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INTRODUCTION
AMLODAC T TABLET is a combination of Amlodipine and Telmisartan which belongs to the group of medicines called Antihypertensive agents. It is used in adults to treat hypertension (high blood pressure) when treatment with single agents is not effective.
Hypertension (also known as high blood pressure) is a medical condition in which the force of the blood exerted against the walls of the artery remains very high, and as a result it may lead to severe damage to the blood vessels supplying several vital organs, such as heart, kidney, or brain. If left untreated, it may cause serious complications such as heart attack, heart failure, stroke or even blindness.
By lowering blood pressure, AMLODAC T TABLET can also reduce the risk of heart attack (myocardial infarction) or stroke. It can also be used to prevent angina pectoris (chest pain caused due to low oxygen supply).
During treatment with AMLODAC T TABLET your doctor will constantly monitor your kidney functions, blood pressure and blood sugar levels to avoid the risk of unwanted side effects. Avoid eating grapefruit or drinking grapefruit juice while taking AMLODAC T TABLET as it may severely decrease your blood pressure.
Before taking AMLODAC T TABLET inform your doctor if you have any heart, liver, or kidney problems. You must also inform your doctor if you have diabetes, low blood pressure or are severely dehydrated due to excessive vomiting or diarrhea.
AMLODAC T TABLET is also not suitable for use in pregnant or breastfeeding women as it may cause serious harm to the growing baby. Stop taking AMLODAC T TABLET and inform your doctor immediately if you become pregnant while undergoing therapy with AMLODAC T TABLET.
The most common side effects of taking AMLODAC T TABLET are low blood pressure, dizziness, tiredness, headache, sleepiness, swollen ankles, and flushing. Contact your doctor if any of these side effect worsens.
USES OF AMLODAC T TABLET
- Treats Hypertension (high blood pressure)
- Treats Angina (chest pain)
- Prevents the risk of heart attack or stroke
HOW AMLODAC T TABLET WORKS
AMLODAC T TABLET effectively controls blood pressure in patients with hypertension. It contains two medicines namely, amlodipine and telmisartan. Telmisartan blocks the actions of certain hormones (angiotensin-II) in the body that causes narrowing of blood vessels and increase in blood pressure.
Amlodipine is a vasodilator. It relaxes the blood vessels by blocking the entry of certain ions (calcium ions) within them that causes narrowing. This allows blood to flow more smoothly across the blood vessels. Collectively, they reduce the strain on the heart and helps the heart to pump blood more smoothly with less pressure.
DIRECTIONS FOR USE
Take AMLODAC T TABLET as directed by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Try to take AMLODAC T TABLET at the same time each day. AMLODAC T 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 health condition. Continue to take AMLODAC T TABLET for the stipulated duration instructed by your doctor without any interruption to achieve better results.
SIDE EFFECTS OF AMLODAC T TABLET
COMMON
- low blood pressure
- swelling of ankles and legs (edema)
- headache, dizziness
- nausea, vomiting, stomach pain, constipation, diarrhea, indigestion
- sleepiness
- abnormal heartbeat (fast or slow)
- muscle cramps
- flushing (warmth and redness of face and neck)
- feeling tired or weak
- vision problems
UNCOMMON
- urinary tract infections, difficulty in passing urine, urge to urinate
- sore throat, common cold
- high blood potassium levels (causing muscle weakness, irregular heartbeat, chest pain)
- difficulty in falling asleep
- feeling depressed or anxious, changes in mood
- vertigo (spinning sensation), shakiness
- orthostatic hypotension (dizziness while standing up from sitting or lying position)
- increased sweating
- back pain, tingling of numbness of body parts
- changes in taste
- ringing in the ears
- dry nose, dry mouth
- hair loss
- impotence (inability to obtain an erection), breast enlargement in men
- changes in body weight
RARE
Stop taking AMLODAC T TABLET and contact your doctor immediately if you experience any of the following side effects such as:
- 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
- inflammation of pancreas (causing severe stomach pain that radiates to the back side of the body)
- sepsis (infection of blood characterized by sever signs of illness and fever)
HOW TO MANAGE SIDE EFFECTS
Nausea and vomiting:
Take AMLODAC T 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.
