RAMIPRIL 2.5MG TABLETS

Active substance: RAMIPRIL

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What you should know about Ramipril Tablets
Please read this carefully before you start to take your medicine.
q This leaflet provides a summary of the information available on your
medicine.
q If you have any questions or are not sure about anything, ask your doctor
or pharmacist.
q 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.
The name of your medicine is Ramipril 1.25mg, 2.5mg, 5mg, and 10mg
Tablets.
Marketing authorisation holder: Sandoz Ltd, 37 Woolmer Way, Bordon,
Hampshire, GU35 9QE.
The manufacturer responsible for batch release is: Sandoz Pharmaceuticals
GmbH, Carl-Zeiss-Ring 3, 85737 Ismaning, Germany.
And / or: LEK S.A., UI. Podlipie 16, 95-010 Strykow, Poland.

What is in this leaflet?
1. What Ramipril Tablets are and what they are used for.
2. Before you take Ramipril Tablets.
3. How to take Ramipril Tablets.
4. Possible side effects.
5. Storing Ramipril Tablets.
1. What Ramipril Tablets are and what they are used for
The active substance in your Ramipril Tablets is ramipril. Ramipril Tablets
are available in four strengths. They are supplied in tablet containers or
blister packs of 20, 28, 30, 50 and 100, 100 x 1 and 250 tablets.
Each tablet contains 1.25mg, 2.5mg, 5mg, or 10mg of ramipril, the active
ingredient. The other ingredients are microcrystalline cellulose,
pregelatinised starch, silicium dioxide precipitated, glycine hydrochloride
and glycerol dibehenate. The 2.5mg tablets also contains yellow iron oxide
(E172), 5mg tablets contains red iron oxide (E172).
Ramipril 1.25mg is an oblong shaped tablet, white, scoreline on both
sides.

Ramipril 2.5mg is an oblong shaped tablet light yellow speckled,
scoreline on one side.
Ramipril 5mg is an oblong shaped tablet, light pink speckled, scoreline
on one side.
Ramipril 10mg is an oblong shaped tablet, white, scoreline on one side.
Ramipril is one of a group of medicines called ACE (angiotensin
converting enzyme) inhibitors. These work by widening blood vessels,
which makes it easier for the heart to pump blood through them, to all
parts of the body. This helps to reduce raised blood pressure. It can also
help the heart to work better if the heart does not pump as well as is
needed.
Uses
Your doctor has probably prescribed Ramipril Tablets for one of the
following reasons:
q To reduce the risk of a heart attack and heart disease, to decrease the
need for heart bypass surgery and to reduce your chances of having a
stroke. This applies to patients who have been shown to already have

heart disease or peripheral vascular disease.
In diabetic patients who show symptoms of high blood pressure, high
cholesterol, peripheral vascular disease, have known
microalbuminuria (small amounts of a protein called albumin in the
urine), or are smokers. In these patients, Ramipril Tablets can reduce
the risk of heart attack, heart disease and stroke and decreases the
risk of requiring surgery to increase blood flow to the heart.
q To lower mild to moderately high blood pressure.
2. Before you take Ramipril Tablets
Do not take Ramipril Tablets if:
q You are hypersensitive (allergic) to ramipril or any of the other
ingredients listed above.
q You are pregnant.
q You are breast-feeding.
q You have a history of angioedema.
q You have low blood pressure.
q You are undergoing haemodialysis (using high flux polyacrylonitrile,
speak to your doctor if you are unsure).
q

You have had certain types of heart problems e.g. aortic and mitral
stenosis (narrowing of the inlet valve into the left ventricle of the
heart), hypertrophic cardiomyopathy (disease of the heart muscle)
and cardiac arrhythmias (irregular heart beat).
Take special care with Ramipril Tablets if:
q You have heart problems (particularly if you are taking medicine for
it), or if you have any kidney or liver disease. Your doctor may need
to change the dose of your medicine.
q If you are dehydrated or have a salt imbalance.
q You are taking diuretic medication (water tablets). Your doctor may
discontinue diuretic therapy and correct volume and/or salt depletion
before starting treatment with ramipril.
q You have severe high blood pressure.
q You are taking any medications which may affect your blood picture.
Your doctor can advise you of this.
q You are taking medication for low potassium levels.
q You are taking allopurinol and/or other immunosuppressants as this
may increase the likelihood of blood picture changes.
q

