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RAMIPRIL 10MG CAPSULES

Active substance(s): RAMIPRIL / RAMIPRIL / RAMIPRIL

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Ph : +91-09845609386

Prepared By
Regulatory Affairs

Artwork No.

170217/1

Colours Used

Customer

Ennogen

Black

Description

Artulo Leaflet

Keyline

Market

UK

Language

English

Size

150 x 510 mm

Min. Font Size

Arial, 9 pt

Page No.

1 of 1

Version No.

6

Date
Software

10-05-17
Coreldraw 12
Checked By
Regulatory Affairs

Checked By
Quality Assurance

Approved By
EU Head - QA

!
Sweating more than usual
!
Loss or decrease of appetite (anorexia)
!
Increased or irregular heartbeat
!
Treatment of high blood pressure
!
Swollen arms and legs. This may be a
The usual starting dose is 1.25mg or 2.5mg
PACKAGE LEAFLET: INFORMATION FOR THE USER
sign of your body holding onto more
once daily. Your doctor will adjust the
water than usual
amount you take until your blood pressure is
controlled. The maximum dose is 10mg
!
Flushing
Artulo 1.25mg Capsules
Artulo 2.5mg Capsules
once daily. If you are already taking
!
Blurred vision
diuretics (water tablets), your doctor may
!
Pain in your joints
Artulo 5mg Capsules
Artulo 10mg Capsules
stop or reduce the amount of the diuretic
!
Fever
[Ramipril]
you take before beginning treatment with
!
Sexual inability in men, reduced sexual
desire in men or women
Artulo Capsules.
Read all of this leaflet carefully before
Children and adolescents : Artulo
!
An increased number of certain white
you start taking this medicine because it
Capsules are not recommended for use in
blood cells (eosinophilia) found during a
!
To
reduce
the
risk
of
you
having
a
contains important information for you.
children and adolescents below 18 years of
blood test
heart attack or stroke
!
Keep this leaflet. You may need to read
age because safety and efficacy of Artulo
!
Blood tests showing changes in the way
The usual starting dose is 2.5 mg once
it again.
Capsules in children has not yet been
your liver, pancreas or kidneys are
daily. Your doctor may then decide to
!
If you have any further questions, ask
established.
working.
increase the amount you take. The usual
your doctor or pharmacist or nurse.
dose is 10 mg once daily.
!
This medicine has been prescribed for
If any of the above apply to you (or you are
Rare (may affect up to 1 in 1,000 people)
you only. Do not pass it on to others. It
not sure) talk to your doctor before taking
!
Feeling shaky or confused
!
Treatment after you have had a heart
may harm them, even if their signs of
Artulo Capsules.
!
Red and swollen tongue
attack
!
Severe flaking or peeling of the skin,
The usual starting dose is 1.25mg once
illness are the same as yours.
itchy, lumpy rash
daily to 2.5mg twice daily. Your doctor will
!
If you get any side effects, talk to your
Other medicines and Artulo Capsules
!
Nail problems (e.g. loosening or
adjust the amount you take. The usual dose
doctor, or pharmacist or nurse. This
Tell your doctor or pharmacist if you are
separation of a nail from its bed)
is 10mg daily. Two administrations per day
includes any possible side effects not
taking, have recently taken or might take
!
Skin rash or bruising
are preferable.
listed in this leaflet. See section 4.
any other medicines. This is because Artulo
!
Blotches on your skin and cold
Capsules can affect the way some other
extremities
!
Elderly
What is in this leaflet:
medicines work. Also some medicines can
!
Red, itchy, swollen or watery eyes
Your doctor will reduce the initial dose and
1. What Artulo Capsules are and what
affect the way Artulo Capsules work.
!
Disturbed hearing and ringing in your
adjust your treatment more slowly.
they are used for
ears
2. What you need to know before you
Your doctor may need to change your dose
!
Feeling weak
!
Patients with kidney impairment
take Artulo Capsules
and/or to take other precautions:
!
Blood tests showing a decrease in the
The usual starting dose is 1.25 mg once
3. How to take Artulo Capsules
!
If you are taking an angiotensin II
