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

• you are a child under 12 years old
• you are allergic to active substance or any of the other ingredients of this medicine (listed in section 6).
• you are taking a medicine to treat your depression known as a monoamine oxidase inhibitor (MAOI)
• you have or have ever had epilepsy (fits).
• you are pregnant or breast-feeding

Talk to your doctor before using Nefopam hydrochloride if:

• you have severe problems with your liver or kidneys
• you have or have had in the past difficulty passing urine
• you are taking other medicines
• you have previously been diagnosed with glaucoma (increased pressure in the eye)

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

Children

Do not give this medicine to children between the ages of 0 to 12 years as the safety has not yet been established.

Do not take Nefopam hydrochloride if you are taking a medicine to treat your depression known as a monoamine oxidase inhibitor (MAOI).

Tell your doctor, dentist or pharmacist if you are taking or have recently taken the medicines listed below:

• Tricyclic antidepressants for depression
• Anticholinergics
• Sympathomimetics

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

Nefopam hydrochloride 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. 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.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with you doctor or pharmacist if you are not sure.

The recommended 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.

How to take the tablets

The tablets are for oral use. They should be swallowed with a glass of water.

Use in children (under 12 years)

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

Use in elderly patients

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

Use in patients with kidney and/or liver problems

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

If you take more tablets than you should, tell your doctor or pharmacist immediately or contact your nearest hospital casualty department. Remember to take the pack and any remaining tablets 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.

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.

The active substance is nefopam hydrochloride 30 mg.

The other ingredients are calcium hydrogen phosphate dehydrate, microcrystalline cellulose, pregelatinised starch, colloidal anhydrous silica, magnesium stearate.

The coating material consists of hydroxypropyl methylcellulose, polyethylene glycol (6000 & 400) and titanium dioxide (E171).

Nefopam hydrochloride 30 mg film-coated tablets are white to off white, round, film-coated biconvex tablets engraved with “20” on one side and “G” on the other side.

The tablets are available in Alu-Alu blister packs containing 90 tablets.