Consumer Medicine Information
What are Ramipril-PS Capsules?
Ramipril is an angiotensin converting enzyme (ACE) inhibitor. It is a drug which is used to reduce the risk of cardiovascular problems (problems related to the heart and blood vessels) in high risk patients, to lower high blood pressure (hypertension), and to help slow down the progression of kidney disease.
Why has my doctor prescribed Ramipril-PS Capsules, and how will they help?
The benefits that you will get from Ramipril-PS Capsules will depend on the reason why your doctor has prescribed it. Please talk to your doctor if you want more information on why it has been prescribed for you.
Ramipril-PS Capsules might be prescribed for you:
- If you have heart or blood vessels disease, have had a heart attack or stroke, or diabetes and one other risk factor, your doctor may decide that Ramipril-PS Capsules is appropriate for you. Ramipril-PS Capsules can reduce your chances of having a heart attack, stroke, or death due to heart disease, by keeping the blood vessel walls and heart muscle healthy.
- If you have high blood pressure (hypertension). Ramipril-PS Capsules is used to lower high blood pressure by relaxing constricted blood vessels in hypertensive patients.
- If you have kidney disease. Ramipril-PS Capsules slows down the progression of kidney disease by lowering blood pressure if it is too high, and improving the health of kidney cells.
Advice before taking Ramipril-PS Capsules:
Follow all directions given to you by your doctor or pharmacist carefully. Do not take Ramipril-PS Capsules if you:
- Have had an allergy to Ramipril-PS Capsules (ramipril), or any of the ingredients in Ramipril-PS Capsules (listed at the end of this leaflet).
- Have previously taken any other ACE-inhibitor medicine that caused your face, lips, tongue or throat to swell, or made it hard for you to breathe.
- Have kidney failure (note that your doctor may give Ramipril-PS Capsules because of your kidney problems).
- Are pregnant or breastfeeding.
Tell your doctor if you have these medical conditions:
- Kidney problems, or having dialysis (note that your doctor may give Ramipril-PS Capsules because of your kidney problems).
- Liver problems.
- Heart problems (note that your doctor may give Ramipril-PS Capsules because of your heart problems).
Tell your doctor if you are taking any other medicines, because some medicines and Ramipril-PS Capsules may interfere with each other. These include:
- Some medicines used to treat high blood pressure.
- Diuretics (medicines used to reduce excess fluid in the body).
- Medicines used to relieve pain, inflammation, swelling and other symptoms, including arthritis.
- Potassium supplements or potassium-containing salt substitutes.
- Lithium (medicine used to treat mood swings and some types of depression).
- Medicines used to treat diabetes
- General anaesthetics.
Treatment with a drug that lowers blood pressure may affect your ability to drive or operate machinery, especially at the start of the treatment or when changing over from other drugs. If you are affected, do not drive or operate machinery.
How do I take Ramipril-PS Capsules?
Ramipril-PS Capsules should be swallowed whole before, during or after meals, with plenty of fluid. Depending on the condition being treated and how you respond to Ramipril-PS Capsules, your doctor will advise an appropriate dose for you. The usual dosage is one capsule daily or one to two tablets daily, up to a maximum of 10 mg daily. If you are taking Ramipril-PS Capsules because you have a heart or blood vessels disease, have had a heart attack or stroke, or diabetes and one other risk factor; the usual maintenance dose is 10 mg per day.
How long do I have to take Ramipril-PS Capsules?
Ramipril-PS Capsules helps control your condition, therefore you must take Ramipril-PS Capsules every day. Continue taking Ramipril-PS Capsules for as long as your doctor tells you.
What if I forget to take my Ramipril-PS Capsules?
If it is almost the time for you to take the next dose, skip the dose you missed and take your next dose at the usual time when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally. Do not take a double dose to make up for the dose you missed. If you are not sure what to do, ask your doctor or pharmacist.
What side effects might occur?
Ramipril-PS Capsules has been evaluated for safety in over 13,000 patients with hypertension, cardiovascular disease or diabetes. The most common side effects are feeling sick (nausea), dizziness, headache, and dry cough. Other side effects: include light-headedness, stomach pain, diarrhoea, unusual tiredness, weakness, ringing or buzzing in the ears, taste disturbances, forgetfulness or confusion. Usually, these side effects are mild and short lived, and do not require stopping treatment.
Following is a list of rare but serious side effects. Do not be alarmed by this list, you will probably not experience any of them. Tell your doctor as soon as possible, if you notice the following:
- Skin rash, symptoms of sunburn (such as redness, itching, swelling, blistering), which may occur more quickly than normal.
- Yellowing of the skin and/or eyes.
- Fast or irregular heart beat, shortness of breath or tightness in the chest.
- Passing little or no urine, or more urine than is normal for you.
- Sign of anaemia such as tiredness, being short of breath and looking pale.
- Numbness, tingling and colour change (white, blue then red) in the fingers or toes when exposed to the cold.
There are other very rare but serious side effects. If any of the following happens, stop taking Ramipril-PS Capsules and either tell your doctor immediately or have someone drive you to the Emergency Department at the nearest hospital:
- Fainting within a few hours of taking a dose, chest pain.
- Severe dizziness and confusion with visual disturbances and speech problems.
- Swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing.
- Pink or red itchy spots on the skin, which may blister and progress to form raised, red, pale-centred marks.
- Severe blisters and bleeding in the lips, eyes, mouth, nose and genitals.Other side effects not listed above may occur in some patients.
What if I take too much (overdose)?
If you take too many Ramipril-PS Capsules, you may feel very dizzy, light-headed, weak or you may faint. If you think that you or anyone else may have taken too much Ramipril-PS Capsules, immediately telephone your doctor or have someone drive you to the Emergency Department at the nearest hospital.
How should I store my Ramipril-PS Capsules?
Store the capsules below 25°C; in dry place. If you notice that your Ramipril-PS Capsules have passed their expiry date, do not take them, and ask advice from your pharmacist.
What do Ramipril-PS Capsules look like?
Ramipril-PS Capsules are available in four different strengths:
- 1.25 mg capsule: Size ‘4’ capsules with yellow cap, imprinted with “RAMI” in black ink and yellow body imprinted with ‘1.25’ in black ink, containing white to off-white powder.
- 2.5 mg capsule: Size ‘4’ capsules with orange cap, imprinted with “RAMI” in black ink and orange body imprinted with “2.5”in black ink, containing white to off-white powder.
- 5 mg capsule:Size ‘4’ capsules with red cap, imprinted with “RAMI” in black ink and red body imprinted with “5”in black ink, containing white to off-white powder
- 10 mg capsule:Size ‘4’ capsules with light blue cap, imprinted with “RAMI” in black ink and light blue body imprinted with “10” in black ink, containing white to off-white powder.
Ingredients:
Ramipril-PS Capsules contain 1.25 mg, 2.5 mg, 5 mg or 10 mg ramipril as the active ingredient. The other ingredients are meglumine, pregelatinised starch, gelatin, yellow iron oxide (E172), titanium dioxide (E171),Quinoline Yellow CI47005, Allura Red AC and Brilliant Blue FCF Ramipril-PS Capsules contain no lactose, sucrose, gluten or tartrazine.
Supplier
Ascent Pharma Pty Ltd
151-153 Clarendon street
South Melbourne VIC 3205
Australian Registration Number:
Ramipril-PS capsules 1.25 mg – AUST R 153844
Ramipril-PS capsules 2.5 mg – AUST R 153845
Ramipril-PS capsules 5 mg – AUST R 153846
Ramipril-PS capsules 10 mg – AUST R 153847
This leaflet was prepared in July 2011
Published by MIMS May 2012