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ADIPINE XL 60MG TABLETS

Active substance(s): NIFEDIPINE / NIFEDIPINE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Nimodrel® XL 30 mg & 60 mg
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.

What is in this leaflet:
1. What Nimodrel is and what it is used for
2. What you need to know before you take Nimodrel
3. How to take Nimodrel
4. Possible side effects
5. How to store Nimodrel
6. Contents of the pack and other information

1. What Nimodrel is and what it is used for
Nimodrel XL Prolonged Release Tablets contain nifedipine which belongs to a group of medicines called calciumchannel blockers that act on the cardiovascular system (the heart and blood vessels). Nimodrel XL is used to treat
high blood pressure or angina (chest pain). They are called prolonged release tablets because they are
manufactured in a way that allows the nifedipine to be released and slowly absorbed by your body over a period
of several hours.
For high blood pressure: Nimodrel XL 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: Nimodrel XL 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 Nimodrel
Do not take Nimodrel:
• if you are allergic to nifedipine, other calcium-channel blockers (e.g verapamil, diltiazem or felodipine) or
any of the other ingredients in Nimodrel (listed in section 6)
• if you have been told that you have a narrowing (stenosis) of the aortic valve in your heart
• if you have experienced a collapse which was caused by a heart problem (cardiogenic shock), during which
you became breathless, pale and had a cold sweat and dry mouth
• if you get a sudden angina attack. Nimodrel will not help relieve symptoms of angina quickly
• if you have unstable angina
• if you suffer from inflammation of the bowel or intestines (such as Crohn’s disease), oesophageal (gullet)
obstruction or have in the past had an obstruction or narrowing of the intestine
• if you have a liver disease that prevents your liver from working properly
• if you have had a heart attack during the last month or to treat a heart attack
• if you are taking the antibiotic rifampicin (used to treat tuberculosis)
• if your blood pressure continues to rise despite treatment (malignant hypertension)
• if you have a Kock pouch (a type of ileostomy - a surgically constructed intestinal reservoir with an opening
through the abdominal wall) in your gut
Warnings and Precautions:
• if you suffer from low blood pressure and you were prescribed Nimodrel for your angina. Your blood pressure
may be decreased further by this treatment
• if you experience chest pains when you first start taking Nimodrel, contact your doctor immediately. Your
doctor may wish to change your 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 Nimodrel, you should stop breast-feeding before you start to
take this medicine
• if you are diabetic, the treatment for your diabetes may need to be adjusted. If you have any questions
about this, ask your doctor
• if you are receiving kidney dialysis and have very high blood pressure with low blood volume, you might
experience a sudden drop in blood pressure when you take Nimodrel
• 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 Nimodrel
• if you are taking other drugs to treat high blood pressure (e.g. beta-blockers). If you are changing from a
beta-blocker to nifedipine, you should gradually reduce your beta-blocker after discussion with your doctor
• if you are giving a urine sample. Nimodrel 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 notice increased breathlessness
• if you notice swelling of the ankles
• 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 Nimodrel
• if you are male and have been unsuccessful in fathering a child by in vitro fertilisation. Medicines like
Nimodrel have been shown to impair sperm function.
Other medicines
Before starting treatment, tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription. If you have to go to a doctor, dentist or
hospital for any reason, tell them that you are taking Nimodrel. This is especially important if you are likely to
have an anaesthetic or an operation.
In particular, tell your doctor if you are taking:
• other drugs to treat high blood pressure
• cimetidine, to treat stomach ulcers
• digoxin, diltiazem, quinidine, or beta-blockers, used to treat heart conditions
• the antibiotic rifampicin
• combination treatment quinupristin/dalfopristin
• cisapride, a drug used to speed up the movement of food through the gullet and stomach
• magnesium sulphate injections during pregnancy (may cause a severe fall in blood pressure)
• the antibiotics erythromycin, or anti-fungal medicines ketoconazole, itraconazole or fluconazole
• indinavir, nelfinavir, ritonavir, amprenavir or saquinavir, used to treat HIV infection
• the antidepressant drugs fluoxetine and nefazodone
• tacrolimus, an immunosuppressant used to prevent the rejection of transplant organs
• phenytoin, carbamazepine and valproic acid, used for the treatment of epilepsy
• the barbiturate phenobarbital, used primarily to treat insomnia and anxiety
Taking Nimodrel with food and drink
You can take Nimodrel with or without food.
Do not drink grapefruit juice or eat grapefruit while taking Nimodrel.
Do not start taking Nimodrel 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 Nimodrel. 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 Nimodrel 30 contains 24 mg salt (sodium chloride). Tell your doctor if you are on a low-salt diet.
Pregnancy, breast-feeding and fertility
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 Nimodrel but only after special consideration and agreement by your doctor.
Do not take Nimodrel if you are breast-feeding. If you need to take Nimodrel, you should stop breast-feeding
before you start taking this medicine.
Driving and using machines:
If you feel dizzy, faint, extremely tired or have visual disturbances after taking Nimodrel, then do not drive or
operate machinery.
This may be more likely when you first start treatment, if you change tablets, or if you have drunk alcohol.
Nimodrel XL tablets contain Lactose
Nimodrel contains lactose monohydrate. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Nimodrel
Always take Nimodrel exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Please read the back of this leaflet



