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TRITACE 2.5MG TABLETS

Active substance: RAMIPRIL

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5. How to store Tritace
• Keep out of the reach and sight of children.
• Do not use Tritace after the expiry date which is stated
on the carton and blister pack. The expiry date refers to
the last day of that month.
• This medicinal product does not require any special
storage conditions.
• Medicines should not be disposed of via waste water or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.

25-02-2015
IST TRITACE GB I02

Istruzione

89028818

62C0006

89026138

167 x 304,8 DP

89028818 4/4

PACK. ITEM:
1011010000
4

4, 1 / 4
-

9pt su 10pt

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.

Sanofi S.p.A.

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.

GB: GREAT BRITAIN

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

 Reflex Blue

1. What Tritace is and what
it is used for

Take special care with Tritace
Check with your doctor or pharmacist before taking your
medicine:
SS If you have heart, liver or kidney problems
SS 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)
SS If you are going to have treatment to reduce your
allergy to bee or wasp stings (desensitization)
SS 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 Tritace treatment one day
beforehand; ask your doctor for advice
SS If you have high amounts of potassium in your
blood (shown in blood test results)
SS 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.
SS If you have collagen vascular disease such as
scleroderma or systemic lupus erythematosus.
SS You 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”).
SS 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 TRITACE”.

Verificare la corrispondenza delle pellicole
con l’artwork approvato - la nostra
responsabilità è limitata al rifacimento
delle eventuali pellicole errate.

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

In this leaflet:
1. What Tritace is and what it is used for
2. Before you take Tritace
3. How to take Tritace
4. Possible side effects
5. How to store Tritace
6. Further information

Arkhé S.n.c.

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.
• 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. Do not
pass it on to others. It may harm them even if their
symptoms are the same as yours.
• If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

Tel. 0862.404140
fax 0862.404140

Your Titration Pack is available in packs containing a
total of 35 tablets.

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

4 - Modifica testo reg.

Your Tritace Tablets Titration Pack contains 3 different
strengths of Tritace Tablets in 3 different cartons.
• 7 x 2.5mg ramipril (yellowish to yellow white
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
• 21 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
• 7 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 11/2014
© Sanofi 2003 - 2014

3 - Modifica testo reg.

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

Ramipril

Do not take Tritace:
±± If you are allergic (hypersensitive) to ramipril, any
other ACE inhibitor medicine or any of the other
ingredients of Tritace 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 kidneys 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.

89028818 1/4

What Tritace Tablets look 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. Before you take Tritace

2 - ripristino disegno tec. 62C0006

What Tritace Tablets contain.
• 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. Further 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
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.

25-02-2015
IST TRITACE GB I02

Istruzione

89028818

62C0006

89026138

89028818 2/4

PACK. ITEM:
4
-

9pt su 10pt

If you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

167 x 304,8 DP

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

1011010000

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.

Common (affects less than 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

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
• 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.

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 include:
Please tell your doctor if any of the following gets serious
or lasts longer than a few days.

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

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.

Rare (affects less than 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 or 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.

Verificare la corrispondenza delle pellicole
con l’artwork approvato - la nostra
responsabilità è limitata al rifacimento
delle eventuali pellicole errate.

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.

Arkhé S.n.c.

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.

GB: GREAT BRITAIN

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.

 Reflex Blue

Always take Tritace 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).

Tel. 0862.404140
fax 0862.404140

Taking 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.

3. How to take Tritace

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

4 - Modifica testo reg.

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

4. Possible side effects
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.

3 - Modifica testo reg.

Please 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 product, ask your doctor or pharmacist.

Uncommon (affects less than 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 heart beats
• 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.
89028818 3/4

Please tell your doctor if you are taking any of the
following medicines. They can increase the chance of
getting side effects if you take them with 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 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)
• 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 “Take special care with Tritace”).

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.

• Blood tests showing more potassium than usual in
your blood.

2 - ripristino disegno tec. 62C0006

Please 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

Taking Tritace with other medicines
Please 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 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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