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 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.

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

• if you are a child under 12 years old
• if you are allergic to nefopam or any of the other ingredients of this medicine (listed in section 6), particularly if resulting in a skin rash, swelling of the face or difficulty in breathing (see section 4)
• if you are taking monoamine oxidase inhibitors (MAOIs) to treat your depression (see “Other medicines and Nefopam Tablets”)
• if you have, or have ever had, epilepsy (fits).

Talk to your doctor or pharmacist before taking Nefopam Tablets if:

• you have severe problems with your liver or kidneys
• you have, or have had in the past difficulty passing urine
• you have problems with your heart
• you were previously diagnosed with glaucoma (increased pressure in the eye).

Nefopam Tablets are NOT recommended for children under 12 years old (see section 3).

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without prescription.

In particular, tell your doctor if you are taking or have recently taken the following medicines:

• monoamine oxidase inhibitors (known as MAOIs) for depression. Nefopam Tablets and MAOIs must NOT be taken together.
• tricyclic antidepressants for depression
• benzodiazepines
• opiods
• anticholinergics
• sympathomimetics.

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

Nefopam Tablets should NOT be taken during pregnancy or while breast-feeding.

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 Tablets can cause drowsiness. You should NOT drive or use machines when you first start to take this medicine until you are certain that you are not getting any side effects. If in any doubt, speak to your doctor before you drive or use machines.

• The recommended 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
• Nefopam dose can be as low as 1 tablet per day
• Swallow your tablets with water.

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

• Over 12 years - as per adults (see above).
• Under 12 years - Nefopam Tablets are NOT to be taken by children under 12 (see section 2, "Children").

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

Your doctor may adjust the dose of Nefopam Tablets depending upon your condition.

If you think that you, or any other person, may have taken too many tablets, contact your doctor or hospital casualty department immediately. Over dosage can cause symptoms such as seizure, disturbance in thinking and perception, unconsciousness, anxiety, fast resting heart rate and abnormally increasing circulatory volume. Take any remaining tablets and this leaflet with you so that the medical staff knows exactly what you have taken.

If you forget to take Nefopam Tablets, 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 Tablets without checking with your doctor first.

Not known: frequency cannot be estimated from the available data

• feeling sick (nausea)
• 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
• tremor
• confusion
• hallucinations (seeing things that are not there)
• being sick (vomitting)
• abdominal pain or diarrhoea
• blurred vision
• drowsiness
• sweating
• trouble sleeping
• headaches
• awareness of your heartbeat (palpitations), or a fast heartbeat (tachycardia).

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 Website: www.mhra.gov.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 30mg.
• The other ingredients are calcium hydrogen phosphate dihydrate, cellulose microcrystalline, starch pregelatinised, hydrogenated vegetable oil, silica colloidal anhydrous and magnesium stearate.
  The coating consists of hydroxyl propyl methylcellulose 2910/hypromellose, titanium dioxide (E171) macrogol/polyethylene glycol and purified water.

Nefopam Tablets are white to off white, round, biconvex film coated tablets with 'NFP' debossed on one side and plain on other side. The tablets are supplied in blister packs of 90 tablets.