WARNING & PRECAUTIONS
PREGNANCY
AMLODAC T 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 AMLODAC T TABLET if you are pregnant, think you may be pregnant or planning to have a baby. If you become pregnant while undergoing therapy with AMLODAC T TABLET, stop taking it and consult your doctor immediately.
BREASTFEEDING
AMLODAC T TABLET is not recommended for use in breastfeeding women. Therefore, consult your doctor before taking it.
DRIVING AND USING MACHINES
Do not drive or handle any heavy tools or machines if you experience dizziness or drowsiness after taking AMLODAC T TABLET.
ALCOHOL
Avoid consumption of alcohol while taking AMLODAC T TABLET as it might make you feel dizzier and drowsier.
KIDNEY
AMLODAC T TABLET should be used with caution in patients with kidney problems (such as kidney transplant, narrowing of renal arteries). Therefore, consult your doctor before taking it.
LIVER
AMLODAC T TABLET is not recommended for use in patients with severe liver impairment (such as cholestasis, jaundice, biliary obstruction). It should be used with caution in patients with mild to moderate liver problems. Therefore, consult your doctor before taking it.
ALLERGY
Do not take AMLODAC T TABLET if you are allergic to Amlodipine or Telmisartan.
HEART DISEASE
AMLODAC T TABLET should be used with caution in patients with heart problems (such as irregular heart rhythm, heart failure, recent heart attack, and problems with heart muscle or valves). Therefore, consult your doctor before taking it.
OTHERS
AMLODAC T TABLET is not recommended for use if you:
- have cardiogenic shock (heart cannot pump blood suddenly)
- have diabetes related kidney problems
Before taking AMLODAC T TABLET, inform your doctor if you:
- have primary hyperaldosteronism (problems in adrenal gland)
- have low blood pressure or are severely dehydrated (due to diarrhea, vomiting or excess sweating)
- have diabetes
- have hyperkalemia (high blood potassium levels)
- have unstable angina (a type of chest pain)
- have narrowing of arteries
Use in pediatrics:
AMLODAC T TABLET is not recommended for use in children and adolescents (aged below 18 years). Therefore, consult your doctor for advice.
Use in geriatrics:
AMLODAC T TABLET should be used with caution in the elderly patients. Therefore, consult your doctor before taking it.
INTERACTIONS
A. Drug-Drug interactions:
Before taking AMLODAC T TABLET, inform your doctor if you are taking any of the following medicines such as:
- other medicines used to treat elevated blood pressure (such as aliskiren, captopril, enalapril, lisinopril, verapamil, diltiazem, losartan, valsartan)
- lithium, St. John’s wort (medicines used to treat depression)
- potassium supplements or potassium-sparing diuretics such as spironolactone, triamterene or amiloride (used to retain or increase potassium levels in the body)
- non-steroidal anti-inflammatory drugs (used for pain relief) such as indomethacin, celecoxib, ibuprofen, aspirin
- heparin (a medicine used to prevent or treat blood clots)
- medicines used to treat bacterial infections (Ex. erythromycin, clarithromycin, telithromycin, trimethoprim)
- medicines to suppress immune system (Ex. cyclosporin, tacrolimus, sirolimus, temsirolimus and everolimus)
- dantrolene (a medicine used to treat muscle spasm)
- medicine used to treat HIV infection (Ex. indinavir, ritonavir, saquinavir)
- medicines used to treat fungal infections (Ex. itraconazole, ketoconazole and fluconazole)
- digoxin (a medicine used to treat irregular heartbeat)
- simvastatin (a medicine used to lower blood cholesterol levels)
- baclofen (a medicine used for relaxing muscles)
- amifostine (a kidney protectant used along with chemotherapeutic agents)
- medicines used to treat mental disorders such as depression, psychosis, or anxiety (Ex. pimozide, amisulpride, haloperidol)
- corticosteroids (used to treat inflammation) Ex. prednisolone
B. Drug-Food interactions:
Do not eat grapefruit or drink grapefruit juice while taking AMLODAC T TABLET as it may increase the risk of side effects.
Overdosage:
If you or anyone else accidentally took more AMLODAC T TABLET, consult your doctor immediately. Overdosage may cause low blood pressure, abnormal heartbeat, and dizziness.
SYNOPSIS
| Drug | : | Amlodipine, Telmisartan |
| Pharmacological Category | : | Calcium channel blocker, Angiotensin II Receptor Blocker |
| Therapeutic Indication | : | Hypertension, Angina, Prevention of Heart Attack or Stroke |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep AMLODAC T TABLET out of reach of children
- Store AMLODAC T TABLET at room temperature
FAQs ABOUT AMLODAC T TABLET
What are the uses of AMLODAC T TABLET?
AMLODAC T TABLET is used to treat hypertension in adults. It can also be used to treat angina and can prevent the risk of heart attack or stroke.
What type of a medicine is AMLODAC T TABLET?
AMLODAC T TABLET is an antihypertensive medicine. It is a combination of two medicines namely amlodipine and telmisartan. Amlodipine is a calcium channel blocker and telmisartan is an angiotensin-II receptor blocker. They both reduces strain on the heart, relaxes blood vessels and makes the heart to pump more blood with lesser force.
What happens when I stop taking AMLODAC T TABLET?
Do not stop taking AMLODAC T TABLET without consulting your doctor as your blood pressure may raise once again. Make sure to take AMLODAC T TABLET for the stipulated duration recommended by your doctor to achieve maximum results.
What is the best time to take AMLODAC T TABLET?
AMLODAC T TABLET can be taken with or without meals. Your doctor will decide the best time for you to take AMLODAC T TABLET based on your age, body weight and disease condition.
What to do if I forgot to take a dose of AMLODAC T TABLET?
If you forgot to take a dose of AMLODAC T TABLET, take it as soon as you remember. However, if it is time for the next dose of AMLODAC T TABLET, skip the missed dose and take the next one regularly. Do not take a double dose of AMLODAC T TABLET to compensate the missed ones.
What precautions should be followed while taking AMLODAC T TABLET?
Before taking AMLODAC T TABLET, inform your doctor if you have any heart, liver or kidney problems. You must also inform your doctor if you have diabetes, low blood pressure volume or are severely dehydrated. Stop taking AMLODAC T TABLET and consult your doctor immediately if you become pregnant. Regularly visit your doctor and take all the necessary blood test recommended by your doctor without fail.
Can I consume alcohol while taking AMLODAC T TABLET?
Avoid consumption of alcohol while taking AMLODAC T TABLET as it might make you feel dizzier and drowsier.
What happens if I accidentally take more AMLODAC T TABLET?
If you or anyone else accidentally took more AMLODAC T TABLET, consult your doctor immediately. Overdosage may cause low blood pressure, abnormal heartbeat, fainting, drowsiness, nausea, vomiting or confusion.
Can I take AMLODAC T TABLET daily?
Take AMLODAC T TABLET as advised by your physician. Your doctor will evaluate your health condition and suggests whether can you take AMLODAC T TABLET every day or not.
Is AMLODAC T TABLET safe to use in diabetic patients?
AMLODAC T TABLET may alter the blood sugar levels in your body. Therefore, it is necessary to inform your doctor if you have diabetes before taking AMLODAC T TABLET as a precaution. Your doctor will closely monitor you blood sugar levels to avoid the risk of side effects.
What are the side effects of AMLODAC T TABLET?
The most common side effects of taking AMLODAC T TABLET are low blood pressure, dizziness, tiredness, headache, sleepiness, swollen ankles, and flushing. Contact your doctor if any of these side effect worsens.
Can I stop taking AMLODAC T TABLET once my symptoms subside?
No. Do not stop taking AMLODAC T TABLET without consulting your doctor. As hypertension is a chronic condition, long term treatment may be necessary to control its symptoms. Therefore, take AMLODAC T TABLET as advised by your doctor for the stipulated duration. Premature discontinuation of therapy may increase your blood pressure once again.
