Nefopam Ielfa

Package Leaflet: Information for the Patient

Nefopam Jelfa

30 mg, coated tablets

Nefopam hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Nefopam Jelfa and what is it used for
• 2. Important information before taking Nefopam Jelfa
• 3. How to take Nefopam Jelfa
• 4. Possible side effects
• 5. How to store Nefopam Jelfa
• 6. Contents of the pack and other information

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

Nefopam is a non-narcotic analgesic weaker than morphine but stronger than acetylsalicylic acid. It is a strong inhibitor of serotonin and noradrenaline reuptake. At higher doses, nefopam also exhibits anticholinergic, antihistamine, and local anesthetic effects.

Indications

• Mild and moderate acute pain, e.g., postoperative pain.
• Moderate chronic pain, e.g., pain in cancer patients.

2. Important information before taking Nefopam Jelfa

When not to take Nefopam Jelfa

• if you are taking monoamine oxidase inhibitors (certain antidepressants) or have taken them in the last two weeks.

Warnings and precautions

Before taking Nefopam Jelfa, discuss it with your doctor, pharmacist, or nurse. Be particularly careful when taking this medicine if you have:

• liver or kidney disease (except in cases of severe kidney failure, no dose adjustment is necessary),
• are elderly (start with a lower dose due to the increased risk of side effects, such as hallucinations, disorientation),
• have an enlarged prostate and difficulty urinating.

Nefopam may cause:

• pink discoloration of urine, which is not a sign of hematuria (red blood cells in urine) or kidney damage,
• asymptomatic increase in aminotransferase activity (liver function should be monitored during long-term treatment).

Children and adolescents

Do not use in children under 12 years old.

Nefopam Jelfa and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. Concomitant use of nefopam with certain antidepressants (monoamine oxidase inhibitors and tricyclic antidepressants) may cause serious consequences: hyperthermia, malignant hypertension, tachycardia, and cardiac arrhythmias. Nefopam may enhance the effects of anticholinergic or sympathomimetic medicines, increasing their side effects. Nefopam used with paracetamol may increase the risk of liver damage. Do not use Nefopam Jelfa with:

• sedatives,
• antihistamines (anti-allergic medicines), although interactions have not been proven.

Reserpine (used to treat hypertension) may reduce the analgesic effect of nefopam.

Nefopam Jelfa with food, drink, and alcohol

See also section 3. No interaction with alcohol has been proven, but you should not drink alcohol while taking nefopam.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Use during pregnancyDue to the uncertain safety of using this medicine during pregnancy, nefopam should only be used if absolutely necessary and when no other medicine can be used. Use during breastfeedingNefopam passes into breast milk, so you should not take this medicine while breastfeeding.

Driving and using machines

Nefopam may cause both stimulation and euphoria, as well as a sedative effect. Therefore, patients taking nefopam should not drive or operate machinery.

3. How to take Nefopam Jelfa

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose is from 1 to 3 tablets, 3 times a day, depending on the response. Initially, 60 mg (2 tablets) 3 times a day is used. In elderly patients, a lower dose of 30 mg (1 tablet) 3 times a day should be used. Take the medicine with or after meals.

Use in children and adolescents

Do not use in children under 12 years old.

Overdose of Nefopam Jelfa

If you have taken more than the recommended dose of Nefopam Jelfa, contact your doctor. In case of overdose, seizures, excitement, hallucinations, tachycardia, increased body temperature, excessive sweating, and cardiac arrhythmias may occur. In such a situation, seek medical help immediately. Emergency treatment for overdose involves laying the patient on their side, ensuring a clear airway. If the patient is conscious, induce vomiting by giving 1-2 glasses of warm salt water (2 teaspoons of salt in a glass of water). This method is only applicable to adults and children over 12 years old.

Missed dose of Nefopam Jelfa

Do not take a double dose to make up for a missed dose. If you miss a dose of Nefopam Jelfa, take it as soon as possible and continue treatment as before. However, if it is almost time for the next dose, skip the missed dose.

Stopping Nefopam Jelfa

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported with nefopam:

Very common (may affect more than 1 in 10 people)

• nausea, which usually does not lead to vomiting
• excessive sweating

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

• dizziness
• confusion
• excessive stimulation
• insomnia
• anxiety
• loss of appetite
• vision disturbances
• rapid heartbeat (tachycardia)
• dry mouth
• difficulty swallowing
• skin rash
• difficulty urinating
• coma, disorientation

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Medicinal Product Monitoring, 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 You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nefopam Jelfa

Store in a temperature below 25°C. Keep this medicine out of the 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 month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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, macrogol 6000, titanium dioxide, simethicone emulsion.

What Nefopam Jelfa looks like and contents of the pack

Nefopam Jelfa is a white, round, biconvex coated tablet. Nefopam Jelfa is packaged in a blister pack containing 20 coated tablets, placed in a cardboard box.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Bausch Health Ireland Limited 3013 Lake Drive Citywest Business Campus Dublin 24, D24PPT3 Ireland

Manufacturer

Jelfa Pharmaceutical Works SA 58-500 Jelenia Góra, ul. Wincentego Pola 21 For more information, contact the local representative of the marketing authorization holder: Jelfa Pharmaceutical Works SA 58-500 Jelenia Góra, ul. Wincentego Pola 21 tel.: (075) 64 33 100 fax: (075) 75 24 455 e-mail: [email protected]

Date of last revision of the leaflet: