Lisinopril 20mg Tablets
|
Lisinopril |
20 mg Tablets |
|
lisinopril dihydrate |
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need 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 20 mg Tablets are and what they are used for
2. Before you take Lisinopril 20 mg Tablets
3. How to take Lisinopril 20 mg Tablets
4. Possible side effects
5. How to store Lisinopril 20 mg Tablets
6. Further Information
1. WHAT LISINOPRIL 20 mg TABLETS ARE AND WHAT ARE THEY USED FOR
Lisinopril belongs to a class of blood pressure medicines called ‘Angiotensin Converting Enzyme (ACE) inhibitors'. These work by widening blood vessels which makes it easier for the heart to pump blood through them, to all parts of the body, and helps to reduce raised blood pressure.
Lisinopril is used to treat:
- High blood pressure (hypertension).
- Heart failure (a condition in which the heart does not pump your blood around the body as well as it should).
- After a heart attack (myocardial infarction) to prevent the heart from weakening down.
2. BEFORE YOU TAKE LISINOPRIL 20 mg TABLETS Do not take lisinopril if you:
- are more then 3 months pregnant (it is also better to avoid Lisinopril in early pregnancy - see pregnancy section);
- have had a reaction to Lisinopril or similar medicines (ACE inhibitors) in the past which has involved difficulty with swallowing or breathing, swelling of the hands, feet or ankles, face, lips, tongue or throat or if you or a member of your family has had a similar reaction for any other reason;
- are allergic to Lisinopril or any of the ingredients in this medicine.
Take special care with Lisinopril
Tell your doctor if you:
- have kidney problems or are undergoing dialysis;
- have liver problems;
- are taking “water tablets”, you have had diarrhoea or vomiting recently or you are on a salt restricted diet as you may experience low blood pressure with symptoms of light headedness or dizziness especially when standing;
- have been told that your high blood pressure is the result of a narrowing of the blood vessels in your kidneys;
- have had in the past an allergic reaction that involved difficulty with swallowing or breathing, swelling of the hands, feet or ankles, face, lips, tongue or throat required medical attention;
- are scheduled to undergo major surgery with anesthesia. You should also tell your dentist before you have an anaesthetic for a dental procedure.
- have been told that you have a problem with the valves of your heart or that your heart muscle is thicker than usual (cardiomyopathy);
- are going to have desensitization treatment (eg, treatment to reduce the effects of an allergy to bee or wasp stings);
- are undergoing blood exchange treatment for a high lipid problem;
- have diabetes.
You must tell your doctor if you think 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).
Lisinopril is recommended in children (above 6 years old) only for the treatment of high blood pressure. Lisinopril should not be used in children with severe kidney impairement.
Taking other medicines
Tell your doctor about all of the medicines you are taking or have recently taken including those which you have bought, but in particular, the following medicines:
- diuretics (water tablets). This may lead to a lower than necessary reduction in your blood pressure. The dose may be adjusted by your doctor.
- other treatment for high blood pressure;
- non-steroidal anti-inflammatory drugs (NSAIDs) such as indometacin and high doses of aspirin (more than 3 grams per day) for arthritis or muscle pain. They may reduce the efficacy of lisinopril in reducing your blood pressure.
- insulin or tablets for diabetes, as they may reduce the blood sugar more than necessary. This is more likely to occur at the beginning of the treatment and in those patients with kidney problems.
- allopurinol (a medicine to treat gout), medicines that interfere with your immune system, steroids or procainamide (a medicine used to control abnormal heart rhythm). When these medicines are administered with lisinopril there is a risk that your white blood cells (the cells that protect from infections) may be reduced in your blood.
- potassium supplements (including salts). Lisinopril tends to make you retain potassium, so any potassium supplements are not recommended.
- antacids (heartburn medication) may reduce the absorption of lisinopril tablets;
- ciclosporin (used to prevent transplant rejection) may increase the risk of retaining potassium when given with lisinopril;
- lithium (for bipolar disorder). Lisinopril may increase the amount of lithium in your blood. Your doctor may need to monitor the levels of lithium and may need to adjust the dose.
- medicines that stimulate the nervous system (sympathomimetics) such as salbutamol and pseudoephedrine found in cough and asthma medication.
Taking alcohol with Lisinopril
Alcohol may increase the blood pressure lowering effects of lisinopril.
Taking Lisinopril with food and drink
Lisinopril 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.
