Medication Guide App

CONSION XL 16 MG PROLONGED-RELEASE CAPSULES HARD

Active substance: GALANTAMINE HYDROBROMIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
Package leaflet: Information for the user
Consion XL 8 mg prolonged-release capsules,
hard
Consion XL 16 mg prolonged-release
capsules, hard
Consion XL 24 mg prolonged-release
capsules, hard
Galantamine
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.
What is in this leaflet:
1. hat Consion XL is and what it is used for
W
2. hat you need to know before you take Consion
W
XL
3. ow to take Consion XL
H
4.
Possible side effects
5. ow to store Consion XL
H
6. ontents of the pack and other information
C
1. What Consion XL is and what it is used for
Consion XL is an antidementia medicine used to
treat the symptoms of mild to moderately severe
dementia of the Alzheimer type, a disease that alters
brain function.
The symptoms of Alzheimer’s disease include
increasing memory loss, confusion and behavioral
changes. As a result, it becomes more and more
difficult to carry out normal daily activities.
These symptoms are believed to be due to a lack of
acetylcholine, a substance responsible for sending
messages between brain cells. Consion XL increases
the amount of acetylcholine in the brain and so could
improve the symptoms of the disease.
2. What you need to know before you take
Consion XL
Do not take Consion XL
• If you are allergic to galantamine or any of
the other ingredients of this medicine (listed in
section 6).
• If you have severe liver and/or severe kidney
disease
Warnings and precautions
Talk to your doctor or pharmacist before taking
Consion XL.
Consion XL should be used in Alzheimer’s disease
and not other forms of memory loss or confusion.
Medicines are not always suitable for everyone. Your
doctor needs to know before you take Consion XL
if you suffer from or have suffered in the past from
any of the following conditions:
• liver or kidney problems
• a heart disorder (e.g. angina, heart attack, heart
failure, slow or irregular pulse)
• electrolyte
disturbances
(e.g.
decreased/
increased blood potassium levels)
• peptic (stomach) ulcer disease
• acute abdominal pain
• a disorder of the nervous system (like epilepsy or
Parkinson’s disease)
• a respiratory disease or infection that interferes
with breathing (like asthma,
obstructive pulmonary disease, or pneumonia)
• if you recently had an operation on the gut or
bladder
• if you have difficulties passing urine
If you need an operation which requires a general
anaesthetic, you should inform the doctor that you
are taking Consion XL.
Your doctor will then decide whether treatment with
Consion XL is suitable for you or if the dose needs
to be changed.
Other medicines and Consion XL
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Consion XL should not be used with medicines that
work in a similar way, these include:
• donepezil or rivastigmine (for Alzheimer’s
disease)
• ambenonium, neostigmine or pyridostigmine (for
severe muscular weakness)
• pilocarpine (for dry mouth or dry eyes) if taken by
mouth.
Some medicines can affect the way Consion XL works,
or Consion XL itself can reduce the effectiveness
of other medicines taken at the same time. These
include:
• paroxetine or fluoxetine (antidepressants)
• quinidine (used for heart rhythm problems)

