Ramipril 5mg capsules

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

Buy It Now

Active ingredient:
Ramipril
Available from:
Milpharm Ltd
ATC code:
C09AA05
INN (International Name):
Ramipril
Dosage:
5mg
Pharmaceutical form:
Capsule
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02050501; GTIN: 08901175011704
Authorization number:
PL 16363/0357

Read the complete document

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.

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. See section 4.

What is in this leaflet:

What Ramipril is and what it is used for

What you need to know before you

take Ramipril

How to take Ramipril

Possible side effects

How to store Ramipril

Contents of the pack and other

information

1.

What Ramipril is and what it is

used for

Ramipril contains a medicine called

ramipril. This belongs to a group

of medicines called ACE inhibitors

(Angiotensin Converting Enzyme

Inhibitors).

Ramipril 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 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

Do not take Ramipril:

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 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 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.

if you have diabetes or impaired kidney

function and you are treated with a

blood pressure lowering medicine

containing aliskiren

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 your medicine:

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 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 are taking medicines or have

conditions which may decrease

sodium levels in your blood. Your

doctor may carry out regular blood

tests, particularly for checking the

levels of sodium in your blood

especially if you are elderly.

If you are taking any of the following

medicines, the risk of angioedema

(rapid swelling under the skin in area

such as the throat) is increased:

Sirolimus, everolimus and other

medicines belonging to the class

of mTOR inhibitors (used to avoid

rejection of transplanted organs) or

vildagliptin or racecadotril.

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 you 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,

irbesartan), in particular if you have

diabetes-related kidney problems.

aliskiren

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 Ramipril”

Children and adolescents

Ramipril is 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.

Other medicines and Ramipril

Tell your doctor or pharmacist if you are

taking or have recently taken any other

medicines, including medicines obtained

without a prescription (including herbal

medicines). This is because Ramipril can

affect the way some other medicines work.

Also some medicines can affect the way

Ramipril works.

Tell your doctor if you are taking any of the

following medicines. They can make the

effect of Ramipril 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.

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:

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

Potassium supplements or salt

substitutes containing potassium,

diuretics (water tablets, in particular

those so called potassium sparing),

other drugs which can increase

potassium in your body (such as

heparin and co-trimoxazole also known

as trimethoprim/sulfamethoxazole).

Steroid medicines for inflammation

such as prednisolone

Allopurinol (used to lower the uric acid

in your blood)

Procainamide (for heart rhythm

problems).

Temsirolimus (for cancer)

Medicines which are most often used

to avoid rejection of transplanted

organs (sirolimus, everolimus and

other medicines belonging to the

class of mTOR inhibitors). See section

“Warnings and precautions”.

Vildagliptin (used for treating type 2

diabetes)

Racecadotril (used against diarrhoea)

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 Ramipril

Aurobindo” and “Warnings and

precautions”).

Tell your doctor if you are taking any of the

following medicines. They may be affected

by Ramipril:

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

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 with food and drink and

alcohol

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.

Ramipril may be taken with or without

food.

Pregnancy, breast-feeding and fertility

Pregnancy

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.

Breast-feeding

You should not take Ramipril if you are

breast-feeding.

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.

3.

How to take Ramipril

Always take Ramipril exactly as your

doctor has told you. You should check

with your doctor or pharmacist if you are

not sure.

The recommended dose is

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.

Package leaflet: Information for the user

Ramipril 1.25 mg capsules

Ramipril 2.5 mg capsules

Ramipril 5 mg capsules

Ramipril 10 mg capsules

Ramipril

P15XXXXX

Black

Half Fold : 300 mm

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.

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.

If you take more Ramipril 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

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 capsule.

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 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

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 (may affect up to 1 in 10

people)

Headache or feeling tired

Feeling dizzy. This is more likely to

happen when you start taking Ramipril

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 (may affect up to 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 (may affect up to 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 (may affect up to 1 in 10,000

people)

Being more sensitive to the sun than

usual.

