Patient leaflet - ORPHENADRINE HYDROCHLORIDE 50 MG TABLETS
ORPHENADRINE HYDROCHLORIDE 50 mg TABLETS
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 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 Orphenadrine is and what it is used for
2. What you need to know before you take Orphenadrine
3. How to take Orphenadrine
4. Possible side effects
5. How to store Orphenadrine
6. Contents of the pack and other information
1. what orphenadrine is and what it is used for
Orphenadrine belongs to a group of drugs called antimuscarinic agents.
Orphenadrine is used to:
- help in the control of Parkinsonism (symptoms of tremor, stiffness and shuffling)
- treat related Parkinson-like side effects of other drugs.
2. what you need to know before you take orphenadrine
Do not take Orphenadrine if you:
- are allergic to orphenadrine hydrochloride or any of the other ingredients of this medicine (listed in
section 6).
- have glaucoma (loss of vision due to abnormally high pressure in the eye)
- have an enlarged prostate causing difficulty passing urine
- have tardive dyskinesia (uncontrollable movements of mouth, tongue and limbs).
Warnings and precautions
Talk to your doctor or pharmacist before taking Orphenadrine:
- if you have difficulties passing urine
- if you have heart, blood vessel or blood circulation problems
- if you have liver or kidney problems
- if you are pregnant or planning on becoming pregnant.
- if you have been told by your doctor that you have an intolerance to some sugars
There is the potential for Orphenadrine to be abused because it may cause an abnormal feeling of well-being.
Other medicines and Orphenadrine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Talk to your doctor if you are taking any of the following:
- amantadine (treatment for Parkinsonism)
- antidepressants
- antihistamines (allergy treatments)
- disopyramide (treatment for abnormal heart rhythm)
- ketoconazole (antifungal treatment)
- metoclopramide (treatment for feeling or/and being sick)
- phenothiazines (tranquillisers).
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Orphenadrine may cause blurred vision, if affected do not drive or operate machinery.
Orphenadrine contains lactose, sucrose and sunset yellow (E110)
Patients who are intolerant to lactose and sucrose should note that Orphenadrine Tablets contain a small amount of lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Please note that Orphenadrine Tablets contain sunset yellow (E110), which can cause allergic reactions.
3. how to take orphenadrine
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 tablets should be swallowed preferably with a drink of water.
The usual dose is:
Adults and the elderly
The starting dose is one tablet taken three times a day. Your doctor may increase the dose depending on your response and particular condition, up to a maximum of eight tablets per day.
Children
Orphenadrine is not recommended for use in children.
If you take more Orphenadrine than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause dry mouth, blurred vision, difficulty urinating, stomach problems and dizziness. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to take Orphenadrine
If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose. Take the remaining dose at the correct time.
If you stop taking Orphenadrine
Do not stop taking your medicine without talking to your doctor first even if you feel better. It is important that you continue to take your tablets without stopping suddenly or you may become unwell.
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 the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:
- an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin
rash or hives).
This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.
The following side effects have been reported:
Not Known: frequency cannot be estimated from the available data
- dry mouth
- blurred vision
- difficulty in passing water
- stomach problems
- dizziness.
- fast heart rate
- nervousness
- an abnormal feeling of well-being
- difficulty sleeping.
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 at:
By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store orphenadrine
Keep this medicine out of the sight and reach of children. Store away from moisture and heat. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. 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.
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6. FURTHER INFORMATION
What Orphenadrine Tablets contain:
- The active substance is orphenadrine hydrochloride 50 mg.
- The other ingredients are lactose, maize starch, talc (E553b), light kaolin (E559) and stearic acid (E570). The tablet coating contains: sucrose, opadry-oy-28–0200, quinoline yellow (E104), sunset yellow (E110), titanium dioxide (E171), sodium benzoate (E211), carnauba wax (E903) and beeswax (E901). The printing ink contains: shellac, black iron oxide (E172) and propylene glycol (E1520).
What Orphenadrine Tablets look like and contents of the pack:
- Orphenadrine Tablets are yellow, sugar-coated, round tablets with convex faces. They are printed 5X1 on one side and plain on the reverse.
- Orphenadrine Tablets come in pack sizes of: 50, 100, 250, 1000, 10000.