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RAMIPRIL 2.5 MG TABLETS

Active substance(s): RAMIPRIL / RAMIPRIL / RAMIPRIL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
5. How to store Ramipril Tablets
!
Loss or decrease of appetite (anorexia).
!
Increased or irregular heartbeats, swollen arms and
Keep this medicine out of the sight and reach of children.
legs. This may be a sign of your body holding onto
Ramipril 1.25 mg Tablets
Do not store above 25°C. Store in the original packaging.
more water than usual.
Ramipril 2.5 mg Tablets
!
Flushing.
Do not use this medicine after the expiry date which is
!
Blurred vision.
Ramipril 5 mg Tablets
stated on the carton and the blister after EXP. The expiry
!
Pain in your joints.
Ramipril 10 mg Tablets
date refers to the last day of that month.
!
Fever.
!
Sexual inability in men, reduced sexual desire in
Ramipril
Do not throw away any medicines via wastewater or
men or women.
household waste. Ask your pharmacist how to throw
!
An increased number of certain white blood cells
throat, swelling of the throat and tongue, swelling
Read all of this leaflet carefully before you start
away medicines you no longer use. These measures will
(eosinophilia) found during a blood test.
around the eyes and lips, difficulty breathing and
taking this medicine because it contains important
help protect the environment.
!
Blood tests showing change in the way your liver,
swallowing.
information for you.
pancreas or kidneys are working.
If you are having dialysis or any other type of blood
!
Keep this leaflet. You may need to read it again.
!
6. Contents of the pack and other information
filtration. Depending on the machine that is used,
If you have any further questions, ask your doctor or
!
Rare (may affect up to 1 in 1,000 people)
Ramipril Tablets may not be suitable for you.
pharmacist.
What Ramipril Tablets contain
!
Feeling shaky or confused.
If you have kidney problems where the blood supply
!
This medicine has been prescribed for you only. Do
!
The active substance is ramipril.
!
!
Red and swollen tongue.
to your kidney is reduced (renal artery stenosis).
not pass it on to others. It may harm them even if
The other ingredients are: sodium hydrogen
!
!
Severe flaking or peeling of the skin, itchy, lumpy
During the last 6 months of pregnancy (see
!
their signs of illness are the same as yours.
carbonate, lactose monohydrate, croscarmellose
rash.
section below on “Pregnancy and breast-feeding”).
If you get any side effects, talk to your doctor or
!
sodium, pregelatinised starch and sodium stearyl
!
Nail problem (e.g. loosening or separation of a nail
If your blood pressure is abnormally low or unstable.
!
pharmacist. This includes any possible side effects
fumarate. The 2.5 mg and 5mg tablets also contain
from its bed).
Your doctor will need to make this assessment.
not listed in this leaflet. See section 4.
yellow iron oxide and the 5 mg tablets also contain
!
Skin rash or bruising.
If you have diabetes or impaired kidney function and
!
red iron oxide.
!
Blotches on your skin and cold extremities.
you are treated with a blood pressure lowering
What is in this leaflet
!
Red, itchy, swollen or watery eyes.
medicine containing aliskiren.
1. What Ramipril Tablets are and what they are used
What Ramipril Tablets look like and contents of the
!
Disturbed hearing and ringing in your ears.
for
pack
!
Feeling weak.
Do not take Ramipril Tablets if any of the above apply to
2. What you need to know before you take Ramipril
Ramipril 1.25 mg Tablets: white to off white, oval shaped,
!
Blood tests showing a decrease in the number of red
you. If you are not sure, talk to your doctor before taking
Tablets
flat tablets.
blood cells, white blood cells or platelets or in the
Ramipril Tablets.
3. How to take Ramipril Tablets
Ramipril 2.5 mg Tablets: yellow, oval shaped flat tablets
amount of haemoglobin.
4. Possible side effects
scored on one side and side walls. Marked R2.
Warnings and precautions
5. How to store Ramipril Tablets
Ramipril 5 mg Tablets: pink oval shaped, flat tablets,
Very rare (may affect up to 1 in 10,000 people)
Talk to your doctor, pharmacist or nurse before taking
6. Contents of the pack and other information
scored on one side and side walls. Marked R3.
!
Being more sensitive to the sun than usual.
Ramipril Tablets:
Ramipril 10 mg Tablets: white to off white, oval shaped,
If you have heart, liver or kidney problems.
!
1. What Ramipril Tablets are and what they are
flat tablets scored on one side and side walls. Marked
Other side effects reported:
If you have lost a lot of body salts or fluids (through
!
used for
R4.
Please tell your doctor if any of the following gets serious
being sick (vomiting), having diarrhoea, sweating
or lasts longer than a few days.
more than usual, being on a low salt diet, taking
Ramipril Tablets contain a medicine called ramipril. This
Pack sizes:
!