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

Concentrated urine (dark in colour),

feel or are sick, have muscle cramps,

confusion and fits which may be due

to inappropriate ADH (anti-diuretic

hormone) secretion. If you have these

symptoms contact your doctor as soon

as possible.

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. This includes any

possible side effects not listed in this

leaflet. You can also report side effects

directly via

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

By reporting side effects you can help

provide more information on the safety of

this medicine

5.

How to store Ramipril

Keep this medicine out of the sight and

reach of children.

Do not store above 25°C.

Keep the blister in the outer carton. Keep

the container tightly closed.

Store in the original package to protect

from moisture.

Do not use this medicine after the expiry

date which is stated on the carton, bottle

label blister foil after EXP. The expiry date

refers to the last day of that month.

Do not throw away any medicines via

wastewater or household waste. Ask your

pharmacist how to throw away medicines

you no longer required. These measures

will help protect the environment.

6.

Contents of the pack and other

information

What Ramipril contains

The active substance is ramipril. Each

hard capsule contains ramipril

1.25 mg, 2.5 mg, 5 mg or 10 mg.

The other ingredients are hydrophobic

colloidal anhydrous silica,

pregelatinized maize starch.

Capsule Shell:

1.25 mg:

Gelatin, sodium lauryl sulphate, iron

oxide yellow (E172), titanium dioxide

(E171)

2.5 mg:

Gelatin, sodium lauryl sulphate, iron

oxide yellow (E172), ponceau 4R

(E124), titanium dioxide (E171)

5 mg & 10 mg: Gelatin, sodium lauryl

sulfate, ponceau 4R (E124), patent

blue V (E131), titanium dioxide (E171)

Printing Ink: Shellac, propylene glycol,

black iron oxide (E172), potassium

hydroxide

What Ramipril looks like and contents

of the pack

Capsules, hard

Ramipril 1.25 mg capsule

Yellow/White size ‘4’ hard gelatin capsules

imprinted with ‘D’ on yellow cap and ‘40’

on white body with black edible ink filled

with white to almost white powder.

Ramipril 2.5 mg capsules

Orange/White size ‘4’ hard gelatin

capsules imprinted with ‘D’ on orange cap

and ‘41’ on white body with black edible

ink filled white to almost white powder.

Ramipril 5 mg capsules

Red/White size ‘4’ hard gelatin capsules

imprinted with ‘D’ on red cap and ‘42’ on

white body with black edible ink filled with

white to almost white powder.

Ramipril 10 mg capsules

Blue/White size ‘4’ hard gelatin capsules

imprinted with ‘D’ on blue cap and ‘43’ on

white body with black edible ink filled with

white to almost white powder.

Ramipril capsules are available in blister

pack and white opaque HDPE bottle pack.

Pack size:

Blister pack: 7, 10, 14, 20, 21, 28, 30, 42,

50, 56, 60, 90, 98 & 100 capsules

Bottle pack: 30, 100, 500 & 1000 capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Milpharm Limited

Ares, Odyssey Business Park

West End Road

South Ruislip HA4 6QD

United Kingdom

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This leaflet was last approved in

11/2017.

P15XXXXX

Half Fold : 300 mm

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.

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. See section 4.

What is in this leaflet:

What Ramipril is and what it is used for

What you need to know before you take

Ramipril

How to take Ramipril

Possible side effects

How to store Ramipril

Contents of the pack and other information

1.

What Ramipril is and what it is used for

Ramipril contains a medicine called ramipril.

This belongs to a group of medicines called

ACE inhibitors (Angiotensin Converting Enzyme

Inhibitors).

Ramipril 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 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

Do not take Ramipril:

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 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 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.

if you have diabetes or impaired kidney function

and you are treated with a blood pressure

lowering medicine containing aliskiren

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

your medicine:

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

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 are taking medicines or have conditions

which may decrease sodium levels in your

blood. Your doctor may carry out regular blood

tests, particularly for checking the levels of

sodium in your blood especially if you are

elderly.

