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TELSORIX™-H

Telmisartan & Hydrochlorothiazide Tablets I.P.

PACKING SIZE / TYPE

10X10 Tablets

Summary

TELSORIX™-H (12.5/40 mg) Tablet is a combination medicine that consists of Hydrochlorothiazide and Telmisartan. It is used for the treatment of high blood pressure. It works by relaxing your blood vessels and helps your heart to pump blood easily. This medicine also reduces the risk of heart attack and stroke.

TELSORIX™-H (12.5/40 mg) Tablet has some side effects like dizziness, headache, dry mouth, stomach pain, weakness, etc. You may also experience increased urination. These side effects may subside by themselves. Consult your doctor if any of these symptoms bother you for a longer time or worsen. Do not use this medicine if you are allergic to it.

TELSORIX™-H (12.5/40 mg) Tablet can be taken with or without food. Do not take more than the prescribed dose. Take this medicine around the same time every day for the ease of remembering and better results. Do not stop taking this medicine without consulting your doctor.

TELSORIX™-H (12.5/40 mg) Tablet is not recommended for use in children below 18 years of age. It is also not recommended if you have severe liver or kidney problems. Inform the doctor of your complete medical history including all medications that you may be using. Consult your doctor if you are pregnant, or are breastfeeding before using this medicine. Using this medicine and also making certain lifestyle changes like regular exercise, weight control, quitting smoking, limiting alcohol use, and lowering the quantity of salt will also help to decrease your blood pressure.

Side Effects

Major & minor side effects for TELSORIX™-H (12.5/40 mg) Tablet

  • Increased urination
  • Itching or rash
  • Stomach pain
  • Dry mouth
  • Chest pain
  • Changes in vision
  • Dizziness
  • Difficulty or painful urination
  • Headache
  • Diarrhoea
  • Back pain
  • Weakness
  • Muscle pain
  • Fever
  • Low blood pressure

 

Usage

What is it prescribed for?

  • Hypertension

Hypertension is high blood pressure that may be caused by genetic or environmental factors. TELSORIX™-H (12.5/40 mg) Tablet is used in the treatment of high blood pressure, it decreases the effects of angiotensin (a hormone that narrows blood vessels), causing blood vessels to relax. This helps your heart to pump blood more freely.

 

Concerns

Commonly asked questions

  • How long does it take for this medicine to take effect?

The effect of TELSORIX™-H (12.5/40 mg) Tablet can be observed within 1-2 hours of intake.

  • How long do the effects of this medicine last?

The effect of TELSORIX™-H (12.5/40 mg) Tablet lasts for a duration of 24 hours.

  • Is it safe to consume alcohol while taking this medicine?

Consumption of alcohol while taking TELSORIX™-H (12.5/40 mg) Tablet may lower your blood pressure and can cause dizziness, headache, and changes in heart rate.

  • Is this a habit forming medicine?

No habit-forming tendency has been reported for TELSORIX™-H (12.5/40 mg) Tablet.

  • Can this medicine be taken during pregnancy?

TELSORIX™-H (12.5/40 mg) Tablet is not recommended for use in pregnancy as it can harm your developing foetus. Hence, consult your doctor before taking this medicine.

  • Can this medicine be taken while breast-feeding?

It is not known whether TELSORIX™-H (12.5/40 mg) Tablet passes into breastmilk or not. Hence, it is not recommended for use while breastfeeding. Consult your doctor before taking this medicine.

 

When not to use?

Allergy

Avoid taking TELSORIX™-H (12.5/40 mg) Tablet if you are allergic to it. Serious allergic reactions to this medicine are rare. However, seek immediate medical attention if you notice any symptoms such as skin rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, breathing difficulty, etc.

Anuria

Anuria is a condition where your kidneys are unable to produce urine. TELSORIX™-H (12.5/40 mg) Tablet is not recommended if you have Anuria as it may increase the risk of kidney damage.

