PACKAGE LEAFLET: INFORMATION FOR THE USER
AdipineTM MR 10 and AdipineTM MR 20 modified release tablets
Active substance: nifedipine
Read all of this leaflet carefully before you start taking this medicine.
- 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What AdipineTM MR is and what it is used for
2. Before you take AdipineTM MR
3. How to take AdipineTM MR
4. Possible side effects
5. How to store AdipineTM MR
6. Further information
1. What AdipineTM MR is and what it is used for
AdipineTM MR contains the active substance nifedipine, which belongs to a group of medicines called calcium channel blockers (calcium antagonists).
Nifedipine lowers blood pressure by relaxing the blood vessels. It does this by blocking calcium channels in the muscle cells of the heart and blood
vessels, which leads to less muscle contraction.
AdipineTM MR is used to:
- treat high blood pressure (hypertension)
- prevent angina pectoris (a heart condition due to a lack of blood and hence oxygen supply to the heart muscle).
2. Before you take AdipineTM MR
DO NOT use AdipineTM MR
- If you are allergic (hypersensitive) to
- the active substance nifedipine
- any other medicine which belongs to the same group called dihydropyridines (such as amlodipine, felodipine, nicardipine, lercanidipine)
- any of the other ingredients of AdipineTM MR(see section 6. “Further information” at the end of this leaflet).
- If you are pregnant
- If you are taking an antibiotic called rifampicin (to treat bacterial infections).
- If you suffer from any of the following medical conditions:
- severe narrowing of the aortic valve (one of the valves of the heart)
- angina attacks of increased frequency or severity
- heart related shock or heart failure
- very low blood pressure.
- If you have had a heart attack within the last month or if you suspect that you are having a heart attack. AdipineTM MR should not be used to prevent a heart attack or to treat acute attacks of angina.
Take special care with AdipineTM MR
Please tell your doctor if you have or have had any medical conditions or illnesses, especially any of the following:
- liver problems
- diabetes: If you are diabetic, changes to your diabetic medication may become necessary during the treatment with AdipineTM MR.
The use of AdipineTM MR is not recommended if you suffer from malignant hypertension (very high blood pressure followed by organ damage in the eyes, brain, lungs and/or kidneys). Ask your doctor for further advice if this applies to you.
Whilst taking AdipineTM MR, you should have your blood pressure checked regularly, as your treatment may need to be adjusted.
Children and adolescents
Children and adolescents should not use AdipineTM MR.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines, herbal remedies, health foods or supplements that you have obtained without a prescription.
You must NOT take rifampicin (used to treat bacterial infections) together with AdipineTM MR.
Before starting treatment, you should remind your doctor about any other medicines you may be taking, particularly:
- medicines to treat high blood pressure (such as beta-blockers)
- medicines to treat angina pectoris (such as nitrates)
- medicines to treat abnormal heart beats (including amiodarone and quinidine)
- digoxin, also known as digitalis (to treat heart conditions)
- tricyclic antidepressants, such as imipramine (to treat depression)
- anti-asthma drugs (theophylline)
- anti-ulcer medicines (cimetidine and ranitidine)
Taking AdipineTM MR with food and drink
You should not drink grapefruit juice during treatment with AdipineTM MR. Grapefruit may enhance the effect of the medicine by raising the blood levels of nifedipine.
You should take the tablets before meals.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Please tell your doctor if you are or think you may be pregnant or if you are planning to become pregnant.
Pregnancy
You must not take AdipineTM MR during pregnancy.
Breast-feeding
Nifedipine is passed into the mother’s milk. You must not take AdipineTM MR if you are breast-feeding. If treatment withAdipineTM MR is necessary during breast-feeding, you should wean.
Driving and using machines
You should be very careful about driving or operating machinery. Your ability to drive or use machines may be impaired especially at the start of therapy, when switching medications or in combination with alcohol.
Important information about some of the ingredients of AdipineTM MR
AdipineTM MR contains milk sugar (lactose). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take AdipineTM MR
Always take AdipineTM MR exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
You should swallow the tablets whole with some water (but NOT grapefruit juice) before meals if possible.
Do not bite, chew or break up the tablets. The length of treatment will be determined by your doctor.
The interval between individual doses should be 4 hours or more.
Adults
Unless otherwise specified, the usual starting dose is 10mg AdipineTM MR every 12 hours. This may be increased to 40mg every 12 hours if necessary. Your doctor may change the dose according to your response to the treatment.
Elderly
Elderly patients may require lower doses of AdipineTM MR.