Adults and the Elderly:
• Dose for high blood pressure: the recommended 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 Nimodrel XL 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: Nimodrel XL 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 Nimodrel than you should
If you accidentally take more Nimodrel than you should, contact your nearest casualty department immediately.
Remember to take the pack and any remaining tablets with you.
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 Nimodrel
Do not worry. Simply leave out that dose completely and then take your next dose at the right time. Do not
take a double dose to make up for a missed dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Nimodrel can cause side effects, although not everyone gets them.
Allergic reactions, although serious, have been reported in rare cases. If you experience any of the following,
contact your doctor or casualty department immediately and do not take the next dose:
• severe, sudden generalised allergic reaction including very rarely life-threatening 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 life-threatening outcome)
• fast heart beat (tachycardia)
• itching (possibly severe), rash, hives or skin redness affecting your whole body
• mild to moderate allergic reactions
• wheezing or breathing difficulties
• skin reaction or blistering/peeling of the skin and/or mucosal reactions (in the mouth/nose or at the
penis/vagina) (Toxic Epidermal Necrolysis)
• yellowing of the whites of the eyes or skin (jaundice)
• a more severe decrease in a specific class of white blood cell (agranulocytosis)
If you experience chest pains when you first start taking Nimodrel, contact your doctor immediately.
The following side effects have also been reported, if you do experience any of these side effects they will
usually go away when treatment is stopped.
Common (may affect up to 1 in 10 people):
• headache
• flushing
• general feeling of being unwell
• constipation
• swelling, particularly of the ankles and legs.
Uncommon (may affect up to 1 in 100 people):
• stomach pain (abdominal pain)
• unspecific pain
• chills
• low blood pressure when rising to the standing position (symptoms include fainting, dizziness, light
headedness, occasional palpitations, blurred vision and sometimes confusion)
• fainting
• irregular heartbeat (palpitations)
• a 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
• an increased need to urinate
• painful or difficult urination
• inability to achieve or maintain an erection (impotence)
• blurred vision
• temporary increase in certain liver enzymes
Rare (may affect up to 1 in 1,000 people):
• pins and needles
• inflammation of the gums
• tender or swollen gums which may bleed
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
The development of breast tissue in older men on long term therapy and heart attacks have also been reported.
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.
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 YellowCard 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 Nimodrel





Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Keep the blister in the outer carton.
Do not use Nimodrel after the expiry date which is stated on the blister and carton. The expiry date refers to
the last day of that month.
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 protect the environment.

6. Contents of the pack and other information
What Nimodrel contains:
• The active substance is nifedipine.
• The other ingredients are povidone K30, lactose monohydrate, talc, hypromellose (E464), magnesium
stearate, carbomer 974P, colloidal anhydrous silica, macrogol 4000, dimethylaminoethyl methacrylate-butyl
methacrylate-methyl methacrylate copolymer, red iron oxide (E172) and titanium dioixide (E171).
What Nimodrel look like and the contents of the pack:
Nimodrel XL 30 mg and 60 mg Prolonged Release Tablets are pale red with a round and biconvex shape, marked
on one side with “30” or “60” respectively. They are available in calendar blister packs of 28 tablets.
Marketing Authorisation Holder and Manufacturer.
The Marketing Authorisation holder and manufacturer is Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, UK.

Is this leaflet hard to see or read? Phone 0161 488 5555 for help.
This leaflet was last revised in 05/2017

Expand Transcript

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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