Galnora 16 mg prolonged-release hard capsules EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Galnora 16 mg prolonged-release hard capsules EFG
galantamine
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Galnora is and what it is used for
- What you need to know before taking Galnora
- How to take Galnora
- Possible side effects
- How to store Galnora
- Contents of the pack and other information
1. What Galnora is and what it is used for
Galnora contains the active substance “galantamine”, an antidementia medicine. It is used in adults to treat mild to moderately severe Alzheimer's disease, a type of dementia that affects brain function.
Alzheimer's disease causes increasing memory loss, confusion, and behavioral changes, making it progressively difficult to carry out routine daily activities.
These symptoms are thought to be caused by a lack of “acetylcholine”, a substance responsible for transmitting messages between brain cells. Galnora increases the amount of acetylcholine in the brain and thereby helps to treat the symptoms of the disease.
The capsules are in the form of “prolonged-release”. This means they release the medicine gradually.
2. What you need to know before taking Galnora
Do not take Galnora
- if you are allergic to galantamine or to any of the other ingredients of this medicine (listed in section 6).
- if you have severe liver or kidney disease.
Warnings and precautions
Talk to your doctor or pharmacist before starting Galnora.
This medicine is only intended for use in Alzheimer's disease and is not recommended for other types of memory loss or confusion.
Serious adverse effects
Galnora may cause serious skin reactions, heart problems, and seizures. You should be alert to these adverse effects while taking Galnora. See section 4 “Be alert to serious adverse effects”.
Before starting treatment with Galnora, your doctor should know if you have or have previously had any of the following conditions:
- liver or kidney problems
- a heart disorder (such as chest pain usually caused by physical activity, heart attack, heart failure, slow or irregular heartbeat, prolonged QTc interval)
- changes in electrolyte levels (natural chemicals in the blood, such as potassium)
- a peptic ulcer (in the stomach)
- obstruction of the stomach or intestine
- a nervous system disorder (such as epilepsy or problems controlling body movements or limbs (extrapyramidal disorder))
- a respiratory disease or infection affecting breathing (such as asthma, obstructive lung disease, or pneumonia)
- problems with urine outflow
Your doctor will decide whether Galnora is suitable for you or whether your dose needs to be adjusted.
Also tell your doctor if you have recently had surgery on the stomach, intestine, or bladder. Your doctor will decide whether Galnora is suitable for you.
Galnora may cause weight loss. Your doctor will monitor your weight regularly while you are taking Galnora.
Children and adolescents
Galnora is not recommended for use in children or adolescents.
Other medicines and Galnora
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Galnora should not be taken together with medicines that work in the same way. These include:
- donepezil or rivastigmine (for Alzheimer's disease)
- ambenonium, neostigmine, or pyridostigmine (for severe muscle weakness)
- pilocarpine (when taken by mouth for dry eyes or mouth)
Some medicines may increase the risk of adverse effects in people taking Galnora. These include:
- paroxetine or fluoxetine (antidepressants)
- quinidine (for irregular heartbeat)
- ketoconazole (an antifungal)
- erythromycin (an antibiotic)
- ritonavir (for human immunodeficiency virus or “HIV”)
- non-steroidal anti-inflammatory painkillers (such as ibuprofen), which may increase the risk of ulcers
- medicines for certain heart disorders 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 examine your heart using an electrocardiogram (ECG)
- medicines that affect the QTc interval.
If you are taking any of these medicines, your doctor may prescribe a lower dose of Galnora.
Galnora may interact with some anaesthetics. If you are scheduled to undergo surgery under general anaesthesia, inform your doctor well in advance that you are taking Galnora.
Consult your doctor or pharmacist if you have any doubts.
Pregnancy and breast-feeding
If you are pregnant, breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
You must not breast-feed while taking Galnora.
Driving and using machines
Galnora may make you feel dizzy or drowsy, especially during the first few weeks of treatment. If you are affected by Galnora, do not drive or operate tools or machinery.
Galnora contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule; therefore, it is essentially “sodium-free”.
3. How to take Galnora
Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.
If you are currently taking galantamine tablets or oral solution and your doctor has informed you that you will be switched to galantamine prolonged-release capsules, carefully read the instructions under "Switching from galantamine tablets or oral solution to Galnora capsules" in this section.
How much to take
You will start treatment with Galnora at a low dose. The usual starting dose is 8 mg, taken once daily. Your doctor will gradually increase your dose every 4 weeks or longer until reaching the most appropriate dose for you. The maximum dose is 24 mg, taken once daily.
Your doctor will explain to you the dose you should start with and when you should increase it.
If you are unsure what to do or find that the effect of Galnora is too strong or too weak, inform your doctor or pharmacist.
Your doctor needs to see you regularly to check that this medicine is working and to discuss with you how you are feeling.
If you have liver or kidney problems, your doctor may prescribe a reduced dose of Galnora or may decide whether this medicine is suitable for you.
Switching from galantamine tablets or oral solution to Galnora capsules
If you are currently taking galantamine tablets or oral solution, your doctor may decide to switch you to Galnora prolonged-release capsules. If this applies to you:
- Take your last dose of galantamine tablets or oral solution in the evening.