If you are taking any of the following medicines,

the risk of angioedema (rapid swelling under

the skin in area such as the throat) is increased:

Sirolimus, everolimus and other medicines

belonging to the class of mTOR inhibitors

(used to avoid rejection of transplanted

organs) or vildagliptin or racecadotril.

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 you 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, irbesartan), in

particular if you have diabetes-related

kidney problems.

aliskiren

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 Ramipril”

Children and adolescents

Ramipril is 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.

Other medicines and Ramipril

Tell your doctor or pharmacist if you are taking

or have recently taken any other medicines,

including medicines obtained without a prescription

(including herbal medicines). This is because

Ramipril can affect the way some other medicines

work. Also some medicines can affect the way

Ramipril works.

Tell your doctor if you are taking any of the

following medicines. They can make the effect of

Ramipril 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.

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:

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

Potassium supplements or salt substitutes

containing potassium, diuretics (water tablets,

in particular those so called potassium sparing),

other drugs which can increase potassium in

your body (such as heparin and co-trimoxazole

also known as trimethoprim/sulfamethoxazole).

Steroid medicines for inflammation such as

prednisolone

Allopurinol (used to lower the uric acid in your

blood)

Procainamide (for heart rhythm problems).

Temsirolimus (for cancer)

Medicines which are most often used to avoid

rejection of transplanted organs (sirolimus,

everolimus and other medicines belonging

to the class of mTOR inhibitors). See section

“Warnings and precautions”.

Vildagliptin (used for treating type 2 diabetes)

Racecadotril (used against diarrhoea)

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 Ramipril Aurobindo” and

“Warnings and precautions”).

Tell your doctor if you are taking any of the

following medicines. They may be affected by

Ramipril:

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

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 with food and drink and alcohol

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.

Ramipril may be taken with or without food.

Pregnancy, breast-feeding and fertility

Pregnancy

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.

Breast-feeding

You should not take Ramipril if you are breast-

feeding.

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.

3.

How to take Ramipril

Always take Ramipril exactly as your doctor has

told you. You should check with your doctor or

pharmacist if you are not sure.

The recommended dose is

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.

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.

Package leaflet: Information for the user

Ramipril 1.25 mg capsules

Ramipril 2.5 mg capsules

Ramipril 5 mg capsules

Ramipril 10 mg capsules

Ramipril

P15XXXXX

Black

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.

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.

If you take more Ramipril 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

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 capsule.

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 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

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 (may affect up to 1 in 10 people)

Headache or feeling tired

Feeling dizzy. This is more likely to happen

when you start taking Ramipril 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 (may affect up to 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

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 (may affect up to 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 (may affect up to 1 in 10,000 people)

Being more sensitive to the sun than usual.

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

Concentrated urine (dark in colour), feel or

are sick, have muscle cramps, confusion and

fits which may be due to inappropriate ADH

(anti-diuretic hormone) secretion. If you have

these symptoms contact your doctor as soon as

possible.

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. This includes any possible side effects

not listed in this leaflet. You can also report side

effects directly via

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more

information on the safety of this medicine

5.

How to store Ramipril

Keep this medicine out of the sight and reach of

children.

Do not store above 25°C.

Keep the blister in the outer carton. Keep the

container tightly closed.

Store in the original package to protect from

moisture.

Do not use this medicine after the expiry date

which is stated on the carton, bottle label blister

foil after EXP. The expiry date refers to the last day

of that month.

Do not throw away any medicines via wastewater

or household waste. Ask your pharmacist how to

throw away medicines you no longer required.

These measures will help protect the environment.

6.

Contents of the pack and other information

What Ramipril contains

The active substance is ramipril. Each hard

capsule contains ramipril 1.25 mg, 2.5 mg,

5 mg or 10 mg.

