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ORPHENADRINE HYDROCHLORIDE 50 MG TABLETS - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

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.

  • 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.

Sources: Original (products.mhra.gov.uk)

Frequently Asked Questions

What is Orphenadrine Hydrochloride used for?

Orphenadrine Hydrochloride is primarily used to relieve muscle pain and stiffness associated with conditions like muscle spasms and injuries.

How does Orphenadrine work in the body?

Orphenadrine works by blocking certain nerve signals in the brain to help reduce muscle spasms and provide pain relief.

Can I take Orphenadrine with other medications?

Always consult your doctor before combining Orphenadrine with other medications, especially those that affect the central nervous system.

What should I do if I miss a dose of Orphenadrine?

If you miss a dose of Orphenadrine, take it as soon as you remember unless it's almost time for your next dose. Do not double up.

Are there any common side effects of taking Orphenadrine?

Yes, common side effects may include dry mouth, dizziness, drowsiness, or constipation. If these persist or worsen, contact your doctor.

Is Orphenadrine safe to use during pregnancy?

The safety of Orphenadrine during pregnancy hasn't been established. Always consult your healthcare provider before using it if you're pregnant or planning to become pregnant.

Can I drink alcohol while taking Orphenadrine?

It's advisable to avoid alcohol while taking Orphenadrine, as it can increase the risk of drowsiness and other side effects.

How should I store Orphenadrine Hydrochloride tablets?

Store Orphenadrine tablets at room temperature, away from moisture and heat. Keep them out of reach of children.

What if I overdose on Orphenadrine?

If you suspect an overdose, seek emergency medical attention immediately or call your local poison control center.

Can children take Orphenadrine Hydrochloride tablets?

Orphenadrine is generally not recommended for children under 12 years old without a doctor's advice.

How long does it take for Orphenadrine to start working?

Many patients notice relief within 30 minutes to an hour after taking an oral dose of Orphenadrine.

Can I drive after taking Orphenadrine?

Orphenadrine may cause drowsiness. If you feel sleepy or dizzy after taking it, it's best to avoid driving or operating heavy machinery.

Are there any foods I should avoid while taking Orphenadrine?

There's no specific food to avoid with Orphenadrine; however, maintaining a balanced diet can help manage overall health during treatment.

What should I do if I experience severe side effects from Orphenadrine?

If you experience severe side effects such as difficulty breathing, swelling of the face or throat, seek immediate medical attention.

Can older adults take Orphenadrine safely?

Older adults may be more sensitive to the effects of Orphenadrine; it's important they discuss potential risks with their doctor before use.

Is it possible to develop a dependence on Orphenadrine?

While dependence is rare, misuse of muscle relaxants can lead to dependency. Always take medications as prescribed by your healthcare provider.

How long can I safely take Orphenadrine Hydrochloride tablets?

The duration of treatment with Orphenadrine should be determined by your healthcare provider based on your specific condition and response to therapy.

What should I tell my doctor before starting Orphenadrine?

Inform your doctor about all medications you're currently taking, any allergies you have, and your full medical history before starting treatment with Orphenadrine.

What happens if I stop taking Orphenadrine suddenly?

It's generally safe to stop taking Orphenadrine abruptly; however, always consult your doctor first for personalized advice regarding discontinuation.