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Active substance(s): NIFEDIPINE

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Adalat® 5 mg soft capsules


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.
This medicine is available using above names but will be referred to as
Adalat capsules throughout this leaflet.
Other strengths are also available.
In this leaflet
1. What Adalat capsules are and what they are used for
2. What you need to know before you take Adalat capsules
3. How to take Adalat capsules
4. Possible side effects
5. How to store Adalat capsules
6. Contents of the pack and other information
Adalat capsules contain nifedipine, which belongs to a group of medicines
called calcium antagonists.
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 the heart.
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.
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 to any of the other ingredients of this medicine.
(listed in section 6).
- 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
 Tell your doctor and do not take Adalat capsules if any of these
apply to you.
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 breastfeeding.
- 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 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 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.
 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 medicines.
Some medicines may affect the way Adalat capsules work. 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
- 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, nelfifinavir, ritonavir, saquinavir or amprenavir (to treat
- 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
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
Pregnancy and breastfeeding
If you are pregnant, think you might 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
the tablets.
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 contain yellow orange S (E110)
May cause allergic reactions.
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 be identified.
- The dose can be increased to a maximum of 20 mg every 8 hours.
- Lower doses may be prescribed for elderly patients or for patients
who have liver problems.
- Swallow the capsules whole with a little water.
- Continue to take the capsules for as long as your doctor has told you
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 unconsciousness.
If you forget to take Adalat capsules
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
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) 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
- 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
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 capsules, 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
- vomiting
- a reduction in the number of white blood cells (leucopenia)
- a more severe decrease in a specific class of white blood cell
- 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 capsules
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:
By reporting side effects, you can help provide more information on the
safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not store above 30oC. Protect from light. Store in the original container.
Only remove the capsule from the blister strip when you are about to take
Do not use after the expiry date which is marked on both the outer carton
and on each blister strip of capsules.
If your capsules become discoloured or show any other signs of
deterioration, consult your doctor or pharmacist who will tell you what to do.
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.
What Adalat capsules contain
Adalat capsules contain the active ingredient, nifedipine.
Each soft capsule contains 5 mg nifedipine
Adalat capsules also contain gelatin, glycerol 85%, purified water, sodium
saccharin E954, peppermint oil, glycerol, macrogol 400, titanium dioxide
(E171) and yellow orange S (E110).
What’s in the pack
Oval, orange soft gelatin capsule containing a yellow viscous fluid.
Each pack contains 50 or 90 capsules.
Manufactured by
Bayer Pharma AG, Kaiser-Wilhelm-Allee, D-51368 Leverkusen, Germany
Bayer HealthCare Manufacturing S.R.L., Garbagnate Milanese, I-20024,
Procured from within the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.

PL 20636/2604

Leaflet revision and issue date (Ref) 19.10.15[4]
Adalat is a trademark of Bayer Aktiengesellschaft.

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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.