Neozipine Xl 30 Mg Prolonged-Release Tablets
CXP089FUB
Package leaflet: Information for the Patient
NEOZIPINE XL 30mg & 60mg PROLONGED-RELEASE TABLETS
(nifedipine)
The name of this medicine is Neozipine XL Prolonged-Release Tablets (nifedipine), which will be referred to as Neozipine XL throughout this
leaflet.
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 your 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 the leaflet. See Section 4.
WHAT IS IN THIS LEAFLET
1. What Neozipine XL are and what they are used for
2. What you need to know before you take Neozipine XL
3. How to take Neozipine XL
4. Possible side effects
5. How to store Neozipine XL
6. Contents of the pack and other information
Neozipine 30 & 60mg Leaflet
WHAT NEOZIPINE XL ARE AND WHAT THEY ARE USED FOR
The active ingredient in your tablets is nifedipine, which belongs to a group of medicines called calcium channel blockers. These work by relaxing blood vessels, so that blood passes through them more easily.
Neozipine XL is used to treat high blood pressure (hypertension) or angina (a painful condition where there is a lack of blood and oxygen to the heart).
If you have angina, you may get chest pains when your heart cannot get enough blood. This usually happens during exercise or stress. Nifedipine helps to prevent this by increasing the blood supply to the heart. The tablets do not work immediately to stop the chest pain from angina.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEOZIPINE XL
Do not take Neozipine XL if you:
• are allergic (hypersensitive) to nifedipine, other calcium channel blockers, or any of the other ingredients in the tablets (these are listed in section 6, Contents of the pack and other information)
• are pregnant, planning to become pregnant or you suspect you are pregnant
• have had a heart attack (myocardial infarction) within the last 4 weeks
• have or have previously had any heart problems
• are taking the antibiotic rifampicin (used to treat some bacterial infections)
• If you have liver disease
• If you have a sudden angina attack, Neozipine XL will not help to relieve these symptoms quickly.
• If your blood pressure continues to rise even though you are being treated (malignant hypertension)
• If you have a ‘Kock pouch' (a surgically constructed intestinal reservoir with an opening through the abdominal wall) in your gut.
• If you have inflammatory bowel disease or Crohn's disease
• If you have ever had an obstruction in your intestine and gullet (tube connecting your throat to your stomach)
Warnings and Precautions
Talk to your doctor or pharmacist before taking Neozipine XL if you:
• have blood flow problems to the fingers and/or toes caused by a narrowing of the blood vessels
• suffer from heart failure, any heart problems or chest pains or if your chest pain gets worse after taking Neozipine XL
• have or have previously had any stomach or gut problems (such as inflammation of the intestines - Crohn's disease, diarrhoea, any kind of obstruction of the stomach or gut or you have had a surgical operation to your stomach or gut).
• are trying to father a child by in vitro fertilization (IVF) - calcium channel blockers have been linked with impaired sperm function
• have low blood pressure (hypotension)
• have diabetes - the treatment for your diabetes may need to be adjusted
• have a condition known as malignant hypertension (where your blood pressure continues to rise despite treatment)
• have liver disease or any liver problems - it may be necessary for your doctor to prescribe you a lower dosage of these tablets
• receive kidney dialysis as you may possibly experience a marked drop in blood pressure
• If you are pregnant
• If you are breastfeeding, you should stop breastfeeding before you start taking this medication
You should not use these tablets to treat an angina attack when it occurs, but rather to reduce the frequency of the angina you experience over time.
A false positive effect may be experienced when performing a barium contrast x-ray.
Other medicines and Neozipine XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any of the following medicines.
• rifampicin (for the treatment of some bacterial infections) -(see section “Do Not Take Neozipine XL”)
• cimetidine (for the treatment of stomach ulcers)
• digoxin, diltiazem, or beta-blockers (medicines used to treat heart conditions)
• other medicines to treat high blood pressure
• phenytoin, carbamazepine or valproic acid (for the treatment of epilepsy)
• cisapride (for the treatment of night-time heartburn)
• diuretics (water tablets)
• quinupristin/dalfopristin, erythromycin, ketoconazole, itraconazole or fluconazole (antibiotics or antifungals)
• tacrolimus (an immunosuppressant used to prevent the rejection of transplant organs)
• fluoxetine or nefazodone (for the treatment of depression)
• indinavir, nelfinavir, ritonavir or saquinavir (used to treat HIV infection)
• phenobarbital (used to treat insomnia and anxiety)
• quinidine, used to treat some heart rhythm problems or muscle cramps
You should tell your doctor that you are taking Neozipine XL if you need to have magnesium sulphate infusions.
