Skip to Content

UK Edition. Click here for US version.

NIFADITAB 30MG PROLONGED-RELEASE TABLETS

Active substance(s): NIFEDIPINE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet – information for the user

Adalat® LA 30mg Prolonged-release tablets
(nifedipine)
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 called Adalat LA 30mg Prolonged-release tablets, but
will be referred to as Adalat LA throughout the remainder of this leaflet.
• This product is also available in other strengths.
What is in this leaflet
1) What Adalat LA is and what it is used for
2) What you need to know before you take Adalat LA
3) How to take Adalat LA
4) Possible side effects
5) How to store Adalat LA
6) Contents of the pack and other information
1) What Adalat LA is and what it is used for
Adalat LA contains nifedipine, which belongs to a group of medicines
called calcium antagonists.
Adalat LA is used to treat high blood pressure or angina (chest
pain).
For high blood pressure: Adalat LA works 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 LA works 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.
2) What you need to know before you take Adalat LA
Do not take Adalat LA:
• If you have had a heart attack within the last month.
• If you get a sudden angina attack. Adalat LA 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 6).
• If you are taking rifampicin, an antibiotic.
• If you have a liver disease that prevents your liver from working
properly.
• If you have inflammation of the bowel or intestines, such as
Crohn’s disease.
• If you have an obstruction or narrowing in your intestines, or have
had this in the past.
• If you have ever had an obstruction in the gullet
(the oesophagus - the tube connecting the throat to the stomach).
• 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 you have a “Kock pouch” (a surgically constructed intestinal
reservoir with an opening through the abdominal wall) in your gut.
• If your blood pressure continues to rise despite treatment
(malignant hypertension).

Also tell your doctor:
• If you are giving a urine sample. Adalat LA may interfere with the
results of certain urine tests.
• If you are to have a barium contrast x-ray (barium meal).
These tablets may affect the results of the test.
• If you are a man who has been unable to father a child by in vitro
fertilisation. Drugs like Adalat LA have been shown to impair sperm
function.
Other medicines and Adalat LA
Tell your doctor if you are taking, have recently taken or might take any
other medicines.
Some medicines may affect the way Adalat LA works. 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).
Adalat LA with food and drink
You can take Adalat LA with or without food.
Do not drink grapefruit juice or eat grapefruit while taking Adalat
LA.
Do not start taking Adalat LA 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 LA. Grapefruit juice is known to increase the blood levels of
the active ingredient, nifedipine. This effect can last for at least 3 days.
One tablet of Adalat LA 30 mg contains 24 mg salt (sodium chloride).
Tell your doctor if you are on a low-salt diet.
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 LA but only after special consideration
and agreement by your doctor.
Do not take Adalat LA if you are breast-feeding. If you need to take
Adalat LA, you should stop breast-feeding before you start taking this
medicine.
Driving and using machines
Adalat LA 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 LA

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

Adalat LA is specially formulated so that you only have to take one dose
each day.

Warnings and precautions
Talk to your doctor before taking Adalat LA
• If you have low blood pressure and you were prescribed Adalat LA
for your angina. 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 need to take Adalat LA, you should
stop breast-feeding before you start to take this medicine.
• 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 LA.
• 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 LA.

Always take this medicine exactly as your doctor has told you. Check
with your doctor if you are not sure.
• Dose for high blood pressure: the usual dose is 1 tablet, once a day.
• Dose for angina: the dose depends on your individual requirements.
Your doctor will decide how much you should take.
• Swallow the tablets whole. Do not bite, chew or break them – if
you do they will not work properly. If you have difficulty swallowing
tablets, consult your doctor as he or she may wish to change your
medicine.
• Continue to take these tablets for as long as your doctor has told
you to.
Take your dose at the same time each day, preferably in the morning.
Take your tablets with a glass of water. Do not take them with grapefruit
juice.
You can take Adalat LA with or without food.

 Talk to your doctor before you take Adalat LA 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 LA.
• If you have chest pains after taking your first dose of Adalat LA.
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.

