Nefopam Hydrochloride Tablets 30mg Taj Pharma

  1. Name of the medicinal product

Nefopam Hydrochloride 30mg Film-coated Tablets

  1. Qualitative and quantitative composition

Each coated tablet contains
Nefopam Hydrochloride                                30 mg.
Excipients                                                      q.s
For the full list of excipients, see section 6.1.

  1. Pharmaceutical form

White to off white, round, biconvex film coated tablets with ‘NFP’ debossed on one side and plain on other side.

  1. Clinical particulars

4.1 Therapeutic indications

Nefopam is indicated for the relief of acute and chronic pain, including post-operative pain, dental pain, musculo-skeletal pain, acute traumatic pain and cancer pain.

4.2 Posology and method of administration

Posology

ADULTS: Dosage may range from 1 to 3 tablets three times daily depending on response. The recommended starting dosage is 2 tablets three times daily.

ELDERLY: Elderly patients may require reduced dosage due to slower metabolism.

It is strongly recommended that the starting dose does not exceed one tablet three times daily as the elderly appear more susceptible to; in particular, the CNS side effects of nefopam and some cases of hallucinations and confusion have been reported in this age group.

Paediatric population: The safety and efficacy of nefopam has not been evaluated in children under 12 years, no dosage recommendation can be given for patients under 12 years.

Renal impairment

Patients with end stage renal disease might experience increased serum peak concentrations during treatment with nefopam. In order to avoid that, it is recommended the daily dose should be reduced not only for the elderly, but also for patients with terminal renal insufficiency.

Method of administration

Oral use

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Nefopam is contra-indicated in patients with a history of convulsive disorders and should not be given to patients taking mono-amine-oxidase (MAO) inhibitors.

4.4 Special warnings and precautions for use

The side effects of Nefopam may be additive to those of other agents with anticholinergic or sympathomimetic activity. It should not be used in the treatment of myocardial infarction since there is no clinical experience in this indication. Hepatic and renal insufficiency may interfere with the metabolism and excretion of nefopam.

Nefopam should be used with caution in patients with angle closure glaucoma. Cases of nefopam dependence and abuse have been reported with nefopam use.

Nefopam should be used with caution in patients with, or at risk of, urinary retention. Rarely a temporary, harmless pink discolouration of the urine has occurred.

4.5 Interaction with other medicinal products and other forms of interaction

Caution should be exercised when nefopam is administered concurrently with tricyclic antidepressants.

It should be noted that nefopam may interfere with some screening tests for benzodiazepines and opioids. These tests for benzodiazepines and opioids may give false positive results for patients taking Nefopam.

4.6 Fertility, pregnancy and lactation

There is no evidence as to the drug safety in human pregnancy, nor is there evidence from animal work that it is free from hazard. Avoid in pregnancy unless there is no safer treatment.

4.7 Effects on ability to drive and use machines

Nefopam may cause drowsiness. If affected do not drive or operate machinery.

4.8 Undesirable effects

The following undesirable effects have been reported with the following frequency:

Not known (cannot be estimated from the available data)

System organ classFrequencyUndesirable effects
Immune system disordersNot knownAllergic reaction, anaphylactic reactions
Psychiatric disordersNot knownNervousness, convulsions, confusional state, hallucination, insomnia
Nervous system disordersNot knownLight-headedness, syncope, dizziness, paraesthesia, tremor, drowsiness, headache, coma
Eye disordersNot knownBlurred vision
Cardiac disordersNot knownPalpitations, tachycardia
Vascular disordersNot knownHypotension
Gastrointestinal disordersNot knownNausea, vomiting, dry mouth, gastrointestinal disturbances (including abdominal pain and diarrhoea)
Skin and subcutaneous tissue disordersNot knownAngioedema, sweating
Renal and urinary disordersNot knownUrinary retention

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

Symptoms

The clinical pattern of nefopam toxicity in overdose is on the neurological (convulsions, hallucinations, coma and agitation) and cardiovascular systems (tachycardia with a hyperdynamic circulation).

Management

Routine supportive measures should be taken and prompt removal of ingested drug by gastric Lavage or induced vomiting with Syrup of Ipecacuanha should be carried out. Oral administration of activated charcoal may help prevent absorption.

Convulsions and hallucinations should be controlled (eg with intravenously or rectally administered diazepam). Beta-adrenergic blockers may help control the cardiovascular complications.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Other Analgesics and antipyretics

Nefopam is a potent and rapidly-acting analgesic. It is totally distinct from other centrally-acting analgesics such as morphine, codeine, pentazocine and propoxyphene.

