8 mg, 16 mg, and 24 mg hard prolonged-release capsules
1. What Galantamine Krka is and what it is used for
Galantamine Krka 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 effects are thought to be caused by a deficiency of “acetylcholine”, a substance that has the task of transmitting signals between brain cells. Galantamine Krka 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 Krka 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 Krka
Do not use Galantamine Krka
- 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 Krka.
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 Krka can cause severe skin reactions, heart problems, and seizures. You must be aware of these side effects when taking Galantamine Krka. See “Pay attention to serious side effects” in section 4.
Before taking Galantamine Krka, your doctor must know 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, prolonged QTc interval )
- 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 Krka 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 Krka is not suitable for you.
Galantamine Krka can cause weight loss. Your doctor will check your weight regularly while you are taking Galantamine Krka.
Children and young people
Galantamine Krka is not recommended for children and adolescents.
Other medicines and Galantamine Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Galantamine Krka 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 Krka. 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’).
- analgesics of the NSAID -type (non-steroidal antiinflammatory / antirheumatic agents such 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 ).
- drugs that affect the QTc interval et.
Your doctor may give you a lower dose of Galantamine Krka if you are taking any of these medicines.
Galantamine Krka may affect certain anesthetics. If you are going to have an operation that requires anesthesia, you should tell your doctor well in advance that you are taking Galantamine Krka.
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 taking Galantamine Krka.
Driving and using machines
Galantamine Krka may make you feel dizzy or tired, especially during the first few weeks of treatment. If Galantamine Krka 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 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.
Galantamine contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per capsule, it is essential ‘sodium-free.
How to use Galantamine Krka
Always use this medicine exactly as your doctor 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 Krka prolonged-release capsules, read the instructions under “Switching from galantamine tablets or oral solution to Galantamine Krka prolonged-release capsules” in this section. .
How much to take
You start treatment with Galantamine Krka 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 feel that Galantamin Krka 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 Krka or decide that this medicine is not suitable for you.
Switching from galantamine tablets or oral solution to Galantamine Krka prolonged-release capsules
If you are currently taking galantamine tablets or oral solution, your doctor may decide that you should switch to Galantamine Krka 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 Krka prolonged-release capsules.
DO NOT TAKE more than 1 prolonged-release capsule per day. While using Galantamine Krka prolonged-release capsules dosage 1 time per day, DO NOT take galantamine tablets or oral solution.
Take Galantamine Krka like this
Galantamine Krka prolonged-release capsules must be swallowed whole, they must NOT be chewed or crushed.
If you have difficulty swallowing, the capsule contents may be emptied and swallowed together with the liquid. The capsule contents must NOT be chewed or crushed.
Galantamine Krka should be taken once a day, in the morning, with water or other beverage and preferably with food. Drink plenty of fluids while taking Galantamine Krka to avoid dehydration.
If you use more Galantamine Krka than you should
If you take more Galantamine Krka then you should contact a 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 Krka
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 Krka
Check with your doctor before stopping Galantamine Krka. 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 Krka and contact a doctor immediately or see the 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 (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 (may occur in up to 1 in 10 users).
Seizures. These are less common in people taking galantamine (may affect up to 1 in 100 people).
You must stop taking Galantamine Krka and seek help immediately if you notice any of the side effects listed above.
Other side effects are
Very common side effect are (can occur in more than 1 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 generally lasts 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 are (may affect up to 1 AV10 users):
- decreased appetite, weight loss
- see, feel and hear things that do not exist (hallucinations)
- dizziness or fainting
- muscle tremors or muscle spasms
- extreme fatigue, weakness or general malaise
- extreme sleep with low energy
- high blood pressure
- pain or discomfort in the stomach
- digestive problems
Less common side effects are (may affect up to 1 in 100):
- allergic reaction
- insufficient water in the body (dehydration)
- tingling or numbness in the skin
- taste changes
- daytime sleepiness
- earring that does not disappear ( tinnitus )
- low blood pressure
- feeling sick (nausea)
- heavy sweating
- weak muscles
- elevated levels of liver enzymes in the blood
Rare side effects are (may affect up to 1 in 1000 people):
- inflammation of the liver ( 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 Krka
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 blister and carton after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C. Store in the original package. Moisture sensitive.
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
The active substance is galantamine.
- 8 mg: Each hard prolonged-release capsule contains 8 mg of galantamine (as hydrobromide).
- 16 mg: Each hard prolonged-release capsule contains 16 mg of galantamine (as hydrobromide).
- 24 mg: Each hard prolonged-release capsule contains 24 mg of galantamine (as hydrobromide).
- The other ingredients in the prolonged-release capsules are: sodium laurilsulfate,ammonium methacrylate copolymer (type B), hypromellose, carbomers, hydroxypropylcellulose, magnesium stearate and talc. See section 2 “Galantamine Krka contains sodium”.
- The other ingredients in the 8 mg capsule are: gelatin, titanium dioxide (E 171), black ink (shellac, propylene glycol, concentrated ammonia solution, black iron oxide (E 172), potassium hydroxide).
- The other ingredients in the capsule cover for 16 mg and 24 mg are: gelatin, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172), black ink (shellac, propylene glycol, concentrated ammonia solution, black iron oxide (E 172) , potassium hydroxide).
What the medicine looks like and contents of the pack
8 mg: White capsule in size 2 (capsule length: 17.6 – 18.4 mm) marked G8 on the capsule cap. The capsule contains a white, oval prolonged-release tablet core.
16 mg: Pink capsule in size 1 (capsule length: 19.0 – 19.8 mm) marked G16 on the capsule cap. The capsule contains two white, oval prolonged-release tablet cores.
24 mg: Orange-pink capsule in size 0 el (capsule length: 23.8 – 24.6 mm) marked G24 on the capsule cap. The capsule contains three white, oval prolonged-release tablet cores.
The capsules are available in cartons of 10, 14, 28, 30, 56, 60, 84, 90 and 100 hard prolonged-release capsules in blister cards.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
KRKA Sverige AB, Göta Ark 175, 118 72 Stockholm, Sweden
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany