Patient Medication Information: uses, side effects, how to take - PMS-Ramipril-HCTZ (Pharmascience, 10.0 mg / 12.5 mg, 10.0 mg / 25.0 mg)
Serious Warnings and Precautions
Pregnancy: Angiotensin converting enzyme (ACE) inhibitors, such as pms-RAMIPRIL-HCTZ, can cause harm or even death to your unborn baby. Therefore, pms-RAMIPRIL-HCTZ should not be taken during pregnancy. If you become pregnant or think you are pregnant, stop taking pms-RAMIPRIL-HCTZ right away and tell your healthcare professional.
What is pms-RAMIPRIL-HCTZ used for?
pms-RAMIPRIL-HCTZ is used in adults to treat essential hypertension (high blood pressure).
How does pms-RAMIPRIL-HCTZ work?
pms-RAMIPRIL-HCTZ is a combination tablet of two medical ingredients, ramipril and hydrochlorothiazide. Ramipril is an angiotensin converting enzyme (ACE) inhibitor that widens blood vessels. While, hydrochlorothiazide is a diuretic or “water pill” that increases the amount of urine output. These work together to lower high blood pressure.
What are the ingredients in pms-RAMIPRIL-HCTZ?
Medicinal ingredients: Ramipril and hydrochlorothiazide.
Non-medicinal ingredients:
- 10 mg/12.5 mg tablets: Colloidal Silicon Dioxide, Crospovidone, Hypromellose, Lactose Monohydrate, Microcrystalline Cellulose, Red Iron Oxide, Sodium, Stearyl Fumarate, and Yellow Iron Oxide.
- 10 mg/25 mg tablets: Colloidal Silicon Dioxide, Crospovidone, Hypromellose, Lactose Monohydrate, Microcrystalline Cellulose, Red Iron Oxide Sodium, Stearyl Fumarate,.
pms-RAMIPRIL-HCTZ comes in the following dosage forms:
Tablets:
- 10 mg ramipril/12.5 mg hydrochlorothiazide
- 10 mg ramipril/25 mg hydrochlorothiazide
Do not use pms-RAMIPRIL-HCTZ if:
- you are allergic to ramipril, hydrochlorothiazide, or any of the other ingredients in pms-RAMIPRIL-HCTZ.
- you are allergic to any other ACE inhibitors, other thiazide diuretics, or sulfonamides.
- you have a personal or family history of angioedema (swelling of tissue under the skin).
- you are pregnant or planning to become pregnant.
- you are breastfeeding or planning to breastfeed.
- you have renal artery stenosis (narrowing of the arteries to one or both kidneys).
- you have hypotension (low blood pressure).
- you have taken ENTRESTO® (sacubitril and valsartan) within the last 36 hours, or are currently taking ENTRESTO®.
- you have anuria (difficulty urinating or producing no urine).
- you have severe kidney problems.
- you are receiving hemodialysis or hemofiltration with high-flux membranes (e.g., polyacrylonitrile) treatment. These treatments are used to remove certain molecules from the blood.
- you are on low-density lipoprotein (LDL) apheresis with dextran sulfate (a treatment used to remove LDL cholesterol from the blood).
- you have severe liver problems.
you have electrolyte disturbances such as:
- hypokalemia(low potassium in the blood),
- hyponatremia(low sodium in the blood), or
- hyperkalemia(high potassium in the blood).
you are taking medicines that contain aliskiren (such as RASILEZ®) that are used to lower blood pressure or angiotensin II receptor antagonists (ARBs) that are used to treat high blood pressure and have one of the following conditions:
- diabetes with end organ damage
- kidney disease
- high potassium levels
- heart failure combined with low blood
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take pms-RAMIPRIL-HCTZ. Talk about any health conditions or problems you may have, including if you:
- have heart problems.
- have diabetes.
- have liver problems.
- have kidney problems.
- have a kidney transplant.
- are allergic to penicillin.
- have recently received or are planning to get allergy shots for bee or wasp stings.
- have a personal or family history of cancer.
- are at a higher risk of developing skin cancer. You may be at a higher risk if you have light skin colour, have a personal or family history of skin cancer, or if you are taking medicines that suppress your immune system.
- are planning to have surgery or anesthesia.
- have a history of bronchial asthma.
- have lupus erythematosus (an autoimmune disease) or gout (a type of arthritis that causes joint pain).
- have Raynaud’s phenomenon (a condition resulting from poor circulation in the extremities, such as fingers and toes). It may begin or worsen.
- have scleroderma (a disease that can cause thickening, hardening, or tightening of the skin, blood vessels and internal organs).
- are dehydrated or suffer from excessive vomiting, diarrhea, or sweating.
- are on a low-salt diet.
- have had breathing or lung problems (including inflammation or fluid in the lungs) in the past following the use of medication containing hydrochlorothiazide or certain diuretics (i.e., “water pills”). If you experience any severe shortness of breath or difficulty breathing after taking ALTACE HCT, stop the medication and seek medical attention immediately.
Other warnings you should know about:
pms-RAMIPRIL-HCTZ can cause the following:
Skin cancer: Hydrochlorothiazide in pms-RAMIPRIL-HCTZ may increase the risk of developing skin cancer such as non-melanoma skin cancer (NMSC), squamous cell carcinoma (SCC), and basal cell carcinoma (BCC). The risk is higher if you have been taking pms-RAMIPRIL-HCTZ for many years (more than 3) or at a high dose. While taking pms-RAMIPRIL-HCTZ:
- you should regularly check your skin for new lesions (e.g., a lump, bump, sore, or patch). These are more likely to occur in areas that are more exposed to the sun (e.g., face, ears, hands, shoulders, upper chest, and back).
- you should limit your exposure to the sun, avoid indoor tanning, and use sun protection when going outside. This includes using sunscreen (SPF 30 or higher), wearing protective clothing, and wearing a hat.
- tell your doctor right away if you get more sensitive to the sun or UV light, or if you develop an unexpected lesion.
- Hypotension (low blood pressure): Treatment with pms-RAMIPRIL-HCTZ can cause hypotension. Your healthcare professional may monitor your health and adjust your dose as needed. Tell your healthcare professional, if you notice an increase in sweating, feel dehydration, are vomiting, or have diarrhea.
Blood problems: Treatment with ACE inhibitors, such as pms-RAMIPRIL-HCTZ, can cause:
- agranulocytosis (decrease in white bloods cells),
- neutropenia (decreased white blood cells), or
- leukopenia (decreased white blood cells).
If you notice any signs of these blood problems including infections, tell your healthcare professional right away.
Liver problems: Treatment with ACE inhibitors, such as pms-RAMIPRIL-HCTZ, can cause liver problems such as:
- hepatitis (inflammation of the liver),
- jaundice (yellowing of the skin or whites of eyes), and
- liver failure.
If you notice any symptoms of liver problems, especially within the first weeks or months of treatment, tell your healthcare professional. You may also be tested to assess your liver function before, during, and after your treatment with pms-RAMIPRIL-HCTZ. This will help them decide if you should reduce or stop your dose.
- Kidney problems: Treatment pms-RAMIPRIL-HCTZ can cause kidney problems resulting in decreased urine, progressive azotemia (high levels of nitrogen in the blood), kidney failure or even death. Your healthcare professional will closely monitor your kidneys before and during your treatment. They may decide to reduce or stop your treatment.
- Angioedema (swelling of tissue under the skin): Treatment with ACE inhibitors, such as pms-RAMIPRIL-HCTZ, can cause angioedema that can be life-threatening. Your healthcare professional will monitor your health for signs of angioedema. If you notice swelling on your body or have difficulty swallowing or breathing, stop taking pms-RAMIPRIL-HCTZ and tell your healthcare professional right away.
