Description

Trade Name:

Zestril 10 mg

10 tablets

Composition:

Lisinopril (as dihydrate) 10 mg

Inactive ingredients are mannitol, calcium hydrogen phosphate dihydrate, maize starch, pregelatinized starch and magnesium stearate. In addition, the pink and brownish-red tablets contain red iron oxide (E172).

Properties:

Zestril contains a medicine called lisinopril. This belongs to a group of medicines called ACE inhibitors.

Zestril vworks by making your blood vessels widen. This helps to lower your blood pressure. It also makes it easier for your heart to pump blood to all parts of your body.

Indications:

Zestril can be used for the following conditions:

• To treat high blood pressure (hypertension).

• To treat heart failure.
• If you have recently had a heartattack (myocardial infarction).

• To treat kidney problems caused by

Type 2 diabetes in people with high blood pressure.

Dosage and administration:

-Try to take your tablets at the same time each day. It does not matter if you take Zestril before or after food.

-Keep taking Zestril for as long as your doctor tells you to, it is a long term treatment. It is important to keep taking Zestril every day.

-Take special care when you have your first dose of Zestril or if your dose is increased. It may cause a greater fall in blood pressure than later doses.

-This may make you feel dizzy or light-headed. If this happens, it may help to lie down. If you are concerned, please talk to your doctor as soon as possible.

-Adults:

Your dose depends on your medical condition and whether you are taking any other medicines. Your doctor will tell you how many tablets to take each day. Check with your doctor or pharmacist if you are unsure.

-For high blood pressure:

The recommended starting dose is 10 mg once a day.

The usual long-term dose is 20 mg once a day.

-For heart failure:

The recommended starting dose is 2.5 mg once a day.

The long-term dose is 5 to 35 mng once a day.

-After a heart attack:

The recommended starting dose is 5, mg within 24 hours of your attack and 5 mg one day later.

The usual long-term dose is 10 mg once a day.

-For kidney problems caused by diabetes:

The recommended dose is either 10 mg or 20 mg once a day.

-If you are elderly, have kidney problems or are taking diuretic medicines your doctor may give you a lower dose than the usual dose.

-Use in children and adolescents

(6 to 16 years old) with high blood pressure:

Zestril is not recommended for children under 6 years or in any children with severe kidney problems.

The doctor will work out the correct dose for your child. The dose depends on the child’s body weight.

-For children who weigh between 20 kg and 50 kg:

The recommended starting dose is 2.5 mg once a day.

-For children who weigh more than 50 kg:

The recommended starting dose is 5 mg once a day.

-If you take more Zestril than prescribed by your doctor, talk to a doctor or go to a hospital immediately. The following effects are most likely to happen:

Dizziness, palpitations.

-If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.

-Do not take a double dose to make up for a forgotten dose.

-Do not stop taking your tablets, even if you are feeling well, unless your doctor tells you to.

Side effects:

-Common:

Headache, Feeling dizzy or light-headed, Diarrhea, A dry cough that does not go away, Being sick (vomiting), Kidney problems (shown in a blood test).

-Uncommon:

Mood changes, Change of color in your fingers or toes, Changes in the way things taste, Feeling sleepy, Spinning feeling, Having difficulty sleeping, Stroke, Fast heart beat, Runny nose, Feeling sick, Stomach pain or indigestion, Skin rash or itching, Impotence, Feeling tired or feeling weak, A very big drop in blood pressure may happen in people with the following conditions: coronary heart, narrowing of the aorta, kidney artery or heart valves; an increase in the thickness of the heart muscle, Changes in blood tests that show how well your liver and kidneys are working, Heart attack, Seen and/or heard hallucinations.

-Rare:

Feeling confused, A lumpy rash (hives), Dry mouth, Hair loss, Psoriasis (a skin problem), Changes in the way things smell, Development of breasts in men, Low levels of sodium in your blood (the symptoms may be tiredness, headache, nausea, vomiting), Sudden renal failure.

-Changes to some of the cells or other parts of your blood: Your doctor may take blood samples from time to time to check whether Zestril has had any effect on your blood. The signs may include feeling tired, pale skin, a sore throat, high temperature (fever), joint and muscle pains, swelling of the joints or glands, or sensitivity to sunlight.

-Very rare:

Sinusitis, Wheezing, Low levels of sugar in your blood, Inflammation of the lungs, Yellowing of the skin or the whites of the eyes (jaundice), Inflammation of the liver, inflammation of the pancreas, Severe skin disorders, Sweating, Passing less water (urine) than normal or passing no water, Liver failure, Lumps, Inflamed gut.

Contraindications:

• if you are allergic to lisinopril or any of the other ingredients of this medicine;

• if you have ever had an allergic reaction to another ACE inhibitor medicine. The allergic reaction may have caused swelling of the hands, feet, ankles, face, lips, tongue or throat. It may also have made it difficult to swallow or breathe (angioedema).

• if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is increased.

• if a member of your family has had severe allergic reactions (angioedema) to an ACE inhibitor or you have had severe allergic reactions without a known cause.
• if you are more than 3 months pregnant.
• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions:

• If you develop a dry cough which is persistent for a long time after starting treatment with Zestril, talk to your doctor.

• Talk to your doctor before taking Zestril:

-if you have a narrowing (stenosis) of the aorta (an artery in your heart) or a narrowing of the heart valves (mitral valves);

-if you have a narrowing (stenosis) of the kidney artery;

-if you have an increase in the thickness of the heart muscle (known as hypertrophic cardiomyopathy);

-if you have problems with your blood vessels (collagen vascular disease);

-if you have low blood pressure. You may notice this as feeling dizzy or

light-headed, especially when standing up.;

-if you have kidney problems or you are having kidney dialysis;

-if you have liver problems;

-if you have diabetes;

-if you have high levels of cholesterol and you are having a treatment called ‘LDL apheresis;

• You must tell your doctor if you think you are (or might become) pregnant. Zestril 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;

• if you are of black origin as Zestril

may be less effective. You may also

more readily get the side effect

‘angioedema’ (a severe allergic

reaction).

• Tell your doctor if you are having or are

going to have treatment to lower the

effects of an allergy such as insect

stings (desensitization treatment). If you take Zestril while you are having this treatment, it may cause a severe allergic reaction.

• If you are going to have an operation

(including dental surgery) tell your doctor or dentist that you are taking Zestril. This is because you can get low blood pressure (hypotension) if you are given certain local or general anesthetics while you are taking Zestril.

• Children and adolescents:

Zestril has been studied in children. For more information, talk to your doctor.

Zestril is not recommended in children under 6 years of age or in any child with severe kidney problems.

• Inform your doctor before taking Zestril if  you are taking any of the following:

-Other medicines to help lower your blood pressure;

-An angiotensin ||- receptor blocker

(ARB) or aliskiren;

-Diuretic medicines;

-Beta-blocker medicines, such as atenolol and propranolol;

-Nitrate medicines (for heart problems).

-Non-steroidal anti-inflammatory drugs (NSAIDS) used to treat pain and arthritis;

-Aspirin (Acetylsalicylic acid), if you are taking more than 3 grams each day;

-Medicines for depression and for mental problems, including lithium;

-Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that can increase the amount of potassium in your blood (e.g. trimethoprim and co-trimoxazole for infections caused by bacteria;

-Cyclosporin, an immunosuppressant

medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin blood to prevent clots;

-Insulin or medicines that you take by

mouth for diabetes;

-Medicines used to treat asthma;

-Medicines to treat nose or sinus congestion or other cold remedies;

-Medicines to suppress the body’s immune response (immunosuppressants);

-Allopurinol (for gout);

-Procainamide (for heartbeat problems);

-Medicines that contain gold, such as sodium aurothiomalate, which may be given to you as an injection.

• The following medicines may increase the risk of angioedema (signs of angioedema include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing):

-Medicines to break up blood clots (tissue plasminogen activator), usually given in hospitals;

-Medicines which are most often used to avoid rejection of transplanted organs (temsirolimus, sirolimus, everolimus);

-Racecadotril used to treat diarrhea;

-Vildagliptin, a medicine used to treat diabetes.

• You must tell your doctor if you think you are (or might become) pregnant.

Your doctor will normally advise you to stop taking Zestril before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Zestril.

Zestril 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 breastfeeding or about to start breastfeeding. Zestril is not recommended for nursing mothers and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn, or was born prematurely.

• Driving and using machines

Some people feel dizzy or tired when taking this medicine. If this happens to you, do not drive or use any tools or machines.

You must wait to see how your medicine affects you before trying these activities.

• Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

• Once you have started taking Zestril your doctor may take blood tests. Your doctor may then adjust your dose so you take the right amount of medicine for you.

Storage:

Store at a temperature not exceeding 30°C

Package:

Carton box holds a strip of 10 tablets and an insert leaflet