Innozide 20/12.5mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
INNOZIDE 20/12.5mg TABLETS (enalapril maleate/hydrochlorothiazide)
Your medicine is known as Innozide 20/12.5mg Tablets but will be referred to as Innozide throughout the following leaflet.
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may want 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Innozide is and what it is used for
2. Before you take Innozide
3. How to take Innozide
4. Possible side effects
5. How to store Innozide
6. Further information
Innozide contains enalapril maleate and hydrochlorothiazide:
• enalapril belongs to a group of medicines known as ACE inhibitors, which work by widening your blood vessels
• hydrochlorothiazide belongs to a group of medicines known as water tablets (diuretics), which increase the volume of urine you produce.
The effect of these medicines is to lower your blood pressure. Innozide is used to treat high blood pressure (hypertension). Taking both medicines that Innozide contains can increase their effect compared to taking just one.
Do not take Innozide if:
• you have ever had an allergic reaction to Innozide, a similar medicine or to any of the ingredients (listed in Section 6). The signs may have been itching, nettle rash, wheezing or swelling of your hands, throat, mouth or eyelids
• you are allergic to a type of medicine called ‘sulphonamides'
• you are more than 3 months pregnant. (It is also better to avoid ‘Innozide' in early pregnancy - see pregnancy section.)
• you are not passing urine
• you have a condition know as renal artery stenosis (narrowing of the arteries that supply the blood to your kidneys)
• you have severe kidney or liver problems
Do not take Innozide if any of the above apply to you. If you are not
sure, talk to your doctor or pharmacist before taking Innozide.
Take special care with Innozide
Check with your doctor or pharmacist before taking your medicine
if:
• you have kidney problems, have had a recent kidney transplantation, are a dialysis patient, or are taking water tablets (diuretics)
• you have blood disorders or liver problems
• you are on a salt restricted diet, or have suffered from excessive vomiting or diarrhoea recently
• you have a heart condition called ‘aortic stenosis', ‘hypertrophic cardiomyopathy' or ‘outflow obstruction'
• you have collagen vascular disease, are taking immunosuppressant therapy (used for the treatment of autoimmune disorders such as rheumatoid arthritis or following transplant surgery)
• you are taking allopurinol, (used for the treatment of gout), or procainamide, (used to treat abnormal heart rhythms). If you develop an infection (symptoms may be high temperature or fever), you should let your doctor know immediately. Your doctor may take a blood sample from time to time to check your white blood cell count
• you have a history of ‘angioedema' while taking other medicines. The signs may have been itching, nettle rash, wheezing or swelling of your hands, throat, mouth or eyelids
• you have diabetes and are taking antidiabetic medicines, including insulin to control your diabetes (you should monitor your blood for low blood glucose levels, especially during the first month of treatment)
• you are taking potassium supplements or potassium containing salt substitutes
• you are taking lithium, used for the treatment of some psychiatric illnesses
• you have been told by your doctor that you have an intolerance to some sugars.
• You must tell your doctor if you think you are (or might become) pregnant. Innozide is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).
If you are about to have any of the following procedures, you should tell your doctor who is treating you that you are taking Innozide:
• any surgery or receive anaesthetics (even at the dentist)
• a treatment called LDL apheresis, to remove cholesterol from your blood using a machine
• desensitisation treatment, to reduce the effect of an allergy to bee or wasp stings.
Routine tests
When you first start to take Innozide, your doctor will monitor your blood pressure frequently to ensure you have been given the correct dose. In addition, for some patients the doctor may want to do some tests to measure your potassium, sodium, magnesium, creatinine and liver enzyme levels.
Tell you doctor if you have or will take an anti-doping test since this medication can produce a positive result.
