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INTRODUCTION

AMLACE TABLET is a combination of Amlodipine and Lisinopril which belongs to the group of medicines called Antihypertensive agents. It is used to treat hypertension (high blood pressure) and certain type of angina (chest pain) called as Prinzmetal or variant angina. It can also be used to prevent heart failure and reduce the chances of hospitalization among the heart patients.

It also protects the function of kidneys particularly in patients who have both hypertension and type II diabetes mellitus.

Before taking AMLACE TABLET inform your doctor if you have any liver or kidney problems. You must also inform your doctor if you have any other heart problems apart from hypertension, angina and heart failure (such as cardiogenic shock or narrowing of heart valves).

Talk to your doctor if you are on a low salt diet or have diabetes or are severely dehydrated due to any recent sickness (such as vomiting or diarrhea) before taking AMLACE TABLET as a precaution.

AMLACE TABLET is not recommended for use in patients with severe hypotension (low blood pressure). It is also not suitable for use in women who are pregnant or breastfeeding due to increased risk of side effects.

The most common side effects of taking AMLACE TABLET are dizziness, swelling of ankles or other body parts, headache, sleepiness, tiredness, racing heartbeat, indigestion, constipation and muscle cramps. Contact your doctor if any of these side effects trouble you.

USES OF AMLACE TABLET

It is used to:

  • Treat hypertension and angina
  • Prevent heart failure
  • Protects kidney functions in patients with hypertension and diabetes

HOW AMLACE TABLET WORKS

AMLACE TABLET is a vasodilator. It relaxes the blood vessels supplying the heart and other organs (such as kidneys). This improves blood flow and oxygen supply to the heart muscles which reduces strain on the heart.

It also allows blood to flow more smoothly across the blood vessels with less pressure. It can improve blood supply to the kidneys which helps in improving kidney functions among diabetic patients. As a result, it reduces blood pressure and improves the functions of the heart and the kidneys.

DIRECTIONS FOR USE

Take AMLACE TABLET as advised by your physician. Swallow the medicines with a glass of water. Do not crush or chew the medicine. AMLACE TABLET can be taken with or without food.

Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition.

Continue to take AMLACE TABLET for the stipulated duration instructed by your doctor to achieve better results.

SIDE EFFECTS OF AMLACE TABLET

COMMON

  • edema (swelling of the ankles or other body parts)
  • headache, dizziness, sleepiness
  • palpitations (fast heartbeat)
  • flushing (redness and warmth of the skin)
  • stomach pain, nausea, diarrhea, constipation, indigestion
  • changes in bowel habit
  • tiredness, weakness
  • blurred vision, double vision
  • muscle pains
  • dry cough, sinus inflammation

UNCOMMON

  • anxiety, depression
  • insomnia (sleeplessness)
  • changes in taste
  • tingling sensation in limbs, loss of pain sensation
  • ringing in the ears
  • increased sweating
  • increased urination at night
  • inability to obtain an erection, enlargement of the breasts in men
  • joint pain, back pain
  • increased potassium levels in blood

RARE

  • confusion
  • red, swollen tongue
  • loosening or separation of a nail from its bed
  • skin rash, itching, redness
  • red, itchy, swollen or watery eyes
  • low RBC, WBC and platelet counts

Stop taking AMLACE TABLET and contact your doctor immediately if you experience any of the following side effects:

  • signs of allergic reactions (such as skin rash, swelling of the face, lips, mouth or throat which can lead to difficulty in breathing or swallowing)
  • severe skin reactions (such as skin rash with itching and redness, blistering and peeling of skin, skin swelling and inflammation of mucous membrane)
  • chest pain, shortness of breath (signs of heart attack)
  • signs of stroke (such as weakness or numbness down on one side of the body, confusion, slurred speech, difficulty in concentrating)
  • signs of kidney failure (decreased urine, cloudy or blood in urine with low back pain, nausea or vomiting, fluid retention in legs, ankles or feet)
  • inflammation of pancreas (causing severe stomach pain that radiates to the back side of the body)
  • sever stomach pain due to obstruction of the gut or inflammation of pancreas
  • dizziness, fainting or lightheadedness, excessive sweating following an exercise or after regular activities (signs of low RBC count in blood)
  • signs of liver problems (such as fever, muscle pain, rashes, itching, stomach pain, diarrhea, discoloration of eyes, skin and urine)
  • increased infections, fever, bleeding or bruising

HOW TO MANAGE SIDE EFFECTS

Nausea and vomiting:

Take AMLACE TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if your nausea worsens.

Dizziness:

Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling dizzy. Do not consume excessive alcohol, as it could aggravate your dizziness. Consult your doctor if your dizziness worsens.

