AROTEL-H Tablets

Category:

AROTEL-H: Each Tablet contains Telmisartan and Hydrochlorthiazide.

Arotel-H is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not controlled enough when telmisartan is used alone.

Description

Arotel-H is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet. Both of these substances help to control high blood pressure.

Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin-ll is a substance produced in your body which causes your blood vessels to narrow thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.

Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which cause your urine output to increase, leading to a lowering of your blood pressure.

 

  • Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
  • The recommended dose is one tablet a day.
  • Try to take a tablet at the same time each day.
  • You can take the tablets with or without food. They should be swallowed with some water or other nonalcoholic drink.
  • It is important that you take the tablets every day until your doctor tells you otherwise.
  • If your liver is not working properly, the usual dose should not exceed 40 mg/12.5 mg once a day.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may need to change the dose of these other medications or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below taken at the same time with Arotel-H:

  • Lithium containing medicines to treat some types of depression., Medicines associated with low blood potassium such as other diuretics, laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G sodium, and salicylic acid and derivatives. , Medicines that may increase blood potassium levels such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors cyclosporin and other medicinal products such as heparin sodium.
  • Medicines that are affected by changes of the blood potassium level such as heart medicines (e.g. digoxin) or medicines to control the rhythm of your heart, medicines used for mental disorders and other medicines such as certain antibiotics or certain medicines to treat allergic reactions.
  • Medicines for the treatment of diabetes, Cholestyramine and colestipol, medicines for lowering blood fat levels., Medicines to increase blood pressure, such as noradrenaline.
  • Muscle relaxing medicines, such as tubocurarine. – Calcium supplements and/or vitamin D supplements.
  • Anti-cholinergic medicines (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson’s disease and as an aid to anaesthesia) such as atropine and biperiden.
  • Amantadine, Other medicines used to treat high blood pressure, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), medicines to treat cancer, gout, or arthritis, If you are taking an ACE-inhibitor or aliskiren, Digoxin.

Common side effects: Dizziness, Feeling sick (nausea), Low blood magnesium level

Uncommon side effects: Decreased blood potassium levels, Anxiety, fainting (syncope), Sensation of tingling, pins and needles (paraesthesia), Feeling of spinning (vertigo), Fast heart beat (tachycardia), heart rhythm disorders, Low blood pressure, a sudden fall in blood pressure when you stand up, Shortness of breath (dyspnoea), Diarrhoea, Flatulence, Dry mouth, Back pain, muscle spasm, muscle pain, chest pain, Erectile dysfunction, Increased blood uric acid levels, Upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), Urinary tract infections, Deficiency in red blood cells (anaemia), high potassium levels, Slow heart rate (bradycardia), Kidney impairment including acute kidney failure, Weakness, Cough.

Rare side effects: Inflammation of the lung, Activation or worsening of systemic lupus erythematosus, Sore throat, inflamed sinuses, Feeling sad, Difficulty falling asleep, Impaired vision, Difficulty breathing, Abdominal pain, constipation, bloating, feeling sick, Inflammation of the stomach, Abnormal liver function, Redness of the skin, Allergic reactions such as itching or rash, Increased sweating, Hives, Joint pain and pain in extremities, Muscle cramps, Flu-like-illness, Pain, Low levels of sodium, Increased levels of creatinine, liver enzymes or creatine phosphokinase in the blood.

Do not take Arotel-H:

  • if you are allergic to telmisartan or a hydrochlorothiazide
  • if you are more than 3 months pregnant.
  • if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the liver and gall bladder) or any other severe liver disease.
  • if you have severe kidney disease.
  • if your doctor determines that you have low potassium levels or high calcium levels in your blood that do not get better with treatment.
  • if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

If any of the above applies to you, do not take the tablets and tell your doctor or pharmacist before taking this medicine.

