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NOYADA 25 MG/5 ML ORAL SOLUTION

Active substance(s): CAPTOPRIL

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Transcript
Instructions are provided below for using the dosing
syringe. If you have any questions about the dose
you should use or how to use the syringe, you should
ask your pharmacist.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Noyada® 25mg/5ml Oral Solution

Captopril

• Open the bottle: press the cap and
turn it anticlockwise (figure 1)

• Holding the bottle, take the
plastic syringe adaptor from the
box and insert the adaptor into
the bottle neck (figure 2).

1

2

Ensure it is well fixed.

• Take the syringe and put it in the
adaptor opening (figure 3).

3

• Turn the bottle upside down.

• Fill the syringe with a small amount of solution by
pulling the piston down (figure 4a), then push the
piston upward in order to remove any possible
bubble (figure 4b). Pull the piston down to the
graduation mark corresponding to the quantity in
milliliters (ml) prescribed by your doctor (figure 4C).

4a

4b

4c

• Turn the bottle the right way
up. Remove the syringe from
the adaptor (figure 5).

5

When you are taking Noyada Oral Solution, you
should not change to using any different captopril
containing medicines except under your doctor’s
supervision.
Elderly patients or patients with kidney disorders:
Your doctor may start you on a lower dose. If you
have a kidney disorder your doctor will increase
the dose gradually until your blood pressure is
adequately controlled up to a maximum of 150 mg
per day.
The dosage may then be adjusted by your doctor to
suit individual requirements.
For the treatment of high blood pressure:
The usual starting dose is 12.5 - 25 mg twice a day.
Your doctor may gradually increase this dose to 100
- 150mg a day. You may also need to be given other
medicines to lower your blood pressure.
If you have kidney or heart problems or low levels
of blood in your body you may be given a lower
starting dose of 6.25mg or 12.5mg which may be
gradually increased to 50mg -100mg a day.
For treatment in heart failure:
The usual starting dose is 6.25 – 12.5mg two or three
times a day. Your doctor may gradually increase this
dose to a maximum of 150mg a day.
After a heart attack - short term treatment:
The usual starting dose is 6.25mg, which will then be
gradually increased by your doctor to a maximum of
100mg a day.
After a heart attack - long term treatment:
The usual starting dose is 6.25mg, which will then be
gradually increased by your doctor to a maximum of
150mg a day.
Use in diabetic patients:
The usual dose is 75 - 100mg a day. Elderly patients
are usually started on a dose of 6.25mg twice daily.
Use in children:
Your doctor will prescribe the most appropriate
strength of Noyada Oral Solution according to the
child’s age, weight and dose.
Make sure that the correct amount is measured out.

Uncommon: May affect up to 1 in 100 people
• A fast or irregular heartbeat, or feeling your heart
beat (palpitations)
• Flushed or looking unusually pale
• Low blood pressure. You may feel dizzy or faint
• Painful, cold and discoloured fingers or toes caused
by lack of blood to the area (Raynaud’s syndrome)
• Fatigue
• A general feeling of being unwell
Rare: May affect up to 1 in 1,000 people
• Loss of appetite
• Drowsiness
• Headache
• Tingling, prickling or numbness of the skin
• Pain and swelling inside the mouth
• Mouth ulcers
• Changes to your kidney function
Your doctor will carry out tests to check this
• Changes in how often you pass urine
• Stomach cramps, abdominal pain, or pain that
moves from the stomach around to your back
Very Rare: May affect up to 1 in 10,000 people
• Bleeding gums or nosebleeds
• Swollen glands
• Changes in your blood. Your doctor will carry out
tests to check this
• Changes in the amount of potassium, sodium and
sugars in your blood. Your doctor will carry out
tests to check this
• Confusion
• Depression
• Fainting
• Blurred vision
• Blocked nose
• Chest tightness or a stabbing pain in your chest
• Changes to your liver function or liver damage.
Your doctor will carry out tests to check this
• Itching and yellowing of the skin
• Sensitivity to light
• Muscle or joint pain
• Difficulty achieving or maintaining an erection
• Swelling of breast tissue in men (gynaecomastia)
• Fever
• Heart attack or heart shock
Reporting of side effects
If you or your child gets 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.
Keep this medicine out of the sight and reach of
children.
Do not refrigerate. Store in the original package in
order to protect from light.
Do not use this medicine after the expiry date which
is stated on the carton and bottle label after EXP.
The expiry date refers to the last day of that month.

• Administer the contents
of the syringe into the
mouth by pushing the
piston to the bottom of
the syringe (figure 6) and
ensure the medicine is
swallowed.

6

Remove the adaptor from the bottle and close the
bottle with the plastic screw cap.

Do not store above 25°C. Use within 21 days of
opening.
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 to protect the environment.

6. Contents of the pack and other
information

Wash the adaptor and the syringe with warm
water. Dry them with a clean paper towel and
replace them into the box with your medicine.
If you take more Noyada Oral Solution than you
should
If you or any one else takes too much Noyada Oral
Solution you should go to your nearest hospital
emergency department or tell your doctor
immediately. Take the carton and bottle with any
remaining solution you have with you.
If you forget to take Noyada Oral Solution
If you miss a dose do not worry. Just carry on taking
your normal dose when the next one is due. Do
not take a double dose to make up for the one you
missed.
If you stop taking Noyada Oral Solution
You should not stop taking Noyada Oral Solution
until your doctor tells you to, even if you feel well.
If you feel you need to stop taking this medicine you
should discuss this with your doctor before you stop
taking it.

What Noyada Oral Solution contains
The active substance is captopril 25mg/5ml.
The other ingredients are disodium EDTA, sodium
benzoate (E211), citric acid (E330), sodium citrate
(E331) and purified water. May also contain sodium
hydroxide (E524) for pH adjustment.
What Noyada Oral Solution looks like and the
contents of the pack
Noyada 25mg/5ml Oral Solution is a clear, colourless
solution supplied in 100ml amber glass bottles. Each
pack contains one bottle of solution, a 5ml dosing
syringe, a syringe adaptor to fit onto the bottle when
measuring the dose and a 30ml dosing cup.
Marketing Authorisation Holder
and Manufacturer:
Martindale Pharamaceuticals Limited,
Bampton Road,
Harold Hill,
Romford,
Essex,
RM3 8UG,
United Kingdom

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

This leaflet was last revised in: March 2015

4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Serious side effects
If you (or your child) experience any of the
following reactions stop taking Noyada Oral
Solution and contact your doctor IMMEDIATELY:
• Swelling of the hands, face, lips or tongue
• Wheezing or difficulty in breathing
• Ulcers, blistering and skin rashes or burning, red,
peeling skin on the lips, tongue and genitals,
sometimes spreading to the eyes, face and body,
(a very rare illness known as Stevens-Johnson
syndrome)
• Sore throat or fever
• Severe dizziness or fainting
• Serious chest pains that travel down your left arm
• Fast, deep breathing, cold clammy skin and
feelings of anxiety
• Severe stomach pain
• Yellowing of the skin and/or eyes

Product licence number:
PL 00156/0362
MA 105/00902

4

5 mL

The starting dose is 0.3mg/kg body weight, divided
into 3 equal doses daily. This may be increased
gradually by the doctor.
For children with kidney problems, premature
babies and newborn babies and infants
The starting dose should be 0.15mg/kg body weight.
Make sure that the correct amount is measured out.
When to take Noyada Oral Solution
You should try to take Noyada Oral Solution at about
the same time every day. As food does not affect
how captopril is absorbed, it can be taken before,
during or after meals.
SHAKE WELL BEFORE USE.
Method of administration:
Your doctor, pharmacist or nurse will show you how
to administer this medicine. The box containing this
medicine will contain a 5ml dosing syringe, a dosing
adaptor and a 30ml dosing cup.

Common: May affect up to 1 in 10 people
• Fits are observed in infants
• Breathing problems in infant when asleep
• Changes in posture in infants
• Low urine amounts in premature infants
• Weight loss in premature infants
• Problems sleeping
• Changes in the way things taste
• Dizziness
• Dry, irritating cough
• Shortness of breath
• Feeling or being sick
• Indigestion or stomach pain
• Diarrhoea or constipation
• Dry mouth
• Itching or a red rash
• Hair loss

5. How to store Noyada Oral Solution

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

1.0 mL

5ml syringe (purple barrel) each numbered
increment is 1ml equivalent to 5mg Noyada Oral
Solution. The smaller increments are 0.2ml or 1mg of
the solution.
0.9

In addition to this some other medicines can also
affect the way Noyada Oral Solution works. It is
especially important to tell your doctor if you are
taking any of the following:
• Medicines used to treat asthma and colds
(sympathomimetics) such as ephedrine and
salbutamol
• Non steroidal anti-inflammatory (NSAIDs)
painkillers, such as indomethacin and ibuprofen
• Medicines that make you pass more urine
(diuretics) such as bendroflumethiazide and
chlortalidone.

Instructions for use:

3. How to take Noyada Oral Solution

3

If any of the above applies to you or your child you
should ask your doctor’s advice before taking this
medicine.
Warnings and precautions
You must tell your doctor if:
• you think you are (or might become) pregnant.
Noyada Oral Solution is not recommended in
pregnancy, and must not be taken if you are more
than 3 months pregnant, as it may cause serious
harm to your baby if used at that stage (see
pregnancy section)
• you are breast-feeding or about to start breastfeeding
• you are on a reduced-salt diet
• you are taking diuretic (water tablets)
• you have recently suffered from excessive vomiting
or diarrhoea
• you are undergoing dialysis
• you have heart problems in particular problems
with the valves of your heart
• you suffer from liver disease
• you have diabetes
• you get swelling in your face, neck or throat
• you get any changes in the colour of your skin or
the whites of your eyes, you must see your doctor
immediately
• you are going to have an operation in hospital or
you are going to the dentist
• you get stomach pains – you need to tell your
doctor you are taking Noyada Oral Solution
• you feel ill, become aware of your heartbeat
and get muscle weakness – you may have high
amounts of potassium in your blood, your doctor
will perform a blood test to check this.
Immunosuppressant therapy
If you are receiving immunosuppressant therapy
your doctor may carry out a number of tests during
your treatment with Noyada Oral Solution to make
sure that you are showing no signs of an infection. If
you begin to have symptoms of an infection such as
a sore throat or fever you should contact your doctor
immediately.
Patients with kidney disease
If you suffer from kidney disease your doctor may
carry out a number of tests both before and during
your treatment with Noyada Oral Solution to check
the levels of protein in your urine.
Wasp sting desensitisation
If you are to have desensitisation treatment for
wasp or bee stings you should tell the doctor who
is treating you that you are taking Noyada Oral
Solution. In rare cases a serious allergic reaction can
happen if you have desensitisation treatment whilst
taking this medicine.
Dialysis
If you are about to have treatment for the removal of
cholesterol from your blood by a machine (called LDL
apheresis) you should tell your doctor you are taking
Noyada Oral Solution. You may be given a different
type of dialysis whilst taking this medicine.
Blood and urine tests
Tell your doctor or nurse you are taking Noyada Oral
Solution before you have any blood or urine tests as
this medicine may interfere with the results of some
tests.
Ethnic differences
If you are Afro-Caribbean you may require higher
doses of Noyada Oral Solution to reduce your blood
pressure.
Taking other medicines and Noyada Oral Solution
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
This is because Noyada Oral Solution can affect the
way some other medicines work.

0.8

Do not take Noyada Oral Solution if:
• you are allergic (hypersensitive) to captopril,
any other ACE inhibitors, or any of the other
ingredients of this medicine (listed in section 6 of
this leaflet)
• you or any members of your family have ever had a
reaction which included swelling of the hands, lips,
face or tongue where the cause was unknown
• you are more than 3 months pregnant (it is better
to avoid Noyada Oral Solution in early pregnancy
(see Pregnancy section).

0.7

2 What you need to know before you
take Noyada Oral Solution

2

Captopril is used to treat the following in adults, the
elderly and children:
• High blood pressure and certain heart conditions.
If high blood pressure is left uncontrolled it
can increase the risk of heart disease or stroke.
Captopril works by lowering your blood pressure
which reduces this risk.
• People whose heart no longer pumps blood as
well as it once did. This condition is known as heart
failure.
• People who have recently suffered a heart attack.
A heart attack happens once one of the major
blood vessels supplying blood to the heart muscle
becomes blocked. This means that the heart does
not receive the oxygen it needs and the heart
muscle becomes damaged.
• Kidney disease in people with diabetes.

