Olmesafe H (12.5/40 mg) Tablet

Manufactured byAristo Pharmaceuticals Pvt. Ltd.
ContainsHydrochlorothiazide (12.5 mg) + Olmesartan (40 mg)
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Description

Olmesafe H (12.5/40 mg) Tablet is a combination medicine used for the treatment of high blood pressure. Frequent monitoring of blood pressure and electrolytes level is necessary during treatment with this medicine. Patients are advised to maintain a strict exercise and diet regimen along with this medicine to get the best possible effect.

Substitutes

List of substitutes for Olmesafe H (12.5/40 mg) Tablet

Side effects

Major & minor side effects for Olmesafe H (12.5/40 mg) Tablet

  • Increased urination
  • Itching or rash
  • Abdominal and stomach pain
  • Dry mouth
  • Myalgia
  • Chest pain
  • Nausea and Vomiting
  • Cough
  • Headache
  • Chills
  • Nasal congestion
  • Unusual tiredness and weakness
  • Blood in urine
  • Joint pain
  • Swelling of feet or lower legs
  • Bladder pain
  • Diarrhea
  • Dizziness

Uses of Olmesafe H (12.5/40 mg) Tablet

What is it prescribed for?

  • Essential hypertension
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Concerns

Commonly asked questions

  • Onset of action
    The effect of this medicine can be observed within 2 hours of administration of the dose.
  • Duration of effect
    The effect of this medicine lasts for an average duration of 24 hours.
  • Safe with alcohol?
    Consumption of alcohol is not recommended during treatment with this medicine due to the increased risk of side effects such as dizziness, lightheadedness, and fainting. It is advised that you do not perform any activities that require high mental alertness such as driving a vehicle or operating machinery if you consume alcohol during treatment with this medicine.
  • Is it habit forming?
    No habit forming tendency has been reported.
  • Usage in pregnancy?
    This medicine is not recommended for use in pregnant women except in life-threatening conditions. All the risks and benefits should be discussed with the doctor before taking this medicine. Your doctor may prescribe a safer alternative based on your clinical condition.
  • Usage while breast-feeding?
    This medicine is not recommended for use in breastfeeding women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before taking this medicine. Your doctor may advise you to discontinue breastfeeding or to discontinue the drug based on your clinical condition.

Allergy

This medicine is not recommended for use in patients with a known allergy to hydrochlorothiazide, other sulfonamides, olmesartan, or any other angiotensin receptor blockers.

Anuria

This medicine is not recommended for use in patients with anuria, a condition where the kidney is unable to produce urine.

Aliskiren

Coadministration of aliskiren and this combination medicine is not recommended due to the increased risk of serious adverse effects. This risk is especially higher in the elderly population and in patients with diabetes and kidney diseases.

Severe renal impairment

This medicine is not recommended for use in patients with severe renal impairment (CrCl < 30 ml/min) due to the increased risk of serious adverse effects.
Warnings for special population

Pregnancy

This medicine is not recommended for use in pregnant women except in life-threatening conditions. All the risks and benefits should be discussed with the doctor before taking this medicine. Your doctor may prescribe a safer alternative based on your clinical condition.

Breast-feeding

This medicine is not recommended for use in breastfeeding women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before taking this medicine. Your doctor may advise you to discontinue breastfeeding or to discontinue the drug based on your clinical condition.
General warnings

Hepatic dysfunction

This medicine should be used with extreme caution in patients suffering from liver diseases due to an increase in the risk of serious adverse effects. Close monitoring of liver function is advised while taking this medicine. Report any symptoms of confusion or jaundice to the doctor on priority. Replacement with a suitable alternative may be required based on the clinical condition.

Volume and electrolyte depletion

This medicine may alter the blood volume and electrolyte levels in some patients. This may cause dizziness, dry mouth, and acid-base imbalance. This risk is especially higher in patients suffering from kidney and liver diseases. Close monitoring of blood pressure and electrolyte levels is recommended for such patients. Appropriate dose adjustments or replacement with a suitable alternative may be required based on the clinical condition.

Renal diseases

This medicine may cause Azotemia in patients with a known history of severe renal diseases. Close monitoring of kidney function is necessary while taking this medicine. Replacement with a suitable alternative may be required based on the clinical condition.

