CEVEDALO 10 mg/10 mg Фильм-Coated Таблетки

Содержание инструкции

1. Cevedalo 10 mg/10 mg film-coated tablets, 10 mg/20 mg film-coated tablets
   1. What is Cevedalo and what is it used for
   2. What you need to know before taking Cevedalo
   3. How to take Cevedalo
   4. Possible side effects
   5. How to store Cevedalo
   6. Contents of the pack and other information

Cevedalo 10 mg/10 mg film-coated tablets, 10 mg/20 mg film-coated tablets

donepezil hydrochloride and memantine hydrochloride

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Cevedalo and what is it used for

Cevedalo contains the active ingredients donepezil hydrochloride and memantine hydrochloride. Both
belong to a group of medicines known as anti-dementia drugs. Donepezil hydrochloride as
an acetylcholinesterase inhibitor increases the levels of a substance (acetylcholine) in the brain involved
in memory function by slowing down the breakdown of acetylcholine. Memantine hydrochloride is
an NMDA receptor antagonist. Memory loss in Alzheimer's disease results from a
disruption of message transmission in the brain. 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. Memantine hydrochloride acts on these NMDA receptors improving
nerve signal transmission and memory.
Cevedalo should only be used in patients who are already taking donepezil and memantine
at the same time and at the same doses as Cevedalo.
Cevedalo is used to treat the symptoms of dementia in people diagnosed with moderate to severe Alzheimer's
disease. Symptoms include memory loss, confusion, and behavioral changes.
As a result, people with Alzheimer's disease find it increasingly difficult to perform their
normal daily activities.
.
Cevedalo is only indicated for adult patients.

2. What you need to know before taking Cevedalo

Do not take Cevedalo

• if you are allergic to donepezil or piperidine derivatives, memantine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before taking Cevedalo if you have or have had:

• a history of seizures or other convulsive disorders (attacks) or convulsions. Cevedalo may cause a new attack. The doctor will monitor your symptoms.
• a recent heart attack (myocardial infarction), a heart problem (in particular sinoatrial node syndrome or a similar condition - donepezil can slow the heart rate) or if you suffer from congestive heart failure or uncontrolled high blood pressure (hypertension).
• a heart condition called "prolonged QT interval" or a history of certain abnormal heart rhythms called torsades de pointes or if someone in your family has "prolonged QT interval"
• low levels of magnesium or potassium in your blood
• stomach or duodenal ulcers or if you are using a certain type of painkiller (non-steroidal anti-inflammatory drugs - NSAIDs). The doctor will monitor your symptoms.
• difficulty urinating. The doctor will monitor your symptoms.
• asthma or other long-term lung diseases. Symptoms may worsen.

Also, inform your doctor if you are pregnant or suspect you may be pregnant.
In these situations, treatment must be carefully monitored and the clinical benefit of
Cevedalo must be regularly reassessed by the doctor.
Tell your doctor before if you have kidney or liver disease. Cevedalo can be used in patients with
mild to moderate kidney or liver disease. Patients with severe liver disease
should not take Cevedalo.
If you suffer from renal insufficiency (kidney problems), your doctor should carefully monitor
kidney function and, if necessary, adjust the doses of donepezil and memantine accordingly.
If you suffer from renal tubular acidosis (RTA, an excess of substances that form acid in the blood
due to kidney dysfunction (poor kidney function)) or severe urinary tract infections (structure
that carries urine), your doctor may need to adjust the dose of the medicine.
The concomitant use of medicines called amantadine (for the treatment of Parkinson's disease),
ketamine (usually used as an anesthetic), dextromethorphan (usually used to treat
cough) and other NMDA antagonists should be avoided.
If you develop signs and symptoms indicative of neuroleptic malignant syndrome (NMS, a
potentially life-threatening disorder characterized by a range of symptoms including fever with muscle rigidity,
sweating and altered level of consciousness) reported in patients taking
donepezil (which is part of Cevedalo), particularly in combination with antipsychotics, or develop unexplained high fever without further clinical manifestations of NMS, treatment should be discontinued.

Children and adolescents
Do not give Cevedalo to children and adolescents under 18 years of age.

Other medicines and Cevedalo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This includes medicines your doctor has not prescribed for you but you
have bought yourself. This also applies to medicines you may take in
the future if you continue to take Cevedalo. This is because these medicines can weaken or strengthen the
effects of Cevedalo.
In particular, tell your doctor if you are taking any of the following types of medicines:

