Memantine Aurobindo

Patient Information Leaflet

Memantina Aurobindo 10 mg film-coated tablets, 20 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Memantina Aurobindo is and what it is used for
2. What you need to know before taking Memantina Aurobindo
3. How to take Memantina Aurobindo
4. Possible side effects
5. How to store Memantina Aurobindo
6. Contents of the pack and other information

1. What Memantina Aurobindo is and what it is used for

Memantina Aurobindo 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 a disruption in message transmission in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors, which are involved in nerve signal transmission important for learning and memory. Memantina Aurobindo belongs to a group of medicines known as NMDA receptor antagonists. Memantina Aurobindo acts on these NMDA receptors, improving nerve signal transmission and memory.
Memantina Aurobindo is used for the treatment of patients with moderate to severe Alzheimer's disease.

2. What you need to know before taking Memantina Aurobindo

Do not take Memantina Aurobindo

• 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 taking Memantina Aurobindo

• if you have a history of epileptic seizures;
• if you have recently had a myocardial infarction (heart attack) or if you suffer from congestive heart failure or uncontrolled hypertension (high blood pressure). In these situations, treatment must be closely monitored and the clinical benefits of Memantina Aurobindo should be regularly reassessed by your treating physician.

In case of renal impairment (kidney problems), your doctor must carefully monitor kidney function and, if necessary, adjust the memantine dosage accordingly.
Concomitant use of medicinal products such as amantadine (used for the treatment of Parkinson's disease), ketamine (a substance generally used as an anesthetic), dextromethorphan (commonly used for cough treatment), and other NMDA antagonists should be avoided.
Children and adolescents
Memantina Aurobindo is not recommended for children and adolescents under 18 years of age.
Other medicines and Memantina Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, Memantina Aurobindo may alter the effects of the following medicines, and your doctor may need to adjust their dosage:

• amantadine, ketamine, dextromethorphan
• dantrolene, baclofen
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
• hydrochlorothiazide (or combinations containing hydrochlorothiazide)
• anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
• anticonvulsants (substances used to prevent and treat epileptic seizures)
• barbiturates (substances generally used to induce sleep)
• dopaminergic agonists (such as L-dopa, bromocriptine)
• neuroleptics (substances used in the treatment of mental disorders)
• oral anticoagulants.

If you are admitted to hospital, inform medical staff that you are taking Memantina Aurobindo.
Memantina Aurobindo with food, drinks and alcohol
You should consult your doctor if you have recently changed or plan to substantially change your diet (e.g. from a normal diet to a strict vegetarian diet), or if you suffer from renal tubular acidosis (RTA, an excess of acid-forming substances in the blood due to kidney dysfunction (insufficient kidney function)) or severe urinary tract infections (the structure that transports urine), as your doctor may need to adjust the dosage of the medicine accordingly.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The use of memantine during pregnancy is not recommended.
Breastfeeding
Women taking Memantina Aurobindo must not breastfeed.
Driving and using machines
Your doctor will advise you on whether it is safe for you to drive or operate machinery given your condition. Furthermore, Memantina Aurobindo may affect your reaction time, making it advisable not to drive or operate machinery.
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. it is essentially "sodium-free".

3. How to take Memantina Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose of Memantina Aurobindo for adult and elderly patients is 20 mg once daily. To
reduce the risk of undesirable effects, reach this dose gradually according to the following daily dosing schedule:

The usual starting dose is half a 10 mg tablet once daily (5 mg) for the first week. The dose is increased to one 10 mg tablet once daily (10 mg) in the second week, and to one and a half 10 mg tablets once daily in the third week. From the fourth week onwards, the usual dose is 2 tablets of 10 mg or one 20 mg tablet once daily (20 mg).
Dosage in patients with impaired renal function
If you have impaired renal function, your doctor may decide on a dosage regimen appropriate for your condition. In such cases, regular monitoring of renal function should be requested by the doctor.
Administration
Memantina Aurobindo should be administered orally once daily. To obtain benefit, you must take the medicine regularly every day at the same time. You should take the tablets with some water. The tablets may be taken with or without food.
Duration of treatment
Continue taking Memantina Aurobindo for as long as you benefit from it. Your doctor will evaluate the treatment at regular intervals.
If you take more Memantina Aurobindo than you should

• In general, overdose with Memantina Aurobindo is not harmful. A greater number of symptoms described in section 4 “Possible side effects” may occur.
• In case of a significant overdose with Memantina Aurobindo, contact your doctor, as you may require medical assistance.

If you forget to take Memantina Aurobindo

• If you realize you have forgotten to take a dose of Memantina Aurobindo, wait and take the next dose at the usual time.
• Do not take a double dose to make up for the missed dose.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In general, the side effects observed are mild to moderate.
Common (may affect up to 1 in 10 people):

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorders, 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 disturbances, heart failure, and venous blood clotting (thrombosis/thromboembolism).

Very rare (may affect up to 1 in 10,000 people):

• Seizures.

Not known (frequency cannot be estimated from the available data):

• Inflammation of the pancreas, inflammation of the liver (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 Memantina Aurobindo.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Memantina Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, carton and bottle after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Memantina Aurobindo contains

• The active substance is memantine hydrochloride. Each film-coated tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine. Each film-coated tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.
• The other ingredients are: Tablet core: microcrystalline cellulose, silicified microcrystalline cellulose, anhydrous colloidal silicon dioxide, sodium starch glycolate (type A), talc, and sodium stearyl fumarate.

Coating: hydroxypropylcellulose, titanium dioxide (E 171), macrogol (6000), talc, iron oxide red (E172) (for 20 mg), and iron oxide yellow (E172) (for 20 mg).
Description of the appearance of Memantina Aurobindo and contents of the pack
Film-coated tablets.
Memantina Aurobindo 10 mg film-coated tablets
White to off-white, thin in the middle, oblong, biconvex, film-coated tablets, with a single notch on both sides and imprinted with “Z” and “03” on both sides of the notch on one side and smooth on the other side.
The tablet can be divided into two equal doses.
Memantina Aurobindo 20 mg film-coated tablets
Light red to light grey, oval, oblong, film-coated tablets, with “Z” printed on one side and “06” on the other side.
Memantina Aurobindo film-coated tablets are available in transparent blisters made of PVC/PE/PVdC/aluminium foil.
Blister pack sizes:
For 10 mg: 56 film-coated tablets.
For 20 mg: 28 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l. – Via San Giuseppe 102 – 21047 Saronno (VA), Italy
Manufacturer
APL Swift Services (Malta) Limited, HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta
Milpharm Limited, Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD, United Kingdom
This medicinal product is authorized in the European Economic Area Member States under the following names:
Italy: Memantina Aurobindo
Portugal: Memantina Aurovitas