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RAMIPRIL 2.5 MG TABLETS

Active substance(s): RAMIPRIL

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!
!

Cramps or pain in your muscles
Blood tests showing more potassium than
usual in your blood.

Uncommon (affects less than 1 in 100 people)
! Balance problems (vertigo)
! 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
abdominal pain, vomiting and diarrhoea
! 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 less than 1 in 1,000 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.
Very rare (affects less than 1 in 10,000 people)
! Being more sensitive to the sun than usual.
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 you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
5. How to store Ramipril Tablets
Keep out of the sight and reach of children.
Do not store above 25°C. Store in the original
packaging.
Do not use Ramipril Tablets after the expiry date
which is stated on the carton and the blister or the
tablet container. The expiry date refers to the last
day of that month.
Medicines should not be disposed 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. Contents of the pack and other information
What Ramipril Tablets contain
! The active substance is ramipril.
The other ingredients are: sodium hydrogen
carbonate, lactose monohydrate, croscarmellose
sodium, pregelatinised starch and sodium stearyl
fumarate. The 2.5 mg and 5mg tablets also contain
yellow iron oxide and the 5 mg tablets also contain
red iron oxide.
What Ramipril Tablets looks like and contents
of the pack
Ramipril 1.25 mg Tablets: white to off white, oval
shaped, flat tablets.
Ramipril 2.5 mg Tablets: yellow, oval shaped flat
tablets scored on one side and side walls. Marked
R2.
Ramipril 5 mg Tablets: pink oval shaped, flat
tablets, scored on one side and side walls. Marked
R3.
Ramipril 10 mg Tablets: white to off white, oval
shaped, flat tablets scored on one side and side
walls. Marked R4.
Pack sizes:
The tablets are supplied in blister packs of 7, 14,
21, 28, 30, 50 and 100.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road
Leicester, LE3 0PA, UK
Manufacturer
Actavis Limited
Reykjavikurvegur
78 IS-220 Hafnarfjordur
Iceland.
This leaflet was last revised in November 2014.
This leaflet does not contain all the information
about your medicine. If you have any questions or
are not sure about anything, ask your doctor or
pharmacist.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ramipril 1.25 mg Tablets
Ramipril 2.5 mg Tablets
Ramipril 5 mg Tablets
Ramipril 10 mg Tablets
Ramipril

Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
! 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
only. Do not pass it on to others. It may harm
them even if their signs of illness are the same
as yours.
! If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
See section 4.
In this leaflet:
1. What Ramipril Tablets are and what they are
used for
2. What you need to know before you take
Ramipril Tablets
3. How to take Ramipril Tablets
4. Possible side effects
5. How to store Ramipril Tablets
6. Contents of the pack and other information
1. What Ramipril Tablets are and what they
are used for
Ramipril Tablets contain a medicine called ramipril.
This belongs to a group of medicines called ACE
inhibitors (Angiotensin Converting Enzyme
Inhibitors).
Ramipril Tablets work by:
! Decreasing your body's production of
substances that could raise your blood
pressure
! Making your blood vessels relax and widen
! Making it easier for your heart to pump blood
around your body.
Ramipril Tablets can be used:
! To treat high blood pressure (hypertension)
! To reduce the risk of you having a heart attack
or stroke
! 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.

2. What you need to know before you take
Ramipril Tablets
Do not take Ramipril Tablets:
! If you are allergic (hypersensitive) to ramipril,
any other ACE inhibitor medicine or any of the
ingredients of Ramipril Tablets 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 Tablets may not be suitable
for you
! If you have kidney problems where the blood
supply to your kidney is reduced (renal artery
stenosis)
! During the last 6 months of pregnancy (see
section below on “Pregnancy and breastfeeding”)
! If your blood pressure is abnormally low or
unstable. Your doctor will need to make this
assessment.
! If you have diabetes or impaired kidney
function and you are treated with a blood
pressure lowering medicine containing
aliskiren.
Do not take Ramipril Tablets if any of the above
apply to you. If you are not sure, talk to your doctor
before taking Ramipril Tablets.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
taking Ramipril Tablets:
! If you have heart, liver or kidney problems
! If you have lost a lot of body salts or fluids
(through being sick (vomiting), having
diarrhoea, sweating more than usual, being on
a low salt diet, taking diuretics (water tablets)
for a long time or having had dialysis)
! If you are going to have treatment to reduce
your allergy to bee or wasp stings
(desensitization)
! If you are going to receive an anaesthetic. This
may be given for an operation or any dental
work. You may need to stop your Ramipril
Tablets treatment one day beforehand; ask
your doctor for advice

!
!
!

!

