Patient leaflet - Gazylan XL 8 mg prolonged-release capsules hard
What Gazylan XL is and what it is used for
Gazylan XL contains the active substance
‘galantamine’, an antidementia medicine. It is
used in adults to treat the symptoms of mild to
moderately severe Alzheimer’s disease, a type of
dementia that alters brain function.
Alzheimer’s disease causes increasing memory
loss, confusion and behavioural changes which
make it increasingly difficult to carry out normal
daily activities. These effects are thought to be
caused by a lack of ‘acetylcholine’, a substance
responsible for sending messages between brain
cells. Gazylan XL increases the amount of
acetylcholine in the brain and treats the signs of
the disease.
The capsules are made in a ‘prolonged-release’
form. This means that they release the medicine
slowly.
What you need to know before you take Gazylan XL
Do not take Gazylan XL
- If you are allergic to galantamine or any of the
other ingredients of this medicine (listed in
- If you have severe liver and/or severe kidney
disease.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Gazylan XL.
This medicine is only used in Alzheimer’s
disease, and is not recommended for other types
of memory loss or confusion.
Serious side effects
Gazylan XL can cause serious skin reactions, heart
problems and fits (seizures). You must be aware of
these side effects while you are taking Gazylan XL.
See ‘Look out for serious side effects’ in section 4.
Before you take Gazylan XL, your doctor needs
to know if you have, or have had, any of the
following:
- liver or kidney problems
- a heart condition (such as chest discomfort that
is often brought on by physical activity, a heart
attack, heart failure, slow or uneven heart beat,
prolonged QTc interval)
- changes in ‘electrolyte’ levels (naturally
occurring chemicals in the blood, such as
potassium)
- a peptic (stomach) ulcer
- blockage of the stomach or intestines (acute
abdominal pain)
- a disorder of the nervous system (such as
epilepsy or problems controlling movements of
the body or limbs (extrapyramidal disorder)
- a respiratory disease or infection that affects
breathing (such as asthma,
obstructive pulmonary disease, or pneumonia)
- problems passing urine
Your doctor will decide if Gazylan XL is suitable
for you, or if the dose needs to be changed.
Also tell your doctor if you recently had an
operation on the stomach, intestines or bladder.
Your doctor may decide that Gazylan XL is not
suitable for you.
Gazylan XL can cause weight loss. Your doctor
will check your weight regularly while you are
taking Gazylan XL.
Children and adolescents
Gazylan XL is not recommended for children and
adolescents.
Other medicines and Gazylan XL
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Gazylan 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 muscle weakness)
pilocarpine (when taken by mouth for dry
mouth or dry eyes)
Some medicines can make side effects more
likely in people taking Gazylan XL.
These include:
- paroxetine or fluoxetine (antidepressants)
- quinidine (for uneven heart beat)
- ketoconazole (an antifungal)
- erythromycin (an antibiotic)
ritonavir (for human immunodeficiency virus
or ‘HIV’).
non-steroidal anti-inflammatory painkillers
(such as ibuprofen) which can increase the risk
of ulcers
- medicines taken for heart conditions or high blood pressure (such as digoxin, amiodarone, atropine, beta-blockers, or calcium channel blocking agents). If you take medicines for an uneven heart-beat, your doctor may check your heart using an electrocardiogram (ECG)
- medicines affecting the QTc interval.
Your doctor may give you a lower dose of Gazylan XL if you are taking some of these medicines.
Gazylan XL may affect some anaesthetics. If you are going to have an operation under a general anaesthetic, tell the doctor that you are taking Gazylan XL, well in advance.
If you have any questions, talk to your doctor or pharmacist for advice.
Pregnancy and breast-feeding
If you are pregnant, 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 breast-feed while you are taking Gazylan XL.
Driving and using machines
Gazylan XL make you feel dizzy or sleepy, especially during the first few weeks of treatment. If Gazylan XL affects you, do not drive or use any tools or machinery.
How to take Gazylan 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.
If you are currently taking galantamine tablets or oral solution and have been told by your doctor to switch to Gazylan XL prolonged-release capsules, carefully read the instructions under ‘Switching from taking galantamine tablets or oral solution to Gazylan XL prolonged-release capsules in this section.
How much to take
You will start treatment with Gazylan XL at a low dose. The usual starting dose is 8 mg, taken once a day. Your doctor may gradually increase your dose, every 4 weeks or more until you reach a dose that is suitable for you. The maximum dose is 24 mg, taken once day.
Your doctor will explain what dose to start with and when the dose should be increased. If you are not sure what to do, or find the effect of Gazylan XL 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.
If you have liver or kidney problems, your doctor may give you a reduced dose of Gazylan XL, or may decide this medicine is not suitable for you.