The other ingredients are hydrophobic colloidal

anhydrous silica, pregelatinized maize starch.

Capsule Shell:

1.25 mg:

Gelatin, sodium lauryl sulphate, iron oxide

yellow (E172), titanium dioxide (E171)

2.5 mg:

Gelatin, sodium lauryl sulphate, iron oxide

yellow (E172), ponceau 4R (E124), titanium

dioxide (E171)

5 mg & 10 mg: Gelatin, sodium lauryl sulfate,

ponceau 4R (E124), patent blue V (E131),

titanium dioxide (E171)

Printing Ink: Shellac, propylene glycol, black

iron oxide (E172), potassium hydroxide

What Ramipril looks like and contents of the

pack

Capsules, hard

Ramipril 1.25 mg capsule

Yellow/White size ‘4’ hard gelatin capsules

imprinted with ‘D’ on yellow cap and ‘40’ on white

body with black edible ink filled with white to almost

white powder.

Ramipril 2.5 mg capsules

Orange/White size ‘4’ hard gelatin capsules

imprinted with ‘D’ on orange cap and ‘41’ on white

body with black edible ink filled white to almost

white powder.

Ramipril 5 mg capsules

Red/White size ‘4’ hard gelatin capsules imprinted

with ‘D’ on red cap and ‘42’ on white body with

black edible ink filled with white to almost white

powder.

Ramipril 10 mg capsules

Blue/White size ‘4’ hard gelatin capsules imprinted

with ‘D’ on blue cap and ‘43’ on white body with

black edible ink filled with white to almost white

powder.

Ramipril capsules are available in blister pack and

white opaque HDPE bottle pack.

Pack size:

Blister pack: 7, 10, 14, 20, 21, 28, 30, 42, 50, 56,

60, 90, 98 & 100 capsules

Bottle pack: 30, 100, 500 & 1000 capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Milpharm Limited

Ares, Odyssey Business Park

West End Road

South Ruislip HA4 6QD

United Kingdom

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This leaflet was last approved in 11/2017.

P15XXXXX

Read the complete document

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT

Ramipril 5 mg capsules

2

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each hard capsule contains ramipril 5 mg.

For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM

Capsules, hard

Red/White size ‘4’ hard gelatin capsules imprinted with ‘D’ on red cap and

‘42’ on white body with black edible ink filled with white to almost white

powder.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Treatment of hypertension.

Cardiovascular

prevention:

reduction

cardiovascular

morbidity

mortality in patients with:

manifest

atherothrombotic

cardiovascular

disease

(history

coronary

heart disease or stroke, or peripheral vascular disease) or

diabetes with at least one cardiovascular risk factor (see section 5.1).

- Treatment of renal disease:

Incipient glomerular diabetic nephropathy as defined by the presence of

microalbuminuria,

Manifest glomerular diabetic nephropathy as defined by macroproteinuria

in patients with at least one cardiovascular risk factor (see section 5.1),

Manifest

glomerular

diabetic

nephropathy

defined

macroproteinuria

3 g/day (see section 5.1).

- Treatment of symptomatic heart failure.

Secondary

prevention

after

acute

myocardial

infarction:

reduction

mortality from the acute phase of myocardial infarction in patients with

clinical

signs

heart

failure

when

started

>

hours

following

acute

myocardial infarction.

4.2

Posology and method of administration

Posology

It is recommended that Ramipril is taken each day at the same time of the day.

Ramipril can be taken before, with or after meals, because food intake does

not modify its bioavailability (see section 5.2). Ramipril has to be swallowed

with liquid. It must not be chewed or crushed.

Adults

Diuretic-Treated patients

Hypotension may occur following initiation of therapy with Ramipril; this is

more likely in patients who are being treated concurrently with diuretics.

Caution is therefore recommended since these patients may be volume and/or

salt depleted.

