Memantinine Aristo 10 mg/ml oral solution EFG
Spain
Table of Contents
- Patient Information Leaflet
- Introduction
- 1. What Memantina Aristo is and what it is used for
- 2. What you need to know before taking Memantina Aristo
- Do not take Memantina Aristo
- 3. How to take Memantina Aristo
- 4. Possible adverse effects
- 5. Storage of Memantine Aristo
- 6. Contents of the pack and other information
- Composition of Memantina Aristo
Patient Information Leaflet
Introduction
Patient Information Leaflet
Memantina Aristo 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.
Contents of this leaflet
- What Memantina Aristo is and what it is used for.
- What you need to know before taking Memantina Aristo.
- How to take Memantina Aristo.
- Possible side effects.
- How to store Memantina Aristo.
- Contents of the pack and other information.
1. What Memantina Aristo is and what it is used for
How Memantina Aristo works
Memantina Aristo contains the active substance memantine hydrochloride. 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 belongs to a group of medicines called NMDA receptor antagonists. Memantina acts on these receptors, improving nerve signal transmission and memory.
What Memantina Aristo is used for
Memantina Aristo is used in the treatment of patients with moderate to severe Alzheimer's disease.
2. What you need to know before taking Memantina Aristo
Do not take Memantina Aristo
- 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 Aristo,
- if you have a history of epileptic seizures (convulsions).
- if you have recently had a myocardial infarction (heart attack), if you have congestive heart disease, or if you have uncontrolled hypertension (high blood pressure).
In the above situations, treatment must be carefully supervised, and your doctor should regularly re-evaluate the clinical benefit of Memantina Aristo.
If you have renal insufficiency (kidney problems), your doctor must closely monitor your kidney function and, if necessary, adjust the dose of memantine.
The use of memantine together with other medicines such as amantadine (used to treat Parkinson's disease), ketamine (a drug generally used to induce anesthesia), dextromethorphan (a cough medicine), and other NMDA antagonists should be avoided.
Children and adolescents
The use of Memantina Aristo is not recommended in children and adolescents under 18 years of age.
Use of Memantina Aristo 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, so your doctor may need to adjust the doses:
- 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 control 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 Aristo.
Memantina Aristo 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, as your doctor may need to adjust the dose of the medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or plan 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 Memantina Aristo should discontinue breastfeeding.
Driving and use of machines
Your doctor will advise you whether your condition allows you to drive and operate machinery safely.
Furthermore, Memantina Aristo may affect your reaction capabilities, so driving or operating machinery may be inappropriate.
Memantina Aristo contains sorbitol (E 420)
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Memantina Aristo
Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Dosage
0.5 ml of oral solution contains 5 mg of memantine hydrochloride.
The recommended dose of Memantina Aristo in adult and elderly patients is 2 ml, equivalent to 20 mg, once daily.
To reduce the risk of adverse effects, this dose should be reached gradually according to the following daily treatment schedule:
Treatment period | Daily dose (ml) |
Week 1 | 0.5 ml once daily (1 x 5 mg) |
Week 2 | 1 ml once daily (1 x 10 mg) |
Week 3 | 1.5 ml once daily (1 x 15 mg) |
Week 4 | 2 ml once daily (1 x 20 mg) |
The usual starting dose is 0.5 ml (equivalent to 5 mg) taken once daily during the first week. This dose is increased to 1 ml (equivalent to 10 mg) once daily during the second week, and to 1.5 ml (equivalent to 15 mg) once daily during the third week. From the fourth week onwards, the recommended dose is 2 ml (equivalent to 20 mg) taken once daily.
Dosage for patients with reduced renal function
If you have kidney problems, your doctor will determine the appropriate dose for your condition. In such cases, your doctor should periodically monitor your kidney function.
Administration
Memantina Aristo should be administered orally once daily. To get the maximum benefit from your medication, you must take it every day at the same time. The solution may be taken with or without food.