Please ask your doctor for advice.
Patients with impaired liver function
If you suffer from any liver problems, your doctor should monitor you carefully during treatment with AdipineTM MR.
Patients with impaired kidney function
In general, no dose adjustment is required for this patient group.
Children and adolescents
AdipineTM MR 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 AdipineTM MR than you should
If you take too many tablets, contact your doctor or nearest hospital casualty department immediately for advice.
The symptoms of overdosage include for example:
- loss of awareness possibly leading to coma
- a fall in blood pressure
- fast heart beat (tachycardia)
- lower heart beat (bradycardia)
- high blood sugar level (hyperglycaemia)
If you forget to take AdipineTM MR
- more than 4 hours before the usual time of your next dose: take the missed dose.
- less than 4 hours before the usual time of your next dose: do not take the missed medicine and wait until your next dose is due.
Never take a double dose to make up for the missed dose.
If you stop taking AdipineTM MR
High blood pressure and angina pectoris require long term treatment. Your doctor will monitor your progress and determine the duration of your treatment. If you wish to stop taking these tablets temporarily or permanently, you should consult your doctor. It is important to reduce the dose gradually, especially if you have been taking high doses.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, AdipineTM MR can cause side effects, although not everybody gets them. For the assessment of the side effects the following frequency rating was used:
The following side effects have been observed in patients treated with nifedipine. The frequency cannot be estimated from available data:
- worsening of angina pectoris
- headaches
- flushing or reddening of the skin associated with a feeling of warmth (erythema, erythromelalgia)
- heart attack
- fast heart beat (tachycardia)
- feeling the heart beats (palpitations)
- tiredness (fatigue)
- dizziness (vertigo)
- swelling of the lower legs due to fluid retention (oedema)
- tingling sensation in the arms or legs (paraesthesia)
- a drop in blood pressure (hypotension)
- gastrointestinal complaints such as diarrhoea, feeling sick (nausea), a feeling of fullness
- allergic skin reactions (e.g. itching, hives, rashes), and in individual cases inflammation and peeling of the skin (exfoliative dermatitis)
- changes in the number of blood cells, the symptoms are:
- fever or chills, sore throat, ulcers in the mouth or throat, unusual tiredness or weakness. This can indicate a reduction in the number of red (anaemia) and white (leucopenia) blood cells.
- unexplained bruises and unusual bleeding. Tell your doctor if you notice any of these symptoms. This can indicate a reduction in the
number of platelets which help the blood to clot (thrombopenia, thrombocytic purpura).
- swelling of the breasts, especially in elderly
- swelling of the gums
- impairment of the liver function, including:
- stoppage in the flow of bile (gall) from the liver to the gut
- increase of some liver enzymes (transaminases)
- stiffness, finger trembling (tremor)
- minor temporary eye disturbances
- increase in the blood sugar (hyperglycaemia). This should be taken into account in patients with diabetes.
Patients who are on haemodialysis and have a very high blood pressure (malignant hypertension) and a low blood volume may have a marked drop in their blood pressure. During the first weeks of therapy, daily urine volume may be increased.
In patients with kidney impairment, the kidney function may temporarily worsen.
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.
5. How to store AdipineTM MR
Keep out of the reach and sight of children.
Store in the original package in a cool, dry place below 25°C.
Nifedipine is light-sensitive. Once you remove the tablets from the packaging, you should not expose them to intensive light for prolonged periods of time.
Do not take AdipineTM MR after the expiry date which is stated on the package after EXP. 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 to protect the environment.
6. Further information
What AdipineTM MR contains
The active substance is nifedipine.
Each AdipineTM MR 10 tablet contains 10 mg of nifedipine.
Each AdipineTM MR 20 tablet contains 20 mg of nifedipine.
The other ingredients are:
lactose, microcrystalline cellulose, macrogol 6000, magnesium stearate, maize starch, hydroxypropylmethyl cellulose, polysorbate 80 (tween 80), talc,
titanium dioxide (E171), red iron oxide (E172).
What AdipineTM MR looks like and contents of the pack
AdipineTM MR 10 and AdipineTM MR 20 modified release tablets are pink-coated round, slightly biconvex tablets with smooth surface.
AdipineTM MR 10 and AdipineTM MR 20 are available in packs containing 10, 20, 30, 50, 56, 60 or 100 tablets.
Blister packages are made of aluminium foil and PVC film.
Not all packaging sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Distributor
Chiesi Limited
Cheadle Royal Business Park
Highfield
Cheadle
SK8 3GY
UK
