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RAMIPRIL 10MG CAPSULES

Active substance(s): 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.

7

Date
Software

13-06-17
Coreldraw 12
Checked By
Regulatory Affairs

Checked By
Quality Assurance

Approved By
EU Head - QA

sign of your body holding onto more
water than usual
!
Flushing
!
Treatment of high blood pressure
!
Blurred vision
The usual starting dose is 1.25mg or 2.5mg
PACKAGE LEAFLET: INFORMATION FOR THE USER
!
Pain in your joints
once daily. Your doctor will adjust the
!
Fever
amount you take until your blood pressure is
controlled. The maximum dose is 10mg
!
Sexual inability in men, reduced sexual
Artulo 1.25mg Capsules
Artulo 2.5mg Capsules
once daily. If you are already taking
desire in men or women
diuretics (water tablets), your doctor may
!
An increased number of certain white
Artulo 5mg Capsules
Artulo 10mg Capsules
stop or reduce the amount of the diuretic
blood cells (eosinophilia) found during a
[Ramipril]
you take before beginning treatment with
blood test
!
Blood tests showing changes in the way
Artulo Capsules.
Read all of this leaflet carefully before
Children and adolescents : Artulo
your liver, pancreas or kidneys are
you start taking this medicine because it
Capsules are not recommended for use in
working.
!
To
reduce
the
risk
of
you
having
a
contains important information for you.
children and adolescents below 18 years of
heart attack or stroke
!
Keep this leaflet. You may need to read
age because safety and efficacy of Artulo
Rare (may affect up to 1 in 1,000 people)
The usual starting dose is 2.5 mg once
it again.
Capsules in children has not yet been
!
Feeling shaky or confused
daily. Your doctor may then decide to
!
If you have any further questions, ask
established.
!
Red and swollen tongue
increase the amount you take. The usual
your doctor or pharmacist or nurse.
!
Severe flaking or peeling of the skin,
dose is 10 mg once daily.
!
This medicine has been prescribed for
If any of the above apply to you (or you are
itchy, lumpy rash
you only. Do not pass it on to others. It
not sure) talk to your doctor before taking
!
Nail problems (e.g. loosening or
!
Treatment after you have had a heart
may harm them, even if their signs of
Artulo Capsules.
separation of a nail from its bed)
attack
!
Skin rash or bruising
The usual starting dose is 1.25mg once
illness are the same as yours.
!
Blotches on your skin and cold
daily to 2.5mg twice daily. Your doctor will
!
If you get any side effects, talk to your
Other medicines and Artulo Capsules
extremities
adjust the amount you take. The usual dose
doctor, or pharmacist or nurse. This
Tell your doctor or pharmacist if you are
!
Red, itchy, swollen or watery eyes
is 10mg daily. Two administrations per day
includes any possible side effects not
taking, have recently taken or might take
!
Disturbed hearing and ringing in your
are preferable.
listed in this leaflet. See section 4.
any other medicines. This is because Artulo
ears
Capsules can affect the way some other
!
Feeling weak
!
Elderly
What is in this leaflet:
medicines work. Also some medicines can
!
Blood tests showing a decrease in the
Your doctor will reduce the initial dose and
1. What Artulo Capsules are and what
affect the way Artulo Capsules work.
number of red blood cells, white blood
adjust your treatment more slowly.
they are used for
cells or platelets or in the amount of
2. What you need to know before you
Your doctor may need to change your dose
haemoglobin.
!
Patients with kidney impairment
take Artulo Capsules
and/or to take other precautions:
The usual starting dose is 1.25 mg once
3. How to take Artulo Capsules
!
If you are taking an angiotensin II
daily. The maximum dose is 5 mg once
Very rare (may affect up to 1 in 10,000
4. Possible side effects
receptor blocker (ARB) or aliskiren (see
daily. In patients with severe kidney
people)
5. How to store Artulo Capsules
also information under the headings "Do
impairment the usual starting dose is 1.25
