Galantagen Retard 24 mg, capsules met verlengde afgifte, hard

Galantagen Retard is an anti dementia medicine used to treat the symptoms of mild to moderately severe dementia of the Alzheimer type, a disease that alters brain function.

The symptoms of Alzheimer’s disease include increasing memory loss, confusion and behavioural changes. As a result, it becomes more and more difficult to carry out normal daily activities.

These symptoms are believed to be due to a lack of acetylcholine, a substance responsible for sending messages between brain cells. Galantagen Retard increases the amount of acetylcholine in the brain and so could improve the symptoms of the disease.

The capsules are made in a “prolonged-release” form. This means that they release the medicine slowly.

Do not take Galantagen Retard

• If you are allergic (hypersensitive) to galantamine or any of the other ingredients of this medicine (listed in section 6).
• If you have severe liver and/or kidney disease

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Warnings and precautions

Talk to your doctor before taking Galantagen Retard.

Galantagen Retard should be used in Alzheimer’s disease and not other forms of memory loss or confusion.

Medicines are not always suitable for everyone. Your doctor needs to know before you take Galantagen Retard if you suffer from or have suffered in the past from any of the following conditions:

• liver or kidney problems
• heart disorders(e.g. angina, heart attack, heart failure, slow or irregular pulse)
• electrolyte disturbances (if your blood potassium levels are decreased or increased)
• peptic (stomach) ulcer disease
• acute abdominal pain
• a disorder of the nervous system (like epilepsy or Parkinson’s disease)
• respiratory diseases or infection that interferes with breathing (like asthma, obstructive pulmonary disease or pneumonia)
• if you recently had an operation on the gut or bladder
• if you have difficulties in passing urine

If you need an operation, which requires a general anaesthetic, you should inform the doctor that you are taking Galantagen Retard.

Your doctor will then decide whether treatment with Galantagen Retard is suitable for you or if the dose needs to be changed.

Other medicines and Galantagen Retard

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

Galantagen Retard 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 muscular weakness)
• pilocarpine (for dry mouth or dry eyes) if taken by mouth

Some medicines can affect the way Galantagen Retard works, or Galantagen Retard itself can reduce the effectiveness of other medicines taken at the same time. Your doctor may prescribe a smaller dose of Galantagen Retard if you are taking any of those medicines. These include:

• paroxetine or fluoxetine (antidepressants)
• quinidine (used for heart rhythm problems)
• ketoconazole (antifungal)
• erythromycin (antibiotic)
• ritonavir (antiviral – HIV protease inhibitor)

Some medicines can increase the number of side effects caused by Galantagen Retard, these include:

• non-steroidal anti-inflammatory painkillers (e.g. ibuprofen) which can increase the risk of ulcers
• medicines taken for heart disorders or high blood pressure (e.g. digoxin, amiodarone, atropine, beta-blockers, or calcium channel blocking agents). If you take medicines for an irregular heartbeat, your doctor may consider an electrocardiogram (ECG).

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If you need an operation, which requires general anaesthetic, please inform your doctor that you are taking Galantagen Retard.

If you have any questions, speak to your doctor or pharmacist for advice.

Galantagen Retard with food and drink

Galantagen Retard should be taken with food if possible.

Drink plenty of liquids during your treatment with Galantagen Retard, to keep yourself hydrated. See section 3 of this leaflet for full details about how to take this medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

You should not breastfeed while you are taking Galantagen Retard .

Driving and using machines

Galantagen Retard may cause dizziness or drowsiness, especially during the first few weeks of treatment. If you experience these symptoms, do not drive or use any tools or machinery.

Galantagen Retard contains Allura Red AC (E 129)

This product contains Allura Red AC (E 129, an azo colouring agent) may cause allergic reactions.

Always take Galantagen Retard exactly as your doctor has told you. Check with your doctor 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 Galantagen Retard read the instructions at the end of this section carefully.

How to take Galantagen Retard

Galantagen Retard should be swallowed whole, NOT chewed or crushed. Galantagen Retard should be taken in the morning, with water or other liquids, and preferably with food.

Galantagen Retard is available in 3 strengths: 8 mg, 16 mg and 24 mg. Galantagen Retard is started at a low dose. Your doctor may then tell you to slowly increase the dose (strength) of Galantagen Retard that you take to find the most suitable dose for you.

1. The recommended starting dose is 8 mg capsule taken once daily. After 4 weeks of treatment, the dose is increased
2. You would then take the 16 mg capsule once daily. After another 4 weeks of treatment at the earliest, your doctor may decide to increase the dose again
3. You would then take the 24 mg capsule once daily.

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Your doctor will explain what dose to start with and when the dose should be increased. If you feel that the effect of Galantagen Retard 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. Your doctor will also check your weight regularly while you are taking Galantagen Retard.

Liver or kidney disease

• If you have mild liver or kidney disease, treatment is started with the 8 mg capsule once daily in the morning
• If you have moderate liver disease, treatment is started with the 8 mg capsule once every other day in the morning. After one week, begin taking the 8 mg capsule once daily in the morning. Do not take more than 16 mg once daily
• If you have severe liver and/or kidney disease, do not take Galantagen Retard

If you take more Galantagen Retard than you should

If you take too much Galantagen Retard, contact a doctor or hospital straight away. Take along any remaining capsules and the packaging with you. Signs or symptoms of overdose may include: sever nausea, vomiting, muscle weakness, slow heartbeat, seizures and loss of consciousness.