Fluid or electrolyte imbalance: Hydrochlorothiazide in pms-RAMIPRIL-HCTZ can cause fluid or electrolyte imbalances such as:
- hypokalemia(low potassium in the blood),
- hyponatremia(low sodium in the blood),
- hypochloremic alkalosis (low chloride in the blood),
- hyperuricemia (high uric acid in the blood), and
- acute gout (a type of arthritis that causes joint pain).
Tell your healthcare professional if you notice any signs or symptoms related to fluid or electrolyte imbalances.
- Photosensitivity: You may become sensitive to the sun while taking pms-RAMIPRIL-HCTZ. Exposure to sunlight should be reduced until you know how you respond. Tell your healthcare professional if you notice any photosensitivity. They may decide to stop your treatment with pms-RAMIPRIL-HCTZ.
Eye problems: Hydrochlorothiazide in pms-RAMIPRIL-HCTZ can cause sudden eye disorders:
- Choroidal effusion (an abnormal build-up of liquid in your eye that may result in vision changes),
- Myopia: (sudden nearsightedness or blurred vision), and
- Glaucoma (an increased pressure in your eye, eye pain. Untreated, it may lead to permanent vision loss).
If your vision changes, stop taking pms-RAMIPRIL-HCTZ and seek immediate medical help. These eye disorders are related and can develop within hours to weeks of starting pms-RAMIPRIL-HCTZ.
See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
Driving and using machines: pms-RAMIPRIL-HCTZ can decrease your blood pressure causing light- headedness, dizziness, and fainting. These can occur more often after your first dose, and when your dose is increased. Before you drive or do tasks that require special attention, wait until you know how you respond to pms-RAMIPRIL-HCTZ.
Check-ups and testing:
- You may have regular visits with your healthcare professional, before, during and after your treatment. These tests may be used to monitor your health such as your kidney function, liver function, and the profile of your blood.
- pms-RAMIPRIL-HCTZ can affect the level of calcium within your blood. Your healthcare professional may stop your treatment with pms-RAMIPRIL-HCTZ before performing tests that assess the function of your parathyroid glands.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with pms-RAMIPRIL-HCTZ:
- other medicines used to lower high blood pressure such as methyldopa.
- medicines known as diuretics (“water pill”) such as potassium-sparing diuretic and potassium-retaining diuretics (e.g., spironolactone, triamterene, or amiloride).
- medicines that increase the potassium in the blood such as a salt substitute that contains potassium, potassium supplements, and a potassium-sparing diuretic (a type of “water pill”).
- medicines that may change the profile of your blood such as immunosuppressants (used to lower the body’s ability to reject a transplanted organ), procainamide (used to treat irregular heartbeats), and cytostatic medicines (used to treat certain types of cancer).
- medicines used to treat fungal infections such as Amphotericin B.
- medicines used to treat cancer such as cyclophosphamide and methotrexate.
- medicines used to lower cholesterol such as bile acid resins.
- medicines used to treat epilepsy such as carbamazepine and topiramate.
- medicines used to treat acid peptic disease such as carbenoxolone.
- medicines known as laxatives that are used to loosen stool or help a bowel movement.
- medicines used to help with sleep such as barbiturates.
- medicines used to help reduce intense pain such as narcotics.
- vitamins and mineral supplements such as calcium or vitamin D.
- medicines known as corticosteroids that are used to treat joint pain, swelling, and other conditions.
- medicines used to treat West Syndrome such as adrenocorticotropic hormone (ACTH).
- medicines used to decrease the effects from allergens (allergy shots).
- medicines used to treat heart conditions such as digoxin.
- medicines used to treat diabetes (antidiabetic) such as insulin, gliptins (e.g., sitaglitin, linagliptin, saxagliptin), and oral hypoglycemic agents (used to lower glucose levels in the blood).
- medicines that change the speed of bowel movements such as atropine, metoclopramide, and domperidone.
- gold used to treat arthritis (swelling and tenderness of joints).
- medicines used to treat gout (a type of arthritis that causes joint pain) such as allopurinol, probenecid, uricosurics, and xanthine oxidase inhibitors.
- medicines used to treat and prevent blood clots such as heparin.
