8 mg, 16 mg, 24 mg prolonged-release capsules, hard
galantamine
1. What Galantamine Sandoz is and what it is used for
Galantamine Sandoz 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 normal activities. These symptoms are thought to be due to a lack of acetylcholine, a substance that is responsible for transmitting signals between brain cells. Galantamine Sandoz increases the amount of acetylcholine in the brain and treats the symptoms of the disease.
Galantamine contained in Galantamine Sandoz 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 take Galantamine Sandoz
Do not take Galantamine Sandoz
- 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 Galantamin Sandoz.
This medicine is only used for Alzheimer’s disease and is not recommended for any other form of memory disorder or confusion.
Serious side effects are
Galantamine Sandoz can cause serious skin reactions, heart problems, and seizures. You must be aware of these side effects while taking Galantamine Sandoz. See “Pay attention to serious side effects” in section 4.
Before taking Galantamine Sandoz you must tell your doctor if you have or have had any of the following:
- liver or kidney problems
- heart problems (for example, chest discomfort that mainly occurs during physical activity, heart attack, heart failure , slow or irregular heartbeat , prolonged QTc interval )
- altered electrolyte levels (chemical substances found naturally in the blood, eg potassium )
- gastric ulcer disease
- stop in the stomach or intestines
- any disease of the nervous system (eg epilepsy or Parkinson’s disease )
- any lung disease or infection that affects breathing (eg asthma , obstructive pulmonary disease or pneumonia )
- difficulty urinating.
Your doctor will decide if Galantamine Sandoz treatment is right for you or if your dosage 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 Sandoz is not suitable for you.
Galantamine Sandoz can cause you to lose weight. Your doctor will check your weight regularly while you are taking Galantamine Sandoz.
Children and young people
Galantamine Sandoz is not recommended for use in children and adolescents.
Other medicines and Galantamine Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Galantamine Sandoz must 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 case of severe muscle weakness)
- pilocarpine (in the form of tablets for dry mouth or eye).
Some medicines can make it easier to get side effects from Galantamine Sandoz. These medicines include:
- paroxetine or fluoxetine (antidepressant)
- quinidine (in case of irregular heartbeat)
- ketoconazole ( antifungal agent)
- erythromycin (a type of antibiotic )
- ritonavir (used in human immunodeficiency disease, ie HIV )
- analgesics of the NSAID -type (non-steroidal antiinflammatory / antirheumatic agents such as ibuprofen ) which can increase the risk of gastric ulcer
- medicines for heart disease or high blood pressure (eg digoxin , amiodarone , atropine, beta-blockers or calcium channel blockers ). If you are taking medication for an irregular heartbeat, your doctor may want to check your heart with an ECG ( electrocardiogram )
- drugs that affect the QTc interval et.
Your doctor may prescribe a lower dose of Galantamine Sandoz if you are also taking any of these medicines.
Galantamine Sandoz may affect some anesthetics. If you need to have an operation that requires anesthesia, you should inform your doctor well in advance that you are taking Galantamine Sandoz.
If you have any further questions, ask your doctor or pharmacist.
Pregnancy and breastfeeding
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 must not breast-feed while using Galantamine Sandoz.
Driving and using machines
Galantamine Sandoz may make you feel dizzy or sleepy, especially during the first few weeks of treatment. If Galantamin Sandoz affects you in this way, 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 sharpened 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 take Galantamine Sandoz
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 Sandoz prolonged-release capsules, read the instructions under “Switching from galantamine tablets or oral solution to galantamine capsules” in this section.
How much Galantamine Sandoz to take
You start taking Galantamine Sandoz in a low dose. The recommended starting dose is 8 mg galantamine once daily. Your doctor may then gradually increase the dose one, every 4 weeks, or less often until you reach a dose that is right for you. The highest dose is 24 mg galantamine once daily.
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 if you think Galantamin Sandoz 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 hear how you are doing.
If you have liver or kidney problems, your doctor may prescribe a lower dose of Galantamine Sandoz, or decide that this medicine is not suitable for you.
Switching from galantamine tablets or oral solution to galantamine capsules
If you are currently taking galantamine tablets or oral solution, your doctor may decide to switch you to Galantamine Sandoz prolonged-release capsules. If this applies to you, you should:
- Take your last dose of galantamine tablets or oral solution in the evening
- Take your first dose of Galantamine Sandoz prolonged-release capsules the next morning.
DO NOT TAKE more than one capsule per day. While taking Galantamine Sandoz prolonged-release capsules once daily, DO NOT take galantamine tablets or oral solution.
How to take Galantamine Sandoz
Galantamine Sandoz should be taken by mouth.