number of red blood cells, white blood
daily. The maximum dose is 5 mg once
4. Possible side effects
receptor blocker (ARB) or aliskiren (see
cells or platelets or in the amount of
daily. In patients with severe kidney
5. How to store Artulo Capsules
also information under the headings "Do
haemoglobin.
impairment the usual starting dose is 1.25
6. Contents of the pack and other
not take Artulo Capsules" and "Warnings
mg. The maximum dose is 2.5 mg once
information
and precautions").
Very rare (may affect up to 1 in 10,000
daily.
people)
!
Being more sensitive to the sun than
!
Patients with liver impairment
1. WHAT ARTULO CAPSULES ARE
Tell your doctor if you are taking any of the
usual.
The usual starting dose is 1.25 mg and you
AND WHAT THEY ARE USED FOR
following medicines. They can make Artulo
will be monitored closely by your doctor.
Capsules work less well:
Not known (frequency cannot be estimated
Artulo Capsules contain ramipril which
!
Medicines used to relieve pain and
from the available data)
If you take more Artulo Capsules than
belongs to a group of medicines called ACE
inflammation (e.g. Non-Steroidal Anti!
Difficulty concentrating
you should
(angiotensin converting enzyme) inhibitors.
Inflammatory Drugs (NSAIDs) such as
!
Swollen mouth
Tell a doctor or go to the nearest hospital
They work by widening the blood vessels
ibuprofen or indometacin and aspirin)
!
Blood tests showing too few blood cells
casualty department straight away. Do not
which makes it easier for the heart to pump
!
Medicines used for the treatment of low
in your blood
drive to the hospital, get somebody else to
blood through them, to all parts of the body.
blood pressure, shock, cardiac failure,
!
Blood tests showing less sodium than
take you or call for an ambulance. Take the
This helps to reduce blood pressure. It can
asthma or allergies such as ephedrine,
usual in your blood
medicine pack with you. This is so the
also help to make the heart work better if it
noradrenaline or adrenaline. Your doctor
!
Concentrated urine (dark in colour), feel
doctor knows what you have taken.
does not pump as well as needed.
will need to check your blood pressure.
or are sick, have muscle cramps,
confusion and fits which may be due to
If you forget to take Artulo Capsules
Artulo Capsules are used to:Tell your doctor if you are taking any of the
inappropriate ADH (anti-diuretic
If you miss a dose, take your normal dose
!
Reduce the risk of a heart attack, heart
following medicines. They can increase the
hormone) secretion. If you have these
when it is next due.
symptoms contact your doctor as soon
Do not take a double dose to make up for a
disease and stroke and decrease the
chance of getting side effects if you take
as possible
forgotten dose.
risk of requiring surgery to increase
them with Artulo Capsules:
!
Fingers and toes changing colour when
blood flow to the heart
!
Medicines used to relieve pain and
you are cold and then tingling or feeling
!
Treat high blood pressure.
inflammation (e.g. Non-Steroidal Antipainful when you warm up (Raynaud's
If you stop taking Artulo Capsules
Inflammatory Drugs (NSAIDs) such as
phenomenon)
Do not stop taking Artulo Capsules without
2. WHAT YOU NEED TO KNOW
ibuprofen or indometacin and aspirin)
!
Breast enlargement in men
first consulting your doctor, as your original
BEFORE YOU TAKE ARTULO
!
Medicines for cancer (chemotherapy)
!
Slowed or impaired reactions
symptoms will return.
CAPSULES
!
Medicines to stop the rejection of organs
!
Burning sensation
after a transplant such as ciclosporin
!
Change in the way things smell
If you have any further questions on the use
Do not take Artulo Capsules:
!
Diuretics (water tablets) such as
!
Hair loss
of this medicine, ask your doctor or
!
If you are allergic to ramipril, other ACE
furosemide
!
An increase in antinuclear antibodies in
pharmacist.
inhibitors or any of the other ingredients
!
Medicines which can increase the
the blood (this would be picked up
in the capsules (listed in section 6).
amount of potassium in your blood such
4. POSSIBLE SIDE EFFECTS
