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COPRALINEB 0.5 MG/2.5 MG PER 2.5 ML NEBULISER SOLUTION
Active substance(s): IPRATROPIUM BROMIDE / SALBUTAMOL SULPHATE / IPRATROPIUM BROMIDE / SALBUTAMOL SULPHATE / IPRATROPIUM BROMIDE / SALBUTAMOL SULPHATE
Copralineb 0.5 mg/2.5 mg per 2.5 ml
Ipratropium bromide and salbutamol
Read all of this leaflet carefully before you start using 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, pharmacist or nurse.
• 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
What is in this leaflet:
1. What Copralineb is and what it is used for
2. What you need to know before you use Copralineb
3. How to use Copralineb
4. Possible side effects
5. How to store Copralineb
6. Contents of the pack and other information
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
What Copralineb is and what it is used for
If you are going to have a general anaesthetic in hospital, please
tell the anaesthetist what drugs you are taking.
Copralineb with food and drink
Food and drink have no influence on Copralineb.
Your medicine is called Copralineb. The active ingredients are
ipratropium bromide and salbutamol. Ipratropium bromide and
salbutamol both belong to a group of medicines called
bronchodilators, which help to improve your breathing by opening
up your airways. This is achieved by preventing the contraction of
the smooth muscles surrounding the airways, therefore allowing
the airways to remain open. Ipratropium bromide acts by blocking
the nerve signals that go to the muscles surrounding the airways,
and salbutamol acts by stimulating the beta2 receptors in the
Pregnancy and breast-feeding
Tell your doctor or pharmacist if you are pregnant, think you might
be pregnant, are planning to become pregnant or are breast-feeding.
Copralineb should not be used during pregnancy or breast
feeding unless your doctor decides that the benefits to the mother
outweigh the risk to the baby.
Ask your doctor for advice before taking any medicine.
Copralineb is used to treat breathing problems in people with
long-standing breathing difficulties (such as chronic bronchitis,
Copralineb will relieve wheezing, shortness of breath and chest
Driving and using machines
If you experience side effects such as dizziness, difficulty focusing
and blurred vision during treatment with Copralineb you should
avoid potentially hazardous tasks such as driving or operating
What you need to know before you use
Do not use Copralineb if:
• you suffer from fast heart rhythms.
• you know that you have an enlarged heart or a condition known
as hypertrophic obstructive cardiomyopathy or HOCM.
• you are allergic to salbutamol, ipratropium bromide or atropine
(including drugs similar to atropine) or to any of the other
ingredients of this medicine (listed in section 6).
How to use Copralineb
Copralineb is for inhalation use. The nebuliser solution is for oral
inhalation after nebulisation.
Always use this medicine exactly as your doctor has told you to.
Check with your doctor (or the nurse if appropriate) if you are not
Warnings and precautions
Talk to your doctor before using Copralineb if:
• you suffer from or think you may suffer from an eye condition
known as glaucoma (increased pressure in the eyes) or if you
suffer from any other eye conditions Your doctor may advise
you to protect your eyes when using Copralineb.
• you know that you (if male) have an enlarged prostate or if you
have problems passing urine (water).
• you have had a recent heart attack (myocardial infarction).
• you have problems with your arteries or get pain in your legs
when you walk.
• you have a history of heart disease, irregular heart rhythm or
angina (please tell your doctor before starting this medication).
• you have diabetes.
• you have an overactive thyroid gland.
• you suffer from cystic fibrosis.
• you have been told that you have a tumour of the adrenal gland.
The recommended dose for adults and children over 12 years of
age is the contents of one ampoule, three or four times a day.
Elderly patients should take the usual adult dose.
Copralineb is not recommended for children under 12 years of age.
The label will tell you how much to take and how often to take it.
Never use more medicine than your doctor has told you to.
Tell your doctor if your breathing problems get worse or your
medicine does not provide as much relief from your breathing
problems as before or if you are using your blue short-acting
“reliever” inhaler more often than is usual for you.
