Drug Ingredient Information
LOSARTAN-50MG+AMLODIPINE-5MG
LOSARTAN
| Information for
patients
|
| Drug Information |
Losartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Losartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Losartan potassium is used
to treat patients with high blood pressure (hypertension) in adults and in children and adolescents 6-18 years of age.
to protect the kidney in hypertensive type 2 diabetic patients with laboratory evidence of impaired renal function and proteinuria = 0.5 g per day (a condition in which urine contains an abnormal amount of protein).
to treat patients with chronic heart failure when therapy with specific medicines called angiotensin-converting-enzyme inhibitors (ACE inhibitors, medicine used to lower high blood pressure) is not considered suitable by your doctor. If your heart failure has been stabilised with an ACE inhibitor you should not be switched to losartan.
in patients with high blood pressure and a thickening of the left ventricle, LOSARTAN POTASSIUM has been shown to decrease the risk of stroke (“LIFE indication”). |
| Drug Alert |
| Alert |
if you are allergic (hypersensitive) to losartan or to any of its other ingredients,
if your liver function is severely impaired,
if you are more than 3 months pregnant. |
| Before Consuming
the Medicine
|
| Avoid Drug |
if you are allergic (hypersensitive) to losartan or to any of its other ingredients,
if your liver function is severely impaired,
if you are more than 3 months pregnant. |
| Drug Special Care |
if you have had a history of angiooedema (swelling of the face, lips, throat, and/or tongue).
if you suffer from excessive vomiting or diarrhoea leading to an extreme loss of fluid and/or salt in your body,
if you receive diuretics (medicines that increase the amount of water that you pass out through your kidneys) or are under dietary salt restriction leading to an extreme loss of fluid and salt in your body.
if you are known to have narrowing or blockage of the blood vessels leading to your kidneys or
if you have received a kidney transplant recently,
if your liver function is impaired.
if you suffer from heart failure with or without renal impairment or concomitant severe life threatening cardiac arrhythmias. Special caution is necessary when you are treated with a ß-blocker concomitantly,
if you have problems with your heart valves or heart muscle,
if you suffer from coronary heart disease (caused by a reduced blood flow in the blood vessels of the heart) or from cerebrovascular disease (caused by a reduced blood circulation in the brain),
if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland, caused by an abnormality within the gland). |
| Drug Drug Interactions |
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,including medicines obtained without a prescription or herbal medicines and natural products.Take particular care if you are taking the following medicines while under treatment with Losartan potassium
other blood pressure lowering medicines as they may additionally reduce your blood pressure.?Blood pressure may also be lowered by one of the following drugs/ class of drugs: tricyclic?antidepressants, antipsychotics, baclofen, amifostine,
medicines which retain potassium or may increase potassium levels (e.g. potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines such as certain diuretics [amiloride, triamterene, spironolactone] or heparin),
non-steroidal anti-inflammatory drugs such as indometacin, including COX-2-inhibitors (medicines that reduce inflammation, and can be used to help relieve pain) as they may reduce the blood pressure lowering effect of losartan.
If your kidney function is impaired, the concomitant use of these medicines may lead to a worsening of the kidney function.
Lithium containing medicines should not be taken in combination with losartan without close supervision by your doctor. Special precautionary measures (e.g. blood tests) may be appropriate. |
| Drug Pregnancy Interaction |
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Losartan potassium before you become pregnant or as soon as you know you are pregnantand will advise you to take another medicine instead of Losartan potassium. Losartan potassium 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. |
| Drug Breast feeding Interaction |
Tell your doctor if you are breast feeding or about to start breast feeding. Losartan potassium 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 a newborn, or born prematurely. Ask your doctor or pharmacist for advice before taking any medicine. |
| Drug Machinery Interaction |
No studies on the effects on the ability to drive and use machines have been performed.Losartan potassium is unlikely to affect your ability to drive or use machines. However, as with many other medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, you should consult your doctor before attempting such activities. |
| Drug More Information |
Losartan potassium has been studied in children. For more information,, talk to your doctor. |
| How to take the
Medicine
|
| Consumption Info |
Losartan potassium may be taken with or without food. |
| Drug quanitty |
The doctor may advise a lower dose, especially when starting treatment in certain patients such as those treated with diuretics in high doses, in patients with liver impairment, or in patients over the age of 75 years. The use of losartan is not recommended in patients with severe hepatic impairment.
Adult patients with high blood pressure
Treatment usually starts with 50 mg losartan (one tablet Losartan potassium 50 mg) once a day. The maximal blood pressure lowering effect should be reached 3-6 weeks after beginning treatment. In some patients the dose may later be increased to losartan (two Losartan potassium 50 mg) once daily. If you have the impression that the effect of losartan is too strong or too weak, please talk to your doctor or pharmacist.