If possible, the diuretic should be discontinued 2 to 3 days before beginning

therapy with Ramipril (see section 4.4).

In hypertensive patients in whom the diuretic is not discontinued, therapy with

Ramipril should be initiated with a 1.25 mg dose. Renal function and serum

potassium should be monitored. The subsequent dosage of Ramipril should be

adjusted according to blood pressure target.

Hypertension

The dose should be individualised according to the patient profile (see section

4.4) and blood pressure control.

Ramipril may be used in monotherapy or in combination with other classes of

antihypertensive medicinal products.

Starting dose

Ramipril should be started gradually with an initial recommended dose of 2.5

mg daily.

Patients with a strongly activated renin-angiotensin-aldosterone system may

experience an excessive drop in blood pressure following the initial dose. A

starting dose of 1.25 mg is recommended in such patients and the initiation of

treatment should take place under medical supervision (see section 4.4).

Titration and maintenance dose

The dose can be doubled at interval of two to four weeks to progressively

achieve target blood pressure; the maximum permitted dose of Ramipril is 10

mg daily. Usually the dose is administered once daily.

Cardiovascular prevention

Starting dose

The recommended initial dose is 2.5 mg of Ramipril once daily.

Titration and maintenance dose

Depending on the patient’s tolerability to the active substance, the dose should

be gradually increased. It is recommended to double the dose after one or two

weeks of treatment and - after another two to three weeks - to increase it up to

the target maintenance dose of 10 mg Ramipril once daily.

See also posology on diuretic treated patients above.

Treatment of renal disease

In patients with diabetes and microalbuminuria:

Starting dose:

The recommended initial dose is 1.25 mg of Ramipril once daily.

Titration and maintenance dose

Depending on the patient's tolerability to the active substance, the dose is

subsequently increased. Doubling the once daily dose to 2.5 mg after two

weeks and then to 5 mg after a further two weeks is recommended.

In patients with diabetes and at least one cardiovascular risk

Starting dose:

The recommended initial dose is 2.5 mg of Ramipril once daily.

Titration and maintenance dose

Depending on the patient’s tolerability to the active substance, the dose is

subsequently increased. Doubling the daily dose to 5 mg Ramipril after one or

two weeks and then to 10 mg Ramipril after a further two or three weeks is

recommended. The target daily dose is 10 mg.

In patients with non- diabetic nephropathy as defined by macroproteinuria

3

g/day.

Starting dose:

The recommended initial dose is 1.25 mg of Ramipril once daily.

Titration and maintenance dose

Depending on the patient’s tolerability to the active substance, the dose is

subsequently increased. Doubling the once daily dose to 2.5 mg after two

weeks and then to 5 mg after a further two weeks is recommended.

Symptomatic heart failure

Starting dose

In patients stabilized on diuretic therapy, the recommended initial dose is 1.25

mg daily.

Titration and maintenance dose

Ramipril should be titrated by doubling the dose every one to two weeks up to

a maximum daily dose of 10 mg. Two administrations per day are preferable.

Secondary prevention after acute myocardial infarction and with heart failure

Starting dose

After 48 hours, following myocardial infarction in a clinically and

haemodynamically stable patient, the starting dose is 2.5 mg twice daily for

three days. If the initial 2.5 mg dose is not tolerated a dose of 1.25 mg twice a

day should be given for two days before increasing to 2.5 mg and 5 mg twice a

day. If the dose cannot be increased to 2.5 mg twice a day the treatment should

be withdrawn.

See also posology on diuretic treated patients above.

Titration and maintenance dose

The daily dose is subsequently increased by doubling the dose at intervals of

one to three days up to the target maintenance dose of 5 mg twice daily.

The maintenance dose is divided in 2 administrations per day where possible.

If the dose cannot be increased to 2.5 mg twice a day treatment should be

withdrawn. Sufficient experience is still lacking in the treatment of patients

with severe (NYHA IV) heart failure immediately after myocardial infarction.

