NEOZIPINE XL 30 MG PROLONGED-RELEASE TABLETS - patient leaflet, side effects, dosage

IS 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.

2

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)
• have had a heart attack (myocardial infarction) within the last 4 weeks
• have a sudden angina attack, Neozipine XL will not help to relieve these symptoms quickly.
• have unstable angina.
• have blood pressure that continues to rise even though you are being treated

( malignant hypertension )

• have been told that you have a narrowing of the aortic heart valve (stenosis).
• 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.
• have liver disease that prevents your liver from working properly
• have ever had an obstruction in your intestine and gullet (tube connecting your throat to your stomach)
• have a ‘Kock pouch’ (a surgically constructed intestinal reservoir with an opening through the abdominal wall) in your gut
• have inflammation of the bowel or intestines, such as Crohn’s disease
• are taking the antibiotic rifampicin (used to treat some bacterial infections)

Warnings and Precautions

Talk to your doctor or pharmacist before taking Neozipine XL if you:

• have low blood pressure (hypotension) and you were prescribed Neozipine XL for your angina. Your blood pressure may be decreased further by this treatment.
• have a heart condition where your heart cannot cope with increased strain (poor cardiac reserve)
• are pregnant or intend to get pregnant
• are breastfeeding, you should stop breastfeeding before you start taking this medication
• have diabetes – the treatment for your diabetes may need to be adjusted
• 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 Neozipine XL.
• know your liver is not working properly. Your doctor may need to do some blood tests. You may be given a lower dosage of these tablets

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 Neozipine XL.
• If you experience chest pains after you take your first dose. Your doctor may wish to change your treatment.
• If you are giving a urine sample. Neozipine XL may interfere with the results of certain urine tests
• If you notice increased breathlessness
• If you notice your ankles become swollen

Also tell your doctor:

• If you are to have a barium contrast x-ray. Neozipine XL may affect the results of the test.
• If you are giving a urine sample. Neozipine XL may interfere with results of certain urine tests.
• If you are trying to father a child by in vitro fertilization (IVF) – calcium channel blockers have been linked with impaired sperm function

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:

• other medicines to treat high blood pressure.
• 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)
• quinupristin/dal­fopristin (a combination antibiotic)
• phenytoin, carbamazepine or valproic acid (for the treatment of epilepsy)
• cisapride (for the treatment of night-time heartburn) diuretics (water tablets)
• magnesium sulphate injections during pregnancy (may cause a severe fall in blood pressure)
• erythromycin (an antibiotic)
• ketoconazole, itraconazole or fluconazole (antifungals)
• indinavir, nelfinavir, ritonavir or saquinavir (used to treat HIV infection)
• fluoxetine or nefazodone (for the treatment of depression)
• tacrolimus (an immunosuppressant used to prevent the rejection of transplant organs)
• phenobarbital (used to treat insomnia and anxiety)

Neozipine XL with food and drink

It is recommended that your tablets should be taken with a glass of water with or without food. Do not start taking Neozopine XL within 3 days of drinking grapefruit or eating grapefruit. Tell your doctor if you have had grapefruit or grapefruit juice in this time. Also, do not drink or eat grapefruit whilst taking Neozipine XL. Grapefruit juice is known to increase the blood levels of the active ingredient nifedipine. This effect can last for at least 3 days.

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 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.

Neozipine XL contains Lactose

If you have been told by your doctor that you have intolerance to some sugars , contact your doctor before taking this medicine.

3. 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.

Dosage: The recommended dose for Neozipine XL is one tablet once a day

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

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. In severe hypertension, the recommended initial dose is one 30mg tablet once-daily. If necessary, the dosage can be increased according to individual requirements up to a maximum of 90mg once-daily.

Neozipine XL is not recommended for children or adolescents under 18 years of age.

Method of administration

Your tablets should be swallowed whole with a glass of water. The tablets should be taken with or without food. The tablets should be taken at approximately 24-hour intervals, i.e. at the same time each day, preferably during the morning. Patients should not consume grapefruit juice during treatment with this medicine. These tablets should not be bitten, chewed or crushed.

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, 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

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 or pharmacist.

4. possible side effects

Like all medicines, Neozipine XL can cause side effects, although not everybody gets them.

Serious side effects

If you notice any of the following symptoms after taking these tablets you should stop taking Neozipine XL Tablets and contact your doctor or pharmacist immediately:

• severe, sudden generalised allergic reaction including very life-threatening shock (e.g. difficulty in breathing, drop of blood pressure, fast pulse), or swelling (including potentially life-threatening swelling of the airways)
• other allergic reactions causing swelling under the skin (possible severe and including swelling of the larynx that may result in life-threatening outcome)
• fast heart beat (tachycardia)
• shortness of breath (frequency not known) or difficulty breathing
• worsening of angina (pain in the chest)
• mild to moderate allergic reactions
• itching (possibly severe), a rash or hives

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.

The following side effects have also been reported:

Common side effects (may affect up to 1 in 10 people)

• constipation
• headache
• flushing
• general feeling of being unwell
• swelling, especially the ankles and legs

Uncommon side effects (may affect up to 1 in 100 people)

• fainting
• irregular heart beat (palpitations)
• abnormal heart beat (arrhythmias)
• low blood pressure when standing up (symptoms include fainting, dizziness, light-headedness, occasional palpitations, blurred vision and sometimes confusion)
• blurred vision
• trembling
• sleep disorders
• anxiety or nervousness
• migraine
• feeling sick (nausea)
• sensation or spinning or whirling motion (vertigo)
• nosebleed
• nasal congestion
• wind (flatulence)
• dry mouth
• joint swelling
• temporary increase in liver enzymes
• erectile dysfunction
• stomach (abdominal pain)
• indigestion or upset stomach
• muscle cramps
• unspecified pain

chills

redness of the skin (erythema)

frequent urination

pain or discomfort when urinating

Rare side effects (may affect up to 1 in 1000 people)

• pins and needles
• inflammation of the gums, tender or swollen gums, bleeding gums

Not known (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
• abdominal pain caused by obstruction or ulcers in the gut
• a reduction in the number of white blood cells (agranulocytosis, leucopenia)
• increased blood sugar (hyperglycaemia)
• decreased skin sensitivity (hypaesthesia)
• drowsiness (somnolence)
• chest pain (angina pectoris)
• 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
• sensitivity to light (photosensitivity allergic reaction)
• eye pain
• heartburn or indigestion (gastroesophageal sphincter insufficiency)

5. 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.

6

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).

Marketing Authorisation Holder:

Kent Pharma UK Limited, The Bower,

4 Roundwood Avenue, Stockley Park, Heathrow, United Kingdom, UB11 1AF.

Manufacturer responsible for batch release:

Kent Pharmaceuticals Ltd, Westminster Industrial Estate, Repton Road, Measham, Swadlincote, Derbyshire, DE12 7DT, United Kingdom.

This leaflet was last revised in August 2020.

CHXP089FUA

Product: Neozipine XL 30mg & 60mg Prolonged-Release Tablets

PL Number: PL 51463/0026–0027

Dimensions: 148mm x 420mm

Colours: Pantone Black C

CHXP089FUA P1

Date: 25 Aug 20