Use in children and adolescents (6 to 18 years old)
The recommended starting dose in patients who weigh between 20 and 50 kg is 0.7 mg of losartan per kg of body weight administered once a day (up to 25 mg of Losartan potassium). The doctor may increase the dose if blood pressure is not controlled.
Adult patients with high blood pressure and type 2 diabetes
Treatment usually starts with 50 mg losartan (one tablet Losartan potassium 50 mg) once a day. The dose may later be increased to losartan (two Losartan potassium 50 mg) once daily depending on your blood pressure response. Losartan may be administered with other blood pressure lowering medicines (e.g. diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used medicines that decrease the level of glucose in the blood (e.g. sulfonylureas, glitazones and glucosidase inhibitors).
Adult Patients with heart failure
Treatment usually starts with 12.5 mg losartan (one tablet Losartan potassium 12.5 mg) once a day. Generally, the dose should be increased weekly step-by-step (i.e., 12.5 mg daily during the first week, 25 mg daily during the second week, 50 mg daily during the third week, daily during the fourth week, 150 mg daily during the fifth week) up to the maintenance dose as determined by your physician. A maximum dose of 150 mg losartan (for example, three of Losartan potassium 50 mg or one tablet each of Losartan potassium and Losartan potassium 50 mg) once daily may be used. In the treatment of heart failure, losartan is usually combined with a diuretic (medicine that increases the amount of water that you pass out through your kidneys) and/or digitalis (medicine that helps to make the heart stronger and more efficient) and/or a beta-blocker. |
| Drug Dose |
The should be swallowed with a glass of water. You should try to take your daily dose at about the same time each day. It is important that you continue to take Losartan potassium until your doctor tells you otherwise. |
| Excess Drug Consumption |
If you accidentally take too many, contact your doctor immediately. Symptoms of overdose are low blood pressure, increased heartbeat, possibly decreased heartbeat. |
| Forgot Drug Consumption |
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten tablet. If you have any further questions on the use of this product, ask your doctor or pharmacist. |
| Stop Drug Consumption |
Do not stop the drug untill your doctor says you to do so. |
| Possible Side
Effects
|
| General Information |
dizziness,
low blood pressure,
debility,
fatigue,
too little sugar in the blood (hypoglycaemia),
too much potassium in the blood (hyperkalaemia),
changes in kidney function including kidney failure,
reduced number of red blood cells (anaemia),
increase in blood urea, serum creatinine and serum potassium in patients with heart failure |
| Common Drug Side Effects |
somnolence,
headache,
sleep disorders,
feeling of increased heart rate (palpitations),
severe chest pain (angina pectoris),
low blood pressure (especially after excessive loss of water from the body within blood vessels e.g. in patients with severe heart failure or under treatment with high dose diuretics),
dose-related orthostatic effects such as lowering of blood pressure appearing when rising from a lying or sitting position,
shortness of breath (dyspnoea),
abdominal pain,
obstipation,
diarrhoea,
nausea,
vomiting,
hives (urticaria),
itching (pruritus),
rash,
localised swelling (oedema),
cough.
hypersensitivity,
angiooedema,
inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura),
numbness or tingling sensation (paraesthesia),
fainting (syncope),
very rapid and irregular heartbeat (atrial fibrillation)
brain attack (stroke),
inflammation of the liver (hepatitis),
elevated blood alanine aminotransferase (ALT) levels, usually resolved upon discontinuation of treatment. |
| Rare Drug Side Effects |
reduced number of thrombocytes,
migraine,
liver function abnormalities,
muscle and joint pain,
flu-like symptoms,
back pain and urinary tract infection,
increased sensitivity to the sun (photosensitivity),
unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis),
impotence,
inflammation of the pancreas (pancreatitis),
low levels of sodium in the blood (hyponatraemia),
depression,
generally feeling unwell (malaise),
ringing, buzzing, roaring, or clicking in the ears (tinnitus). |
| Very Rare Drug Side Effects |
no data available |
| Drug Side Effects Symptoms |
no data available |
| How to Store the
Medicine
|
| How to Store the Medicine |
Keep out of the reach and sight of children.Do not use Losartan potassium after the expiry date which is stated on the carton or the bottle label. The expiry date refers to the last day of that month.
Blisters
Store Losartan potassium in the original package in order to protect from light and moisture. Do not open the blister pack until you are ready to take the medicine.
Bottles
Store Losartan potassium in the original container in order to protect from light. Do not store above 25OC.Keep the bottle tightly closed in order to protect from moisture.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 |
AMLODIPINE
| Information for
patients
|
| Drug Information |
Amlodipine is one of a group of medicines called calcium antagonists.
Your medicine is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, a rare form of which is Prinzmetal’s or variant angina.
