Nemedan
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How to use Nemedan
Package Leaflet: Information for the User
Nemedan, 20 mg, Film-Coated Tablets
Memantine Hydrochloride
Read the Package Leaflet Carefully Before Taking the Medicinal Product
- Keep this package leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicinal product has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.
Table of Contents of the Package Leaflet:
- 1. What is Nemedan and What is it Used For
- 2. Important Information Before Taking Nemedan
- 3. How to Take Nemedan
- 4. Possible Side Effects
- 5. How to Store Nemedan
- 6. Contents of the Package and Other Information
1. What is Nemedan and What is it Used For
What is Nemedan
Nemedan contains the active substance memantine and belongs to a group of medicines called anti-dementia medicines.
Memory loss in Alzheimer's disease is due to disturbances in the transmission of nerve impulses
that carry information in the brain. In the brain, there are so-called N-methyl-D-aspartate (NMDA) receptors,
which are involved in the transmission of nerve signals important for the learning process and for memory.
Nemedan belongs to a group of medicines called NMDA receptor antagonists. Nemedan, by acting on NMDA receptors,
improves the transmission of nerve impulses and memory.
What is Nemedan Used For
Nemedan is used to treat patients with moderate to severe Alzheimer's disease.
2. Important Information Before Taking Nemedan
When Not to Take Nemedan
- if you are allergic (hypersensitive) to memantine hydrochloride or any of the other ingredients of Nemedan (see section 6).
Warnings and Precautions
When to be Extra Careful While Taking Nemedan
You should inform your doctor if:
- you have had seizures in the past;
- you have recently had a heart attack, have congestive heart failure, or have uncontrolled high blood pressure.
In these situations, treatment with Nemedan should be carried out under close medical supervision,
and your doctor should regularly assess the effects of the therapy.
When memantine is given to patients with kidney problems, the doctor should closely monitor kidney function and,
if necessary, adjust the dose of the medicinal product.
You should avoid taking other medicines such as: amantadine (for the treatment of Parkinson's disease), ketamine (a substance usually used as an anesthetic), dextromethorphan (usually used to treat cough), and other NMDA receptor antagonist medicines.
Children and Adolescents
Nemedan is not recommended for children and adolescents under 18 years of age.
Nemedan and Other Medicines
You should inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, even those that are available without a prescription.
In particular, taking Nemedan may cause changes in the effects of and require modification of the dose of the following medicines:
- amantadine, ketamine, dextromethorphan;
- dantrolene, baclofen;
- cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine;
- hydrochlorothiazide (and all combination products containing hydrochlorothiazide);
- anticholinergic medicines (usually used to treat movement disorders or intestinal cramps);
- antiepileptic medicines (used to prevent and stop seizures);
- barbiturates (mainly used as sedatives);
- dopaminergic agonists (such as L-dopa, bromocriptine);
- neuroleptics (used to treat mental disorders);
- oral anticoagulants.
If you are hospitalized, you should inform your doctor that you are taking Nemedan.
Nemedan with Food and Drink
You should inform your doctor if you have recently changed your diet (e.g., switched from a normal diet to a strict vegetarian diet) or have been diagnosed with renal tubular acidosis (RTA, excessive blood acidity due to kidney dysfunction) or severe urinary tract infections (structures through which urine flows). In these cases, it may be necessary for your doctor to adjust the dose of the medicinal product.
Pregnancy, Breast-Feeding, and Fertility
Women who are pregnant, breast-feeding, or planning to become pregnant should inform their doctor before starting treatment.
Pregnancy
Memantine is not recommended for use in pregnant women.
Breast-Feeding
Women taking Nemedan should not breast-feed.
Driving and Using Machines
Your doctor should inform you whether your illness allows you to drive or use machines safely.
Nemedan may also affect your reaction speed, making it inadvisable to drive or use machines.
3. How to Take Nemedan
Nemedan should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
Dosage
The recommended dose of Nemedan for adults and the elderly is 20 mg once a day.
