RAMIPRIL 10MG CAPSULES HARD

Active substance: RAMIPRIL

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Ramipril
Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
Ÿ this leaflet. You may need to read it again.
Keep
Ÿ have any further questions, ask your
If you
doctor or pharmacist.
Ÿmedicine has been prescribed for you only.
This
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
Ÿ get any side effects, talk to your doctor or
If you
pharmacist. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet:
1. What Ramipril Capsules are and what are they
used for
2. What you need to know before you take
Ramipril Capsules
3. How to take Ramipril Capsules
4. Possible side effects
5. How to store Ramipril Capsules
6. Contents of the pack and other information.
1. What Ramipril Capsules are and what are they
used for
Ramipril belongs to the group of medicines called
Angiotensin Converting Enzyme (ACE) inhibitors
that act on the heart and blood vessels.
Ramipril works by:
Ÿ
Decreasing your body's production of

substances that could raise your blood
pressure
Ÿ
Making your blood vessels relax and widen
Ÿ
Making it easier for your heart to pump blood
around your body.
Ramipril can be used:
Ÿ
To treat high blood pressure (hypertension)
Ÿ
To reduce the risk of you having a heart attack or

stroke
Ÿreduce the risk or delay the worsening of
To

kidney problems (whether or not you have
diabetes)
Ÿ treat your heart when it cannot pump
To
enough blood to the rest of your body (heart
failure)
Ÿtreatment following heart attack (myocardial
As
infarction) complicated with heart failure.
1. What you need to know before you take
ramipril capsules
Do not take Ramipril Capsules if any of the
following apply to you:
Ÿ
If you are allergic to ramipril, any other ACE
inhibitor medicine or any of the ingredients of
this medicine (listed in section 6). Signs of an
allergic reaction may include rash, swallowing
or breathing problems, swelling of your face,
lips, throat or tongue
Ÿ have ever had a serious allergic reaction
If you
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
Ÿ are having dialysis or any other type of
If you
blood filtration. Depending on the machine that
is used ramipril may not be suitable for you.
Ÿ
If you have kidney problems where the blood
supply to your kidney is reduced (renal artery
stenosis)
Ÿ
During the last 6 months of pregnancy (see
section below on “Pregnancy and breastfeeding”)
Ÿ
If your blood pressure is abnormally low or
unstable. Your doctor will need to make this
assessment.
Do not take ramipril if any of the above apply to
you. If you are not sure, talk to your doctor before
taking ramipril.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Ramipril Capsules
Ÿ have problems with your heart, kidneys
You
and/or liver.
Ÿ have collagen vascular disease such as
If you
sclerodermaor systemic lupus erythematosus
Ÿ
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)
Ÿ are going to have treatment to reduce your
If you
allergy to bee or wasp stings (desensitization)
Ÿ are going to receive an anaesthetic. This
If you
may be given for an operation or any dental
work. You may need to stop your ramipril
treatment one day beforehand; ask your doctor
for advice
Ÿ have high amounts of potassium in your
If you
blood (shown in blood test results)
Ÿ must tell your doctor if you think you are (or
You
might become) pregnant. Ramipril Capsules 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 “.
Children and adolescents
Ramipril capsules are not recommended for use in
children and adolescents below 18 years of age
because safety and efficacy of ramipril in children
has not yet been established.
If any of the above apply to you (or you are not sure),
talk to your doctor before taking Ramipril capsules
Other medicines and Ramipril Capsule
Tell your doctor or pharmacist if you are taking, have

recently taken or might take any other medicines
This is because Ramipril Capsules can affect the
way some other medicines work. Also some
medicines can affect the way Ramipril Capsules
works.
Please tell your doctor if you are taking any of the
following medicines. They can make ramipril
capsules work less well:
Ÿ
Medicines used to relieve pain and inflammation
(e.g. Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs) such as ibuprofen or indometacin and
aspirin)
Ÿ
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
capsules:
Medicines used to relieve pain and inflammation
(e.g. Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs) such as ibuprofen or indometacin and
aspirin)
Ÿ
Medicines for cancer (chemotherapy)
Ÿ
Medicines to stop the rejection of organs after a
transplant such as cyclosporine
Ÿ
Diuretics (water tablets) such as furosemide
Ÿ
Medicines which can increase the amount of
potassium in your blood such as
spironolactone, triamterene, amiloride,
potassium salts and heparin (for thinning blood)
Ÿ
Steroid medicines for inflammation such as
prednisolone
Ÿ
Allopurinol (used to lower the uric acid in your
blood)
Ÿ
Procainamide (for heart rhythm problems).
Please tell your doctor if you are taking any of the
following medicines. They may be affected by
ramipril:
Ÿ
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
Ÿ
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.
Ramipril Capsules with food and drink
Ramipril Capsules may be taken with or without
food.
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.
Pregnancy and breast-feeding
You must tell your doctor if you think that you are (or
might become) pregnant.
You should not take ramipril 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, 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 if you are breastfeeding.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
You may feel dizzy, while taking ramipril. This is
more likely to happen when you start taking ramipril
or start taking a higher dose. If this happens, do not
drive or use any tools or machines.
1. How to take Ramipril Capsules
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Swallow the capsule(s) whole with a glass of water.
The capsules can be taken before, with or after food.
To help you remember to take your medicine, try to
get into the habit of taking it at the same time each
day. Do not crush or chew the capsules.

