5 mg and 10 mg film-coated tablets 
donepezil hydrochloride

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Donepezil Actavis is and what it is used for 
2. What you need to know before taking Donepezil Actavis 
3. How to take Donepezil Actavis 
4. Possible side effects 
5. How to store Donepezil Actavis 
6. Package contents and other information 

1. What Donepezil Actavis is and what it is used for

Donepezil Actavis belongs to a group of medicines called acetylcholinesterase inhibitors. It is used to treat dementia symptoms in mild to moderate Alzheimer’s disease. The drug is intended for adult patients only.

Donepezil contained in Donepezil Actavis may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Donepezil Actavis

Do not take Donepezil Actavis

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

Warnings and cautions

Treatment with Donepezil Actavis should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer’s disease.

Talk to your doctor or pharmacist before taking Donepezil Actavis if you

  • have ever had a stomach ulcer or ulcer in the duodenum or if you are taking medication to treat pain and inflammation, called NSAIDs.
  • have ever had a seizure. Donepezil may cause seizures. Your doctor will monitor your symptoms.
  • have had a heart condition (especially if you have an irregular heartbeat, sick-sinus syndrome, or any other condition that affects your heart rhythm), as donepezil may cause your heart to beat more slowly.
  • have asthma or another long-term lung disease.
  • have ever had liver disease.
  • have trouble emptying the bladder.
  • should undergo an operation that requires you to be anesthetized, as does one of the anesthetics may need to be adjusted.

Children and young people

Donepezil Actavis is not recommended for use in children and adolescents below 18 years.

Other medicines and Donepezil Actavis

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. This is especially important if you are using

  • drugs for the treatment of pain and inflammation ( NSAIDs )
  • antibiotics such as erythromycin or rifampicin
  • medicines for fungal infections, such as ketoconazole or itraconazole
  • muscle relaxants, such as suxamethone
  • antidepressants such as fluoxetine
  • antispasmodics such as phenytoin or carbamazepine
  • drugs for heart disease, such as quinine, or high blood pressure, such as beta-blockers
  • other medicines that have the same effect as donepezil (like galantamine or rivastigmine) and certain medicines for diarrhea, Parkinson’s disease, and asthma.
  • general anesthesia (anesthesia)

Donepezil Actavis and alcohol

You must avoid drinking alcohol while being treated with donepezil, as alcohol intake may weaken the effect of donepezil.

Pregnancy and breastfeeding

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 this medicine.

Donepezil Actavis should not be used by breastfeeding women.

Driving and using machines

Donepezil Actavis and the disease may impair your ability to drive and use machines. This medicine can cause fatigue, dizziness, and muscle cramps, especially at the beginning of treatment, and if you are affected by such symptoms, do not drive or use machines. You should discuss this with your doctor before performing such activities.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist

Donepezil Actavis contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Donepezil Actavis

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The strength of the tablet you are going to take may change depending on how long you have been taking the medicine and what your doctor recommends.

Normally, you will start by taking a 5 mg tablet every night. After one month, the doctor may increase the dose one to 10 mg (two tablets of 5 mg or one tablet of 10 mg) every night. The maximum recommended dose is 10 mg every night.

Take Donepezil Actavis by mouth with a glass of water in the evening before going to bed.

Dose one does not need to be adjusted if you have kidney problems.

For adults with mild to moderate liver disease, your doctor may need to adjust someone. There are no data in patients with severe hepatic impairment.

Use for children and adolescents

Donepezil is not recommended for use in children and adolescents.

You should always follow your doctor’s advice on how and when to take the medicine. Do not change the dose on your own without a prescription from a doctor. Do not stop taking the tablets unless your doctor tells you to.

How long to take Donepezil Actavis

Your doctor will tell you how long you should continue to take the tablets. You will need to see your doctor regularly to review your treatment and assess your symptoms.

If you take more Donepezil Actavis then you should

Do not take more tablets than your doctor has prescribed. If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

If you go to the hospital, take the tablets and the carton to the hospital so that the doctor knows what you have taken.

