Galnora 24 mg prolonged-release hard capsules EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Galnora 24 mg prolonged-release hard capsules EFG
galantamine
Read the entire leaflet carefully before you start taking this medicine, because 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 other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse 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 the symptoms of 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 more difficult to carry out routine daily activities.
These effects are thought to be caused by a deficiency 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 components 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 should only be used for 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 aware of 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 (naturally occurring chemicals in the blood, such as potassium)
- a peptic ulcer (in the stomach)
- obstruction of the stomach or intestine
- a disorder of the nervous system (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
The use of Galnora is not recommended 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 likelihood 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 certain anaesthetics. If you are due to have surgery under general anaesthesia, inform your doctor well in advance that you are taking Galnora.
Talk to your doctor or pharmacist if you have any questions.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
You must not breastfeed while taking Galnora.
Driving and using machines
Galnora may make you feel dizzy or drowsy, especially during the first few weeks of treatment. If Galnora affects you in this way, 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 administering 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 switching to galantamine prolonged-release capsules, read carefully 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 more until reaching the most appropriate dose for you. The maximum dose is 24 mg, taken once daily.
Your doctor will explain to you the starting dose 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 not 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 per day. While taking one daily capsule of Galnora, 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. Bring the packaging and any remaining capsules with you. Signs of an 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 miss 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 experiences them.
Be alert to 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 skin peeling, 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 help if you notice 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 disappear gradually as the body adapts to the treatment and generally last only a few days. If you experience these effects, your doctor may recommend drinking more fluids and may prescribe a medicine to help you feel better.
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 type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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 sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and on the carton after EXP.
The expiry date refers to the last day of the month indicated.
Do not store above 30°C. Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. Ask your pharmacist how to properly 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 24 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, and talc. See section 2 “Galnora contains sodium”.
- Other components in the 24 mg capsule are gelatin, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), printing ink (shellac, propylene glycol, concentrated ammonia solution, iron oxide black (E172), potassium hydroxide).
Appearance of Galnora and contents of the pack
Orange-pink coloured hard capsules of size 0 (capsule length: 23.8 – 24.6 mm) with the imprint G24. Contains three white, oval-shaped 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 Member States of the European Economic Area under the following names:
Member State | Medicinal product name |
Germany | Galidurel |
Austria, Slovenia | Galema SR |
Spain | Galnora |
France | Galema L.P. |
Italy | Galema |
Netherlands | Bergal SR |
Portugal | Galantamine Galema SR |
Date of the most recent review of this leaflet: September 2022
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/