Cholestasis (Obstruction of bile duct)

Avoid taking TELSORIX™-H (12.5/40 mg) Tablet if you have cholestatic jaundice (a condition that is caused by reduced bile flow from your liver to the small intestine) or obstruction in the bile duct as this medicine is eliminated from your body through bile. Hence, such conditions may increase the risk of serious side effects.

Aliskiren

Aliskiren is a drug used to treat high blood pressure. Using Aliskiren together with TELSORIX™-H (12.5/40 mg) Tablet may increase the risk of serious side effects such as kidney problems, low blood pressure, and high potassium levels in your blood. In severe cases, this could lead to kidney failure, muscle paralysis, irregular heart rhythm, and cardiac arrest.

Angioedema

Angioedema is an allergic reaction to any food, medicine or pollen in which there is a painless swelling under the skin. Symptoms of angioedema are swelling of the face, extremities, eyes, lips, or tongue, as well as trouble swallowing or breathing. TELSORIX™-H (12.5/40 mg) Tablet is not recommended if you have a history of angioedema as a result of using hydrochlorothiazide, or for those who have genetic angioedema.

 

Warnings

Warnings for special population

Pregnancy

TELSORIX™-H (12.5/40 mg) Tablet is not recommended for use in pregnancy as it can harm your developing foetus. Hence, consult your doctor before taking this medicine.

Breast-feeding

It is not known whether TELSORIX™-H (12.5/40 mg) Tablet passes into breastmilk or not. Hence, it is not recommended for use while breastfeeding. Consult your doctor before taking this medicine.

General warnings

Alteration in blood volume and electrolyte levels

Use TELSORIX™-H (12.5/40 mg) Tablet with caution as it may alter the blood volume levels and electrolyte levels in your body. Your doctor may suggest tests to closely monitor your electrolyte levels if necessary while taking this medicine. Report any symptoms such as weakness, lethargy, dry mouth muscle pain, drowsiness, dizziness, irregular heartbeat, etc., to your doctor immediately.

Kidney diseases

TELSORIX™-H (12.5/40 mg) Tablet may cause azotemia (elevated levels of urea and other nitrogen compounds in the blood) if you have a history of kidney problems. Your doctor may suggest tests to closely monitor your kidney function if necessary while taking this medicine.

Use in athletes

TELSORIX™-H (12.5/40 mg) Tablet is not recommended to be used by athletes as per the World Anti-Doping Agency (WADA).

Hyperkalemia

Hyperkalemia is an increase of potassium levels in your blood. TELSORIX™-H (12.5/40 mg) Tablet may increase the potassium levels leading to serious side effects such as heart rhythm irregularities (improper beating of the heart). It is advised that you avoid potassium-rich foods (potatoes, bananas) and other medicines that may increase potassium levels (ACE inhibitors and potassium supplements) during treatment with this medicine.

Hypotension

Hypotension is low blood pressure. Use TELSORIX™-H (12.5/40 mg) Tablet with caution as it may lead to very low blood pressure.

Use in children

It is not recommended to use TELSORIX™-H (12.5/40 mg) Tablet in children below 18 years of age as the safety and efficacy data for use are not available.

 

Dosage

Missed Dose

Do not skip any dose of TELSORIX™-H (12.5/40 mg) Tablet. If you forget to take a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose. Do not double your dose to make up for the missed one.

Overdose

Never take more than the prescribed dose. If you suspect that you might have taken an overdose of TELSORIX™-H (12.5/40 mg) Tablet, seek immediate medical attention.

 

Interactions

ll drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.

Interaction with Alcohol

Description

N/A

Instructions

Consumption of alcohol while taking TELSORIX™-H (12.5/40 mg) Tablet may lower your blood pressure and can cause dizziness, headache, and changes in heart rate.

