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INTRODUCTION
ACMETEL AM is a combination of Amlodipine and Telmisartan which belongs to a group of medicines called Antihypertensives. It is used to treat high blood pressure. High blood pressure (also known as hypertension) 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 of several organs, thus causing heart attack, heart or kidney failure, stroke, or even blindness.
Amlodipine is a Calcium channel blocker and Telmisartan is an Angiotensin-II antagonist. Collectively, they act together and reduces blood pressure by relaxing the blood vessels supplying the heart, thus making it easier for your heart to pump blood around your body.
Before taking ACMETEL AM inform your doctor if you have diabetes, low blood pressure, heart diseases and liver or kidney problems. ACMETEL AM is generally not recommended for use in pregnant women and in children (below 18 years). Consult your doctor before taking. Avoid grapefruit juice while taking ACMETEL AM as it may cause unwanted interactions. The common side effects of ACMETEL AM are dizziness, swelling in the ankle, tiredness, headache or upset stomach.
USES OF ACMETEL AM
- Treats High Blood Pressure (Hypertension)
HOW ACMETEL AM WORKS
ACMETEL AM effectively reduces blood pressure, where amlodipine acts by reducing the contractility of the heart muscles and telmisartan acts by blocking the actions of a peptide called Angiotensin – II, which is responsible for increasing blood pressure. Collectively, they relax the blood vessels supplying the heart, thus making it easier for your heart to pump blood around your body.
DIRECTIONS FOR USE
Take ACMETEL AM with or without food. Swallow it as a whole and do not crush or chew the medicine. Do not stop taking ACMETEL AM unless advised by your doctor.
SIDE EFFECTS OF ACMETEL AM
COMMON
- dizziness
- sleepiness
- ankle swelling (oedema)
- headache
- tiredness, weakness
- palpitations
- indigestion
- nausea
- diarrhea
- constipation
- double vision, visual disturbances
- muscle cramps
- flushing of the face or neck
UNCOMMON
- urinary tract infections
- upper respiratory tract infections (sore throat, common cold, inflamed sinus)
- anemia
- fainting
- hair loss
- vertigo (spinning sensation)
- slow heartbeat
- orthostatic hypotension (dizziness while standing up from sitting or lying position)
- increased sweating
- chest pain
- shortness of breath
- mood changes
- trembling
- ringing in ears
- numbness or tingling sensation in hands or legs
- dry mouth
- cough
- weight loss or gain
- back pain
- impotence (inability to achieve erection)
- altered taste
RARE
- confusion
- drowsiness
- fast heartbeat (tachycardia)
- rapid swelling of the skin and mucosa
- sepsis (high fever and severe illness)
- signs of low blood sugar (sweating, shakiness, increased hunger, fast heartbeat)
- eczema, redness of skin, rash
- tendon pain
- low platelet count (easy bruising or bleeding)
Stop taking ACMETEL AM and contact your doctor immediately if you experience any of the following side effects:
- severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis (skin rash, itching, blistering reddening of skin all over the body, peeling and swelling of the skin, swelling of mucous membrane)
- heart attack or irregular heartbeat
- signs of inflamed pancreas (severe stomach and back pain, usually felling unwell)
- sepsis (infection of blood due to severe infection occurs due to body’s extreme inflammatory response)
- severe allergic reactions (such as swelling of the face, lips, tongue, and/or throat which can lead to difficulty in breathing or swallowing)
HOW TO MANAGE SIDE EFFECTS
Headache:
Rest and drink plenty of fluids. Apply a wet or cold cloth to forehead and rest in a quiet, comfortable, dark room.
Constipation:
Take fiber rich foods in your diet such as fresh fruits, vegetables and whole grain cereals, and drink plenty of fluids. Exercise more regularly and stay active.
Nausea:
Try to take this medicine with, or just after, a meal or snack and stick to simple meals and do not eat oil rich or spicy food.
WARNING & PRECAUTIONS
PREGNANCY
ACMETEL AM is not recommended in early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby. Consult your doctor for advice.
BREASTFEEDING
ACMETEL AM may pass into breast milk in small amounts, hence it should be used with caution during breastfeeding. Consult your doctor for advice.
DRIVING AND USING MACHINES
Do not drive or operate any tools or machines if you experience dizziness, fainting or spinning sensation while taking ACMETEL AM.
ALCOHOL
Avoid consumption of alcohol while taking ACMETEL AM as it may make you feel dizzy.
KIDNEY
ACMETEL AM should be used with caution in patients with kidney disease (renal artery stenosis). Consult your doctor for advice.
LIVER
ACMETEL AM should be used with caution if you have liver disease (biliary obstruction). Consult your doctor for advice.
ALLERGY
Tell your doctor if you are allergic to Amlodipine or Telmisartan or any other ingredients of ACMETEL AM.
HEART DISEASE
ACMETEL AM is not recommended for use in patients with recent heart attack, aortic stenosis, cardiogenic shock, heart failure and should be used with caution in patient’s having unstable angina. Consult your doctor for advice.