!
Being more sensitive to the sun than
6. Contents of the pack and other
not take Artulo Capsules" and "Warnings
mg. The maximum dose is 2.5 mg once
usual.
information
and precautions").
daily.
Not known (frequency cannot be estimated
!
Patients with liver impairment
from the available data)
1. WHAT ARTULO CAPSULES ARE
Tell your doctor if you are taking any of the
The usual starting dose is 1.25 mg and you
!
Difficulty concentrating
AND WHAT THEY ARE USED FOR
following medicines. They can make Artulo
will be monitored closely by your doctor.
!
Swollen mouth
Capsules work less well:
!
Blood tests showing too few blood cells
Artulo Capsules contain ramipril which
!
Medicines used to relieve pain and
in your blood
If you take more Artulo Capsules than
belongs to a group of medicines called ACE
inflammation (e.g. Non-Steroidal Anti!
Blood tests showing less sodium than
you should
(angiotensin converting enzyme) inhibitors.
Inflammatory Drugs (NSAIDs) such as
usual in your blood
Tell a doctor or go to the nearest hospital
They work by widening the blood vessels
ibuprofen or indometacin and aspirin)
!
Concentrated urine (dark in colour), feel
casualty department straight away. Do not
which makes it easier for the heart to pump
!
Medicines used for the treatment of low
or are sick, have muscle cramps,
drive to the hospital, get somebody else to
blood through them, to all parts of the body.
blood pressure, shock, cardiac failure,
confusion and fits which may be due to
take you or call for an ambulance. Take the
This helps to reduce blood pressure. It can
asthma or allergies such as ephedrine,
inappropriate ADH (anti-diuretic
medicine pack with you. This is so the
also help to make the heart work better if it
noradrenaline or adrenaline. Your doctor
hormone) secretion. If you have these
doctor knows what you have taken.
does not pump as well as needed.
will need to check your blood pressure.
symptoms contact your doctor as soon
as possible
If you forget to take Artulo Capsules
Artulo Capsules are used to:Tell your doctor if you are taking any of the
!
Fingers and toes changing colour when
If you miss a dose, take your normal dose
!
Reduce the risk of a heart attack, heart
following medicines. They can increase the
you are cold and then tingling or feeling
when it is next due.
painful when you warm up (Raynaud's
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
phenomenon)
forgotten dose.
risk of requiring surgery to increase
them with Artulo Capsules:
!
Breast enlargement in men
blood flow to the heart
!
Medicines used to relieve pain and
!
Slowed or impaired reactions
!
Treat high blood pressure.
inflammation (e.g. Non-Steroidal Anti!
Burning sensation
If you stop taking Artulo Capsules
Inflammatory Drugs (NSAIDs) such as
!
Change in the way things smell
Do not stop taking Artulo Capsules without
2. WHAT YOU NEED TO KNOW
ibuprofen or indometacin and aspirin)
!
Hair loss
first consulting your doctor, as your original
BEFORE YOU TAKE ARTULO
!
Medicines for cancer (chemotherapy)
!
An increase in antinuclear antibodies in
symptoms will return.
CAPSULES
!
Medicines to stop the rejection of organs
the blood (this would be picked up
after a transplant such as ciclosporin
during a blood test)
If you have any further questions on the use
Do not take Artulo Capsules:
!
Diuretics (water tablets) such as
!
Various skin conditions including blisters
of this medicine, ask your doctor or
!
If you are allergic to ramipril, other ACE
furosemide
on the skin and mucous membranes
pharmacist.
inhibitors or any of the other ingredients
!
Medicines which can increase the
(pemphigus), worsening of a condition
in the capsules (listed in section 6).
amount of potassium in your blood such
4. POSSIBLE SIDE EFFECTS
causing red, flaky, crusty patches of skin
Signs of an allergic reaction may include
as spironolactone, triamterene,
(psoriasis), a rash resembling psoriasis
a rash, swallowing or breathing
amiloride, potassium salts, trimethoprim
(dermatitis psoriasiform) or a rash