• other medicines for Alzheimer's disease, for example galantamine
• painkillers or treatment for arthritis, for example aspirin, non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac sodium
• anticholinergic medicines (usually used to treat movement disorders or intestinal cramps), e.g. tolterodine
• medicines for bacterial infections, e.g. clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
• antifungal medicines, for example ketoconazole and itraconazole
• antiprotozoal agents (used to treat infections caused by protozoa) for example quinine
• antidepressants, for example fluoxetine, citalopram, escitalopram, amitriptyline
• medicines for psychosis, for example pimozide, sertindole, ziprasidone
• anticonvulsants (used to prevent and relieve seizures) e.g. phenytoin, carbamazepine
• antidyskinetic medicines (used to treat Parkinson's disease), for example amantadine
• diuretics (used to reduce the amount of water in the body), e.g. hydrochlorothiazide or any combination with hydrochlorothiazide
• dopaminergic agonists (substances such as L-dopa, bromocriptine)
• medicines for a heart condition or rhythm problems, for example quinidine, beta-blockers (propanolol, sotalol and atenolol), procainamide, amiodarone
• medicines for the treatment of ulcers, for example cimetidine, ranitidine
• muscle relaxants, for example diazepam, succinylcholine, dantrolene, baclofen
• general anesthetic, for example ketamine
• cough suppressants (cough sedatives), for example dextromethorphan
• neuroleptics (used in the treatment of mental disorders), e.g. clozapine, risperidone
• oral anticoagulants (blood thinners), for example clopidogrel, warfarin
• barbiturates (usually used to induce sleep)
• nicotine for nicotine replacement therapy
• medicines obtained without a prescription (e.g. herbal remedies)

If you are about to undergo an operation requiring general anesthesia, tell your doctor and
anesthetist that you are taking Cevedalo. This is because the medicine may affect the amount of
anesthetic needed.
Tell your doctor or pharmacist the name of the person assisting you. This person will help you
take the medicine as prescribed.
If you go to hospital, let the doctors know that you are taking Cevedalo.

Cevedalo with food, drinks and alcohol
You should inform your doctor if you have recently changed or intend to significantly change your
diet (e.g. switching from a normal diet to a strict vegetarian diet), as the doctor
may need to adjust the dose of the medicine.
Cevedalo should not be taken with alcohol because alcohol can alter its effects.

Pregnancy and breastfeeding
If you are pregnant, if you suspect or are planning a pregnancy or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy:
The use of Cevedalo in pregnant women is not recommended.

Breastfeeding:
Women taking Cevedalo should not breastfeed.

Driving and using machines
Alzheimer's disease may impair your ability to drive vehicles or use machines, and
you should not engage in these activities unless your doctor tells you it is safe to do so.
Cevedalo may cause fatigue, dizziness and muscle cramps. If you experience any of these effects, do not
drive or use machines.

Cevedalo contains sodium
Cevedalo contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. How to take Cevedalo

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any
doubts, consult your doctor or pharmacist.
Inform your doctor or pharmacist of the name of the person assisting you. This person will help you
take the medicine as prescribed.

Dosage
The recommended dose of Cevedalo for adults and the elderly is one 10 mg/20 mg tablet once
a day.

Patients with impaired renal function:
If you have impaired renal function, your doctor will decide on a dose appropriate for your condition. In
this case, monitoring of renal function must be performed by the doctor at regular
intervals.

Administration
Cevedalo must be administered orally once a day. To benefit from the medicine
take it regularly, every evening before going to sleep.
If you experience abnormal dreams, nightmares or difficulty sleeping (see section 4), your doctor may
advise you to take Cevedalo in the morning.
Cevedalo should be swallowed with a little water. The tablets can be taken with or without
food.

If you take more Cevedalo than you should
If you take more medicine than you should, contact your doctor or the emergency room immediately
Symptoms of overdose may include nausea and vomiting, drooling, sweating, low heart rate, low blood pressure (dizziness or lightheadedness when standing up), breathing problems, loss of consciousness and seizures (attacks) or epileptic fits.

If you forget to take Cevedalo
If you forget to take Cevedalo, take one tablet the next day at the usual time. Do not
take a double dose to make up for the missed tablet.
If you forget to take the medicine for more than one week, call your doctor before taking
the medicine again.

If you stop taking Cevedalo
Do not stop taking the tablets unless your doctor has told you to do so. If you stop
taking Cevedalo, the benefits of the treatment will gradually disappear.

For how long should you take Cevedalo?
Your doctor will advise you how long you should continue to take the medicine. From time to time
you will need to consult your doctor who will review the treatment and assess the symptoms.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor if you experience any of these effects while taking Cevedalo.
Serious side effects:
Inform your doctor immediately if you notice any of these serious side effects
while taking Cevedalo. Urgent medical treatment may be necessary.

• Liver problems, for example hepatitis. Symptoms of hepatitis are nausea or vomiting, loss of appetite, general feeling of unwellness, fever, itching, yellowing of the skin and eyes and dark urine (can affect up to 1 in 1,000 people)
• Gastric or duodenal ulcers. Symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the navel and the sternum (can affect up to 1 in 100 people).
• Bleeding in the stomach or intestine. This can cause the passage of tarry black stools or visible blood from the rectum (can affect up to 1 in 100 people).
• Heart failure (can affect up to 1 in 100 people).
• Venous blood clotting (thrombosis/thromboembolism) (can affect up to 1 in 100 people).
• Convulsions (attacks) or seizures (can affect up to 1 in 100 people).
• Fever with muscle rigidity, sweating or decreased level of consciousness (a disorder called "neuroleptic malignant syndrome") (can affect up to 1 in
• 10,000).
• Muscle weakness, soreness or pain, particularly if at the same time you do not feel well or have a high temperature: this may be caused by an abnormal breakdown of skeletal muscle cells (rhabdomyolysis). Such breakdown does not always disappear, even after stopping Cevedalo, and can be potentially fatal and cause kidney problems (can affect up to 1 in 10,000 people).
• Inflammation of the pancreas (frequency cannot be defined based on available data)
• Changes in heart activity observable with an electrocardiogram (ECG) and called "QT prolongation" (frequency cannot be defined based on available data)
• Fast and irregular heartbeat, fainting which may be a symptom of a potentially life-threatening condition known as torsades de pointes (frequency cannot be defined based on available data)

