Lisinopril 20 Mg Tablets
rnmrn
MICRO LABS LIMITED
Bangalore, INDIA
|
1) Product |
: Lisinopril Tablets - BBUK |
Colours used |
|
2) Strength |
: 2.5/5/10/20 mg |
Black |
|
3) Component |
: Leaflet | |
|
4) No of colours |
: 1 | |
|
5) Dimension |
: 220 x 360 mm | |
|
6) Artwork Code |
: NA | |
|
7) Pharma code |
: NA | |
|
8) Font type and Size : Arial Narrow, 9pt 9) Technical specification : na |
Colours Not for Printing | Keylines | |
|
WOA Code No. : WA |
NA |
Revision: 00 |
|
Reason for change |
NA |
Date : 01-04-2015 |
Approved
By
Sign/
Date
Contract Giver/ PL holder
Regulatory
Affairs
Packaging
Development
Production Head (Site)
Head Head
QC (Site) QA (Site)
>
Do not take this medicine after the expiry date shown on the label. Any out of date medicines should be returned to your pharmacist for disposal
Do not store Lisinopril Tablets above 25 °C.
Keep out of the reach and sight of children.
Do not use Lisinopril Tablets after the expiry date which is stated on the label/carton. The expiry date refers to the last day of that month.
Do not use Lisinopril Tablets if you notice description of the visible signs of deterioration.
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.
|
lllllllll 3harmacode lllllllll |
PACKAGE LEAFLET: INFORMATION FOR THE USER |
m |
|
Lisinopril 2.5 mg, 5 mg, | ||
|
10 mg and 20 mg Tablets |
BROWN & BURK | |
|
Lisinopril Dihydrate |
What Lisinopril Tablets contains
The active substance is lisinopril dihydrate. Each tablet contains 2.5 mg, 5 mg, 10 mg or 20 mg of the active ingredient.
The other ingredients are mannitol, calcium hydrogen phosphate dihydrate, pregelatinised maize starch, croscarmellose sodium and magnesium stearate. The 10 mg and 20 mg tablets also contain red, black and yellow iron oxide colourings (E172).
What Lisinopril Tablets looks like and contents of the pack
Lisinopril 2.5 mg, 5 mg, 10 mg and 20 mg Tablets are available in packs of 28 or 50*.
Marketing Authorisation Holder and Manufacturer
Brown & Burk UK Ltd 5 Marryat Close Hounslow West Middlesex TW4 5DQ United Kingdom
This leaflet was last approved in 04/2015.
* Only marketed pack sizes will be shown
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 Lisinopril Tablets are and what they used for
2. Before you take Lisinopril Tablets
3. How to take Lisinopril Tablets
4. Possible side effects
5. How to store Lisinopril Tablets
6. Further information
The name of your medicine is Lisinopril Tablets. The active ingredient, Lisinopril, belongs to a group of medicines called angiotensin converting enzyme (ACE) inhibitors which work by widening your blood vessels. This helps reduce blood pressure and also relieves the workload of the heart in patients with heart failure and following a heart attack.
Lisinopril Tablets are useful in the treatment of:
• high blood pressure (hypertension)
• heart failure
• patients who are stable but have had a heart attack within the last 24 hours
BBUK Code Artwork Code
Do not take Lisinopril Tablets
- you are allergic (hypersensitive) to lisinopril, a similar medicine or any of the other ingredients of Lisinopril Tablets (see section 6).Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
- if you are more than 3 months pregnant. (It is also better to avoid Lisinopril in early pregnancy -see pregnancy section).
- if you suffer from swellings, particularly of the hands, feet, face, tongue or throat, that have no apparent cause (angioedema) or if you have an inherited disorder which causes such swellings (hereditary angioedema).
Take special care with Lisinopril Tablets
- if you are (or might become) pregnant. Lisinopril 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 have a narrowing of a valve in the heart (aortic stenosis/outflow obstruction).