Unlike the narcotic agents, Nefopam has been shown not to cause respiratory depression. There is no evidence from pre-clinical research of habituation occurring with Nefopam.

5.2 Pharmacokinetic properties

Nefopam is absorbed from the gastro-intestinal tract. Peak plasma concentrations occur about 1-3 hours after oral administration. About 73% is bound to plasma proteins. It has an elimination half-life of about 4 hours. It is extensively metabolised and excreted mainly in urine. Less than 5% of a dose is excreted unchanged in the urine. About 8% of a dose is excreted via the faeces.

5.3 Preclinical safety data

Not applicable.

  1. Pharmaceutical particulars

6.1 List of excipients

Core Tablet

Calcium Hydrogen Phosphate Dihydrate, Cellulose Microcrystalline

Starch Pregelatinized, Hydrogenated Vegetable Oil, Silica, Colloidal anhydrous, Magnesium Stearate

Coating

Hypromellose (HPMC 2910),Titanium Dioxide, Macrogol/PEG, Purified Water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

24 Months

6.4 Special precautions for storage

Not applicable.

6.5 Nature and contents of container

Tablets are packed in either an ALU-ALU blister pack (consisting of ALU/ OPA/PVC (50/25 /60 microns) and Aluminium Foil 25 microns) or PVC – ALU blister pack (consisting of PVC 250 micron and Aluminium Foil 20 microns).

Each pack contains 3 blisters of 30 tablets hence a total pack size of 90 tablets.

6.6 Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com

 

Nefopam Hydrochloride Tablets 30mg Taj Pharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

NEFOPAM HYDROCHLORIDE 30MG FILM-COATED TABLETS

Nefopam hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • 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.

What is in this leaflet

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

The name of your medicine is Nefopam hydrochloride 30mg Film-coated Tablets (referred to as Nefopam throughout this leaflet). Nefopam belongs to a group of medicines called analgesics, commonly known as pain killers or pain relievers.

The active substance, nefopam hydrochloride, 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 does NOT stop the pain from happening, but you will not be able to feel the pain as much.

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

  1. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEFOPAM

Do not take Nefopam:

  • you are a child under 12 years old
  • if you are allergic or have ever had an allergic reaction to nefopam hydrochloride or any of the 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, “Possible side effects”)
  • if you are taking monoamine oxidase inhibitors (MAOIs) to treat your depression (see “Other medicines and Nefopam”)
  • if you have, or have ever had, epilepsy (fits).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Nefopam 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).

Children

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

Other medicines and Nefopam

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 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.

Pregnancy and breast-feeding

Nefopam 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.

Driving and using machines

Nefopam 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.

  1. HOW TO TAKE NEFOPAM

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

Dosage for adults:

  • 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.

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.

Use in children and adolescents:

  • Over 12 years – as per adults (see above).
  • Under 12 years – Nefopam is NOT to be taken by children under 12 (see section 2, “Children”).

Dosage for elderly patients:

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

Dosage for patients with kidney and/or liver problems:

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

If you take more Nefopam than you should

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

If you forget to take Nefopam, take it as soon as you remember. Do NOT take a double dose to make up for a forgotten dose.

If you stop taking Nefopam

Do NOT stop taking Nefopam without checking with your doctor first.

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

  1. POSSIBLE SIDE EFFECTS

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

If you or someone you know taking this medicine experiences any of the following side effects, STOP taking this medicine and contact your doctor IMMEDIATELY:

  • swelling of the skin and soft tissue around the eyes, nose and throat with difficulty breathing (angioedema)
  • allergic reactions-like hives (itchy red spots on the skin), itching, nasal congestion (known as rhinitis), rash, watery or itchy eyes, coughing, fainting, dizziness, confusion, or weakness.
  • convulsion
  • 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
  • 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).

Reporting of side effects

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

By reporting side effects you can help provide more information on the safety of this medicine.

  1. HOW TO STORE NEFOPAM
  • 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 and blister after Exp. The expiry date refers to the last day of that month.
  • 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.
  1. CONTENTS OF THE PACK AND OTHER INFORMATION

What Nefopam contains

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 macrogol/polyethylene glycol and purified water.

What Nefopam looks like and contents of the pack

Nefopam hydrochloride 30 mg 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.

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com