Should the decision be taken to treat these patients, it is recommended that

therapy be started at 1.25 mg once daily and that particular caution be

exercised in any dose increase.

Special populations

Patients with renal impairment

Daily dose in patients with renal impairment should be based on creatinine

clearance (see section 5.2):

If creatinine clearance is

60 ml/min, it is not necessary to adjust the

initial dose (2.5 mg/day); the maximal daily dose is 10 mg;

If creatinine clearance is between 30-60 ml/min, it is not necessary to

adjust the initial dose (2.5 mg/day); the maximal daily dose is 5 mg;

If creatinine clearance is between 10-30 ml/min, the initial dose is1.25

mg/day and the maximal daily dose is 5 mg;

In haemodialysed hypertensive patients: ramipril is slightly dialysable; the

initial dose is 1.25 mg/day and the maximal daily dose is 5 mg; the

medicinal product should be administered few hours after haemodialysis is

performed.

Patients with hepatic impairment (see section 5.2)

In patients with hepatic impairment, treatment with Ramipril must be initiated

only under close medical supervision and the maximum daily dose is 2.5 mg

Ramipril.

Older people

Initial doses should be lower and subsequent dose titration should be more

gradual because of greater chance of undesirable effects especially in very old

and frail patients. A reduced initial dose of 1.25 mg ramipril should be

considered.

Paediatric population

The safety and efficacy of ramipril in children has not yet been established.

Currently available data for Ramipril are described in sections 4.8, 5.1, 5.2

& 5.3 but no specific recommendation on posology can be made.

Method of administration

Oral use.

4.3

Contraindications

Hypersensitivity to the active substance, to any of the excipients listed in

section 6.1 or any other ACE (Angiotensin Converting Enzyme) inhibitors

History of angioedema (hereditary, idiopathic or due to previous

angioedema with ACE inhibitors or AIIRAs)

Extracorporeal treatments leading to contact of blood with negatively

charged surfaces (see section 4.5)

Significant bilateral renal artery stenosis or renal artery stenosis in a single

functioning kidney

Second

third

trimester of pregnancy (see sections 4.4 and 4.6)

Ramipril must not be used in patients with hypotensive or

haemodynamically unstable states.

The concomitant use of Ramipril with aliskiren-containing products is

contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60

ml/min/1.73 m

) (see Sections 4.5 and 5.1).

4.4

Special warnings and precautions for use

Special populations

Pregnancy: ACE inhibitors such as ramipril, or Angiotensin II Receptor

Antagonists (AIIRAs) should not be initiated during pregnancy. Unless

continued ACE inhibitor/ AIIRAs therapy is considered essential, patients

planning pregnancy should be changed to alternative anti-hypertensive

treatments which have an established safety profile for use in pregnancy.

When pregnancy is diagnosed, treatment with ACE inhibitors/ AIIRAs

should be stopped immediately, and, if appropriate, alternative therapy

should be started (see sections 4.3 and 4.6).

Patients at particular risk of hypotension

- Patients with strongly activated renin-angiotensin-aldosterone system

Patients with strongly activated renin-angiotensin-aldosterone system are at

risk of an acute pronounced fall in blood pressure and deterioration of renal

function due to ACE inhibition, especially when an ACE inhibitor or a

concomitant diuretic is given for the first time or at first dose increase.

Significant activation of renin-angiotensin-aldosterone system is to be

anticipated and medical supervision including blood pressure monitoring is

necessary, for example in:

Patients with severe hypertension

Patients with decompensated congestive heart failure

Patients with haemodynamically relevant left ventricular inflow or outflow

impediment (e.g. stenosis of the aortic or mitral valve)

Patients with unilateral renal artery stenosis with a second functional

kidney

Patients in whom fluid or salt depletion exists or may develop (including

patients with diuretics)

Patients with liver cirrhosis and/or ascites

Patients undergoing major surgery or during anaesthesia with agents that

produce hypotension.

