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ADANIF XL 60MG TABLETS

Active substance(s): NIFEDIPINE

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Adults including the elderly
• The usual starting dose is one 30mg
tablet taken once a day.
• The dose may be increased to a
maximum
of
90mg
once
daily
depending on your response to the
drug.
• Take at about the same time each day,
preferably in the morning.
• If you are already taking other nifedipine
containing medicines your doctor may
have switched you to a long-acting
formulation, such as Adanif XL Tablets. If
this is the case the starting dose above
should be used.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Adanif® XL 30mg Tablets
Adanif® XL 60mg Tablets
Nifedipine

In this leaflet:
1. What Adanif XL Tablets are and what
they are used for
2. Before you take Adanif XL Tablets
3. How to take Adanif XL Tablets
4. Possible side effects
5. How to store Adanif XL Tablets
6. Further information

1. What Adanif XL Tablets are and
what they are used for
Your medicine is called Adanif XL 30mg or
60mg Tablets; they contain nifedipine as
the active ingredient. (They will be called
Adanif XL Tablets throughout this leaflet.)

What this medicine does
Your doctor has prescribed Adanif XL
Tablets for:
• High blood pressure (hypertension):
nifedipine works by widening blood
vessels, allowing blood to flow more
freely, thus reducing the strain on your
heart.
• Angina (lack of oxygen to the muscles
of the heart leading to pain in the centre
of the chest radiating over the left side
of the body, up the neck and down the
left arm). Nifedipine reduces the
frequency of angina attacks by opening
the blood vessels (arteries) of the heart
allowing more oxygen and blood to
reach the muscles of the heart.
Adanif XL Tablets contain nifedipine, a
medicine known as a selective calcium
channel blocker.

2. Before you take Adanif XL Tablets
Do not take Adanif XL Tablets
• if you are allergic (hypersensitive) to
nifedipine or other similar medicines
such as amlodipine and felodipine or
any of the other ingredients of Adanif XL
Tablets (see Section 6);
• if you are breast-feeding;
• if you have any other heart conditions
such as:
- your heart is not pumping blood
properly, a condition known as
cardiogenic shock;
- you have a narrowing of the main
artery (the aorta) from the heart to the
rest of the body. This condition is known
as an aortic stenosis;
- unstable angina;
- if you have had a heart attack within
the past month;
• if you are having an acute angina
attack – DO NOT TAKE Adanif XL Tablets
when an angina attack occurs;
• if your blood pressure continues rising
despite treatment;
• to prevent a heart attack;
• if you have liver problems;
• if you suffer with any narrowing or
obstruction of your intestines (guts) or
oesophagus (gullet);
• if you suffer from Crohn’s disease or any
disease that causes swelling or
inflammation of the intestines (gut);
• if you have an ileostomy bag (a special
bag, also called a Kock pouch,
attached to the intestines to collect
waste fom the body);
• if you are taking rifampicin, an
antibiotic. See ”Using other medicines”
section.

Talk to your doctor, pharmacist or nurse
if any of the following apply to you:
• if you already have low or very low
blood pressure (a systolic pressure of less
than 90mmHg). Symptoms of this may
include feeling dizzy or passing out when
you stand up;
• if you have a heart condition or you
have been told your heart is failing;
• if you are diabetic (high levels of sugar in
the blood);
• if you are having kidney dialysis;
• if you are having an x-ray procedure
that uses a barium meal or contrast (a
special solution used for diagnosing
patients
having
certain
x-ray
procedures);
• if you have any urine tests. Nifedipine
may
increase
the
amounts
of
vanillymendelic acid (a waste product
excreted in your water) if measured
using certain methods.
Tell your doctor or pharmacist if you have
any of the above.