Alcohol can increase the effect of ramipril, this can be dangerous and
you should speak to your doctor if you are unsure.
You need to tell your doctor or dentist that you are taking ramipril if
you are about to undergo a surgical / dental procedure where an
aesthetic might be used.
Pregnancy:
Ramipril should not be used in the first trimester of pregnancy. When
pregnancy is planned/confirmed switch to an alternative treatment. Do
not take blood pressure lowering drugs as this may cause defects to
the unborn baby. Ask your doctor or pharmacist for advice before
taking any medicine.
Lactation:
Ramipril Tablets should not be taken by women who are
breast-feeding as Ramipril passes into breast milk and may be
harmful to the baby.
Driving and using machines:
It is not advisable to drive or operate machinery for several hours

after the first dose of Ramipril Tablets or after an increase in dose.
Do not take alcohol.You should not drive or operate machinery if you
feel dizzy or tired while taking Ramipril Tablets.
This is more likely to occur at the start of treatment or when your
dose is increased.
Drinking alcohol may make the dizziness or sleepiness worse.
Using other medicines:
Please inform your doctor or pharmacist if you are taking or have
recently taken any other medicines, even those not prescribed.
You should especially inform your doctor if you have been taking
diuretics (water tablets), medicines for high blood pressure,
medicines for diabetes, lithium, antidepressants, treatment for gout,
types of painkillers called NSAIDs (these include drugs like ibuprofen
and diclofenac), corticosteroids, drugs to suppress the immune
system (e.g. after transplant surgery) or medicines containing
potassium.

3. How to take Ramipril Tablets
Always follow your doctor's instructions as to how and when to
take your medicine, your pharmacist may be able to advise you if
you are not sure. Exactly how many tablets, and how often you
must take them, will be written on the label. Please read it carefully.
The recommended doses are given below. However, doctors
sometimes prescribe different doses to these: if this applies to you,
discuss it with your doctor, if you have not already done so.
Swallow the tablet whole with a glass of water. Take the dose at
approximately the same time each day.
Adults:
For people who have a weakened heart after having a heart attack:
The usual starting dose begins between 3-10 days after the heart
attack and consists of one 1.25mg or 2.5mg tablet twice a day.
After at least 2 days your doctor will increase your dose to 2.5mg
or 5mg. This dose will usually be increased by your doctor to a
maintenance dose of 10mg once a day taken as one 5mg tablet
twice a day, then eventually one 10mg tablet once per day.

maximum dosage should not exceed 10mg.
If you have a creatinine clearance between 50 - 20ml/min, the
maximum dosage should not exceed 5mg.
If you have a creatinine clearance less than 20ml/min, the maximum
dosage should not exceed 2.5mg.
Patients receiving diuretic treatment: It can be dangerous to take
ramipril and diuretics (water tablets) at the same time. Your doctor
may ask you to stop taking your diuretics 2-3 days before taking
your ramipril. If this is not possible your doctor may give you a
special dosing schedule.
Liver Problems: For patients with liver problems, the maximum daily
dosage should be no more than 2.5mg once daily and even then only
under close medical supervision.
Elderly: Your doctor should adjust your dose according to the renal
function of the elderly patient, as shown above under 'Kidney
Disease'.
Children: Ramipril Tablets are not recommended for use in children.

If you have any concerns regarding your treatment, discuss them with
your doctor. Do not stop taking Ramipril Tablets without first
consulting your doctor, as your original symptoms will return.
If you have forgotten to take your medicine, take the missed dose as
soon as you remember, unless it is nearly time for the next dose. Do
not double the next dose to make up for the missed one. If you are at
all concerned about this you should consult your doctor or
pharmacist.
If you have taken too many Ramipril Tablets, contact your doctor or
local hospital accident and emergency department immediately.
You may experience low blood pressure, which will result in dizziness.
If you take more Ramipril than you should:
If you have taken too many tablets, or if someone accidentally
swallows some, immediately contact your doctor or the nearest
hospital for advice.

