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Product

Therapeutic Category

Galantamine-Hydrobromide-Tablets-USP
Galantamine-Hydrobromide-12mgTablets-USPGalantamine-Hydrobromide-8mgTablets-USPGalantamine-Hydrobromide-4mgTablets-USP

Galantamine Hydrobromide Tablets, USP

GALANTAMINE (ga LAN ta meen) is used to treat mild to moderate dementia caused by Alzheimer's disease.


UK Generic Name

Galantamine Hydrobromide Tablets, USP


Packing


Therapeutic Category

Parasympathomimetic (Cholinergic) Agents


Storage

This medicine does not require any special storage conditions.


adobe-pdf-logoProduct Insert(PIL)

adobe-pdf-logoPrescribing Information(SPC)


Product Description

Product Overview


What is Galantamine

GALANTAMINE (ga LAN ta meen) is used to treat mild to moderate dementia caused by Alzheimer’s disease.

Galantamine Hydrobromide Tablets, USP Galantamine 4 mg tablets
Galantamine 8 mg tablets
Galantamine 12 mg tablets

WHAT GALANTAMINE IS AND WHAT IT IS USED FOR

Galantamine 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. Galantamine increases the amount of acetylcholine in the brain and treats the signs of the disease.

Galantamine Hydrobromide Tablets







WHAT YOU NEED TO KNOW BEFORE YOU TAKE GALANTAMINE

Do not take Galantamine
• if you are allergic to galantamine or to any of the other ingredients of this medicine.
• if you have severe liver or severe kidney disease.

WARNINGS AND PRECAUTIONS

Talk to your doctor or pharmacist before taking Galantamine. This medicine is only used in Alzheimer’s disease, and is not recommended for other types of memory loss or confusion.

SERIOUS SIDE EFFECTS

Galantamine can cause heart problems, fits (seizures). You must be aware of these side effects while you are taking Galantamine. See ‘look out for serious side effects’
Before you take Galantamine, 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)

Your doctor will decide if Galantamine 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 Galantamine is not suitable for you
Galantamine can cause weight loss. Your doctor will check your weight regularly while you are taking Galantamine.

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

Other medicines and Galantamine

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Galantamine 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 Galantamine. 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 Galantamine if you are taking any of these medicines.

Galantamine may affect some anaesthetics. If you are going to have an operation under a general anaesthetic, tell the doctor that you are taking Galantamine, 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 breastfeed while you are taking Galantamine.

Driving and using machines
Galantamine may make you feel dizzy or sleepy, especially during the first few weeks of treatment. If Galantamine affects you, do not drive or use any tools or machinery.
Galantamine 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.
Galantamine 12 mg (orange –brown) tablets contain orange-yellow S aluminium lake
The colouring in these tablets may cause allergic reaction.

How to take Galantamine tablets

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 Galantamine at a low dose. The usual starting dose is 4mg, taken twice a day (a total of 8 mg 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 12 mg, 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 Galantamine 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 Galantamine, or may decide this medicine is not suitable for you.

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

If you take more Galantamine than you should
If you take too much Galantamine, 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,
• weak muscles, slow heart beat, fits (seizures) and loss of consciousness.

If you forget to take Galantamine
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 Galantamine
Check with your doctor before you stop taking Galantamine. 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 Galantamine and see a doctor immediately if you notice any of the following:
• 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 Galantamine (may affect up to 1 in 10 people).
• Fits (seizures). These are uncommon in people taking Galantamine (may affect up to 1 in 100 people).

OTHER SIDE EFFECTS:

Very Common side effects (may affectmore than1 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.

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
• Stomach pain or discomfort
• Diarrhoea

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

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 or pharmacist. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly (see details below). By reporting side effects you help provide more information on the safety of this medicine.

HOW TO STORE GALANTAMINE

Keep 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 after EXP.
The expiry date refers to the last day of that month.
This medicine 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 to protect the environment.

Contents of the pack and other information

WHAT GALANTAMINE CONTAINS:

• The active substance is galantamine. Each tablet contains 4mg, 8mg or 12 mg of galantamine (as hydrobromide).

• The other ingredients are:

Colloidal anhydrous silica, crospovidone, lactose monohydrate, magnesium stearate and microcrystalline cellulose, hypromellose, propylene glycol, talc and titanium dioxide (E171).
The 4mg tablet also contain yellow ferric oxide (E172),
The 8mg tablets also contains red ferric oxide (E172),
The12 mg tablets also contain red ferric oxide (E172) and orange-yellow TAJ aluminium lake (E110).

What Galantamine looks like and contents of the pack
Galantamine 4 mg tablets are off-white, round tablets and marked ‘G4’ on one side and ‘TA’ on the other side. Each pack contains blisters of 14 or 56 tablets.
Galantamine 8 mg tablets are pink, round tablets marked ‘G8’ on one side and ‘TAJ’ on the other side. Each pack contains blisters of 14, 56, or 112 tablets.
Galantamine 12 mg tablets are orange-brown, round and marked ‘G12’ on one side and ‘TAJ’ on the other side. Each pack contains blisters of 56, 112 or 168 tablets.

Not all pack sizes may be marketed.

Galantamine Hydrobromide Tablets, USP

Manufactured For: TAJDEAROB PHARMACEUTICALS LTD.
ADENT-ABURI HIGH WAY ADENTA ACCRA GHANA.

Galantamine Hydrobromide Tablets, USP

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Taj Dearob Pharmaceuticals is an Ghana based pharmaceutical company that markets a broad range of innovative therapeutic medicines including UK Generics, high-end Oncology products, more info.