Package leaflet: Information for the patient

Nefopam Jelfa
30 mg, coated tablets
Nefopamum hydrochloridum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

What Nefopam Jelfa is and what it is used for
Important information before taking Nefopam Jelfa
How to take Nefopam Jelfa
Possible side effects
How to store Nefopam Jelfa
Contents of the pack and other information

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

Nefopam is a non-narcotic analgesic weaker than morphine but stronger than acetylsalicylic acid. It is a potent inhibitor of serotonin and noradrenaline reuptake. At higher doses, nefopam also exhibits cholinolytic, antihistaminic, and local anesthetic properties.
Indications

Mild to moderate acute pain, e.g. postoperative pain.
Less severe chronic pain, e.g. pain associated with neoplastic diseases.

2. Important information before taking Nefopam Jelfa

When not to use Nefopam Jelfa

if the patient is allergic to the active substance (nefopam hydrochloride) or to any of the other ingredients of this medicine (listed in section 6),
if the patient suffers from epilepsy,
in children under 12 years of age,
during treatment with monoamine oxidase inhibitors (certain antidepressants) or within two weeks after their discontinuation.

Warnings and precautions
Before starting treatment with Nefopam Jelfa, discuss it with your doctor, pharmacist, or nurse.
Exercise particular caution when administering the medicine to:

patients with liver or kidney disorders (except in cases of severe renal failure, dosage adjustment is not necessary),
elderly patients (treatment should be initiated with low doses due to increased risk of adverse effects such as hallucinations and disorientation),
patients with benign prostatic hyperplasia and difficulty in urination.

Nefopam may cause:

pink discoloration of urine, which is not due to hematuria (presence of red blood cells in urine) or kidney damage,
asymptomatic increase in aminotransferase activity (liver function should be monitored during prolonged treatment).

Children and adolescents
Do not use in children under 12 years of age.
Nefopam Jelfa and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines you plan to take.
Concomitant use of nefopam with antidepressants such as monoamine oxidase inhibitors or tricyclic antidepressants may lead to serious consequences: hyperthermia, malignant hypertension (severe form of arterial hypertension), tachycardia, and cardiac arrhythmias.
Nefopam may enhance the effects of cholinolytic drugs (used in the treatment of, among others, bronchial asthma, gastrointestinal spasms, gastric ulcers and reflux, Parkinson's disease) or sympathomimetic drugs (used in the treatment of, among others, bronchial asthma, chronic obstructive pulmonary disease, upper respiratory tract infections, circulatory disorders related to postural changes from lying to standing, occasionally in the treatment of hypertension and depression), thereby increasing their adverse effects.
Concomitant use of nefopam with paracetamol may increase the risk of liver damage.
Do not use Nefopam Jelfa with:

sedatives,
antihistamines (antiallergic drugs), although interactions have not been proven.

Reserpine (used in the treatment of hypertension) reduces the analgesic effect of nefopam.
Nefopam Jelfa with food, drink, and alcohol
See also section 3.
An interaction with alcohol has not been proven, however, alcohol consumption should be avoided during treatment with nefopam.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Use during pregnancy
Due to the not fully established safety of the drug during pregnancy, nefopam should be used only if absolutely necessary and when alternative treatments are impossible or contraindicated.
Use during breastfeeding
Nefopam passes into breast milk; therefore, the drug should not be used during breastfeeding.
Driving and operating machinery
Nefopam may cause either stimulation and euphoria or sedative effects.
Therefore, patients taking nefopam are advised not to drive or operate machinery.

3. How to use Nefopam Jelfa

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Recommended dose: 1 to 3 tablets three times daily, depending on the body's response.
Initially, 60 mg (2 tablets) should be administered three times a day.
In elderly patients, lower doses should be used, i.e. 30 mg (1 tablet) three times a day.
The medicine should be taken during or after meals.
Use in children and adolescents
Do not use in children under 12 years of age.
Taking more than the recommended dose of Nefopam Jelfa
If you take more than the recommended dose of Nefopam Jelfa, contact your doctor immediately.
In case of overdose, symptoms may include seizures, excitement, hallucinations, rapid heartbeat
(tachycardia), increased body temperature, profuse sweating, and disturbances in heart function.
In such a case, call a doctor immediately.
Immediate management in case of overdose consists of placing the patient in the lateral position
and ensuring airway patency. If the patient is conscious, vomiting should be induced
by administering 1–2 glasses of warm salt solution (2 teaspoons of salt per glass of water).
This method is applicable only in adults and children over 12 years of age.
Missed dose of Nefopam Jelfa
Do not take a double dose to make up for a missed dose. If a dose of Nefopam Jelfa is missed,
take it as soon as possible and continue treatment according to previous instructions. However,
if the time for the next dose is approaching, skip the missed dose.
Stopping Nefopam Jelfa
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Below are the adverse reactions observed during the use of nefopam.

Very common (may affect more than 1 in 10 patients):

nausea, which in most cases does not lead to vomiting
excessive sweating

Frequency not known (cannot be estimated from available data):

dizziness
confusion
excessive excitation
insomnia
anxiety
loss of appetite
visual disturbances
rapid heartbeat (tachycardia)
dry mouth
difficulty swallowing
skin rashes
difficulty in urination
drowsiness, confusion

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Nefopam Jelfa
Store below 25 °C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via the sewage system or household waste. Ask a pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Nefopam Jelfa contains
The active substance is nefopam hydrochloride.
One coated tablet contains 30 mg of nefopam hydrochloride.
The other ingredients are: calcium hydrogen phosphate dihydrate, potato starch,
hydroxypropylcellulose, talc, magnesium stearate, hypromellose, polyethylene glycol 6000, titanium dioxide,
simethicone emulsion.

What Nefopam Jelfa looks like and contents of the pack
Nefopam Jelfa is white, round, biconvex coated tablets.
Nefopam Jelfa is packed in blisters containing 20 coated tablets, placed in a cardboard box.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer
Przedsiębiorstwo Farmaceutyczne Jelfa SA
58-500 Jelenia Gora, ul. Wincentego Pola 21

For further information, please contact the local representative of the Marketing Authorisation Holder:
Przedsiębiorstwo Farmaceutyczne Jelfa SA
58-500 Jelenia Gora, ul. Wincentego Pola 21
Tel.: (075) 64 33 100
Fax: (075) 75 24 455
E-mail: [email protected]