Patient leaflet - Apozyl 5 mg orodispersible tablets
1. What APOZYL is and what it is used for 2. What you need to know before you take APOZYL 3. How to take APOZYL
- 4. Possible side effects
- 5. How to store APOZYL
- 6. Contents of the pack and other information
- 1. What APOZYL is and what it is used for
APOZYL contains the active substance donepezil hydrochloride. APOZYL (donepezil hydrochloride) belongs to a group of medicines called
acetylcholinesterase inhibitors. Donepezil increases the levels of a substance (acetylcholine) in the brain involved in memory function by slowing down the breakdown of acetylcholine.
It is used to treat the symptoms of dementia in people diagnosed as having mild and moderately severe Alzheimer’s disease. The symptoms include increasing memory loss, confusion and behavioural changes. As a result, sufferers of Alzheimer’s disease find it more and more difficult to carry out their normal daily activities.
APOZYL is for use in adult patients only.
2. What you need to know before you take APOZYL
Do NOT take APOZYL
if you are allergic to donepezil hydrochloride, or to piperidine derivatives, or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking APOZYL if you have or have had:
stomach or duodenal ulcers
seizures (fits) or convulsions
a heart condition (such as irregular or very slow heart beat, heart failure, myocardial infraction) a heart condition called ‘prolonged QT interval’ or a history of certain abnormal heart rhythms called Torsade de Pointes or if anyone in your family has ‘prolonged QT intervals’
low level of magnesium or potassium in your blood
asthma or other long term lung disease liver problems or hepatitis
difficulty passing urine or mild kidney disease
Also tell your doctor if you are pregnant or think you might be pregnant.
Children and adolescents
APOZYL is not recommended for use in children and adolescents (younger than 18 years of age).
Other medicines and APOZYL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that your doctor has not prescribed for you but which you have bought yourself from a chemist/pharmacist. It also applies to medicines you may take some time in the future if you continue to take APOZYL. This is because these medicines may weaken or strengthen the effects of APOZYL.
In particular it is important to tell your doctor if you are taking any of the following types of medicines: medicines for heart rhythm problems e.g. amiodarone, sotalol
medicines for depression e.g. citalopram, escitalopram, amitriptyline, fluoxetine medicines for psychosis e.g. pimozide, sertindole, ziprasidone
medicines for bacterial infections e.g. clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin
anti-fungal medicine e.g. ketoconazole other Alzheimer’s disease medicines, e.g. galantamine
Dimension: 180 x 420 mm
Date: 09 Nov 2023
pain killers or treatment for arthritis e.g. aspirin, non-steroidal anti-inflammatory (NSAID) drugs such as ibuprofen, or diclofenac sodium anticholinergics medicines, e.g. tolterodine anticonvulsants e.g. phenytoin, carbamazepine medication for a heart condition e.g. quinidine, beta-blockers (propranolol and atenolol) muscle relaxants e.g. diazepam, succinylcholine general anaesthetic
medicines obtained without a prescription e.g. herbal remedies
If you are going to have an operation that requires you to have a general anaesthetic, you should tell your doctor and the anaesthetist that you are taking APOZYL. This is because your medicine may affect the amount of anaesthetic needed.
APOZYL can be used in patients with kidney disease or mild to moderate liver disease. Tell your doctor first if you have kidney or liver disease. Patients with severe liver disease should not take APOZYL.
Tell your doctor or pharmacist the name of your caregiver. Your caregiver will help you to take your medicine as it is prescribed.
APOZYL with food, drink and alcohol
Food will not influence the effect of APOZYL.
APOZYL should not be taken with alcohol because alcohol may change its effect.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.
APOZYL should not be used while breast-feeding.
Driving and using machines
Alzheimer’s disease may impair your ability to drive or operate machinery and you must not perform these activities unless your doctor tells you that it is safe to do so.
Also, your medicine can cause tiredness, dizziness and muscle cramp. If you experience any of these effects, you must not drive or operate machinery.
APOZYL contain lactose and aspartame
APOZYL contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
APOZYL 5 mg orodispersible tablets contains 5 mg of aspartame (E951) and APOZYL 10 mg orodispersible tablets contains 10 mg of aspartame (E951). Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
APOZYL contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take APOZYL
How much APOZYL should you take
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Initially, the recommended dose is 5 mg every night before you go to bed. After one month, your doctor may tell you to take 10 mg every night before you go to bed.
If you experience abnormal dreams, nightmares or difficulty in sleeping (see section 4) your doctor may advise you to take APOZYL in the morning.
The tablet strength you will take may change depending on the length of time you have been taking the medicine and on what your doctor recommends. The maximum recommended dose is 10 mg each night.