Interaction with Medicine

Dexamethasone

Captopril

Insulin

Amitriptyline

Diclofenac

Disease interactions

Congestive heart failure

Congestive heart failure (CHF) is a condition in which your heart is unable to pump blood efficiently. Use TELSORIX™-H (12.5/40 mg) Tablet with caution if you have CHF due to the increased risk of serious side effects.

Diabetes

Diabetes is a condition in which your blood sugar levels are abnormally high. TELSORIX™-H (12.5/40 mg) Tablet increases the risk of altered blood glucose levels. People having diabetes should use this medicine with caution. Your doctor will advise you to monitor your blood glucose levels regularly while you are taking this medicine.

Food interactions

It is advised to avoid potassium-containing foods (potatoes, bananas and tomatoes) and supplements while taking TELSORIX™-H (12.5/40 mg) Tablet due to the increased risk of weakness, confusion, irregular heartbeat, etc. Report such symptoms to the doctor immediately. Your dietitian/doctor may suggest appropriate changes in your diet based on your clinical condition.

Lab interactions

Information not available.

This is not an exhaustive list of possible drug interactions. You should consult your doctor about all the possible interactions of the drugs you’re taking.

 

General Instructions

Take TELSORIX™-H (12.5/40 mg) Tablet with or without food. Do not take in larger amounts than prescribed.

TELSORIX™-H (12.5/40 mg) Tablet may cause dehydration. Drink plenty of fluids and inform your doctor if you develop extreme thirst, dry mouth or muscle weakness.

It may cause dizziness. Get up slowly when you rise from a sitting or lying position. Consult your doctor if you experience any undesirable effects.

Do not stop taking the medicine without consulting your doctor as it may cause withdrawal symptoms.

Do not chew, crush or break the tablet. Take the tablet immediately after peeling it from the strip. Keep the medicine away from the reach of children and pets. Ensure that unused medicine is disposed of properly.

Other Details

Miscelleneous

Can be taken with or without food, as advised by your doctor

To be taken as instructed by doctor

May cause sleepiness

How it works

TELSORIX™-H (12.5/40 mg) Tablet consist of Hydrochlorothiazide and Telmisartan. Hydrochlorothiazide is a diuretic (water pill) that removes excess water and sodium from your body. It also relaxes blood vessels and promotes the smooth flow of blood. Telmisartan works by blocking the action of angiotensin (a hormone that narrows blood vessels), causing blood vessels to relax. This improves blood flow and helps the heart to pump more efficiently. Thus TELSORIX™-H (12.5/40 mg) Tablet helps to lower the blood pressure.

Legal Status

Approved

Approved

Approved

Approved

Classification

Category

Angiotensin receptor blockers, Thiazide diuretics, Angiotensin II inhibitors with thiazides, Antihypertensive combinations, Angiotensin receptor blockers and thiazide diuretics

Schedule

Schedule H

 

References

Dailymed.nlm.nih.gov. 2021. DailyMed - TELMISARTAN AND HYDROCHLOROTHIAZIDE 40 MG/12.5 MG- telmisartan and hydrochlorothiazide tabletTELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/12.5 MG- telmisartan and hydrochlorothiazide tabletTELMISARTAN AND HYDROCHLOROTHIAZIDE 80 MG/25 MG- telmisartan and hydrochlorothiazide tablet. [online] Available at: < [Accessed 16 August 2021].

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5b476740-e3f0-4f68-b07c-cd9eb2fa27ca>

Medicines.org.uk. 2021. Actelsar HCT 40 mg/12.5 mg tablets & Actelsar HCT 80 mg/12.5 mg tablets - Summary of Product Characteristics (SmPC) - (emc). [online] Available at: < [Accessed 16 August 2021].

https://www.medicines.org.uk/emc/medicine/28638>

Accessdata.fda.gov. 2021. [online] Available at: < [Accessed 16 August 2021].

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021162s034lbl.pdf>

Accessdata.fda.gov. 2021. [online] Available at: < [Accessed 16 August 2021].

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020850s022s023lbl.pdf>

 

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