Orphenadrine Hydrochloride 50mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you
start taking this medicine.
• 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• 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.
IN THIS LEAFLET:
1. What Orphenadrine is and what it is used for
2. Before you take Orphenadrine
3. How to take Orphenadrine
4. Possible side effects
5. How to store Orphenadrine
6. Further information
OWHAT 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.
©BEFORE YOU TAKE ORPHENADRINE
Do NOT take Orphenadrine if you:
• are allergic (hypersensitive) to orphenadrine hydrochloride or any of the other ingredients of this medicine • 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). Take special care with Orphenadrine Tell your doctor before you start to take this medicine if you:
• have difficulties passing urine • have heart, blood vessel or blood circulation problems • have liver or kidney problems • are pregnant or planning on becoming pregnant.
There is the potential for Orphenadrine to be abused because it may cause an abnormal feeling of well-being.
Taking 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).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Pregnancy and breast-feeding If you are pregnant, planning to become pregnant or breast-feeding, ask your doctor for advice before taking this medicine.
Driving and using machines
Orphenadrine may cause blurred vision, if affected do not drive or operate machinery. Important information about some of the ingredients of Orphenadrine
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.
HOW TO TAKE ORPHENADRINE
Always take Orphenadrine exactly as your doctor has told you. You should 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.
POSSIBLE SIDE EFFECTS
Like all medicines, Orphenadrine can cause side effects, although not everybody gets them.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.
If the following happens, stop taking the This leaflet was last revised: January 2011. tablets and tell your doctor immediately pl 00289/0771 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:
• dry mouth
• blurred vision
• difficulty in passing water
• stomach problems
• dizziness.
These effects usually disappear on their own. If they don't disappear your doctor may reduce your dose in order to control them.
Less common side effects are:
• fast heart rate
• nervousness
• an abnormal feeling of well-being
• difficulty sleeping.
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.
HOW TO STORE ORPHENADRINE
Keep out of the reach and sight of children. Store away from moisture and heat. Do not use Orphenadrine after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month. 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.
FURTHER INFORMATION
What Orphenadrine Tablets contain:
• The active ingredient 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.
Not all pack sizes may be marketed.
TEVA UK LIMITED
PM 01776 55229-A