Like all medicines, this medicine can cause
problems, swelling of your lips, face,
alone or in combination with
(pemphigoid or lichenoid exanthema or
side effects, although not everybody gets
enanthema).
them.
throat or tongue.
sulfamethoxazole (for infections) and
!
If you have ever had a serious allergic
heparin (for thinning blood)
Reporting of side effects
Stop taking Artulo Capsules and see a
reaction called "angioedema". The signs
!
Steroid medicines for inflammation such
If you get any side effects, talk to your
doctor straight away, if you notice any of
include itching, hives (urticaria), red
as prednisolone
doctor, pharmacist or nurse. This includes
the following serious side effects - you
marks on the hands, feet and throat,
!
Allopurinol (used to lower the uric acid in
any possible side effects not listed in this
may need urgent medical treatment:
swelling of the throat and tongue,
your blood)
leaflet. You can also report side effects
!
Swelling of the face, lips or throat which
swelling around the eyes and lips,
!
Procainamide (for heart rhythm
directly via the Yellow Card Scheme at:
make it difficult to swallow or breathe, as
difficulty breathing and swallowing
problems)
www.mhra.gov.uk/yellowcard
well as itching and rashes. This could be
,
If you are having dialysis or any other
!
Temsirolimus (for cancer)
By reporting side effects you can help
a sign of a severe allergic reaction to
type of blood filtration. Depending on the
!
Sirolimus, everolimus (for prevention of
provide more information on the safety of
Artulo Capsules
machine that is used, Artulo Capsules
graft rejection)
this medicine.
!
Severe skin reactions including rash,
may not be suitable for you
!
Vildagliptin (used for treating type 2
ulcers in your mouth, worsening of a
,
If you have kidney problems where the
diabetes)
5. HOW TO STORE ARTULO
pre-existing skin disease, reddening,
blood supply to your kidney is reduced
!
Racecadotril (used against diarrhoea).
CAPSULES
blistering or detachment of skin (such as
(renal artery stenosis)
Stevens-Johnson syndrome, toxic
,
During the last 6 months of pregnancy
Tell your doctor if you are taking any of the
epidermal necrolysis or erythema
Keep this medicine out of the sight and
multiforme).
reach of children.
(see section below on "Pregnancy and
following medicines. They may be affected
Do not use this medicine after the expiry
breast-feeding")
by Artulo Capsules:
date which is stated on the carton and
Tell your doctor immediately if you
,
If your blood pressure is abnormally low
!
Medicines for diabetes such as oral
blister packs after EXP. The expiry date
experience:
or unstable. Your doctor will need to
glucose lowering medicines and insulin.
refers to the last day of that month. Do not
!
Faster heart rate, uneven or forceful
make this assessment
Artulo Capsules may lower your blood
store above 25°C. Store in the original
heartbeat (palpitations), chest pain,
,
If you have diabetes or impaired kidney
sugar. Check your blood sugar closely
package. Do not throw away any medicines
tightness in your chest or more serious
function and you are treated with a
while taking Artulo Capsules
via wastewater or household waste. Ask
problems including heart attack and
blood pressure lowering medicine
!
Lithium (for mental health problems).
your pharmacist how to throw away
stroke
containing aliskiren.
Artulo Capsules may increase the
medicines you no longer use. These
!
Shortness of breath or a cough. These
amount of lithium in your blood. Your
measures will help protect the environment.
could be signs of lung problems
Do not take Artulo Capsules if any of the
lithium levels will need to be closely
!
Bruising more easily, bleeding for longer
above apply to you. If you are not sure, talk
checked by your doctor.
6. CONTENTS OF THE PACK AND
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
OTHER INFORMATION
bleeding from the gums), purple spots,
Capsules.
not sure), talk to your doctor before taking
blotching on the skin or getting
