Patient leaflet - Amantadine Hydrochloride 10 mg / ml oral solution
1. What Amantadine oral solution is and what it is used for
Amantadine is a dopaminergic drug which means it can increase the levels of certain chemicals which transmit impulses in the nervous system, including the brain.
This medicine is used to treat Parkinson’s disease by improving muscle control and reducing stiffness, shakiness and shuffling.
2. What you need to know before you take Amantadine oral solution
Do not take this medicine if:
- you are allergic (hypersensitive) to amantadine hydrochloride or any of the other ingredients of this medicine (listed in Section 6).
- you have or have had heart disease (such as heart failure, inflamamation and disease of the heart muscle, slow unusual or irregular heart beat, including torsade de pointes).
- you have prolonged QT interval or if you have family members with a history of congenital QT syndrome (defect in the electrical system of the heart that can produce an abnormal heart rhythm).
- you are being treated with budipine or other drugs that disrupts the electrical activity of the heart
- you have low potassium and magnesium levels in your blood
- you have ever had an ulcer in your stomach or small intestine
- you suffer from fits (convulsions), for example epilepsy.
- you have severe mental condition in which contact with reality is lost and inability to think and judge clearly.
- you have increased pressure in the eye (closed angle glaucoma). If any of the above applies to you, or if you are not sure, speak to your doctor or pharmacist before you take this medicine.
Warnings and precautions
Talk to your doctor before taking this medicine if:
- you suffer from any liver or kidney disease
- you have a history of disease involving the heart and blood vessels
- you are currently suffering from any heart problems or heart failure (heart problems which cause shortness of breath or ankle swelling)
- you have any kind of mental illness with disturbances in thinking, emotional reactions, behaviour and memory loss
- you suffer from recurrent eczema
- you suffer from stomach ulcers
If any of the above applies to you, or if you are not sure, speak to your doctor, pharmacist or nurse before you take this medicine. Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings.
Your doctor may need to adjust or stop your dose of Amantadine hydrochloride.
If blurred vision or other visual problems occur please contact an eye doctor immediately.
Other medicines and Amantadine oral solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Amantadine and medicines that can cause a type of abnormal heart rhythm (QT interval prolongation) should not be used together. These include:
medicines used to suppress or prevent heart rhythm disturbances (antiarrhythmics), such as class IA antiarrhythmics (e.g. quinidine, disopyramide, procainamide) and class III (e.g., amiodarone, sotalol)
- tricyclic and tetracyclic antidepressants (e.g. amitriptyline)
- macrolide antibiotics (e.g. erythromycin, clarithromycin)
- quinolone antibiotics (eg, sparfloxacin and grepafloxacin)
- medicines used in fungal infections (antifungals), specifically those called azoles
- other medicines such as halofantrine and quinine (used to treat malaria), co-trimoxazole (combination of trimethoprim and sulfamethoxazole, used as an antibiotic), pentamidine (antiprotozoal used to treat certain infections), cisapride (used to treat gastroesophageal reflux) and bepridil (used to treat angina). Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines as below.
- medicines known to cause abnormal heart rhythm like budipine
- anti-cholinergics - (used to treat Parkinson’s disease) such as procyclidine
- anti-spasmodics - (used to treat stomach spasms or cramps) such as hyoscine
- anti-histamines - used to treat allergies such as astemizole, terfenadine
- levodopa - used to treat Parkinson’s disease
- anti-psychotics - (used to improve thoughts, feelings and behaviour when these are disturbed in certain medical conditions) such as chlorpromazine, haloperidol, thioridazine, pimozide.
- diuretics (water tablets) - (used to relieve water retention and reduce high blood pressure) such as hydrochlorothiazide, amiloride or triamterene.
Amantadine oral solution with food, drink and alcohol
Do not drink alcohol while taking this medicine. Alcohol may make the side effects of this medicine worse.
Pregnancy and breast-feeding
If you think you might be pregnant or want to become pregnant, then ask your doctor or pharmacist for advice before taking this medicine. If you could become pregnant, you should use a reliable method of contraception during the treatment and for 5 days after the final dose of amantadine.
Do not take this medicine if you are breast-feeding because amantadine passes into breast milk and could harm your baby.
Driving and using machines
This medicine may make your vision blurred or make you feel dizzy. If you are affected you should not drive or use machines until the effect has worn off.
Amantadine oral solution contains
- Sorbitol (E420): If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
- Methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216): These may cause allergic reactions in some people that could occur sometime after taking this medicine. The signs may include a rash, swelling or breathing problems and swelling of your lips, face, throat or tongue.
If you have any concerns over whether this medicine is suitable for you talk to your doctor, pharmacist or nurse.
3. How to take Amantadine oral solution
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The box containing this medicine contains a plastic measuring cup. The cup is marked in ml (millilitres)
to help you measure out the correct amount. Take your medicine using the measuring cup and rinse it out with water after each use. The recommended dose in Parkinson’s disease:
Adults:
The starting dose is usually 10 ml (100 mg) once each day after a meal, preferably in the morning for the first week, which is then increased to 10 ml (100 mg) twice daily after meals. Your doctor will determine the best dose for you and may gradually adjust the dose during your treatment, depending upon your response. Do not take more than 40 ml (400 mg) a day.