Difficulty concentrating.
diuretics (water tablets) for a long time or having had
belongs to a group of medicines called ACE inhibitors
The tablets are supplied in blister packs of 7, 14, 21, 28,
!
Swollen mouth.
dialysis).
(Angiotensin Converting Enzyme Inhibitors).
30, 50 and 100. Not all pack sizes may be marketed.
!
Blood tests showing too few blood cells in your
If you are going to have treatment to reduce your
!
blood.
allergy to bee or wasp stings (desensitization).
Ramipril Tablets work by:
Marketing Authorisation Holder
!
Blood tests showing less sodium than usual in your
If you are going to receive an anaesthetic. This may
!
Decreasing your body's production of substances
!
Morningside Healthcare Ltd
blood.
be given for an operation or any dental work. You
that could raise your blood pressure.
115 Narborough Road
!
Concentrated urine (dark in colour), feel or are sick,
may need to stop your Ramipril Tablets treatment
Making your blood vessels relax and widen.
!
Leicester
have muscle cramps, confusion and fits which may
one day beforehand; ask your doctor for advice.
Making it easier for your heart to pump blood around
!
LE3 0PA
be due to inappropriate ADH (anti-diuretic hormone)
If you have high amounts of potassium in your blood
!
your body.
UK
secretion. If you have these symptoms contact your
(shown in blood test results).
doctor as soon as possible.
If you have collagen vascular disease such as
!
Ramipril Tablets can be used:
Manufacturer
!
Fingers and toes changing colour when you are cold
scleroderma or systemic lupus erythematosus.
!
To treat high blood pressure (hypertension).
Actavis Limited
and then tingling or feeling painful when you warm
You must tell your doctor if you think that you are (or
!
!
To reduce the risk of you having a heart attack or
Reykjavikurvegur
up (Raynaud's phenomenon).
might become) pregnant. Ramipril Tablets are not
stroke.
78 IS-220
!
Breast enlargement in men.
recommended in the first 3 months of pregnancy
!
To reduce the risk or delay the worsening of kidney
Hafnarfjordur Iceland.
!
Slowed or impaired reactions.
and may cause serious harm to your baby after 3
problems (whether or not you have diabetes).
!
Burning sensation.
months of pregnancy (see section “Pregnancy and
!
To treat your heart when it cannot pump enough
This leaflet was last revised in July 2017.
!
Change in the way things smell.
breast-feeding”).
blood to the rest of your body (heart failure).
!
Hair loss.
If you are taking medicines or have conditions which
!
!
As treatment following heart attack (myocardial
This leaflet does not contain all the information about
may decrease sodium levels in your blood. Your
infarction) complicated with heart failure.
your medicine. If you have any questions or are not sure
Reporting of side effects
doctor may carry out regular blood tests, particularly
about anything, ask your doctor or pharmacist.
If you get any side effects, talk to your doctor or
for checking the levels of sodium in your blood
2. What you need to know before you take
pharmacist. This includes any possible side effects not
especially if you are elderly.
Ramipril Tablets
listed in this leaflet. You can also report side effects
!
If you are taking medicines called mTOR inhibitors
directly via the Yellow Card Scheme at:
(e.g. temsirolimus, everolimus, sirolimus) or
Do not take Ramipril Tablets
www.mhra.gov.uk/yellowcard.
vildagliptin or racecadotril as they may increase the
!
If you are allergic to ramipril, any other ACE inhibitor
By reporting side effects you can help provide more
risk of angioedema, a serious allergic reaction.
medicine or any of the ingredients of this medicine
information on the safety of this medicine.
!
If you are taking any of the following medicines used
listed in section 6. Signs of an allergic reaction may

to treat high blood pressure:
include a rash, swallowing or breathing problems,
 An angiotensin II receptor blocker (ARBs) (also
swelling of your lips, face, throat or tongue.
known as sartans - for example valsartan,
!
If you have ever had a serious allergic reaction
telmisartan, irbesartan), in particular if you have
called “angioedema”. The signs include itching,
diabetes-related kidney problems.
hives (urticaria), red marks on the hands, feet and
 Aliskiren.

Your doctor may check your kidney function, blood
pressure, and the amount of electrolytes (e.g.
potassium) in your blood at regular intervals.

Your doctor may need to change your dose and/or to
rashes. This could be a sign of a severe allergic
!
Your doctor will adjust the amount you take until your
take other precautions:
reaction to Ramipril Tablets.
blood pressure is controlled.
If you are taking an angiotensin II receptor blocker
!
Severe skin reactions including rash, ulcers in your
!
!