Treatment of high blood pressure
Ÿ usual starting dose is 1.25 mg or 2.5 mg
The
once daily
Ÿ doctor will adjust the amount you take until
Your
your blood pressure is controlled.
Ÿ maximum daily dose should not exceed 10
The
mg.
Ÿ are taking water tablets (diuretics) already,
If you
your doctor may stop or reduce the amount of
the diuretic you take before beginning treatment
with ramipril
To reduce the risk of you having a heart attack or
stroke
Ÿ usual starting dose is 2.5 mg once daily.
The
Ÿ doctor may then decide to increase the
Your
amount you take.
Ÿ usual dose is 10 mg once daily.
The
Treatment to reduce or delay the worsening of
kidney problems
Ÿ may be started on a dose of 1.25 mg or 2.5
You
mg once daily.
Ÿ doctor will adjust the amount you are
Your
taking.
Ÿ usual dose is 5 mg or 10 mg once daily.
The
Treatment of heart failure
Ÿ usual starting dose is 1.25 mg once daily.
The
Ÿ doctor will adjust the amount you take.
Your
Ÿ maximum dose is 10 mg daily. Two
The
administrations per day are preferable.
Treatment after you have had a heart attack
Ÿ usual starting dose is 1.25 mg once daily to
The
2.5 mg twice daily.
Ÿ doctor will adjust the amount you take.
Your
Ÿ usual dose is 10 mg daily. Two
The
administrations per day are preferable.
Elderly
Your doctor will reduce the initial dose and adjust
your treatment more slowly.
If you forget to take Ramipril Capsules at the right
time, take them as soon as you remember.
However, if it is almost time for your next dose, skip
the missed dose and go back to your regular dosing
schedule. Do not take a double dose to make up for
a forgotten capsule.
If you take more Ramipril Capsules than you
should, consult your doctor or go to the nearest
hospital casualty department immediately. Do not
drive to the hospital, get somebody else to take you
or call for an ambulance. Take this leaflet or the
medicine pack with you so your doctor will know
what you have taken.
4. Possible side effects
Like all medicines, this medicine 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:
Ÿ
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
Ÿ
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:
Ÿ heart rate, uneven or forceful heartbeat
Faster

(palpitations), chest pain, tightness in your
chest or more serious problems including heart
attack and stroke
Ÿ
Shortness of breath or a cough. These could be
signs of lung problems
Ÿ
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
Ÿ
Severe stomach pain which may reach through
to your back. This could be a sign of pancreatitis
(inflammation of the pancreas).
Ÿ chills, tiredness, loss of appetite, stomach
Fever,
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)
Ÿ
Headache or feeling tired
Ÿ
Feeling dizzy. This is more likely to happen when
you start taking ramipril or start taking a higher
dose
Ÿ
Fainting, hypotension (abnormally low blood
pressure), especially when you stand or sit up
quickly
Ÿ tickly cough, inflammation of your sinuses
Dry
(sinusitis) or bronchitis, shortness of breath
Ÿ
Stomach or gut pain, diarrhoea, indigestion,
feeling or being sick
Ÿ rash with or without raised area
Skin
Ÿ pain
Chest
Ÿ
Cramps or pain in your muscles
Ÿ tests showing more potassium than usual
Blood
in your blood.
Uncommon (affects less than 1 in 100 people)
Ÿ
Balance problems (vertigo)
Ÿ
Itching and unusual skin sensations such as
numbness, tingling, pricking, burning or
creeping on your skin (paraesthesia)
Ÿ or change in the way things taste
Loss
Ÿ problems
Sleep
Ÿ
Feeling depressed, anxious, more nervous than
usual or restless
Ÿ
Blocked nose, difficulty breathing or worsening
of asthma
Ÿswelling in your gut called “intestinal
A