You may see what looks like a complete tablet in the toilet or in your
stools. This is normal – it’s the outer shell of the tablet which is not
digested by the body.
Use in children and adolescents: Adalat LA is 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 LA than you should
 Get medical help immediately. If possible, take your tablets or the
box with you to show the doctor.
Taking too many tablets 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 LA
Take your normal dose immediately and continue taking your tablets at
the usual time of day, waiting at least 12 hours before taking the 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

All of these symptoms usually go away when treatment with Adalat LA is
stopped.
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 (see details below). By reporting side effects
you can help provide more information on the safety of this medicine.
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
5) How to store Adalat LA

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 lifethreatening shock (e.g. difficulty in breathing, drop of blood pressure,
fast pulse), 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.
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 LA, 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
data)
• stomach pain or distress caused by a mass of foreign material found in
the stomach which may require surgery for removal
• difficulty swallowing
• abdominal pain, caused by obstruction of the gut or ulcers in the gut
• 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

Keep out of the sight and reach of children.
Do not store above 30oC.
Store in original package.
Protect from strong light.
Do not use after the expiry date which is marked on both the outer
carton and on each blister strip of tablets.
• If your medicine becomes discoloured or shows any sign of
deterioration, return it 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) Contents of the pack and other information
What Adalat LA contains
Each prolonged-release tablet contains 30 mg nifedipine.
The other ingredients are: Propylene glycol, cellulose acetate,
hypromellose 3 CPS, hypromellose 5 CPS, hydroxypropylcellulose,
polyethylene oxide, macrogol, magnesium stearate, sodium chloride,
titanium dioxide (E171), black iron oxide (E172) and red iron oxide
(E172).
What Adalat LA looks like and the contents of the pack
Each tablet is pink, round convex prolonged-release tablet with a laser
hole on one side and marked with ‘Adalat 30’
Adalat LA comes in packs of 28 tablets.
Manufactured by
Bayer Pharma AG. D-51368 Leverkusen, Germany, or
Bayer HealthCare AG. D-51368 Leverkusen, Germany.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER, UK.
Repackaged by XXXXXXXXXXXXXXX
PL: 33532/0201

POM

Leaflet dated 16th October 2015
Leaflet coded XXXXXXXXXX
Adalat® LA is a registered trademark of Bayer Aktiengesellschaft

Package leaflet – information for the user

Nifaditab 30mg Prolonged-release tablets
(nifedipine)
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 called Nifaditab 30mg Prolonged-release tablets, but
will be referred to as Nifaditab throughout the remainder of this leaflet.
What is in this leaflet
1) What Nifaditab is and what it is used for
2) What you need to know before you take Nifaditab
3) How to take Nifaditab
4) Possible side effects
5) How to store Nifaditab
6) Contents of the pack and other information
1) What Nifaditab is and what it is used for
Nifaditab contains nifedipine, which belongs to a group of medicines
called calcium antagonists.
Nifaditab is used to treat high blood pressure or angina (chest pain).
For high blood pressure: Nifaditab works 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: Nifaditab works 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.

Also tell your doctor:
• If you are giving a urine sample. Nifaditab may interfere with the
results of certain urine tests.
• If you are to have a barium contrast x-ray (barium meal).
These tablets may affect the results of the test.
• If you are a man who has been unable to father a child by in vitro
fertilisation. Drugs like Nifaditab have been shown to impair sperm
function.
Other medicines and Nifaditab
Tell your doctor if you are taking, have recently taken or might take any
other medicines.
Some medicines may affect the way Nifaditab works. 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).
Nifaditab with food and drink
You can take Nifaditab with or without food.
Do not drink grapefruit juice or eat grapefruit while taking Nifaditab.

2) What you need to know before you take Nifaditab
Do not take Nifaditab:
• If you have had a heart attack within the last month.
• If you get a sudden angina attack. Nifaditab 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 6).
• If you are taking rifampicin, an antibiotic.
• If you have a liver disease that prevents your liver from working
properly.
• If you have inflammation of the bowel or intestines, such as
Crohn’s disease.
• If you have an obstruction or narrowing in your intestines, or have
had this in the past.
• If you have ever had an obstruction in the gullet
(the oesophagus - the tube connecting the throat to the stomach).
• 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 you have a “Kock pouch” (a surgically constructed intestinal
reservoir with an opening through the abdominal wall) in your gut.
• If your blood pressure continues to rise despite treatment
(malignant hypertension).
 Tell your doctor and do not take Nifaditab if any of these apply to
you.
Warnings and precautions
Talk to your doctor before taking Nifaditab
• If you have low blood pressure and you were prescribed Nifaditab
for your angina. 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 need to take Nifaditab, you should
stop breast-feeding before you start to take this medicine.
• 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 Nifaditab.
• 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 Nifaditab.
 Talk to your doctor before you take Nifaditab 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 Nifaditab.
• If you have chest pains after taking your first dose of Nifaditab.
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.

