Nefopam hydrochloride 30 mg Film-coated Tablets

Package leaflet: Information for the User

Nefopam Hydrochloride 30 mg Film-coated Tablets

1. What Nefopam hydrochloride is and what it is used for

The name of your medicine is Nefopam Hydrochloride 30 mg Film-coated Tablets (referred to as ‘Nefopam hydrochloride’ throughout this leaflet). Nefopam hydrochloride includes the active substance nefopam hydrochloride.

Nefopam hydrochloride belongs to a group of medicines called analgesics, commonly known as pain killers or pain relievers. It interrupts the pain messages being sent to your brain, and it also acts in your brain to stop pain messages being felt. This means that Nefopam hydrochloride does not stop the pain from happening, but you will not be able to feel the pain as much.

Nefopam hydrochloride is used to relieve acute and chronic pain (for example pain after an operation, dental pain, joint or muscle pain, after an injury, or pain caused by cancer).

Nefopam hydrochloride should not be used to treat the pain from a heart attack.

2. What you need to know before you use Nefopam hydrochloride

Do not take Nefopam hydrochloride if:

• 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

3. How to take Nefopam hydrochloride

Dosage

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 have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOP taking this medicine and contact your doctor immediately if you experience:

• swelling of the skin and soft tissue around the eyes, nose and throat with difficulty breathing (angioedema)
• allergic reactions (anaphylaxis)
• convulsions, tremor
• coma

Other side effects include:

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

5. How to Store Nefopam hydrochloride

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date, which is stated on carton and blister after EXP. The expiry date refers to the last day of that month.
• This medicinal product does not require any special storage conditions.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. Those measures will help protect the environment.

6. Contents of the pack and other information