ADALAT 5 MG SOFT CAPSULES

Active substance: NIFEDIPINE

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Package leaflet - information for the user

0 Adalat

®



5 mg

Soft capsules
Nifedipine




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.







Tell your doctor about any other medicines that you are taking,
or took recently. This includes any products you bought without a
prescription.

What Adalat capsules are
ar

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.




You can take Adalat capsules either with or without food.

Befor
Before you take Adalat capsules

Do not drink grapefruit juice or eat grapefruit while taking 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 the active ingredient (nifedipine), to any other
similar medicines (known as dihydropyridines) or to any of the other
ingredients. The ingredients of Adalat capsules are 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 hypertension).

Your doctor will take special care:







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 breastfeeding
If you are pregnant, think you might be pregnant or are planning a family,
tell your doctor before taking Adalat capsules.
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 breastfeeding. If you need to
take Adalat capsules while breastfeeding, tell your doctor before taking
the tablets.

Driving and using machines

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



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
conditions).
• Quinupristin/dalfopristin (a combination antibiotic).
• Phenytoin, carbamazepine or valproic acid (to treat epilepsy).
• Cisapride (to treat reduced movements of the gullet and stomach).
egnancy
• Magnesium sulphate injections during pregnancy (may cause a
severe fall in blood pressure).
• Erythromycin (an antibiotic).
• Ketoconazole, itraconazole or fluconazole (anti-fungal
medicines).
Indinavir
• Indinavir, nelfinavir, ritonavir, saquinavir or amprenavir (to treat
HIV).
• Fluoxetine or nefazodone (to treat depression).
T
• Tacrolimus (to prevent the rejection of transplanted organs).
• Phenobarbital (usually used to treat insomnia or anxiety).

Food and drink with Adalat capsules

Do not take Adalat capsules:




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

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.




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.

Also tell your doctor:

this leaflet
What Adalat capsules are
Befor
Before you take Adalat capsules
How to take Adalat capsules
Possible side effects
ef
How to store Adalat capsules
Further information

Adalat capsules contain nifedipine, which belongs to a group of medicines
called calcium antagonists.




REVISED

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

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.

2

2013

Tell your doctor:

Keep this leaflet. You may need to read it again.

1

November

T
Talk to your doctor before you take Adalat
capsules if any of these apply to you.

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

In
1
2
3
4
5
6

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.

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.

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.

3

How to take Adalat capsules

Take the capsules as prescribed by your doctor.
• 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.

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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.
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: 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 too many capsules
Get medical help immediately. If possible, take your capsules
immediately
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 the 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 the missed dose.

4

Possible side effects
ef

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

Serious side effects
If you notice:
• severe, sudden generalised allergic reaction including very rarely lifethreatening 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 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.















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)
• 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
capsules is stopped.

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

5

How to store Adalat capsules
stor

Keep this medicine out of the reach and sight of children.

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)

Store your medicine in its original container. Protect from strong light and
only remove the capsule from the blister strip when you are about to take
it.

Contact your doctor immediately before you continue
treatment as these may be signs of a severe reaction.

Do not use after the expiry date which is marked on both the outer carton
and on each blister strip of capsules.

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

Do not store above 30ºC.

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.

6

Further information

What Adalat capsules contain
Adalat capsules contain the active ingredient, nifedipine.
Adalat capsules also contain glycerol, purified water, saccharin sodium,
peppermint oil and macrogol 400.
The capsule shell contains gelatine, glycerol, titanium dioxide (E171) and
yellow orange S (E110).

What’s in the pack
Each oval, soft gelatine capsule is filled with a viscous yellow liquid
containing 5 mg of nifedipine.
Each pack contains 90 capsules.
Marketing authorisation holder: Bayer plc, Bayer House, Strawberry
Hill, Newbury, Berkshire RG14 1JA
Manufacturer: Bayer Pharma AG, Leverkusen, Germany or Bayer
HealthCare Manufacturing S.r.l. Garbagnate, Italy
This leaflet was last revised: November 2013
Product licence number: PL 00010/0079

U
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PMR 81941130 (O8/01/MU-0201312083) Pantone: Schwarz, Orange 021

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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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