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RAMIPRIL 1.25 MG TABLETS

Active substance: RAMIPRIL

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RAMIPRIL 1.25 mg TABLETS
AND RAMIPRIL 2.5 mg TABLETS
PACKAGE LEAFLET: INFORMATION
FOR THE USER

Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription (including herbal
medicines). This is because Ramipril can affect
the way some other medicines work. Also some
medicines can affect the way Ramipril works.

• To reduce the risk or delay the worsening of
kidney problems (whether or not you have
diabetes)
• To treat your heart when it cannot pump
enough blood to the rest of your body (heart
failure)
• As treatment following heart attack
(myocardial infarction) complicated with heart
failure.
BEFORE YOU TAKE RAMIPRIL TABLETS

Do NOT take Ramipril
• If you are allergic (hypersensitive) to ramipril,
any other ACE inhibitor medicine or any of the
ingredients of Ramipril listed in section 6.
Signs of an allergic reaction may include a
rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue
• If you have ever had a serious allergic
reaction called “angioedema”The signs
.
include itching, hives (urticaria), red marks on
the hands, feet and throat, swelling of the
throat and tongue, swelling around the eyes
and lips, difficulty breathing and swallowing
• If you are having dialysis or any other type of
blood filtration. Depending on the machine
that is used, Ramipril may not be suitable for
you
• If you have kidney problems where the blood
supply to your kidney is reduced (renal artery
stenosis)
• If you are more than 3 months pregnant (it is
also better to avoid Ramipril in early
pregnancy – see pregnancy section)
• If your blood pressure is abnormally low or
unstable. Your doctor will need to make this
assessment.

Please tell your doctor if you are taking any of
the following medicines. They may be affected
by Ramipril:
• Medicines for diabetes such as oral glucose
lowering medicines and insulin. Ramipril may
lower your blood sugar amounts. Check your
blood sugar amounts closely while taking
Ramipril
• Lithium (for mental health problems). Ramipril
may increase the amount of lithium in your
blood. Your lithium amount will need to be
closely checked by your doctor.
If any of the above apply to you (or you are not
sure), talk to your doctor before taking Ramipril.
Taking Ramipril with food and alcohol
• Drinking alcohol with Ramipril may make you
feel dizzy or light headed. If you are
concerned about how much you can drink
while you are taking Ramipril, discuss this
with your doctor as medicines used to reduce
blood pressure and alcohol can have additive
effects
• Ramipril may be taken with or without food.

Pregnancy and breast-feeding
You must tell your doctor if you think that you
are (or might become) pregnant. Your doctor will
normally advise you to stop taking Ramipril
before you become pregnant or as soon as you
know you are pregnant and will advise you to
take another medicine instead of Ramipril.
Ramipril is not recommended in early
pregnancy and must not be taken when more
than 3 months pregnant, as it may cause serious
harm to your baby (if used after the third month
of pregnancy).Tell your doctor if you are
breast-feeding or about to start breast-feeding.
Do not take Ramipril if any of the above apply to Ramipril is not recommended for mothers who
are breast-feeding, and your doctor may choose
you. If you are not sure, talk to your doctor
another treatment for you if you wish to
before taking Ramipril.
breast-feed, especially if your baby is newborn,
Take special care with Ramipril
or was born prematurely.
Check with your doctor or pharmacist before
Ask your doctor or pharmacist for advice before
taking your medicine:
taking any medicine.
• If you have heart, liver or kidney problems
• If you have lost a lot of body salts or fluids
Driving and using machines
(through being sick (vomiting), having
You may feel dizzy, while taking Ramipril. This is
diarrhoea, sweating more than usual, being
more likely to happen when you first start taking
on a low salt diet, taking diuretics (water
it or first start taking a higher dose. If this happens,
tablets) for a long time or having had dialysis)
do not drive or use any tools or machines.
• If you are going to have treatment to reduce
your allergy to bee or wasp stings
3 HOW TO TAKE RAMIPRIL TABLETS
(desensitization)
• If you are going to receive an anaesthetic. This
Always take Ramipril exactly as your doctor has
may be given for an operation or any dental
told you. You should check with your doctor or
work. You may need to stop your Ramipril
pharmacist if you are not sure.
treatment one day beforehand; ask your
doctor for advice
Taking this medicine
• If you have high amounts of potassium in
• Take this medicine by mouth at the same time
your blood (shown in blood test results)
of day each day
• If you have collagen vascular disease such as • Swallow the tablets with liquid
scleroderma or systemic lupus erythematosus • Do not crush or chew the tablets.
• You must tell your doctor if you think that you
How much to take
are (or might become) pregnant. Ramipril is
Treatment of high blood pressure
not recommended in early pregnancy and
• The usual starting dose is 1.25 mg or 2.5 mg
must not be taken if you are more than 3
once daily
months pregnant, as it may cause serious
• Your doctor will adjust the amount you take
harm to your baby at that stage, see section
until your blood pressure is controlled
“Pregnancy and breast-feeding”
.
• The maximum dose is 10 mg once daily
Children
• If you are already taking diuretics (water
Ramipril is not recommended for use in children
tablets), your doctor may stop or reduce the
and adolescents below 18 years of age because
amount of the diuretic you take before
there is no information available in this
beginning treatment with Ramipril.
population.

