Patient leaflet - Lotprosin XL 16 mg prolonged-release capsules hard
1 What Lotprosin XL capsules are and what they are used for
Lotprosin XL capsules contain the active substance ‘galantamine’, an antidementia medicine. It is taken by 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. Lotprosin XL capsules increase the amount of acetylcholine in the brain and treat the signs of the disease.
The capsules are made in a ‘prolonged-release’ form. This means that they release the medicine slowly.
2 What you need to know before you take Lotprosin XL capsules
Do not take Lotprosin XL capsules:
- If you are allergic to galantamine or any of the other ingredients of this medicine (listed in section 6).
- If you have severe liver or severe kidney disease.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Lotprosin XL capsules.
This medicine is only taken for Alzheimer’s disease and is not recommended for other types of memory loss or confusion.
Serious side effects
Lotprosin XL capsules can cause serious skin reactions, heart problems and fits (seizures). You must be aware of these side effects while you are taking Lotprosin XL capsules. See ‘Look out for serious side effects’ in section 4.
Before you take Lotprosin XL capsules, 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 heartbeat or 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
- 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 Lotprosin XL capsules are 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 Lotprosin XL capsules are not suitable for you.
Lotprosin XL capsules can cause weight loss. Your doctor will check your weight regularly while you are taking Lotprosin XL capsules.
Children and adolescents
Lotprosin XL capsules are not recommended for children and adolescents.
Other medicines and Lotprosin XL capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Lotprosin XL capsules should not be taken 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 Lotprosin XL. These include:
- paroxetine or fluoxetine (antidepressants)
- quinidine (for uneven heartbeat)
- 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 heartbeat, your doctor may check your heart using an electrocardiogram (ECG)
- medicines affecting QTc interval.
Your doctor may give you a lower dose of Lotprosin XL capsules if you are taking some of these medicines.
Lotprosin XL capsules may affect some anaesthetics. If you are going to have an operation under a general anaesthetic, tell the doctor that you are taking Lotprosin XL capsules, well in advance.
If you have any questions, talk to your doctor, pharmacist or nurse 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 breastfeed while you are taking Lotprosin XL capsules.
Driving and using machines
Lotprosin XL capsules may make you feel dizzy or sleepy, especially during the first few weeks of treatment. If Lotprosin XL capsules affect you, do not drive or use any tools or machinery.
3 How to take Lotprosin XL capsules
Always take Lotprosin XL capsules 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 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.
How much to take
You will start treatment with Lotprosin XL capsules 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 a 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 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 and to discuss how you are feeling. Lotprosin XL 8mg, 16mg and 24mg Prolonged-release Capsules, hard
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If you have liver or kidney problems, your doctor may give you a reduced dose of Lotprosin XL capsules, or may decide this medicine is not suitable for you.
Switching from taking Galantamine tablets or oral solution to Lotprosin XL capsules
If you are currently taking Galantamine tablets or oral solution, your doctor may decide you should switch to Lotprosin XL 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 Lotprosin XL capsules.
DO NOT take more than one capsule in a day. While you are taking once-daily Lotprosin XL capsules, DO NOT take Galantamine tablets or oral solution.
How to take
Lotprosin XL capsules must be swallowed whole and NOT chewed or crushed. Take your dose of Lotprosin XL capsules once a day in the morning, with water or other liquids. Try to take Lotprosin XL capsules with food.
Drink plenty of liquids while you are taking Lotprosin XL capsules, to keep yourself hydrated.
If you take more Lotprosin XL capsules than you should
If you take too many Lotprosin XL capsules, contact a doctor or hospital straight away. Take along any remaining capsules and the packaging with you. The signs of overdose may include: severe nausea and vomiting, weak muscles, slow heartbeat, fits (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, contact your doctor.
If you stop taking Lotprosin XL capsules
Check with your doctor before you stop taking Lotprosin XL capsules. 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.
Look out for serious side effects.
Stop taking your medicine and see a doctor immediately or go to your nearest emergency department 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. These skin reactions are rare in people taking Lotprosin XL capsules (may affect up to 1 in 1,000 people).
- Heart problems, including changes in heartbeat (such as a slow beat or extra beats) or palpitations (heartbeat feels fast or uneven). Heart problems may show as an abnormal tracing on an ‘electrocardiogram’ (ECG), and can be common in people taking Lotprosin XL capsules (may affect up to 1 in 10 people).
- Fits (seizures). These are uncommon in people taking Lotprosin XL capsules (may affect up to 1 in 100 people).
You must stop taking Lotprosin XL capsules and get help immediately if you notice any of the side effects above.
Other side effects:
Very common side effects (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 side effects (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 side effects (may affect up to 1 in 100 people):
- Allergic reaction
- Not enough water in the body (dehydration)
- Nightmares
- 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 side effects (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.
5 How to store Lotprosin XL capsules
Keep this medicine out of the sight and reach of children. Do not take 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.
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 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
Accord, Barnstaple, EX32 8NS, UK
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 May 2026.
If you would like a leaflet with larger text, please contact
01271 385257.