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Sanofi India Limited

CARDACE H 10 Tablet 15's

Hypertension
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    Introduction About CARDACE H 10 TABLET

    CARDACE H 10 TABLET is a combination of Ramipril and Hydrochlorothiazide which belongs to the group of medicines called Angiotensin-converting enzyme (ACE) inhibitors and Diuretics respectively. It is used in the management of essential hypertension.

    Hypertension is a condition in which force of the blood is consistently high against the walls of the arteries which can increase the risk of heart disease, kidney disease and stroke.

    Before taking CARDACE H 10 TABLET, inform your doctor if you are pregnant or breast-feeding. Inform your doctor if you have any problems related to kidney, liver, lungs or heart and if you have other conditions such as diabetes, gout, myopia, glaucoma, collagen vascular disease or parathyroid disease.

    CARDACE H 10 TABLET is not recommended for use in children and adolescents less than 18 years of age. If you are taking any other medicines for other conditions or if you have history of allergy, inform to your doctor as it may manage drug-related interactions and serious side effect.

    The most common side effect of CARDACE H 10 TABLET are headache, dizziness, stomach pain, tiredness and nausea. Consult your doctor for advice if your symptoms get worsen over the time.

    Uses Of CARDACE H 10 TABLET

    • Used to manage essential hypertension (high blood pressure)

    How CARDACE H 10 TABLET Works

    CARDACE H 10 TABLET helps to reduce high blood pressure, where Ramipril works by inhibiting the activity of an enzyme called Angiotensin converting enzyme (an enzyme which is responsible for causing constriction of blood vessels) which enhances easy flow of blood around the body. Hydrochlorothiazide works by decreasing the extra fluid volume also works by managing reabsorption of sodium in the kidneys, which in turn it relaxes the blood vessels and makes the blood flow more easily in the passage of blood vessels and thus lowers the blood pressure.

    How to use CARDACE H 10 TABLET

    Always take CARDACE H 10 TABLET as directed by your physician. Take this medicine with or without food, swallow the medicine as a whole and do not crush or chew the medicine. Your doctor will prescribe the right dose depends on your child’s age, body weight and disease condition.

    Side Effects Of CARDACE H 10 TABLET

    Common

    • headache
    • tiredness
    • dizziness
    • orthostatic hypotension (dizziness while standing up from sitting or lying position)
    • dry cough, inflammation of sinus
    • stomach pain, indigestion
    • diarrhea
    • nausea
    • chest pain
    • pain or cramps in muscles
    • signs of high potassium levels in the blood (muscle weakness, chest pain, irregular heartbeat)

    Uncommon

    • numbness, tingling, pricking, burning or creeping sensation in arms, legs or feet
    • altered taste sensation, loss of appetite
    • sleep problems
    • depression, anxious, restlessness
    • heartburn, dry mouth
    • constipation
    • increased urination
    • excess sweating
    • increased or irregular heartbeats
    • flushing
    • blurred vision
    • fever
    • reduced libido in men or women
    • joint pain

    Rare

    • red and swollen tongue
    • nail problems (loosening or separation of a nail from its bed)
    • cold hands or feet
    • anemia
    • hearing problems or ringing in ear sensation
    • signs of low while blood cells (fever, infections, mouth sores)
    • signs of low platelet count (easy bruising or bleeding)

    Stop taking CARDACE H 10 TABLET and contact your doctor immediately if you experience any of the following side effects:

    • severe allergic reactions (such as swelling of the face, lips, tongue and/or throat which can lead to difficulty in breathing or swallowing, as well as itching and rashes)
    • severe skin reactions such as stevens johnson syndrome, toxic epidermal necrolysis or erythema multiforme (such as rash, blistering, reddening and detachment of skin, mouth ulcers and worsening of previous skin disease)
    • signs of lung problems (such as shortness of breath or cough)
    • fast or irregular heartbeat, chest pain, chest tightness, including heart attack or stroke
    • signs of inflamed pancreas (such as severe stomach and back pain)
    • signs of liver problems such as hepatitis or liver damage (such as fever, chills, loss of appetite, stomach pain, nausea, (jaundice) yellowing of skin or white of the eyes)
    • signs of blood or bone marrow problems (such as easy bruising, prolonged bleeding, bleeding from gums, purple spot and blotches on the skin, sore throat, repeated infections, pale skin, tiredness, fainting and dizziness)

    How To Manage Side Effects

    Diarrhoea:

    Drink plenty of fluids such as water, fruit juices or electrolytes (ORS) to avoid dehydration in your body. Consult your doctor if your symptom does not improve.

    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. Consult your doctor if your symptom does not improve.