Artulo Capsules.
What Artulo Capsules contains:
infections more easily than usual, sore
Warnings and precautions
Artulo Capsules contain 1.25mg, 2.5mg,
throat and fever, feeling tired, faint, dizzy
5mg and 10mg of the active substance
or having pale skin. These can be signs
Talk to your doctor, pharmacist or nurse
Artulo Capsules with food and alcohol
ramipril.
of blood or bone marrow problems
before taking Artulo Capsules:
!
Drinking alcohol with Artulo Capsules
!
Severe stomach pain which may reach
!
If you have heart, liver or kidney
may make you feel dizzy or lightthrough to your back. This could be a
The other ingredients are: starch
problems
headed. If you are concerned about how
sign of pancreatitis (inflammation of the
pregelatinised, gelatin, polyethylene glycol
!
If you have lost a lot of body salts or
much you can drink while you are taking
pancreas)
and the colourings, black iron oxide (E172)
fluids (through being sick (vomiting),
Artulo Capsules, discuss this with your
and titanium dioxide (E171). The 2.5mg
!
Fever, chills, tiredness, loss of appetite,
having diarrhoea, sweating more than
doctor as medicines used to reduce
capsules also contains Brilliant blue (E 133),
stomach pain, feeling sick, yellowing of
usual, being on a low salt diet, taking
blood pressure and alcohol can have
Carmoisine (E 122) (see section 2), Yellow
your skin or eyes (jaundice). These can
diuretics (water tablets) for a long time
additive effects
iron oxide (E 172) and 5mg capsules also
be signs of liver problems such as
or having had dialysis)
!
Artulo Capsules may be taken with or
contains Ponceau 4R (E 124) (see section
hepatitis (inflammation of the liver) or
!
If you are going to have treatment to
without food.
2), Brilliant blue (E 133), yellow iron oxide
liver damage
reduce your allergy to bee or wasp
!
Signs of changes in kidney function,
(E 172) and 10mg capsules also contain the
stings (desensitization)
Pregnancy and breast-feeding
including kidney failure, can include
colourings indigo carmine (E132) and yellow
!
If you are going to receive an
Pregnancy
production of less urine, nausea and
iron oxide (E172).
anaesthetic. This may be given for an
You must tell your doctor if you think that
vomiting, confusion, high blood
The printing ink contains shellac (E904),
operation or any dental work. You may
you are (or might become) pregnant.
pressure, stomach pains, slight
dehydrated alcohol (E1510), isopropyl
backache, and build-up of fluid in the
alcohol, butyl alcohol, strong ammonia
need to stop your ramipril treatment one
You should not take Artulo Capsules in the
body.
solution (E527), black iron oxide (E172),
day beforehand; ask your doctor for
first 12 weeks of pregnancy and you must
purified water and potassium hydroxide
advice
not take them at all after the 13th week as
Other side effects include:
(E525).
!
If you have high amounts of potassium
their use during pregnanct may possibly be
Tell your doctor if any of the following gets
in your blood (shown in blood test
harmful to the baby. If you become pregnant
serious or lasts longer than a few days.
What Artulo Capsules look like and
results)
while on Artulo Capsules, tell your doctor
contents of the pack
!
If you are taking medicines or have
immediately. A switch to a suitable
Common (may affect up to 1 in 10 people)
Artulo 1.25mg: Hard gelatin capsule.
conditions which may decrease sodium
alternative treatment should be carried out
!
Headache or feeling tired
Capsule body: light grey. Capsule cap: light
levels in your blood. Your doctor may
in advance of a planned pregnancy.
!
Feeling dizzy. This is more likely to
grey. Marked with “R” on cap and “1.25” on
carry out regular blood tests, particularly
happen when you start taking Artulo
body. Capsule contains white or almost
for checking the levels of sodium in your
Breast-feeding
Capsules or start taking a higher dose
white powder.
blood especially if you are elderly
You should not take Artulo Capsules if you
!