Children
Innozide is not recommended for use in children.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription as some drugs may affect each other's action. This includes herbal medicines. Also some other medicines can affect the way Innozide work:
• potassium sparing water tablets (diuretics) such as spironolactone, eplerenone, triamterene or amiloride, potassium supplements, or potassium-containing salt substitutes. Innozide may increase the levels of potassium in your blood leading to high potassium levels. This causes few signs and is usually seen by a test
• water tablets (diuretics) such as thiazides, furosemide, bumetanide
• other medicines that lower blood pressure, such as nitroglycerine, nitrates, and vasodilators
• lithium, used for the treatment of some psychiatric illnesses. Innozide should not be taken with this drug
• barbiturates (sedatives used for sleeplessness or epilepsy)
• tricyclic antidepressants such as amitriptyline, used for depression, antipsychotics such as phenothiazines, used for severe anxiety
• pain killers such as morphine or anaesthetics, because your blood pressure may become too low
• cholestyramine or colestipol (used to help control cholesterol levels)
• medicines used for, stiffness and inflammation associated with painful conditions, particularly those affecting your muscles, bones and joints:
- including gold therapy which can lead to flushing of your face, feeling sick (nausea), vomiting and low blood pressure, when taken with Innozide, and
- non-steroidal anti-inflammatory drugs (NSAIDs), for example diflunisal or diclofenac. They may prevent your blood pressure from being well controlled and may increase the level of potassium in your blood
• medicines such as ephedrine, used in some cough and cold remedies, or noradrenaline and adrenaline used for low blood pressure, shock, cardiac failure, asthma or allergies. If used with Innozide these drugs may keep your blood pressure high
• ACTH ( to test whether your adrenal glands are working properly)
• Corticosteroids (used to treat certain conditions such as rheumatism, arthritis, allergic conditions, asthma or certain blood disorders)
• Allopurinol ( used to treat gout)
• Ciclosporins ( immunosuppressive agents used for autoimmune disorders)
• Medicines for the treatment of cancer
• Antacids ( used for indigestion relief )
• Procainamide, amiodarone or sotalol ( used to treat abnormal heart rhythms)
• Digitalis (used to treat heart rhythm problems)
• Carbenoxalone ( used to treat stomach ulcers)
• Excessive use of laxatives
• antidiabetic medicines such as insulin. Innozide may cause your blood sugar levels to drop even further if you take it with antidiabetics.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Innozide.
Taking Innozide with food and drink
Innozide can be taken with or without food. However, if you drink alcohol while taking Innozide, it may cause your blood pressure to drop too much and you may experience dizziness, lightheadedness or faintness. You should keep your alcohol intake to a minimum.
Pregnancy and breast-feeding Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Innozide before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Innozide. Innozide is not recommended during pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. Innozide is not recommended for mothers who are breastfeeding.
Driving and using machines
Certain side effects, such as dizziness and weariness, have been reported with Innozide which may affect some patients' ability to drive or operate machinery.
Important information about some of the ingredients of Innozide
Innozide contains lactose, which is a type of sugar. It is important to tell your doctor if you suffer from lactose intolerance.
Taking this medicine
• You should take this medicine by mouth.
• Always take Innozide exactly as your doctor told you.
• The number of tablets you take each day will depend upon your condition.
You should check with your doctor or pharmacist if you are not sure.
REMEMBER, this medicine is for you. Do not share it with anyone else. It may not suit them.
The usual dose for many people is:
• One tablet each day.
• Your doctor may increase the dose to two tablets each day.
• Do not take more or less than your doctor has prescribed.
If you take more Innozide than you should
Contact your doctor immediately if you think you have taken more of your tablets than you should. The most common signs and symptoms of an overdose are a fall in blood pressure and stupor (a state of almost complete lack of consciousness). Other symptoms may include dizziness or light-headedness due to a fall in blood pressure, forceful and rapid heartbeat, rapid pulse, anxiety, cough, kidney failure, and rapid breathing.
If you forget to take Innozide
• If you forget to take a tablet, skip the missed dose.
• Take the next dose as usual.
• Do not take a double dose to make up for a forgotten dose.
