NEFOPAM 30 mg Tablets

Contents of the leaflet

1. B. PATIENT INFORMATION LEAFLET
2. Leaflet accompanying the packaging: information for the user
3. Nefopam Holsten, 30 mg, coated tablets
   1. You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Nefopam Holsten and what is it used for
5. Important information before taking Nefopam Holsten
   1. When not to take Nefopam Holsten:
   2. Warnings and precautions
   3. Children
   4. Nefopam Holsten and other medicines
   5. Nefopam Holsten with food, drink, or alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
6. How to take Nefopam Holsten
   1. Adults:
   2. Use in children:
   3. Taking a higher dose of Nefopam Holsten than recommended
   4. Overdose of Nefopam Holsten may result in the occurrence of psychiatric or neurological symptoms (seizures, hallucinations, and agitation) and cardiac symptoms (rapid heart rate or tachycardia).
   5. Missing a dose of Nefopam Holsten
   6. Stopping treatment with Nefopam Holsten
7. Possible side effects
   1. Very common side effects (may occur in more than 1 in 10 people):
   2. Common side effects (occur in 1 to 10 in 100 people):
   3. Rare side effects (may occur in up to 1 in 1000 people):
   4. Reporting side effects
8. How to store Nefopam Holsten
9. Contents of the pack and other information
   1. What Nefopam Holsten contains
   2. What Nefopam Holsten looks like and contents of the pack
   3. Marketing authorization holder and manufacturer: Marketing authorization holder
   4. This medicine is authorized in the Member States of the European Economic Area under the following names:
   5. For more detailed information on this medicine, you should contact the marketing authorization holder.
   6. Date of last revision of the leaflet: 12.2023

B. PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the user

Nefopam Holsten, 30 mg, coated tablets

Nefopam hydrochloride

You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

The active substance of Nefopam Holsten is nefopam hydrochloride - a pain-relieving medicine that acts on the central nervous system. This medicine is not related to morphine-like pain-relieving medicines (morphine-containing pain-relieving medicines) or aspirin.

Nefopam Holsten is indicated for the relief of moderate or severe pain, such as:

• muscle pain;
• post-operative pain;
• joint pain;
• pain caused by cancer;
• toothache.

Treatment only concerns pain relief. It does not cure the underlying cause of the disease.

2. Important information before taking Nefopam Holsten

When not to take Nefopam Holsten:

• if you are allergic to nefopam or any of the other ingredients of Nefopam Holsten (listed in section 6);
• if you are taking monoamine oxidase inhibitor medicines (medicines that may be used to treat symptoms of depression, panic attacks, social phobia, Parkinson's disease);
• if you have had seizures (epilepsy);
• if you have liver or kidney function disorders.

Warnings and precautions

Before taking the medicine, you should inform your doctor or pharmacist:

• if you experience anxiety;
• if your heart rate is faster than usual (tachycardia) or if you have had a heart attack; in such a case, your doctor will consult a cardiologist;
• if you have glaucoma (increased pressure inside the eye);
• if your prostate gland is enlarged (hyperplasia) or if you have difficulty urinating (urinary retention);
• if you are taking other medicines. You should also read the section "Nefopam Holsten and other medicines";
• if you are elderly; a dose reduction may be necessary. The recommended dose is 1 tablet 3 times a day. Nefopam Holsten is not recommended for children. Cases of dependence and abuse of nefopam have been reported during its use.

You should consult a doctor if you have had or currently have any of the above conditions.

Children

Nefopam Holsten is not recommended for children.

Nefopam Holsten and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken.

Nefopam is contraindicated if you are taking monoamine oxidase inhibitor medicines, such as selegiline, tranylcypromine, or others (medicines used to treat symptoms of depression, panic attacks, social phobia, Parkinson's disease).

The side effects of Nefopam Holsten may be intensified if you are taking other medicines with a similar effect on the central nervous system.

There are many medicines whose depressant effect on the central nervous system may be additive and lead to impaired alertness. These medicines include morphine derivatives (pain-relieving medicines, cough medicines), barbiturates, benzodiazepines, anxiolytics, sedatives, certain antidepressants, certain antihistamines, certain antihypertensives, and baclofen.