Hypotension

Symptomatic hypotension may occur in patients with volume depletion or patients who are treated with high-dose diuretics. It is advised to correct this condition before initiating treatment with this combination medicine.

Hyperkalemia

This medicine may increase the potassium levels in the blood (hyperkalemia). This may cause serious side effects such as fatal cardiac rhythm irregularities. It is advised to avoid potassium-rich foods (potatoes, bananas) and other medicines that may increase potassium levels (ACE inhibitors and potassium supplements) during treatment with this medicine.

Systemic Lupus Erythematosus

This medicine should be used with caution in patients with a known history of Systemic Lupus Erythematosus due to the increased risk of worsening of the patient's condition. Report any unusual symptoms to the doctor immediately. Appropriate dose adjustments or replacement with a suitable alternative may be necessary based on the clinical condition of the patient.

Pediatric population

This medicine is not recommended for use in children since the safety and efficacy of use are not clinically established.

Eye diseases

This medicine should be used with extreme caution in patients with a known history of eye diseases such as acute myopia or secondary angle-closure glaucoma due to the increased risk of worsening of the patient's condition. Close monitoring of eye function is recommended for such patients. Report any unusual symptoms to the doctor immediately. Appropriate dose adjustments or replacement with a suitable alternative may be necessary based on the clinical condition of the patient.

Use in athletes

This medicine is not recommended to be used by athletes as per the World Anti-Doping Agency (WADA).

Missed Dose

Take the missed dose as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose. Do not double your dose to make up for the missed one.

Overdose

Seek emergency medical treatment or contact the doctor in case of an overdose.
All 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 is not recommended during treatment with this medicine due to the increased risk of side effects such as dizziness, lightheadedness, and fainting. It is advised that you do not perform any activities that require high mental alertness such as driving a vehicle or operating machinery if you consume alcohol during treatment with this medicine.
Interaction with Medicine

Dexamethasone

Aliskiren

Captopril

Insulin

Antidepressants

Nonsteroidal anti-inflammatory medicines

Disease interactions

Diabetes

This medicine should be used with caution in patients with a known history of diabetes mellitus due to the increased risk of altered blood glucose levels. Close monitoring of blood glucose levels is advised for such patients. Replacement with a suitable alternative may be required based on the clinical condition.

Hyperuricemia

This medicine should be used with caution in patients with a history of gout or chronic renal failure due to the increased risk of hyperuricemia. Close monitoring of uric acid level is recommended for such patients. Replacement with a suitable alternative may be necessary based on the clinical condition of the patient.

Congestive heart failure

This medicine should be used with extreme caution in patients with congestive heart failure due to the increased risk of renal impairment and worsening of the patient's condition. Close monitoring of heart function, blood pressure, and kidney function is recommended for such patients. Replacement with a suitable alternative may be required based on the clinical condition.

Angioedema

This medicine is not recommended for use in patients with a history of angioedema or a family history of angioedema due to the increased risk of recurrent symptoms. Report any incidence of swelling of the face, lips, and eyes to the doctor on priority. Replacement with a suitable alternative may be required based on the clinical condition.
Food interactions
It is advised to avoid potassium containing foods and supplements while taking this medicine due to the increased risk of weakness, confusion, irregular heartbeat, etc. Report any unusual 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.
Take this medicine exactly as advised by your doctor. Do not take in larger amounts than prescribed. It is advised to take this medicine at daytime to prevent sleep disturbance. Drink an adequate amount of water. Monitoring of kidney function and electrolytes levels is necessary while taking this medicine. Report any adverse effects to the doctor on priority. Do not stop the use of this medicine without consulting your doctor.
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
Hydrochlorothiazide increases the excretion of water and sodium through the urine. Olmesartan relaxes the blood vessels and promotes the smooth flow of blood. Their combination is thus effective in reducing the blood pressure.
Legal Status

Approved

Approved

Approved

Unknown

Classification

Category

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

Schedule

Schedule H

[Internet]. 2017 [cited 28 September 2017]. Available from:

https://www.medicines.org.uk/emc/medicine/22877

DailyMed - olmesartan medoxomil-hydrochlorothiazide tablet, film coated [Internet]. Dailymed.nlm.nih.gov. 2017 [cited 28 September 2017]. Available from:

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=91d45442-4232-4111-9dd8-0d787085af6d

[Internet]. 2017 [cited 28 September 2017]. Available from:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021532s013s014lbl.pdf
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