Children

Make sure your doctor knows if you are
taking a medicine listed here:
Medicines that may decrease the levels
and effects of nifedipine are:
• Rifampicin an antibiotic used for
legionnaire’s disease and leprosy.
• Phenytoin used to treat epilepsy and
pain around the face.
• Carbamazepine used to treat epilepsy.
• Phenobarbital used to help you sleep
and to treat some types of epilepsy.
Medicines that may increase the levels
and effects of nifedipine are:
• Macrolide antibiotics such as erythromycin,
clarithromycin and azithromycin used for
many types of infections, such as tonsillitis,
bronchitis and skin infections.
• Anti-HIV Protease Inhibitors such as
ritonavir, indinavir and nelfinavir used to
treat HIV.
• Azole anti-fungals (anti-mycolytics) such
as ketoconazole, itraconazole and
fluconazole used for many types of
fungal infections.
• Fluoxetine and Nefazodone used to
treat
depression
and
obsessivecompulsive disorders.
• Quinupristin and Dalfopristin antibiotics
used for various skin and blood
infections.
• Cisapride used for night-time heartburn.
• Valproic acid used to treat epilepsy.
• Cimetidine used to treat stomach ulcers
and for reducing the amount of
stomach acid.
• Diltiazem used for angina and high
blood pressure.
Other medicines that are affected by
nifedipine are:
• Beta-blocking medicines such as
propranolol or atenolol used to help
prevent heart attacks and an irregular
heartbeat or to treat high blood
pressure and angina. These medicines
may decrease blood pressure too much
and can lead to dizziness especially
when you go from a sitting to standing
position or a lying to sitting position.
• Digoxin used for heart failure and
abnormal
heartbeats.
Nifedipine
reduces clearance of digoxin so your
doctor may reduce the dose of digoxin
to prevent overdosing.
• Quinidine used to treat increased and
abnormal heartbeats. The levels of
quinidine are reduced by nifedipine,
regardless of dose of quinidine taken.
Blood pressure and levels of quinidine
should be monitored.
• Tacrolimus used to suppress the immune
system and prevent organ rejection in
transplant patients. Nifedipine increases
levels of tacrolimus so a reduction in
dose may be necessary.
Tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.

• Adanif XL tablets 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.

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 Adanif XL
Tablets.
• If you have chest pains after taking your
first dose of Adanif XL Tablets. 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.

If you take more Adanif XL Tablets than
you should
• If you take more Adanif XL Tablets than
your doctor has prescribed, or you think
a child has accidentally swallowed any,
call your doctor or go to the nearest
hospital
emergency
department
immediately. Take the medicine or this
leaflet with you to show the doctor.

If you forget to take Adanif XL Tablets

• Do not take double the amount to make
up for a forgotten dose.
• Take the next dose immediately.
• Continue taking your tablets at your
usual time of day; but wait at least 12
hours before taking your next dose.

If you stop using Adanif XL Tablets

• Do not stop taking Adanif XL Tablets
suddenly.
• Speak to your doctor before you stop
taking Adanif XL Tablets.
If you have any further questions on the
use of this product, ask your doctor or
pharmacist.

4. Possible Side Effects
Like all medicines, Adanif XL Tablets can
cause
side
effects,
although
not
everybody gets them.

Take immediate action if you have any
of the following side effects:
severe allergic reaction which may
include a red and lumpy skin rash, difficulty
breathing, swelling of face, mouth, lips or
eyelids, unexplained high temperature
(fever) and feeling faint. If the swelling
affects your throat and makes breathing
and swallowing difficult, go to hospital
straight away.

Common (up to 1 in 10 people)
• headache;
• flushing due to widening of the blood
vessels (vasodilation);
• constipation;
• swelling (oedema), sometimes of the
hands, feet and/or ankles;
• generally feeling unwell.

Using Adanif XL Tablets with food and
drink

Do not take Adanif XL Tablets within 3 days
of having anything containing grapefruit.
• Do not take Adanif XL Tablets with
grapefruit or grapefruit juice because it
may increase the levels of nifedipine
leading to an increased effect or even
overdose.
• Swallow the tablets whole with a glass of
water, with or without food.

Uncommon (up to 1 in 100 people)







Pregnancy and breast-feeding




• Speak to your doctor or pharmacist for
advice before taking Adanif XL Tablets,
if you are pregnant, thinking of getting
pregnant or breast-feeding.
• Speak to your doctor or pharmacist for
advice before taking Adanif XL Tablets,
especially if you are having magnesium
sulphate injections (used for magnesium
deficiency).
• Nifedipine may affect male fertility, your
fertility will return once you stop taking
the drug. If you are trying to father a
child without success, tell your doctor
that you are taking nifedipine.













Driving and using machines
• Adanif XL Tablets may decrease your
ability to drive or operate machinery
safely.
• Do not drive or operate machines if you
are affected.