- medicines used to treat bipolar disease such as lithium.
- medicines known as neutral endopeptidase (NEP) inhibitors. If you are unsure ask your healthcare professional.
- nonsteroidal anti-inflammatory drugs (NSAIDs) that are used to reduce pain and swelling such as ibuprofen, naproxen, celecoxib, indomethacin, and acetylsalicylic acid (aspirin).
- medicines that have the potential to lower blood pressure such as nitrates.
- medicines used to treat depression (antidepressants) such as selective serotonin re - uptake inhibitors (e.g., citalopram, escitalopram, and sertraline).
- medicines used to relieve muscle spasms such as tubocurare.
- medicines known as sympathomimetic agents that reduce nasal congestion such as cough and cold medicines.
- medicines known as mammalian target of rapamycin (mTOR) inhibitors such as sirolimus, temsirolimus, and everolimus. These are used to lower the body’s ability to reject a transplanted organ or to treat certain types of cancer.
- alcohol.
- large amounts of liquorice.
How to take pms-RAMIPRIL-HCTZ:
- pms-RAMIPRIL-HCTZ is not for initial therapy.
- You must be stabilized on ramipril and hydrochlorothiazide before taking pms-RAMIPRIL-HCTZ. If your dosage matches the dosages in pms-RAMIPRIL-HCTZ, your healthcare professional may prescribe pms-RAMIPRIL-HCTZ (instead of each medicinal ingredient as a separate pill).
- Your healthcare professional will decide the dose and length of pms-RAMIPRIL-HCTZ for you. They may start with a low dose and slowly adjust the dose as needed. Take pms-RAMIPRIL-HCTZ exactly as prescribed by your healthcare professional.
pms-RAMIPRIL-HCTZ can be taken with or without food. The tablet(s) should be swallowed whole with liquid (approximately half a glass). Do NOT chew or crush the tablets. If pms-RAMIPRIL-HCTZ causes upset stomach, take it with food or milk.
- It is recommended that your daily dose is taken about the same time every day in the morning.
- Your healthcare professional will monitor your health throughout your treatment and may interrupt, reduce or stop your dose.
Usual dose:
The usual daily dose is 2.5 mg/12.5 mg of ramipril and hydrochlorothiazide. The maximum daily dose is 10 mg/50 mg of ramipril and hydrochlorothiazide.
Overdose:
| If you think you, or a person you are caring for, have taken too much pms-RAMIPRIL-HCTZ, contact a healthcare professional, hospital emergency department, or regional Poison control Centre immediately, even if there are no symptoms. |
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Missed Dose:
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose. Instead, take your next scheduled regular dose. Do not double your dose at any time.
What are possible side effects from using pms-RAMIPRIL-HCTZ?
These are not all the possible side effects you may have when taking pms-RAMIPRIL-HCTZ. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- difficulty in maintaining your balance while standing
- cough
- upset stomach
- constipation
- flushing of the skin
- runny or stuffy nose
- bronchitis (inflammation of the lining of your lungs)
- swollen lymph nodes
- mouth ulcer
- tongue pain
- attention disturbances
- problems with sleeping
- sexual difficulties
- impotence
- reduced libido
- breast enlargement in men
- hearing, taste or smell changes
- loss of hair
- back pain
- eye modification (pink eye, less tearing, yellow vision)
- inflammation or enlargement of salivary glands
- Raynaud’s phenomenon (episodes of reduced blood flow)
Tell your healthcare professional if any of these affects you severely.