The maximum dose is 10 mg once daily.
(ARB) or aliskiren (see also information under the
mouth, worsening of a pre-existing skin disease,
!
If you are already taking diuretics (water tablets),
See also information under the heading “Do not take
headings “Do not take Ramipril Tablets” and
reddening, blistering or detachment of skin (such as
your doctor may stop or reduce the amount of the
Ramipril Tablets”.
“Warnings and precautions”).
Stevens-Johnson syndrome, toxic epidermal
diuretic you take before beginning treatment with
necrolysis or erythema multiform).
Ramipril Tablets.
Children and adolescents
Tell your doctor if you are taking any of the following
Ramipril Tablets are not recommended for use in
medicines. They may be affected by Ramipril Tablets:
Tell your doctor immediately if you experience:
To reduce the risk of you having a heart attack or stroke
children and adolescents below 18 years of age because
Medicines for diabetes such as oral glucose
!
Faster heart rate, uneven or forceful heartbeat
!
!
The usual starting dose is 2.5 mg once daily.
the safety and efficacy of Ramipril Tablets in children has
lowering medicines and insulin. Ramipril Tablets
(palpitations), chest pain, tightness in your chest or
!
Your doctor may then decide to increase the amount
not yet been established.
may lower your blood sugar amounts. Check your
more serious problems including heart attack and
you take.
blood sugar amounts closely while taking Ramipril
stroke.
!
The usual dose is 10 mg once daily.
If any of the above apply to you (or you are not sure), talk
Tablets.
Shortness of breath or a cough. These could be
!
to your doctor before taking Ramipril Tablets.
Lithium (for mental health problems). Ramipril
!
signs of lung problems.
Treatment to reduce or delay the worsening of kidney
Tablets may increase the amount of lithium in your
Bruising more easily, bleeding for longer than
!
problems
blood. Your lithium amount will need to be closely
Other medicines and Ramipril Tablets
normal, any sign of bleeding (e.g. bleeding from the
!
You may be started on a dose of 1.25 mg or 2.5 mg
checked by your doctor.
Tell your doctor or pharmacist if you are taking, have
gums), purple spots blotching on the skin or getting
once daily.
If any of the above apply to you (or you are not sure), talk
recently taken or might take any other medicines,
infections more easily than usual, sore throat and
!
Your doctor will adjust the amount you are taking.
to your doctor before taking Ramipril Tablets.
including medicines obtained without a prescription
fever, feeling tired, faint, dizzy or having pale skin.
!
The usual dose is 5 mg or 10 mg once daily.
(including herbal medicines). This is because Ramipril
These can be signs of blood or bone marrow
Tablets can affect the way some other medicines work.
Taking Ramipril Tablets with food and alcohol
problems.
Treatment of heart failure
Also some medicines can affect the way Ramipril Tablets
Drinking alcohol with Ramipril Tablets may make
!
Severe stomach pain which may reach through to
!
!
The usual starting dose is 1.25 mg once daily.
work.
you feel dizzy or light-headed. If you are concerned
your back. This could be a sign of pancreatitis
!
Your doctor will adjust the amount you take.
about how much you can drink while you are taking
(inflammation of the pancreas).
!
The maximum dose is 10 mg daily. Two
Tell your doctor if you are taking any of the following
Ramipril Tablets, discuss this with your doctor as
Fever, chills, tiredness, loss of appetite, stomach
!
administrations per day are preferable.
medicines. They can make Ramipril Tablets work less
medicines used to reduce blood pressure and
pain, feeling sick, yellowing of your skin or eyes
well:
alcohol can have additive effects.
(jaundice). These can be signs of liver problems
Treatment after you have had a heart attack
Medicines used to relieve pain and inflammation
!
Ramipril Tablets may be taken with or without food.
!
such as hepatitis (inflammation of the liver) or liver
!
The usual starting dose is 1.25 mg once daily to 2.5
(e.g. Non-Steroidal Anti-Inflammatory Drugs
damage.
mg twice daily.
(NSAIDs) such as ibuprofen or indometacin and
Pregnancy and breast-feeding
!
Your doctor will adjust the amount you take.
aspirin).
Pregnancy
Other side effects include:
!
The usual dose is 10 mg daily. Two administrations
Medicines used for the treatment of low blood
!
You must tell your doctor if you think that you are (or
Tell your doctor if any of the following gets serious or
per day are preferable.
pressure, shock, cardiac failure, asthma or allergies
might become) pregnant.
lasts longer than a few days.
such as ephedrine, noradrenaline or adrenaline.
You should not take Ramipril Tablets in the first 12 weeks
Older people
Your doctor will need to check your blood pressure.
of pregnancy, and you must not take them at all after the
Common (may affect up to 1 in 10 people)
Your doctor will reduce the initial dose and adjust your
13th week as their use during pregnancy may possibly
Headache or feeling tired.
