Package leaflet: Information for the user

Donepezil Hydrochloride 1 mg/ml Oral Solution

For use in adults Donepezil hydrochloride

You and your caregiver should read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

•    Keep this leaflet. Y ou 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).

What is in this leaflet

1.    What Donepezil Hydrochloride 1 mg/ml Oral Solution is and what it is used for

2.    What you need to know before you take Donepezil Hydrochloride 1 mg/ml Oral Solution

3.    How to take Donepezil Hydrochloride 1 mg/ml Oral Solution

4.    Possible side effects

5.    How to store Donepezil Hydrochloride 1 mg/ml Oral Solution

6.    Contents of the pack and other information

1. What Donepezil Hydrochloride 1 mg/ml Oral Solution is and what it is used for

Donepezil belongs to a group of medicines called acetylcholinesterase inhibitors.

It is used to treat the symptoms of dementia in people diagnosed as having mild to 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.

Donepezil Hydrochloride 1 mg/ml Oral Solution is for use in adult patients only.

2. What you need to know before you take Donepezil Hydrochloride 1 mg/ml Oral Solution

Do not take Donepezil Hydrochloride 1 mg/ml Oral Solution:

■    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 Donepezil Hydrochloride 1 mg/ml Oral Solution if you have ever had:

•    stomach or duodenal ulcers

•    seizures (fits) or convulsions

•    a heart condition (irregular or very slow heart beat)

•    asthma or other long term lung disease

•    liver problems or hepatitis

•    difficulty passing urine or mild kidney disease

•    inherited intolerance of a sugar known as fructose

Also tell your doctor if you are pregnant or think you might be pregnant.

Children and adolescents

Donepezil Hydrochloride 1 mg/ml Oral Solution is not recommended for use in children and adolescents below the age of 18 years.

Other medicines and Donepezil Hydrochloride 1 mg/ml Oral Solution

Tell your doctor or pharmacist if you are taking, or have recently taken, any other medicine.

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 sometimes in the future if you continue to take Donepezil Hydrochloride 1 mg/ml Oral Solution. This is because these medicines may weaken or strengthen the effects of Donepezil Hydrochloride 1 mg/ml Oral Solution.

Especially tell your doctor if you are taking any of the following types of medicines:

•    other Alzheimer’s disease medicines, e.g. galantamine

•    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

•    antibiotics e.g. erythromycin, rifampicin

•    anti-fungal medicine e.g. ketoconazole

•    anti-depressants e.g. fluoxetine

•    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 Donepezil Hydrochloride 1 mg/ml Oral Solution. This is because Donepezil Hydrochloride 1 mg/ml Oral Solution may affect the amount of anaesthetic needed.

Donepezil Hydrochloride 1 mg/ml Oral Solution 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 Donepezil Hydrochloride 1 mg/ml Oral Solution.

Tell your doctor or pharmacist the name of your caregiver. Your caregiver will help you to take your medicine as it is prescribed.

Donepezil Hydrochloride 1 mg/ml Oral Solution with food, drink and alcohol

Food will not influence the effect of Donepezil Hydrochloride 1 mg/ml Oral Solution.

Donepezil Hydrochloride 1 mg/ml Oral Solution should not be taken with alcohol because alcohol may change its effect.

Pregnancy, breast-feeding and fertility

Donepezil Hydrochloride 1 mg/ml Oral Solution should not be used while breastfeeding.

If you are pregnant, think you might be pregnant or are planning to have a baby, ask your doctor for advice before taking any medicine.

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.

Donepezil Hydrochloride 1 mg/ml Oral Solution contains sorbitol, methyl parahydroxybenzoate and sodium metabisulphite.

This medicine contains:

•    sorbitol (E 420) - if you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product. Sorbitol is a source of fructose. A 5 ml dose of Donepezil Hydrochloride 1 mg/ml Oral Solution supplies 1.25 g of sorbitol and a 10 ml dose of Donepezil Hydrochloride 1 mg/ml Oral Solution supplies 2.5 g of sorbitol.

•    methyl parahydroxybenzoate (E 218) which may cause allergic reactions (possibly delayed).

•    sodium metabisulphite (E 223) which may rarely cause hypersensitivity reactions and bronchospasm.

3. How to take Donepezil Hydrochloride 1 mg/ml Oral Solution

How much Donepezil Hydrochloride 1 mg/ml Oral Solution should you take?

Usually, you will start by taking 5 ml every night. After one month, your doctor may tell you to take 10 ml every night. To take a 5 ml dose pour the liquid into the dosing spoon to the line of 5 ml. To take a 10 ml dose pour the liquid into the dosing spoon to the line of 10 ml. The amount of Donepezil Hydrochloride 1 mg/ml Oral Solution you will take may change depending on the length of time you have been taking this medicine and on what your doctor recommends.

The maximum recommended dose is 10 ml each night. After taking your dose you should wash the dosing spoon with water and leave to air dry.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Do not alter the dose yourself without your doctor’s advice.

Route and method of administration

Donepezil Hydrochloride 1 mg/ml Oral Solution should be taken orally in the evening just prior to retiring.

For how long should you take Donepezil Hydrochloride 1 mg/ml Oral Solution?

