DEMENCO

Package leaflet: Information for the user

DEMENCO 10 mg film-coated tablets

Memantine hydrochloride
Generic medicine
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, as it may 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 DEMENCO is and what it is used for
2. What you need to know before taking DEMENCO
3. How to take DEMENCO
4. Possible side effects
5. How to store DEMENCO
6. Contents of the pack and other information

1. What DEMENCO is and what it is used for

How DEMENCO works
DEMENCO contains the active substance memantine hydrochloride. This belongs to a group of
medicines known as anti-dementia drugs.
Memory loss in Alzheimer's disease is due to a disturbance in signal transmission in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors involved in nerve signal transmission, which is important for learning and memory.
DEMENCO belongs to a group of medicines known as NMDA receptor antagonists. DEMENCO acts on these NMDA receptors, improving nerve signal transmission and memory.
DEMENCO is used for the treatment of patients with moderate to severe Alzheimer's disease.

2. What you need to know before taking DEMENCO

Do not take DEMENCO

• if you are allergic to memantine 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 DEMENCO:

• 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 high blood pressure.

In these situations, treatment should be closely monitored and the clinical benefits of DEMENCO reassessed regularly by your treating physician.
If you have renal impairment (kidney problems), your doctor must carefully monitor kidney function and, if necessary, adjust the memantine dosage accordingly.
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), your doctor may need to adjust the dosage of the medicine accordingly.
Avoid concomitant use of medicines such as amantadine (used to treat Parkinson's disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (commonly used to treat cough), and other NMDA antagonists.
Children and adolescents
DEMENCO is not recommended for children and adolescents under 18 years of age.
Other medicines and DEMENCO
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, the effects of the following medicines might be altered by DEMENCO, and dose adjustment may be necessary:

• 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 (substances 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 DEMENCO.
DEMENCO with food and drink
Talk to your doctor if you have recently changed or plan to substantially change your diet (e.g. from a normal diet to a strictly vegetarian diet), as your doctor may need to adjust the dose of the medicine accordingly.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
The use of memantine during pregnancy is not recommended.
Breastfeeding
Women taking DEMENCO 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.
Moreover, DEMENCO may affect your reaction time, making it inadvisable to drive or operate machinery.
DEMENCO contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. How to take DEMENCO

Always take DEMENCO exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of DEMENCO 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 dosage schedule:

The usual starting dose is half a tablet once daily (1 x 5 mg) for the first week.
The dose is increased to one tablet once daily (1 x 10 mg) in the second week and to one and a half tablets once daily in the third week. From the fourth week onwards, the usual dose is two tablets once daily (1 x 20 mg).
Dosage in patients with reduced renal function
In case of reduced renal function, your treating physician may decide on a dosage regimen suitable for your condition. In such cases, your doctor must monitor your renal function at regular intervals.
Administration
DEMENCO must be administered orally once daily. To benefit from it, you must take the medicine regularly every day at the same time. Swallow the tablets with some water. The tablets may be taken with or without food.
Duration of treatment
Continue taking DEMENCO for as long as you benefit from it. Your doctor will evaluate the treatment at regular intervals.
If you take more DEMENCO than you should

• In general, overdosing on DEMENCO is not harmful. A greater number of symptoms described in section 4. "Possible side effects" may occur.
• In case of a significant overdose of DEMENCO, contact your doctor or seek medical help, as you may require medical assistance.

If you forget to take DEMENCO

• If you forget to take a dose of DEMENCO, wait and take the next dose at the scheduled time.
• Do not take a double dose to make up for the missed dose.

If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
In general, the side effects observed are mild to moderate.
Common (affects 1 to 10 people in 100)

• Headache, drowsiness, constipation, increased liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure, and drug hypersensitivity.

Uncommon (affects 1 to 10 people in 1,000)

• Fatigue, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure, and venous blood clotting (thrombosis/thromboembolism).

Very rare (affects less than 1 person in 10,000)

• 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 memantine.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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 DEMENCO

Keep this medicine out of the sight and reach of children.
Do not use DEMENCO after the expiry date which is stated on the packaging and blister 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 DEMENCO contains
The active substance is memantine hydrochloride. Each film-coated tablet contains 10 mg of
memantine hydrochloride, equivalent to 8.31 mg of memantine.
The other ingredients are silicified microcrystalline cellulose, sodium croscarmellose, talc and
magnesium stearate, in the tablet core; hypromellose (E464), titanium dioxide (E171) and macrogol
400 in the tablet coating.
What DEMENCO looks like and contents of the pack
DEMENCO is a film-coated tablet, white to off-white in colour, capsule-shaped, with 'CL 29' engraved on one side and a score line on both sides (approximate dimensions 12.1 x 5.1 mm).
The tablet can be divided into two equal doses.
DEMENCO is available in packs of 28, 42, 56, 98 and 112 tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Ecupharma S.r.l. - Via Mazzini 20 - 20123 Milano (Italy).
Manufacturer responsible for batch release
Macleods Pharma UK Limited
Wynyard Park House,
Wynyard Avenue,
Wynyard, Billingham,
TS22 5TB,
United Kingdom
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
Poland