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 详细处方信息以本药内容附件PDF文件（20108518140437.pdf）的“原文Priscribing Information”为准
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【药理及毒理】
本品药理毒理资料全，不需做毒理试验。
【适应症】
1.适用于治疗高血压病。（可单独服用，也可与其它降压药物联合使用如氢氯噻嗪。）
2. 适用于治疗心力衰竭或左心肌功能不全导致的心肌梗塞。
【用法用量】
1.用于治疗高血压病：
口服，每次2～4mg，每日1次。建议初剂量每日1mg或2mg。建议间隔周调整一次剂量，每日不能超过8 mg。
2.用于治疗心力衰竭或左心肌功能不全导致的心肌梗塞：
建议开始用量每次1mg，每日一次。可达到每天4 mg，如果4 mg也不能控制，可以继续加大剂量治疗。
【品种特点】
本品口服吸收迅速，且不受饮食因素的影响，连服4 d即达血浆稳态浓度。几乎全部药物在7 d内被排泄到体外。具有高度亲脂性，易穿透到机体各组织尤其是心肌和血管壁，和其他ACEI药物如雷米普利(ramipril)、雷米普利拉(rimiprilat)、培哚普利(perindopril)、依那普利拉、卡托普利相比较，群多普利是其中最具亲脂性。
经实验证明，本品反复给药无蓄积作用 ，因此老年高血压病人使用本品无需改变剂量。
群多普利与盐酸维拉帕米合并用药对严重的高血压或靶器官损坏的高血压患者尤为有利。本复方制剂是将苯烷基胺钙拮抗剂和血管紧张素转化酶抑制剂(ACEI)的作用结合在一起。该复方制剂可作为早期高血压的首选治疗，而且使用复方制剂可增加病人的依从性。

Gopten (trandolapril)
Main use：High blood pressure
Active ingredient：Trandolapril
Manufacturer：Abbott
   
How does it work?
Gopten capsules contain the active ingredient trandolapril, which is a type of medicine called an ACE inhibitor. (NB. Trandolapril is also available without a brand name, ie as the generic medicine.)

ACE inhibitors work by blocking the action of a compound in the body called angiotensin converting enzyme (ACE). Normally ACE produces another compound called angiotensin II, as part of the body's natural control of blood pressure. Angiotensin II causes blood vessels to constrict and narrow, which increases the pressure within the blood vessels.

As trandolapril blocks the action of ACE, it reduces the production of angiotensin II. This means that the blood vessels are allowed to relax and widen. The overall effect of this is a drop in blood pressure, hence trandolapril can be used to lower high blood pressure.

The reduced pressure within the blood vessels means that the heart doesn't have to work as hard to pump the blood around the body. This means that ACE inhibitors such as trandolapril can be used when the heart is not pumping as efficiently as it should be following a heart attack. Trandolapril has been shown to help prevent heart failure in people with a weak heart after suffering a heart attack, and to improve survival in this group of people.

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What is it used for?
Mild to moderate high blood pressure (hypertension).
Preventing heart failure and improving survival in people with a poorly functioning heart (left ventricular dysfunction) after suffering a heart attack.

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Warning!
Some people may experience dizziness caused by low blood pressure in the first few days of taking this medicine, and in particular the first dose. For this reason, the first dose should preferably be taken at bedtime. Your doctor may want you to take the first dose of this medicine under medical supervision in hospital if you are aged over 70 years, have low blood pressure, very high blood pressure, low levels of fluids or salt in your blood (eg due to dehydration), severe or unstable heart failure, kidney problems, or are taking high doses of diuretic medicines, multiple diuretic medicines, or certain other medicines that dilate your blood vessels.

If you feel dizzy during treatment this can be relieved by lying down until the symptoms pass. If affected you should avoid performing potentially hazardous tasks such as driving or operating machinary. If you frequently feel dizzy you should let your doctor know, as your dose of this medicine may need reducing.

Alcohol may enhance the blood pressure lowering effect of this medicine, which can increase dizziness and may increase the risk of fainting.

ACE inhibitors can sometimes cause an allergic reaction called angioedema. Stop taking this medicine and consult your doctor immediately if you experience difficulty breathing or swallowing, or swelling of your face, lips, tongue, throat, hands, feet or ankles while taking this medicine. This type of allergic reaction has been reported more frequently in people of Afro-Caribbean origin.

Your blood pressure, kidney function and the amount of potassium in your blood should be regularly monitored while you are taking this medicine.

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Use with caution in
Elderly people.
Decreased liver function.
Decreased kidney function.
Narrowing of the arteries that supply blood to the kidneys (renal artery stenosis).
Decreased fluid volume in the body, eg due to diuretic therapy, low salt diet, kidney dialysis, diarrhoea, vomiting, dehydration.
People also taking diuretic medicines.
Heart failure.
People with hardening of the arteries (athersclerosis), eg in the heart (cardiovascular disease), brain (cerebrovascular disease) or legs (peripheral vascular disease).
Diabetes.
Diseases affecting connective tissue, eg scleroderma, systemic lupus erythematosus or rheumatoid arthritis (collagen vascular diseases).
People with kidney failure requiring a certain type of haemodialysis (high-flux membrane).
People receiving therapy to remove certain types of fat from the blood using a machine (LDL apheresis).
People undergoing therapy to decrease allergy to bee or wasp stings (desensitisation).

