RAMIPRIL 10 MG CAPSULES HARD

Active substance: RAMIPRIL

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Package leaflet : Information for the user

Ramipril 1.25 mg
capsules, hard
Ramipril 2.5 mg
capsules, hard
Ramipril 5 mg
capsules, hard
Ramipril 10 mg
capsules, hard
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 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 or
pharmacist. This includes any possible side
effects not listed in this leaflet
What is in this leaflet:
1. What Ramipril capsules are and what 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 they are used for
Ramipril capsules contain a medicine called
ramipril. This belongs to a group of medicines
called ACE inhibitors (Angiotensin Converting
Enzyme Inhibitors).
Ramipril capsules works 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 capsules 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 capsules
Do not take Ramipril capsules:
• If you are allergic (hypersensitive) 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 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 capsules 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 breast
feeding”)
• If your blood pressure is abnormally low or
unstable. Your doctor will need to make this
assessment.
Do not take Ramipril capsules if any of the above
apply to you. If you are not sure, talk to your
doctor before taking Ramipril capsules.
Warnings and precautions:
Talk to your doctor or pharmacist before taking
Ramipril capsules:
• 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
capsules 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 is 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 any of the above apply to you (or you are not
sure), talk to your doctor before taking Ramipril
capsule.
Children
Ramipril capsules are not recommended for use
in children and adolescents below 18 years of
age because the safety and efficacy of ramipril in
children has not yet been established.

Ramipril
English (170 x 550 mm) V-2
06_12_14 (Ramipril (ACC-IE) PIL)

Other medicines and Ramipril capsules:
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).
Please tell your doctor if you are taking any of the
following medicines. They can make Ramipril
capsules work less well:
• Medicines used to relieve pain and
inflammation (e.g. Non-Steroidal
Anti-Inflammatory 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 capsules:
• Medicines used to relieve pain and
inflammation (e.g. Non-Steroidal
Anti-Inflammatory 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)
Please tell your doctor if you are taking any of the
following medicines. They may be affected by
Ramipril capsules:
• Medicines for diabetes such as oral glucose
lowering medicines and insulin. Ramipril
capsules may lower your blood sugar amounts.
Check your blood sugar amounts closely while
taking Ramipril capsules
• Lithium (for mental health problems). Ramipril
capsules 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
capsules.
Ramipril capsules with food, drink and
alcohol
• Drinking alcohol with Ramipril capsules may make
you feel dizzy or light-headed. If you are
concerned about how much you can drink while
you are taking Ramipril capsules, discuss this with
your doctor as medicines used to reduce blood
pressure and alcohol can have additive effects.
• Ramipril capsules may be taken with or without
food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
Pregnancy
You must tell your doctor if you think that you are
(or might become) pregnant
You should not take Ramipril capsules 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
capsules, tell your doctor immediately. A switch to
a suitable alternative treatment should be carried
out in advance of a planned pregnancy.
Breast-feeding
You should not take Ramipril capsules if you are
breast-feeding.
Driving and using machines
You may feel dizzy, while taking Ramipril
capsules. This is more likely to happen when you
start taking Ramipril capsules or start taking a
higher dose. If this happens, do not drive or use
any tools or machines.

3. How to take Ramipril capsules
Always take this medicine exactly as your doctor
has told you. 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 capsules whole with liquid.
• Do not crush or chew the capsules.
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 capsules.
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 capsules 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 capsules
• 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 capsules.
If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Stop taking Ramipril capsules 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 capsules.
• 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 capsules 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
• 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.

Ramipril
English (170 x 550 mm) V-2
06_12_14 (Ramipril (ACC-IE) PIL)

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
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. By reporting
side effects you can help provide more
information on the safety of this medicine.
For UK - You can also report side effects directly
via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
For Ireland –
You can also report side effects directly via
HPRA Pharmacovigilance, Earlsfort Terrace, IRL
- Dublin 2; Tel: +353 1 6764971; Fax: +353 1
6762517. Website: www.hpra.ie; E-mail:
medsafety@hpra.ie.

5. How to store Ramipril
capsules
• Keep out of the sight and reach of children
• Do not use this medicine after the expiry date
which is stated on the carton after “EXP”. The
expiry date refers to the last day of that month.
• Store below 25°C. Store in the original package
in order to protect from moisture.
• Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines you
no longer use. These measures will help protect
the environment.

6. Contents of the pack and
other information
What Ramipril capsules contains:
The active substance is ramipril.
For 1.25 mg: Each hard capsule contains 1.25 mg
Ramipril.
For 2.5mg: Each hard capsule contains 2.5 mg
Ramipril.
For 5 mg: Each hard capsule contains 5 mg
Ramipril.
For 10 mg: Each hard capsule contains 10 mg
Ramipril.
The other ingredients are:
• Capsule content: Pregelatinised maize starch
• Capsule shell:
Ramipril 1.25 mg: Gelatin, titanium dioxide (E
171), iron oxide yellow (E 172)
Ramipril 2.5 mg: Gelatin, titanium dioxide (E
171), iron oxide yellow (E 172), erythrosine
(E127)
Ramipril 5 mg: Gelatin, titanium dioxide (E 171),
erythrosine (E127), patent blue V (E131)
Ramipril 10 mg: Gelatin, titanium dioxide (E 171),
iron oxide black (E 172), erythrosine (E127) ,
indigocarmine(E132)
Printing ink of capsule shell: Shellac, propylene
glycol, potassium hydroxide, black iron oxide
(E172)
What Ramipril capsules look like and
contents of the pack:
Ramipril capsules 1.25mg: Yellow/white, size ‘4’
hard gelatin capsules, imprinted ‘R’ on cap and
‘1.25’ on body with black ink, containing white to
off white powder.
Ramipril capsules 2.5mg: Orange/White size ‘4’
hard gelatin capsules, imprinted ‘R’ on cap & ‘2.5’
on body with black ink, containing white to off
white powder.
Ramipril capsules 5 mg: Scarlet/White size ‘4’
hard gelatin capsules, imprinted ‘R’ on cap & ‘5’
on body with black ink, containing white to off
white powder.
Ramipril capsules 10 mg: Blue/White, size ‘4’
hard gelatin capsules, imprinted ‘R’ on cap & ‘10’
on body with black ink, containing white to off
white powder.
Ramipril Capsules are available in blisters packs
of 7, 14, 21, 28, 30, 50, 90 and 100 hard
capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF,
United Kingdom
This medicinal product is authorised in the
Member States of the EEA under the following
names:
Name of the
Member State : Name of the medicinal
product
The Netherlands Ramipril Accord
1,25/2,5/5/10 mg Capsule hard
Poland
Ramipril Accord
Portugal
Ramipril Accord
Romania
Ramipril Accord
1,25/2,5/5/10 mg Capsule
Ireland
Ramipril 1.25/2.5/5/10 mg
Capsules hard
UK
Ramipril 1.25/2.5/5/10 mg
Capsules hard
This leaflet was last revised in 12/2014

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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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