If you forget to take Galantagen Retard

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, you should contact your doctor.

If you stop taking Galantagen Retard

You should consult your doctor before you stop taking Galantagen Retard. 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.

If you are currently taking Galantamine tablets or oral solution, your doctor may decide to switch you to Galantagen Retard.

• Take your last dose of Galantamine tablets or oral solution in the evening
• The next morning, take your first dose of Galantagen Retard .

DO NOT take more than one capsule in a day. While you are taking once-daily Galantagen Retard, DO NOT take Galantamine tablets or oral solution.

Children

Galantagen Retard is not recommended for children.

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Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be due to the disease itself.

Stop taking your medicine and see a doctor immediately if you experience:

• Heart problems including changes in heart beat (slow or irregular) (uncommon)
• Palpitations (pounding heart beat)(uncommon)
• Disturbance in the mechanism of conducting impulses in the heart (uncommon)
• Conditions like blackout (uncommon)
• Fits (uncommon)
• Allergic reaction. Signs include rash, itching or hives, swelling of the face, lips, tongue, shortness of breath (uncommon)
• Inflammation of the liver (hepatitis) (rare)

Common: may affect up to 1 in 10 people

• Weight loss
• Loss of appetite
• Decreased appetite
• Feeling faint
• Dizziness
• Trembling
• Headache
• Drowsiness
• Abnormally tired
• Stomach pain or discomfort
• Diarrhoea
• Indigestion
• Increased sweating
• Muscle spasms
• Falling
• High blood pressure
• Feeling weak
• General feeling of discomfort
• Seeing, feeling, or hearing things that are not real (hallucinations)
• Feeling sad (depression).

Uncommon: may affect up to 1 in 100 people

• Increased liver enzymes in the blood (laboratory test result that tells how well your liver is working)
• Tingling, pricking, or numbness of the skin
• Change in the sense of taste
• Excessive sleepiness
• Blurred vision
• Ringing or buzzing in the ears (tinnitus)
• Feeling the need to vomit
• Muscle weakness
• Excessive water loss in the body
• Low blood pressure

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 Reddening of the face

Other side effects:

Very common: affects more than 1 user in 10

• Feeling sick and/or vomiting. If these undesired effects 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 have these effects, your doctor may recommend that you drink more liquids and, if necessary, may prescribe a medicine to stop you being sick.

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 via the national reporting system. By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the label, carton and blister after the letters EXP. The expiry date refers to the last day of that month.

If your medicine is packaged in Aluminum/Aluminum blisters:

Store in the original carton to protect from moisture.

If your medicine is packaged in PVDC blisters:

Do not store above 25 ºC. Store in the original carton to protect from moisture

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.

6. Contents of the pack and other information

What Galantagen Retard contains:

The active substance is galantamine

• Galantagen Retard 8 mg hard prolonged release capsules contains 8 mg galantamine (as hydrobromide).
• Galantagen Retard 16 mg hard prolonged release capsules contains 16 mg galantamine (as hydrobromide).
• Galantagen Retard 24 mg hard prolonged release capsules contains 24 mg galantamine (as hydrobromide).

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The other ingredients are:

Tablet core (Contents of the capsule): Polyvinyl acetate, silica colloidal anhydrous, povidone, hydrogenated vegetable oil, sodium lauryl sulphate and magnesium stearate.

Capsule Shell:

Gelatin, titanium dioxide (E171), Allura Red AC (E129)

Printing Ink: Shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).

What Galantagen Retard looks like and contents of the pack

Galantagen Retard is available in three strengths, each of which can be recognised by its lettering:

Galantagen Retard 8 mg hard prolonged release capsules are hard gelatin capsules with a white body and pink cap, printed in black ink ‘MYLAN’ over ‘GT8’ on the body and the cap.

Galantagen Retard 16 mg hard prolonged release capsules are hard gelatin capsules with a white body and pink cap, printed in black ink ‘MYLAN’ over ‘GT16’on the body and the cap.

Galantagen Retard 24 mg hard prolonged release capsules are hard gelatin capsules with a white body and pink cap, printed in black ink ‘MYLAN’ over ‘GT24’ on the body and the cap.

The 8 mg, 16 mg and 24 mg are available in:

• PVDC blisters containing 7, 10, 28, 30, 56, 84, 98, or 100 capsules
• Aluminum/Aluminum blisters containing 7, 10, 28, 30, 56, 84, 98, or 100 capsules

Not all pack sizes may be marketed.

Dit geneesmiddel is ingeschreven in het register onder nummer:

RVG 107655 - Galantagen Retard 8 mg

RVG 107656 -Galantagen Retard 16 mg

RVG 107657 -Galantagen Retard 24 mg

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten

Manufacturer

McDermott Laboratories Limited trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13,Ireland

Generics [UK ] Ltd. Station Close, Potters Bar, Hertfordshire, EN6 1TL United Kingdom

This medicinal product is authorised in the Member States of the EEA under the following names:

NL/H/2053/001-003

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Member State	Medicinal Product Name
Italy	Galantamina Mylan 8mg, 16mg and
	24mg
The Netherlands	Galantagen Retard 8mg, 16mg, 24mg,
	capsules met verlengde afgifte, hard

This leaflet was last approved in augustus 2013.

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