Switching from taking galantamine tablets or oral solution to Gazylan XL prolonged-release capsules
If you are currently taking galantamine tablets or oral solution, your doctor may decide you should switch to Gazylan XL prolonged-release capsules. If this applies to you:
- Take your last dose of galantamine tablets or oral solution in the evening
- The next morning, take your first dose of Gazylan XL prolonged-release capsules.
DO NOT take more than one capsule in a day. While you are taking once-daily Gazylan XL, DO NOT take galantamine tablets or oral solution.
How to take
Gazylan XL must be swallowed whole and NOT chewed or crushed. Take your dose of Gazylan XL once a day in the morning, with water or other liquids. Try to take Gazylan XL with food.
Drink plenty of liquids while you are taking Gazylan XL, to keep yourself hydrated.
If you take more Gazylan XL than you should
If you take too much Gazylan XL, contact a doctor or hospital straight away. Take any remaining capsules and the packaging with you. The signs of overdose may include:
- severe nausea and vomiting
- weak muscles, slow heart beat, fits (seizures) and loss of consciousness.
If you forget to take Gazylan 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, contact your doctor.
If you stop taking Gazylan XL
Check with your doctor before you stop taking Gazylan 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.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Look out for serious side effects
Stop taking Gazylan XL and see a doctor or go to your nearest emergency department immediately if you notice any of the following;
Skin reactions, including:
- Severe rash with blisters and peeling skin, particularly 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.
What is in this leaflet
Package leaflet: Information for the user
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BLACK Template
IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier. We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.
SKU (s): 231-10-06322
231-10-06332
231-10-06342
(excluding codes)
Perforated: Univers. 9 pt TevaArt Ref: PID: 165127_s1 P: Galantamine (Gazylan) XL UK Prolonged release Capsules 8 16 24mg 28 PHA 27 March 2024
Version: 2
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500 mm
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These skin reactions are rare in people taking Gazylan XL (may affect up to 1 in 1,000 people).
Heart problems, including changes in heart beat (such as a slow beat, extra beats) or palpitations (heart beat feels fast or uneven). Heart problems may show as an abnormal tracing on an electrocardiogram (ECG), and can be common in people taking Gazylan XL (may affect up to 1 in 10 people).
Fits (seizures). These are uncommon in people taking Gazylan XL (may affect up to 1 in 100 people).
Conditions like blackout (may affect up to 1 in 10 people)
An allergic reaction. The signs may include a rash, swallowing or breathing problems, or swelling of your lips, face, throat or tongue (may affect up to 1 in 100 people)
You must stop taking Gazylan XL and get help immediately if you notice any of the side effects above.
Other side effects:
Very common (may affect more than 1 in 10 people):
- Nausea and vomiting. These side effects are more likely to happen in the first few weeks of treatment or when the dose is increased. They tend to disappear gradually as the body gets used to the medicine and generally only last for a few days. If you have these effects, your doctor may recommend that you drink more liquids, and may prescribe a medicine to stop you being sick.
Common (may affect up to 1 in 10 people):
- Decreased appetite; weight loss
- Seeing, feeling, or hearing things that are not there (hallucinations)
- Depression
- Feeling dizzy or fainting
- Muscle tremors or spasms
- Headache
- Feeling very tired, weak or generally unwell
- Feeling very sleepy with low energy
- High blood pressure
- Stomach pain or discomfort
- Diarrhoea
- Indigestion
- Falls
- Wounds
Uncommon (may affect up to 1 in 100 people):
- Not enough water in the body (dehydration)
- Tingling or numb feeling of the skin (pins and needles)
- Change in sense of taste
- Daytime sleepiness
- Problems controlling movements of the body or limbs (extrapyramidal disorder)
- Blurred vision
- Ringing in the ears that does not go away (tinnitus)
- Low blood pressure
- Flushing
- Feeling the need to vomit (retch)
- Excessive sweating
- Weak muscles
- Increased level of liver enzymes in the blood
Rare (may affect up to 1 in 1,000 people):
- Inflamed 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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
How to store Gazylan 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.
Contents of the pack and other information
What Gazylan XL contains:
The active substance is galantamine. Each Gazylan XL 8 mg prolonged-release capsule, hard contains 8 mg galantamine (as hydrobromide).
Each Gazylan XL 16 mg prolonged-release capsule, hard contains 16 mg galantamine (as hydrobromide).
Each Gazylan XL 24 mg prolonged-release capsule, 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 Gazylan XL looks like and contents of the pack
Gazylan 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 ‘prolonged-release’ form. This means that they release the medicine more slowly.
The capsules are available in the following blister packs:
7, 10, 14, 28, 30, 56, 60, 84, 90, 98, 100, 112, 119, 120, 300 prolonged-release capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva UK Limited, Ridings Point, Whistler Drive, Castleford, WF10 5HX, United Kingdom
Manufacturer
Pharmathen International S.A.
Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300
Greece
This leaflet was last revised in 03/2024
PL 00289/1890-2
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