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LOTPROSIN XL 8MG PROLONGED-RELEASE CAPSULES HARD

Active substance(s): GALANTAMINE HYDROBROMIDE

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Lotprosin XL 8mg, 16mg and 24mg
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.
• The full name of this medicine is Lotprosin XL 8mg, 16mg and
24mg Prolonged-release Capsules, hard but within the leaflet it
will be referred to as Lotprosin XL capsules.

Other medicines and Lotprosin XL capsules

What is in this leaflet:
1 What Lotprosin XL capsules are and what they are
used for
2 What you need to know before you take
3 How to take
4 Possible side effects
5 How to store
6 Contents of the pack and other information

1 What Lotprosin XL capsules are and what they are
used for

Lotprosin XL capsules are 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.
Lotprosin XL capsules increases the amount of acetylcholine in the brain
and so could improve the symptoms of the disease.

Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including those obtained without a
prescription.
Lotprosin XL capsules 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 Lotprosin XL capsules work, or
Lotprosin XL capsules 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 Lotprosin XL capsules if you
are also taking any of the medicines listed above.
Some medicines can increase the number of side effects caused by
Lotprosin XL capsules, 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 Lotprosin XL capsules.
If you have any questions, speak to your doctor or pharmacist for advice.

Lotprosin XL capsules with food and drink

Lotprosin XL capsules should be taken with food if possible.
Drink plenty of liquids during your treatment with Lotprosin XL capsules,
to keep yourself hydrated.
See section 3 of this leaflet for full details about how to take this
medicine.

Pregnancy and breast-feeding

Do not take Lotprosin XL capsules

Before taking Lotprosin XL capsules, speak to your doctor for advice if
you are pregnant, think you could be pregnant, or you are planning a
pregnancy.
You should not breastfeed while you are taking Lotprosin XL capsules.

Warnings and precautions

Lotprosin XL capsules 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.

2 What you need to know before you take
• If you are allergic (hypersensitive) to galantamine or to any of the
other ingredients of this medicine (listed in section 6).
• If you have severe liver and/or severe kidney disease.

Driving and using machines

Talk to your doctor or pharmacist before taking Lotprosin XL capsules.
Lotprosin XL capsules 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 Lotprosin XL capsules 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 Lotprosin XL capsules.
Your doctor will then decide whether treatment with Lotprosin XL
capsules is suitable for you or if the dose needs to be changed.

3 How to take

Always take Lotprosin XL capsules exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
If you are currently taking Galantamine immediate release tablets or oral
solution and have been told by your doctor to switch to Lotprosin XL
capsules, read the instructions at the end of this section carefully.
Lotprosin XL capsules should be swallowed whole, NOT chewed or
crushed. Lotprosin XL capsules should be taken in the morning, with
water or other liquids, and preferably with food.
Lotprosin XL capsules are available in 3 strengths: 8mg, 16mg and 24mg.
Lotprosin XL capsules are started at a low dose. Your doctor may then tell
you to slowly increase the dose (strength) of Lotprosin XL capsules that
you take to find the most suitable dose for you.
1. The treatment is started with 8mg taken once daily. After 4 weeks of
treatment, the dose is increased.
2. You would then take 16mg 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 24mg once daily.

Continued on next page

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AAAF6544

colours/plates:

Galantamine (Lotprosin XL) 8mg/16mg/24mg Prolonged-release Capsules PIL - UK

1. Black
item no:
print proof no:
origination date:
approved for print/date

AAAF6544
2
24.07.13

originated by:

DR

revision date:

31.07.13

revised by:
supplier:

DR
Pharmathen

dimensions:

170x250

3.

pharmacode:
min pt size:

2.
4.

7pt

5.
6.
Non Printing Colours

Technical Approval
date sent:

24.07.13

technically app. date:

25.07.13

1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated
Any technical chanages made by the supplier after approval are not the responsibility of the Artwork Studio

Your doctor will explain what dose to start with and when the dose
should be increased. If you feel that the effect of Lotprosin XL capsules is
too strong or too weak, talk to your doctor or pharmacist.
Your doctor will need to see you regularly to check that this medicine is
working for you and to discuss how you are feeling. Your doctor will also
check your weight regularly while you are taking Lotprosin XL capsules.

Use in children

Lotprosin XL capsules are not recommended for children.

Liver or kidney disease

• If you have mild liver or kidney disease, treatment is started with 8mg
once daily in the morning.
• If you have moderate liver or kidney disease, treatment is started with
8mg once every other day in the morning. After one week, begin
taking 8mg once daily in the morning. Do not take more than 16mg
once daily.
• If you have severe liver and/or kidney disease, do not take Lotprosin XL
capsules.

How do I switch from taking Galantamine immediate
release tablets or oral solution to Lotprosin XL capsules?

If you are currently taking Galantamine immediate release tablets or oral
solution, your doctor may decide to switch you to Lotprosin XL capsules.
• Take your last dose of Galantamine immediate release tablets or oral
solution in the evening
• The next morning, take your first dose of Lotprosin XL capsules.
DO NOT take more than one capsule in a day. While you are taking
Lotprosin XL capsules, DO NOT take Galantamine immediate release
tablets or oral solution.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

If you take more Lotprosin XL capsules than you should

If you take too much Lotprosin XL capsules, 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 Lotprosin XL capsules

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 Lotprosin XL capsules

You should consult your doctor before you stop taking Lotprosin XL
capsules. It is important to continue taking this medicine to treat your
condition.

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.
Side effects include:
Very common side effects: affects more than one user in 10
• Feeling sick and/or vomiting. If these side 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 side effects: affects 1 to 10 users in 100
• 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).
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AAAF6544

Uncommon side effects: affects 1 to 10 users in 1000
• 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
• Hypersensitivity
• Seizures
Rare side effects: affects 1 to 10 users in 10000
• Inflammation of the liver (hepatitis).

Reporting of side effects

If you get 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 internet at www.mhra.gov.uk/
yellowcard Alternatively you can call Freephone 0808 100 3352 (available
from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available
from your local pharmacy. By reporting side effects you can help provide
more information on the safety of this medicine

5 How to store

Keep out of the sight and reach of children.
Do not use Lotprosin XL capsules after the expiry date which is stated on
the carton and blister after EXP.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6 Contents of the pack and other information
What Lotprosin XL capsules contain:

The active substance is galantamine.
• Lotprosin XL 8mg Prolonged-release Capsules contain 8mg
galantamine (as hydrobromide).
• Lotprosin XL 16mg Prolonged-release Capsules contain 16mg
galantamine (as hydrobromide).
• Lotprosin XL 24mg Prolonged-release Capsules contain 24mg
galantamine (as hydrobromide).
The other ingredients are:
Capsule contents: Cellulose microcrystalline, Hypromellose,
Ethylcellulose and Magnesium stearate. Capsule shell: Gelatin and
Titanium dioxide (E 171).
• The 16mg capsule also contains red iron oxide (E 172).
• The 24mg capsule also contains Indigo carmine (E 132), Erythrosin
(E 127), Red Iron Oxide (E 172) and Yellow iron oxide (E 172).

What Lotprosin XL capsules look like and contents of the
pack

Lotprosin XL Prolonged-release Capsules , hard are available in three
strengths, each of which can be recognised by its colour:
• 8mg: Opaque white size 2 hard gelatine capsules containing one
round biconvex tablet
• 16mg: Opaque flesh size 2 hard gelatine capsules containing two
round biconvex tablets
• 24mg: Opaque orange size 2 hard gelatine capsules containing three
round biconvex tablets.
Pack size: 28
Marketing Authorisation Holder
Actavis Group PTC ehf., Reykjavikurvegur 76-78,
220 Hafnarfjordur, Iceland
Manufacturers
Pharmathen S.A., Dervenakion 6 , Pallini 15351, Attiki Greece
or
Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture,
Block No 5, Rodopi 69300, Greece
This leaflet was last revised in July 2013

If you would like a
leaflet with larger
text, please contact
01271 311257.
Actavis, Barnstaple, EX32 8NS, UK

colours/plates:

Galantamine (Lotprosin XL) 8mg/16mg/24mg Prolonged-release Capsules PIL - UK

1. Black
item no:
print proof no:
origination date:
approved for print/date

AAAF6544
2
24.07.13

originated by:

DR

revision date:

31.07.13

revised by:
supplier:

DR
Pharmathen

dimensions:

170x250

3.

pharmacode:
min pt size:

2.
4.

7pt

5.
6.
Non Printing Colours

Technical Approval
date sent:

24.07.13

technically app. date:

25.07.13

1.
2.
3.

* Please note the technical approval is provided by the supplier and is valid on the date indicated
Any technical chanages made by the supplier after approval are not the responsibility of the Artwork Studio

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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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