Headache:

Rest and relax. Keep yourself hydrated by drinking plenty of fluids such as water or electrolytes. Applying a pain-relieving balm on your forehead can be beneficial. Do not consume excessive alcohol, as it could aggravate your headache. Consult your doctor if your headache worsens.

Constipation:

Eat plenty of fibre rich foods such as fresh fruits, vegetables and cereals. Drink plenty of fluids. Exercise more regularly. Consult your doctor if this side effect bothers you.

WARNING & PRECAUTIONS

PREGNANCY

AMLACE TABLET is not recommended for use in pregnant women as it may cause serious harm to the growing fetus. Therefore, inform your doctor before taking this medicine if you are pregnant, think you may be pregnant or planning to have a baby. If you accidentally become pregnant while undergoing therapy with AMLACE TABLET, inform your doctor immediately.

BREASTFEEDING

AMLACE TABLET is not recommended for use in breast-feeding women. Therefore, consult your doctor before taking it.

DRIVING AND USING MACHINES

Do not drive or operate any heavy tools or machines if you feel dizzy after taking AMLACE TABLET.

ALCOHOL

Avoid consumption of alcohol while taking AMLACE TABLET as it may severely decrease your blood pressure and make you feel dizzier or faint.

KIDNEY

AMLACE TABLET is not recommended for use in patients with severe kidney impairment (including dialysis or narrowing or renal arteries). It should be used with caution in patients with other kidney problems (including kidney transplantation). Therefore, consult your doctor before taking it.

LIVER

AMLACE TABLET should be used with caution in patients with liver problems. Therefore, consult your doctor before taking it.

ALLERGY

Do not take AMLACE TABLET if you are allergic to Amlodipine, Lisinopril or to any other calcium antagonists (such as nifedipine, diltiazem) or ACE inhibitors (such as captopril, enalapril).

HEART DISEASE

AMLACE TABLET is not recommended for use in patients with severe heart problems such as heart failure, aortic stenosis (narrowing of arteries) or cardiogenic shock (inability of heart to pump blood). It should be used with caution in patients having a history of recent heart attack or heart failure. Therefore, consult your doctor before taking it.

OTHERS

AMLACE TABLET is not recommended for use if you:

  • have severe low blood pressure (hypotension)
  • have diabetes with impaired kidney functions

Before taking AMLACE TABLET, inform your doctor if you have:

  • severe uncontrollable increase in blood pressure (hypertensive crisis)
  • have problems in the blood vessels supplying the brain
  • are on a salt-restricted diet
  • are severely dehydrated due to any recent sickness such as vomiting or diarrhea
  • have low WBC, RBC and platelet count in the blood
  • have diabetes
  • have any autoimmune disease that affects the skin or collagen (Ex. lupus erythematosus, rheumatoid arthritis or scleroderma)
  • are scheduled for any upcoming surgery
  • are scheduled for LDL apheresis (a procedure to remove cholesterol from the blood)
  • have any desensitization treatment (used to reduce the effect of an allergy to bee or wasp stings)
  • have high blood potassium levels
  • previously had stroke or mini stroke

Use in Paediatrics:

AMLACE TABLET can be used in children and adolescents (aged between 6-18 years) if prescribed by a physician. It is not recommended for use in children aged below 6 years. Therefore, consult your doctor before consumption.

Use in Geriatrics:

AMLACE TABLET should be used with caution in elderly patients. Therefore, consult your doctor before taking it.

INTERACTIONS

A. Drug-Drug interactions:

Before taking AMLACE TABLET, inform your doctor if you are taking any of the following medicines such as:

