Nabila 10 mg/ml oral solution EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
NABILA 10 mg/ml oral solution EFG
Memantine hydrochloride
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 may 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 Nabila is and what it is used for
- What you need to know before taking Nabila
- How to take Nabila
- Possible side effects
- How to store Nabila
- Contents of the pack and other information
1. What Nabila is and what it is used for
How Nabila works
Nabila contains memantine hydrochloride as the active substance, which 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.
Nabila belongs to the group of medicines called NMDA receptor antagonists.
This medicine acts on these receptors, improving the transmission of nerve signals and memory.
What Nabila is used for
Nabila is used for the treatment of patients with moderate to severe Alzheimer's disease.
2. What you need to know before taking Nabila
Do not take Nabila:
- if you are allergic to memantine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting Nabila:
- if you have a history of epileptic seizures.
- if you have recently had a myocardial infarction (heart attack), if you have congestive heart failure, or if you have uncontrolled high blood pressure (hypertension).
In the above situations, treatment must be carefully monitored and your doctor should regularly re-evaluate the clinical benefit of Nabila.
You must inform your doctor if you have recently changed or intend to make substantial changes to 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 kidney dysfunction (kidney problem)) or severe urinary tract infections (the structure that carries urine), as your doctor may need to adjust the dose of the medicine.
If you have renal impairment (kidney problems), your doctor must closely monitor kidney function and, if necessary, adjust the doses of memantine.
The use of memantine should be avoided together with other medicines such as amantadine (used to treat Parkinson's disease), ketamine (a drug generally used to induce anaesthesia), dextromethorphan (a cough medicine), and other NMDA antagonists.
Children and adolescents
Nabila is not recommended for use in children and adolescents under 18 years of age.
Taking Nabila with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Specifically, taking Nabila may cause changes in the effects of the following medicines, so your doctor may need to adjust the dose:
- 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 Nabila.
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.
Pregnancy: The use of memantine is not recommended in pregnant women.
Breastfeeding: Women taking memantine should not breastfeed.
Driving and using machines
Your doctor will advise you whether your condition allows you to drive and use machines safely. In addition, Nabila may affect your reaction ability, so driving or operating machinery may be inappropriate.
Nabila contains sorbitol
This medicine contains 100 mg of sorbitol per ml of solution.
3. How to take Nabila
Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Dosage
Each milliliter (ml) of Nabila oral solution contains 10 milligrams (mg) of memantine hydrochloride.
The recommended dose of Nabila in adult and elderly patients is 2 ml, 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 schedule:
Week 1 | 0.5 ml |
Week 2 | 1 ml |
Week 3 | 1.5 ml |
Week 4 and onwards | 2 ml |
? The usual starting dose is 0.5 ml once daily (5 mg) during the first week.
? This dose is increased in the second week to 1 ml once daily (10 mg).
? In the third week, the dose is increased to 1.5 ml once daily (15 mg).
? From the fourth week onwards, the recommended dose is 2 ml once daily (20 mg).
Dosage for patients with reduced renal function
If you have reduced kidney function, your doctor will decide the appropriate dose for your condition. In this case, your doctor should periodically monitor your kidney function.
Administration
? Nabila must be taken orally once daily.
? To get the maximum benefit from your medication, you must take it every day at the same time.
? The solution can be taken directly or mixed with a small amount of water.
? The solution can be taken with or without food.
Instructions for correct use
? Open the bottle: press down and turn the cap counterclockwise (Figure 1).
? Insert the syringe adapter into the neck of the bottle (Figure 2).
? Take the syringe and insert it into the opening of the adapter (Figure 3).
? Turn the bottle upside down (Figure 4).
? Draw a small amount of solution into the syringe by pulling the plunger down (Figure 4A). Then push the plunger in to remove any air bubbles (Figure 4B). Finally, draw the solution by pulling the plunger until the flat part of the plunger aligns with the prescribed millilitre (ml) graduation mark (Figure 4C).
? Place the bottle in an upright position (Figure 5A).
? Remove the syringe from the adapter (Figure 5B).
? Place the syringe into your mouth and slowly press the plunger to administer the medicine. Alternatively, transfer the medicine to a spoon or glass with a small amount of water and drink it directly.
? Wash the syringe with water and let it dry for next use (Figure 6).
? Close the bottle with the cap – leave the adapter inserted in the bottle.
Duration of treatment
Continue taking Nabila for as long as it benefits you. Your doctor should periodically evaluate your treatment.
If you take more Nabila than you should
In general, taking an excessive amount of Nabila is not expected to cause harm. You may experience an increase in the symptoms described in section 4 “Possible side effects”. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.
If you forget to take NABILA
If you realize you have missed a dose of Nabila, wait and take the next dose at the usual time.
Do not take a double dose to make up for a missed dose.
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.
Frequent (may affect up to 1 in 10 patients):
? Headache
? Drowsiness
? Constipation
? Elevated liver function tests (according to blood tests)
? Dizziness
? Loss of balance
? Difficulty breathing
? High blood pressure
? Hypersensitivity to the medicine
Uncommon (may affect up to 1 in 100 patients):
? Fatigue
? Fungal infections
? Confusion
? Hallucinations
? Vomiting
? Gait disturbance
? Heart failure
? Blood clots in the venous system (venous thrombosis/venous thromboembolism)
Very rare (may affect up to 1 in 10,000 patients):
? Seizures
Frequency not known (cannot be estimated from available data):
- Pancreatitis
- Hepatitis (liver inflammation)
- 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 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 Nabila
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and on the label of the bottle after EXP. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
After opening, the contents of the bottle should be used within 3 months.
Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of NABILA
- The active substance is memantine hydrochloride. Each ml of solution contains 10 mg of memantine hydrochloride, equivalent to 8.32 mg of memantine.
- The other components (excipients) are: potassium sorbate (E202), non-crystallizing liquid sorbitol (E-420) and purified water.
Appearance of the product and contents of the pack
Nabila oral solution is a clear, colourless solution.
Nabila oral solution is supplied in a 100 ml bottle with a dosing syringe and a syringe adapter.
Marketing Authorization Holder
Exeltis Healthcare, S.L
Avda. de Miralcampo, 7.
Polígono Industrial Miralcampo.
19200 Azuqueca de Henares (Guadalajara).
Spain
Manufacturer
Jenson R+ (Ireland) Ltd.
Unit 15, Daingean Hall,
N4 Axis Centre,
Longford,
N39 W6K0, Ireland
Date of the most recent revision of this leaflet: April 2018
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS):
http://www.aemps.gob.es/