Generally, it is recommended to correct dehydration, hypovolaemia or salt

depletion before initiating treatment (in patients with heart failure, however,

such corrective action must be carefully weighed out against the risk of

volume overload).

Dual blockade of the renin-angiotensin-aldosterone system (RAAS)

There is evidence that the concomitant use of ACE-inhibitors,

angiotensin II receptor blockers or aliskiren increases the risk of

hypotension, hyperkalaemia and decreased renal function (including

acute renal failure). Dual blockade of RAAS through the combined

use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is

therefore not recommended (see Section 4.5 and 5.1).

If dual blockade therapy is considered absolutely necessary, this

should only occur under specialist supervision and subject to frequent

close monitoring of renal function, electrolytes and blood pressure.

ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly

in patients with diabetic nephropathy.

-

Transient or persistent heart failure post MI

-

Patients at risk of cardiac or cerebral ischemia in case of acute

hypotension

The initial phase of treatment requires special medical supervision.

Older people

See section 4.2.

Surgery

It is recommended that treatment with angiotensin converting enzyme

inhibitors such as ramipril should be discontinued where possible one day

before surgery.

Monitoring of renal function

Renal function should be assessed before and during treatment and dosage

adjusted especially in the initial weeks of treatment. Particularly careful

monitoring is required in patients with renal impairment (see section 4.2).

There is a risk of impairment of renal function, particularly in patients with

congestive heart failure or after a renal transplant.

Hypersensitivity/

Angioedema

Angioedema has been reported in patients treated with ACE inhibitors

including ramipril (see section 4.8).

Concomitant use of mTOR inhibitors (e.g. sirolimus, everolimus,

temsirolimus):

Patients taking concomitant mTOR inhibitors (e.g. sirolimus, everolimus,

temsirolimus), vildagliptin or racecadotril therapy may be at increased risk for

angioedema (e.g. swelling of the airways or tongue, with or without

respiratory impairment) (see section 4.5).

In case of angioedema, Ramipril must be discontinued.

Emergency therapy should be instituted promptly. Patient should be kept

under observation for at least 12 to 24 hours and discharged after complete

resolution of the symptoms. Intestinal angioedema has been reported in

patients treated with ACE inhibitors including Ramipril (see section 4.8).

These patients presented with abdominal pain (with or without nausea or

vomiting).

Anaphylactic reactions during desensitization

The likelihood and severity of anaphylactic and anaphylactoid reactions to

insect venom and other allergens are increased under ACE inhibition. A

temporary discontinuation of Ramipril should be considered prior to

desensitization.

Electrolyte Monitoring:

Hyperkalaemia

Hyperkalaemia has been observed in some patients treated with ACE

inhibitors including Ramipril. Patients at risk for development of

hyperkalaemia include those with renal insufficiency, age (> 70 years),

uncontrolled diabetes mellitus, hypoaldosteronism or those using potassium

salts, potassium retaining diuretics and other plasma potassium increasing

active substances (e.g. heparin, co-trimoxazole also known as

trimethoprim/sulfamethoxazole), or conditions such as dehydration, acute

cardiac decompensation, metabolic acidosis. If concomitant use of the above

mentioned agents is deemed appropriate, regular monitoring of serum

potassium is recommended (see section 4.5).

Electrolyte Monitoring: Hyponatraemia

Syndrome of Inappropriate Antidiuretic Hormone (SIADH) and subsequent

hyponatraemia has been observed in some patients treated with ramipril. It is

recommended that serum sodium levels be monitored regularly in the elderly

and in other patients at risk of hyponatraemia.