If you have high amounts of potassium in your
blood (shown in blood test results)
If you have collagen vascular disease such as
scleroderma or systemic lupus erythematosus
You must tell your doctor if you think that you
are (or might become) pregnant. Ramipril
Tablets are not recommended in the first 3
months of pregnancy and may cause serious
harm to your baby after 3 months of pregnancy,
see section “Pregnancy and breast-feeding”.
if you are taking any of the following medicines
used to treat high blood pressure:
an angiotensin II receptor blocker (ARBs)
,
(also known as sartans - for example
valsartan, telmisartan, irbesartan), in
particular if you have diabetes-related
kidney problems.
aliskiren
,

Your doctor may check your kidney function, blood
pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.
See also information under the heading “Do not
take Ramipril Tablets”.
Children
Ramipril Tablets are not recommended for use in
children and adolescents below 18 years of age
because there is no information available in this
population.
If any of the above apply to you (or you are not
sure), talk to your doctor before taking Ramipril
Tablets.
Other medicines and Ramipril Tablets
Please tell your doctor or pharmacist if you are
taking, have recently taken or might take any other
medicines, including medicines obtained without a
prescription (including herbal medicines). This is
because Ramipril Tablets can affect the way some
other medicines work. Also some medicines can
affect the way Ramipril Tablets work.
Please tell your doctor if you are taking any of the
following medicines. They can make Ramipril
Tablets 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.
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
Tablets:
! Medicines used to relieve pain and
inflammation (e.g. Non-Steroidal AntiInflammatory Drugs (NSAIDs) such as
ibuprofen or indometacin and aspirin)
! Medicines for cancer (chemotherapy)
! Medicines to stop the rejection of organs after
a transplant such as ciclosporin
! Diuretics (water tablets) such as furosemide

!

!
!
!

Medicines which can increase the amount of
potassium in your blood such as
spironolactone, triamterene, amiloride,
potassium salts and heparin (for thinning
blood)
Steroid medicines for inflammation such as
prednisolone
Allopurinol (used to lower the uric acid in your
blood)
Procainamide (for heart rhythm problems).

Your doctor may need to change your dose and/or
to take other precautions:
! If you are taking an angiotensin II receptor
blocker (ARB) or aliskiren (see also
information under the headings “Do not take
Ramipril Tablets” and “Warnings and
precautions”).
Please tell your doctor if you are taking any of the
following medicines. They may be affected by
Ramipril Tablets:
! Medicines for diabetes such as oral glucose
lowering medicines and insulin. Ramipril
Tablets may lower your blood sugar amounts.
Check your blood sugar amounts closely while
taking Ramipril Tablets
! Lithium (for mental health problems). Ramipril
Tablets 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
Tablets.
Taking Ramipril Tablets with food and alcohol
! Drinking alcohol with Ramipril Tablets may
make you feel dizzy or light-headed. If you are
concerned about how much you can drink
while you are taking Ramipril Tablets, discuss
this with your doctor as medicines used to
reduce blood pressure and alcohol can have
additive effects.
! Ramipril Tablets 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.
You should not take Ramipril Tablets in the first 12
weeks of pregnancy, and you must not take them at
all after the 13th week as their use during
pregnancy may possibly be harmful to the baby.
If you become pregnant while on Ramipril Tablets,
tell your doctor immediately. A switch to a suitable
alternative treatment should be carried out in
advance of a planned pregnancy.
You should not take Ramipril Tablets if you are
breast-feeding.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
You may feel dizzy while taking Ramipril Tablets.
This is more likely to happen when you start taking
Ramipril Tablets or start taking a higher dose. If this
happens, do not drive or use any tools or
machines.

Important information about some of the
ingredients of Ramipril Tablets
Contains lactose. If you have been told by your
doctor that you have an intolerance to some sugars
contact your doctor before taking this medicinal
product.
3. How to take Ramipril Tablets
Always take Ramipril Tablets exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
Taking this medicine
! Take this medicine by mouth at the same time
of the day each day.
! Swallow the tablets with liquid.
! Do not crush or chew the tablets.
How much to take
Treatment of high blood pressure
! The usual starting dose is 1.25 mg or 2.5 mg
once daily.
! Your doctor will adjust the amount you take
until your blood pressure is controlled.
! The maximum dose is 10 mg once daily.
! If you are already taking diuretics (water
tablets), your doctor may stop or reduce the
amount of the diuretic you take before
beginning treatment with Ramipril Tablets.
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.
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.
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.
If you take more Ramipril Tablets 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 with you.
This is so the doctor knows what you have taken.

If you forget to take Ramipril Tablets
! 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 Tablets can cause side
effects, although not everybody gets them.
Stop taking Ramipril Tablets 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 make it
difficult to swallow or breathe, as well as itching
and rashes. This could be a sign of a severe
allergic reaction to Ramipril Tablets.
! 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
multiform).
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 include:
Please tell your doctor if any of the following gets
serious or lasts longer than a few days.
Common (affects less than 1 in 10 people)
! Headache or feeling tired
! Feeling dizzy. This is more likely to happen
when you start taking Ramipril Tablets or start
taking a higher dose
! Fainting, hypotension (abnormally low blood
pressure), especially when you stand or sit up
quickly
! Dry tickly cough, inflammation of your sinuses
(sinusitis) or bronchitis, shortness of breath
! Stomach or gut pain, diarrhoea, indigestion,
feeling or being sick
! Skin rash with or without raised area
! Chest pain

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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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