The capsules must be swallowed whole and must NOT be chewed or crushed.
Galantamine Sandoz – one dose should be taken once daily, in the morning, with water or other beverage.
Try to take Galantamine Sandoz with food.
Be sure to get plenty of fluids while taking Galantamine Sandoz to maintain fluid balance.
If you use more Galantamine Sandoz than you should
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. Take any remaining prolonged-release capsules and packing with you. Signs of overdose can be e.g. severe nausea and vomiting, muscle weakness, slow heartbeat, seizures, and unconsciousness.
If you forget to use Galantamine Sandoz
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.
Contact your doctor if you forget to take more than one dose.
If you stop using Galantamine Sandoz
Talk to your doctor before stopping Galantamine Sandoz. 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 effects are.
- Stop taking the medicine and see a doctor or go to the nearest emergency room immediately if you experience any of the following:
- Skin reactions , such as:
- Severe skin rash with blisters and scaly skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome).
- A red rash covered with small nodules that can spread all 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 Sandoz (may affect up to 1 in 1,000 people).
- Heart problems such as change in heart rate (slow heart rate or extra beats) or palpitations (heart beating fast or unevenly). Heart problems can be seen as an abnormal curve on an ECG ( electrocardiogram ) and can be common in people taking Galantamine Sandoz (may occur in up to 1 in 10 users).
- Seizures . These are less common in people taking Galantamine Sandoz (may affect up to 1 in 100 people).
You must stop taking Galantamine Sandoz and seek help immediately if you get any of the side effects described above.
Other side effects:
Very common side effects (may affect more than 1 user in 10)
- Nausea and vomiting. These side effects are more common during the first weeks of treatment or when the dose is increased. They usually disappear gradually as the body gets used to the drug and generally lasts only a few days. If you get such side effects , your doctor may recommend that you drink more fluids, and possibly prescribe medication for the nausea.
Common side effects (may affect up to 1 in 10 people)
- decreased appetite, weight loss
- see, feel or hear things that do not exist (hallucinations)
- Depression
- dizziness or fainting
- muscle tremors or spasms s
- headache
- severe fatigue, weakness or general malaise
- severe drowsiness and lack of energy
- high blood pressure
- pain or discomfort from the stomach
- diarrhea
- digestive problems
- fall accidents
- wound injuries.
Less common side effects are (may affect up to 1 in 100)
- allergic reaction
- dehydration in the body (dehydration)
- tingling or numbness in the skin
- taste changes
- sleepiness during the day
- dimsyn
- ringing in the ears that does not disappear ( tinnitus )
- low blood pressure
- redness / hot flashes
- feeling of having to vomit (ulcers)
- heavy sweating
- weak muscles
- increased amount of liver enzymes in the blood.
Rare side effects are (may affect up to 1 in 1000 users)
- liver inflammation ( hepatitis ).
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 Sandoz
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, jar, and blister after EXP. or Exp. The expiration date is the last day of the specified month.
This medicine does not require any 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.A Galantamine Sandoz 8 mg prolonged-release capsule contains 8 mg galantamine (as hydrobromide).A Galantamine Sandoz 16 mg prolonged-release capsule contains 16 mg of galantamine (as hydrobromide).A Galantamine Sandoz 24 mg prolonged-release capsule contains 24 mg of galantamine (as hydrobromide).
- Other ingredients are:Capsule contents: microcrystalline cellulose, hypromellose, ethylcellulose and magnesium stearate. Capsule shell:8 mg: gelatin and titanium dioxide (E171).16 mg: gelatin, titanium dioxide (E171) and red iron oxide (E172).24 mg: gelatin, titanium dioxide (E171), indigo carmine (E132), erythrosine (E127), red iron oxide (E172) and yellow iron oxide (E172).
What the medicine looks like and contents of the pack
Galantamine Sandoz 8 mg hard prolonged-release capsules are opaque, white, size 2, hard gelatin capsules, containing one round biconvex tablet.
Galantamine Sandoz 16 mg prolonged-release hard capsules are opaque, beige, size 2, hard gelatin capsules, containing two round biconvex tablets.
Galantamine Sandoz 24 mg prolonged-release hard capsules are opaque, orange, size 2, hard gelatin capsules, containing three round biconvex tablets.
The capsules are made in depot form. This means that they release the drug slowly.
The capsules are available in the following packages:
Transparent PVC / PE / PVDC aluminum blister with 7, 28, 30, 56, 84, 90, 98, 250, 500 prolonged-release capsules
or
White, opaque jar in HD polyethylene with screw cap with 100 prolonged-release capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer:
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark