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LUVENTA XL 16 MG PROLONGED-RELEASE CAPSULES HARD

Active substance(s): GALANTAMINE HYDROBROMIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Luventa XL 8 mg prolonged-release capsules, hard
Luventa XL 16 mg prolonged-release capsules, hard
Luventa 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. See section 4.
What is in this leaflet:
1. What Luventa XL is and what it is used for
2. What you need to know before you take
Luventa XL
3. How to take Luventa XL
4. Possible side effects
5. How to store Luventa XL
6. Contents of the pack and other information
1. What Luventa XL is and what it is
used for
Luventa 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. Luventa 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 Luventa XL
Do not take Luventa 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 Luventa XL.
Luventa XL should be used in Alzheimer’s
disease and not other forms of memory loss
or confusion.
Luventa XL can cause serious skin reactions,
heart problems and fits (seizures). You must
be aware of these effects while you are taking
Luventa XL. See “4. Possible side effects”.
Medicines are not always suitable for
everyone. Your doctor needs to know before
you take Luventa 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 Luventa XL.
Your doctor will then decide whether
treatment with Luventa XL is suitable for you
or if the dose needs to be changed.
Other medicines and Luventa XL
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines.
Luventa 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 Luventa
XL works, or Luventa 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
Luventa XL if you are also taking any of the
medicines listed above.
Some medicines can increase the number
of side effects caused by Luventa 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 Luventa XL.
Your doctor will also check your weight
regularly while you are taking Luventa XL.
If you have any questions, speak to your
doctor or pharmacist for advice.
Luventa XL with food and drink
Luventa 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 Luventa XL.
Driving and using machines
Luventa 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 Luventa 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.
Luventa XL is started at a low dose. Your
doctor may then tell you to slowly increase
the dose of Luventa XL that you take to find
the most suitable dose for you.
1.The treatment is started with 8 mg taken
once daily. After 4 weeks of treatment, the
dose is increased.
2.You would then take 16 mg once daily. After
another 4 weeks of treatment at the earliest,
your doctor may decide to increase the dose
again.
3.You would then take 24 mg once daily.
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 Luventa 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,

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;
• Skin reactions, including:
• Severe rash with blisters and peeling skin,
particulary around the mouth, nose, eyes
and genitals (Stevens-Johnson syndrome).
• Red rash covered with small pus-filled
bumps that can spread over the body,
sometimes with a fever (acute generalised
exanthematous pustulosis).
• Rash that may blister, with spots that look
like small targets.
These skin reactions are rare in people
taking Luventa XL (may affect up to 1 in 1,000
people).
• 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
You must stop taking Luventa XL and
get help immediately if you notice any of
the side effects above.
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
• Fits (seizures)
Rare (may affect up to 1 in 1,000 people)
• Inflammation of the liver (hepatitis).
Reporting of side effects
If you get any side effects, talk to your
doctor or 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 Website:
www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more
information on the safety of this medicine.
5. How to store Luventa 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 Luventa XL contains:
The active substance is galantamine.
• Each Luventa XL 8 mg prolonged-release
capsules, hard contains 8 mg galantamine (as
hydrobromide)
• Each Luventa XL 16 mg prolonged-release
capsules, hard contains 16 mg galantamine
(as hydrobromide)
• Each Luventa 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 (E132), Erythrosin (E127), Red
Iron Oxide (E172), Yellow iron oxide (E172).
What Luventa XL looks like and contents
of the pack
Luventa XL prolonged-release capsules, hard
are available in three strengths, each of which
can be recognised by its colour:
8 mg: White capsules containing one round
biconvex prolonged-release tablet
16 mg: Pale pink capsules containing two
round biconvex prolonged-release tablet
24 mg: Orange capsules containing three
round biconvex prolonged-release tablets
The capsules are made in a ‘prolongedrelease’ 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
Fontus Health Ltd
60 Lichfield Street, Walsall. WS4 2BX
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
This leaflet was last revised in 07/2016.

2814104/3

your doctor may decide to switch you to
Galantamine prolonged-release 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
Luventa XL, DO NOT take Galantamine
immediate release tablets or oral
solution.
Use in children
Luventa XL is not recommended for children.
Method of administration
Luventa XL should be swallowed whole, NOT
chewed or crushed. Luventa XL should be
taken in the morning, with water or other
liquids, and preferably with food. Drink plenty
of liquids during your treatment with Luventa
XL, to keep yourself hydrated.
If you take more Luventa XL than you should
If you take too much Luventa 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 Luventa 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 Luventa XL
You should consult your doctor before you
stop taking Luventa 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.

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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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