100 mg hard capsules 
amantadine hydrochloride

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

  • Save 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 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 Dinetrel is and what it is used for 
2. What you need to know before using Dinetrel 
3. How to use Dinetrel 
4. Possible side effects 
5. How to store Dinetrel 
6. Contents of the packaging and other information 

1. What Dinetrel is and what it is used for

Amantadine is a dopaminergic drug, which means it can increase levels of certain chemicals that transmit impulses to the nervous system, including the brain.

Dinetrel is used for:

  • treatment of Parkinson’s disease by improving muscle control and reducing stiffness, tremors, and trailing feet.

Amantadine hydrochloride contained in Dinetrel 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.

2. What you need to know before using Dinetrel

Do not use Dinetrel

  • if you are allergic to amantadine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
  • if you have seizures (seizures), e.g. epilepsy
  • if you have ever had ulcers in your stomach or small intestine
  • if you have severe kidney disease
  • if you are pregnant or trying to conceive (see section Pregnancy, breast-feeding and fertility )
  • if you are breast-feeding (see section Pregnancy, breast-feeding, and fertility ).

If any of the above apply to you or you are not sure, talk to your doctor or pharmacist before taking Dinetrel.

Warnings and cautions

Talk to your doctor or pharmacist before taking Dinetrel:

  • if you have liver or kidney disease
  • if you have had cardiovascular disease
  • if you currently have heart problems or heart failure (heart problems that cause shortness of breath or swelling in the ankles)
  • if you have a mental illness, e.g. schizophrenia or dementia
  • if you have increased pressure in the eye ( glaucoma ).

Other medicines and Dinetrel

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines as they may affect the way Dinetrel works.

anticholinergic agents (used to treat Parkinson’s disease ), such as procyclidine
antispasmodic (used to treat stomach spasms or cramps), such as hyoscine
levodopa used to treat Parkinson’s disease
psychotic drugs (used to improve mood, emotions, and behavior when there are disorders in them due to a disease), such as chlorpromazine, haloperidol
diuretics ( diuretic tablets) (used to treat the accumulation of fluid in the body and high blood pressure ), such as hydrochlorothiazide, amiloride, or triamterene

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Dinetrel with food, drink, and alcohol

Do not drink alcohol during treatment with Dinetrel as it may increase the risk of side effects and overdose of the drug.

Pregnancy, breastfeeding, and fertility

Do not take Dinetrelom if you are pregnant or trying to become pregnant. Do not take Dinetrel if you are breast-feeding because amantadine passes into breast milk and may harm your baby.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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.

Dinetrel may cause blurred vision or dizziness. If this happens, do not drive or use machines until the symptoms have passed.

Dinetrel 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.

3. How to use Dinetrel

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

Swallow the capsules whole with water.

The recommended dose for Parkinson’s disease:

Adults 1 capsule (100 mg) daily for the first week. Your doctor will increase the dose one to 2 capsules daily (200 mg). Higher doses of up to 4 capsules (400 mg) daily may be given in some cases.
Adults over 65 years 1 capsule (100 mg) once daily.

If you have kidney problems, your doctor may prescribe a lower dose

If you use more Dinetrel than you should  

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Show any remaining tablets or the empty package to the doctor.

If you forget to use Dinetrel

If you forget to take a dose at the right time, take the missed dose as soon as you remember. However, do not take a double dose to make up for a forgotten dose.

If you stop using Dinetrel

Do not suddenly stop taking Dinetrel as your symptoms may get worse.

If you want to stop taking Dinetrel, consult your doctor who will tell you how to reduce the dose gradually.

If you are taking psychotropic drugs (for the treatment of mental disorders) and suddenly stop taking Dinetrel, you may experience the following symptoms:

  • fever
  • sweating
  • fast heart rate
  • muscle stiffness (difficulty moving)
  • lost control of the bladder (sudden, the urgent need for urination).

If any of these symptoms occur, contact your doctor immediately.

Some patients may notice that the effect of this medicine starts to diminish after a few months of regular use. Tell your doctor if this happens.

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. These side effects are often mild and may go away after a few days of treatment. Tell your doctor or pharmacist if the side effects are severe or last for more than a couple of days.

If any of the following symptoms occur, contact your doctor or nearest hospital immediately:

  • dizziness or confusion
  • fainting
  • seizures (seizures).

Tell your doctor or pharmacist if you have any of the following or other problems with Dinetrel:

A very common side effect is (can occur in more than 1 in 10) 

  • swollen ankles
  • red skin spots.

Common side effects are (may affect up to 1 in 10 people)

  • anxiety
  • excessive elation
  • Depression
  • difficulty sleeping
  • confusion
  • nightmares
  • difficult to concentrate
  • headache
  • fatigue
  • difficulties in controlling movements
  • unclear number
  • nervousness
  • muscle aches
  • hallucinations
  • fast or irregular heartbeat
  • low blood pressure when you get up. It may make you feel dizzy or faint.
  • dry mouth
  • loss of appetite
  • nausea or vomiting
  • constipation
  • sweating.

Less common side effects are (may affect up to 1 in 100 people)

  • dimsyn.

Rare side effects are (may affect up to 1 in 1000 people)

  • disorientation (not knowing where you are)
  • a thought or behavior disorders, such as delusions
  • tremors
  • mobility difficulties
  • neuroleptic malignant syndrome. May cause heat sensation and muscle stiffness.
  • diarrhea
  • rash
  • eye problems, such as itching or redness
  • lost bladder control. You may have difficulty urinating or a sudden urge to urinate.
  • corneal ulcer, corneal swelling, impaired visual acuity.

Very rare side effects are (may affect up to 1 in 10 000 people)

  • heart problems that can cause shortness of breath or swollen ankles
  • decreased number of white blood cells which increases the likelihood of getting infection s
  • changes in blood tests that show liver function
  • sensitivity to sunlight.

Has been reported (occurs in an unknown number of users):

  • the compelling need to behave unusually – a strong impulse to excessive gambling, altered or increased sexual interest, uncontrollable and excessive need to buy things and spend money, binge eating (eating large amounts of food in a short time), or compulsive eating ( to eat more food than normal and more than is needed to satisfy your hunger)
  • delirium (state of confusion)
  • hypomania and mania (increased energy, self-confidence and well-being, morbidly agitated)

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

5. How to store Dinetrel

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 and carton after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

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 amantadine hydrochloride. A hard gelatin capsule contains 100 mg of amantadine hydrochloride.

Other ingredients are:

  • Capsule contents: lactose monohydrate, povidone (E1201), and magnesium stearate (E470b).
  • Capsule shell: gelatin, titanium dioxide (E171), sodium lauryl sulfate, and red iron oxide (E172).
  • Ink – white: shellac (E904), titanium dioxide (E171), and propylene glycol (E1520)

What the medicine looks like and the contents of the pack

Daintree is brown-red, hard gelatin capsules of size 3 with white embossing AM100 on both the upper and lower part of the capsule.

The capsules are packaged in PVC / PVdC aluminum blisters. Pack sizes: 5, 7, 10, 14, 28, 30 and 56 capsules.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Morningside Healthcare (Malta) Ltd.

93, Mill Street

Qormi QRM 3102

Malta

Local representative

2care4 Generics ApS

Stenhuggervej 12-14

6710 Esbjerg V

Denmark

Manufacturer

Morningside Pharmaceuticals Ltd.

5 Pavilion Way

Loughborough, LE11 5GW, UK

Muhammad Nadeem

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