- if you have an enlarged heart (hypertrophic cardiomyopathy) or an enlarged right heart ventricle (cor pulmonale),
- if you have had a heart attack,
- if you have low blood pressure,
- if you have kidney problems or narrowing of the artery to the kidney,
- if you are undergoing dialysis treatment,
- if you are on a low salt diet,
- if you have recently had a bout of vomiting or diarrhoea.
- if you have diabetes.
- if you are having an operation or an anaesthetic.
- if you are Afro-Caribbean and taking Lisinopril tablets as the only treatment for your high blood pressure, you may have a reduced response to this medicine. This may mean that you may need a higher dose than usually recommended.
Your doctor may want to carry out tests to monitor your kidney function and the amount of potassium in your blood.
Taking Lisinopril Tablets using other medicines
Tell your doctor if you are taking, or have recently taken, any other medicine. This includes medicines that you buy without prescription.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
• Beta-blocker medicines such as atenolol and propranolol.
• Diuretics (water tablets including those which conserve potassium).
• Other medicines for your high blood pressure or heart problems (antihypertensives).
• Non-steroidal anti-inflammatory medicines (NSAIDs) such as indometacin and high doses of aspirin (more than 3 grams per day), which are used to treat arthritis or muscle pain.
• Medicines for mental disorders such as lithium, antipsychotics or tricyclic antidepressants.
• Potassium tablets or potassium containing salt substitutes.
• Medicines for the treatment of diabetes, such as insulin or those taken orally, to lower blood sugar.
• Medicines to break up blood clots.
• Medicines that stimulate the central nervous system (sympathomimetics). These include ephedrine, pseudoephedrine and salbutamol and may be found in some decongestants, cough/cold remedies and asthma medication.
• Medicines that suppress the body's immune response (immunosuppressants), treatment with allopurinol (for gout) or procainamide (for abnormal heartbeats).
• Gold (such as sodium aurothiomalate). This may be given to you as an injection and possible side effects of gold include feeling flushed, sick or dizzy and low blood pressure. These reactions are more likely to occur if you are also taking an ACE-
inhibitor such as Lisinopril Tablets.
If you are on desensitisation treatment, e.g. for an allergic reaction to wasp or bee stings, let the doctor treating you know, prior to the start of therapy, that you are taking lisinopril.
Your doctor may monitor your blood pressure and kidney function prior to and during treatment.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking Lisinopril Tablets with food and drink
Lisinopril Tablets can be taken with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking lisinopril before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of lisinopril. Lisinopril is not recommended in early 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.
Breastfeeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Lisinopril is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Driving and using machines
Your Lisinopril Tablets are unlikely to affect your ability to drive a car or to operate machinery. However, you should not perform tasks that require special attention until you know how your medicine will affect you as occasionally dizziness or tiredness may occur.
CD
CO
Always follow your doctor's instructions as to how and when to take your medicine; your pharmacist may be able to advise you if you are not sure. Exactly how many tablets, and how often you must take them, will be written on the label. Please read it carefully.
The recommended doses are given below. However, doctors sometimes prescribe different doses to these: if this applies to you, discuss it with your doctor, if you have not already done so.
Swallow the tablets whole with water. Take the dose at approximately the same time each day.
Adults and elderly patients over 65 years:
High blood pressure: If you are already taking water tablets (diuretics) for high blood pressure the (Hypertension) doctor may discontinue them, or reduce the dose 2 to 3 days before starting treatment with lisinopril.
The recommended starting dose is 2.5 mg once daily. This may be adjusted by your doctor until your blood pressure is controlled. The usual effective dose range is 10 mg to 20 mg once daily. The maximum recommended dose is 40 mg once daily.
Heart failure: If you are taking water tablets (diuretics), your doctor may reduce the dose of diuretic before starting treatment with lisinopril.
Treatment will be started under close medical supervision by your doctor or in hospital. The recommended starting dose is 2.5 mg. This may be adjusted by your doctor until effective control is achieved. (This is usually a dose of 5 mg to 20 mg.)
Heart attack: Treatment may be started within 24 hours of having a heart attack as long as your blood pressure is not too low.
The usual dose is 5 mg straight away, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg once every day.