    Dizziness:

    Lie down until dizziness passes away and then move slowly and carefully. Take plenty amount of rest and drink plenty of fluids. Consult your doctor if your symptom worsens.

    Headache:

    Apply hot or cold-water bag on your head. Try taking rest in a quiet and dark room. Drink tea or coffee. Consult your doctor if your symptom worsens.

    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 your symptom does not improve.

    Warning & Precautions

    Pregnancy

    CARDACE H 10 TABLET is not recommended for use during pregnancy, as it may cause serious harm to the baby. Consult your doctor for advice before taking CARDACE H 10 TABLET.

    Breastfeeding

    CARDACE H 10 TABLET is not recommended for use in breast-feeding women. Consult your doctor for advice before taking CARDACE H 10 TABLET.

    Driving and Using Machines

    Do not drive or operate any machines if you experience light-headedness, dizziness and fainting due to low blood pressure. Consult your doctor for advice before taking CARDACE H 10 TABLET.

    Alcohol

    Consumption of alcohol is not recommended during management with CARDACE H 10 TABLET as it may cause dizziness, light-headedness or orthostatic hypotension (dizziness while standing up from sitting or lying position due to low blood pressure).

    Kidney

    CARDACE H 10 TABLET is not recommended for use in patients with severe kidney impairment, renal artery stenosis or patients undergoing dialysis. Consult your doctor for advice before taking CARDACE H 10 TABLET.

    Liver

    CARDACE H 10 TABLET is not recommended for use in patients with severe liver impairment and should be used with caution in patients with progressive liver disease. Consult your doctor for advice before taking CARDACE H 10 TABLET.

    Allergy

    Do not take CARDACE H 10 TABLET if you are allergic to Ramipril and Hydrochlorothiazide or any other ingredients of this medicine.

    Lungs

    CARDACE H 10 TABLET should be used with caution in patients with history of bronchial asthma. Consult your doctor for advice before taking CARDACE H 10 TABLET.

    Heart Disease

    CARDACE H 10 TABLET is not recommended for use in patients with low or unstable blood pressure and it should be used with caution in patients with heart problems. Consult your doctor for advice before taking CARDACE H 10 TABLET.

    Others

    CARDACE H 10 TABLET is not recommended for you, if you have:

    • difficulty urination
    • personal or family history of angioedema
    • electrolyte disturbances

    Before taking CARDACE H 10 TABLET, inform your doctor if you have:

    • diabetes
    • scleroderma or systemic lupus erythematosus
    • dehydration problems
    • upcoming major surgery including dental surgery which requires anaesthesia for numbness or sedation
    • personal or family history of skin cancer
    • high levels of potassium in the blood
    • acute myopia and secondary angle-closure glaucoma
    • parathyroid disease
    • gout or increased levels of uric acid in the blood
    • raynaud’s phenomenon (condition resulting from poor circulation in the extremities, such as fingers and toes)

    Use in pediatrics:

    CARDACE H 10 TABLET is not recommended for use in children and adolescents less than 18 years of age. Consult with your doctor for advice before taking CARDACE H 10 TABLET.

    Use in geriatrics:

    CARDACE H 10 TABLET should be used with caution in elderly patients above 65 years of age, usually initiating the management with the lowest effective. Consult with your doctor for advice before taking CARDACE H 10 TABLET.

    Interactions

    A. Drug-Drug interactions:

    Before taking CARDACE H 10 TABLET inform your doctor if you are taking any of following medicines:

    • indomethacin, ibuprofen, aspirin, (used to relieve pain and swelling)
    • ephedrine, noradrenaline or adrenaline (used to manage low blood pressure, asthma, allergies or heart failure)
    • sacubitril/valsartan (used to manage long-term heart failure)
    • cyclophosphamide, methotrexate (used to manage cancer)
    • ciclosporin, sirolimus, everolimus (used to manage organ rejection after transplant)
    • furosemide (used to manage edema or high blood pressure)
    • spironolactone, amiloride, triamterene (used to retain or increase potassium levels)
    • heparin (used to manage blood clots)
    • prednisolone, hydrocortisone (used to manage swelling)
    • allopurinol (used to manage gout or decrease uric acid levels in blood)
    • procainamide (used to manage irregular heart rate)
    • temsirolimus (used to manage cancer)
    • carbenoxolone (used to manage peptic disease)
    • racecadotril (used to manage diarrhea)
    • vildagliptin (used to manage diabetes)
    • lithium (used to manage mental health problems)
    • trimethoprim alone or in combination with sulfamethoxazole, co-trimoxazole (used to manage bacterial infections)
    • gold (used to manage arthritis)
    • phenobarbital, phenytoin, carbamazepine, topiramate (used to manage seizures)
    • citalopram, escitalopram and sertraline (used to manage depression)
    • morphine (used to manage severe pain)
    • cholestyramine and colestipol resins (used to manage high cholesterol)
    • adrenocorticotropic hormone (used to manage west syndrome)
    • calcium and vitamin D supplements
    • amphotericin B (used to manage fungal infections)

    Overdosage:

    If you or anyone else accidentally takes too much of CARDACE H 10 TABLET, consult your doctor immediately. Overdosage may cause side effects such as electrolyte depletion, slow heart rate, increased urination, kidney failure, muscle weakness and paralysis of intestine.

