NEFALGIC contains nefopam as active ingredient. It belongs to the group called “OTHER ANALGESIC AND ANTIPYRETICS” (N : Central nervous system).

NEFALGIC is indicated in adults as symptomatic treatment of acute painful conditions, especially post-operative pains.

Contra-indications

DO NOT TAKE NEFALGIC solution for injection:

·         If you are allergic to nefopam or any of the other ingredients of this medicine (listed in section 6).

·         In children below 15 years.

·         If you had previous history of convulsions.

·         If you suffer from urinary retention linked to uretroprostatic disorders.

·         If you suffer from acute angle glaucoma (increase of pressure into the eye).

Warnings and precautions

·         A risk of addiction exists with NEFALGIC.

·         In case of concomitant use of a morphinic drug, the brutal stopping of the morphine drug can provoke a withdrawal syndrome because NEFALGIC is not a morphinic agent.

·         If you suffer from a cardiovascular pathology you should not take this medicine as it can increase the cardiac frequency.

·         Due to its cholinergic effects, the treatment with nefopam is not advisable for elderly people.

Other medicines and NEFALGIC solution for injection

Treatment with NEFALGIC must be cautiously monitored in association with drugs which depress the central nervous system because of the risk of increased central depression, such as:

-          morphine derivatives (analgesics, antitussives and narcotic substitutes)

-          benzodiazepines; hypnotics; neuroleptics; sedative H1 antihistamines; sedative antidepressants (medicines used to reduce anxiety and sleeplessness)

-          central antihypertensives

-          baclofene

-          thalidomide

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

Pregnancy and breast-feeding

The effect of this medicine during pregnancy is unknown. Consequently, the use of this medicine is not advisable during pregnancy.

Nefopam is excreted into mother milk, it is not advisable to take it during 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.

Driving and using machines

Due to the possible risk of giddiness, the drivers and machine users have to be vigilant.

Noticeable excipients

None

Dosage

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

The dosage is strictly individual.

The recommended dose is generally 1 ampoule (IV or IM route), to be renewed until 6 ampoules per day if necessary.

Mode and way of use

NEFALGIC can be administered by deep intramuscular route (IM) or slow intravenous route (IV) (more than 15 minutes). By IV route, it is necessary to lay down in order to avoid some side effects such as nausea, dizziness, sweats.

NEFALGIC can be administered in infusion too, with glucose solution or physiological salt solution.

Frequency and time to take it

The injections can be renewed every 6 hours (IM route) or every 4 hours (IV route).

A minimal 4 hours interval between 2 injections is usually respected.

Duration of treatment

The duration of the treatment prescribed by your physician must be strictly respected.

If you take more NEFALGIC solution for injection than you should

The accidental overdose can lead to possible cardiovascular troubles, convulsions, hallucinations which need a monitoring of the cardiac and respiratory functions with in-hospital treatment of the symptoms.

Consult immediately your physician or your pharmacist.

If you forget to take NEFALGIC solution for injection

Do not take a double dose to make up for a forgotten dose.

If you stop taking NEFALGIC solution for injection

The stopping of the treatment does not provoke a withdrawal syndrome (state of deprivation or lack felt after the stop of certain drugs with reappearance or worsening of the disorders).

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

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

The most common side effects are (may affect up to 1 in 10 people): vertigo, nausea with or without vomiting, somnolence, sweats, pain at the injection site. It has also been observed troubles such as dryness of mouth, acceleration of heartbeat, palpitations, urinary retention.

More rarely (may affect up to 1 in 10,000 people) have been reported: excitability, irritability, hallucinations, abuse, drug addiction, convulsions, allergic reactions (urticaria, Quincke's oedema, anaphylactic shock).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

To report any side effect(s):

National Pharmacovigilance and Drug Safety Centre (NPC)

o    Fax: +966-11-205-7662

o    Call NPC at +966-11-2038222, Exts: 2317-2356-2353-2354-2334-2340.

o    Toll free phone: 8002490000

o    E-mail: npc.drug@sfda.gov.sa

o    Website: www.sfda.gov.sa/npc

Keep this medicine out of the sight and reach of children.

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.

Store below 30°C.

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.