Galantamine Orion - Galantamine uses, dose and side effects

Galantamine Orion contains the active substance “galantamine”, a dementia medicine. It is used in adults to treat the symptoms of mild to moderate Alzheimer’s disease, a type of dementia that affects brain function.

Alzheimer’s disease leads to increasing memory disorders, confusion, and behavioral changes that make it increasingly difficult to cope with everyday activities. These effects are thought to be caused by a deficiency of acetylcholine, a substance that is responsible for transmitting signals between brain cells. Galantamine Orion increases the amount of acetylcholine in the brain and treats the signs of the disease.

The capsules are designed as prolonged-release capsules. This means that the release of one of the drugs takes place at a slower rate.

Galantamine contained in Galantamine Orion may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

2. What you need to know before you use Galantamine Orion

Do not use Galantamine Orion

Do not take Galantamine Orion

• 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 kidney disease

Warnings and cautions

Talk to your doctor or pharmacist before taking Galantamine Orion.

This medicine is used only for Alzheimer’s disease and is not recommended for other types of memory disorders or confusion.

Serious side effects are

Galantamine Orion can cause severe skin reactions, heart problems, and seizures. You must be aware of these side effects when taking Galantamine Orion. See “Pay attention to serious side effects” in section 4.

Before taking Galantamine Orion, your doctor must tell you if you have, or have had, any of the following:

liver or kidney problems
heart problems (such as chest discomfort that often occurs as a result of physical activity, heart attack, heart failure , slow or irregular heartbeat)
changes in electrolyte levels (chemical substances found naturally in the blood, such as potassium )
gastric ulcer
blockage in the stomach or intestines
any disease of the nervous system (such as epilepsy or Parkinson’s disease )
any lung disease or infection that affects breathing (such as asthma , obstructive pulmonary disease, or pneumonia )
problems urinating.

Your doctor will decide if Galantamine Orion is right for you, or if your dose needs to be changed.

Also tell your doctor if you have recently had surgery on your stomach, intestines, or bladder. Your doctor may decide that Galantamine Orion is not suitable for you.

Galantamine Orion may cause weight loss. Your doctor will check your weight regularly while you are taking Galantamine Orion.

Children and young people

Galantamine Orion is not recommended for use in children and adolescents.

Other medicines and Galantamine Orion

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

Galantamine Orion should not be used with other medicines that work in a similar way. These medicines include:

donepezil or rivastigmine (for Alzheimer’s disease )
ambenone, neostigmine or pyridostigmine (in severe forms of muscle weakness)
pilocarpine (taken by mouth in case of dry mouth or eye dryness).

Some medicines can cause side effects to become more common in people taking Galantamine Orion. These medicines include:

paroxetine or fluoxetine (antidepressant)
quinidine (for irregular heartbeat)
ketoconazole (an antifungal agent)
erythromycin (an antibiotic )
ritonavir (against human immunodeficiency virus or HIV )
analgesic drugs of the NSAID -type (non-steroidal antiinflammatory / antirheumatic drugs as ibuprofen ) which can increase the risk of gastric ulcer
medicines for heart problems or high blood pressure (such as digoxin , amiodarone , atropine, beta-blockers or calcium channel blockers ). If you are taking medicines for an irregular heartbeat, your doctor may check your heart with an ECG ( electrocardiogram ).

Your doctor may give you a lower dose of Galantamine Orion if you are taking any of these medicines.

Galantamine Orion may affect certain anesthetics. If you are going to have an operation that requires anesthesia, you must tell your doctor well in advance that you are taking Galantamine Orion.

If you have any further questions, ask your doctor or pharmacist.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, 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 using Galantamine Orion.

Driving and using machines

Galantamine Orion may make you feel dizzy or tired, especially during the first few weeks of treatment. If Galantamine Orion affects you, do not drive or use any tools or machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Galantamine Orion

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

If you are currently taking galantamine in the form of tablets or oral solution, and have been told by your doctor to switch to Galantamine Orion prolonged-release capsules, read the instructions under “Switching from galantamine tablets or oral solution to Galantamine Orion prolonged-release capsules” in this section.

How much should you take?

You start treatment with Galantamine Orion in a low dose. The usual starting dose is 8 mg once a day. Your doctor may gradually increase your dose every 4 weeks or more until you reach a dose that is right 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 think Galantamin Orion is too strong or too weak, talk to your doctor or pharmacist.

Your doctor will need to see you at regular intervals to check that the medicine is working and to talk to you about how you are feeling.

If you have liver or kidney problems, your doctor may give you a lower dose of Galantamine Orion or decide that this medicine is not suitable for you.

Switching from galantamine tablets or oral solution to Galantamine Orion prolonged-release capsules

If you are currently taking galantamine tablets or oral solution, your doctor may decide to switch you to Galantamine Orion prolonged-release 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 Galantamine Orion prolonged-release capsules.

DO NOT TAKE more than 1 prolonged-release capsule per day. While using Galantamine Orion-release capsules dosage 1 time per day, DO NOT take galantamine tablets or oral solution.

How to take Galantamine Orion

Galantamine Orion prolonged-release capsules must be swallowed whole and must NOT be chewed or crushed. Take a dose of Galantamine Orion once daily in the morning, with water or other liquid. Try taking Galantamine Orion with food.

Drink plenty of fluids while taking Galantamine Orion to avoid dehydration.

If you use more Galantamine Orion than you should

If you take more Galantamine Orion than you should contact your doctor or hospital immediately. Take any remaining prolonged-release capsules and packing with you. Signs of overdose may be:

severe nausea and vomiting
weak muscles, slow heartbeat, seizures and unconsciousness.

If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you forget to use Galantamine Orion

If you forget to take a dose , skip that dose completely and take the next dose at the usual 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 using Galantamine Orion

Check with your doctor before stopping Galantamine Orion. It is important that you continue to take this medicine to treat your condition.

If you have any further questions on the use of this product, ask your doctor or pharmacist .

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Pay attention to the serious side effect s

Stop taking Galantamine Orion and see a doctor immediately or see your nearest emergency department if you notice any of the following:

Skin reactions , including:

Severe skin rash with blisters and flaky skin, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome ).
Red rash covered with small blisters that can spread over the body, sometimes with fever ( acute generalized exanthematous pustulosis ).
Rash that can form blisters, with spots that resemble small targets.These skin reactions are rare in people taking Galantamine Orion (may affect up to 1 in 1,000 people).

Heart problems including changes in heart rate (such as slow beats or extra beats) or palpitations (fast or uneven heart rhythm). Heart problems can be seen as an abnormal curve on an electrocardiogram ( ECG ) and can be common among people taking Galantamine Orion (may affect up to 1 in 10 users).

Seizures. These are less common among people taking Galantamine Orion (may affect up to 1 in 100 people).

You must stop taking Galantamine Orion and seek help immediately if you notice any of the side effects listed above.

Other side effects are

Very common side effects (may affect more than 1 user in 10)

nausea and vomiting. These side effects are more likely to occur in the first few weeks of treatment or when the dose is increased . It usually disappears gradually as the body gets used to the drug, and they generally last only a few days. If you experience such side effects , your doctor may recommend that you drink more fluids, and you may be prescribed nausea medication.

Common side effects (may affect up to 1 in 10 people)

decreased appetite, weight loss
see, feel and hear things that do not exist (hallucinations)
Depression
dizziness or fainting
muscle tremors or muscle spasms
headache
extreme fatigue, weakness or general malaise
extreme sleep with low energy
high blood pressure
pain or discomfort in the stomach
diarrhea
digestive problems
case
wound.

Uncommon side effects (may affect up to 1 in 100 people)

allergic reaction
insufficient water in the body (dehydration)
tingling or numbness in the skin
taste changes
daytime sleepiness
dimsyn
earring that does not disappear ( tinnitus )
low blood pressure
hemorrhage
feeling sick (nausea)
heavy sweating
weak muscles
elevated levels of liver enzymes in the blood.

Rare side effects (may affect up to 1 in 1,000 people)

inflammation of the liver ( hepatitis ).

Reporting of side effects is
if you get side effects are, speak with your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects , you can help increase the safety of medicines.

The Medical Products Agency

Box 26

751 03 Uppsala

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Galantamine Orion

Keep this medicine 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 expiration date is the last day of the specified month.

No special storage instructions.

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 packaging and other information

Content declaration

The active substance is galantamine.

• Each Galantamine Orion 8 mg hard prolonged-release capsule contains galantamine hydrobromide equivalent to 8 mg galantamine

• Each Galantamine Orion 16 mg hard prolonged-release capsule contains galantamine hydrobromide equivalent to 16 mg galantamine

• Each Galantamine Orion 24 mg hard prolonged-release capsule contains galantamine hydrobromide equivalent to 24 mg galantamine

Other ingredients are:

Capsule contents

Microcrystalline cellulose, hypromellose, ethylcellulose, magnesium stearate

Capsule cover

8 mg: gelatin, titanium dioxide (E171)

16 mg: gelatin, titanium dioxide (E171), red iron oxide (E172).

24 mg: gelatin, titanium dioxide (E171), indigo carmine (E132), erythrosine (E127), red iron oxide (E172), yellow iron oxide (E172).

What the medicine looks like and contents of the pack

Galantamine Orion prolonged-release hard capsules are available in three strengths and each is recognizable by its color:

8 mg: white capsules containing a round biconvex prolonged-release tablet
16 mg pale pink capsules content spirit two round biconvex release tablet s
24 mg orange capsules content spirit three circular biconvex release tablet s

The capsules are available in blister packs of 28, 84, 112 or 300 prolonged-release capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Orion Corporation

Orionintie 1

02200 Espoo

Finland

Manufacturer