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Translol XL AM Tablet 10'S
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INTRODUCTION
TRANSLOL XL AM TABLET is a combination of Amlodipine and Metoprolol which belongs to the group of medicines called Anti-hypertensives. It is used to treat (hypertension). It is a condition in which the force of the blood against the blood vessel walls is too high which is characterized by symptoms such as headache, irregular heartbeat, vision changes, feeling of overtiredness, nausea, vomiting, confusion, anxiety and chest pain.
During treatment with TRANSLOL XL AM TABLET practice regular exercise (such as walking), eating healthy and salt-restricted diet and managing weight will also help to control your blood pressure effectively. Avoid taking grapefruit or its juice while taking TRANSLOL XL AM TABLET as it may increase the blood pressure lowering effect of this medicine.
TRANSLOL XL AM TABLET is not recommended for use in patients with lungs problems (such as asthma, chronic obstructive pulmonary disease), kidney disease or failure, liver disease, heart problems (such as heart conduction or rhythm problems, severe or uncontrolled heart failure), metabolic acidosis and low blood pressure.
Before taking TRANSLOL XL AM TABLET, inform your doctor if you have controlled heart failure and slow heart rate, diabetes mellitus, blood vessel disorder, psoriasis (severe skin rashes), myasthenia gravis and hypertensive crisis (severe increase in blood pressure).
TRANSLOL XL AM TABLET is not recommended for use in pregnant and breast-feeding women. TRANSLOL XL AM TABLET is not recommended for use in children and adolescents (aged under 18 years). It should be used with caution in elderly patients (aged 65 years and above).
The most common side effects of taking TRANSLOL XL AM TABLET are dizziness, headache, tiredness, nausea, slow heart rate or stomach pain. Consult your doctor if any of the side effects worsen.
USES OF TRANSLOL XL AM TABLET
- Treats High Blood Pressure (hypertension)
HOW TRANSLOL XL AM TABLET WORKS
TRANSLOL XL AM TABLET helps to reduce high blood pressure, where amlodipine works by inhibiting the movement of calcium ions into both vascular smooth muscle and cardiac muscle resulting in lower blood pressure by relaxing the blood vessels and improving the flow of blood to the heart muscles. Metoprolol works by reducing the force of contraction of the heart muscles by the blocking the effects of certain hormones called adrenaline and making the heart to beat more easily thus it lowers the blood pressure.
DIRECTIONS FOR USE
Take TRANSLOL XL AM TABLET as advised by your physician. Swallow TRANSLOL XL AM TABLET with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF TRANSLOL XL AM TABLET
COMMON
- tiredness
- headache, dizziness
- slow heart rate
- feeling faint on standing due to low blood pressure
- shortness of breath with or without strenuous physical activity
- nausea or vomiting
- stomach pain
- visual disturbances or double vision
- muscle cramps
- ankle swelling
UNCOMMON
- mood changes, anxiety, depression, sleeplessness
- trembling, taste abnormalities, fainting
- numbness or tingling sensation in your limbs, loss of pain sensation
- ringing in the ears
- low blood pressure
- sneezing/running nose caused by inflammation of the lining of the nose (rhinitis)
- cough, dry mouth
- hair loss, increased sweating, itchy skin, red patches on skin, skin discolouration
- disorder in passing urine, increased need to urinate at night, increased number of times of passing urine
- inability to obtain an erection, discomfort or enlargement of the breasts in men
- pain, feeling unwell
- joint or muscle pain, back pain
- weight increase or decrease
RARE
- nightmares
- nervousness, anxiety
- sexual dysfunction or reduced sex drive
- inability to think clearly
- sleepiness or difficulty in sleeping
- difficulty breathing
- heart failure, irregular heart rate
- palpitation
- water retention causing swelling
- raynaud’s phenomenon (causing pain, numbness, coldness and blueness of the fingers)
- diarrhoea or constipation
- skin rash
- muscle cramps
Stop taking TRANSLOL XL AM TABLET and contact your doctor immediately if you experience any of the following side effects:
- allergic reaction (such as itching, difficulty breathing or swelling of the face, lips, throat or tongue)
- wheeziness, chest pain, shortness of breath or difficulty in breathing
- severe skin reactions including intense skin rash, hives, reddening of the skin over the whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (stevens johnson syndrome, toxic epidermal necrolysis) or other allergic reaction
- abnormal heartbeat, heart attack
- inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell
HOW TO MANAGE SIDE EFFECTS
Nausea or vomiting:
Stick to simple meals while taking this medicine. Avoid eating oily rich, fried or spicy foods. Do not lie down or sleep immediately after eating. Consult your doctor if the symptom does not improve.
Headache:
Drink ample amount of water and avoid skipping meals. Get adequate rest. Try to be relaxed and stress free. Apply pain relieving balm on your forehead if necessary. Consult your doctor if the symptom does not improve.
Tiredness:
Drink plenty of fluid and eat balanced diet and frequent meals. Do regular minimal exercise and follow regular sleep schedule. Consult your doctor if the symptom does not improve.
Diarrhea:
Drink lots of fluids, such as water or fruit juices to keep yourself hydrated. Avoid taking any medicine on your own for treating diarrhea. Consult your doctor if the symptom did not improve.
Stomach pain:
Rest and relax. Eat and drink slowly or try to have smaller and frequent meals. Keep a heat pad on your stomach. Do not self-treat on your own and consult your doctor if the symptom did not improve on its own.
WARNING & PRECAUTIONS
PREGNANCY
TRANSLOL XL AM TABLET is not recommended for use in pregnant women. Consult your doctor for advice.
BREASTFEEDING
TRANSLOL XL AM TABLET is not recommended for use in breast-feeding women. Consult your doctor for advice.
DRIVING AND USING MACHINES
Do not drive or handle any machines if you experience tiredness or dizziness while taking this medicine.
ALCOHOL
Avoid consumption of alcohol during treatment with TRANSLOL XL AM TABLET as it may increase the blood pressure lowering effect of this medicine.
KIDNEY
TRANSLOL XL AM TABLET is not recommended for use in patients with kidney disease or failure. Consult your doctor before taking TRANSLOL XL AM TABLET.
LIVER
TRANSLOL XL AM TABLET is not recommended for use in patients with liver disease. It should be used with caution in patients with liver cirrhosis. Consult your doctor before taking TRANSLOL XL AM TABLET.
ALLERGY
Do not take TRANSLOL XL AM TABLET if you are allergic (hypersensitive) to Amlodipine or Metoprolol. It should be used with caution in patients with history of allergic reactions such as insect stings, foods or other substances.
LUNGS
TRANSLOL XL AM TABLET is not recommended for use in patients with breathing difficulties or asthma including COPD (chronic obstructive pulmonary disease causing cough, wheezing or breathlessness, phlegm or increase in chest infections). Consult your doctor before taking TRANSLOL XL AM TABLET.
HEART DISEASE
TRANSLOL XL AM TABLET is not recommended for use in patients with heart conduction or rhythm problems, severe or uncontrolled heart failure, shock caused by heart problems, heart attack, prinzmetal’s angina (suffer from a tight, painful feeling in the chest in periods of rest). TRANSLOL XL AM TABLET should be used with caution in patients with controlled heart failure and slow heart rate. Consult your doctor before taking TRANSLOL XL AM TABLET.
OTHERS
TRANSLOL XL AM TABLET is not recommended for use if you have:
- blocked blood vessels including blood circulation problems (which may cause your fingers and toes to tingle or turn pale or blue)
- untreated phaeochromocytoma
- metabolic acidosis
- low blood pressure
- diabetes associated with frequent episodes of low blood sugar (hypoglycaemia)
Before taking TRANSLOL XL AM TABLET inform your doctor if you have:
- diabetes mellitus
- blood vessel disorder
- treated phaeochromocytoma (high blood pressure due to tumour near the kidney)
- psoriasis (severe skin rashes)
- myasthenia gravis
- dry eyes
- hypertensive crisis (severe increase in blood pressure)
Use in Pediatrics:
TRANSLOL XL AM TABLET is not recommended for use in children and adolescents (aged under 18 years). Consult your child’s doctor for advice.
Use in Geriatrics:
TRANSLOL XL AM TABLET should be used with caution in elderly patients (aged 65 years or above), usually the treatment will be initiated with a lower dosage by your doctor. Consult your doctor before taking TRANSLOL XL AM TABLET.
INTERACTIONS
A. Drug-Drug interactions:
Before taking TRANSLOL XL AM TABLET inform your doctor, if you are taking or receiving any of these medicines:
- verapamil, nifedipine, diltiazem, hydralazine, clonidine or prazosin (used to treat high blood pressure)
- monoamine oxidase inhibitors such as phenelzine, tricyclic (Ex. amitriptyline) or selective serotonin reuptake inhibitors (SSRIs) antidepressants (Ex. escitalopram, fluoxetine), st. john’s wort (used to treat depression)
- disopyramide, quinidine, amiodarone and propafenone (used to treat irregular heartbeat)
- ketoconazole, itraconazole (used to treat fungal infections)
- ritonavir, indinavir, nelfinavir (treats HIV infection)
- rifampicin, erythromycin, clarithromycin (treats bacterial infection)
- dantrolene infusion (used for severe body temperature abnormalities)
- tacrolimus, sirolimus, temsirolimus, cyclosporine and everolimus (used to alter the way your immune system works to prevent organ rejection after transplant)
- simvastatin (used to lower cholesterol)
- cimetidine (used to treat stomach ulcers)
- barbiturates such as phenobarbital (treats epilepsy)
- phenothiazines such as compazine (used to treat mental illness)
- lidocaine, cyclopropane or trichloroethylene (used as anesthetics)
- aldesleukin (used to treat some cancers)
- alprostadil (treats erectile dysfunction)
- temazepam, nitrazepam, diazepam (used to treat insomnia)
- indomethacin or celecoxib (treats pain)
- contraceptive pill or hormone replacement therapy (Ex. oestrogens) (used to prevent pregnancy)
- hydrocortisone, prednisolone (used to treat inflammatory conditions)
- beta-blocker eye drops (Ex. timolol) (used to treat glaucoma)
- medicines used to treat diabetes such as metformin, insulin
- moxisylyte (used in raynaud’s syndrome)
- mefloquine (treats malaria)
- tropisetron (used to prevent nausea and vomiting)
- aminophylline, theophylline (used to treat asthma)
- ergotamine (used to migraine headache)
- digoxin (used to treat heart conditions)
- hydroxychloroquine (used to treat rheumatoid arthritis)
- diphenhydramine (used to treat allergy)
- adrenaline (epinephrine) or noradrenaline (norepinephrine) (used in anaphylactic shock)
B. Drug - Food interaction:
Avoid consumption of grapefruit juice and grapefruit while taking TRANSLOL XL AM TABLET, this is because grapefruit and grapefruit juice can lead to an unpredictable increase in the blood pressure lowering effect of TRANSLOL XL AM TABLET.
Overdosage:
If you or anyone else accidentally take too much of TRANSLOL XL AM TABLET, consult your doctor immediately or visit the nearby hospital. Overdosage symptoms of TRANSLOL XL AM TABLET are low blood pressure (fatigue and dizziness), slow pulse, heart conduction problems, shortness of breath, unconsciousness, coma, cardiac arrest, nausea and vomiting, blue colouring of the skin, low blood sugar levels and high levels of potassium in the blood.
SYNOPSIS
| Drug | : | Amlodipine and Metoprolol |
| Pharmacological Category | : | Calcium channel blockers, Beta-Blockers |
| Therapeutic Indication | : | Hypertension (high blood pressure) |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep TRANSLOL XL AM TABLET out of reach of children
- Store TRANSLOL XL AM TABLET at room temperature
FAQs ABOUT TRANSLOL XL AM TABLET
Q: What to do if I miss to take a dose of TRANSLOL XL AM TABLET?
A: You should take TRANSLOL XL AM TABLET immediately when you remember. If it is time for your next dose skip the missed dose and follow your regular dose schedule. Do not double the dose to match up your missed dose.
Q: For how long should I take TRANSLOL XL AM TABLET?
A: You should continue taking TRANSLOL XL AM TABLET unless your doctor tells you to stop the medicine. Blood pressure medicines will be usually taken for lifetime to prevent complications due to high blood pressure. Your doctor may change treatment with other hypertensive drug, if you do not attain effective therapeutic outcome with TRANSLOL XL AM TABLET.
Q: Can TRANSLOL XL AM TABLET be taken during pregnancy?
A: TRANSLOL XL AM TABLET is not recommended for use in pregnant women. If you think you may be pregnant or planning to get pregnant, consult your doctor before taking this medicine. Inform your doctor immediately if you get pregnant during treatment with TRANSLOL XL AM TABLET.
Q: Is TRANSLOL XL AM TABLET safe to use in patients with heart problems?
A: TRANSLOL XL AM TABLET is not recommended for use in patients with heart conduction or rhythm problems, severe or uncontrolled heart failure, shock caused by heart problems, heart attack, prinzmetal’s angina (suffer from a tight, painful feeling in the chest in periods of rest). It should be used with caution in patients with controlled heart failure and slow heart rate. Consult your doctor before taking TRANSLOL XL AM TABLET.
Q: Can TRANSLOL XL AM TABLET be used in elderly patients?
A: Yes, TRANSLOL XL AM TABLET should be used with caution in elderly patients (above 65 years of age), especially when taken in higher doses. Your doctor may initiate the treatment with the lowest effective dose which may prevent the risk of increased side effects. Consult your doctor before taking TRANSLOL XL AM TABLET.
REFERENCES
1. KD Tripathi. Antihypertensive drugs. Essentials of Medical Pharmacology. Seventh edition. May 2013. Page – 561.
2. N. Srinivasa Rao, Abraham Oomman, P. L. Bindumathi, Vikram Sharma, Satish Rao, Latha Subramanya Moodahadu, Ashis Patnaik and B. R. Naveen Kumar. Efficacy and tolerability of fixed dose combination of metoprolol and amlodipine in Indian patients with essential hypertension. Jul-Sep. 2013. [Accessed on 20th October 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3952407/
3. Padmini Devi, Denis Xavier, Alben Sigamani, Sudhanshu Pandey, Tinku Thomas, Sreenivas Murthy, Kamal Sharma, Balraj Bosco, Ketan Mehta, Sindhu Joshi, Rajeev Gupta, Girija Singh, Jagadish Hiremath, Chadha Ds, Ashokan Nambiar, Prem Pais. Effect of fixed dose combinations of metoprolol and amlodipine in essential hypertension: MARS--a randomized controlled trial. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. December 2011. [Accessed on 20th October 2022] https://pubmed.ncbi.nlm.nih.gov/22352120/
4. Torrent pharmaceuticals Ltd. Tolol AM 50 (Metoprolol Succinate Prolonged release and Amlodipine Tablets). [Revised in May 2020] [Accessed on 20th October 2022] https://www.torrentian.com/pisheet/Upload/PI_Sheet/2931.pdf
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- Kidney Function Test
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