1. What Adipine is and what it is used for
Adipine XL Prolonged Release Tablets contain nifedipine which belongs to a group of medicines called calcium-channel blockers that act on the cardiovascular system (the heart and blood vessels). Adipine has been prescribed by your doctor to treat your high blood pressure or to reduce the frequency of your anginal attacks. 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.
In high blood pressure, nifedipine works by widening the blood vessels. This creates less resistance to the blood flow, and results in lower blood pressure, which in turn reduces the strain on your heart.
In angina, nifedipine works by opening up the arteries supplying the heart muscle and this allows more blood and oxygen to reach the muscle, decreasing the chances of angina (chest pains) occurring when extra strain is placed upon the heart.
2. Before you take Adipine
Do not take Adipine:
- if you are allergic to nifedipine, other calcium-channel blockers (e.g verapamil, diltiazem or felodipine) or any of the other ingredients in Adipine
- if you are pregnant, likely to become pregnant or are breast-feeding
- 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)
- if the severity or frequency of your angina has rapidly worsened over a matter of hours or days
- to treat an angina attack as it occurs, but rather to reduce the frequency of the angina you experience over time
- 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
- 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)
Take special care with Adipine and always tell your doctor if:
- you suffer from low blood pressure
- you experience chest pains when you first start taking Adipine, contact your doctor immediately
- you are diabetic, the treatment for your diabetes may need to be adjusted
- you are receiving kidney dialysis and have very high blood pressure with low blood volume
- 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
- you have to give a urine sample, have an barium contrast x-ray or undergo surgery
- you are male and have been unsuccessful in fathering a child by in vitro fertilisation. Medicines like Adipine have been shown to impair sperm function.
Your doctor may, under certain conditions, think it necessary to keep you on Adipine whilst you are pregnant. If this is the case particular care must be taken if you are also having magnesium sulphate injections.
Taking 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 Adipine. 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 anti-epileptic drug phenytoin
- the antibiotic rifampicin
- combination treatment quinupristin/dalfopristin
- cisapride, a drug used to speed up the movement of food through the gullet and stomach
The effect of the following drugs on Adipine is uncertain. Therefore, as an additional precaution, please tell your doctor if you are taking:
- the antibiotics erythromycin, ketoconazole, itraconazole or fluconazole
- indinavir, nelfinavir, ritonavir or saquinavir, used to treat HIV infection
- the antidepressant drugs fluoxetine and nefazodone
- tacrolimus, an immunosuppressant used to prevent the rejection of transplant organs
- carbamazepine and valproic acid, used for the treatment of epilepsy
- the barbiturate phenobarbital, used primarily to treat insomnia and anxiety
Taking Adipine with food and drink
Do not drink grapefruit juice at the same time or soon after taking Adipine because grapefruit juice can increase the blood levels of nifedipine.
Pregnancy and breast-feeding
Do not take Adipine if you are pregnant, trying to become pregnant or are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines:
If you feel dizzy or extremely tired after taking Adipine, then do not drive or operate machinery.
Important information about some of the ingredients of Adipine
Adipine 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 Adipine
Always take Adipine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Adipine is formulated so that you only have to take your tablets once a day. It is important that you take your tablets at the same time each day, preferably in the morning. Your tablet must be swallowed whole with a glass of water and not with grapefruit juice. Do not break or chew your tablets.
Adults:
The usual adult dose for treating high blood pressure or preventing angina is 30 mg or 60 mg once a day. Your doctor may decide to increase your dose to a maximum of 90 mg of Adipine once a day.
If you are elderly, lower doses of this medicine may be prescribed by your doctor.
Do not stop taking your medicine until your doctor tells you.
Children:
Adipine 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 Adipine than you should
If you accidentally take more Adipine than you should, contact your nearest casualty department immediately. Remember to take the pack and any remaining tablets with you.
If you forget to take Adipine
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, Adipine can cause side effects, although not everyone gets them.
- rash or skin redness affecting your whole body
- swelling of the face, lips and tongue
- wheezing or breathing difficulties
- fever
- yellowing of the skin and whites of the eyes
Allergic reactions, although serious, have been reported in rare cases. If you experience any of the following, contact your doctor or casualty department immediately:
If you experience chest pains when you first start taking Adipine, 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 (affecting less than 1 in 10 people):
- headache
- an irregular heartbeat
- flushing
- general weakness or loss of strength and energy
- constipation
- dizziness
- swelling, particularly of the ankles and legs.
Uncommon (affecting less than 1 in 100 people):
- pain, particularly in the stomach area, chest and legs
- general feeling of being unwell
- low blood pressure when rising to the standing position
- fainting
- a fast heart beat
- diarrhoea
- a dry mouth
- indigestion
- wind
- feeling sick
- leg cramps
- sleep disorders
- nervousness
- drowsiness
- pins and needles
- dizziness
- difficulty in breathing
- itching
- rash
- passing large volumes of urine
- an increased need to urinate at night
Rare (affecting less than 1 in 1,000 people):
- allergic reactions (described above)
- an allergic inflammation of the liver causing rash, fever or yellowing of the skin and whites of the eyes
- chills
- chest pains
- swelling of the face, lips and tongue
- fever
- problems with your circulatory system
- loss of appetite
- belching
- problems with your gut
- inflammation of the gums
- tender or swollen gums which may bleed
- blood tests which show changes in the way the liver is working
- vomiting
- problems with your joints that may be painful
- muscle pain
- increased sensitivity of the skin (particularly to touch)
- trembling
- mood changes
- nose bleeds
- lumpy, itchy red rash that appears on the body, lips, eyes, or tongue
- sweating
- problems with the eyes that may be painful or cause blurred vision
- pain, discomfort or burning sensation when passing urine
- failure to achieve or maintain an erection
Very rare (affecting less than 1 in 10,000 people):
- severe allergic reaction (described above)
- a mass of foreign material found in the stomach
- difficulty swallowing
- inflammation of the gullet
- problems with the gums
- obstruction of the gut
- ulcers in the gut
- yellowing of the skin or whites of the eyes caused by liver or blood problems
- signs of infection e.g. unexplained fever due to low levels of white blood cells
- weight loss
- muscle cramps
- skin flaking
- red or purple discolourations on the skin
- blistering of the skin when exposed to sunlight
- too much sugar in the blood, resulting in increased thirst, frequent urination, weight loss and tiredness.
- blurred vision
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.
6. Further information
What Adipine 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 Adipine look like and the contents of the pack:
Adipine 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 Pharmaceuticals Limited
Cheadle Royal Business Park
Highfield
Cheadle
SK8 3GY
UK
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