To minimize the risk of side effects, the dose of Nemedan should be increased gradually, according to the following scheme. Tablets of a different strength may also be used for this purpose.
At the beginning of treatment, Nemedan 5 mg film-coated tablets are used once a day. The dose will be increased by 5 mg every week until the recommended (maintenance) dose is reached.
The recommended maintenance dose is 20 mg once a day and is achieved at the beginning of the fourth week.
Dosage in Patients with Renal Impairment
In patients with impaired kidney function, the dose of Nemedan is determined by the doctor.
In such patients, regular monitoring of kidney function is necessary, at intervals determined by the doctor.
Method of Administration
Nemedan should be taken orally, once a day. To ensure the treatment is effective, the medicinal product should be taken regularly every day at the same time.
The tablets should be swallowed with water. The medicinal product can be taken with or without food.
Duration of Treatment
Treatment should be continued for as long as it is beneficial. Your doctor will regularly assess the course of treatment.
Overdose of Nemedan
- Generally, taking too much Nemedan does not pose a risk to health. In such cases, increased side effects as described in section 4 "Possible Side Effects" may occur.
- In the event of significant overdose of Nemedan, you should contact your doctor or another doctor, as appropriate action may be necessary.
Missed Dose of Nemedan
- If you forget to take a dose, you should take the next dose of Nemedan at the usual time.
- Do not take a double dose to make up for a missed dose.
If you have any doubts about taking this medicinal product, you should consult your doctor or pharmacist.
4. Possible Side Effects
Like all medicines, Nemedan can cause side effects, although not everybody gets them.
Generally, the observed side effects are mild to moderate.
Common(may affect up to 1 in 10 people):
- Headache, drowsiness, constipation, elevated liver enzyme levels, dizziness, balance disorders, shallow breathing, high blood pressure, and hypersensitivity to the medicinal product.
Uncommon(may affect up to 1 in 100 people):
- Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbances, heart failure, and venous thrombosis/thromboembolism.
Rare(may affect up to 1 in 1,000 people):
- Seizures.
Unknown(frequency cannot be estimated from the available data):
- Pancreatitis, hepatitis, and psychotic reactions.
Alzheimer's disease is associated with depression, suicidal thoughts, and suicide. Such cases have been reported in patients treated with Nemedan.
Reporting Side Effects
If you experience any side effects, including those not listed in this package leaflet, you should inform your doctor or pharmacist.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181 C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicinal product.
5. How to Store Nemedan
Keep this medicinal product out of the sight and reach of children.
Do not use Nemedan after the expiry date stated on the carton and blister after the words "Expiry Date".
The expiry date refers to the last day of that month.
There are no special precautions for the storage of the medicinal product.
After removal from the blister, the tablets can be stored for 7 days (e.g., in a pill box).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the Package and Other Information
What Nemedan Contains
The active substance is memantine hydrochloride. Each film-coated tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.
The other ingredients are:
Core: microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, talc, magnesium stearate; and
Coating No: 28 Opadry Pink 20A34056:hypromellose 2910, hydroxypropylcellulose, talc, titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172).
What Nemedan Looks Like and Contents of the Package
Nemedan film-coated tablets are pink, oval, film-coated tablets with the imprint "20" on one side.
Nemedan film-coated tablets are available in blisters containing 30 tablets.
Marketing Authorization Holder and Manufacturer/Importer
G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
To obtain more detailed information and information on the names of the medicinal product in other EEA member states, please contact the representative of the marketing authorization holder:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Phone: 022/ 636 52 23; 636 53 02
e-mail: [email protected]
Date of Last Revision of the Package Leaflet:
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- ImporterG.L. Pharma GmbH
- 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.
- Alternatives to NemedanDosage form: Tablets, 10 mgActive substance: memantinePrescription requiredDosage form: Tablets, 20 mgActive substance: memantinePrescription requiredDosage form: Tablets, 10 mgActive substance: memantineManufacturer: Biofarm Sp. z o.o. Phytopharm Klęka S.A.Prescription required
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