during a blood test)
Signs of an allergic reaction may include
as spironolactone, triamterene,
!
Various skin conditions including blisters
a rash, swallowing or breathing
amiloride, potassium salts, trimethoprim
on the skin and mucous membranes
Like all medicines, this medicine can cause
problems, swelling of your lips, face,
alone or in combination with
(pemphigus), worsening of a condition
side effects, although not everybody gets
causing red, flaky, crusty patches of skin
them.
throat or tongue.
sulfamethoxazole (for infections) and
(psoriasis), a rash resembling psoriasis
!
If you have ever had a serious allergic
heparin (for thinning blood)
(dermatitis psoriasiform) or a rash
Stop taking Artulo Capsules and see a
reaction called "angioedema". The signs
!
Steroid medicines for inflammation such
(pemphigoid or lichenoid exanthema or
doctor straight away, if you notice any of
include itching, hives (urticaria), red
as prednisolone
enanthema).
the following serious side effects - you
marks on the hands, feet and throat,
!
Allopurinol (used to lower the uric acid in
may need urgent medical treatment:
swelling of the throat and tongue,
your blood)
Reporting of side effects
!
Swelling of the face, lips or throat which
swelling around the eyes and lips,
!
Procainamide (for heart rhythm
If you get any side effects, talk to your
make it difficult to swallow or breathe, as
difficulty breathing and swallowing
problems)
doctor, pharmacist or nurse. This includes
well as itching and rashes. This could be
,
If you are having dialysis or any other
!
Temsirolimus (for cancer)
any possible side effects not listed in this
a sign of a severe allergic reaction to
type of blood filtration. Depending on the
!
Sirolimus, everolimus (for prevention of
leaflet. You can also report side effects
Artulo Capsules
machine that is used, Artulo Capsules
graft rejection)
!
Severe skin reactions including rash,
directly via the Yellow Card Scheme at:
may not be suitable for you
!
Vildagliptin (used for treating type 2
www.mhra.gov.uk/yellowcard
ulcers in your mouth, worsening of a
,
If you have kidney problems where the
diabetes)
pre-existing skin disease, reddening,
By reporting side effects you can help
blood supply to your kidney is reduced
!
Racecadotril (used against diarrhoea).
provide more information on the safety of
blistering or detachment of skin (such as
(renal artery stenosis)
Stevens-Johnson syndrome, toxic
this medicine.
,
During the last 6 months of pregnancy
Tell your doctor if you are taking any of the
epidermal necrolysis or erythema
5. HOW TO STORE ARTULO
multiforme).
(see section below on "Pregnancy and
following medicines. They may be affected
CAPSULES
breast-feeding")
by Artulo Capsules:
Tell your doctor immediately if you
,
If your blood pressure is abnormally low
!
Medicines for diabetes such as oral
experience:
Keep this medicine out of the sight and
or unstable. Your doctor will need to
glucose lowering medicines and insulin.
!
Faster heart rate, uneven or forceful
reach of children.
make this assessment
Artulo Capsules may lower your blood
heartbeat (palpitations), chest pain,
Do not use this medicine after the expiry
,
If you have diabetes or impaired kidney
sugar. Check your blood sugar closely
tightness in your chest or more serious
date which is stated on the carton and
function and you are treated with a
while taking Artulo Capsules
problems including heart attack and
blister packs after EXP. The expiry date
blood pressure lowering medicine
!
Lithium (for mental health problems).
refers to the last day of that month. Do not
stroke
containing aliskiren.
Artulo Capsules may increase the
!
Shortness of breath or a cough. These
store above 25°C. Store in the original
amount of lithium in your blood. Your
package. Do not throw away any medicines
could be signs of lung problems
Do not take Artulo Capsules if any of the
lithium levels will need to be closely
via wastewater or household waste. Ask
!
Bruising more easily, bleeding for longer
above apply to you. If you are not sure, talk
checked by your doctor.