Elderly (over 65 years of age):
Patients are more susceptible to the effects of amantadine as a result your doctor will give the lowest possible dose.
Patients with renal impairment:
It will be administered with great caution in these patients. So in these cases the doctor will perform the dose adjustment based on the creatinine clearance (laboratory test that assesses the functioning of the kidneys) of the patient.
Children:
This medicine is not suitable for use in children.
Method of administration:
This medicine should be taken orally after a meal.
If you take more Amantadine oral solution than you should
If you accidentally take too much oral solution, or someone else takes any of your medicine, you should tell your doctor at once or contact the nearest accident and emergency department. Show any left-over medicines or the empty bottle to the doctor.
If you forget to take Amantadine oral solution
If you miss a dose, take another as soon as you remember, unless it is almost time for your next dose. Then go on as before. Do not take a double dose to make up for a forgotten dose.
If you stop taking this medicine
Do not stop taking this medicine suddenly as your symptoms may get worse.
If you want to stop taking this medicine ask your doctor who will tell you how to reduce the dose gradually.
If you are taking anti-psychotics (used to treat mental disturbances) and you suddenly stop taking this medicine, you may develop a collection of symptoms including:
- fever
- sweating
- a rapid heart beat
- muscle stiffness (difficulty in movement)
- loss of bladder control (you may have a sudden urge to pass water). If you develop any of these symptoms you should contact your doctor immediately.
Some patients may notice that this medicine loses its effect after they have taken it regularly for a few months. If you notice this, tell your doctor. 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.
If any of the following symptoms occur you should tell your doctor or contact the nearest hospital straight away:
- dizziness or lightheadedness
- fainting
- convulsions (fits)
Tell your doctor or pharmacist if you think you have any of these or other problems with this medicine:
Very common: may affect more than 1 in 10 people
- swollen ankles, feet and legs
- red blotchy spots on the skin.
Common: may affect up to 1 in 10 people
- loss of appetite
- anxiety
- depression
- feeling tired
- feeling overexcited
- hallucinations
- difficulty in controlling movements
- blurred vision
- low blood pressure when standing up. This may make you feel dizzy or faint
- feeling or being sick
- difficulty concentrating
- feeling nervous
- difficulty sleeping
- muscle pain
- headache
- nightmares
- slurred speech
- fast or irregular heartbeat
- dry mouth
- constipation
- sweating.
Uncommon: may affect up to 1 in 100 people
- blurred vision
Rare: may affect up to 1 in 1000 people
- confusion
- disturbed thoughts or behaviour such as feeling paranoid
- Neuroleptic Malignant Syndrome (NMS). You may feel hot and have muscle stiffness
- loss of bladder control. You may have difficulty in passing water or have a sudden urge to pass water.
- disorientation (not knowing where you are)
- shakiness
- difficulty moving
- diarrhoea
- skin rash
- problems with your eyes such as itchiness or redness
- corneal lesion, corneal oedema, reduced visual acuity
- Very rare: may affect up to 1 in 10,000 peopleheart problems which cause shortness of breath or ankle swelling
- reduction in the number of white blood cells which makes infections more likely
- changes in blood tests which show how the liver is working
- sensitivity to sunlight
Not known: frequency cannot be estimated from the available data
- Urge to behave in an unusual way - strong impulse to gamble excessively, altered or increased sexual interest, uncontrollable excessive shopping or spending, binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger
- Abnormally low body temperature (below 35ºC) has been observed especially in children.
If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 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 Website: 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 Amantadine oral solution
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 packaging. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Use within 140 days of opening.
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 Amantadine oral solution contains
- The active substance is amantadine hydrochloride
- The other ingredients are methyl parahydroxy benzoate (E218), propyl parahydroxy benzoate (E216), sorbitol 70% (E420), sodium citrate dihydrate, lemon flavour, propylene glycol and purified water.
- This medicine contains 0.2 g sorbitol in each ml dose.
- This medicine contains 8 mg propylene glycol in each ml dose. What Amantadine oral solution looks like and contents of the pack
Amantadine oral solution is a clear, colourless liquid with slightly sweet taste and lemon flavour. This medicine comes in bottles of 150 ml oral solution with a 15 ml dosing cup. The dosing cup is marked in ml (millilitres), to help you measure out the correct amount. Take your medicine using the measuring cup and rinse it out with water after each use.
Marketing Authorisation Holder and Manufacturer:
Macarthys Laboratories Limited
T/A Martindale Pharma
Bampton Road,
Harold Hill,
Romford, Essex,
RM3 8UG
United Kingdom
This medicinal product is authorised the Member states of the EEA under the following names:
Netherlands Amantadine Ethypharm 10mg/ml drank UK Amantadine hydrochloride 10mg/ml oral solution Italy Amantadina cloridrato Ethypharm
Austria Amantadin Ethypharm 10mg/ml Lösung zum Einnehmen Germany Amantadin Ethypharm 10mg/ml Lösung zum Einnehmen
This leaflet was last revised in March 2020.
To request a copy of this leaflet in braille, large print or audio format, please contact the licence holder at the address above. D05343
Continued overleaf D05343
5343-C
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
This medicine will be referred to as Amantadine oral solution in the rest of this leaflet.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- 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 side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Amantadine hydrochloride
10 mg/ml oral solution