Other side effects:

Very common (may affect more than 1 in 10 people)

• Diarrhea
• Nausea or vomiting
• Headache

Common (may affect up to 1 in 10 people)

• Muscle cramps
• Fatigue
• Drowsiness
• Difficulty sleeping (insomnia)
• Cold
• Loss of appetite
• Hallucinations (seeing or hearing things that are not really there)
• Unusual dreams, including nightmares
• Agitation
• Aggressive behavior
• Fainting
• Dizziness
• Feeling of discomfort in the stomach
• Skin rash
• Itching
• Urinary leakage
• Pain
• Accidents (patients may be more prone to falls and accidental injuries)
• Constipation
• Vomiting
• Elevated liver function tests
• Balance disorders
• Difficulty breathing
• High blood pressure
• Hypersensitivity to drugs

Uncommon (may affect up to 1 in 100 people)

• Low heart rate
• Fungal infections
• Confusion
• Abnormal gait
• Excessive salivation
• Mild increase in serum muscle creatine kinase concentration

Rare (may affect up to 1 in 1,000 people)

• Rigidity, tremor or involuntary movement especially of the face and tongue but also of the limbs
• Heart rhythm disturbance

Not known (frequency cannot be defined based on available data)

• Psychotic reactions
• Increased libido, hypersexuality
• Pisa syndrome (a condition involving involuntary muscle contraction, with abnormal lateral flexion of the body and head)

Alzheimer's disease has been associated with depression, suicidal ideation and suicide. These events
have been reported in patients treated with memantine hydrochloride, which is part of Cevedalo.

If any of these side effects gets serious, or if you notice any side effect not listed in this leaflet, tell your doctor or
pharmacist immediately.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, speak to your
doctor or pharmacist. You can also report side effects directly through 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 Cevedalo

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

6. Contents of the pack and other information

What the medicine containsCevedalo

• The active ingredients are donepezil hydrochloride and memantine hydrochloride

Cevedalo 10 mg/10 mg film-coated tablets
Each tablet contains 10 mg of donepezil hydrochloride (equivalent to 10.43 mg of donepezil
hydrochloride monohydrate and to 9.12 mg of donepezil) and 10 mg of memantine hydrochloride (equivalent to 8.31
mg of memantine).
Cevedalo 10 mg/20 mg film-coated tablets
Each tablet contains 10 mg of donepezil hydrochloride (equivalent to 10.43 mg of donepezil
hydrochloride monohydrate and to 9.12 mg of donepezil) and 20 mg of memantine hydrochloride (equivalent to 16.62
mg of memantine).

• The excipients are:

Cevedalo 10 mg/10 mg film-coated tablets
Mannitol, cellulose, microcrystalline (101), corn starch, hydroxypropylcellulose (≈95000Da),
sodium croscarmellose, magnesium stearate, coating (Opadry® II 85F20694 blue: partially hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol (4000), talc, indigotine (E132)).
Cevedalo 10 mg/20 mg film-coated tablets
Mannitol, cellulose, microcrystalline (101), corn starch, hydroxypropylcellulose (≈95000Da),
sodium croscarmellose, magnesium stearate, coating (Opadry® II 85F18422 white: partially
hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol (4000), talc).

Description of the appearance of Cevedalo and contents of the pack
Cevedalo film-coated tablets 10 mg/10 mg, 10 mg/20 mg is available in packs of 28
film-coated tablets in a PVC / PE EVOH OE / PCTFE / aluminum blister in a
cardboard box
Donepezil hydrochloride + Memantine hydrochloride, 10 mg + 10 mg film-coated tablets are
blue, round and convex film-coated tablets, with a diameter of 9.0 mm ± 0.2 mm.
Donepezil hydrochloride + Memantine hydrochloride, 10 mg + 20 mg film-coated tablets are
white to off-white, round and convex film-coated tablets, with a diameter of 9.0 mm ±
0.2 mm.

Marketing Authorisation Holder
Istituto Luso Farmaco d’Italia S.p.A. – Milanofiori – Strada 6 – Edificio L – Rozzano, Milano

Manufacturer
Atlantic Pharma – Produções Farmacêuticas, S.A. -Rua da Tapada Grande, nº2, Abrunheira 2710-089
Sintra Portugal