your pharmacist how to throw away
than normal, any sign of bleeding (e.g.
to your doctor before taking Artulo
If any of the above apply to you (or you are
medicines you no longer use. These
bleeding from the gums), purple spots,
Capsules.
not sure), talk to your doctor before taking
measures will help protect the environment.
blotching on the skin or getting
Artulo Capsules.
infections more easily than usual, sore
Warnings and precautions
6. CONTENTS OF THE PACK AND
throat and fever, feeling tired, faint, dizzy
OTHER INFORMATION
or having pale skin. These can be signs
Talk to your doctor, pharmacist or nurse
Artulo Capsules with food and alcohol
of blood or bone marrow problems
before taking Artulo Capsules:
!
Drinking alcohol with Artulo Capsules
!
Severe stomach pain which may reach
What Artulo Capsules contains:
!
If you have heart, liver or kidney
may make you feel dizzy or lightthrough to your back. This could be a
Artulo Capsules contain 1.25mg, 2.5mg,
problems
headed. If you are concerned about how
sign of pancreatitis (inflammation of the
5mg and 10mg of the active substance
!
If you have lost a lot of body salts or
much you can drink while you are taking
pancreas)
ramipril.
fluids (through being sick (vomiting),
Artulo Capsules, discuss this with your
!
Fever, chills, tiredness, loss of appetite,
having diarrhoea, sweating more than
doctor as medicines used to reduce
stomach pain, feeling sick, yellowing of
The other ingredients are: starch
usual, being on a low salt diet, taking
blood pressure and alcohol can have
your skin or eyes (jaundice). These can
pregelatinised, gelatin, polyethylene glycol
diuretics (water tablets) for a long time
additive effects
be signs of liver problems such as
and the colourings, black iron oxide (E172)
or having had dialysis)
!
Artulo Capsules may be taken with or
hepatitis (inflammation of the liver) or
and titanium dioxide (E171). The 2.5mg
!
If you are going to have treatment to
without food.
liver damage
capsules also contains Brilliant blue (E 133),
reduce your allergy to bee or wasp
!
Signs of changes in kidney function,
Carmoisine (E 122) (see section 2), Yellow
stings (desensitization)
Pregnancy and breast-feeding
including kidney failure, can include
iron oxide (E 172) and 5mg capsules also
!
If you are going to receive an
Pregnancy
production of less urine, nausea and
contains Ponceau 4R (E 124) (see section
anaesthetic. This may be given for an
You must tell your doctor if you think that
vomiting, confusion, high blood
2), Brilliant blue (E 133), yellow iron oxide
operation or any dental work. You may
you are (or might become) pregnant.
pressure, stomach pains, slight
(E 172) and 10mg capsules also contain the
backache, and build-up of fluid in the
colourings indigo carmine (E132) and yellow
need to stop your ramipril treatment one
You should not take Artulo Capsules in the
body.
iron oxide (E172).
day beforehand; ask your doctor for
first 12 weeks of pregnancy and you must
The printing ink contains shellac (E904),
advice
not take them at all after the 13th week as
dehydrated alcohol (E1510), isopropyl
Other side effects include:
!
If you have high amounts of potassium
their use during pregnanct may possibly be
alcohol, butyl alcohol, strong ammonia
Tell your doctor if any of the following gets
in your blood (shown in blood test
harmful to the baby. If you become pregnant
solution (E527), black iron oxide (E172),
serious or lasts longer than a few days.
results)
while on Artulo Capsules, tell your doctor
purified water and potassium hydroxide
!
If you are taking medicines or have
immediately. A switch to a suitable
(E525).
Common (may affect up to 1 in 10 people)
conditions which may decrease sodium
alternative treatment should be carried out
!
Headache or feeling tired
levels in your blood. Your doctor may
in advance of a planned pregnancy.
What Artulo Capsules look like and
!
Feeling dizzy. This is more likely to
carry out regular blood tests, particularly
contents of the pack
happen when you start taking Artulo
for checking the levels of sodium in your
