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RAMIPRIL 5MG CAPSULES

Active substance(s): RAMIPRIL

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Artwork No.

220515/10

Colours Used

Customer

Ennogen

Black

Description

Artulo Leaflet

Keyline

Market

UK

Language

English

Size

150 x 420 mm

Min. Font Size

Arial, 9 pt

Page No.

1 of 2

Version No.

3

Date

e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Software

Prepared By
Regulatory Affairs

28-05-15
Coreldraw 12
Checked By
Regulatory Affairs

Checked By
Quality Assurance

Approved By
EU Head - QA

150mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Artulo 1.25mg Capsules
Artulo 5mg Capsules

Artulo 2.5mg Capsules
Artulo 10mg Capsules

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 or nurse.
! 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 or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet:
1. What Artulo Capsules are and what they
are used for
2. What you need to know before you take
Artulo Capsules
3. How to take Artulo Capsules
4. Possible side effects
5. How to store Artulo Capsules
6. Contents of the pack and other
information
1. WHAT ARTULO CAPSULES ARE AND
WHAT THEY ARE USED FOR
Artulo Capsules contain Ramipril which
belongs to a group of medicines called ACE
(angiotensin converting enzyme) inhibitors.
They work by widening the blood vessels
which makes it easier for the heart to pump
blood through them, to all parts of the body.
This helps to reduce blood pressure. It can
also help to make the
heart work better if it
does not pump as well
as needed.

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Pharma code

Artulo Capsules are
used to:! Reduce the risk of a
heart attack, heart
disease and stroke
and decrease the
risk of requiring
surgery to increase
blood flow to the
heart
! Treat high blood
pressure.

2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE ARTULO CAPSULES

225 mm

Do not take Artulo Capsules if you:
! Are allergic (hypersensitive) to Ramipril,
other ACE inhibitors or any of the other
ingredients in the capsules (listed in
section 6)
! Have a history of a condition known as
angioneurotic oedema (Quincke's Disease)
! Are pregnant (see Pregnancy and
Breastfeeding section)
! Have low blood pressure
! Have kidney problems where the blood
supply to your kidneys are reduced (renal
artery stenosis)
! Are having dialysis or any other type of
blood filtration. Depending on the type of
machine used, Artulo Capsules may not be
suitable for you
! Have diabetes or impaired kidney function
and you are treated with a blood pressure
lowering medicine containing aliskiren.
Warnings and precautions
Talk to your doctor or pharmacist or nurse
before taking Artulo Capsules if you:
! Have heart, liver or kidney disease
! Have collagen vascular disease such as
scleroderma or systemic lupus
erythematosus
! Are going to have treatment to reduce your
allergy to bee or wasp stings
(desensitization)
! Are going to have an anaesthetic. This
may be given for an operation or any
dental work. You may need to stop taking
your Artulo treatment one day beforehand.
Ask your doctor for advice
! Are taking diuretics (water tablets). Your
doctor may stop your diuretic medication
and correct volume and/or sodium
depletion before starting you on Artulo
Capsules
! Have high amounts of potassium in your
blood
! Have lost a lot of body salts or fluids
(through being sick, diarrhoea, sweating
more than usual, being on a low salt diet,
or on dialysis)
! Are elderly
! 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,
ibesartan, etc.), in particular if you have
diabetes-related kidney problems.
, aliskiren.