!
treatment more slowly.
Tell your doctor if you are taking any of the following
be harmful to the baby.
Feeling dizzy. This is more likely to happen when
!
medicines. They can increase the chance of getting side
If you become pregnant while on Ramipril Tablets, tell
you start taking Ramipril Tablets or start taking a
Taking this medicine
effects if you take them with Ramipril Tablets:
your doctor immediately. A switch to a suitable
higher dose.
!
Take this medicine by mouth at the same time of the
Medicines used to relieve pain and inflammation
!
alternative treatment should be carried out in advance of
Fainting, hypotension (abnormally low blood
!
day each day.
(e.g. Non-Steroidal Anti-Inflammatory Drugs
a planned pregnancy.
pressure), especially when you stand or sit up
!
Swallow the tablets whole with liquid.
(NSAIDs) such as ibuprofen or indometacin and
quickly.
!
Do not crush or chew the tablets.
aspirin).
Breast-feeding
Dry tickly cough, inflammation of your sinuses
!
Medicines for cancer (chemotherapy).
!
You should not take Ramipril Tablets if you are breast(sinusitis) or bronchitis, shortness of breath.
If you take more Ramipril Tablets than you should
Medicines to stop the rejection of organs after a
!
feeding.
Stomach or gut pain, diarrhoea, indigestion, feeling
!
Tell a doctor or go to the nearest hospital casualty
transplant such as ciclosporin.
Ask your doctor or pharmacist for advice before taking
or being sick.
department straight away. Do not drive to the hospital,
Diuretics (water tablets) such as furosemide.
!
any medicine.
Skin rash with or without raised area.
!
get somebody else to take you or call for an ambulance.
Medicines which can increase the amount of
!
Chest pain.
!
Take the medicine pack with you. This is so the doctor
potassium in your blood such as spironolactone,
Driving and using machines
Cramps or pain in your muscles.
!
knows what you have taken.
triamterene, amiloride, trimethoprim alone or in
You may feel dizzy while taking Ramipril Tablets. This is
Blood tests showing more potassium than usual in
!
combination with sulfamethoxazole, also known as
more likely to happen when you start taking Ramipril
your blood.
If you forget to take Ramipril Tablets
co-trimoxazole (for infections), potassium salts and
Tablets or start taking a higher dose. If this happens, do
!
If you miss a dose, take your normal dose when it is
heparin (for thinning blood).
not drive or use any tools or machines.
Uncommon (may affect up to 1 in 100 people)
next due.
an mTOR inhibitor (e.g., temsirolimus, sirolimus,
!
Balance problems (vertigo).
!
!
Do not take a double dose to make up for a forgotten
everolimus; medicines used to treat certain types of
Ramipril Tablets contain lactose
Itching and unusual skin sensations such as
!
tablet.
cancer or to prevent the body's immune system from
If you have been told by your doctor that you have an
numbness, tingling, pricking, burning or creeping on
rejecting a transplanted organ). See also
intolerance to some sugars contact your doctor before
your skin (paraesthesia).
If you have any further questions on the use of this
information under the heading “Warnings and
taking this medicinal product.
Loss or change in the way things taste.
!
medicine, ask your doctor or pharmacist.
precautions”.
Sleep problems.
!
Steroid medicines for inflammation such as
!
3. How to take Ramipril Tablets
Feeling depressed, anxious, more nervous than
!
4. Possible side effects
prednisolone.
usual or restless.
Allopurinol (used to lower the uric acid in your
!
Blocked nose, difficulty breathing or worsening of
!
Always take this medicine exactly as your doctor has told
Like all medicines, this medicine can cause side effects,
blood).
asthma.
you. You should check with your doctor or pharmacist if
although not everybody gets them.
Procainamide (for heart rhythm problems).
!
A swelling in your gut called “intestinal angioedema”
!
you are not sure.
Stop taking Ramipril Tablets and see a doctor
Temsirolimus (for cancer).
!
presenting with symptoms like abdominal pain,
straight away, if you notice any of the following
Sirolimus, everolimus (for prevention of graft
!
vomiting and diarrhoea.
How much to take
serious side effects - you may need urgent medical
rejection).
Heartburn, constipation or dry mouth.
!
Treatment of high blood pressure
treatment:
Vildagliptin (used for treating type 2 diabetes).
!
Passing more water (urine) than usual over the day.
!
!
The usual starting dose is 1.25 mg or 2.5 mg once
!
Swelling of the face, lips or throat which makes it
Sweating more than usual.
!
daily.
difficult to swallow or breathe, as well as itching and

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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