RAMIPRIL GENERICHEALTH

ramipril


Consumer Medicine Information

What is in this leaflet

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.

What Ramipril generichealth is used for

The benefits that you will get from Ramipril generichealth 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 generichealth 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 generichealth is appropriate for you. Ramipril generichealth 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 generichealth is used to lower high blood pressure by relaxing constricted blood vessels in hypertensive patients.

If you have kidney disease. Ramipril generichealth slows down the progression of kidney disease by lowering blood pressure if it is too high, and improving the health of kidney cells.

Before you take Ramipril generichealth

When not to take it

Follow all directions given to you by your doctor or pharmacist carefully. Do not take Ramipril generichealth if you:

Have had an allergy to Ramipril generichealth (ramipril), or any of the ingredients in Ramipril generichealth (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 generichealth 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 generichealth because of your kidney problems).

Liver problems.

Heart problems (note that your doctor may give Ramipril generichealth because of your heart problems).

Tell your doctor if you are taking any other medicines, because some medicines and Ramipril generichealth 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 to take Ramipril generichealth

How to take it

Ramipril generichealth 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 generichealth, 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 generichealth 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 to take it for

Ramipril generichealth helps control your condition, therefore you must take Ramipril generichealth every day. Continue taking Ramipril generichealth for as long as your doctor tells you.

If you take too much

If you take too much Ramipril generichealth, you may feel very dizzy, lightheaded, weak or you may faint. If you think that you or anyone else may have taken too much Ramipril generichealth , immediately telephone your doctor or have someone drive you to the Emergency Department at the nearest hospital.

While you are taking Ramipril generichealth

If you forget to take it

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.

Side Effects

Ramipril generichealth 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,
  • 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 generichealth 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
  • 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.

How to store Ramipril generichealth

Store the capsules below 25°C; in dry place.

If you notice that your Ramipril generichealth has passed its expiry date, do not take it, and ask advice from your pharmacist.

Product description

What Ramipril generichealth tablets look like

Ramipril generichealth is 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 generichealth contains 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
  • Brilliant Blue FCF

Ramipril generichealth contains no lactose, sucrose, gluten or tartrazine.

Sponsor

Generic Health Pty Ltd
Level 1, 1102 Toorak Road
Camberwell VIC 3124

Australian Registration Number

Ramipril generichealth 1.25 mg – AUST R 134787

Ramipril generichealth 2.5 mg – AUST R 134792

Ramipril generichealth 5 mg – AUST R 134797

Ramipril generichealth 10 mg – AUST R 134802

This leaflet was prepared in September 2017.

Published by MIMS November 2017