MEMANTINE KERN PHARMA 10 mg/ml ORAL SOLUTION
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Introduction
Patient Information Leaflet
Memantina Kern Pharma 10 mg/ml Oral Solution EFG
Memantine Hydrochloride
Read this leaflet carefully before starting to take this medicine because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
Contents of the pack:
- What Memantina Kern Pharma is and what it is used for
- What you need to know before taking Memantina Kern Pharma
- How to take Memantina Kern Pharma
- Possible side effects
- Storage of Memantina Kern Pharma
- Contents of the pack and further information
1. What Memantina Kern Pharma is and what it is used for
How Memantina Kern Pharma works
Memantina Kern Pharma belongs to a group of medicines called antidementia medicines.
Memory loss in Alzheimer's disease is due to an alteration in brain signals. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors that participate in the transmission of important nerve signals in learning and memory. Memantine belongs to the group of medicines called NMDA receptor antagonists. Memantine acts on these receptors, improving the transmission of nerve signals and memory.
What Memantina Kern Pharma is used for
Memantina Kern Pharma is used in the treatment of patients with moderate to severe Alzheimer's disease.
2. What you need to know before taking Memantina Kern Pharma
Do not take Memantina Kern Pharma
- if you are allergic to the active substance 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 taking Memantina Kern Pharma.
- if you have a history of seizures (convulsions)
- if you have recently had a myocardial infarction (heart attack), if you suffer from congestive heart failure or if you have uncontrolled hypertension (high blood pressure).
In these situations, treatment should be carefully supervised, and your doctor should regularly reassess the clinical benefit of memantine.
If you have kidney problems, your doctor should closely monitor your kidney function and, if necessary, adjust the dose of memantine.
The use of memantine with other medicines such as amantadine (for the treatment of Parkinson's disease), ketamine (a general anesthetic), dextromethorphan (a cough medicine), and other NMDA antagonists should be avoided.
Memantine is not recommended for use in children and adolescents under 18 years of age.
Taking Memantina Kern Pharma with other medicines
Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.
In particular, the administration of memantine may affect 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 with hydrochlorothiazide),
anticholinergics (substances used to treat movement disorders or intestinal spasms),
anticonvulsants (substances used to prevent and eliminate seizures),
barbiturates (substances 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 hospitalized, inform your doctor that you are taking Memantina Kern Pharma.
Taking Memantina Kern Pharma with food, drinks, and alcohol
You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g., from a normal diet to a strict vegetarian diet) or if you have renal tubular acidosis (RTA, excess of acid-producing substances in the blood due to kidney dysfunction) or severe urinary tract infections (urine tract), as your doctor may need to adjust the dose of the medicine.
Pregnancy, breastfeeding, and fertility
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.
Memantine is not recommended for use in pregnant women.
Women taking memantine should stop breastfeeding.
Driving and using machines
Your doctor will inform you whether your illness allows you to drive and use machines safely.
Memantine may also affect your reaction ability, so driving or operating machines may be inappropriate.
Memantina Kern Pharma contains sorbitol
This medicine contains sorbitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.
3. How to take Memantina Kern Pharma
Follow the administration instructions of this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist.
Dosage
Each ml of solution contains 10 mg of memantine hydrochloride.
The recommended dose of memantine in adult and elderly patients is 2 ml, equivalent to 20 mg, administered once daily. To reduce the risk of side effects, this dose is gradually achieved by following the daily scheme:
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 (5 mg) once daily for the first week. This dose is increased in the second week to 1 ml once daily (1 x 10 mg) and in the third week to 1.5 ml once daily (15 mg) once daily in the third week. From the fourth week onwards, the recommended dose is 2 ml once daily (20 mg).
Dosage for patients with renal impairment
If you have kidney problems, your doctor will decide on the appropriate dose for your condition. In this case, your doctor should regularly monitor your kidney function.
Administration
Memantine should be administered orally once daily. To get the most out of your medication, you should take it every day and at the same time. The solution should be taken with a little water. The solution can be taken with or without food.
Duration of treatment
Continue taking memantine as long as it is beneficial for you. Your doctor should evaluate the effects of your treatment periodically.
If you take more Memantina Kern Pharma than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.
- Generally, taking an excessive amount of Memantina should not cause you any harm. You may experience an increase in the symptoms described in section 4 "Possible side effects".
- If you take an overdose of Memantina, contact your doctor or seek medical advice, as you may need medical attention.
If you forget to take Memantina Kern Pharma
- If you realize you have forgotten to take your dose of memantine, wait and take the next dose at the usual time.
- Do not take a double dose to make up for the forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Memantina Kern Pharma can cause side effects, although not everybody gets them.
Side effects are usually mild to moderate.
Frequent (may affect 1 to 10 in every 100 patients):
- Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorder, difficulty breathing, high blood pressure, and hypersensitivity to the medicine.
Uncommon (may affect 1 to 10 in every 100 patients):
- Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbance, heart failure, and venous thrombosis/thromboembolism.
Rare (may affect less than 1 in every 1000 patients):
- Seizures.
Frequency not known (frequency cannot be estimated from available data):
- Pancreatitis, hepatitis, 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 side effects
If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.
If you think any of the side effects you are experiencing are serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
5. Storage of Memantina Kern Pharma
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 label after "EXP". The expiry date is the last day of the month stated.
No special storage conditions are required.
Once opened, the contents of the bottle should be used within 2 months.
Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.
6. Contents of the pack and further information
Composition of Memantina Kern Pharma
- The active substance is memantine hydrochloride. Each ml of solution contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.
- The other ingredients are non-crystallizable liquid sorbitol (E420), potassium sorbate (E202), and purified water.
Appearance of the product and pack contents
Memantina Kern Pharma oral solution is a clear, colorless to slightly yellowish solution.
Memantina Kern Pharma oral solution is presented in a 100 ml plastic bottle with a 2 ml graduated dosing syringe.
Other presentations
Memantina Kern Pharma 10 mg tablets
Memantina Kern Pharma 20 mg tablets
Marketing authorization holder and manufacturer
Kern Pharma, S.L.
Pol. Ind. Colón II, C/ Venus 72
08228 Terrassa (Barcelona)
Spain
Date of last revision of this leaflet:May2013
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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