Nefopam hydrochloride 30 mg film-coated tablets

• 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.

Name of the product will be referred to as 'nefopam hydrochloride tablets' throughout the leaflet.

1. What Nefopam hydrochloride tablet is and what it is used for
2. What you need to know before you take Nefopam hydrochloride tablet
3. How to take Nefopam hydrochloride tablet
4. Possible side effects
5. How to store Nefopam hydrochloride tablet
6. Contents of the pack and other information

• you are a child under 12 years old
• you have ever had an allergic reaction to nefopam hydrochloride or any of the ingredients resulting in a skin rash, swelling of the face or difficulty in breathing (see section 6. Contents of the pack and other information)
• you are taking monoamine oxidase inhibitors (MAOIs) to treat your depression
• you have, or have ever had, epilepsy (fits).

Talk to your doctor or pharmacist before taking nefopam hydrochloride

If the answer to any of the following is ‘yes’, you must tell your doctor - your doctor may decide to alter your treatment.

• Are you pregnant or breast feeding?
• Do you have severe problems with your liver or kidneys?
• Do you have, or have you had in the past difficulty passing urine?
• Are you taking other medicines?
• Have you previously been diagnosed with glaucoma (increased pressure in the eye)?

Nefopam hydrochloride should not be taken in children under 12 years.

If any of the above apply to you, your doctor may decide to alter your treatment.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines:

• Monoamine oxidase inhibitors (known as MAOIs) for depression. You must tell your doctor if you are taking this medicine.
• Tricyclic antidepressants for depression
• Anticholinergics
• Sympathomimetics

Tell your doctor or dentist if you are taking any of these medicines.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Nefopam hydrochloride should not be taken during pregnancy or while breast-feeding.

Please contact your doctor if you become pregnant during your treatment.

Nefopam hydrochloride can cause drowsiness. Do not drive or operate heavy machinery unless you know how nefopam hydrochloride affects you.

The usual initial dose is two tablets taken three times a day. Your doctor may increase this dose up to a maximum of three tablets taken three times a day according to your needs.

Ask your doctor or pharmacist if:

• you are not sure how many tablets to take or when to take them
• you think the effect is too strong or too weak

Swallow your tablets with water.

Over 12 years - as per adults (see above).

Under 12 years - Nefopam hydrochloride should not be taken by children under 12.

In older patients the doctor may reduce the number of tablets that are taken.

Your doctor may adjust the dose of nefopam hydrochloride depending upon your condition.

If you accidentally take more tablets than your prescribed dose, tell your doctor or pharmacist immediately and if necessary contact your nearest hospital casualty department. Remember to take the pack and any remaining medicines with you.

If you forget to take nefopam hydrochloride, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.

Do not stop taking nefopam hydrochloride without first checking with your doctor.

• swelling of the skin and soft tissue around the eyes, nose and throat (angioedema), or allergic reactions (anaphylaxis).

• feeling sick
• feeling light-headed, dizzy or nervous, or fainting
• a decrease in blood pressure
• numbness or tingling in the extremities
• a dry mouth
• having difficulty passing urine
• convulsions (fits), tremor
• confusion
• hallucinations (seeing things that aren’t there).

• being sick
• abdominal pain or diarrhoea
• blurred vision
• drowsiness
• sweating
• trouble sleeping
• headaches
• awareness of your heartbeat (palpitations), or a fast heartbeat (tachycardia).
• coma

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.co.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.

• The active substance is nefopam hydrochloride
• The other ingredients are:
  Tablet Core:
  Microcrystalline cellulose,
  Pregelatinized starch,
  Dicalcium phosphate dihydrate,
  Silica colloidal anhydrous,
  Magnesium stearate,
  Tablet Film-coating:
  Hypromellose (6cP),
  Titanium dioxide (E171),
  Macrogol

Nefopam hydrochloride tablets are white to off white, round shape, film coated tablets debossed with "EM" on one side and "62" on the other side

The tablets are available in aluminium-PVC/PVDC blister or aluminium-PVC blister with 30’s and 90’s tablets

Not all pack sizes may be marketed.