Important information about some of the
ingredients in Adanif XL Tablets




• Adanif XL Tablets contain lactose
monohydrate – if you have been told by
your doctor that you have an
intolerance to some sugars, contact
your doctor before taking this medicine.



feeling anxious;
problems sleeping;
migraines;
trembling or involuntary movements;
changes in your vision;
pain of the abdomen, stomach,
intestines (gut) or generally all over;
dizziness;
low blood pressure (leading to fainting
or feeling dizzy), especially when you
stand-up if sitting or sit up after lying
down;
fainting or loss of consciousness;
increased heart rate;
an irregular and/or forceful heart beat
(palpitations);
nosebleeds;
blocked nose or congestion;
chills;
dry mouth;
indigestion;
wind (flatulence);
feeling sick (nausea);
changes to the levels of some liver
enzymes;
muscle cramps;
swelling of the joints;
giddiness
or
feeling
unbalanced
(vertigo);
redness or flushing of the skin;
difficulty achieving or maintaining an
erection (impotence);
passing an increased amount of water
or pain when urinating.

Reporting of side effects
If you get any side effects, talk to your doctor
or pharmacist. 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 Adanif XL Tablets
Keep out of the sight and reach of
children.
Do not use after the expiry date stated on
the carton. The expiry date refers to the last
day of that month.
Do not store above 25°C. Store in the
original package to protect from light.
Do not use if you notice any damage or
discoloration of the tablets. Return them to
your pharmacist.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines
no longer required. These measures will
help to protect the environment.

6.Further Information
What Adanif XL Tablets contain:
• The active substance is nifedipine.
• The other ingredients are: tablet core talc
(E533b),
povidone
(E1201),
hypromellose (E464) and carbomer
974P, lactose monohydrate, silica
colloidal anhydrous and magnesium
stearate; coating - Eudragit “E”, titanium
dioxide (E171), ferric oxide (E172), talc
(E533b),
magnesium
stearate,
hypromellose and macrogol 4000.

What Adanif XL Tablets look like and
contents of the pack
Adanif XL 30mg and 60mg Tablets: round
tablets with a pale red colour.
Each carton of Adanif XL Tablets contains
28 tablets.

Marketing Authorisation Holder
Focus Pharmaceuticals Limited,
Capital House,
1st Floor,
85 King William Street,
London
EC4N 7BL,
United Kingdom.
Tel: 01283 495 280 Fax: 01283 495 290
Email: medinfo@focuspharma.co.uk

Manufacturer
Lamp San Prospero S.P.A.,
Via della Pace,
25/A,
41030 San Prospero (MO),
Italy.
For any information about this medicinal
product, please contact the Marketing
Authorisation Holder, details provided
above.

For information in large print, audio
CD or Braille please telephone
01283 495 280 or email
medinfo@focuspharma.co.uk
This leaflet was revised 06/2015.

Rare (up to 1 in 1000 people)
• change in sensitivity to touch (either
increased, decreased or loss), tingling,
pins and needles and very sensitive skin;
• itching, rash, swelling or blisters (hives);
• swelling or enlargement of the gums.

3.How to take Adanif XL Tablets
Always take Adanif XL Tablets exactly as
your doctor has told you. Check with your
doctor or pharmacist if you are not sure.
ALWAYS: swallow the tablet whole, with a
glass of water; at about the same time
each day.
DO NOT bite, chew or break-up the tablet.
Do not take within 3 days of having
grapefruit or grapefruit juice.

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• 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. 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 get serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.

Using other medicines

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

Other side effects (where the frequency is
not known)
• breathlessness or difficulty breathing;
• being sick (vomiting);
• formation of a mass of foreign material in
the stomach or intestines (gut);
• blockage or obstruction of the intestines
(gut);
• ulceration of the intestines (gut);
• difficulty swallowing or keeping down
food or drink;
• lesions or ulcers in the throat, mouth and
skin;
• low resistance to infections due to a
reduced number of white blood cells
(leucopenia);
• high levels of sugar in your blood
(hyperglycaemia) that makes you feel
thirsty or need to urinate more often;
• reduced sense of touch or sensation;
• feeling sleepy or drowsy;
• eye pain;
• chest pain;
• yellowing of the skin or eyes (jaundice);
• severe skin disorder which causes the
outer layer of skin to detach;
• raised, purple-red spotting on the skin;
• itching, reddening or scaling of the skin;
• muscle or joint pain.

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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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