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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 Artulo".
Children: Artulo Capsules are not
recommended for use in children and
adolescents below 18 years of age because
safety and efficacy of Artulo Capsules in
children has not yet been established.
If any of the above applies to you, or you are
not sure, talk to your doctor before taking this
medicine.
Other medicines and Artulo Capsules
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines. This is because Artulo
Capsules can affect the way some other
medicines work. Also, some medicines can
affect the way Artulo Capsules work.
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 Artulo Capsules" and "Warnings and
precautions").
In particular tell your doctor if you are
taking any of the following:
Please tell your doctor if you are taking any of
the following medicines. They can make Artulo
Capsules 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 Artulo Capsules:
! 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).
Please tell your doctor if you are taking any of
the following medicines. They may be affected
by Artulo Capsules:
! Medicines for diabetes such as oral
glucose lowering medicines and insulin.
Artulo Capsules may lower your blood
sugar. Check your blood sugar closely
while taking Artulo Capsules
! Lithium (for mental health problems).
Artulo Capsules may increase the amount
of lithium in your blood. Your lithium levels
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
Artulo Capsules.
Pregnancy and breastfeeding
You must tell your doctor if you think that you
are (or might become) pregnant.
You should not take Artulo Capsules in the first
12 weeks of pregnancy, and you must not take
them at all after the 13th (2nd and 3rd
trimesters) week as their use during
pregnancy may possibly be harmful to the
baby.
If you become pregnant while on Artulo
Capsules, 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 Artulo Capsules if you are
breast-feeding.
Ask your doctor or pharmacist for advice
before taking any medicine.
Artulo Capsules with food and alcohol
Drinking alcohol with Artulo Capsules may
make you feel dizzy or light-headed. If you are
concerned about how much you can drink
while you are taking Artulo Capsules, discuss
this with your doctor as medicines used to
reduce blood pressure and alcohol can have
additive effects. Artulo Capsules may be taken
with or without food.

Front

420 mm

182 mm

195 mm

[Ramipril]

e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

220515/10

Colours Used

Customer

Ennogen

Black

Description

Artulo Leaflet

Keyline

Market

UK

Language

English

Size

150 x 420 mm

Min. Font Size

Arial, 9 pt

Page No.

2 of 2

Version No.

3

Date

28-05-15

Software

Prepared By
Regulatory Affairs

Coreldraw 12
Checked By
Regulatory Affairs

Checked By
Quality Assurance

Approved By
EU Head - QA

150mm

Driving and using machines
You may feel dizzy, while taking Artulo
Capsules. This is more likely to happen when
you start taking Artulo Capsules or start taking
a higher dose. If this happens, do not drive or
use any tools or machines.
3. HOW TO TAKE ARTULO CAPSULES
Always take Artulo Capsules exactly as your
doctor has told you.
You should check with your doctor or
pharmacist if you are not sure.
Take this medicine by mouth at the same time
of the day each day.
Swallow the capsules with liquid.

195 mm

Doses:
! Treatment of high blood pressure
The usual starting dose is 1.25mg or 2.5mg
once daily. Your doctor will adjust the amount
you take until your blood pressure is
controlled. The maximum dose is 10mg 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 Artulo Capsules.
Treatment to reduce or delay the
worsening of kidney problems
You may be started on a dose of 1.25mg or
2.5mg once daily.
Your doctor will adjust the amount you are
taking. The usual dose is 5mg or 10mg once
daily.

!

! Treatment of heart failure
The usual starting dose is 1.25mg once daily.
Your doctor will adjust the amount you take.
The maximum dose is 10mg daily.
Two administrations per day are preferable.
Treatment after you have had a heart
attack
The usual starting dose is 1.25mg once daily
to 2.5mg twice daily. Your doctor will adjust the
amount you take. The usual dose is 10mg
daily. Two administrations per day are
preferable.

!

! Elderly
Your doctor will reduce the initial dose and
adjust your treatment more slowly.

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Dry mouth, irritation or swelling in the
mouth, stomach pains, diarrhoea or
constipation, feeling or being sick, changes
in liver enzymes (including jaundice) have
been reported. Rare reports of pancreatitis
(inflammation of the pancreas)
Reddening of the skin areas with
accompanying heat sensation
Hair loss
Reduced circulation to the hands and/or
feet (Raynaud's phenomenon)
Sensitivity of the skin to light and effects
on the nails (loosening) has been
observed
Dry, tickling cough, bronchitis and a runny
or stuffy nose
Conjunctivitis (eye infection)
Disturbance of balance
Headache
Nervousness
Restlessness
Tremor
Problems with sleeping
Confusion
Loss of appetite
Depressed mood
Feeling of anxiety
Pins and needles
Muscle cramps, muscle and joint pains
Fever
Vasculitis (inflammation of the blood
vessels)
Sexual inability in men, and reduced
sexual desire (libido)
Change in sense of taste
Blood tests may show an increase in some
liver test results
An increase in blood urea nitrogen,
creatinine levels, serum potassium levels
and a decrease in serum sodium levels
may also be observed
An increase in the number of eosinophilia
blood cells has also been reported.