Serious side effects and what to do about them
| Symptom/ Effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| COMMON | |||
Hypotension (low blood pressure): dizziness, fainting, light-headedness (may occur when you go from lying or sitting to standing up), blurred vision, nausea, vomiting, or fatigue | ✓ | ||
| Decreased or increased levels of potassium in the blood: irregular heartbeats, muscle weakness, generally feeling unwell, muscle spasms, cramping, constipation, feeling of skipped heart beats or palpitations, fatigue, tingling, or numbness | ✓ | ||
| Non-melanoma skin cancer: lump or discoloured patch on the skin that stays after a few weeks and slowly changes; lumps can be red/pink, firm and sometimes turn into ulcers; and cancerous patches are usually flat and scaly | ✓ | ||
| Neuralgia (pain that follows the path of the nerve): sudden attacks of severe sharp shooting pain | ✓ | ||
| UNCOMMON | |||
| Allergic reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing, effect on the eyes, itching, fever, wheezing, drop in blood pressure, or feeling sick to your stomach and throwing up | ✓ | ||
| Tachycardia (abnormally fast heartbeat) | ✓ | ||
Myocardial infarction (heart attack): pressure or squeezing pain between the shoulder blades, in the chest, jaw, left arm or upper abdomen, shortness of breath, dizziness, fatigue, light- headedness, clammy skin, sweating, indigestion, anxiety, feeling faint, palpitations, or possible irregular heartbeat | |||
| Stroke (bleeding or blood clot in the brain): sudden numbness, weakness or tingling of the face, arm, or leg, particularly on one side of the body, sudden | ✓ | ||
Serious side effects and what to do about them
| Symptom/ Effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| headache, blurry vision, difficulty swallowing or speaking, lethargy, dizziness, fainting, vomiting, trouble understanding, or trouble with walking and loss of balance | |||
| Angioedema (swelling of tissue under the skin): abdominal pain (with or without nausea or vomiting), difficulty breathing, swollen face, hands and feet, genitals tongue, throat, swelling of the digestive tract causing diarrhea, nausea, or vomiting | ✓ | ||
Behavior and mood changes: depression (sad mood that won’t go away), nervousness, difficultly sleeping or sleeping too much, or confusion | |||
| Bronchospasm (when there is a sudden narrowing of the airway): difficulty breathing with wheezing, or coughing | ✓ | ||
| Kidney problems: increased or decreased urination, nausea, vomiting, swelling of extremities, fatigue, fever, thirst, dry skin, irritability, dark urine, blood in the urine, rash, weight gain (from retaining fluid), loss of appetite, abnormal blood test results, or mental status changes (drowsiness, confusion, coma) | ✓ | ||
| Liver problems: yellowing of the skin or eyes (jaundice), dark urine, abdominal pain or swelling, nausea, vomiting, loss of appetite, or unusual tiredness | ✓ | ||
| Hyperglycemia (high blood sugar): frequent urination, thirst, and hunger, dry skin, headache, blurred vision, or fatigue | ✓ | ||
Electrolyte imbalance: weakness, drowsiness, muscle pain or cramps, or irregular heartbeat | ✓ | ||
| RARE | |||
| Decreased platelets: bruising, bleeding, fatigue, or weakness | ✓ | ||
| Decreased white blood cells: infections, fatigue, fever, aches, pains, or flu-like symptoms | ✓ | ||
| VERY RARE | |||
| Toxic Epidermal Necrolysis (TEN) (severe skin reaction): redness, blistering and/or peeling of large areas of the skin | ✓ | ||
Serious side effects and what to do about them
| Symptom/ Effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Acute respiratory distress (inflammation of lung tissue or excess fluid in the lungs): severe shortness of breath or difficulty breathing, fever, weakness, and confusion | ✓ | ||
| UNKNOWN FREQUENCY | |||
Eye disorders:
| ✓ | ||
Anemia (decreased number of red blood cells): fatigue, loss of energy, weakness, shortness of breath, irregular heartbeats, or pale complexion | ✓ | ||
| Pancreatitis (inflammation of the pancreas): upper abdominal pain that lasts and gets worse when you lie down, nausea, vomiting, fever, rapid heartbeat, or tenderness when touching the abdomen | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store between 15°C and 25°C. Protect from heat and humidity.
Keep out of the reach and sight of children.
If you want more information about pms-RAMIPRIL-HCTZ:
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Pharmascience Inc.
Montréal, Québec
H4P 2T4
www.pharmascience.com