  • racecadotril (a medicine used to treat diarrhea)
  • medicines that supplement potassium to the body (Ex. spironolactone, triamterene or amiloride)
  • trimethoprim containing antibiotics (used for infections)
  • medicines used to prevent organ transplant rejection (Ex. ciclosporin, temsirolimus, sirolimus, everolimus)
  • heparin (used to prevent blood clots)
  • medicines used for heart conditions such as hypertension, chest pain, irregular heartbeats or heart failure (Ex. atenolol, propranolol, furosemide, bumetanide, nitroglycerin, valsartan, aliskiren, procainamide, sacubitril/valsartan)
  • lithium (a medicine used in some types of mental illness)
  • tricyclic antidepressants (used to treat depression) Ex. amitriptyline
  • antipsychotics (used to treat serious mental illnesses) Ex. clozapine, risperidone
  • anesthetics (used to prevent pain during surgery) Ex. propofol, thiopental, proparacaine, lignocaine
  • medicines used to relieve pain (Ex. morphine, aspirin, ibuprofen, celecoxib, valdecoxib)
  • thrombolytics (used to dissolve blood clots) Ex. reteplase, tenecteplase
  • gold therapy (used to treat rheumatic conditions)
  • medicines used to suppress cough (such as dextromethorphan, guaiphenesin, pseudoephedrine)
  • anti-diabetic medicines and insulin (used to lower the blood glucose level) Ex. vildagliptin, metformin
  • other medicines used to treat high blood pressure or angina (Ex. diltiazem, verapamil)
  • ketoconazole, itraconazole (used to treat fungal infections)
  • ritonavir, indinavir, nelfinavir (used in treatment of HIV infections)
  • rifampicin, erythromycin, clarithromycin (used to treat bacterial infections)
  • dantrolene (a medicine used to treat muscle spasms)
  • medicines used to control elevated cholesterol levels (Ex. simvastatin)
  • St. John’s wort (an herbal medicine used to treat depression)

B. Drug - Food interaction:

Avoid drinking grapefruit juice while taking AMLACE TABLET, as it could reduce your blood pressure to an abnormal level.

Overdosage:

If you or anyone else accidentally took more AMLACE TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdosage might include dizziness, fainting, light-headedness, weakness, shock, cool or clampy skin, fast heartbeat, anxiety, cough and shortness of breath.

SYNOPSIS

Drug :   Amlodipine, Lisinopril
Pharmacological Category :   Calcium Channel Blockers, ACE inhibitors
Therapeutic Indication :   Hypertension, Angina, Heart Failure, Kidney Failure
Dosage Forms :   Tablet

MORE INFORMATION

  • Keep AMLACE TABLET out of the sight and reach of children
  • Store AMLACE TABLET at room temperature

FAQs ABOUT AMLACE TABLET

What are the uses of AMLACE TABLET?

AMLACE TABLET is used to treat hypertension (high blood pressure) and certain type of angina (chest pain). It can also be used to prevent heart failure and reduce the chances of hospitalization among the heart patients. It also protects the function of kidneys particularly in patients who have both hypertension and type II diabetes mellitus.

How AMLACE TABLET works?

AMLACE TABLET is a vasodilator. It relaxes the blood vessels supplying the heart and other organs. This improves blood flow and oxygen supply to the heart muscles which reduces strain on the heart. It also allows blood to flow more smoothly across the blood vessels with less pressure. It can improve blood supply to the kidneys which helps in improving kidney functions among diabetic patients. As a result, it reduces blood pressure and improves the functions of the heart and the kidneys.

What happens when I stop taking AMLACE TABLET?

Do not stop taking AMLACE TABLET without consulting your doctor as your symptoms may re-appear once again. Make sure to take AMLACE TABLET for the stipulated duration recommended by your doctor to achieve maximum results.

What is the best time to take AMLACE TABLET?

AMLACE TABLET can be taken with or without meals. Your doctor will decide the best time for you to take AMLACE TABLET based on your age, body weight and disease condition.

What to do if I forgot to take a dose of AMLACE TABLET?

If you have missed a dose of AMLACE TABLET, take it as soon as you remember. However, if it is time for the next dose of AMLACE TABLET, skip the missed dose and take the next one regularly. Do not take a double dose of AMLACE TABLET to compensate the missed ones.

What precautions should be followed while taking AMLACE TABLET?

Before taking AMLACE TABLET, inform your doctor if you have any liver or kidney problems. You must also inform your doctor if you have severe high or low blood pressure or other heart problems (such as narrowing of the arteries, cardiogenic shock or a recent heart attack). Do not take AMLACE TABLET if you are pregnant or breastfeeding. Regularly visit your doctor and take all the necessary blood tests recommended by your doctor without fail.

Can I consume alcohol while taking AMLACE TABLET?

Avoid consumption of alcohol while taking AMLACE TABLET as it might make you feel dizzier and drowsier.

What happens if I accidentally take more AMLACE TABLET?

If you or anyone else accidentally took more AMLACE TABLET, consult your doctor immediately. Symptoms of overdosage might include dizziness, fainting, light-headedness, weakness, shock, cool or clampy skin fast heartbeat, anxiety, cough and shortness of breath.

Can I take AMLACE TABLET daily?

Take AMLACE TABLET as advised by your physician. Your doctor will evaluate your health condition and suggests whether can you take AMLACE TABLET every day or not.

Can AMLACE TABLET cause ankle swelling?

AMLACE TABLET may cause edema or swelling of ankles in few patients. If you experience ankle swelling, keep your legs on a table or slightly elevated from the ground level. If this symptom bothers you, contact your doctor.