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any
possible side effects not listed in this leaflet.
You can also report side effects directly via the
Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this
medicine.

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If you forget to take Artulo 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 dose.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.
If you stop taking Artulo Capsules
Do not stop taking Artulo Capsules without
first consulting your doctor, as your original
symptoms will return.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause
side effects, although not everybody gets
them.
If you experience any of the following side
effects STOP taking Artulo and seek
immediate medical help:
! Your breathing becomes difficult and noisy
! You get any swelling of the face, tongue or
throat.

225 mm

These could be signs of an allergic
reaction and urgent medical help should
be sought.
Talk to your doctor immediately if:
! You feel ill after your first dose (a few
people may react to their first dose and
feel very dizzy, weak, faint and sick)
! You get a lot of infections with a lot of sore
throats and mouth ulcers
! You notice a rash, skin eruption or effects
on your skin or eyes, itching or a high
temperature
! You notice swelling of the face, tongue or
throat.
Ask your doctor if you should continue to take
Artulo Capsules.
The most common side effects include feeling
sick, dizziness and headache. Other possible,
but less common side effects are described
below:
!

!
!
!
!

Angioneurotic (Quincke's oedema): in very
rare cases this condition has occurred
which includes symptoms such as swelling
of the face, tongue and throat. Itchy skin,
rash, shortness of breath sometimes fever
Low blood pressure with dizziness,
weakness and feeling sick
Fainting
Rare reports of chest pain, fast or
changing heart beat and angina
Artulo may affect the kidneys. Pre-existing
proteinurea (elevated protein levels) may
deteriorate

Keep out of the sight and reach of children.
Do not store above 25°C.
Store in the original container.
Do not use Artulo Capsules after the expiry
date which is stated on the carton and the
blister or the capsule 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 Artulo Capsules contain:
Artulo Capsules contain 1.25mg, 2.5mg, 5mg
and 10mg of the active substance Ramipril.
The other ingredients are: starch
pregelatinised, gelatin and the colourings
black iron oxide (E172) and titanium dioxide
(E171). The 2.5mg, 5mg and 10mg also
contain the colourings FD&C Blue (E132) and
yellow iron oxide (E172).
The printing ink contains shellac (E904) and
potassium hydroxide (E525).
What Artulo Capsules look like and
contents of the pack
Artulo 1.25mg Capsules: Hard gelatin capsule.
Capsule body: light grey. Capsule cap: light
grey. Marked with “R” on cap and “1.25” on
body. Capsule contains white or almost white
powder
Artulo 2.5mg Capsules: Hard gelatin capsule.
Capsule body: light grey. Capsule cap: light
green. Capsule contains white or almost white
powder. Marked with “R” on the cap and “2.5”
on the body.
Artulo 5mg Capsules: Hard gelatin capsule.
Capsule body: light grey. Capsule cap: green.
Capsule contains white or almost white
powder. Marked with “R” on the cap and “5” on
the body
Artulo 10mg Capsules: Hard gelatin capsule.
Capsule body: light grey. Capsule cap: dark
green. Capsule contains white or almost
white powder. Marked with “R” on the cap and
“10” on the body.
Artulo Capsules are packed in blisters of 28
capsules
Manufacturer and Marketing Authorisation
Holder
Ennogen Pharma Limited
Unit G4, Riverside Industrial Estate,
Riverside Way, Dartford, DA1 5BS, UK.
This leaflet was last amended in May 2015.

Pharma code
6 mm

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Back

420 mm

5. HOW TO STORE ARTULO CAPSULES
If you take more Artulo 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.

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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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