8 mg, 16 mg, 24 mg prolonged-release capsules, hard
galantamine
What Galantamine Actavis is and what it is used for
Galantamine Actavis contains the active substance “galantamine” and is a medicine used to treat dementia. 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 increased memory loss, confusion, and behavioral changes that make it more difficult to perform normal daily 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 Actavis 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 Actavis may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Galantamine Actavis
Do not use Galantamine Actavis
- 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 using Galantamine Actavis.
This medicine is for use in Alzheimer’s disease and is not recommended for other types of memory loss or confusion.
Serious side effects are
Galantamine Actavis can cause severe skin reactions, heart problems, and seizures. You must be aware of these side effects when taking Galantamine Actavis. See “Pay attention to serious side effects” in section 4.
Before taking Galantamine Actavis, your doctor needs to know if you have, or have had, any of the following:
- liver or kidney problems
- heart disease (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
- a nervous system disease (such as epilepsy or Parkinson’s disease )
- a lung disease or infection that affects breathing (such as asthma , obstructive pulmonary disease or pneumonia )
- problems urinating.
Your doctor will decide if Galantamine Actavis 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 Actavis is not suitable for you.
Galantamine Actavis may cause weight loss. Your doctor will check your weight regularly while you are taking Galantamine Actavis.
Children and young people
Galantamine Actavis is not recommended for use in children and adolescents.
Other medicines and Galantamine Actavis
Tell your doctor or pharmacist if you have recently taken, or might take any other medicines.
Galantamine Actavis should not be used with medicines that work similarly. These medicines include:
- donepezil or rivastigmine (for Alzheimer’s disease )
- ambenone, neostigmine or pyridostigmine (in case of severe 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 Actavis. 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’).
- non-steroidal anti-inflammatory painkillers (such as ibuprofen ), which may increase the risk of stomach ulcers
- 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 irregular heartbeat, your doctor may check your heart with an ECG ( electrocardiogram )
- Drugs that affect the QTc interval .
Your doctor may give you a lower dose of Galantamine Actavis if you are taking any of these medicines.
Galantamine Actavis 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 Actavis.
If you need to have an operation that requires anesthesia, tell your doctor that you are taking Galantamine Actavis.
If you have any further questions, ask your doctor or pharmacist for advice.
Pregnancy and breastfeeding
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 taking Galantamine Actavis.
Driving and using machines
Galantamine Actavis may make you feel dizzy or tired, especially during the first few weeks of treatment. If Galantamin Actavis 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.
3. How to use Galantamine Actavis
Always use Galantamine Actavis exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
If you are currently taking galantamine immediate-release tablets or oral solution, and have been told by your doctor to switch to Galantamine Actavis prolonged-release capsules, read the instructions at the end of this section carefully.
How much should you take?
You start treatment with Galantamine Actavis in a low dose. The usual starting dose is 8 mg once a day. Thereafter, your doctor may gradually increase the dose once every 4 weeks or more, until you reach the dose that suits you best. 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 if you feel that the effect of Galantamin Actavis prolonged-release capsules 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 talk to you about how you are feeling.
If you have liver or kidney disease, your doctor may give you a lower dose of Galantamine Actavis or decide that this medicine is not suitable for you.
Switching from galantamine tablets or oral solution to Galantamine Actavis prolonged-release capsules
If you are currently taking galantamine tablets or oral solution, your doctor may decide to switch you to Galantamine Actavis 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 Galantamin Actavis prolonged-release capsules.
DO NOT TAKE more than one prolonged-release capsule per day. While taking Galantamine Actavis prolonged-release capsules DO NOT take galantamine tablets or oral solution.
Take Galantamine Actavis like this
Galantamine Actavis prolonged-release capsules must be swallowed whole and must NOT be chewed or crushed. Take a dose of Galantamine Actavis once daily in the morning with water or another liquid. Try to take Galantamine Actavis with food.
Drink plenty of fluids while taking Galantamine Actavis to avoid dehydration.
If you use more Galantamine Actavis than you should
If you have ingested too much medicine or if, for example, 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 may include severe nausea and vomiting, muscle weakness, slow heartbeat, seizures, and unconsciousness.
If you forget to use Galantamine Actavis
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, you should consult your doctor.
If you stop using Galantamine Actavis
Check with your doctor before stopping Galantamine Actavis. It is important to continue taking this medicine to treat your illness.
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.
Stop taking Galantamine Actavis and contact 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 Actavis (may affect up to 1 in 1,000 people).
- Heart problems including changes in heart rhythm (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 Actavis (may affect up to 1 in 10 people).
- Seizures . These are less common among people taking Galantamine Actavis (may affect up to 1 in 100 people).
You must stop taking Galantamine Actavis and seek help immediately if you notice any of the side effects listed above.
Other side effects:
Very common side effects 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. They usually disappear gradually as the body gets used to the drug, and generally last no longer than a few days. If you have these side effects , your doctor may recommend that you drink more fluids, and you may be prescribed a medicine for your nausea.
Common side effects are (may affect up to 1 in 10):
- decreased appetite, weight loss
- see, feel or hear things that exist (hallucinations)
- Depression
- dizziness or fainting
- muscle tremors or muscle cramps
- 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
Less common side effects are (may affect up to 1 in 100)
- allergic reaction
- insufficient water in the body (dehydration)
- low blood pressure
- tingling or numbness in the skin
- taste changes
- daytime sleepiness
- dimsyn
- earring that does not disappear ( tinnitus )
- hemorrhage
- 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 Actavis
Keep out of 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.
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.
- Galantamine Actavis 8 mg prolonged-release capsules contain 8 mg galantamine (as hydrobromide)
- Galantamine Actavis 16 mg prolonged-release capsules contain 16 mg galantamine (as hydrobromide)
- Galantamine Actavis 24 mg prolonged-release capsules contain 24 mg galantamine (as hydrobromide)
Other ingredients are:
Capsule contents: microcrystalline cellulose, hypromellose, methylcellulose, and magnesium stearate.
Capsule shell: gelatin and titanium dioxide (E171).
The 16 mg capsule also contains red iron oxide (E172).
The 24 mg capsule also contains 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 Actavis hard prolonged-release capsules are available in three strengths, each of which can be recognized by its color:
8 mg: Opaque, white, size 2, hard gelatin capsules containing a round biconvex tablet
16 mg: Opaque, skin-colored, size 2, hard gelatin capsules containing two round biconvex tablets
24 mg: Opaque, orange, size 2, hard gelatin capsules containing three round biconvex tablets
Pack sizes:
7, 28, 30, 56, 84, 90, 98, 112, 250, 500 depot capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC EHF.
Reykjavikurvegur 76-78
IS-220 Hafnarfjordur
Iceland
Manufacturer
Pharmathen SA
6 Dervenakion str.
15351 Pallini
Attiki
Greece
or
Pharmathen International SA
Industrial Park
Sapes Rodopi Prefecture
Block No 5, Rodopi, 69300
Greece