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Not to be used in
History of swelling of the lips, face or tongue (angioedema) with no known cause, or caused by previous use of an ACE inhibitor medicine.
Hereditary angioedema (angioneurotic oedema).
Narrowing of the main artery of the body (aortic stenosis).
Any condition in which there is obstruction to the pumping of blood out of the heart (outflow tract obstruction).
Pregnancy.
Breastfeeding.
Children.
Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Gopten capsules contain lactose).

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

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Pregnancy and breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine should not be used in pregnancy, particularly in the second and third trimesters, as it may be harmful to the unborn baby. Seek further medical advice from your doctor. If you get pregnant while taking this medicine, you should stop taking it and consult your doctor immediately.

It is not known if this medicine passes into breast milk. The manufacturer states that it should not be taken by women who are breastfeeding. Women who need treatment with this medicine should not breastfeed. Seek further medical advice from your doctor.

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Side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Headache.
Dizziness.
Dry cough.
Feeling weak.
Low blood pressure (hypotension).
Awareness of your heartbeat (palpitations).
Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain.
Dry mouth.
Inflammation of the lining of the nose (rhinitis).
Skin reactions such as rash, itching, hair loss or sweating.
Faster than normal heartbeat (tachycardia).
Irregular heartbeats (arrhythmias).
Chest pain (angina).
Shortness of breath.
Increased level of potassium in the blood (hyperkalaemia).
Severe swelling of lips, face, tongue or throat (angioedema - see warning above).
Inflammation of the pancreas (pancreatitis).
Problems with kidney function.
Disturbances in the normal levels of blood cells in the blood (tell you doctor if you get a sore throat, mouth ulcers, high temperature (fever), or feel tired or generally unwell while taking this medicine).
Problems with liver function, including jaundice or hepatitis (consult your doctor promptly if you develop unexplained itching, yellowing of the skin or eyes, unusually dark urine, nausea and vomiting, abdominal pains, loss of appetite or flu-like symptoms while taking this medicine).

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

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How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.

Trandolapril has an additive effect with other medicines that decrease blood pressure, particularly other medicines used to treat high blood pressure (antihypertensives). In people taking antihypertensive medicines it may cause a large drop in blood pressure with the first dose, particularly in people taking diuretic medicines such as furosemide. This may cause dizziness, which can usually be relieved by lying down until the symptoms pass. If you are taking a diuretic medicine, your doctor may reduce your dose or ask you to stop taking it for a few days before starting trandolapril. This is to prevent your blood pressure from dropping too low. If you frequently feel dizzy while taking this medicine in combination with other medicines that can lower blood pressure you should let your doctor know, as your doses may need adjusting. Other medicines that decrease blood pressure include the following:
other ACE inhibitors, eg enalapril
aldesleukin
alpha-blockers such as prazosin
alprostadil
angiotensin II receptor antagonists such as losartan
antipsychotics
benzodiazepines, eg temazepam, diazepam
baclofen
beta-blockers such as propranolol
calcium-channel blockers such as verapamil, nifedipine
clonidine
diazoxide
diuretics, eg furosemide, bendroflumethiazide
dopamine agonists, eg bromocriptine, apomorphine
hydralazine
levodopa
MAOI antidepressants, eg phenelzine
methyldopa
minoxidil
moxonidine
moxisylyte
nicorandil
nitrates, eg glyceryl trinitrate
tizanidine.

Non-steroidal anti-inflammatory drugs (NSAIDs, eg indometacin, aspirin, diclofenac, ibuprofen) may reduce the blood pressure lowering effect of trandolapril, and may increase the risk of a decline in kidney function. You should avoid taking this type of painkiller unless recommended by your doctor.

There may be a risk of raised potassium levels in the blood (hyperkalaemia) if any of the following medicines are taken with trandolapril, hence these are not normally recommended for use in combination with trandolapril. If you are taking any of the following with this medicine, you should have regular blood tests to monitor the amount of potassium in your blood:
angiotensin II receptor antagonists, eg losartan
ciclosporin
drospirenone
epoetin (this may also oppose the blood pressure lowering effect of trandolapril)
heparin
potassium-containing salt substitutes (eg Lo-Salt)
potassium salts, eg potassium citrate for cystitis
potassium-sparing diuretics (eg spironolactone, triamterene, amiloride)
potassium supplements.
Trandolapril may increase the blood level of the medicine lithium and for this reason, it is not normally recommended for people taking lithium. People taking this medicine in combination with lithium should have the level of lithium in their blood closely monitored.

Trandolapril may possibly enhance the blood sugar lowering effect of insulin and oral antidiabetic medicines, and so could increase the risk of low blood sugar (hypoglycaemia). People with diabetes should therefore carefully monitor their blood sugar while taking this medicine, particularly in the first few weeks of treatment.

There may be an increased risk of a drop in the normal numbers of white blood cells in the blood if this medicine is taken in combination with any of the following medicines:
allopurinol
azathioprine
immunosuppressant therapy
procainamide.

If you are taking any of these in combination with this medicine, you should have regular blood tests to monitor the levels of your blood cells, particularly if you also have any kidney problems or diseases affecting connective tissue, eg scleroderma, systemic lupus erythematosus (collagen vascular diseases). Tell your doctor if you experience any signs of infection, such as fever, sore throat or mouth ulcers, as these could be signs of problems with your white blood cells.

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Other medicines containing the same active ingredient
Trandolapril capsules are also available without a brand name, ie as the generic medicine.

Tarka contains trandolapril in combination with the calcium channel blocker verapamil.

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 详细处方信息以本药内容附件PDF文件（20108518140437.pdf）的“原文Priscribing Information”为准
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于2010-09-30更新