    Synopsis

    Drug :   Ramipril, Hydrochlorothiazide
    Pharmacological Category :   Angiotensin-II converting enzyme inhibitors, Diuretics
    Therapeutic Indication :   Hypertension
    Dosage Forms :   Tablet, Capsule

    More Information

    • Keep CARDACE H 10 TABLET out of reach to children
    • Store at normal room temperature

    FAQs About CARDACE H 10 TABLET

    Does CARDACE H 10 TABLET increases urination?

    Yes, CARDACE H 10 TABLET contains hydrochlorothiazide a diuretic agent which works by removing excess fluid from the body through kidneys which leads to increased passage of urination. Excess water loss in body may result in dehydration. During management with CARDACE H 10 TABLET if you are always feeling tired, thirsty or you have muscle cramps constantly, immediately consult your doctor for advice.

    What to do If I forget to take CARDACE H 10 TABLET?

    You should take CARDACE H 10 TABLET immediately when you remember. If it is time for your next dose skip the dose and follow your regular dose schedule. Do not double the dose to match up your missed dose.

    Can CARDACE H 10 TABLET cause kidney problems?

    Yes, CARDACE H 10 TABLET can cause kidney problems such as decreased urination, kidney failure, progressive azotemia (high levels of nitrogen in the blood). Your doctor may closely monitor your kidney function before and during management with CARDACE H 10 TABLET.

    Does CARDACE H 10 TABLET cause blood related problems?

    Yes, CARDACE H 10 TABLET may cause reduction in white blood cell count. Your doctor may monitor white blood cells in the initial phase of the management or in patients with impaired kidney function. If you have any signs or symptoms of infection such as fever, chills, cough, body pain, tiredness during management with CARDACE H 10 TABLET, your doctor immediately.

    Can CARDACE H 10 TABLET taken during pregnancy?

    No, CARDACE H 10 TABLET is not recommended for use in pregnancy as it may cause serious harm to the baby. If you are women of childbearing potential, follow effective method of birth control to manage pregnancy while taking CARDACE H 10 TABLET.

    References

    1. KD. Tripathi. Cardiovascular Drugs & Diuretics. Essentials of medical pharmacology. Seventh edition. 2013. Page – 503-505; 584.

    2. Pfizer. Ramipril and Hydrochlorothiazide Alone and in Combination for the Treatment of Essential Hypertension. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on October 2012] [Accessed 8th April 2022] https://clinicaltrials.gov/ct2/show/NCT00355589

    3. J Scholze, A Breitstadt, V Cairns, B Bauer, N Bender, C Priestley, C Moreadith, J Phillips, E Vander Elst, G Koch. Short report: ramipril and hydrochlorothiazide combination therapy in hypertension: a clinical trial of factorial design. The East Germany Collaborative Trial Group.  NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. February 1993. [Accessed 8th April 2022] https://pubmed.ncbi.nlm.nih.gov/8385183/

    4. Actavis Ltd. Health Products Regulatory Authority (HPRA). [Revised on January 2020] [Accessed 8th April 2022] https://www.hpra.ie/img/uploaded/swedocuments/bf027b56-e8da-498b-8b83-727d3ec0484d.pdf

    5. Watson Pharma Private Limited. U.S. Food & Drug Administration. [Revised in August 2020] [Accessed 8th April 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020504s026lbl.pdf

    6. Cipla Ltd. RAMIPRES-H Tablets (Ramipril + Hydrochlorothiazide). Ciplamed.com [Revised on April 2017] [Accessed 8th April 2022] https://www.ciplamed.com/content/ramipres-h-tablets

    7. Bausch Health, Canada Inc. Health Products and Food Branch (HPFB). Product monograph. [Revised on June 2021] [Accessed 8th April 2022] https://bauschhealth.ca/wp-content/uploads/2021/11/Altace-HCT-PM-EN-2021-06-08.pdf

    Useful Diagnostic Tests

    • Kidney Function Test

    Author Details

    Written By Dr. Janet.C - Pharm.D
    Reviewed For Accuracy By Dr. Thamada Manikanta Praveen - MBBS, MD (General Medicine)
    Last updated on 19 Nov 2022 | 11:49 PM(IST)
    Lab updated