Always follow your doctor or pharmacist’s advice about how and when to take your medicine.
DO NOT alter the dose yourself without your doctor’s advice.
How to take your medicine
The tablet should be placed on your tongue and
allowed to disintegrate before swallowing, with or without water, according to your preference.
Use in Children and adolescents
APOZYL is not recommended for use in children and adolescents (younger than18 years of age).
If you take more APOZYL than you should
Contact your doctor or the nearest hospital emergency department immediately if you take more of the medicine than you should. Take this leaflet and any remaining tablets with you.
Overdose symptoms may include nausea (feeling sick) and vomiting (being sick), drooling, sweating, slow heart rate, low blood pressure
(light-headedness or dizziness when standing), breathing problems, losing consciousness and seizures (fits) or convulsions.
If you forget to take APOZYL
If you forget to take your medicine, take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet.
If you forget to take your medicine for more than one week, call your doctor before taking any more medicine.
If you stop taking APOZYL
Do not stop taking the tablets unless told to do so by your doctor. If you stop taking APOZYL, the benefits of your treatment will gradually fade away.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
For how long should you take APOZYL
Your doctor or pharmacist will advise you on how long you should continue to take your tablets. You will need to see your doctor from time to time to review your treatment and assess your symptoms.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported by people taking APOZYL.
Tell your doctor if you have any of these effects while you are taking APOZYL.
Serious side effects:
You must tell your doctor immediately if you notice these serious side effects mentioned. You may need urgent medical treatment.
liver damage e.g. hepatitis. The symptoms of hepatitis are nausea (feeling sick) or vomiting (being sick), loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine (may affect up to 1 in 1,000 people)
stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the navel and the breast bone (may affect up to 1 in 100 people) bleeding in the stomach or intestines. This may cause you to pass black tar like stools or visible blood from the rectum (may affect up to 1 in 100 people)
seizures (fits) or convulsions (may affect up to 1 in 100 people)
fever with muscle stiffness, sweating or a lowered level of consciousness (a disorder called “Neuroleptic Malignant Syndrome”) (may affect up to 1 in 10,000 people)
muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell, have a high temperature or have dark urine. They may be caused by an abnormal muscle breakdown which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people)
fast, irregular heart beat and fainting, which could be symptoms of a life-threatening condition known as Torsade de Pointes (frequency cannot be estimated from the available data)
Other side effects
Very common side effects (may affect more than 1 in 10 people):
diarrhoea
headache
Common side effects (may affect up to 1 in 10 people):
muscle cramp
tiredness
difficulty in sleeping (insomnia)
the common cold
hallucinations (seeing or hearing things that are not really there)
unusual dreams including nightmares agitation
aggressive behaviour fainting
dizziness
stomach feeling uncomfortable rash
passing urine uncontrollably pain
accidents (patients may be more prone to falls and accidental injury)
Uncommon side effects (may affect up to 1 in 100 people):
slow heart beat
salivary hypersecretion
Rare side effects (may affect up to 1 in 1000 people):
stiffness, shaking or uncontrollable movement especially of the face and tongue but also of the limbs
Not known (frequency cannot be estimated from the available data)
Changes in the heart activity which can be seen on an electro-cardiogram (ECG) called ‘prolonged QT interval’
libido increased, hypersexuality
Pisa syndrome (a condition involving involuntary muscle contraction with abnormal bending of the body and head to one side)
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store APOZYL
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 outer carton and blister (EXP). The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What APOZYL orodispersible tablets contain
The active substance is donepezil hydrochloride. Two different strengths of tablets are available. Each 5 mg orodispersible tablet contains 5 mg of donepezil hydrochloride and each 10 mg orodispersible tablet contains 10 mg of donepezil hydrochloride.
The other ingredients are: Polacrilin potassium, cellulose microcrystalline (E460), lactose monohydrate (spray dried), monosodium citrate anhydrous, aspartame (E951), croscarmellose sodium (E468), silica colloidal anhydrous (E551) and magnesium stearate (E572).
What APOZYL looks like and contents of the pack
White to off-white, round, flat tablets with bevelled edges, embossed with ‘5’ on one side and plain on the other.
White to off-white, round, flat tablets with bevelled edges, embossed with ‘10’ on one side and plain on the other.
APOZYL is available in packs of:
7, 14, 28, 30, 50, 56, 60, 98 and 120 orodispersible tablets in blister packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Novumgen Limited
20-22 Wenlock Road, London,
N1 7GU, United Kingdom.
Manufacturer
Genepharm S.A
18th Km Marathonos Avenue,
153 51 Pallini
Greece.
The leaflet was last revised in Nov 2023. Read all of 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 further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. Barcode