RAMIPRIL 5MG CAPSULES

Active substance: RAMIPRIL

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PATIENT INFORMATION LEAFLET

RAMIPRIL 1.25 mg CAPSULES/
RAMIPRIL 2.5 mg CAPSULES/
RAMIPRIL 5 mg CAPSULES/
RAMIPRIL 10 mg CAPSULES
Read all of this leaflet carefully before you
start taking this medicine • Keep this leaflet. You
may need to read it again • If you have any further
questions, please ask your doctor or pharmacist • This
medicine has been prescribed for you personally and
you should not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
In this leaflet:
1. What Ramipril Capsules are and what they are used
for
2. Before you take Ramipril Capsules
3. How to take Ramipril Capsules
4. Possible side effects
5. Storing Ramipril Capsules
The active substance in Ramipril Capsules is ramipril.
Ramipril Capsules come in 4 strengths:
• 1.25 mg Ramipril (yellow and white capsules)
• 2.5 mg Ramipril (orange and white capsules)
• 5 mg Ramipril (maroon and white capsules)
• 10 mg Ramipril (blue and white capsules).
Each capsule also contains pregelatinised starch, gelatin,
sodium laurylsulphate, methyl hydroxybenzoate and
propyl hydroxybenzoate.
The 1.25 mg capsule also contains the colours yellow
ferric oxide (E172) and titanium dioxide (E171). The
2.5 mg capsules also contains the colours sunset yellow
(E110), ponceau 4 R (E124), carmoisine (E122) and
titanium dioxide (E171). The 5 mg capsule also contains
the colours ponceau 4 R (E124), brilliant blue (E133),
carmoisine (E122) and titanium dioxide (E171). The 10 mg
capsule also contains the colours brilliant blue (E133),
erythrosine (E127), carmoisine (E122) and titanium
dioxide (E171). Ramipril Capsules come in a blister pack
containing 28 capsules.
Marketing Authorisation Holder and Manufacturer:
Bristol Laboratories Limited, Unit 3, Canalside,
Northbridge Road, Berkhamsted, Herts, HP4 1EG.
Distributed by: Generics [UK] Limited, Station Close,
Potters Bar, Hertfordshire, EN6 1TL.
WHAT RAMIPRIL CAPSULES ARE AND WHAT
THEY ARE USED FOR
Ramipril Capsules contain the active ingredient ramipril.
Ramipril belongs to a group of medicines called ACE
(angiotensin converting enzyme) inhibitors, which act on
heart and blood vessels. Ramipril Capsules are
prescribed to you for one or more of the following
reasons:
• to lower your blood pressure if it is high.
• to help your heart pump blood if you have heart failure
and are being treated with diuretics (water tablets)
and also sometimes with a group of drugs called
glycosides
• to prevent your heart from weakening further if you
have had a heart attack

• in patients who are 55 years or older and suffer from
heart and circulation problems, or who have
previously had a stroke, Ramipril Capsules may be
prescribed to reduce the risk of a heart attack, stroke,
further heart or circulatory problems or to decrease the
risk of requiring a surgical procedure to increase the
blood flow to the heart. Ramipril Capsules may also
be given to you if you are a diabetic of 55 years or
older and if you smoke, have suffered heart or
circulatory problems, have high blood pressure, high
cholesterol levels or low levels of high density
lipoproteins (HDL), or have proteins in the urine.
BEFORE YOU TAKE RAMIPRIL CAPSULES
Do not take Ramipril Capsules if:
• you have previously suffered from angioneurotic
oedema (a swelling of the skin or airways)
• you have low blood pressure or your blood pressure is
unstable.
• you are pregnant
• you are breast-feeding
• you have problems with the blood supply to your
kidneys
• if you are allergic to Ramipril or any ingredients
mentioned above.
Ramipril Capsules are not recommended for children.
Tell your doctor before taking your medicine if:
• you have any heart valve problems, such as
blockages or murmurs, as Ramipril may not be suitable
for use
• you have kidney problems, so that your doctor can
assess your kidney problem and if necessary adjust
your dose of Ramipril Capsules
• you have liver problems, as your doctor may want to
monitor you closely
• you are on haemodialysis
• you have lupus erythematous or scleroderma
• you are taking any diuretics, medicines for blood
pressure, heart disease, diabetes, anti-coagulants
(eg. Heparin), Lithium, treatment for gout,
corticosteroids, non-steroidal anti-inflammatory drugs,
drugs to depress the immune system or medicines
containing potassium
• you are dehydrated or are suffering from salt
depletion, for example as a result of excessive
sweating, diarrhoea,or vomiting
• you are undergoing desensitisation therapy (a course
of treatment to build up your immunity to an allergen)
• you need surgery or an anesthetic. Tell your doctor or
dentist that you are taking Ramipril Capsules as they
may need to alter your treatment.
Pregnancy - You should not take Ramipril Capsules
if you are pregnant. Tell your doctor as soon as possible
if you think you have become pregnant whilst taking
Ramipril Capsules or if you intend to become pregnant.
Breast feeding - It is recommended that mothers
taking Ramipril Capsules do not breast-feed their
babies.
Driving and operating machines - Ramipril
Capsules may cause dizziness or tiredness, especially
when you first start taking this medicine. Drinking