Your doctor or pharmacist will advise you on how long you should continue to take your medicine. You will need to see your doctor from time to time to review your treatment and assess your symptoms.

If you take more Donepezil Hydrochloride 1 mg/ml Oral Solution than you should

DO NOT take more medicine than your doctor has told you to. Call your doctor immediately if you take more than you should. If you cannot contact your doctor, contact the local hospital Accident and Emergency department at once. Always take the bottle and the carton with you to the hospital so that the doctor knows what has been taken.

Symptoms of overdosing include feeling and 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 Donepezil Hydrochloride 1 mg/ml Oral Solution

If you forget to take your medicine, just take your normal dose of medicine the following day at the usual time. Do not take a double dose to make up for a forgotten dose. If you forget to take your medicine for more than one week, call your doctor before taking any more.

If you stop taking Donepezil Hydrochloride 1 mg/ml Oral Solution

Do not stop taking Donepezil Hydrochloride 1 mg/ml Oral Solution unless told to do so by your doctor. If you stop taking Donepezil Hydrochloride 1 mg/ml Oral Solution 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.

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 Donepezil Hydrochloride 1 mg/ml Oral Solution.

Tell your doctor if you have any of these effects while you are taking Donepezil Hydrochloride 1 mg/ml Oral Solution.

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 feeling or being sick, loss of appetite, feeling generally unwell, fever, itching yellowing of the skin and eyes and dark coloured urine (probably affecting fewer than 1 in 1,000)

•    stomach or duodenal ulcers. The symptoms of ulcers are stomach pain and discomfort (indigestion) felt between the navel and the breast bone (probably affecting fewer than in 100)

•    bleeding in the stomach or intestines. This may cause you to pass black tar like stools or visible blood from the rectum (probably affecting fewer than 1 in 100)

•    seizures (fits) or convulsion (probably affecting fewer than 1 in 100)

•    fever with muscle stiffness, sweating or a lowered level of consciousness (a disorder called “Neuroleptic Malignant Syndrome) (probably affecting fewer than 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).

Very common side effects (probably affecting more than 1 in 10):

•    diarrhoea

•    feeling or being sick

•    headaches

Common side effects (probably affecting up to 1 in 10)

•    muscle cramp

•    tiredness

•    difficulty in sleeping (insomnia)

•    the common cold

•    loss of appetite

•    hallucinations (seeing or hearing things that are not really there)

•    unusual dreams including nightmares

•    agitation

•    aggressive behaviour

•    fainting

•    dizziness

•    stomach feeling uncomfortable

•    rash

•    itching

•    passing urine uncontrollably

•    pain

•    accidents (patients may be more prone to falls and accidental injury)

Uncommon side effects (probably affecting fewer than 1 in 100)

•    slow heart beat

Rare side effects (probably affecting fewer than 1 in 1,000)

•    stiffness, shaking or uncontrollable movement especially of the face and tongue but also of the limbs.

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. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Donepezil Hydrochloride 1 mg/ml Oral Solution

■    Keep this medicine out of the sight and reach of children.

■    This medicinal product does not require any special temperature storage conditions.

■    Once the bottle is opened, use within 2 months. You may find it helpful to write the date you first opened the bottle in the space provided on the bottle label.

■    Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

■    If your doctor tells you to stop taking your medicine, you should return any you have not used to your pharmacist.

■    Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Donepezil Hydrochloride 1 mg/ml Oral Solution contains?

The active substance is donepezil hydrochloride.

•    5 ml of Donepezil Hydrochloride 1 mg/ml Oral Solution contain 5 mg of donepezil hydrochloride

•    10 ml of Donepezil 1 mg/ml Oral Solution contain 10 mg of donepezil hydrochloride

•    Each 5 ml dose contains 1.25 g of sorbitol.

The other ingredients are sorbitol solution (E 420), hydroxyethyl cellulose, sodium benzoate (E 211), methyl parahydroxybenzoate (E 218), propylene glycol (E 1520), sodium metabisulphite (E 223), strawberry flavour, HCI sol 10 %, purified water.

What Donepezil Hydrochloride 1 mg/ml Oral Solution looks like and contents of the pack?

Donepezil Hydrochloride 1 mg/ml Oral Solution is a clear colourless liquid with a strawberry flavour.

Donepezil Hydrochloride 1 mg/ml Oral Solution is available in one strength of 1 mg/ml and is supplied in bottles of 150 ml. The package also includes a 10 ml dosing spoon with intermediate graduations of 5 and 10 ml.

Marketing Authorisation Holder

Lamda Laboratories SA

59 Ioannou Metaxa Street

Karellas

Koropi

GR-19400

Greece

Manufacturer

Rafarm SA Thesi Pousi-Xatzi Agiou Louka Street Paiania Attikis GR-19002 Greece

For any information about this medicinal product, please contact the Marketing Authorisation Holder, details provided above.

This medicinal product is authorised in the Member States of the EEA under the following names:

United Kingdom    Donepezil Hydrochloride 1 mg/ml oral solution

Germany    Donepezilhydrochlorid Lamda 1 mg/ml Losung zum Einnehmen

This leaflet was last revised in 03/2016.

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