If you stop taking Innozide
Do not stop taking your medicine, unless your doctor has told you to. If you do your blood pressure may increase. If your blood pressure becomes too high it may affect your heart and kidneys.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
• burning, aching pain with an empty feeling and hunger, particularly when the stomach is empty (caused by a peptic ulcer), excessive sweating, itching, hives (urticaria), hair loss, protein in your urine (usually detected by a test)
• impotence, decreased libido, flushing, ringing in your ears, feeling lethargic, high temperature
• increases in blood urea and decreases in blood sodium levels (usually detected by a test), weakness (malaise)
• low level of magnesium in the blood (hypomagnesemia)
• kidney problems
• joint pain
Rare (affects less than 1 in 1,000 people)
• strange dreams, sleeping problems
• decreases in your white blood cells, red blood cells, platelets, bone marrow depression (all are usually detected by tests)
• swollen glands, autoimmune diseases, low blood flow to your fingers and toes causing redness and pain (Raynaud's), fluid on your lungs, runny or sore nose
• eosinophilic pneumonia (signs may be cough, high temperature and difficulty breathing)
• pain, swelling or ulcers in your mouth, infection or pain and swelling of your tongue, kidney problems such as lower back pain and reduction in the volume of urine you pass
• swollen nasal lining
• difficulty breathing, respiratory distress
• liver failure or hepatitis, this may cause yellowing of your skin (jaundice)
• excessive redness of your skin, blisters, skin peeling off in sheets
• development of breasts in men
• increased liver enzymes or blood ‘bilirubin' (usually detected by a blood test), increases in blood sugar
• muscle weakness, sometimes due to low potassium (paresis)
Very rare (affects less than 1 in 10,000 people)
• intestinal ‘angioedema'. Signs may include stomach pain, feeling sick and vomiting, elevated calcium level in blood
Others (it is unknown how many people may be affected)
A complex side effect has also been reported which may include
some or all of the following signs:
• fever, inflammation of your blood vessels, pain and inflammation of muscles or joints
• blood disorders affecting the components of your blood (usually detected by a blood test)
• rash, hypersensitivity to sunlight and other effects on your skin.
If any of these side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
Like all medicines Innozide can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
It is vital to stop taking Innozide and seek medical attention immediately if you begin to have the following symptom:
• allergic reaction - you may get an itch, short of breath or wheezy and develop swelling of your hands, mouth, throat, face or eyes.
Stop taking Innozide immediately and see your doctor if you have any of the following side effects
• severe dizziness, light-headedness, especially at the start of treatment or when your dose is increased or when you stand up.
Other possible side effects
Very common (affects more than 1 in 10 people)
• blurred vision, cough, feeling sick (nausea), weakness Common (affects less than 1 in 10 people)
• headache, depression, low blood pressure, fainting
• chest pain, heart rhythm changes, angina, fast heart beat, shortness of breath
• diarrhoea, pain around your stomach area (abdomen), changes in taste, fluid retention (oedema), feeling tired
• rash, hypersensitivity/angioneurotic oedema: angioneurotic oedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported
• increased blood potassium level, increases in serum creatinine (both are usually detected by a test); low levels of potassium in the blood, increased levels of cholesterol, increased levels of triglycerides, increased levels of uric acid in the blood
• muscle cramps
Uncommon (affects less than 1 in100 people)
• anaemia, anxiety, a sense of heightened awareness or a shaky feeling (caused by low blood sugar), confusion, feeling sleepy, difficulty sleeping, feeling nervous, tingling or numbness, feeling like you are spinning (vertigo)
• low blood pressure (which may make you feel dizzy when you stand up), racing or uneven heart beats, heart attack or stroke (in high risk patients)
• runny nose, sore throat and hoarseness, difficulty breathing or asthma
• a blockage in your intestine (ileus), pancreatitis, being sick, indigestion, constipation, not feeling like eating properly (anorexia), stomach irritation, dry mouth, flatulence, gout
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not use Innozide after the expiry date which is stated on the carton and blister strip. The expiry date refers to the last day of that month.
• Do not store your tablets above 25°C.
• Store in the original container.
• Do not put them into another container as they might get mixed up.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• 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.
What Innozide contains
• The active ingredients in Innozide are enalapril maleate and hydrochlorothiazide. Each tablet contains 20mg enalapril and 12.5mg hydrochlorothiazide.
• The other ingredients are: lactose monohydrate, maize starch, pregelatinised starch, magnesium stearate, yellow iron oxide (E172) and sodium bicarbonate.
What Innozide looks like and contents of the pack
• Innozide tablets are yellow, fluted shaped tablets marked ‘MSD 718' on one side and scored on the other.
• Innozide is available as calendar blister packs of 28 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by Frosst Iberica, S.A., Via Complutense, 140. 28805 - Alcala de Henares, Madrid, Spain and/or MERCK SHARP DOHME, B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands.
|POM| PL 19488/1328
Leaflet revision date: 31st May 2013
Innozide is a registered trademark of Merck Sharp & Dohme Ltd., UK.
S1328 LEAFLET Innozide 20130531