Fainting, hypotension (abnormally low
!
If you are taking medicines called mTOR
are breast-feeding.
blood pressure), especially when you
Artulo 2.5mg: Hard gelatin capsule.
inhibitors (e.g. temsirolimus, everolimus,
Ask your doctor or pharmacist for advice
stand or sit up quickly
Capsule body: light grey. Capsule cap: light
sirolimus) or vildagliptin or racecadotril
before taking any medicine.
!
Dry tickly cough, inflammation of your
green. Capsule contains white or almost
as they may increase the risk of
sinuses (sinusitis) or bronchitis,
white powder. Marked with “R” on the cap
shortness of breath
and “2.5” on the body.
angioedema, a serious allergic reaction
Driving and using machines
!
Stomach or gut pain, diarrhoea,
!
If you have a collagen vascular disease
You may feel dizzy, while taking Artulo
indigestion, feeling or being sick
Artulo 5mg: Hard gelatin capsule. Capsule
such as scleroderma or systemic lupus
Capsules. This is more likely to happen
!
Skin rash with or without raised area
body: light grey. Capsule cap: green.
erythematosus
when you start taking Artulo Capsules or
!
Chest pain
Capsule contains white or almost white
!
If you think that you are (or might
start taking a higher dose. If this happens,
!
Cramps or pain in your muscles
powder. Marked with “R” on the cap and “5”
become) pregnant. Artulo Capsules are
do not drive or use any tools or machines.
!
Blood tests showing more potassium
on the body.
not recommended in the first 3 months
than usual in your blood.
of pregnancy and may cause serious
Artulo 2.5mg Capsules contains
Artulo 10mg : Hard gelatin capsule.
harm to your baby after 3 months of
Carmoisine (E122)
Uncommon (may affect up to 1 in 100
Capsule body: light grey. Capsule cap: dark
pregnancy (see section below on
This may cause allergic reactions.
people)
green. Capsule contains white or almost
"Pregnancy and breast-feeding")
!
Balance problems (vertigo)
white powder. Marked with “R” on the cap
!
If you are taking any of the following
Artulo 5mg Capsules contains Ponceau
!
Itching and unusual skin sensations
and “10” on the body.
medicines used to treat high blood
4R (E124)
such as numbness, tingling, pricking,
pressure:
This may cause allergic reactions.
burning or creeping on your skin
Artulo Capsules are packed in blisters of 28
?
an angiotensin II receptor blocker
(paraesthesia)
capsules.
(ARBs) (also known as sartans - for
3. HOW TO TAKE ARTULO CAPSULES
!
Loss or change in the way things taste
!
Sleep problems
Marketing Authorisation Holder
example valsartan, telmisartan,
!
Feeling depressed, anxious, more
Ennogen Pharma Limited
irbesartan), in particular if you have
Always take this medicine exactly as your
nervous than usual or restless
Unit G4, Riverside Industrial Estate,
diabetes-related kidney problems
doctor has told you.
!
Blocked nose, difficulty breathing or
Riverside Way, Dartford, DA1 5BS, UK.
?
aliskiren.
Check with your doctor if you are not sure.
worsening of asthma
Take this medicine by mouth at the same
!
A swelling in your gut called "intestinal
Manufacturer
Your doctor may check your kidney function,
time of the day each day.
angioedema" presenting with symptoms
Ennogen Pharma Ltd
blood pressure, and the amount of
like abdominal pain, vomiting and
Unit G4 Riverside Industrial Estate,
electrolytes (e.g. potassium) in your blood at
Swallow the capsules with liquid. Do not
diarrhoea
Riverside Way, Dartford DA1 5BS
regular intervals.
crush or chew the capsules.
!
Heartburn, constipation or dry mouth
See also information under the heading "Do
!
Passing more water (urine) than usual
Alternative Manufacturer:
not take Artulo Capsules".
over the day
Fine Foods & Pharmaceuticals NTM S.p.A
!
Sweating more than usual
Via R Follereau, 25, 24027, Nembro (BG)
!
Loss or decrease of appetite (anorexia)
Italy
!
Increased or irregular heartbeat
!
Swollen arms and legs. This may be a
This leaflet was last amended in June
2017.
5001033

The recommended doses:

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