[5095688] LIT. RAMIPRIL CAP 10 MG (FLAT) (R6) (DWS-UK-R) SIZE : 140X500MM RLL-DWS : 09.05.12VS, 08.05.12nj (91455)

angioedema” presenting with symptoms like
abdominal pain, vomiting and diarrhoea
Ÿ
Heartburn, constipation or dry mouth
Ÿ
Passing more water (urine) than usual over the
day
Ÿ
Sweating more than usual
Ÿ or decrease of appetite (anorexia)
Loss
Ÿ
Increased or irregular heartbeats, swollen arms
and legs. This may be a sign of your body
holding onto more water than usual
Ÿ
Flushing
Ÿ
Blurred vision
Ÿ in your joints
Pain
Ÿ
Fever
Ÿ
Sexual inability in men, reduced sexual desire in
men or women
Ÿ
An increased number of certain white blood cells
(eosinophilia) found during a blood test
Ÿ tests showing change in the way your
Blood
liver, pancreas or kidneys are working.
Rare (affects less than 1 in 1,000 people)
Ÿ
Feeling shaky or confused
Ÿ and swollen tongue
Red
Ÿ
Severe flaking or peeling of the skin, itchy, lumpy

rash
Ÿ problem (e.g. loosening or separation of a
Nail

nail from its bed)
Ÿ rash or bruising
Skin
Ÿ
Blotches on your skin and cold extremities
Ÿ itchy, swollen or watery eyes
Red,
Ÿ
Disturbed hearing and ringing in your ears
Ÿ
Feeling weak
Ÿ tests showing a decrease in the number of
Blood

red blood cells, white blood cells or platelets or
in the amount of haemoglobin.
Very rare (affects less than 1 in 10,000 people)
Ÿ more sensitive to the sun than usual.
Being

Other side effects reported:
Please tell your doctor if any of the following gets
serious or lasts longer than a few days.
Ÿ
Difficulty concentrating
Ÿ
Swollen mouth
Ÿ tests showing too few blood cells in your
Blood
blood
Ÿ tests showing less sodium than usual in
Blood
your blood
Ÿ
Fingers and toes changing colour when you are
cold and then tingling or feeling painful when you
warm up (Raynaud's phenomenon)
Ÿ enlargement in men
Breast
Ÿ
Slowed or impaired reactions
Ÿ
Burning sensation
Ÿ
Change in the way things smell
Ÿ loss.
Hair
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet.
5. How to store Ramipril Capsules
Keep out of the reach and sight of children.
Do not take Ramipril Capsules after the expiry date
which is stated on the carton (EXP).
The expiry date refers to the last day of that month.
Store in the original package.
Medicines should not be disposed of via
wastewater or household waste. Ask you
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 capsules contain
The active ingredient is ramipril. Each capsule
contains 10 mg ramipril
The other ingredients are pregelatinised starch
(Maize), gelatin, titanium dioxide (E171) and patent
blue (E131).
The black printing ink contains shellac, propylene
glycol, potassium hydroxide and black iron oxide
(E172).
What Ramipril capsules look like and contents of
the pack
Ramipril 10 mg Capsules are blue and white and
white printed with 'R' on the cap and '10' on the body.
They contain a white to off-white granular powder.
Ramipril capsules are available as strip packs of 21,
28, 30, 56 and 60 capsules. Not all pack sizes may
be marketed.
Marketing Authorisation Holder:
Ranbaxy (UK) Limited
Building 4, Chiswick Park
566 Chiswick High Road
London, W4 5YE
United Kingdom
Manufacturer:
Ranbaxy Ireland Limited
Spafield, Cork Road,
Cashel, Co-Tipperary
Ireland
Basics GmBH, 201 Hemmelrather Weg, Gebaude
Giz 1,
Leverkusen 51377, Germany
This medicinal product is authorised in the
Member States of the EEA under the following
names:
UK: Ramipril 10 mg Capsules, hard
PL: Ramicor capsules 10 mg
PT: Ramipril Ranbaxy 10 mg Cápsulas
IE: Bellramil Capsules 10 mg, hard
LT: Corpril 10 mg kietos kapsulés
This leaflet was last revised in May 2012.

FONT SIZE : 8.6pt

Ramipril 10 mg Capsules, hard

How much to take

5095688

Package leaflet: Information for the user:

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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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