Warnings and precautions:

Talk to your doctor before taking this medicine if you are suffering or have ever suffered from any of the following conditions or illnesses:

  • Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (water tablets), low-salt diet, diarrhoea, vomiting, or haemodialysis.
  • Kidney disease or kidney transplant., Renal artery stenosis (narrowing of the blood vessels to one or both kidneys), Liver disease, Heart trouble, Diabetes, Gout
  • Raised aldosterone levels, Systemic lupus erythematosus
  • The active ingredient hydrochlorothiazide can cause an unusual reaction, resulting in a decrease in vision and eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to weeks of taking Arotel-H. This can lead to permanent vision impairment, if not treated.

Talk to your doctor before taking Arotel-H:

  • if you are taking any of the following medicines used to treat high blood pressure:
    • an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
    • aliskiren.
  • Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
  • if you are taking digoxin.
  • if you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Arotel-H.
  • If you experienced breathing or lung problems (including inflammation or fluid in the lungs) following hydrochlorothiazide intake in the past. If you develop any severe shortness of breath or difficulty breathing after taking Arotel-H, seek medical attention immediately.

Treatment with hydrochlorothiazide may cause electrolyte imbalance in your body. Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea (feeling sick), vomiting, tired muscles, and an abnormally fast heart rate (faster than 100 beats per minute). If you experience any of these you should tell your doctor.

You should also tell your doctor, if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal.

In case of surgery or anaesthetics, you should tell your doctor that you are taking this medicine.

These tablets may be less effective in lowering the blood pressure in black patients.

Children and adolescents: This medicine is not recommended in children and adolescents up to the age of 18 years.

Arotel-H with food and alcohol: You can take Arotel-H with or without food. Avoid taking alcohol until you have talked to your doctor. Alcohol may make your blood pressure fall more and/or increase the risk of you becoming dizzy or feeling faint.

Pregnancy and breast-feeding

Pregnancy: You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking this medicine before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Arotel-H. These tablets are not recommended during pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding: Tell your doctor if you are breast-feeding or about to start breast-feeding. These tablets are not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed.

Driving and using machines: Some people feel dizzy or tired when taking Arotel-H If you feel dizzy or tired, do not drive or operate machinery.

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Arotel-H is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not controlled enough when telmisartan is used alone.

Description

Arotel-H is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet. Both of these substances help to control high blood pressure.

Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin-ll is a substance produced in your body which causes your blood vessels to narrow thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II so that the blood vessels relax, and your blood pressure is lowered.

Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which cause your urine output to increase, leading to a lowering of your blood pressure.

 

  • Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
  • The recommended dose is one tablet a day.
  • Try to take a tablet at the same time each day.
  • You can take the tablets with or without food. They should be swallowed with some water or other nonalcoholic drink.
  • It is important that you take the tablets every day until your doctor tells you otherwise.
  • If your liver is not working properly, the usual dose should not exceed 40 mg/12.5 mg once a day.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may need to change the dose of these other medications or take other precautions. In some cases you may have to stop taking one of the medicines. This applies especially to the medicines listed below taken at the same time with Arotel-H:

  • Lithium containing medicines to treat some types of depression., Medicines associated with low blood potassium such as other diuretics, laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G sodium, and salicylic acid and derivatives. , Medicines that may increase blood potassium levels such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors cyclosporin and other medicinal products such as heparin sodium.
  • Medicines that are affected by changes of the blood potassium level such as heart medicines (e.g. digoxin) or medicines to control the rhythm of your heart, medicines used for mental disorders and other medicines such as certain antibiotics or certain medicines to treat allergic reactions.
  • Medicines for the treatment of diabetes, Cholestyramine and colestipol, medicines for lowering blood fat levels., Medicines to increase blood pressure, such as noradrenaline.
  • Muscle relaxing medicines, such as tubocurarine. – Calcium supplements and/or vitamin D supplements.
  • Anti-cholinergic medicines (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson’s disease and as an aid to anaesthesia) such as atropine and biperiden.
  • Amantadine, Other medicines used to treat high blood pressure, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), medicines to treat cancer, gout, or arthritis, If you are taking an ACE-inhibitor or aliskiren, Digoxin.

