Galantamine CINFA 24 mg prolonged-release hard capsules EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
galantamine cinfa 24 mg prolonged-release hard capsules EFG
Read the entire leaflet carefully before you start taking this medicine.
- 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 must not be given to other people, even if they have the same symptoms as you, since it could harm them.
- If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Leaflet contents:
- What galantamine cinfa is and what it is used for.
- Before you take galantamine cinfa.
- How to take galantamine cinfa.
- Possible side effects.
- How to store galantamine cinfa.
- Contents of the pack and other information.
1. What galantamina cinfa is and what it is used for
Galantamina cinfa 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 believed to be caused by a lack of "acetylcholine", a substance responsible for transmitting messages between brain cells. Galantamina cinfa increases the amount of acetylcholine in the brain and thereby treats the symptoms of the disease.
2. What you need to know before starting galantamine cinfa
Do not take galantamina cinfa
- If you are allergic to galantamine or to any of the other ingredients listed in section 6 of this leaflet.
- If you have severe liver or kidney disease.
Warnings and precautions
Talk to your doctor or pharmacist before taking galantamine cinfa. 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
Galantamine cinfa may cause serious skin reactions, heart problems, and seizures. You should be alert to these adverse effects while taking galantamine cinfa. See section 4.
Before starting treatment with galantamine cinfa, your doctor should know if you have or have had any of the following conditions:
- Liver or kidney problems.
- A heart disorder (such as chest discomfort 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).
- Peptic ulcer (stomach ulcer).
- Blockage in the stomach or intestines.
- A nervous system disorder (such as epilepsy or Parkinson's disease).
- A respiratory disease or infection affecting breathing (such as asthma, chronic obstructive pulmonary disease, or pneumonia).
- Problems with urine outflow.
Also tell your doctor if you have recently had surgery on the stomach, intestines, or bladder. Your doctor will decide whether galantamine cinfa is suitable for you.
Galantamine cinfa may cause weight loss. Your doctor will regularly monitor your weight while you are taking galantamine cinfa.
Children and adolescents
The use of galantamine cinfa is not recommended in children or adolescents.
Use of galantamine cinfa with other medicines
Tell your doctor or pharmacist if you are using, have recently used, or plan to use any other medicines.
Galantamine cinfa 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 galantamine cinfa. 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 analgesics (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.
Your doctor may prescribe a lower dose of galantamine cinfa if you are also taking any of the medicines listed above.
Galantamine cinfa may affect certain anesthetics. If you are scheduled for surgery under general anesthesia, inform your doctor well in advance that you are taking galantamine cinfa.
Consult your doctor or pharmacist if you have any doubts.
Pregnancy and breastfeeding
Before taking this medicine, consult your doctor for advice if you are pregnant, may be pregnant, or are planning to become pregnant.
You must not breastfeed while taking galantamine cinfa.
Driving and using machines
Galantamine cinfa may make you feel dizzy or drowsy, especially during the first weeks of treatment. If galantamine cinfa affects you in this way, do not drive or operate tools or machinery.
3. How to take galantamina cinfa
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, please 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 galantamina cinfa prolonged-release capsules, carefully read the instructions under “Switching from galantamine tablets or oral solution to galantamina cinfa capsules” in this section.
How much to take
You will start treatment with galantamina cinfa 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 which dose to start with and when to increase it. If you are unsure what to do, or find that the effect of galantamina cinfa 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 well for you and to discuss how you are feeling.
If you have liver or kidney problems, your doctor may prescribe a reduced dose of galantamina cinfa or may decide whether this medicine is not suitable for you.
Switching from galantamine tablets or oral solution to galantamina cinfa capsules
If you are currently taking galantamine tablets or oral solution, your doctor may decide to switch you to galantamina cinfa 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 galantamina cinfa prolonged-release capsules.
DO NOT take more than one capsule per day. While taking galantamina cinfa capsules once daily, DO NOT take galantamine tablets or oral solution.
How to take it
Galantamina cinfa capsules must be swallowed whole and must NOT be chewed or crushed. Take your dose of galantamina cinfa once daily in the morning, with water or other liquids. Try to take galantamina cinfa with food.
Drink plenty of fluids while taking galantamina cinfa to stay hydrated.
If you take more galantamina cinfa than you should
If you take too much galantamina cinfa, consult your doctor or go to the hospital immediately. Bring 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 galantamina cinfa
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 a missed dose.
If you miss more than one dose, consult your doctor.
If you stop taking galantamina cinfa
Consult your doctor before stopping treatment with galantamina cinfa. It is important to continue taking this medicine to treat your condition.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this one may cause adverse effects, although not everyone experiences them.
Be alert for serious adverse effects
Stop taking galantamina cinfa and consult a doctor or go immediately to the nearest emergency service if you experience 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 across the body, sometimes accompanied by fever (acute generalized exanthematous pustulosis).
- Rash that may cause blisters, with spots resembling small targets.
These skin reactions are rare in people taking galantamina cinfa (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 rapid or irregular heartbeat). Heart problems may appear as an abnormal tracing on an electrocardiogram (ECG), and may be common in people taking galantamina cinfa (may affect up to 1 in 10 people).
Seizures. This is uncommon in people taking galantamina cinfa (may affect up to 1 in 100 people).
You must stop taking galantamina cinfa and seek immediate medical 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 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 adapts to the medicine and typically last only a few days. If you experience these effects, your doctor may recommend drinking more fluids and may prescribe a medication 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.
- High 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.
- Blurred vision.
- Persistent ringing in the ears (tinnitus).
- Low blood pressure.
- Flushing.
- Feeling the need to vomit (nausea).
- Excessive sweating.
- Muscle weakness.
- Increased levels of liver enzymes in 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, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of galantamine cinfa
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the blister after "EXP". The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at the pharmacy.
Ask your pharmacist how to dispose of any unused medicines and their packaging. Doing so will help protect the environment.
6. Contents of the pack and other information
Composition of galantamina cinfa:
The active substance is galantamine.
- Each 24 mg prolonged-release hard capsule contains 24 mg of galantamine (as galantamine hydrobromide).
The other components are:
Capsule contents
Microcrystalline cellulose, hypromellose, ethylcellulose, magnesium stearate.
Capsule shell
Gelatin, titanium dioxide (E171), indigo carmine (E132), erythrosine (E127), iron oxide red (E172), iron oxide yellow (E172).
Appearance of the medicine and contents of the pack
Prolonged-release galantamine hard capsules are available in three strengths, each identifiable by its colour:
Orange-coloured capsules containing three round, biconvex prolonged-release tablets.
The capsules are formulated as 'prolonged-release', meaning they release the medicine more slowly.
The capsules are available in the following blister pack sizes:
7, 28, 30, 56, 84, 98, 100 prolonged-release capsules.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain
Manufacturer
Pharmaten, S.A.
6, Dervenakion Str., Pallini Attiki
Greece
Or
Pharmaten International S.A.
Industrial Park Sapes, Rodopi Prefecture, Block No. 5, Rodopi 69300
Greece
This medicine is registered in the EEA Member States under the following names:
Germany Masparen 8mg, 16mg, 24mg Hard Capsules, Retard
Netherlands Masparen Retard 1x daily 8mg, 16mg, 24mg
Spain Galantamina cinfa 8mg, 16mg, 24mg prolonged-release hard capsules EFG
United Kingdom Consion XL 8mg, 16mg, 24mg prolonged release capsules
Date of the most recent review of this leaflet: March 2021
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77290/P_77290.html
QR code to: https://cima.aemps.es/cima/dochtml/p/77290/P_77290.html