It may still be alright for you to take Neozipine XL and your doctor will be able to decide what is suitable for you. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Neozipine XL with food and drink
It is recommended that your tablets should be taken with a glass of water with or without food. Grapefruit juice can affect the amount of Neozipine XL (nifedipine) in the blood: therefore patients should not consume grapefruit or grapefruit juice during treatment with this medicine.
Pregnancy and breast-feeding
Do not take this medicine if you are pregnant, likely to become pregnant or suspect you are pregnant. Do not take this medicine if you are breast-feeding, tell your doctor who will advise you.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
These tablets may cause dizziness, tiredness, headaches, feelings of sickness and slowed or impaired reaction times. Additionally, a large drop in blood pressure may, very rarely, result in visual disturbances. These symptoms may occur at the beginning of treatment, after a change in medication or usage with alcohol. If you are affected by any of these symptoms do not drive or operate machines and check with your doctor or pharmacist.
Neozipine XL contains Lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Method of administration
Your tablets should be swallowed whole with a glass of water. The tablets should be taken regularly in the morning with or without food. Patients should not consume grapefruit juice during treatment with this medicine. These tablets should not be bitten, chewed or crushed.
Hypertension
The recommended starting dose is a 20mg tablet once a day. This may be increased according to individual requirements up to a maximum of 90mg once a day.
If you take more Neozipine XL than you should
If you have accidentally taken more than the prescribed dose, contact your nearest hospital casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you. The most common signs and symptoms of overdose are a fall in blood pressure, feeling sick (nausea), vomiting, headache, red spots on the face 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 Neozipine XL
It is important that you take your medicine every day. However, if you forget to take one or more doses, take your next dose when it is due and then go on as prescribed. 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 or pharmacist.
. POSSIBLE SIDE EFFECTS
. HOW TO TAKE NEOZIPINE XL
Always take your tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The label on the carton will tell you how many tablets you should take and when.
Your doctor will decide on the right starting dose for you and on any increase in the dose depending on your condition and whether you are taking any other medicines. Do not change your dose unless your doctor tells you to do so.
If you have already had a heart attack, you should not use these tablets for preventing further heart attacks.
If you experience chest pains after you take your first dose, you should stop taking the medicine and contact your doctor as soon as possible.
If you have a urine test, tell your doctor that you are taking these tablets, as this medicine can affect the result.
Dosage
The recommended dose for Neozipine XL is:
Angina
The recommended starting dose is one 30mg tablet once a day. This may be increased by your doctor to 90mg once a day if necessary.
Neozipine XL is not recommended for children or adolescents under 18 years of age.
Like all medicines, Neozipine XL can cause side effects, although not everybody gets them. If you get any of the following symptoms after taking these tablets you should stop taking Neozipine XL tablets and contact your doctor or pharmacist immediately:
• any sudden wheeziness, difficulty in breathing or dizziness, swelling around the eyes, face, lips or throat
• peeling and blistering of the skin anywhere
• rash affecting your whole body
A small number of patients have had an increase in anginal (heart) pain at the start of treatment. If this happens you should stop taking your tablets and contact your doctor as soon as possible.
The following side effects have also been reported:
Very common side effects (affecting more than 1 in 10 people)
• swelling of the legs and ankles; flushing of the face or larynx
• headache
• giddiness; light headedness
• feeling of pressure in the head
Common side effects (affecting up to 1 in 10 people)
• low blood pressure (you may feel faint especially on standing up)
• worsening of heart failure causing shortness of breath
• worsening of angina (pain in the chest)
• more rapid heart beat than usual or irregular heart beat
• constipation
• feeling sick (nausea)
• tiredness (fatigue)
• dizziness
• feeling unwell
Uncommon side effects (affecting fewer than 1 in 100 people)
• abnormal heart beat (arrhythmias)
• finger twitching, pins and needles; numbness of fingers or toes
• worsening circulation in the fingers or toes if you have Raynaud's disease
• eye pain and temporary disturbance of vision
• shaking
• fever and general feeling of being unwell, particularly when starting treatment
• symptoms of heart burn (oesophageal reflux) if you already suffer from systemic sclerosis - your doctor will tell you if you have this condition
• inflammation of the liver (hepatitis)
• problems with the lining of the womb
• sleep disorders
• anxiety reactions
• Migraine
• vertigo
• nosebleed, nasal congestion
• flatulence
• dry mouth
• joint swelling
• increase in liver enzymes
• erectile dysfunction
• gastro or abdominal pain
• indigestion
• allergic reaction
• unspecified pain
• chills
• Redness of the skin (erythema)
• Frequent urination
• Pain or discomfort when urinating
Rare side effects (affecting fewer than 1 in 1000 people)
• skin rash
• muscle cramps
• Itchy skin
• swelling or soreness of the gums
• discomfort or pain from touch to the skin by normal stimuli, including clothing (dysaesthesia)
• build up of foreign material in the stomach which might need removal. Symptoms may include a feeling of fullness, feeling sick (nausea), being sick (vomiting), pain and some bleeding may occur.
• development of breast tissue in older men (gynaecomastia)
Very rare side effects (affecting fewer than 1 in 10,000 people)
• bedwetting;
• temporary loss of consciousness
• depression
• increased sensitivity of the skin to sunlight
• tinnitus (ringing in the ears) and swelling in the eyes
• difficulty in breathing (due to fluid build-up on the lungs)
• certain blood disorders which may increase the risk of bleeding, bruising or infections
• allergic reactions and serious skin hives leading to blistering or peeling of the skin
• temporary worsening of kidney function in patients with chronic kidney problems
• heart block (symptoms include frequent fainting, light headedness and palpitations)
Not known (cannot be estimated from the available data)
• a reduction in the number of white blood cells (agranulocytosis, leucopenia)
• increased blood sugar (hyperglycaemia)
• decreased skin sensitivity (hypoaesthesia)
• drowsiness (somnolence)
• chest pain (angina pectoris)
• liver problems such as jaundice (yellowing of the skin and eyes)
• small raised areas of bleeding in the skin (palpable purpura)
• breathlessness or difficulty breathing (dyspnoea)
• joint and muscle pain (arthralgia, myalgia)
• difficulty swallowing
• vomiting
• Stomach ulcer or stomach obstruction
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.
. HOW TO STORE NEOZIPINE XL
Keep all medicines out of the sight and reach of children.
Store your tablets in the original package.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
. CONTENTS OF THE PACK AND OTHER INFORMATION
What Neozipine XL contain:
The active ingredient is nifedipine. Each tablet contains 30mg or 60mg of nifedipine.
The other ingredients are carbomer, colloidal silicon dioxide (E551), hypromellose (E464), lactose monohydrate, magnesium stearate (E572), methacrylic acid copolymer, macrogol, povidone (E1201), red iron oxide (E172), talc (E553b) titanium dioxide (E171).
What Neozipine XL looks like and the contents of the pack:
Neozipine XL 30mg and 60mg Prolonged-Release Tablets are round, biconvex tablets, pale red in colour. Your medicine is available in calendar packs of 28 tablets (2 blisters of 14 tablets each).
Manufacturing Authorisation Holder:
Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire, NN8 6GT, UK.
Manufacturer responsible for batch release:
Kent Pharmaceuticals Limited, Crowbridge Road, Ashford, Kent, TN24 0GR, U.K.
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.
This leaflet was last revised in November 2015.
CXP089FUB
Customer: Originated by: (AWG) TC
Product: Neozipine 30mg and 60mg Tablets Dimensions: 200mm x 390mm Item Code: CXP089FUB Date: 11/11/2015
Revision: SAFETY VARIATION
ARTWORK FOR SUBMISSION Supersedes: n/a