Copralineb should be used with a suitable nebuliser, e.g. PARI LC
PLUS Nebuliser, jet nebulizer. Please read the full instructions for
use of the nebuliser in the leaflet provided with PARI LC PLUS
before starting the inhalation.
Copralineb can cause tooth decay. Please pay attention to proper
oral hygiene, particularly in children, and get your teeth checked
regularly by your dentist.
Instructions for use
• Prepare your nebuliser for use according to the manufacturer’s
instructions and advice from your doctor.
• Carefully remove an ampoule from the labelled strip by twisting
and pulling. Never use an ampoule that has been opened
already or if the nebuliser solution is discoloured (diagram A).
• Hold the ampoule upright and twist off the cap (diagram B).
• Squeeze the contents into the reservoir of your nebuliser
Other medicines and Copralineb
Certain medicines may interact with Copralineb and may worsen
side effects or reduce the effect of Copralineb.
You must always tell your doctor if you are taking any of the
• other asthma medicines, including inhalers and tablets for asthma
and including treatments known as “relievers” such as
salbutamol and “preventers” such as beclometasone dipropionate.
These may increase the effect of Copralineb and increase the
severity of side effects.
• beta-blockers i.e. medicines that are commonly used to treat
heart conditions such as chest pain that occurs on exertion
(called angina pectoris), irregular heart beats or arrhythmias
and high blood pressure (called hypertension).
They include drugs such as propranolol, which may cause
blood potassium levels to fall when given at the same time as
• certain drugs to treat depression (such “anti-depressants” are
drugs that are prescribed for patients suffering from depression
and anxiety). This class of drug includes medicines such as
monoamine oxidase inhibitors (e.g. phenelzine) or tricyclic
antidepressants (e.g. amitriptyline).
• digoxin (for heart problems) may cause heart rhythm problems
when given with Copralineb.
• diuretics (“water tablets”) can potentiate urinary blockade.
• steroid tablets (these are medicines that are used to reduce
inflammatory processes within the body and include drugs such
as prednisolone), which may increase the airway blockade.
• anaesthetic agents may increase the susceptibility of the effects
of salbutamol on the heart - you will be monitored closely or
your doctor might decide to discontinue Copralineb if you are
going to have an operation.
Continued on the next page >>
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• Follow the manufacturer’s instructions and the advice from your
doctor on how to assemble and how to use your nebuliser.
• After you have used your nebuliser, throw away any nebuliser
solution that is left in the reservoir. Any nebuliser solution left in
the ampoule should also be thrown away.
• Clean your nebuliser thoroughly according to the manufacturer’s
instructions. It is important that the nebuliser is kept clean.
Frequency not known but may also occur
• tooth decay.
Do not dilute the nebuliser solution or mix it with other medicines,
unless your doctor tells you to.
The single dose ampoules of Copralineb do not contain
preservatives and therefore it is important to use the contents
immediately after opening. A new ampoule must be used each
time you use Copralineb in your nebuliser.
Although it is not known exactly how often this happens, some
people might experience chest pain (due to problems such as
angina). Tell your doctor as soon as possible if you develop these
symptoms whilst receiving treatment with Copralineb, but do not
stop using this medicine unless told to do so.
Partly used, opened or damaged ampoules should be discarded.
You should never use an ampoule, which has been opened earlier.
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 the 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.
It is important that you follow these instructions in order to avoid
any contamination of the nebuliser solution within the ampoules.
Do not swallow the nebuliser solution or use it in injections.
Do not allow the nebuliser solution or mist to enter your eyes.
If you use more Copralineb than you should
If you have taken a slightly larger dose than usual, you may notice
a faster heart beat (palpitations) or tremor. Other symptoms might
include chest pain, changes in blood pressure, flushing,
restlessness or dizziness. These effects usually wear off in a few
hours. The level of potassium in your blood may fall and the
doctor may want to monitor the potassium in your blood by taking
a blood test to measure the levels from time to time. Tell your doctor
if you are worried by any of these symptoms or if they persist.
How to store Copralineb
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 label after EXP. The expiry date refers to the last
day of that month.