The solution must not be poured or dispensed directly into the mouth from the bottle or syringe. Measure the dose using the syringe and pour it into a spoon or into a glass of water.
Instructions for use
- Open the bottle: Press down on the cap and unscrew it counterclockwise.
- Insert the dosing syringe adapter into the neck of the bottle (Figure 1). Make sure the adapter is securely fitted.
- Insert the syringe into the adapter (Fig. 1).
Turn the bottle upside down with its mouth facing downward (Fig. 2).
- Fill the dosing syringe with a small amount of solution by gently pulling the plunger (Fig. 3A). Then push the plunger upward to expel the contents and remove any air bubbles (Fig. 3B). Next, pull the plunger down to the mark in milliliters (ml) corresponding to the dose prescribed by your doctor (Fig. 3C).
- Place the bottle upright on its base. Remove the syringe from the adapter.
- Empty the contents of the syringe into a spoon or into a glass containing a small amount of water by pushing the plunger and fully emptying the syringe (Fig. 4).
- Take the entire contents of the spoon or glass of water.
- Rinse the syringe with water only (Fig. 5).
- Close the bottle with the screw cap.
Duration of treatment
Continue taking Memantina Aristo for as long as it benefits you. Your doctor should periodically evaluate your treatment.
If you take more Memantina Aristo than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: (91) 5620420, indicating the medication and the amount ingested.
In general, taking an excessive amount of Memantina Aristo should not cause you any harm. You may experience an increase in the symptoms described in section 4 "Possible side effects".
If you forget to take Memantina Aristo
- If you realize you have forgotten to take your dose of Memantina Aristo, wait and take the next dose at the usual time.
Do not take a double dose to make up for missed doses.
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 people):
- Headache, drowsiness, 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 people):
- Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbance, heart failure, and formation of blood clots in the venous system (venous thrombosis/venous thromboembolism).
Very rare (may affect up to 1 in 10,000 people):
- Seizures.
Frequency not known (frequency cannot be estimated from the 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 through the national reporting system:
Spanish Pharmacovigilance System for Human Medicines Website: www.notificaRAM.es
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Memantine Aristo
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton 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 must be used within 6 months.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, 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 Memantina Aristo
• The active substance is Memantine hydrochloride.
• 1 ml of solution contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.
• 0.5 ml of solution contains 5 mg of memantine hydrochloride, equivalent to 4.15 mg of memantine.
• Other components: potassium sorbate, liquid sorbitol 70% (non-crystalline) (E420), purified water.
Appearance of the medicinal product and contents of the container
Memantina Aristo oral solution is a clear, colourless to slightly yellowish solution.
Amber glass bottle with a graduated syringe (graduation marks every 0.5 ml) and a syringe adapter. Available in bottles containing 30 ml, 50 ml, or 100 ml of solution.
Hospital pack: 500 ml.
Only certain pack sizes may be marketed.
Marketing Authorization Holder
Aristo Pharma Iberia S.L.
C/ Solana 26
28850 – Torrejón de Ardoz, Madrid, Spain
Manufacturer
Laboratorios Medicamentos Internacionales, S.A. (Medinsa)
C/ Solana 26
28850 – Torrejón de Ardoz, Madrid, Spain
ARISTO PHARMA GMBH
Wallenroder Strasse 8-10
13435 Berlin, Germany
NEURAXPHARM ARZNEIMITTEL GMBH & CO. KG
Elisabethselbert Strasse 23
Langenfeld – 40764, Germany
This medicinal product is authorized in the European Economic Area member states under the following names:
Germany: Memantin Aristo 10 mg/ml Lösung zum Einnehmen
Poland: Memantin NeuroPharma 10 mg/ml Roztwór doustny
Portugal: Memantina Aristo 10 mg/ml solução oral
Spain: Memantina Aristo 10 mg/ml solución oral EFG
Date of latest revision of this leaflet: September 2017
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/