0.6

Noyada Oral Solution contains the active substance
captopril which belongs to the group of
medicines called Angiotensin Converting Enzyme
(ACE) Inhibitors. ACE inhibitors work by helping to
widen your blood vessels, which then make it easier
for your heart to pump blood through them.

0.5

1. What Noyada Oral Solution is and
what it is used for

0.4

1. What Noyada Oral Solution is and what it is used
for
2. What you need to know before you take Noyada
Oral Solution
3. How to take Noyada Oral Solution
4. Possible side effects
5. How to store Noyada Oral Solution
6. Contents of the pack and other information

1

What is in this leaflet

0.3

D02961

Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
• If you or your child get any side effects, talk to
your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet
(see section 4).

0.2

doctor, pharmacist or nurse.

• This medicine has been prescribed for you only.

• Nitrates, medicines used to treat chest pain
(angina) and heart problems such as glycerol
trinitrate and isosorbide dinitrate
• Procainamide, a medicine used to treat an irregular
heartbeat
• Aspirin (acetylsalicylic acid) and other medicines
used to thin the blood
• Any other medicines to treat high blood pressure
e.g. beta-blockers such as propanolol and atenolol,
or calcium channel blockers such as amlodipine
and nifedipine
• Potassium supplements, salt substitutes containing
potassium or any other medicines which can
increase potassium in your body, such as amiloride
and spironolactone
• Medicines used to treat diabetes (Insulins and
sulphonylurea). Your dose may have to be adjusted
while you are taking Noyada Oral Solution
• Lithium, a medicine used to treat a type of
depression known as bipolar disorder
• Medicines used for cancer treatment or in patients
who had a transplantation, (cytostatic agents/
immunosuppressant agents), such as fluorouracil
methotrexate, ciclosporin and azathioprine
• Medicines used to treat depression and other
mental health problems such as amitriptylline
and chlorpromazine. Taking these medicines with
Noyada Oral Solution may make you feel dizzy or
faint on standing up from a seated position.
• Allopurinol, a medicine used to treat gout
If you are due to have surgery
Before surgery and anaesthesia (even at the dentist)
you should tell your doctor or dentist that you are
taking Noyada Oral Solution as there may be a
sudden fall in your blood pressure.
Pregnancy, breast-feeding and fertility
Pregnancy
You must tell your doctor if you think you are (or
might become) pregnant. Your doctor will normally
advise you to stop taking Noyada Oral Solution
before you become pregnant or as soon as you
know you are pregnant and will advise you to take
another medicine instead of Noyada Oral Solution.
Noyada Oral Solution is not recommended in early
pregnancy, and must not be taken when more than
3 months pregnant, as it may cause serious harm to
your baby if used after the third month of pregnancy.
Breast-feeding
Tell your doctor if you are breast-feeding or about to
start breast-feeding. Breast-feeding newborn babies
(first few weeks after birth), especially premature
babies, is not recommended whilst taking Noyada
Oral Solution.
In the case of an older baby your doctor should
advise you on the benefits and risks of taking Noyada
Oral Solution whilst breast-feeding, compared with
other treatments.
Driving or using machines
Captopril can affect your ability to drive, usually
when you first start taking your medicine or if your
doctor changes your dose. If you do feel lightheaded or dizzy when taking Noyada Oral Solution,
you should not drive or use machinery.
Noyada Oral Solution contains Sodium
Noyada 25mg/5ml Oral Solution contains 10.68 mg
sodium per maximum daily dose. To be taken into
consideration by patients on a controlled sodium
diet.

0.1

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

Other side effects

30ml dosing cup. Each numbered increment is 5ml equivalent to 25mg Noyada Oral Solution.
Continued overleaf
D02961

100mm Measurement Verification Bar
2961-C

DEVELOPMENT ARTWORK
Component Code: D02961
Prod: Noyada 25mg/5ml
Oral solution
Trim size: 148.5 x 515 mm
Version Control Date

By

Version A Created 19/01/15 AC
Version B

26/03/15 AC

Version C

26/03/15 AC

Version D
Version E
Version F
Version G
Version H
Version I
Version J
Version K
Version L
Version M
Version N
Grand Fromage Creative Limited
1 Blighs Road, Sevenoaks,
Kent, TN13 1DA, UK
t: 01732749 749
e: alan@grand-fromage.co.uk
www.grand-fromage.co.uk

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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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