alcohol may also make these symptoms worse. If this
happens to you, do not drive or use machinery. It is
recommended that you do not drive or operate
machinery for several hours after taking Ramipril
Capsules for the first time or if you are increasing your
dose of Ramipril Capsules for the first time.
Using other medicines - Please inform your doctor or
pharmacist if you are taking or have recently taken any
other medicines, even those not prescribed.
HOW TO TAKE RAMIPRIL CAPSULES
Take the capsule exactly as directed by your doctor. If
you do not understand these instructions, ask your
pharmacist, nurse or doctor to explain them to you. The
usual doses are shown below. You should always follow
your doctor's instructions as to how and when to take
your medicines. Ramipril Capsules should be swallowed
with a drink of water. If you have trouble swallowing the
capsule, inform your doctor.
For treating high blood pressure, the usual dose is 1.25 mg
once a day. Your doctor may increase the dose after one
or two weeks of the treatment. In most cases of high
blood pressure, a dose of 2.5 mg or 5 mg is required
once a day, but your doctor may increase the dose up to
a maximum of 10 mg per day.
For treating congestive heart failure, the usual starting
dose is 1.25 mg per day, although your doctor may
increase the dose after one or two weeks of treatment. In
most cases a dose of 2.5 mg or 5 mg is required once a
day, but your doctor may increase the dose up to a
maximum of 10 mg per day.
Following a heart attack the usual starting dose is 2.5 mg
twice a day, which may be increased to 5 mg twice a
day after a few days, or in some cases, the dose may be
reduced to 1.25 mg twice a day.
To reduce the risk of heart attack, stroke and surgery to
improve the blood flow to your heart, the usual starting
dose is 2.5 mg once a day. However, the dose may be
increased to 5 mg after 1 week and then up to 10 mg
after another 3 weeks.
If you are elderly, taking diuretics, or have kidney or liver
problems, your doctor may start you with a low dose,
and increase the dose if necessary.
If you take more Ramipril Capsules than you
should - If you take more capsules than what you have
been told to, or if you take the wrong strength of Ramipril
Capsules, tell your doctor immediately or go to
the nearest hospital casualty department.
If you forget to take Ramipril Capsules - If you
miss a dose, take the missed dose as soon as possible,
and then continue with your normal course. If it is almost
time for you to take the next dose, skip the missed dose
and then take your next dose when it is due. Do not
take a double dose to make up the missed dose.
POSSIBLE SIDE EFFECTS
Like all medicines, Ramipril Capsules can have side
effects.
If any of the following happen, stop taking
Ramipril Capsules and tell your doctor

immediately or go to the casualty department
at your nearest hospital:
• if your breathing becomes difficult and noisy
• you get swelling of the tongue, face or throat.
These are all very serious side effects. If you have them
you may have had a serious allergic reaction to Ramipril
Capsules. You may need urgent medical attention or
hospitalisation. These very serious side effects are rare.
Tell your doctor immediately or go to the
casualty department at your nearest hospital if
you notice any of the following:
• if you feel ill after your first dose and feel very dizzy,
weak, faint and sick
• you get a lot of infections with sore throats or mouth
ulcers
• you notice a rash, skin eruption or other effects on the
skin or eyes, itching or a high temperature.
These are all serious side effects. You may need urgent
medical attention. Serious side effects are rare.
Ramipril may also cause the following unwanted sideeffects in some people: feeling sick, dizziness,
headache, light-headedness, visual or hearing
disturbances, dry tickling cough, bronchitis, a runny or
stuffy nose, fever, dry mouth, loss of appetite, vomiting,
stomach pains, diarrhoea, or constipation, jaundice,
hepatitis, pancreatitis (inflammation of the pancreas),
vasculitis (inflammation of the blood vessels), effects on
the heart such as angina, chest pain, and irregularity of
the heart beat, such as palpitations, reduced circulation
to the hands and or feet, pins and needles, muscle
cramps, joint pains, tiredness and weakness, hair loss,
mood changes, nervousness, restlessness, shaking,
confusion, disturbance of balance, problems with
sleeping, changes in sense of taste, sensitivity of the skin
to light, effects on the nails (loosening), sexual inability
in men, reduced sexual desire.
Treatment with Ramipril Capsules may impair renal and
liver function in some individuals. Blood tests may show
increased levels of blood urea nitrogen, creatinine and
serum potassium, whereas serum sodium levels may
decrease.
If you notice any of the above side effects or if
you notice any unusual or unexpected effects
that are not mentioned in this leaflet after
taking Ramipril Capsules, please inform your
doctor or pharmacist.
STORING RAMIPRIL CAPSULES
Keep Ramipril Capsules out of the reach and
sight of children. Do not use the capsules after the
expiry date shown on the carton. Do not store above
25°C. Store in the original blister pack.
Further Information - For any additional information
on this medicinal product, please contact the Marketing
Authorisation Holder: Bristol Laboratories Limited, Unit 3,
Canalside, Northbridge Road, Berkhamsted, Herts, HP4
1EG, United Kingdom.

Date of leaflet preparation: October 2007

10001134

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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