Common side effects: Dizziness, Feeling sick (nausea), Low blood magnesium level

Uncommon side effects: Decreased blood potassium levels, Anxiety, fainting (syncope), Sensation of tingling, pins and needles (paraesthesia), Feeling of spinning (vertigo), Fast heart beat (tachycardia), heart rhythm disorders, Low blood pressure, a sudden fall in blood pressure when you stand up, Shortness of breath (dyspnoea), Diarrhoea, Flatulence, Dry mouth, Back pain, muscle spasm, muscle pain, chest pain, Erectile dysfunction, Increased blood uric acid levels, Upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), Urinary tract infections, Deficiency in red blood cells (anaemia), high potassium levels, Slow heart rate (bradycardia), Kidney impairment including acute kidney failure, Weakness, Cough.

Rare side effects: Inflammation of the lung, Activation or worsening of systemic lupus erythematosus, Sore throat, inflamed sinuses, Feeling sad, Difficulty falling asleep, Impaired vision, Difficulty breathing, Abdominal pain, constipation, bloating, feeling sick, Inflammation of the stomach, Abnormal liver function, Redness of the skin, Allergic reactions such as itching or rash, Increased sweating, Hives, Joint pain and pain in extremities, Muscle cramps, Flu-like-illness, Pain, Low levels of sodium, Increased levels of creatinine, liver enzymes or creatine phosphokinase in the blood.

Do not take Arotel-H:

  • if you are allergic to telmisartan or a hydrochlorothiazide
  • if you are more than 3 months pregnant.
  • if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the liver and gall bladder) or any other severe liver disease.
  • if you have severe kidney disease.
  • if your doctor determines that you have low potassium levels or high calcium levels in your blood that do not get better with treatment.
  • if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

If any of the above applies to you, do not take the tablets and tell your doctor or pharmacist before taking this medicine.

Warnings and precautions:

Talk to your doctor before taking this medicine if you are suffering or have ever suffered from any of the following conditions or illnesses:

  • Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (water tablets), low-salt diet, diarrhoea, vomiting, or haemodialysis.
  • Kidney disease or kidney transplant., Renal artery stenosis (narrowing of the blood vessels to one or both kidneys), Liver disease, Heart trouble, Diabetes, Gout
  • Raised aldosterone levels, Systemic lupus erythematosus
  • The active ingredient hydrochlorothiazide can cause an unusual reaction, resulting in a decrease in vision and eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to weeks of taking Arotel-H. This can lead to permanent vision impairment, if not treated.

Talk to your doctor before taking Arotel-H:

  • if you are taking any of the following medicines used to treat high blood pressure:
    • an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
    • aliskiren.
  • Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
  • if you are taking digoxin.
  • if you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Arotel-H.
  • If you experienced breathing or lung problems (including inflammation or fluid in the lungs) following hydrochlorothiazide intake in the past. If you develop any severe shortness of breath or difficulty breathing after taking Arotel-H, seek medical attention immediately.

Treatment with hydrochlorothiazide may cause electrolyte imbalance in your body. Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea (feeling sick), vomiting, tired muscles, and an abnormally fast heart rate (faster than 100 beats per minute). If you experience any of these you should tell your doctor.

You should also tell your doctor, if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal.

In case of surgery or anaesthetics, you should tell your doctor that you are taking this medicine.

These tablets may be less effective in lowering the blood pressure in black patients.

Children and adolescents: This medicine is not recommended in children and adolescents up to the age of 18 years.

Arotel-H with food and alcohol: You can take Arotel-H with or without food. Avoid taking alcohol until you have talked to your doctor. Alcohol may make your blood pressure fall more and/or increase the risk of you becoming dizzy or feeling faint.

Pregnancy and breast-feeding

Pregnancy: You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking this medicine before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Arotel-H. These tablets are not recommended during pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding: Tell your doctor if you are breast-feeding or about to start breast-feeding. These tablets are not recommended for mothers who are breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed.

Driving and using machines: Some people feel dizzy or tired when taking Arotel-H If you feel dizzy or tired, do not drive or operate machinery.

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