Product Information

Reminyl – the only way to effectively alleviate the symptoms of AD

Many of us feel that the fresh scent of spring flowers cheer us up and let us know that warmer days are just around the corner. But believe or not that’s not the only way that they can make us feel better. They are the source of a remarkable phyto-nutrient called galantamine (sold under the brand name Reminyl and marketed in the US as Razadyne).

Galantamine is not a new herbal supplement. Its properties as a memory restorer appear to have been recognised as far back as Ancient Greek civilisation although it was not “rediscovered” until the 1950s by researchers in Bulgaria. Nowadays it is a first line treatment for the symptoms of mild to moderately severe dementia and in particular Alzheimer’s Disease (AD). But this little gem of a supplement is not just an excellent memory improver, it may also be useful for improving muscle function, counteracting jet lag, combating fatigue, and perhaps even in overcoming sexual impotence!

What is Galantamine?

Galantamine is an alkaloid that is either created synthetically or sourced from the bulbs and flowers of the Caucasian snowdrop (galanthus nivalis) and galanthus woronowii (Amaryllidaceae) as well as other plant genera such as the daffodil and lycoris including the red spider lily.. The use of galantamine in traditional medicine has been popular for a long time throughout Eastern Europe. Indeed, isolating galantamine as an active ingredient probably sprung from the use of snowdrops in traditional East European medicine.

Galantamine and the treatment of Alzheimer’s Disease and memory loss

Unfortunately, memory loss and other symptoms of cognitive impairment are part of the ageing process eventually affecting all of us to a greater or lesser extent. For some people, the problems are only relatively slight but for others, they develop into full blown dementia. AD is the most common form of dementia and it is a huge health care problem. In the US alone it is estimated that approximately 4 million people suffer from AD, with over 360,000 new cases being diagnosed each year.

Age is the single greatest risk factor for developing dementia. As populations increasingly age, so the number of people living with dementia increases. At the age of 65 the prevalence of dementia is around 1% but this increases dramatically to 30-50% by the age of 85. Women are more affected than men - probably due to the fact that women live longer than men and so there are more older women than older men.

Age isn’t the only risk factor – all those risk factors that apply to heart disease such as lack of exercise, high blood pressure and cholesterol, obesity and smoking are just as relevant for AD. Low income, low educational level, and low intellect also appear to play their part. Some people may even have a genetic disposition to the disease.

AD is a devastating, incurable disease. The symptoms include progressive memory loss, increasing confusion and behavioural changes. As a result, it becomes increasingly difficult for sufferers to carry out their normal daily activities – even simple tasks such as washing, getting dressed and getting something to eat can eventually become impossible. The disease can be just as devastating for the carers and families of sufferers – the impact and the burden on them should not be under estimated.

The exact cause of AD is unknown although a number of factors are thought to play their part. A lack of the neurotransmitter acetylcholine has been implicated. Neurotransmitters are chemicals that work as the brain’s messenger service. When one neuron (brain cell) needs to communicate with another one, it does so by releasing the relevant neurotransmitters which are capable of crossing the minute gaps (synapses) that exist between neurons. There are a number of different neurotransmitters with neurons expressing certain types of neurotransmitters sometimes forming distinct systems. Activating these systems affects large parts of the brain. Acetycholine forms the basis of the cholinergic system and has a direct affect on learning and short term memory. In the normal, healthy brain, acetylcholine levels are finely balanced allowing us to function properly. However, if one becomes deficient in acetylcholine these functions are directly affected – as demonstrated by the classic symptoms of AD.

Galantamine works by increasing the amount of acetycholine available in the brain which in turn improves the symptoms of AD, as well as those of age related memory loss that eventually affects us all. While it can’t cure AD (unfortunately nothing can at the moment), galantamine can help to prevent and alleviate the incredibly distressing and debilitating symptoms of the disease.

The goal is to try and return the amount of acetylcholine in the brain to normal, healthy levels. Galantamine achieves this in two ways:
1. By inhibiting acetylcholinesterase. Acetylcholinesterase is an enzyme that is responsible for destroying acetylcholine. By preventing (inhibiting) acetylcholinesterase from acting upon acetylcholine and destroying it, acetylcholine levels are raised.
2. By modulating nicotinic receptors. Neurotransmitter receptors are proteins on the surface of neurons that bind to specific neurotransmitters. Nicotinic receptors are the most important acetylcholine receptors in the brain. Galantamine makes them more receptive to acetylcholine and protects them from age-related deterioration in both function and numbers. By doing this, galantamine effectively boosts the efficiency of neurotransmission via acetylcholine.

It is this dual action that makes galantamine unique. Other medications may inhibit acetylcholinesterase but that is all that they do. By acting on two fronts, galantamine is the real star when it comes to increasing acetylcholine levels which, in turn, helps to prevent and alleviate the symptoms of AD and similar types of dementia.