Treatment of heart failure
• The usual starting dose is 1.25 mg once daily
• Your doctor will adjust the amount you take
• The maximum dose is 10 mg daily. Two
administrations per day are preferable.
Treatment after you have had a heart attack
• The usual starting dose is 1.25 mg once daily
to 2.5 mg twice daily
• Your doctor will adjust the amount you take
• The usual dose is 10 mg daily. Two
administrations per day are preferable.
Elderly
• Your doctor will reduce the initial dose and
adjust your treatment more slowly.

Pharma Code (top to bottom
on the front face when reading the
text design right way up):

Please tell your doctor if you are taking any of
the following medicines. They can increase the
chance of getting side effects if you take them
with Ramipril:
WHAT RAMIPRIL TABLETS IS AND WHAT
1 IT IS USED FOR
• Medicines used to relieve pain and
inflammation (e.g. Non Steroidal AntiRamipril contains a medicine called ramipril.
Inflammatory Drugs (NSAIDs) such as
This belongs to a group of medicines called ACE
ibuprofen or indometacin and aspirin)
inhibitors (Angiotensin Converting Enzyme
• Medicines for cancer (chemotherapy)
Inhibitors).
• Medicines to stop the rejection of organs after
a transplant such as ciclosporin
Ramipril works by
• Diuretics (water tablets) such as furosemide
• Decreasing your body’s production of
• Medicines which can increase the amount of
substances that could raise your blood
potassium in your blood such as
pressure
spironolactone, triamterene, amiloride,
• Making your blood vessels relax and widen
potassium salts and heparin (for thinning
• Making it easier for your heart to pump blood
blood)
around your body.
• Steroid medicines for inflammation such as
prednisolone
Ramipril can be used to
• Allopurinol (used to lower the uric acid in
• To treat high blood pressure (hypertension)
your blood)
• To reduce the risk of you having a heart attack
• Procainamide (for heart rhythm problems).
or stroke

BLACK

Please tell your doctor if you are taking any of
the following medicines. They can make
Ramipril work less well:
• Medicines used to relieve pain and
inflammation (e.g. Non Steroidal AntiInflammatory Drugs (NSAIDs) such as
ibuprofen or indometacin and aspirin)
• Medicines used for the treatment of low blood
pressure, shock, cardiac failure, asthma or
allergies such as ephedrine, noradrenaline or
adrenaline. Your doctor will need to check your
blood pressure.

434 mm
160 mm

IN THIS LEAFLET:

1. What Ramipril Tablets is and what it is used
for
2. Before you take Ramipril Tablets
3. How to take Ramipril Tablets
4. Possible side effects
5. How to store Ramipril Tablets
6. Further information

Treatment to reduce or delay the worsening of
kidney problems
• You may be started on a dose of 1.25 mg or
2.5 mg once daily
• Your doctor will adjust the amount you are
taking
• The usual dose is 5 mg or 10 mg once daily.

L:
W:

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, ask your
doctor or pharmacist.
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm them
even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

2

To reduce the risk of you having a heart attack
or stroke
• The usual starting dose is 2.5 mg once daily
• Your doctor may then decide to increase the
amount you take
• The usual dose is 10 mg once daily.

If any of the above apply to you (or you are not
sure), talk to your doctor before taking Ramipril.

• Heartburn, constipation or dry mouth
• Passing more water (urine) than usual over
the day
• Sweating more than usual
• Loss or decrease of appetite (anorexia)
• Increased or irregular heartbeats
• Swollen arms and legs. This may be a sign of
your body holding onto more water than
usual
• Flushing
• Blurred vision
• Pain in your joints
• Fever
• Sexual inability in men, reduced sexual desire
in men or women
• An increased number of certain white blood
cells (eosinophilia) found during a blood test
• Blood tests showing changes in the way your
liver, pancreas or kidneys are working.
Rare (affects fewer than 1 in 1000 people):
• Feeling shaky or confused
• Red and swollen tongue
• Severe flaking or peeling of the skin, itchy,
lumpy rash
• Nail problem (e.g. loosening or separation of
a nail from its bed)
• Skin rash or bruising
• Blotches on your skin and cold extremities
• Red, itchy, swollen or watery eyes
• Disturbed hearing and ringing in your ears
• Feeling weak
• Blood tests showing a decrease in the number
of red blood cells, white blood cells or
platelets or in the amount of haemoglobin.

If you take more Ramipril than you should
Tell a doctor or go to the nearest hospital
casualty department straight away. Do not drive
to the hospital, get somebody else to take you
or call for an ambulance. Take the medicine pack
Very rare (affects fewer than 1 in 10,000 people):
with you. This is so the doctor knows what you
• Being more sensitive to the sun than usual.
have taken.
If you forget to take Ramipril
If you miss a dose, take your normal dose when
it is next due. Do not take a double dose to
make up for a forgotten tablet.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Ramipril can cause side
effects, although not everybody gets them.
Stop taking Ramipril and see a doctor straight
away if you notice any of the following serious
side effects – you may need urgent medical
treatment:
• Swelling of the face, lips or throat which
makes it difficult to swallow or breathe, as
well as itching and rashes. This could be a
sign of a severe allergic reaction to Ramipril
• Severe skin reactions including rash, ulcers in
your mouth, worsening of a pre-existing skin
disease, reddening, blistering or detachment
of skin (such as Stevens-Johnson syndrome,
toxic epidermal necrolysis or erythema
multiforme).
Tell your doctor immediately if you experience:
• Faster heart rate, uneven or forceful heartbeat
(palpitations), chest pain, tightness in your
chest or more serious problems including
heart attack and stroke
• Shortness of breath or a cough. These could
be signs of lung problems
• Bruising more easily, bleeding for longer than
normal, any sign of bleeding (e.g. bleeding
from the gums), purple spots blotching on the
skin or getting infections more easily than
usual, sore throat and fever, feeling tired,
faint, dizzy or having pale skin. These can be
signs of blood or bone marrow problems
• Severe stomach pain which may reach
through to your back. This could be a sign of
pancreatitis (inflammation of the pancreas)
• Fever, chills, tiredness, loss of appetite,
stomach pain, feeling sick, yellowing of your
skin or eyes (jaundice). These can be signs of
liver problems such as hepatitis (inflammation
of the liver) or liver damage.

Other side effects reported:
Please tell your doctor if any of the following
gets serious or lasts longer than a few days.
• Difficulty concentrating
• Swollen mouth
• Blood tests showing too few blood cells in
your blood
• Blood tests showing less sodium than usual in
your blood
• Fingers and toes changing colour when you
are cold and then tingling or feeling painful
when you warm up (Raynaud's phenomenon)
• Breast enlargement in men
• Slowed or impaired reactions
• Burning sensation
• Change in the way things smell
• Hair loss.
If any of the side effects gets serious, or you
notice any side effects not listed on this leaflet,
please tell your doctor or pharmacist.

5

HOW TO STORE RAMIPRIL TABLETS

• Keep out of the reach and sight of children.
• Do not use Ramipril after the expiry date
which is stated on the cartons and blister
packs after 'EXP'. The expiry date refers to the
last day of that month.
• Do not store above 25°C. Store in the original
package in order to protect from moisture.
• Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

6

FURTHER INFORMATION

What Ramipril Tablets contains
• The active substance is ramipril. One tablet
contains 1.25 mg ramipril. One tablet contains
2.5 mg ramipril.
• The other ingredients are microcrystalline
cellulose (E460), sodium stearyl fumarate,
magnesium hydroxide (E528), 2.5 mg
strength: iron oxide yellow (E172).

What Ramipril Tablets looks like and contents of
the pack
• Tablet
• 1.25 mg: White to off white, round tablet,
Other side effects include:
scored on both sides and debossed with
Please tell your doctor if any of the following
“1.25” on one side of the score and with “RL

gets serious or lasts longer than a few days.
on the other side of the score.
The score line is only to facilitate breaking for
Common (affects fewer than 1 in 10 people):
ease of swallowing and not to divide into
• Headache or feeling tired
equal doses.
• Feeling dizzy. This is more likely to happen
when you start taking Ramipril or start taking • 2.5 mg: Yellow, round tablet, scored on both
sides and debossed with “2.5” on one side of
a higher dose
the score and with “RL on the other side of

• Fainting, hypotension (abnormally low blood
the score.
pressure), especially when you stand or sit up
The tablet can be divided into equal halves.
quickly
• Dry tickly cough, inflammation of your sinuses • Ramipril is available in pack sizes of 14, 15, 20,
28, 30, 50, 56, 60, 90 and 100 tablets. Not all
(sinusitis) or bronchitis, shortness of breath
pack sizes may be marketed.
• Stomach or gut pain, diarrhoea, indigestion,
feeling or being sick
Marketing Authorisation Holder and
• Skin rash with or without raised area
Manufacturer
• Chest pain
• Cramps or pain in your muscles
TEVA UK limited, Eastbourne, BN22 9AG.
• Blood tests showing more potassium than
usual in your blood.
Uncommon (affects fewer than 1 in 100 people): This leaflet was last revised in February 2010.
• Balance problems (vertigo)
PL 00289/1360-1361
• Itching and unusual skin sensations such as
numbness, tingling, pricking, burning or
creeping on your skin (paraesthesia)
• Loss or change in the way things taste
• Sleep problems
• Feeling depressed, anxious, more nervous
than usual or restless
• Blocked nose, difficulty breathing or
worsening of asthma
• A swelling in your gut called “intestinal
angioedema” presenting with symptoms like
63818-U
abdominal pain, vomiting and diarrhoea

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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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