If you have taken more medicine than you should have taken, tell
your doctor immediately or go to the nearest hospital. If you need
to visit a doctor or need to go into hospital then you should take all
of your medicines with you, including any you may have bought
without a prescription; these should be in their original packaging
if at all possible. Take this leaflet with you to show the doctor.
Do not refrigerate or freeze. Do not store above 25°C.
Keep the nebuliser solution in the outer pouch or carton in order
to protect from light.
After first opening the pouch, the closed ampoule should be used
within 3 months.
If you forget to use Copralineb
If you forget to take a dose at the right time, take it as soon as you
remember. Do not take a double dose to make up for a forgotten
For single use only. Use immediately after first opening the ampoule.
Discard immediately after first use.
Partly used, opened or damaged ampoules should be disposed in
accordance with local requirements.
If you stop using Copralineb
You should not stop taking Copralineb without prior discussion
with your doctor.
Do not use this medicine if you notice the nebuliser solution is
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
hyperactivity in children
eye pain or other problems with the eyes including blurring of
vision, mydriasis (the excessive dilation of the pupil of the eye)
and glaucoma (increased pressure in the eyes).
Do no 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.
Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them. Some of the side-effects may be
serious and require medical intervention.
Contents of the pack and other
What Copralineb contains
Each 2.5 ml Copralineb contains:
• The active substances are 0.5 mg of ipratropium bromide as
525 micrograms ipratropium bromide monohydrate and
salbutamol 2.5 mg as sulphate.
• The other ingredients are sodium chloride, water for injection
and sulfuric acid.
Serious side effects
If your asthma or wheezing gets worse immediately after inhaling
Copralineb, or your breathing becomes more difficult and you
become short of breath do not take any more Copralineb but use
your short-acting ‘reliever’ inhaler straightaway. You should stop
using Copralineb and should contact your doctor immediately.
Your doctor may prescribe alternative treatment for your condition.
What Copralineb looks like and contents of the pack
The pack is a Plastic Form fill Seal (FFS) ampoule containing
2.5 ml of nebuliser solution, 5 of which are over wrapped in a
triple laminated pouch and then packed into cardboard cartons
containing 10, 20, 30, 40, 50, 60, 80, 100, 120 and 150 ampoules.
If you experience eye pain or eye discomfort, blurred vision or red
eyes, or if you see halos or coloured spots then you should
contact your doctor straightaway as treatment for these symptoms
may be required.
Not all pack sizes may be marketed.
If you think that you may be allergic to Copralineb or if you think
you may be having an allergic reaction to the nebuliser solution
then you should stop using Copralineb straightaway and contact
your doctor immediately.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
A reduction in the level of potassium (hypokalaemia) in the blood
due to the salbutamol component of Copralineb can occur - and
this may cause muscle weakness, twitching or abnormal heart
rhythm. This is more likely to happen if you are taking Copralineb
with some other asthma treatments, with inhaled steroids or
steroid tablets or with diuretics (“water tablets”). Your doctor may
need to take a blood test to measure your potassium levels from
time to time.
Lek Pharmaceuticals d.d,
Verovškova 57, 1526 Ljubljana,
Side effects can occur with the following frequencies:
Common, affects 1 to 10 per 100 users
• palpitations or rapid heartbeat
• dryness of the mouth
• nausea (feeling sick)
• speech difficulties
• problems with blurred vision.
Salutas Pharma GmbH,
39179 Barleben, Germany
This leaflet was last revised in 06/2017
Uncommon, affects 1 to 10 per 1,000 users
• increased blood pressure
• abnormal or very fast heartbeat
• a feeling of nervousness
• vomiting (being sick)
• difficulty in passing urine (water).
Rare, affects 1 to 10 per 10,000 users
• anaphylactic (allergic) reactions including swelling, which may
affect the tongue, lips and face
• breathing difficulties and shortness of breath
• reduced blood pressure
• mouth and throat irritation
• upset stomach / upset bowels
• muscular pains
• weakness and cramps
Artwork Proof Box
laetus code: 000
Ref: V006: TW corrective action, Safety update SPC & PIL + RFI + V010 + PA RFI
Dimensions: 210 x 500 mm
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.