- The following morning, take your first dose of Galnora prolonged-release capsules.
DO NOT take more than one capsule in a day. While taking one daily capsule of Galnora capsules, DO NOT take galantamine tablets or oral solution.
How to take it
Galnora capsules must be swallowed whole and must NOT be chewed or crushed. If you find the capsules difficult to swallow, you may open the capsule and swallow the entire contents – do NOT chew or crush the contents.
Take your dose of Galnora once daily in the morning, with water or other liquids. Try to take Galnora with food. Drink plenty of fluids while taking Galnora to stay hydrated.
If you take more Galnora than you should
If you take too much Galnora, consult your doctor or go to the hospital immediately. Take the package and any remaining capsules with you. Signs of overdose may include:
- severe nausea and vomiting
- muscle weakness, slow heartbeat, seizures, and loss of consciousness.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or
call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the
amount ingested.
If you forget to take Galnora
If you forget to take a dose, skip that dose and continue your treatment as usual with the next scheduled dose.
Do NOT take a double dose to make up for forgotten doses.
If you forget to take more than one dose, consult your doctor.
If you stop taking Galnora
Consult your doctor before stopping treatment with Galnora. It is important to continue taking this medicine to treat your condition.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Be alert for serious adverse effects
Stop taking your medicine and consult a doctor or go to the nearest emergency service immediately if you notice any of the following adverse effects.
Skin reactions, including:
- Severe rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome).
- Red rash covered with small pus-filled bumps that may spread over the body, sometimes with fever (acute generalized exanthematous pustulosis).
- Rash that may cause blisters, with spots resembling 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 heartbeat (such as slow heartbeat or extra beats) or palpitations (feeling a fast or irregular heartbeat). Heart problems may be seen as an abnormal tracing on an electrocardiogram (ECG), and may be common in people taking Galnora (may affect up to 1 in 10 people).
Seizures. This is uncommon in people taking Galnora (may affect up to 1 in 100 people).
You must stop taking this medicine and seek immediate medical help if you experience any of the adverse effects listed above.
Other adverse effects
Very common adverse effects (may affect more than 1 in 10 people):
- Nausea and/or vomiting.
These adverse effects are more likely to occur during the first weeks of treatment or when the dose is increased. They usually gradually disappear as the body adjusts to the treatment and typically last only a few days. If you experience these effects, your doctor may recommend drinking more fluids and may prescribe a medicine to help relieve your discomfort.
Common adverse effects (may affect up to 1 in 10 people):
- Decreased appetite, weight loss
- Seeing, feeling, or hearing things that are not present (hallucinations)
- Depression
- Feeling dizzy or faint
- Tremors or muscle spasms
- Headache
- Feeling very tired, weak, or generally unwell
- Feeling very sleepy and having low energy
- Increased blood pressure
- Abdominal pain or discomfort
- Diarrhea
- Indigestion
- Falls
- Injuries
Uncommon adverse effects (may affect up to 1 in 100 people):
- Allergic reaction
- Insufficient body water (dehydration)
- Tingling or numbness of the skin
- Change in taste sensation
- Daytime sleepiness
- Problems controlling body movements or limbs (extrapyramidal disorder)
- Blurred vision
- Ringing in the ears that does not go away (tinnitus)
- Low blood pressure
- Flushing
- Feeling the need to vomit (nausea)
- Excessive sweating
- Muscle weakness
- Increased levels of liver enzymes in the blood.
Rare adverse effects (may affect up to 1 in 1,000 people):
- Inflamed liver (hepatitis)
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Galnora
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the carton following EXP.
The expiry date refers to the last day of the stated month.
Do not store above 30°C. Keep in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater drains or household waste. Unused medicines and their containers should be taken to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of Galnora
- The active substance is galantamine.
Each prolonged-release hard capsule contains 16 mg of galantamine (as bromide salt).
- Other components in the prolonged-release granules are sodium lauryl sulfate, ammonium methacrylate copolymer (type B), hypromellose, carbomer, hydroxypropyl cellulose, magnesium stearate, talc. See section 2 “Galnora contains sodium”.
- Other components in the 16 mg capsule are gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black printing ink (shellac, propylene glycol, concentrated ammonia solution, black iron oxide (E172), potassium hydroxide).
Appearance of Galnora and contents of the pack
Pink hard capsules of size 1 (capsule length: 19.0 - 19.8 mm) with the imprint G16. Contains two white, oval, prolonged-release tablet cores.
Prolonged-release hard capsules are available in packs of 10, 14, 28, 30, 56, 60, 84, 90 and 100 capsules.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
KRKA Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain
This medicinal product is authorized in the European Economic Area member states under the following names:
Member State | Name of the medicinal product |
Germany | Galidurel |
Austria, Slovenia | Galema SR |
Spain | Galnora |
France | Galema L.P. |
Italy | Galema |
Netherlands | Bergal SR |
Portugal | Galantamine Galema SR |
Date of the last revision of this leaflet: September 2022
Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/