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
0800 198 5000.
The product code(s) for this leaflet is: PL 00427/0083.
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 further questions, ask your doctor or pharmacist.
This medicine has been prescribed only for you. 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Procyclidine Rosemont is and what it is used for 2. What you need to know before you take Procyclidine Rosemont 3. How to take Procyclidine Rosemont 4. Possible side effects 5. How to store Procyclidine Rosemont 6. Contents of the pack and other information
1. What Procyclidine Rosemont is and what it is used for
The name of your medicine is Procyclidine Rosemont 5mg/5ml Oral Solution (called Procyclidine in this leaflet). It contains procyclidine hydrochloride. This belongs to a group of medicines called anticholinergics.
Procyclidine can be used for the symptoms of Parkinsonism (usually slow movement, muscle stiffness and shaking fingers). These symptoms can be caused by Parkinson’s Disease, but there are other causes as well.
2. What you need to know before you take Procyclidine Rosemont
Do not take Procyclidine and tell your doctor if:
you are allergic (hypersensitive) to procyclidine hydrochloride or any other ingredients in this liquid (see section 6). An allergic reaction can include a rash, itching or shortness of breath
you have difficulty passing water (urine)
you have a blockage in the stomach or bowel
you have glaucoma (increased pressure in the eye).
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Procyclidine.
Warnings and Precautions
Before you take procyclidine, tell your doctor if:
you have an enlarged prostate gland
you have problems with face and tongue movements
you have liver or kidney problems.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Procyclidine.
Other medicines and Procyclidine:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because procyclidine can affect the way some other medicines work. Also some medicines can affect the way procyclidine works.
Tell your doctor if you are taking any of these medicines
medicines used to treat schizophrenia such as clozapine
medicines used for depression such as amitriptyline and paroxetine
medicines used for Parkinson’s Disease such as levodopa or amantadine (also used to treat some viral infections)
ketoconazole - used to treat some fungal infections
medicines used to treat Alzheimer’s disease such as tacrine and memantine
medicines used to treat an irregular heart beat such as quinidine, disopyramide
nefopam used as a painkiller
antihistamines - used for allergies
nitrate tablets that dissolve in the mouth - used to treat angina pain
medicines used to treat nausea and vomiting such as domperidone, metoclopramide.
If you are taking a mixture of procyclidine and medicines for psychoses (e.g. chlorpromazine, trifluoperazine), you should be aware that going to a hot, humid climate may cause fever.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, planning to become pregnant or are breast-feeding.
Driving and using machines
While taking this medicine you may feel light-headed, your eye-sight can become blurry or you could get an unusual feeling of excitement (elation). If this happens, you should not drive a car or use any tools or machines.
Important information about what is in this medicine
Liquid Maltitol (E965) - If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Methyl and Propyl parahydroxybenzoates (E218 and E216) – May cause allergic reactions (possibly delayed).
Propylene Glycol - This medicine contains 111.1mg of propylene glycol in each 5ml.
Sodium – This medicine contains less than 1 mmol sodium (23mg) per 5ml, that is to say essentially ‘sodium-free’.
3. How to take Procyclidine Rosemont
Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the doctor or pharmacist if you are not sure.
Taking this medicine
this medicine contains 5mg of procyclidine hydrochloride in each 5ml
take this medicine by mouth.
Adults
The usual doses for adults are given below:
Parkinsonism
a total daily dose of 30mg each day
this dose may be increased up to 60mg by your doctor
this dose can be split into two or three smaller doses to be taken through the day
at the start of treatment you may be asked to take 2.5mg three times each day
this may be increased further by 2.5mg – 5mg daily every 2-3 days until your symptoms are under control.
Parkinsonism that is caused by other medicines
usually not more than 20mg each day
your doctor may stop treatment after 3-4 months to check if you still need the treatment.
Children
This medicine is not usually given to children.
Elderly
If you are an older person you may be more sensitive to the medicine. The chances of you getting side effects are increased.
If you take more Procyclidine than you should
Talk to a doctor or go to a hospital straight away. Take the medicine pack with you so the doctor knows what you have taken. The following effects may happen: feeling restless or agitated, feeling confused, unable to sleep, pupils becoming larger and unusually fast heart beats. These can last up to 4 days. Hearing or seeing things that are not there may also happen. If you have taken larger amounts than you should, the following effects may happen: feeling drowsy, change in consciousness and coma.
If you forget to take Procyclidine
Do not take a double dose (two doses at the same time) to make up for forgotten doses. Skip the missed dose then go on as before.
If you stop taking Procyclidine
Keep taking procyclidine until your doctor tells you to stop. Do not stop taking your medicine suddenly.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, procyclidine can cause side effects, although not everybody gets them.
If you get any of the following side effects, see your doctor as soon as possible:
hallucinations
difficulty in passing water (urine)
blurred vision and dizziness
feeling confused, worried, nervous or irritable
reduced concentration or memory.
Tell your doctor if you get any of these side effects:
dry mouth
feeling sick (nausea) or being sick (vomiting)
constipation
inflamed gums
skin rashes.
If you are taking tranquillisers
If you are taking tranquillisers, you may notice you have unusual body movements, particularly your hands, arms and legs.
If you are taking procyclidine to control these side effects, you may notice that these side effects become worse. If this happens, see your doctor, who may then change the dose of your tranquilliser.
If any of the side effects get serious, 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
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 Procyclidine Rosemont
Keep out of the sight and reach of children.
Do not store above 25°C.
Do not use after the expiry date which is stated on the label and carton (exp: month, year).
The expiry date refers to the last day of that month.
Do not use Procyclidine Rosemont if you notice that the appearance or smell of your medicine has changed. Talk to your pharmacist.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicine no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Procyclidine Rosemont contains
The active ingredient is procyclidine hydrochloride
The other ingredients are citric acid (E330), sodium citrate (E331), methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), propylene glycol (E1520), liquid maltitol (E965), grape flavour (containing propylene glycol) and purified water.
What Procyclidine Rosemont looks like and contents of the pack
A colourless solution with an odour of grape.
It comes in a brown glass bottle holding 150ml of solution.
Marketing Authorisation Holder and Manufacturer
Rosemont Pharmaceuticals Ltd Yorkdale Industrial Park Braithwaite Street Leeds LS11 9XE UK