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Donepezil Hydrochloride 1mg/1ml Oral Solution

Active Ingredient:
donepezil hydrochloride
Company:  
Rosemont Pharmaceuticals Limited See contact details
ATC code: 
N06DA02
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 05 May 2023
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL00427/0223.

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Donepezil Hydrochloride 1mg/1ml Oral Solution

Package leaflet: Information for the user

Donepezil Hydrochloride 1mg/1ml Oral Solution

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. 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).

What is in this leaflet:

1. What Donepezil Hydrochloride 1mg/1ml Oral Solution is and what it is used for
2. What you need to know before you take Donepezil Hydrochloride 1mg/1ml Oral Solution
3. How to take Donepezil Hydrochloride 1mg/1ml Oral Solution
4. Possible side effects
5. How to store Donepezil Hydrochloride 1mg/1ml Oral Solution
6. Contents of the pack and other information

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

2. What you need to know before you take Donepezil Hydrochloride 1mg/1ml Oral Solution
Do not take Donepezil Hydrochloride 1mg/1ml Oral Solution:
  • if you are allergic to (hypersensitive) to donepezil hydrochloride, or to piperidine derivatives, or any of the other ingredients of Donepezil Hydrochloride 1mg/1ml Oral Solution listed in section 6
  • if you are breast feeding

Warnings and precautions:

Talk to your doctor or pharmacist before taking Donepezil Hydrochloride 1mg/1ml Oral Solution if you have ever 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 have ‘prolonged QT interval’
  • low levels 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
  • 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 1mg/1ml Oral Solution is not recommended for use in children and adolescents (younger than 18 years of age).

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

Especially 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 medicines e.g. ketoconazole
  • 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
  • anticonvulsants e.g. phenytoin, carbemazepine
  • 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 1mg/1ml Oral Solution. This is because Donepezil Hydrochloride 1mg/1ml Oral Solution may affect the amount of anaesthetic needed.

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

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

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

Pregnancy, breast-feeding and fertility

Donepezil Hydrochloride 1mg/1ml Oral Solution must 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.

Important information about some of the ingredients of Donepezil Hydrochloride 1mg/1ml Oral Solution.

This medicine contains:

  • sorbitol (E420). This medicine contains 250mg sorbitol in each 1ml dose. Sorbitol is a source of fructose. If your doctor has told you that you have intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you take or receive this medicine. A 5ml dose of Donepezil Hydrochloride 1mg/1ml Oral Solution supplies 1.25g of sorbitol and a 10ml dose of Donepezil Hydrochloride 1mg/1ml Oral Solution supplies 2.5g of sorbitol.
  • propylene glycol (E1520). This medicine contains 62.2mg propylene glycol in each 1ml dose.
  • benzoic acid (E210). This medicine contains 0.83mg benzoic acid in each 1ml dose.
  • methyl parahydroxybenzoate (E218). May cause allergic reactions (possibly delayed).
  • sodium metabisulphite (E223). Which may rarely cause hypersensitivity reactions and bronchospasm.
  • this medicine contains less than 1mmol sodium (23mg) per 1ml dose, that is to say essentially “sodium-free”.

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

Usually, you will start by taking 5ml every night. After one month, your doctor may tell you to take 10ml every night. To take a 5ml dose pour the liquid into the dosing spoon to the line of 5ml. To take a 10ml dose pour the liquid into the dosing spoon to the line of 10ml. The amount of Donepezil Hydrochloride 1mg/1ml 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 10ml 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 1mg/1ml Oral Solution should be taken orally in the evening just prior to retiring. If you do experience abnormal dreams, nightmares, or difficulty in sleeping (see section 4) your doctor may advise you to take Donepezil Hydrochloride 1mg/1ml Oral Solution in the morning.

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

Do not stop taking Donepezil Hydrochloride 1mg/1ml Oral Solution unless told to do so by your doctor. If you stop taking Donepezil Hydrochloride 1mg/1ml Oral Solution the benefits of your treatment will gradually fade away.

If you take more Donepezil Hydrochloride 1mg/1ml 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 1mg/1ml 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.

4. Possible side effects

Like all medicines, Donepezil Hydrochloride 1mg/1ml Oral Solution can cause side effects, although not everybody gets them.

The following side effects have been reported by people taking Donepezil Hydrochloride 1mg/1ml Oral Solution.

Tell your doctor if you have any of these effects while you are taking Donepezil Hydrochloride 1mg/1ml 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 1000)
  • 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 1 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
  • salivary hypersecretion

Rare side effects (probably affecting fewer than 1 in 1000)

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

Not known side effects (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’
  • Fast, irregular heart beat, fainting which could be symptoms of a life-threatening condition known as Torsade de Pointes
  • Libido increased, hypersexuality
  • Pisa syndrome (a condition involving involuntary muscle contraction with abnormal bending of the body and head to one side).

You should tell your doctor if you notice any other side effects not listed in this leaflet while you are taking Donepezil Hydrochloride 1mg/1ml Oral Solution.

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 (see details below). By reporting side effects you can help provide more information on the safety of the medicines.

United Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store.

5. How to store Donepezil Hydrochloride 1mg/1ml Oral Solution
  • Keep 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 Donepezil Hydrochloride 1mg/1ml Oral Solution after the expiry date that is printed 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 or household waste. 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 1mg/1ml Oral Solution contains?

The active substance is donepezil hydrochloride.

  • 5ml of Donepezil Hydrochloride 1mg/1ml Oral Solution contains 5mg of donepezil hydrochloride
  • 10ml of Donepezil 1mg/1ml Oral Solution contains 10mg of donepezil hydrochloride
  • Each 5ml dose contains 1.25g of sorbitol
  • The other ingredients are sorbitol solution (E420), hydroxyethylcellulose, sodium benzoate (E211), methyl parahydroxybenzoate (E218), propylene glycol (E1520),sodium metabisulfite (E223), strawberry flavour (containing flavouring substances, propylene glycol (E1520), ethyl maltol, maltol), HCI sol 10% (for pH adjustment) and purified water.

What does Donepezil Hydrochloride 1mg/1ml Oral Solution look like?

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

What is in a pack of Donepezil Hydrochloride 1mg/1ml Oral Solution?

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

Marketing Authorisation Holder
Rosemont Pharmaceuticals Ltd
Rosemont House
Yorkdale Industrial Park
Braithwaite
Street
Leeds
LS11 9XE
UK

Manufacturer:
Rafarm SA
Thesi Pousi- Hatzi
Agiou Louka
Peania
Attiki 19002
P.O. Box 37
Greece

or

Rosemont Pharmaceuticals Ltd
Rosemont House
Yorkdale Industrial Park
Braithwaite Street
Leeds
LS11 9XE

(alternative manufacturer)

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 and United Kingdom (Northern Ireland) under the following names:

United Kingdom Donepezil Hydrochloride 1mg/1ml Oral Solution

Greece Rafazil 1mg/ml oral solution

Cyprus Rafazil 1mg/ml oral solution

This leaflet was last revised in April 2023.

H2MD1RBJ4

V2

Rosemont Pharmaceuticals Limited
Company image
Address
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
WWW
http://www.rosemontpharma.com
Telephone
+44 (0)113 244 1400
Fax
+44 (0)113 245 3567
Customer Care direct line
+44 (0)800 919 312
Out of Hours Telephone
+44 (0)795 762 3515
Out of Hours contact
[email protected]