And what is even better is that galantamine retains its efficacy as a treatment. With other medications a gradual tolerance builds up which results in the medications losing their efficacy. When this happens, the symptoms of AD start to get worse rather than improve. It usually takes about a year of medication for this to happen. Galantamine, on the other hand, appears to retain its efficacy indefinitely and drug tolerance is simply not a problem.

If all of that wasn’t enough, there is a good argument to be made for the ability of galantamine to possibly extend life. People who develop dementia face a shortened life expectancy – on average 3.3 years after the onset of the disease. As we have already discussed, galantamine slows down the progress of the disease, and, by doing this, it would seem logical to suggest this may indeed extend the life expectancy of the sufferer.

Galantamine and other conditions

Galantamine is also capable of relieving sore muscles and helps to alleviate neuromuscular conditions such as neuritis and neuralgia. This link to muscular function is not surprising given that acetylcholine is the primary neurotransmitter of the peripheral nervous system for both skeletal and smooth muscles (smooth muscles are those found in the walls of most internal organs) and, as we have previously discussed, galantamine acts to increase acetylcholine levels. Galantamine also acts as a muscle stimulant.

Research suggests that galantamine may also have a role in overcoming jet lag, fatigue syndromes, and maybe even impotence.

Galantamine really is quite amazing - who would have thought that spring flowers could have such an impact on your health and well being and play a leading role in the fight against AD and the devastation that it and similar dementias can cause to people’s lives?

Dosage

It is usuval to start with a low dose and then your health care provider can adjust as necessary. It should be taken orally twice a day, preferably with your morning and evening meals.

Side effects

Galantamine is remarkably well tolerated. Adverse side effects are almost nonexistent - the worst that may occur is mild gastrointestinal upset, such as nausea.

Warnings

You should not take galantamine if you are allergic to any of the ingredients of Reminyl (or Razadyne) or have had an allergic reaction to the medication in the past. Do not take this medication if you have or have had severe liver or kidney disease or significant combined liver and kidney problems.

Do not take Reminyl (or Razadyne) if you are already taking any medications or supplements (either prescription or over the counter) without first discussing this further with your doctor/pharmacist. You should also obtain advice from your doctor before taking galantamine if you have a heart disorder, stomach ulcer or duodenal ulcer, suffer from acute abdominal pain, galactose intolerance, lactase deficiency or glucose-galactose malabsorption problems, epilepsy, respiratory diseases that affect breathing (like asthma), experience difficulties in passing urine or have had a recent operation on the gut or bladder. You should also obtain medical advice before taking galantamine if you are pregnant, trying to become pregnant or if you are breast feeding.

You should not drive or operate machinery while taking Reminyl (Razadyne).

Manufacturer's Insert

REMINYL ®

Reminyl ® 4 mg, 8mg and 12 mg Tablets (galantamine hydrobromide). This leaflet contains important information. Please read it carefully before taking your medicine. If you are a carer and will be giving Reminyl ® to the person you look after, it is also important that you read this leaflet on their behalf. If you have any questions or concerns after reading the leaflet, speak to your doctor or pharmacist.

WHAT IS REMINYL ®?

The name of this medicine is Reminyl ®, it contains the active ingredient galantamine hydrobromide. Reminil ® comes in 3 different strengths of tablets, as indicated below:

• the off-white tablets contain 4 mg galantamine and are marked G4;
• the pink tablets contain 8 mg galantamine and are marked G8;
• the orange-brown tablets contain 12 mg galantamine and are marked G12;

The tablets also contain the inactive ingredients colloidal anhydrous silica, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, propylene glycol, talc and titanium dioxide (E111). The tablets contain the following colouring agents: 4mg tablets: yellow ferric oxide (E172); 8 mg tablets: red ferric oxide (E172); 12 mg tablets: red ferric oxide (E172) and orange yellow S aluminium lake (E110). Warning: The colouring E110 in the 12mg tablets can cause an allergic reaction, like asthma, in some people. An allergic reaction to E110 is more likely in people who are allergic to aspirin (acetylsalicylic acid). Speak to your doctor for advice before taking any tablets. The 4 mg tablets come in packs of 14 tablets, the 8 mg tablets in packs of 14 or 56 and the 12 mg tablets in packs of 56 or 168. The marketing authorization for Reminyl ® is held by Shire Pharmaceuticals Limited, East Anton, Andover, Hampshire SP10 5RG, UK. The tablets are manufactured by Janssen-Cilag SpA, Via C Janssen, Borgo San Michelle, 04010 Latina, Italy.

WHAT IS REMINYL ® FOR?