• ketoconazole (antifungal)
• erythromycin (antibiotic)
• ritonavir (antiviral - HIV protease inhibitor).
Your doctor may prescribe a smaller dose of Consion
XL if you are also taking any of the medicines listed
above.
Some medicines can increase the number of side
effects caused by Consion XL, these include:
• non-steroidal anti-inflammatory painkillers (e.g.
ibuprofen) which can increase the risk of ulcers
• medicines taken for heart disorders or high
blood pressure (e.g. digoxin, amiodarone,
atropine, beta-blockers, or calcium channel
blocking agents). If you take medicines for an
irregular heart-beat, your doctor may consider an
electrocardiogram (ECG).
If you need an operation which requires a general
anaesthetic, you should inform the doctor that you
are taking Consion XL.
Your doctor will also check your weight regularly
while you are taking Consion XL.
If you have any questions, speak to your doctor or
pharmacist for advice.
Consion XL with food and drink
Consion XL should be taken with food if possible.
See section 3 of this leaflet for full details about how
to take this medicine.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking
this medicine.
You should not breastfeed while you are taking
Consion XL.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
Consion XL may cause dizziness or drowsiness,
especially during the first few weeks of treatment. If
you experience these symptoms, do not drive or use
any tools or machinery.
3. How to take Consion XL
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
Consion XL is started at a low dose. Your doctor may
then tell you to slowly increase the dose of Consion
XL that you take to find the most suitable dose for
you.
1. he treatment is started with 8 mg taken once
T
daily. After 4 weeks of treatment, the dose is
increased.
2. ou would then take 16 mg once daily. After
Y
another 4 weeks of treatment at the earliest, your
doctor may decide to increase the dose again.
3. ou would then take 24 mg once daily.
Y
Your doctor will explain what dose to start with and
when the dose should be increased.
Your doctor will need to see you regularly to check
that this medicine is working for you and to discuss
how you are feeling.
Liver or kidney disease
• If you have mild liver or kidney disease, treatment
is started with 8 mg capsule once daily in the
morning.
• If you have moderate liver or kidney disease,
treatment is started with 8 mg capsule once every
other day in the morning. After one week, begin
taking 8 mg capsule once daily in the morning.
Do not take more than 16 mg once daily.
• If you have severe liver and/or kidney disease, do
not take Consion XL.
How do I switch from taking Galantamine
immediate release tablets or oral solution to
Galantamine prolonged release capsules?
If you are currently taking Galantamine immediate
release tablets or oral solution, your doctor may
decide to switch you to Galantamine prolongedrelease capsules.
• Take your last dose of Galantamine immediate
release tablets or oral solution in the evening
• The next morning, take your first dose of
Galantamine prolonged-release capsules.
DO NOT take more than one capsule in a day. While
you are taking once-daily Consion XL, DO NOT
take Galantamine immediate release tablets or oral
solution.
Use in children
Consion XL is not recommended for children.
Method of administration
Consion XL should be swallowed whole, NOT
chewed or crushed. Consion XL should be taken
in the morning, with water or other liquids, and
preferably with food. Drink plenty of liquids during
your treatment with Consion XL, to keep yourself
hydrated.