4. Possible side effects
As with all medicines, Ramipril Tablets may cause undesirable effects
in some people. These include:
Common side effects (affecting 1 in 10 people in every 100 people)
include:
Dizziness, headache and faintness may occur on standing due to low
blood pressure, chest pain, angina, temporary loss of consciousness,
diarrhoea, vomiting, kidney problems, cough.
Uncommon side effects (affecting 1 in 10 people every 1000 people)
include:
Mood swings, taste disturbance, sleep disturbance, dizziness and
spinning sensation, tingling, prickling, pins and needles, electrical-type
buzzing, burning, itching and partial numbness, heart attack, stroke,
irregular heart beat, blood not reaching extremities of the body (a
condition called Raynaud's), inflammation of the nasal membrane,
shortness of breath, nausea, abdominal pain and indigestion, anorexia,
rash, eczema, dermatitis, impotence, fatigue, weakness, kidney

problems, liver problems.
Rare side effects (affecting 1 in 10 people in every 10,000 people)
include:
Decreases in protein molecule (haemoglobin), decrease in cell count,
mental confusion, dry mouth, build-up of excess fluid in body tissues,
kidney failure, enlarged male breasts, low concentration of sodium in
the blood.
Very rare side effects (affecting less than 1 person in every 10,000
people) include:
Decrease in production of essential parts of blood and immune system,
anaemia, reduced white cell count, increase loss of red blood cells, an
increase in white blood cells, auto immune disease, abnormal
contraction of the wind pipe, infection of the nasal cavities, chronic
asthma, inflammation of the pancreas, liver abnormalities, swelling of
the face and airways, sweating, skin blistering and peeling of the top
layer of the skin, skin disease resulting from drug reaction, kidney
failure.

Tell your doctor at once if:
q You feel ill after your first dose (a few people may react to their first
dose and feel very dizzy, weak, faint and sick).
q You get a lot of infections with sore throats or mouth ulcers.
q You notice a rash, skin eruption or other effects on your skin or eyes,
itching or a high temperature.
q You notice swelling of the face, tongue or throat.
Ask your doctor if you should continue taking the tablets.
Stop taking Ramipril Tablets immediately and go to your doctor or
casualty department if:
q Your breathing becomes difficult and noisy.
q You get any swelling of the face, tongue or throat.
If you notice any side effects not mentioned in this leaflet, please inform
your doctor or pharmacist.
5. Storing your Ramipril Tablets
Do not take this medicine after the expiry date stated on the container.
Any out of date or unused medicines should be returned to your

pharmacist for disposal. If you notice any visible signs of deterioration in
the tablets, take them to your pharmacist for advice before taking them.
Do not store above 25°C.
Container: Store in the original container. Keep the container tightly
closed.
Date of preparation: May 2006.
Keep out of the reach and sight of children. REMEMBER this medicine is
for you. Only a doctor can prescribe it for you. Never give it to others, it
may harm them even if their symptoms are the same as yours.
This leaflet applies to Ramipril 1.25mg, 2.5mg, 5mg, and 10mg Tablets only.

Ramipril
BARCODE

Reducing the risk of heart attack and cardiac death in patients at
high risk of cardiovascular diseases, and in high-risk diabetics: Your
starting dose will probably be one 1.25mg once daily. Your doctor
will probably double the dose after 2-3 weeks. The maintenance
daily dose is 5mg. You may eventually have your dose increased to
10mg taken as a single dose or divided into two doses, if your
doctor thinks it is necessary.
Hypertension (high blood pressure): The usual dose for patients is
1.25mg to 2.5mg tablet once a day. Your doctor may decide to
increase the dose after two to three weeks of treatment. Most
people with hypertension need doses of 2.5mg or 5mg once a day,
but your doctor may decide you need a different dose, up to a
maximum of 10mg once a day. Alternatively your doctor may decide
to treat you with a diuretic (water tablets) and ramipril.
Kidney Disease: For patients with kidney disease, your doctor will
adjust your dose so it is suitable for you.
If you have a creatinine clearance more than 50ml/min, the

2.5mg
Tablets

28
tablets

Each tablet contains ramipril
2.5mg.
For oral administration only.
Use as directed by your
physician.
Please read the enclosed
leaflet.
Do not store above 25°C.
Store in the original container.
Keep container tightly closed.
Keep out of the reach and sight
of children.
Sandoz Ltd,
Woolmer Way, Bordon,
Hants, GU35 9QE.
PL04416/0648
SZ94108LL01B

POM

Ramipril

Batch No:

Expiry Date:

2.5mg
Tablets

28
tablets

Each tablet contains ramipril
2.5mg.
For oral administration only.
Use as directed by your
physician.
Please read the enclosed
leaflet.
Do not store above 25°C.
Store in the original container.
Keep container tightly closed.
Keep out of the reach and sight
of children.
Sandoz Ltd,
Woolmer Way, Bordon,
Hants, GU35 9QE.
PL04416/0648
SZ94108LL01B


Peel Here But Do Not Remove

SZ94108LL01B

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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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