Neutropenia/agranulocytosis

Neutropenia/agranulocytosis, as well as thrombocytopenia and anaemia, have

been rarely seen and bone marrow depression has also been reported. It is

recommended to monitor the white blood cell count to permit detection of a

possible leucopoenia. More frequent monitoring is advised in the initial phase

of treatment and in patients with impaired renal function, those with

concomitant collagen disease (e.g. lupus erythematosus or scleroderma), and

all those treated with other medicinal products that can cause changes in the

blood picture (see sections 4.5 and 4.8).

Ethnic differences

ACE inhibitors cause higher rate of angioedema in black patients than in non

black patients. As with other ACE inhibitors, ramipril may be less effective in

lowering blood pressure in black people than in non black patients, possibly

because of a higher prevalence of hypertension with low renin level in the

black hypertensive population.

Cough

Cough has been reported with the use of ACE inhibitors. Characteristically,

the cough is nonproductive, persistent and resolves after discontinuation of

therapy. ACE inhibitor-induced cough should be considered as part of the

differential diagnosis of cough.

4.5

Interaction with other medicinal products and other forms of interaction

Clinical trial data has shown that dual blockade of the renin-angiotensin-

aldosterone-system (RAAS) through the combined use of ACE-inhibitors,

angiotensin II receptor blockers or aliskiren is associated with a higher

frequency of adverse events such as hypotension, hyperkalaemia and

decreased renal function (including acute renal failure) compared to the use

of a single RAAS-acting agent (see Sections 4.3, 4.4 and 5.1).

Contra-indicated combinations

Extracorporeal treatments leading to contact of blood with negatively charged

surfaces such as dialysis or haemofiltration with certain high-flux membranes

(e.g. polyacrylonitril membranes) and low density lipoprotein apheresis with

dextran sulphate due to increased risk of severe anaphylactoid reactions (see

section 4.3). If such treatment is required, consideration should be given to

using a different type of dialysis membrane or a different class of

antihypertensive agent.

Precautions for use

Potassium salts, heparin, potassium-retaining diuretics and other plasma

potassium increasing active substances (including Angiotensin II antagonists,

trimethoprim

and in fixed dose combination with sulfamethoxazole,

tacrolimus, ciclosporin): Hyperkalaemia may occur, therefore close

monitoring of serum potassium is required.

Co-trimoxazole (trimethoprim/sulfamethoxazole)

Patients taking concomitant co-trimoxazole (trimethoprim/sulfamethoxazole) may be

at increased risk for hyperkalaemia (see section 4.4).

Antihypertensive agents (e.g. diuretics) and other substances that may

decrease blood pressure (e.g. nitrates, tricyclic antidepressants, anaesthetics,

acute alcohol intake, baclofen, alfuzosin, doxazosin, prazosin, tamsulosin,

terazosin): Potentiation of the risk of hypotension is to be anticipated (see

section 4.2 for diuretics)

Vasopressor sympathomimetics and other substances (e.g. isoproterenol,

dobutamine, dopamine, epinephrine) that may reduce the antihypertensive

effect of Ramipril: Blood pressure monitoring is recommended.

Allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics

and other substances that may change the blood cell count: Increased

likelihood of haematological reactions (see section 4.4).

Lithium salts: Excretion of lithium may be reduced by ACE inhibitors and

therefore lithium toxicity may be increased. Lithium level must be monitored.

Antidiabetic agents including insulin: Hypoglycaemic reactions may occur.

Blood glucose monitoring is recommended.

Non-steroidal anti-inflammatory drugs and acetylsalicylic acid: Reduction of

the antihypertensive effect of Ramipril is to be anticipated. Furthermore,

concomitant treatment of ACE inhibitors and NSAIDs may lead to an

increased risk of worsening of renal function and to an increase in kalaemia.

mTOR inhibitors

(e.g. Temsirolimus, Everolimus and Sirolimus) or DPPIV

inhibitors (vildagliptin)

:

Patients taking concomitant mTOR inhibitors therapy or vildagliptin may be at

increased risk for angioedema (see section 4.4).

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