If you have low blood pressure you may start treatment on 2.5 mg each day. If you begin to get low blood pressure while taking the tablet the doctor may reduce your dose to 5 mg or 2.5 mg. However if you have continuous low blood pressure the doctor may stop treating you with Lisinopril Tablets.
Your treatment will usually last for about 6 weeks but if you have symptoms of heart failure, treatment will probably be continued.
Children:
Lisinopril Tablets are not recommended for children.
If you wish to stop treatment, discuss this with your doctor first as your original symptoms will return.
If you take more Lisinopril Tablets than you should
If you or someone else has taken more then the prescribed dose, contact your doctor or local hospital accident and emergency department immediately. Signs of an overdose include dizziness and palpitations (racing heartbeat).
If you forget to take Lisinopril Tablets
Do not take a double dose to make up for a forgotten tablet dose. If you have forgotten to take your medicine, take the missed dose as soon as you remember. If the next dose
is due within 8 hours, take the missed dose now and skip the next dose, then continue as before.
If you stop taking Lisinopril Tablets
Do not discontinue the treatment without consulting your doctor even if you feel better. It is important that you take Lisinopril Tablets for as long as your doctor prescribes it. If you have any further questions on the use of this product, ask your doctor or pharmacist
— CL
Like all medicines, Lisinopril Tablets can cause side effects, although not everybody gets them.
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.
It is vital to stop taking Lisinopril Tablets and seek medical attention immediately if you begin to have the following symptom:
• Allergic reaction- you may get an itch, shortness of breath or wheeziness and develop swelling of your hands, mouth, throat, face or eyes.
• Severe skin disorder, like sudden unexpected rash or peeling of the skin
• Symptoms of a fever and serious feeling of being unwell.
Common (affects less than 1 in 10 people)
• Headache
• Dizziness or light-headedness especially when standing up quickly
• Diarrhoea
• A dry cough that does not go away
• Vomiting
• Lisinopril may affect the kidneys, causing abnormally low or no urine to be passed.
Uncommon (affects less than 1 in 100 people)
• Mood changes
• Change of colour (pale blue followed by redness) and/or numbness or tingling in the fingers or toes
• Changes in the way things taste
• Feeling sleepy or difficulty in going to sleep, strange dreams
• Rapid heartbeat
• Running nose
• Nausea (feeling sick)
• Vertigo (spinning feeling)
• Stroke
• Stomach pain or indigestion
• Skin rash
• Itching
• Impotence
• Tiredness
• Weakness (loss of strength).
• An excessive drop in blood pressure may be experienced in patients with coronary heart disease, or those with a narrowing of the aorta (aortic stenosis), the kidney artery (renal artery stenosis) or the heart valves (mitral valve stenosis), or those patients with an increase in the thickness of the heart muscle (hypertrophic cardiomyopathy).
• Changes in blood tests that show how well your liver and kidneys are working.
• Heart attack
Rare (affects less than 1 in 1,000 people)
• Confusion
• Dry mouth
• Hair loss
• Psoriasis
• Sink rash (hives)
• Development of breasts in men.
• Rarely, there may be changes to some of the cells or other parts of your blood. It is possible that your doctor may occasionally take blood samples to check whether Lisinopril has had any effect on your blood. Sometimes these changes may show themselves as tiredness or a sore throat, or they may be accompanied by a fever, joint and muscle pains, swelling of the joints or glands, or sensitivity to sunlight.
• Changes in the way things smell.
• Sudden renal failure.
Very rare (affects less than 1 in 10,000 people)
• Sinus pain
• Wheezing
• Low levels of sugar in your blood (hypoglycaemia)
• Inflammation of the lungs
• Yellow skin and/or eyes (jaundice) Inflammation of the liver or pancreas
• Severe skin disorders (symptoms of which include redness, blistering and peeling)
• A patch or lump on the skin which slowly grows in size.
• Sweating.
• Passing less water (urine) than normal or passing no water.
• Liverfailure.
• Inflamed gut.
Others (it is unknown how many people may be affected)
• Fainting
• Mood changes including feeling depressed.
• Low levels of sodium in your blood.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
4
1
2
3
220 x 360 mm