Can AMLODAC T TABLET be taken during pregnancy?
AMLODAC T 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 AMLODAC T TABLET if you are pregnant, think you may be pregnant or planning to have a baby. If you become pregnant while undergoing therapy with AMLODAC T TABLET, stop taking it and consult your doctor immediately.
Is AMLODAC T TABLET safe to use in kidney disease?
AMLODAC T TABLET should be used with caution in patients with kidney diseases (such as those having renal artery stenosis, kidney transplant or in those undergoing haemodialysis). Your doctor will access your health condition and suggest a suitable dose for you. Therefore, it is important to inform your doctor if you have any kidney problems before taking AMLODAC T TABLET as a precaution.
Can the use of AMLODAC T TABLET affect the liver?
Yes. AMLODAC T TABLET may affect the way your liver work. It can elevate the levels of certain liver enzymes in your body. Therefore, it is strictly not recommended for use in patients with severe liver diseases. It should be used with caution in patients with other minor liver problems. Consult your doctor before taking it.
REFERENCES
1. KD Tripathi. Antihypertensive drugs. Essentials of Medical Pharmacology. Seventh edition. 2013. Page – 561 &562.
2. Jaswant Goyal, Zafer Yab Khan, Prerna Upadhyaya, Barkha Goyal and Shipra Jain. Comparative Study of High Dose Monotherapy of Amlodipine or Telmisartan, and Their Low Dose Combination in Mild to Moderate Hypertension. June 20, 2014. [Accessed on July 23, 2021] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4129356/
3. Sang-Hyun Ihm,1 Hui-Kyung Jeon,1 Tae-Joon Cha,2 Taek-Jong Hong,3 Sang-Hyun Kim,4 Nae-Hee Lee,5 Jung Han Yoon,6 Namsik Yoon,7 Kyung-Kuk Hwang,8 Sang-Ho Jo,9 and Ho-Joong Youn. Efficacy and safety of two fixed-dose combinations of S-amlodipine and telmisartan (CKD-828) versus S-amlodipine monotherapy in patients with hypertension inadequately controlled using S-amlodipine monotherapy: an 8-week, multicenter, randomized, double-blind, Phase III clinical study. NIH. National Library of Medicine. National Center of Biotechnology Information. PMC. PubMed Central. November 2016. [Accessed on 15th August 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5125808/
4. Glenmark Arzneimittel GmbH. Electronic Medicines Compendium (EMC). [Revised in November 2019] [Accessed on 14th July 2022] https://www.medicines.org.uk/emc/files/pil.9981.pdf
5. Dr. Reddy’s Laboratories (UK) Ltd. Electronic Medicines Compendium (EMC). [Revised in August 2018] [Accessed on 14th July 2022] https://www.medicines.org.uk/emc/files/pil.3478.pdf
6. Bristol Laboratories Ltd. Electronic Medicines Compendium (EMC). [Revised in August 2018] [Accessed on 14th July 2022] https://www.medicines.org.uk/emc/product/11442/smpc#DOCREVISION
7. Boehringer Ingelheim Pharma GmbH & Co. KG. European Medical Agency (EMA). [Accessed on 14th July 2022] https://www.ema.europa.eu/en/documents/product-information/twynsta-epar-product-information_en.pdf
8. Alembic Pharmaceuticals Limited. Dailymed.com. [Revised in September 2019]. [Accessed on 14th July 2022] https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15b438b4-4874-43f4-a50a-4e6f3e5530ac#:~:text=the%20risk%20...-,Telmisartan%20and%20amlodipine%20tablets%20are%20indicated%20for%20the%20treatment%20of,primarily%20strokes%20and%20myocardial%20infarctions.
9. Cipla Ltd. CRESAR AM Tablets (Telmisartan + Amlodipine). Ciplamed. [Revised on March 2020]. [Accessed on 14th July 2022] https://www.ciplamed.com/content/cresar-am-tablets
USEFUL DIAGNOSTIC TESTS
- Kidney Function Test
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