If you take more Consion XL than you should
If you take too much Consion XL, contact a doctor
or hospital straight away. Take along any remaining
capsules and the packaging with you. Signs or
symptoms of overdose may include, among others:
severe nausea, vomiting, muscle weakness, slow
heart beat, seizures and loss of consciousness.
If you forget to take Consion XL
If you forget to take one dose, miss out the forgotten
dose completely and take the next dose at the
normal time.
Do not take a double dose to make up for a
forgotten dose.
If you forget to take more than one dose, you should
contact your doctor.
If you stop taking Consion XL
You should consult your doctor before you stop
taking Consion XL. It is important to continue taking
this medicine to treat your condition.
If you have any further questions on the use of this
medicine ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Some of these effects may be due to the disease
itself.
Stop taking your medicine and see a doctor
immediately if you experience;
• Heart problems including changes in heart beat
(slow or irregular)
• Palpitations (pounding heart beat)
• Conditions like blackout
• An allergic reaction. The signs may include a rash,
swallowing or breathing problems, or swelling of
your lips, face, throat or tongue
Side effects include:
Very common (may affect more than 1 in 10
people)
• Feeling sick and/or vomiting. If these undesired
effects occur, they are mainly experienced early
on in the treatment or when the dose is increased.
They tend to disappear gradually as the body
gets used to the treatment and generally will
not last for more than a few days. If you have
these effects, your doctor may recommend that
you drink more liquids and, if necessary, may
prescribe a medicine to stop you being sick.
Common (may affect up to 1 in 10 people)
• Weight loss
• Loss of appetite
• Decreased appetite
• Slow heart beat
• Feeling faint
• Dizziness
• Trembling
• Headache
• Drowsiness
• Abnormally tired
• Stomach pain or discomfort
• Diarrhoea
• Indigestion
• Increased sweating
• Muscle spasms
• Falling
• High blood pressure
• Feeling weak
• General feeling of discomfort
• Seeing, feeling, or hearing things that are not
real (hallucinations)
• Feeling sad (depression).
Uncommon (may affect up to 1 in 100 people)
• Increased liver enzymes in the blood (laboratory
test result that tells how well your liver is
working)
• Possible skipped heart beat
• Disturbance in the mechanism of conducting
impulses in the heart
• Sensation of abnormal heart beats (palpitations)
• Tingling, pricking, or numbness of the skin
• Change in the sense of taste
• Excessive sleepiness;
• Blurred vision
• Ringing or buzzing in the ears (tinnitus)
• Feeling the need to vomit
• Muscle weakness
• Excessive water loss in the body
• Low blood pressure
• Reddening of the face.
• Allergic reaction
Rare (may affect up to 1 in 1,000 people)
• Inflammation of the liver (hepatitis).
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet.
5. How to store Consion XL
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 foil after the
letters EXP. The expiry date refers to the last day of
that month.
This medicinal product 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.
6. Contents of
the pack and other
information
What Consion XL contains:
The active substance is galantamine.
• Each Consion XL 8 mg prolonged-release
capsules, hard contains 8 mg galantamine (as
hydrobromide)
• Each Consion XL 16 mg prolonged-release
capsules, hard contains 16 mg galantamine (as
hydrobromide)
• Each Consion XL 24 mg prolonged-release
capsules, hard contains 24 mg galantamine (as
hydrobromide)
The other ingredients are:
Capsule content
Cellulose
microcrystalline,
Hypromellose,
Ethylcellulose, Magnesium stearate
Capsule shell
8 mg: Gelatin, Titanium dioxide (E171)
16 mg: Gelatin, Titanium dioxide (E171), red iron
oxide (E172).
24 mg: Gelatin, Titanium dioxide (E171). Indigo
carmine (E 132), Erythrosin(E 127), Red Iron Oxide
(E 172), Yellow iron oxide (E 172).
What Consion XL looks like and contents of
the pack
Consion XL prolonged-release capsules, hard are
available in three strengths, each of which can be
recognised by its colour:
8mg: White capsules containing one round biconvex
prolonged-release tablet
16mg: Pale pink capsules containing two round
biconvex prolonged-release tablet
24mg: Orange capsules containing three round
biconvex prolonged-release tablets
The capsules are made in a ‘prolonged-release’
form. This means that they release the medicine
more slowly.
The capsules are available in the following blister
packs:
7, 28, 30, 56, 84, 98, 100 prolonged release
capsules
Not all pack sizes may be marketed.
Marketing
Authorisation
Holder
and
Manufacturer
Marketing Authorisation Holder
Pharmathen S.A.
Dervenakion 6, Pallini, Attiki, 153 51
Greece
Manufacturer
Pharmathen S.A.
Dervenakion 6, Pallini, Attiki, 153 51
Greece
and
Pharmathen International S.A.
Industrial Park Sapes, Rodopi Prefecture, Block No
5, Rodopi 69300
Greece
Distributed by
Lupin (Europe) Limited
Victoria Court
Bexton Road
Knutsford
Cheshire WA16 0PF
United Kingdom
This medicinal product is authorised in the Member
States of the EEA under the following names:
Germany
Masparen 8mg, 16mg, 24mg
Hartkapseln, retardiert
Netherlands
Masparen Retard 1x daags 8mg,
16mg, 24mg
Belgium
Masparen 8mg, 16mg, 24mg gélule
à libération prolongée & Masparen
8mg, 16mg, 24mg hartkapsel,
retardiert
Spain
Galantamina cinfa 8mg, 16mg,
24mg cápsulas duras de liberación
prolongada EFG
United Kingdom Consion XL 8mg, 16mg, 24mg
prolonged release capsules
This leaflet was last revised in 02/2013

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.

Hide
(web4)