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ADALAT 10 MG SOFT CAPSULES

Active substance: NIFEDIPINE

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PACKAGE LEAFLET - INFORMATION FOR THE USER

Adalat® 10 mg Soft Capsules / Nifedipine 10 mg Soft Capsules

Also tell your doctor:

This product is available as any of the above names but will be referred to as Adalat
capsules throughout the remainder of this leaflet.

 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.

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

Other medicines and Adalat capsules

(nifedipine)

 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 gets serious, or if you notice any side effects not listed in
this leaflet, please tell your doctor or pharmacist.
In this leaflet
1.
2.
3.
4.
5.
6.

What Adalat capsules are
Before you take Adalat capsules
How to take Adalat capsules
Possible side effects
How to store Adalat capsules
Further information

1. What Adalat capsules are
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.
2. 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 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).
→ Tell your doctor and do not take Adalat capsules if any of these apply to

you.
Your doctor will take special care:
 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.

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 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).
 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 capsules
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 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
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.
 To start with, you may be given a lower strength (5 mg) capsule every 8 hours.
This allows your doctor to monitor how you are responding so that the best longterm 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 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 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

Reporting of side effects

Like all medicines, Adalat capsules can have side effects, although not everybody gets
them.
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 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 25°C. Protect from light. Store in the original package.
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. Further 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 10 mg of nifedipine.

→ Contact your doctor immediately before you continue treatment as these may

Adalat capsules also contain glycerol, polyethylene glycol 400, peppermint oil, purified
water and saccharin sodium.

be signs of a severe reaction.
Less serious side effects

The capsule shell contains gelatin, glycerol, titanium dioxide (E171) and sunset yellow
FCF (E110).

Apart from the side effects listed above, these are the other side effects of Adalat
capsules, starting with the more common ones:

What’s in the pack

Common side effects
(These may affect up to 1 in 10 people)

Adalat capsules are orange, soft gelatine capsule filled with a viscous yellow liquid.
Adalat capsules are available in blister packs of 50 or 100 soft capsules.







PL No: 15814/1193

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)















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.

POM

Manufactured by Meda Manufacturing GmbH, Cologne, 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.): 25.03.2015.
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
796.

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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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