Memantin CINFA 5 mg/spray oral EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
memantina cinfa 5 mg/dose, oral solution EFG
Memantinum hydrochloridum
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, pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. See section 4.
Leaflet Contents
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What memantina cinfa is and what it is used for.
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What you need to know before taking memantina cinfa.
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How to take memantina cinfa.
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Possible side effects.
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How to store memantina cinfa.
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Contents of the pack and other information.
1. What memantina cinfa is and what it is used for
How memantina cinfa works
Memantina cinfa contains memantine as the active substance.
It belongs to a group of medicines known as anti-dementia drugs.
Memory loss in Alzheimer's disease is due to disturbances in brain signaling. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors, which are involved in the transmission of nerve signals important for learning and memory. Memantina cinfa belongs to a group of medicines called NMDA receptor antagonists. Memantina cinfa acts on these receptors, improving nerve signal transmission and memory.
What memantina cinfa is used for
Memantina cinfa is used in the treatment of patients with moderate to severe Alzheimer's disease.
2. What you need to know before starting to take memantina cinfa
Do not take memantina cinfa
- if you are allergic to memantine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take memantina cinfa:
- if you have a history of epileptic seizures (convulsions),
- if you have recently had a myocardial infarction (heart attack), if you suffer from congestive heart disease, or if you have uncontrolled hypertension (high blood pressure).
In the above situations, treatment should be carefully monitored and your doctor should regularly reassess the clinical benefit of memantina.
If you have renal impairment (kidney problems), your doctor should closely monitor kidney function and, if necessary, adjust the dosage of memantina.
The use of memantina together with other medicines such as amantadine (used to treat Parkinson's disease), ketamine (a medicine generally used as an anaesthetic), dextromethorphan (a medicine used to treat cough), and other NMDA antagonists should be avoided.
Children and adolescents
The use of memantina is not recommended in children and adolescents under 18 years of age.
Taking memantina cinfa with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Specifically, administration of memantina may cause changes in the effects of the following medicines, and your doctor may need to adjust the dosage:
- amantadine, ketamine, dextromethorphan,
- dantrolene, baclofen,
- cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine,
- hydrochlorothiazide (or any combination containing hydrochlorothiazide),
- anticholinergics (substances generally used to treat movement disorders or intestinal spasms),
- anticonvulsants (substances used to prevent and stop seizures),
- barbiturates (substances generally used to induce sleep),
- dopaminergic agonists (substances such as L-dopa, bromocriptine),
- neuroleptics (substances used in the treatment of mental illnesses),
- oral anticoagulants.
If you are admitted to hospital, inform your doctor that you are taking memantina.
Taking memantina cinfa with food and drink
You should inform your doctor if you have recently changed or intend to substantially change your diet (for example, from a normal diet to a strict vegetarian diet), or if you have renal tubular acidosis (RTA, excess acid-producing substances in the blood due to renal dysfunction (kidney problem)) or severe urinary tract infections (urine passage infections), as your doctor may need to adjust the dose of the medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. The use of memantina is not recommended in pregnant women.
Women taking memantina should stop breastfeeding.
Driving and using machines
Your illness may affect your ability to drive or operate machinery, and you should not perform these activities unless your doctor tells you it is safe to do so. Memantina may cause dizziness and drowsiness, particularly at the beginning of treatment or when the dose is increased. If you experience these effects, you should not drive or operate machinery.
Memantina cinfa contains sorbitol
This medicine contains 100 mg of sorbitol in each ml.
Sorbitol is a source of fructose. If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, you (or your child) should consult your doctor before taking this medicine.
3. How to take memantina cinfa
Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.
Dosage
One spray contains 5 mg of memantine hydrochloride.
The recommended dose of memantine in adult and elderly patients is four sprays, equivalent to 20 mg administered once daily. To reduce the risk of adverse effects, this dose should be reached gradually according to the following daily regimen:
week 1 | one pulse |
week 2 | two pulses |
week 3 | three pulses |
week 4 and onwards | four pulses |
The usual starting dose is one spray once daily (5 mg) during the first week. This dose is increased in the second week to two sprays once daily (10 mg), and in the third week to three sprays once daily (15 mg). From the fourth week onwards, the recommended dose is four sprays once daily (20 mg).
Instructions for correct use of the dispenser:
Before first use, the dispenser must be screwed onto the bottle. To remove the screw cap from the bottle, turn it counterclockwise and unscrew it completely (Fig. 1).
Assembling the dispenser onto the bottle:
The dispenser must be removed from the plastic bag (Fig. 2) and placed on top of the bottle, carefully inserting the plastic tube down into the bottle. The dispenser should be held at the neck of the bottle and turned clockwise until it is securely attached (Fig. 3). For intended use, the dispenser should be screwed on only once at the beginning and must never be unscrewed.