Reminyl ® is used to treat the symptoms of mild to moderately severe dementia of the ~ Alzheimer type, a disease that alters brain function. The symptoms include progressive memory loss, increasing confusion and behavioral changes. As a result, sufferers find it becomes more and more difficult to carry out their normal daily activities. Symptoms of dementia of the A1zheimer type are believed to be related to a lack of acetylcholine, a substance responsible for sending messages between brain cells. Reminyl ® works by increasing the amount of acetylcholine in the brain and so improves the symptoms of the disease.

WHEN REMINYL ® SHOULD NOT BE USED?

Reminyl ® should not be taken:

By people who have had an allergic reaction to galantamine (Reminyl ®) or to any of the other ingredients. Check the ingredients by reading the section above called 'What is Reminyl ®'. An allergic reaction may be recognised as a rash, itching, swollen face or lips, or shortness of breath- By people who have either severe liver or severe kidney disease. By people who have significant, combined liver and kidney problems. Speak to your doctor if you suffer from these problems or have suffered from them in the past.

BEFORE TAKING REMINYL ®

Medicines are not always suitable for everyone. Do you have any of the following conditions? Have you suffered from these in the past? Liver or kidney problems; Heart disorders; Stomach ulcer or duodenal ulcer; Acute abdominal pain; Epilepsy; Respiratory diseases that affect breathing (like asthma); A recent operation on the gut or bladder or difficulties in passing urine; Galactose intolerance, lactase deficiency or glucose-galactose malabsorption. As Reminyl ® contains lactose it may not be suitable for you.
If the answer to any of these questions is 'Yes', speak to your doctor for advice before any Reminyl ® is taken.
Your doctor will decide whether this medicine is suitable for you. Your doctor may adjust the amount of medicine that you take.
If you are pregnant, trying to become pregnant or breast-feeding, do not take any Reminyl ® before speaking to your doctor for advice. If you need to have a general anesthetic for an operation, tell the doctor that Reminyl ® is being taken.
Reminyl ® is not recommended for children. Reminyl ® is not recommended for driving or operating machinery(Reminyl ® as well as the disease itself, can affect the ability to drive or operate machinery. Please discuss this with your doctor).

OTHER MEDICINES:

Always tell the doctor; nurse or pharmacist if any other medicines are being taken because taking some medicines together can be harmful.
Reminyl ® should not be taken with other medicines that act the same way. If medicines for diarrhea, Parkinson's disease or asthma are taken, check with your doctor to see if these affect Reminyl ®. Tell your doctor if drugs for certain heart disorders or high blood pressure (e.g. digoxin or the so-called beta-blockers) are being taken.
Your doctor may prescribe a smaller dose of Reminyl ® if certain drugs are being taken at the same time (for example certain antidepressants (such as paroxetine, fluoxetine or fluvoxamine), quinidine (used for heart rhythm problems), ketoconazole (an antifungal or ritonavir (a treatment for HIV).

If you are not sure, speak to your doctor or pharmacist for advice.

HOW TO TAKE REMINYL ®

Reminyl ® should be taken by mouth. It should be taken twice a day, preferably with morning and evening meals.
Reminyl ® is usually started at a low dose. Your doctor may then slowly increase the amount of Reminyl ® that you take to find the most suitable dose for you.
Treatment with Reminyl ® is usually started at a dose of 4 mg taken twice daily. This dose will be taken for at least four weeks. Your doctor will then increase the dose to 8mg taken twice daily. This dose will be taken for at least 4 weeks. If your doctor decides to increase your dose again, you should take 12 mg twice daily.
What if a dose of Reminyl ® is forgotten?
If a dose is missed, the next dose should be taken as usual. Then continue as before. If more than one dose has been missed, contact your doctor for advice. Do not take 2 doses at the same time to make up for a missed dose.

OVERDOSE:

If too much Reminyl ® has been taken, contact a doctor or hospital straightaway. Take any remaining tablets and the packaging with you.

AFTER TAKING THIS MEDICINE:

If undesired effects such as nausea and vomiting 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 are experiencing these effects your doctor may recommend that you drink more liquids and, if necessary, they may prescribe medicine to stop you being sick.
Other possible side effects include: abdominal pain, diarrhea, indigestion, decreased appetite and weight loss. Also, headache, dizziness, tiredness, sleepiness or sleeplessness and confusion might be experienced as well as a runny or blocked nose, a urinary tract infection and falling, sometimes resulting in injury.
In very rare cases trembling has occurred. A slow heartbeat or fainting has also been reported. Should such symptoms be experienced, contact a doctor as medical assistance might be necessary.
Do not be alarmed by this list of possible side effects. You may not have any of them. Tell your doctor or pharmacist if you are worried or think that Reminyl ® is causing you any problem.

HOW TO STORE REMINYL ®

As with all medicines, Reminyl ® should be kept in a safe place where children cannot see or reach it. There are no special storage instructions for Reminyl ® tablets. Medicines can be kept for a limited period only. Therefore, do not use Reminyl ® after the date printed on the packaging. Always return any leftover medicines to your pharmacist.