Breast-feeding
Artulo 1.25mg: Hard gelatin capsule.
Capsules or start taking a higher dose
blood especially if you are elderly
You should not take Artulo Capsules if you
Capsule body: light grey. Capsule cap: light
!
Fainting, hypotension (abnormally low
!
If you are taking medicines called mTOR
are breast-feeding.
grey. Marked with “R” on cap and “1.25” on
blood pressure), especially when you
inhibitors (e.g. temsirolimus, everolimus,
Ask your doctor or pharmacist for advice
body. Capsule contains white or almost
stand or sit up quickly
sirolimus) or vildagliptin or racecadotril
before taking any medicine.
white powder.
!
Dry tickly cough, inflammation of your
as they may increase the risk of
sinuses (sinusitis) or bronchitis,
Artulo 2.5mg: Hard gelatin capsule.
shortness of breath
angioedema, a serious allergic reaction
Driving and using machines
Capsule body: light grey. Capsule cap: light
!
Stomach or gut pain, diarrhoea,
!
If you have a collagen vascular disease
You may feel dizzy, while taking Artulo
green. Capsule contains white or almost
indigestion, feeling or being sick
such as scleroderma or systemic lupus
Capsules. This is more likely to happen
white powder. Marked with “R” on the cap
!
Skin rash with or without raised area
erythematosus
when you start taking Artulo Capsules or
and “2.5” on the body.
!
Chest pain
!
If you think that you are (or might
start taking a higher dose. If this happens,
!
Cramps or pain in your muscles
become) pregnant. Artulo Capsules are
do not drive or use any tools or machines.
Artulo 5mg: Hard gelatin capsule. Capsule
!
Blood tests showing more potassium
not recommended in the first 3 months
body: light grey. Capsule cap: green.
than usual in your blood.
of pregnancy and may cause serious
Artulo 2.5mg Capsules contains
Capsule contains white or almost white
harm to your baby after 3 months of
Carmoisine (E122)
powder. Marked with “R” on the cap and “5”
Uncommon (may affect up to 1 in 100
pregnancy (see section below on
This may cause allergic reactions.
on the body.
people)
"Pregnancy and breast-feeding")
!
Balance problems (vertigo)
!
If you are taking any of the following
Artulo 5mg Capsules contains Ponceau
Artulo 10mg : Hard gelatin capsule.
!
Itching and unusual skin sensations
medicines used to treat high blood
4R (E124)
Capsule body: light grey. Capsule cap: dark
such as numbness, tingling, pricking,
pressure:
This may cause allergic reactions.
green. Capsule contains white or almost
burning or creeping on your skin
?
an angiotensin II receptor blocker
white powder. Marked with “R” on the cap
(paraesthesia)
(ARBs) (also known as sartans - for
3. HOW TO TAKE ARTULO CAPSULES
and “10” on the body.
!
Loss or change in the way things taste
!
Sleep problems
example valsartan, telmisartan,
Artulo Capsules are packed in blisters of 28
!
Feeling depressed, anxious, more
irbesartan), in particular if you have
Always take this medicine exactly as your
capsules.
nervous than usual or restless
diabetes-related kidney problems
doctor has told you.
!
Blocked nose, difficulty breathing or
?
aliskiren.
Check with your doctor if you are not sure.
Manufacturer and Marketing
worsening of asthma
Take this medicine by mouth at the same
Authorisation Holder
!
A swelling in your gut called "intestinal
Your doctor may check your kidney function,
time of the day each day.
Ennogen Pharma Limited
angioedema" presenting with symptoms
blood pressure, and the amount of
Unit G4, Riverside Industrial Estate,
like abdominal pain, vomiting and
electrolytes (e.g. potassium) in your blood at
Swallow the capsules with liquid. Do not
Riverside Way, Dartford, DA1 5BS, UK.
diarrhoea
regular intervals.
crush or chew the capsules.
!
Heartburn, constipation or dry mouth
See also information under the heading "Do
This leaflet was last amended in May
!
Passing more water (urine) than usual
not take Artulo Capsules".
2017.
over the day
5001033

The recommended doses:

Expand Transcript

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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