
Swallow the capsules whole with a little water.
Continue to take the capsules for as long as your doctor has told you to.
Do not take them with grapefruit juice.
You can take Adalat capsules either with or without food.
Use in children and adolescents: Adalat capsules are 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 capsules than you should
→ Get medical help immediately. If possible, take your capsules or the box with
you to show the doctor.
Taking too many capsules 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
Tell your doctor:
If you forget to take Adalat capsules
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 capsules.
If you have chest pains after taking your first dose of Adalat capsules. Your
doctor may wish to change your treatment.
If you notice increased breathlessness.
If you notice swelling of the ankles.
Take your normal dose immediately and continue taking your capsules as prescribed,
waiting 8 hours before taking your 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
Reporting of side effects
Like all medicines, this medicine can cause side effects, although not everybody gets
Serious 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.
If you notice:
5. How to store Adalat capsules
severe, sudden generalised allergic reaction including very rarely life-threatening
shock (e.g. difficulty in breathing, drop of blood pressure, fast pulse) or 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.
Keep out of the sight and reach of children.
Do not store above 30°C. Protect from strong light. Store in the original container.
Only remove the capsule 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 capsules. The expiry date refers to the last day of that month.
Do not dispose of medicines in household rubbish. Any unused Adalat capsules
should be returned to a pharmacist (chemist) who will dispose of them properly.
This helps the environment.
If your medicine becomes discoloured or show signs of any deterioration, consult
your doctor or pharmacist who will tell you what to do
6. Contents of the pack and other information
If you develop:
What Adalat capsules contain
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)
Adalat capsules contain the active ingredient, nifedipine.
Each capsule contains 5 mg of nifedipine.
→ 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
capsules, starting with the more common ones:
Common side effects
(These may affect up to 1 in 10 people)
general feeling of being unwell
swelling, particularly of the ankles and legs
Uncommon side effects
(These may affect up to 1 in 100 people)
stomach pain (abdominal pain)
low blood pressure when standing up (symptoms include fainting, dizziness, light
headedness, occasional palpitations, blurred vision and sometimes confusion)
irregular heartbeat (palpitations)
indigestion or upset stomach
feeling sick (nausea)
anxiety or nervousness
reddening of the skin
sensation of spinning or whirling motion (vertigo)
increase in the need to pass water (urinate)
painful or difficult urination
inability to achieve or maintain an erection (impotence)
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)
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)
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)
All of these symptoms usually go away when treatment with Adalat capsules is
Adalat capsules also contain glycerol, polyethylene glycol 400, peppermint oil, purified
water and saccharin sodium.
The capsule shell contains gelatin, glycerol, titanium dioxide (E171) and sunset yellow
What’s in the pack
Adalat capsules are orange, oval shaped, soft gelatine capsule filled with a viscous
Adalat capsules are available in blister packs of 50 or 100 soft capsules.
Manufactured by Meda Manufacturing GmbH, Cologne, Germany OR Bayer Pharma
AG, Leverkusen, Germany.
Procured from within the EU and repackaged by the Product Licence holder:
O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.
Leaflet revision and issue date (Ref.): 22.11.2016.
Adalat is a registered trade mark of Bayer AG, Germany.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332
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.