What are the side effects of AMLACE TABLET?

The most common side effects of taking AMLACE TABLET are dizziness, swelling of ankles or other body parts, headache, sleepiness, tiredness, racing heartbeat, indigestion, constipation and muscle cramps. Contact your doctor if any of these side effects trouble you.

Can I stop taking AMLACE TABLET once my symptoms subside?

No. Do not stop taking AMLACE TABLET without consulting your doctor. As hypertension is a chronic condition, long term treatment may be necessary to control its symptoms. Therefore, take AMLACE TABLET as advised by your doctor for the stipulated duration. Sudden withdrawal of the therapy may increase your blood pressure once again.

Can the use of AMLACE TABLET affect the liver?

Yes. AMLACE TABLET may affect the way your liver work. Therefore, it should be used with caution in patients with liver problems. Consult your doctor before taking it.

Can AMLACE TABLET cause erectile dysfunction?

AMLACE TABLET may cause problems in erection in few individuals. Consult your doctor if it bothers you.

Is AMLACE TABLET safe to use in diabetic patients?

AMLACE TABLET may alter the blood sugar levels in your body. It can also hide the symptoms of low blood sugar. Therefore, it is necessary to inform your doctor if you have diabetes before taking AMLACE TABLET as a precaution. Your doctor will closely monitor your blood sugar levels to avoid the risk of side effects. Also, inform your doctor if you experience any unusual tiredness, hunger or thirst while undergoing therapy with AMLACE TABLET.

Can AMLACE TABLET be used during pregnancy?

AMLACE TABLET is not recommended for use in pregnant women as it may cause serious harm to the growing foetus. Therefore, inform your doctor before taking AMLACE TABLET if you are pregnant, think you may be pregnant or planning to have a baby.

What kind of foods should be avoided while taking AMLACE TABLET?

AMLACE TABLET has the capacity to increase blood potassium level which can lead to irregular heartbeat. To prevent any such occurrence, it is advisable to avoid potassium rich foods such as bananas, oranges, green leafy vegetables and potassium containing supplements while taking AMLACE TABLET.

REFERENCES

1. KD. Tripathi. Antianginal and Other Anti-ischaemic Drugs. Antihypertensive Drugs. Cardiovascular drugs. Drugs affecting Renin-angiotensin system. Essentials of Medical Pharmacology. Seventh Edition. 2013. Page – 502, 549 & 562.

2. Amila Arslanagic, Irfan Zulic, Azra Bajraktarevic. Clinical study on safety and efficacy of the administration of amlodipine in a combination with lisinopril in hypertensive patients. NIH. National Library of Medicine. National Center for biotechnology information. Pubmed.gov. 2005. [Accessed on 8th December 2022]. https://pubmed.ncbi.nlm.nih.gov/16268059/

3. Accord Healthcare Limited. Electronic Medicines Compendium (EMC). [Revised in July 2021] [Accessed on 8th December 2022]. https://www.medicines.org.uk/emc/files/pil.6068.pdf

4. Gerard Laboratories. Electronic Medicines Compendium (EMC). [Revised in September 2021] [Accessed on 8th December 2022]. https://www.medicines.org.uk/emc/files/pil.10114.pdf

5. Zentiva Pharma UK Limited. Electronic Medicines Compendium (EMC). [Revised in December 2021] [Accessed on 8th December 2022]. https://www.medicines.org.uk/emc/files/pil.13960.pdf

6. Cipla Ltd. Amlopres-L Tablets (Amlodipine+Lisinopril). Ciplamed.com. [Revised in December 2019]. [Accessed on 8th December 2022]. https://www.ciplamed.com/content/amlopres-l-tablets

7. Central Drugs Standard Control Organization. Amlodipine besylate Eq. to Amlodipine 5mg + Lisinoril eq. to Lisinopril anhydrous 5mg tablet. March 1997. [Accessed on 8th December 2022]. https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadApprovalNewDrugs/dciApprovedfdc.pdf

USEFUL DIAGNOSTIC TESTS

  • Kidney Function Test

AUTHOR DETAILS

Written By Srilekha. R, B.Pharm
Last updated on 09 Dec 2022 | 01:30 PM(IST)

PRODUCT DETAILS
    Net Qty
    1 N
    Item Weight
    17.5 g
    Ingredient
    AMLODIPINE BESYLATE 5MG+LISINOPRIL 5MG
    Hsn Code
    30049072
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Amlace Tablet 10'S
Amlace Tablet 10'S Mkt: Usv Private Ltd
₹ 82.00 MRP ₹ 100.00