OTHERS
Inform your physician before taking ACMETEL AM if you have or had,
- diabetes
- raised aldosterone levels
- low blood pressure (due to dehydration or salt deficiency in the body)
- elevated potassium levels in blood
Use in pediatrics:
ACMETEL AM is not recommended for use in children and adolescents less than 18 years of age. Consult your doctor for advice
Use in geriatrics:
ACMETEL AM should be used with caution in elderly patients particularly at higher doses. Consult your doctor for advice.
INTERACTIONS
A. Drug-Drug interactions:
Before taking ACMETEL AM, inform your doctor if you are taking:
- enalapril, lisinopril, ramipril (treats high blood pressure or heart failure)
- aliskiren (used to high blood pressure)
- lithium (used to treat mental illness such as depression)
- potassium-sparing diuretics (used to retain potassium levels in blood)
- acetylsalicylic acid or ibuprofen (treats pain and inflammation)
- cyclosporin (used to suppress overactive immune response)
- rifampicin, erythromycin, clarithromycin (used to treat bacterial infections)
- dantrolene infusion (used to treat body temperature abnormalities)
- sirolimus, temsirolimus and everolimus (used to alter the way your immune system works)
- ritonavir, nelfinavir, indinavir (used to treat HIV/AIDS)
- ketoconazole, itraconazole (used to treat fungal infection)
- diltiazem, verapamil (used to treat heart problems)
- diuretics such as hydrochlorothiazide, chlorthalidone (used to treat edema or high blood pressure)
- digoxin (treats heart conditions)
- simvastatin (lowers high cholesterol levels)
- baclofen (used to treat muscle spasm)
- amifostine (used to treat cancer)
- neuroleptics or antidepressants (used to treat depression or psychiatric disorders)
- heparin, (treats blood clot)
- st. john’s wort (herbal medicine)
B. Drug-Food interactions:
Do not eat grapefruit or drink grapefruit juice while taking ACMETEL AM as it increases the level of this medicine in the blood resulting in lower blood pressure than desired. Consult your doctor before taking it.
Overdosage:
If you or anyone else accidentally take too much of ACMETEL AM, consult your doctor immediately. Overdosage can cause severe low blood pressure such as fainting, dizziness, weakness and increase in heartrate.
SYNOPSIS
| Drug | : | Amlodipine, Telmisartan |
| Pharmacological Category | : | Calcium channel blockers, Angiotensin-II receptor blockers |
| Therapeutic Indication | : | High blood pressure |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep ACMETEL AM out of reach of children
- Store ACMETEL AM at room temperature
FAQs ABOUT ACMETEL AM
What will happen if I stop taking ACMETEL AM?
You should not stop taking ACMETEL AM without talking to your doctor first as it may increase the blood pressure.
Is it safe to take ACMETEL AM for a long time?
Yes, it is safe to take ACMETEL AM for long time, if advised by your doctor. Your doctor will determine the dose and duration of treatment depending upon the condition and response to the treatment in managing your blood pressure.
What happens if I forget to take ACMETEL AM?
If you miss a dose taking ACMETEL AM, take it as soon as you remember and do not double the dose.
How can I effectively control my blood pressure while taking ACMETEL AM?
Your doctor may generally advice you to do regular physical exercises, lifestyle changes and dietary changes, especially salt restricted diet. Reducing stress will effectively help in controlling blood pressure rather than taking ACMETEL AM alone.
Can I take ACMETEL AM before driving?
Do not take ACMETEL AM before driving as it can cause side effects such as dizziness, sleepiness, vertigo, or tiredness. If this is a matter of concern, consult your doctor for alternative medicines.
REFERENCES
1. KD Tripathi MD. Antihypertensive drugs. Essentials of Medical Pharmacology 7th ed. New Delhi, May 2013. Page – 561.
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 23rd March 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4129356/
3. Telmisartan/Amlodipine Alembic. [Accessed on 23rd March 2022] https://mri.cts-mrp.eu/Human/Downloads/EE_H_0301_003_FinalPL.pdf
4. Actavis Ltd. Electronic Medicines Compendium (EMC). [Revised in July 2021] [Accessed on 23rd March 2022] https://www.medicines.org.uk/emc/files/pil.12400.pdf
5. Dr. Reddy’s Laboratories (UK) Ltd. Electronic Medicines Compendium (EMC). [Revised in August 2018] [Accessed on 23rd March 2022] https://www.medicines.org.uk/emc/files/pil.3478.pdf
6. Sanofi India Limited. Windlas Biotech Private Limited. [Revised on July, 2019] [Accessed on 23rd March 2022] https://www.sanofi.in/-/media/Project/One-Sanofi-Web/Websites/Asia-Pacific/Sanofi-IN/Home/science-and-innovation/for-healthcare-professionals/product-information/Telsite-am-PI-June-2018.pdf?la
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- Kidney Function Test
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