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INTRODUCTION
AMLOSAFE 3D TABLET is a combination of Amlodipine, Hydrochlorothiazide and Telmisartan which belongs to the group of medicines called Antihypertensive agents. It is used 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, AMLOSAFE 3D TABLET can also reduce the risk of heart attack (myocardial infarction) or stroke. It can also be used to treat and prevent angina pectoris (chest pain caused due to low oxygen supply).
During treatment with AMLOSAFE 3D TABLET your doctor will constantly monitor your kidney functions, blood pressure, electrolyte levels and blood sugar levels to avoid the risk of unwanted side effects. Avoid eating grapefruit or drinking grapefruit juice while taking AMLOSAFE 3D TABLET as it may severely decrease your blood pressure.
Before taking AMLOSAFE 3D 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.
AMLOSAFE 3D TABLET is also not suitable for use in pregnant or breastfeeding women as it may cause serious harm to the growing baby. Stop taking AMLOSAFE 3D TABLET and inform your doctor immediately if you become pregnant while undergoing therapy with AMLOSAFE 3D TABLET.
The most common side effects of taking AMLOSAFE 3D 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 AMLOSAFE 3D TABLET
- Treats Hypertension (high blood pressure)
- Treats Angina (chest pain)
- Prevents the risk of heart attack or stroke
HOW AMLOSAFE 3D TABLET WORKS
AMLOSAFE 3D TABLET is an antihypertensive medicine. It relaxes your blood vessels and improves blood flow across them. It also reduces thickness of the blood by removing excess fluids from the body in the form of urine. Collectively, it reduces the strain on the heart and helps the heart to pump blood more smoothly with less pressure.
DIRECTIONS FOR USE
Take AMLOSAFE 3D TABLET as directed by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Try to take AMLOSAFE 3D TABLET at the same time each day. AMLOSAFE 3D 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 AMLOSAFE 3D TABLET for the stipulated duration instructed by your doctor without any interruption to achieve better results.
SIDE EFFECTS OF AMLOSAFE 3D 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 AMLOSAFE 3D 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 AMLOSAFE 3D 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
AMLOSAFE 3D 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 AMLOSAFE 3D TABLET if you are pregnant, think you may be pregnant or planning to have a baby. If you become pregnant while undergoing therapy with AMLOSAFE 3D TABLET, stop taking it and consult your doctor immediately.
BREASTFEEDING
AMLOSAFE 3D 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 AMLOSAFE 3D TABLET.
ALCOHOL
Avoid consumption of alcohol while taking AMLOSAFE 3D TABLET as it might make you feel dizzier and drowsier.
KIDNEY
AMLOSAFE 3D TABLET is not recommended for use in patients with severe kidney problems. It should be used with caution in patients with other kidney problems (such as kidney transplant, narrowing of renal arteries). Therefore, consult your doctor before taking it.
LIVER
AMLOSAFE 3D 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 AMLOSAFE 3D TABLET if you are allergic to Amlodipine, Telmisartan or Hydrochlorothiazide.
HEART DISEASE
AMLOSAFE 3D TABLET is not recommended for use in patients with serious heart problem (such as heart failure or heart attack). It 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
AMLOSAFE 3D TABLET is not recommended for use if you:
- have cardiogenic shock (heart cannot pump blood suddenly)
- have diabetes related kidney problems
Before taking AMLOSAFE 3D 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)
- are low sodium diet
- have diabetes
- have hyperkalemia (high blood potassium levels)
- have unstable angina (a type of chest pain)
- have narrowing of arteries
- have gout (painful joints)
- have had skin cancer
Use in pediatrics:
AMLOSAFE 3D TABLET is not recommended for use in children and adolescents (aged below 18 years) due to lack of safety data. Therefore, consult your doctor for advice.
Use in geriatrics:
AMLOSAFE 3D TABLET should be used with caution in the elderly patients. Therefore, consult your doctor before taking it.
