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TRITACE 5MG TABLETS

Active substance(s): RAMIPRIL

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5. How to store TRITACE
• Keep this medicine out of the sight and reach of
children.
• Do not use this medicine after the expiry date which
is stated on the carton and blister pack after EXP. The
expiry date refers to the last day of that month.
• This medicine does not require any special storage
conditions.
• Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

89031227
89030459

167 x 315mm DP

89031227. 4/4

02-11-2016
IST TRITACE GB I02

62C0007 V.1.0
1

4, 1 / 4
-

9,5 pt su 10 pt

TRITACE 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.

-

TRITACE 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.

1111000110

TRITACE contains a medicine called ramipril. This
belongs to a group of medicines called ACE inhibitors
(Angiotensin Converting Enzyme Inhibitors).

PACK. ITEM: Istruzioni

1. What TRITACE is and what
it is used for

Warnings and precautions
Talk to your doctor or pharmacist before taking
TRITACE:
SSIf you have heart, liver or kidney problems
SSIf 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)
SSIf you are going to have treatment to reduce your
allergy to bee or wasp stings (desensitization)
SSIf you are going to receive an anaesthetic. This
may be given for an operation or any dental work.
You may need to stop your TRITACE treatment one
day beforehand; ask your doctor for advice
SSIf you have high amounts of potassium in your
blood (shown in blood test results)
SSIf 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.
SSIf you are taking medicines called mTOR
inhibitors (e.g. temsirolimus, everolimus,
sirolimus) or vildagliptin or racecadotril as they
may increase the risk of angioedema, a serious
allergic reaction.
SSIf you have collagen vascular disease such as
scleroderma or systemic lupus erythematosus
SSYou must tell your doctor if you think that you
are (or might become) pregnant. TRITACE 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 below on
“Pregnancy and breast-feeding”).
SSIf 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 TRITACE”.

GB: GREAT BRITAIN

Manufacturer Sanofi S.p.A.
SS 17 Km 22, Scoppito (AQ), Italy

What is in this leaflet:
1. What TRITACE is and what it is used for
2. What you need to know before you take TRITACE
3. How to take TRITACE
4. Possible side effects
5. How to store TRITACE
6. Contents of the pack and other information

Sanofi S.p.A.

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder Sanofi, One Onslow
Street, Guildford, Surrey, GU1 4YS, UK
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com

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.

Verificare la corrispondenza dell’artwork
approvato - la nostra responsabilità è
limitata al rifacimento dei file forniti.

Your Titration Pack is available in packs containing a
total of 50 tablets.

Is this leaflet hard to see
or read?
Phone 0845 372 7101
for help

Arkhé S.n.c.

Your Tritace Tablets Titration Pack contains 3
different strengths of Tritace Tablets in 3 different
cartons.
• 10 x 2.5mg ramipril (yellowish to yellow oblong
tablets with a score-line. The upper face is marked
with 2.5 and a logo ( ) and the lower face is
marked with HMR and 2.5
• 30 x 5mg ramipril (pale red oblong tablets with a
score-line. The upper face is marked with 5 and
a logo ( ) and the lower face is marked with
HMP and 5
• 10 x 10mg ramipril (white to almost white
oblong tablets with a score-line. The upper face
is marked with HMO/HMO and the lower face is
unmarked

This leaflet was last revised in 10/2016
© Sanofi 2003 - 2016

Tel. 0862.404140
fax 0862.090006

All strengths are supplied in PVC/aluminium blisters
in packs of 28 tablets.

Ramipril

Do not take TRITACE:
±± 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, TRITACE 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 TRITACE if any of the above apply to you.
If you are not sure, talk to your doctor before taking
TRITACE.

89031227 1/4

What TRITACE looks like and contents of the pack
• Tritace® 1.25mg Tablets are white to almost white
oblong tablets with score-line. The upper face is
marked with 1.25 and a logo ( ) and the lower
face is marked with HMN and 1.25. The score line
is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
• Tritace® 2.5mg Tablets are yellowish to yellow
oblong tablets with a score-line. The upper face is
marked with 2.5 and a logo ( ) and the lower face
is marked with HMR and 2.5. The tablet can be
divided into equal halves.
• Tritace® 5mg Tablets are pale red oblong tablets
with a score-line. The upper face is marked with 5
and a logo ( ) and the lower face is marked with
HMP and 5. The tablet can be divided into equal
halves.
• Tritace® 10mg Tablets are white to almost white
oblong tablets with a score-line. The upper face
is marked with HMO/HMO and the lower face is
unmarked. The tablet can be divided into equal
halves.

Tritace® 1.25mg - 2.5mg
5mg - 10mg Tablets
Tritace® Tablets Titration Pack

2. What you need to know before you take
TRITACE

 Reflex Blue

What TRITACE contains
• The active substance is ramipril.
• The other ingredients are Hypromellose,
pregelatinised maize starch, microcrystalline
cellulose, sodium stearyl fumarate.
• The 2.5mg tablets also contain yellow ferric oxide
(E172).
• The 5mg tablets also contain red ferric oxide
(E172).

This leaflet does not contain all the information
about your medicine. If you have any questions
or are not sure about anything, ask your doctor or
pharmacist.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

1 - Prima realizzazione

6. Contents of the pack and other information

This medicinal product is authorised in the Member
States of the EEA under the following names:
Tritace 1.25 mg tablets, Tritace 2.5 mg tablets,
Tritace 5 mg tablets, Tritace 10 mg tablets,
Tritace Titration Pack tablets.

Children and adolescents
TRITACE is not recommended for use in children and
adolescents below 18 years of age because the safety
and efficacy of TRITACE 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 TRITACE.

89031227
89030459

89031227 2/4

02-11-2016
IST TRITACE GB I02

1
-

9,5 pt su 10 pt

Taking this medicine
Take this medicine by mouth at the same time of the
day each day.
Swallow the tablets/capsules whole with liquid.
Do not crush or chew the tablets/capsules.

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

167 x 315mm DP

Older people
Your doctor will reduce the initial dose and adjust
your treatment more slowly.

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 TRITACE 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.

62C0007 V.1.0

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.

Other side effects include:
Tell your doctor if any of the following gets serious or
lasts longer than a few days.

2, 3 / 4

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.

Other side effects reported:
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.

Sanofi S.p.A.

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.

Very rare (may affect up to 1 in 10,000 people)
• Being more sensitive to the sun than usual.

-

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.

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.

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 problems (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.

1111000110

How much to take
Treatment of high blood pressure
• The usual starting dose is 1.25 mg or 2.5 mg once
daily.
• Your doctor will adjust the amount you take until
your blood pressure is controlled.
• The maximum dose is 10 mg once daily.
• If you are already taking diuretics (water tablets),
your doctor may stop or reduce the amount of the
diuretic you take before beginning treatment with
TRITACE.

PACK. ITEM: Istruzioni

Always take this medicine exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.

Stop taking TRITACE 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 TRITACE
• 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).

GB: GREAT BRITAIN

3. How to take TRITACE

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

Verificare la corrispondenza dell’artwork
approvato - la nostra responsabilità è
limitata al rifacimento dei file forniti.

TRITACE with food and alcohol
• Drinking alcohol with TRITACE may make you feel
dizzy or light-headed. If you are concerned about
how much you can drink while you are taking
TRITACE, discuss this with your doctor as medicines
used to reduce blood pressure and alcohol can
have additive effects.
• TRITACE may be taken with or without food.

Driving and using machines
You may feel dizzy, while taking TRITACE. This is more
likely to happen when you start taking TRITACE or start
taking a higher dose. If this happens, do not drive or
use any tools or machines.

Arkhé S.n.c.

If any of the above apply to you (or you are not sure),
talk to your doctor before taking TRITACE.

4. Possible side effects

Tel. 0862.404140
fax 0862.090006

Tell your doctor if you are taking any of the following
medicines. They may be affected by TRITACE:
• Medicines for diabetes such as oral glucose lowering
medicines and insulin. TRITACE may lower your blood
sugar amounts. Check your blood sugar amounts
closely while taking TRITACE
• Lithium (for mental health problems). TRITACE may
increase the amount of lithium in your blood. Your
lithium amount will need to be closely checked by
your doctor.

If you have any further questions on the use of
this medicine, ask your doctor or pharmacist.

89031227 3/4

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 TRITACE:
• Medicines used to relieve pain and inflammation
(e.g. Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs) such as ibuprofen or indometacin and
aspirin)
• Medicines for cancer (chemotherapy)
• Medicines to stop the rejection of organs after a
transplant such as ciclosporin
• Diuretics (water tablets) such as furosemide
• Medicines which can increase the amount of
potassium in your blood such as spironolactone,
triamterene, amiloride, potassium salts,
trimethoprim alone or in combination with
sulfamethoxazole (for infections) and heparin (for
thinning blood)
• Steroid medicines for inflammation such as
prednisolone
• Allopurinol (used to lower the uric acid in your
blood)
• Procainamide (for heart rhythm problems)
• Temsirolimus (for cancer)
• Sirolimus, everolimus (for prevention of graft
rejection)
• 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 TRITACE” and “Warnings and precautions”).

If you forget to take TRITACE
• 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 tablet/capsule.

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.

 Reflex Blue

Tell your doctor if you are taking any of the following
medicines. They can make TRITACE 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.

Breast-feeding
You should not take TRITACE if you are breast-feeding.
Ask your doctor or pharmacist for advise before
taking any medicine.

If you take more TRITACE 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.

1 - Prima realizzazione

Other medicines and TRITACE
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
This is because TRITACE can affect the way some other
medicines work. Also some medicines can affect the
way TRITACE works.

Pregnancy and breast-feeding
Pregnancy
You must tell your doctor if you think that you are
(or might become) pregnant.
You should not take TRITACE 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 TRITACE, tell your doctor immediately. A switch to a
suitable alternative treatment should be carried out in
advance of a planned pregnancy.

Expand view ⇕

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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