Using the dispenser for dispensing:
The dispenser head has two positions and rotates easily—counterclockwise (open position) and clockwise (closed position). The dispenser head must not be pressed while in the closed position. The solution should therefore be dispensed in the open position. To achieve this, rotate the dispenser head one-eighth turn in the direction of the arrow until resistance is felt (Fig. 4). The dispenser is then ready for use.
Preparing the dispenser:
When used for the first time, the dispenser does not dispense the correct amount of oral solution. Therefore, it must be primed by fully pressing down the dispenser head five consecutive times (Fig. 5).
The solution dispensed during this process must be discarded. The next time the dispenser head is fully pressed down (equivalent to one spray), it will dispense the correct dose (1 spray equals 0.5 mL of oral solution and contains 5 mg of the active substance, memantine hydrochloride; Fig. 6).
Correct use of the dispenser:
Place a glass with a little water or a spoon under the nozzle and firmly but calmly and steadily press the dispenser head fully down (not too slowly) until the end of the stroke (Fig. 7, Fig. 8).
The dispenser head can then be released and is ready for the next spray.
The dispenser must only be used with memantina cinfa 5 mg/spray oral solution in the provided bottle, not with other products or containers. If the dispenser does not function properly as described during use and according to these instructions, the patient should consult their doctor or pharmacist. The dispenser must be closed after use.
Dosage for patients with renal impairment
If you have kidney problems, your doctor will determine the appropriate dose for your condition. In this case, your doctor should periodically monitor your kidney function.
Dosage for patients with hepatic impairment
Consult your doctor if you have liver problems.
Administration
Memantina cinfa must be administered orally once daily. To get the maximum benefit from your medication, you should take it every day at the same time. The solution should be taken with a small amount of water. The solution may be taken with or without food.
Duration of treatment
Continue taking memantina for as long as it benefits you. Your doctor should periodically evaluate your treatment.
If you take more memantina cinfa than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medication and the amount ingested. It is recommended to bring the package leaflet and the medicine container to the healthcare professional.
In general, taking an excessive amount of memantine should not cause harm. You may experience an increase in the symptoms described in section 4, “Possible side effects.”
If you forget to take memantina cinfa
If you realize you have missed your dose of memantina, wait and take the next dose at the usual time.
Do not take a double dose to make up for missed doses.
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.
In general, adverse effects are classified as mild to moderate.
Common (may affect up to 1 in 10 patients):
- Headache, somnolence, constipation, elevated liver function tests, dizziness, loss of balance, shortness of breath, high blood pressure, and hypersensitivity to the medicine.
Uncommon (may affect up to 1 in 100 patients):
- Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbance, heart failure, and formation of blood clots in the venous system (venous thrombosis/venous thromboembolism).
Rare (may affect up to 1 in 10,000 patients):
- Seizures.
Frequency not known (cannot be estimated from available data):
- Inflammation of the pancreas, hepatitis (inflammation of the liver), and psychotic reactions.
Alzheimer's disease has been associated with depression, suicidal ideation, and suicide. These events have been reported in patients treated with memantine.
Reporting of adverse effects
If you experience any type of adverse effect, consult 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 System for Pharmacovigilance of Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of memantine 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 label of the bottle following EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions. After opening, the contents of the bottle should be used within 12 weeks.
The bottle with the dispenser attached must be stored and transported in an upright (vertical) position only.
Medicines must not be disposed of via wastewater or household waste. Empty containers and unused medicines should be returned to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Package contents and other information
Composition of memantina cinfa
The active substance is memantine hydrochloride.
Each pump actuation (one spray) releases 0.5 ml of solution containing 5 mg of memantine hydrochloride, equivalent to 4.16 mg of memantine. Each ml of solution contains 10 mg of memantine hydrochloride.
The other components are potassium sorbate (E-202), non-crystallizable liquid sorbitol (E-420) and purified water.
Appearance of the product and contents of the container
Memantina cinfa oral solution is a clear, colourless to slightly yellowish solution.
Memantina cinfa oral solution is supplied in 100 ml amber glass bottles. A dosing device is included.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta.
31620 Huarte (Navarra)-Spain
Manufacturer
Chanelle Medical Unlimited Company
Dublin Road
Loughrea
Co. Galway (Ireland)
Date of latest revision of this leaflet: May 2020
Detailed information on this medicine is available on the website of the Spanish Agency for 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 leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/78316/P_78316.html
QR code to: https://cima.aemps.es/cima/dochtml/p/78316/P_78316.html