In patients with high blood pressure your medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina Amlodipine works by
improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. Your medicine does not provide immediate relief of chest
pain from angina |
| Drug Alert |
| Alert |
•if you are allergic (hypersensitive) to Amlodipine, or any of the other ingredients of your medicine, or to any other calcium antagonists. This may be itching, reddening of the skin or difficulty in breathing;
•if you have narrowing of the aortic heart valve (aortic stenosis), unstable angina or cardiogenic shock |
| Before Consuming
the Medicine
|
| Avoid Drug |
Do not take Amlodipine:
•if you are allergic (hypersensitive) to Amlodipine, or any of the other ingredients of your medicine , or to any other calcium antagonists. This may be itching, reddening of the skin or difficulty in breathing;
•if you have narrowing of the aortic heart valve (aortic stenosis), unstable angina or cardiogenic shock;
•if you are pregnant or breast feeding |
| Drug Special Care |
You should inform your Doctor if you have or have had any of the following conditions:
•Recent heart attack (within the last month).
•Severe increase in blood pressure (Hypertensive crisis).
•Liver disease |
| Drug Drug Interactions |
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription |
| Drug Pregnancy Interaction |
If you think you might be pregnant, or are planning to get pregnant, tell your doctor before you take Amlodipine
Women of child bearing potential should ensure that they use effective contraception |
| Drug Breast feeding Interaction |
You should not take Amlodipine if you are breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine |
| Drug Machinery Interaction |
Amlodipine is unlikely to affect your ability to drive or use machines. |
| Drug More Information |
Your medicine can be used before or after food. Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipine. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Amlodipine.
Children
Safety and effectiveness have been studied in 6-17 year old boys and in girls. Amlodipine has not been
studied in children under the age of 6 years. For more information, talk to your doctor. |
| How to take the
Medicine
|
| Consumption Info |
|
| Drug quanitty |
The usual dose of Amlodipine is one tablet daily. |
| Drug Dose |
The usual dose of Amlodipine is one tablet daily. |
| Excess Drug Consumption |
Taking too may tablets at once may make you unwell. If you take too may Amlodipine tablets contact your doctor at once or go to the nearest hospital casualty department |
| Forgot Drug Consumption |
Do not worry. If you forget to take a tablet, leave out that dose completely. Take your next dose at the right time. Do not take a double dose to make up for a missed dose |
| Stop Drug Consumption |
Your doctor will advise you how long to take your medicine. Your condition may return if you stop using your medicine before you are advised.
If you have any further questions on how to take this product, ask your doctor or pharmacist |
| Possible Side
Effects
|
| General Information |
|
| Common Drug Side Effects |
•Headache, dizziness, sleepiness.
•Palpitations (awareness of your heart beat), flushing.
•Abdominal pain, feeling sick (nausea).
•Ankle swelling (oedema), tiredness.
Other side-effects that have been reported include the following list. If any of these get serious, or
if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist |
| Rare Drug Side Effects |
•Unusual bruising and bleeding (red blood cell damage).
•Severe skin reactions.
•Excess sugar in blood (diabetes).
•Increased sensitivity of the skin, pins and needles, loss of pain sensation.
•Heart attack.
•Hives.
•Abdominal bloating (gastritis).
•Cough.
•Inflamed pancreas.
•Abnormal liver function, inflammation of the liver, yellowing of the skin (jaundice), liver enzyme increases.
If any of the side effects gets serious, or if you notice any side effects not listed in this , please tell your doctor or pharmacist |
| Very Rare Drug Side Effects |
•Mood changes, sleeplessness.
•Trembling, taste abnormalities, fainting, weakness.
•Visual disturbances, ringing in the ears.
•Low blood pressure.
•Shortness of breath, sneezing/running nose.
•Altered bowel habit, indigestion, dry mouth, vomiting (being sick).
•Hair loss, increased sweating, itchy skin, red patches on skin.
•Increased need to urinate especially at night, inability to obtain an erection.
•Chest pain, weakness, pain, feeling unwell.
•Joint or muscle pain, muscle cramps, back pain.
•Weight increase or decrease.
•Enlargening of male breasts |
| Drug Side Effects Symptoms |
Like all medicines, Amlodipine can cause side effects, although not everybody gets them. Tell your doctor immediately if you experience any of the following symptoms after taking this medicine.
Although they are very rare, the symptoms can be severe.
•Sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body).
The following Common side-effects have been reported. If any of these cause you problems or if they last for more than one week, you should contact your doctor |
| How to Store the
Medicine
|
| How to Store the Medicine |
Keep out of the reach and sight of children.
Do not store above 25oC.
Do not use your medicine after the expiry date which is stamped on the pack. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via wastewater of household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment |
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