In case of overdose, the following symptoms may occur: nausea, vomiting, drooling, sweating, slow heart rate, difficulty breathing, muscle weakness, fainting, and seizures.

If you forget to take Donepezil Actavis

Do not take a double dose to make up for a forgotten dose.

If you forget to take a tablet, just take one tablet the next day at the usual time. If you forget to take the medicine for more than a week, consult your doctor before taking any more medicines.

If you stop taking Donepezil Actavis

When treatment is stopped, the beneficial effects of donepezil gradually diminish. Do not stop taking the tablets even if you feel well unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects are

You must talk to your doctor immediately if you notice these mentioned serious side effects. You may need urgent medical attention.

  • liver damage e.g. hepatitis. The symptoms of hepatitis are nausea or vomiting, loss of appetite, general malaise, fever, itching, yellowing of the skin and eyes, and dark-colored urine (Rare: may affect up to 1 in 1,000 people)
  • stomach ulcer. The symptoms of stomach ulcers are abdominal pain and discomfort (indigestion) between the navel and the sternum (Uncommon: may affect up to 1 in 100 people)
  • bleeding in the stomach or intestines. This can lead to black stools or visible blood from the rectum (Uncommon: may affect up to 1 in 100 people)
  • uncontrolled muscle contractions (seizures) or short-term seizures with subsequent muscle twitching (Uncommon: may affect up to 1 in 100 people)
  • fever with muscle stiffness, sweating or decreased consciousness (this is a condition called malignant neuroleptic syndrome or neuroleptic malignant syndrome, very rare: may affect up to 1 in 10,000 people).
  • Muscle weakness, soreness, or pain, especially if you also feel sick, have a high fever, or dark urine. The symptoms can be caused by an abnormal breakdown of the muscles which can be life-threatening and lead to kidney problems (a condition called rhabdomyolysis ).

Other side effects ar

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

  • diarrhea
  • nausea
  • headache.

Common (may affect up to 1 in 10 people):

  • common cold
  • loss of appetite
  • hallucinations, aggressive behavior, restlessness, which have disappeared with dose reduction or treatment interruption
  • dizziness, insomnia, fainting
  • vomiting, stomach upset
  • itching, rash
  • muscle cramps
  • urinary incontinence
  • fatigue, pain
  • accident.
  • abnormal dreams and nightmares

Uncommon (may affect up to 1 in 100 people):

  • slow heart rate
  • small increases in the muscle enzyme creatine kinase in blood samples.

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

  • stiffness or uncontrolled movements, especially in the face and tongue but also in the arms and legs
  • heart disorders

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

5. How to store Donepezil Actavis

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 blister/tablet jar and outer carton. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is donepezil hydrochloride. Each film-coated tablet contains a donepezil hydrochloride monohydrate equivalent to 5 mg or 10 mg donepezil hydrochloride.
  • The other ingredients in the tablet core are lactose monohydrate, corn starch, microcrystalline cellulose, magnesium stearate; tablet coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide E171, and iron oxide yellow E172 (only in 10 mg tablet).

What the medicine looks like and the contents of the pack

5 mg film-coated tablet is white, round, and biconvex, debossed with “DZ 5” on one side.

10 mg film-coated tablet is a light yellow, round and biconvex, debossed with “DZ 10” on one side.

Pack sizes :

Blisters: 7, 28, 30, 50, 50x 1, 56, 60, 84, 98, 100 and 120 film-coated tablets

Tablet can: 28, 30, 100 and 250 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Actavis Group PTC.ehf

Reykjavíkurvegur 76-78

220 Hafnarfjörður

Iceland

Manufacturer

Actavis Ltd.

BLB016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta

Actavis Group PTC ehf.

Reykjavikurvegur 78, 220 Hafnarfjörður, Iceland

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

2600, Dupnitsa 
Bulgaria

Muhammad Nadeem

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