INTERACTIONS
A. Drug - Drug interactions:
Before taking AMLOSAFE 3D TABLET, inform your doctor if you are taking any of the following medicine such as:
- antidepressants such as lithium, citalopram, fluoxetine, paroxetine, nefazodone, St. John’s wort (herbal medicine used to treat depression)
- other medicines used to treat elevated blood pressure (such as aliskiren, bosentan, methyldopa, guanethidine, captopril, enalapril, lisinopril, verapamil, diltiazem, losartan, valsartan)
- 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)
- 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)
- 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
- allopurinol (a medicine used to treat gout)
- cyclophosphamide or methotrexate (medicine used to treat cancer)
- laxatives (used to treat constipation) Ex. lactulose
- simvastatin, cholestyramine and colestipol (medicines to lower the cholesterol)
- insulin, metformin (medicines used to treat diabetes)
- tubocurarine, dantrolene (medicine used as a muscle relaxant)
- calcium supplements and/or vitamin D supplements
- atropine or biperiden used for abdominal or stomach spasms or cramps
- amantadine (medicine used to treat Parkinson’s disease)
- medicines to control the heart rhythm (Ex. quinidine, disopyramide, amiodarone, sotalol, digoxin)
- medicines used to treat mental disorders (Ex. thioridazine, chlorpromazine, levomepromazine)
- medicines to treat allergic reactions (Ex. terfenadine)
B. Drug-Food interactions:
Do not eat grapefruit or drink grapefruit juice while taking AMLOSAFE 3D TABLET as it may increase the risk of side effects
Overdosage:
If you or anyone else accidentally took more AMLOSAFE 3D TABLET, consult your doctor immediately. Overdosage may cause low blood pressure, abnormal heartbeat, and dizziness.
SYNOPSIS
| Drug | : | Amlodipine, Telmisartan, Hydrochlorothiazide |
| Pharmacological Category | : | Calcium channel blocker, Angiotensin II Receptor Blocker, Thiazide diuretics |
| Therapeutic Indication | : | Hypertension, Angina, Prevention of Heart Attack or Stroke |
| Dosage Forms | : | Tablet, Capsule |
MORE INFORMATION
- Keep AMLOSAFE 3D TABLET out of reach of children
- Store AMLOSAFE 3D TABLET at room temperature
FAQs ABOUT AMLOSAFE 3D TABLET
What are the uses of AMLOSAFE 3D TABLET?
AMLOSAFE 3D TABLET is used to treat hypertension. It can also be used to treat angina and can prevent the risk of heart attack or stroke.
What type of a medicine is AMLOSAFE 3D TABLET?
AMLOSAFE 3D TABLET is an antihypertensive medicine. It relaxes your blood vessels and improves blood flow across them. It also reduces thickness of the blood by removing excess fluids from the body in the form of urine. Collectively, it reduces the strain on the heart and helps the heart to pump blood more smoothly with less pressure.
What happens when I stop taking AMLOSAFE 3D TABLET?
Do not stop taking AMLOSAFE 3D TABLET without consulting your doctor as your blood pressure may raise once again. Make sure to take AMLOSAFE 3D TABLET for the stipulated duration recommended by your doctor to achieve maximum results.
What is the best time to take AMLOSAFE 3D TABLET?
AMLOSAFE 3D TABLET can be taken with or without meals. Your doctor will decide the best time for you to take AMLOSAFE 3D TABLET based on your age, body weight and disease condition.
What to do if I forgot to take a dose of AMLOSAFE 3D TABLET?
If you forgot to take a dose of AMLOSAFE 3D TABLET, take it as soon as you remember. However, if it is time for the next dose of AMLOSAFE 3D TABLET, skip the missed dose and take the next one regularly. Do not take a double dose of AMLOSAFE 3D TABLET to compensate the missed ones.
What precautions should be followed while taking AMLOSAFE 3D TABLET?
Before taking AMLOSAFE 3D 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 AMLOSAFE 3D 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 AMLOSAFE 3D TABLET?
Avoid consumption of alcohol while taking AMLOSAFE 3D TABLET as it might make you feel dizzier and drowsier.
What happens if I accidentally take more AMLOSAFE 3D TABLET?
If you or anyone else accidentally took more AMLOSAFE 3D TABLET, consult your doctor immediately. Overdosage may cause low blood pressure, abnormal heartbeat, fainting, drowsiness, nausea, vomiting or confusion.
Can I take AMLOSAFE 3D TABLET daily?
Take AMLOSAFE 3D TABLET as advised by your physician. Your doctor will evaluate your health condition and suggests whether can you take AMLOSAFE 3D TABLET every day or not.
Is AMLOSAFE 3D TABLET safe to use in diabetic patients?
AMLOSAFE 3D TABLET may alter the blood sugar levels in your body. Therefore, it is necessary to inform your doctor if you have diabetes before taking AMLOSAFE 3D 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 AMLOSAFE 3D TABLET?
The most common side effects of taking AMLOSAFE 3D 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 AMLOSAFE 3D TABLET once my symptoms subside?
No. Do not stop taking AMLOSAFE 3D TABLET without consulting your doctor. As hypertension is a chronic condition, long term treatment may be necessary to control its symptoms. Therefore, take AMLOSAFE 3D TABLET as advised by your doctor for the stipulated duration. Premature discontinuation of therapy may increase your blood pressure once again.
Can AMLOSAFE 3D TABLET be taken during pregnancy?
AMLOSAFE 3D 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 AMLOSAFE 3D TABLET if you are pregnant, think you may be pregnant or planning to have a baby. If you become pregnant while undergoing therapy with AMLOSAFE 3D TABLET, stop taking it and consult your doctor immediately.
Is AMLOSAFE 3D TABLET safe to use in kidney disease?
AMLOSAFE 3D TABLET is not recommended for use in patients with severe kidney problems. It should be used with caution in patients with other kidney problems (such as kidney transplant, narrowing of renal arteries). 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 AMLOSAFE 3D TABLET as a precaution.
Can the use of AMLOSAFE 3D TABLET affect the liver?
Yes. AMLOSAFE 3D 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. Drugs Affecting Renin-Angiotensin System and Plasma Kinins. Essentials of medical pharmacology. Seventh edition. 2013. Page – 559, 505-508, & 561 &562.
2. Jitsuo Higaki, Issei Komuro, Kosuke Shiki, Ganghyuck Lee, Atsushi Taniguchi, Hiroshi Ikeda, Daisuke Kuroki, Seiichiro Nishimura and Toshio Ogihara. Effect of hydrochlorothiazide in addition to telmisartan/amlodipine combination for treating hypertensive patients uncontrolled with telmisartan/amlodipine: a randomized, double-blind study. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed Central. October 2016. [Accessed on 4th November 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5339800/
3. P. F. ADRIAN MAGEE AND EDWARD D. FREIS. Is Low-Dose Hydrochlorothiazide Effective? Veterans Administration and Georgetown University Medical Centers, Washington, D.C. [Accessed on 4th November 2022] https://www.ahajournals.org/doi/pdf/10.1161/01.hyp.8.6_pt_2.ii135
4. Dr. Reddy’s Laboratories (UK) Ltd. Electronic Medicines Compendium (EMC). [Revised in August 2018] [Accessed on 4th November 2022] https://www.medicines.org.uk/emc/files/pil.3478.pdf
5. Bristol Laboratories Ltd. Electronic Medicines Compendium (EMC). [Revised in August 2018] [Accessed on 4th November 2022] https://www.medicines.org.uk/emc/product/11442/smpc#DOCREVISION
6. 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
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. Accord Healthcare Limited. Electronic Medicines Compendium (EMC). [Revised on June 2020] [Accessed 17th August 2021] https://www.medicines.org.uk/emc/files/pil.8605.pdf
9. Cipla Ltd. Cresar Plus Tablet (Telmisartan+Hydrochlorthiazide+Amlodipine). Ciplamed.com. [Revised in September 2020]. [Accessed on 4th November 2022] https://ciplamed.com/content/cresar-plus-tablets
10. Torrent Pharmaceuticals Ltd. Telday Trio (Telmisartan, Amlodipine and Hydrochlorthiazide Tablets). [Revised in September 2015]. [Accessed on 4th November 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2599.pdf
USEFUL DIAGNOSTIC TESTS
- Kidney Function Test
AUTHOR DETAILS
Written By Srilekha. R, B.Pharm
Last updated on 07 Nov 2022 | 02:26 PM(IST)
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