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Reminyl (galantamine hydrobromide)

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Reminyl® is a brand name for galantamine, which is a phytonutrient extracted from the common snowdrop plant.

It’s been shown to act as an acetylcholinesterase inhibitor and block the age-related breakdown of the neurotransmitter acetylcholine (ACh). This has important implications for those concerned with Alzheimer’s since galantamine can improve ACh levels and it is the principal neurotransmitter ‘lost’ in the disease. Accordingly, this has become the principle use and focus for galantamine around the world.

In addition, galantamine also supports proper nicotinic receptor activity, an effect known to influence memory function. It may be this action that has led to it being utilised for other generalised states of vascular dementia. 

Other off-label uses for galantamine have been detailed for the alleviation of depression. There is also anecdotal evidence that points to galantamine having a potential role in weight loss, due to its appetite suppressant effects.

This leaflet contains important information. Please read it carefully before use. 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. Reminyl 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). Note: The coloring 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.

 

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 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 your 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 8 mg taken twice daily. This dose will be taken for at least 4 weeks. Your doctor may decide to increase your dose again.

 

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 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

 

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.

 

KEEP OUT OF REACH OF CHILDREN

Label

Package leaflet: Information for the user

Reminyl® 8mg Tablets
(galantamine hydrobromide)
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 name of your medicine is Reminyl 8mg Tablets but will be referred to as Reminyl throughout this leaflet. Please note that this leaflet also contains information about other strengths such as Reminyl 4mg and 12mg Tablets.

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

1. What Reminyl is and what it is used for:  
Reminyl contains the active substance ‘galantamine hydrobromide’, 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.

These effects are thought to be caused by a lack of ‘acetylcholine’, a substance responsible for sending messages
between brain cells. Reminyl increases the amount of acetylcholine in the brain and treats the signs of the disease.

Alzheimer’s disease causes increasing memory loss, confusion and behavioural changes which make it increasingly difficult to carry out normal daily activities.

2. What you need to know before you take Reminyl:
Do not take Reminyl if you are allergic to galantamine or to 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 or pharmacist before taking Reminyl. This medicine is only used in Alzheimer’s disease, and is not recommended for other types of memory loss or confusion.

Serious side effects
Reminyl can cause serious skin reactions, heart problems, fits (seizures). You must be aware of these side effects while you are taking Reminyl. See ‘look out for serious side effects’ in section 4.
Before you take Reminyl, 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) 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 Parkinson’s disease)
a respiratory disease or infection that affects breathing (such as asthma, obstructive pulmonary disease or
pneumonia) problems passing urine Your doctor will decide if Reminyl 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 Reminyl is not suitable for you Reminyl can cause weight loss. Your doctor will check your weight regularly while you are taking Reminyl.

Children and adolescents
Reminyl is not recommended for children and adolescents.

Other medicines and Reminyl
Tell your doctor or pharmacist if you are taking or have recently taken or might take
any other medicines. Reminyl should not be used with medicines that work in a similar way, these include:

donepezil or rivastigmine (forAlzheimer’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 Reminyl.
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).

Your doctor may give you a lower dose of Reminyl if you are taking any of these medicines.
Reminyl may affect some anaesthetics. If you are going to have an operation under a general anaesthetic, tell the doctor that you are taking Reminyl, 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 Reminyl. Driving and using machines Reminyl may make you feel dizzy or sleepy, especially during the first few weeks of treatment. If Reminyl affects you, do not drive or use any tools or machinery.

Reminyl tablets contain lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Reminyl 12mg (orange –brown) Tablets contain orange-yellow S aluminium lake The colouring in these tablets may cause allergic reaction.

3. How to take Reminyl Always take this medicine exactly as your doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.


How much to take: You will start treatment with Reminyl at a low dose. The usual starting dose is 4mg, taken twice a day (a total of 8mg 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 12mg, taken twice a day (a total of 24mg 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 Reminyl 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.

If you have a liver or kidney problems, your doctor may give you a reduced dose of Reminyl, or may decide this medicine is not suitable for you. weak muscles, slow heart beat, fits (seizures) and loss of consciousness. If you forget to take Reminyl

How to take:  Take your dose of Reminyl twice a day, in the morning and evening, with water
or other liquids. Try to take Reminyl with food. Drink plenty of liquids while you are taking Reminyl, to keep yourself hydrated.

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 take more Reminyl than you should Check with your doctor before you stop taking Reminyl. It is important to continue taking this medicine to treat your condition.

If you take too much Reminyl, contact a doctor or hospital straight away. Take any remaining tablets and the packaging with you. The signs of overdose may include, severe nausea and vomiting, If you stop taking Reminyl

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.

Common side effects (may affect more than 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

Look out for serious side effects Stop taking Reminyl 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 (StevensJohnson syndrome).
- Red rash covered with small pus-filled bumps that can spread over the body, sometimes with a fever (acute
generalized exanthematous pustulosis).
- Rash that may blister, with spots that look like small targets.
These skin reactions are rare in people taking Reminyl (may affect up to 1 in 1,000 people).

Uncommon side effects (may affect up to 1 in 100 people):
- Allergic reaction
- Not enough water in the body (dehydration)
- Tingling or numb feeling of the skin (pins and needles)
- Change in sense of taste
- Daytime sleepiness
- 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

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 Reminyl (may affect up to 1 in 10 people). Fits (seizures). These are uncommon in
people taking Reminyl (may affect up to 1 in 100 people).

You must stop taking Reminyl 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 medicines 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.

Rare side effects (may affect up to 1 in1,000 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 at: www.mhra.gov.uk/yellowcard By reporting side effects you help provide more information on the safety of this medicine.

5. How to store Reminyl:
There are no special storage conditions for Reminyl.

Keep out of the sight and reach of children. Do not take your tablets after the expiry date which is stated on the carton and blister label after ‘Exp’. The expiry date refers to the last day of that month.

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. If your tablets become discoloured or show any signs of deterioration, you should seek the advice of your pharmacist

6. Contents of the pack and other information What Reminyl contains:
Reminyl contain 8mg galantamine (as hydrobromide) as the active ingredient.

The tablets also contain the inactive ingredients:
colloidal anhydrous silica, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose,
hypromellose, propylene glycol, talc, titanium dioxide (E171) and red ferric oxide (E172).

What Reminyl looks like and contents of the pack Reminyl film-coated tablets are available in three strengths, each of which can be recognized by its colour and lettering: The tablets are pink in colour and biconvex
with the inscription ‘JANSSEN’ on one side and ‘G8’ on the other side. The tablets come in blister packs of 56 tablets.

Manufactured by: Janssen-Cilag SpA, Via
C Janssen, 04010 Borgo San Michelle,
Latina, Italy.

 

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