Do not start taking Nifaditab 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 Nifaditab. Grapefruit juice is known to increase the blood levels of
the active ingredient, nifedipine. This effect can last for at least 3 days.
One tablet of Nifaditab 30 mg contains 24 mg salt (sodium chloride).
Tell your doctor if you are on a low-salt diet.
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 Nifaditab but only after special consideration and
agreement by your doctor.
Do not take Nifaditab if you are breast-feeding. If you need to take
Nifaditab, you should stop breast-feeding before you start taking this
medicine.
Driving and using machines
Nifaditab 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 Nifaditab
Nifaditab is specially formulated so that you only have to take one dose
each day.
Always take this medicine exactly as your doctor has told you. Check
with your doctor if you are not sure.
• Dose for high blood pressure: the usual dose is 1 tablet, once a day.
• Dose for angina: the dose depends on your individual requirements.
Your doctor will decide how much you should take.
• Swallow the tablets whole. Do not bite, chew or break them – if
you do they will not work properly. If you have difficulty swallowing
tablets, consult your doctor as he or she may wish to change your
medicine.
• Continue to take these tablets for as long as your doctor has told
you to.
Take your dose at the same time each day, preferably in the morning.
Take your tablets with a glass of water. Do not take them with grapefruit
juice.
You can take Nifaditab with or without food.
You may see what looks like a complete tablet in the toilet or in your
stools. This is normal – it’s the outer shell of the tablet which is not
digested by the body.
Use in children and adolescents: Nifaditab is 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 Nifaditab than you should
 Get medical help immediately. If possible, take your tablets or the
box with you to show the doctor.
Taking too many tablets 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 Nifaditab
Take your normal dose immediately and continue taking your tablets at
the usual time of day, waiting at least 12 hours before taking the 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

All of these symptoms usually go away when treatment with Nifaditab is
stopped.
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 (see details below). By reporting side effects
you can help provide more information on the safety of this medicine.
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
5) How to store Nifaditab

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 lifethreatening shock (e.g. difficulty in breathing, drop of blood pressure,
fast pulse), 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.
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 Nifaditab, 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
data)
• stomach pain or distress caused by a mass of foreign material found in
the stomach which may require surgery for removal
• difficulty swallowing
• abdominal pain, caused by obstruction of the gut or ulcers in the gut
• 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

Keep out of the sight and reach of children.
Do not store above 30oC.
Store in original package.
Protect from strong light.
Do not use after the expiry date which is marked on both the outer
carton and on each blister strip of tablets.
• If your medicine becomes discoloured or shows any sign of
deterioration, return it 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) Contents of the pack and other information
What Nifaditab contains
Each prolonged-release tablet contains 30 mg nifedipine.
The other ingredients are: Propylene glycol, cellulose acetate,
hypromellose 3 CPS, hypromellose 5 CPS, hydroxypropylcellulose,
polyethylene oxide, macrogol, magnesium stearate, sodium chloride,
titanium dioxide (E171), black iron oxide (E172) and red iron oxide
(E172).
What Nifaditab looks like and the contents of the pack
Each tablet is pink, round convex prolonged-release tablet with a laser
hole on one side and marked with ‘Adalat 30’
Nifaditab comes in packs of 28 tablets.
Manufactured by
Bayer Pharma AG. D-51368 Leverkusen, Germany, or
Bayer HealthCare AG. D-51368 Leverkusen, Germany.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER, UK.
Repackaged by XXXXXXXXXXXXXXX
PL: 33532/0201
Leaflet dated 16th October 2015
Leaflet coded XXXXXXXXXX

POM

Expand view ⇕

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.

Hide