Breast-feeding
Tell your doctor if you are breast-feeding or about to start breastfeeding. 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
Lisinopril can cause tiredness and dizziness which can affect your ability to use and operate machines. If you experience tiredness or dizziness do not drive or use machinery.
3. HOW TO TAKE LISINOPRIL 20 mg TABLETS
It is important that you take the tablet each day at the same time, preferably with a glass of water.
If you are taking lisinopril for the first time you may feel lightheaded or dizzy for a short time and it may help to sit or lie down.
ALKALOID
The dose you take will depend on your condition and whether you are taking any other medicines. Lisinopril 20 mg tablets are only suitable for doses of 20 mg or higher:
For high blood pressure:
The usual starting dose is 2.5 mg taken once a day. The dose will be increased according to your blood pressure readings until the desired level of control is achieved. The maximum dose is 40 mg once a day.
The dose in children (age 6-16 years) will be prescribed by your doctor.
For heart failure (whether the heart is not pumping the blood appropriately):
The usual starting dose is 2.5 mg. The usual long-term dose is 5 to 20 mg taken once a day.
After a heart attack:
Treatment may be started within 24 hours of your heart attack. The usual dose is 5 mg on day 1 and day 2, then 10 mg once a day thereafter. Patients with low blood pressure may be given a lower dose of 2.5 mg once a day.
Always take Lisinopril tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
If you take more Lisinopril than you should
The most likely symptom would be very low blood pressure. If you think you may have taken too much lisinopril, you should seek medical attention.
If you forget to take Lisinopril
Do not take a double dose to make up for a missed dose. If you miss a dose, take your next tablet when it is due.
If you stop taking Lisinopril tablets
If you stopped taking this medication before your doctor has recommended your blood pressure may increase or your heart may become weaker again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Lisinopril can cause side effects. Do not be alarmed by this list of possible side effects, you may not have any of them. Most patients do not notice any side effects. However, if you do and they bother you, talk to your doctor.
Stop taking Lisinopril and seek medical attention immediately if any of the following situations occur:
- If you develop difficulty in breathing with or without swelling of the face, lips, tongue and/or throat.
- If you develop swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing.
- If you develop severe itching of the skin (with raised lumps).
Common side effects that may occur (between 1 in 10 and 1 in 100 patients):
- headache;
- dizziness or light-headedness especially when standing up quickly;
- diarrhoea;
- cough;
- vomiting;
- Lisinopril may affect the kidneys, causing abnormally low or no urine to be passed.
Uncommon side effects that may occur (between 1 in 100 and 1 in 1,000 patients):
- 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;
- 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).
Rare side effects that may occur (between 1 in 1,000 and 1 in 10,000 patients):
- confusion;
- dry mouth;
- hair loss;
- psoriasis;
- development of breasts in men.
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.
Very rare side effects that may occur (less than 1 in 10,000 patients):
- sinus pain;
- wheezing;
- 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);
- sweating.
Tell your doctor if you have any side effects that are not mentioned in this leaflet.
5. HOW TO STORE LISINOPRIL 20 mg TABLETS
- Keep your tablets in the pack in which they were supplied.
- Store in the original package.
- Keep your tablets out of the reach and sight of children.
Do not take your tablets after the expiry date on the container. The expiry date refers to the last day of the 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 Lisinopril 20 mg Tablets contain: The active substance is lisinopril dihydrate. Each tablet contains 21.78 mg lisinopril dihydrate equivalent to 20 mg lisinopril.
The other ingredients are: calcium hydrogen phosphate anhydrous, magnesium stearate, starch pregelatinised, mannitol, povidone and maize starch. Lisinopril 20 mg tablets also contain Iron oxide red and yellow (E 172).
What Lisinopril 20 mg Tablets look like and content of the pack: The tablets are ochre pink, round, biconvex with a scoreline on one side. The scoreline is only to facilitate swallowing and not to divide into equal doses.
Lisinopril 20 mg tablets are available in calendar packs of 28 tablets in a carton.
Marketing Authorisation Holder and Manufacturer:
ALKALOID-INT d.o.o., Slandrova ulica 4, 1231 Ljubljana -Crnuce, Slovenia.
For any information about this medicinal product, please contact Marketing Authorisation Holder:
ALKALOID-INT d.o.o.
Tel. 00 386 1 300 42 90 Fax: 00 386 1 300 42 91 E-mail: info@alkaloid.si
PL 34088/0001
O
CN
Leaflet prepared: February 2011.