Nefopam may affect some benzodiazepine and opioid tests. These tests may give false-positive results in patients taking Nefopam Holsten.

The severity and frequency of side effects increase if Nefopam Holsten is used simultaneously with other pain-relieving medicines, such as codeine, pentazocine, or dextropropoxyphene.

Nefopam Holsten with food, drink, or alcohol

Not applicable.

Pregnancy and breastfeeding

There are no data on the use of nefopam in pregnant women.

Nefopam Holsten should not be used during pregnancy, unless the clinical situation of the woman justifies treatment with nefopam.

Nefopam Holsten passes into breast milk. Nefopam Holsten should not be used during breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine.

Driving and using machines

You should not drive or operate machinery if you experience any of the following symptoms:

• dizziness;
• nausea;
• drowsiness;
• vision problems.

3. How to take Nefopam Holsten

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.

Adults:

The usual dose is 1 tablet 3 times a day, and the initial dose is 2 tablets. About 6 hours after the first dose, treatment can be continued with 1 tablet 3 times a day.

If the pain does not subside, you should contact your doctor. It may be recommended to increase the dose to 2 tablets 3 times a day. You should never take more than 3 tablets at the same time. Therefore, you should never take more than 3 tablets 3 times a day (= 9 tablets).

Taking the tablets with 3 meals a day will allow for regular dosing of the medicine. This will help you remember to take Nefopam Holsten.

Use in children:

Nefopam Holsten is not recommended for children.

Taking a higher dose of Nefopam Holsten than recommended

If you take a higher dose of Nefopam Holsten than recommended, you should tell your doctor or pharmacist or contact the emergency department of the nearest hospital. You should remember to take the packaging and any remaining medicine with you.

Overdose of Nefopam Holsten may result in the occurrence of psychiatric or neurological symptoms (seizures, hallucinations, and agitation) and cardiac symptoms (rapid heart rate or tachycardia).

If your heart rate accelerates significantly after taking too much Nefopam Holsten, hospitalization may be necessary. You should inform your doctor. Your doctor may administer diazepam and supportive measures.

Missing a dose of Nefopam Holsten

If you miss a dose of Nefopam Holsten, you should take the next dose during the next meal. You should not take a double dose to make up for the missed dose.

Stopping treatment with Nefopam Holsten

You should never stop taking Nefopam Holsten on your own. It is very likely that the pain will return. Stopping treatment should always be discussed with your doctor.

If you have any further questions about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

Side effects that may require immediate medical attention:

• Allergic reactionsoccur frequently (may occur in up to 1 in 10 people). If you experience an allergic reaction (itching, hives, skin redness, malaise, etc.), you should contact your doctor immediately.
• Faintingoccurs rarely (may occur in up to 1 in 1000 people). You should inform your family that such a side effect may occur, and that they should contact a doctor if it happens.

Very common side effects (may occur in more than 1 in 10 people):

• Drowsiness.If you experience this side effect, you should not drive or operate machinery.
• Sweating.
• Nausea.
• Vomiting.

Common side effects (occur in 1 to 10 in 100 people):

• • Faster heart rate than usual (tachycardia).
• • Irregular heartbeat (arrhythmia).
• • Low blood pressure (hypotension).
• • Dry mouth
• • Abdominal pain.
• • Diarrhea.
• • Dizziness (systemic vertigo, a feeling that you or your surroundings are moving or spinning).
• • Dizziness.
• • False sensations, disturbances of sensation.
• • Tremors.
• • Urinary retention.

Rare side effects (may occur in up to 1 in 1000 people):

• Itching.
• • Hives.
• • Reddening of the skin (flushing).
• • Malaise.
• • Increased sensitivity after surgery.You should immediately report this side effect to medical staff.
• Hallucinations.
• • Seizures.
• • Agitation.
• • Irritability.If you experience such symptoms, you should stop taking this medicine and immediately contact your doctor or pharmacist.
• Abuse and/or dependence.If you have a tendency to abuse drugs or have addiction problems, you should inform your doctor.
• Post-operative disorientation.
• • Vision disturbances.
• • Insomnia.
• • Headache.
• • Impaired kidney function.If you experience decreased kidney function, visible in blood and urine tests, your doctor will provide you with appropriate advice.
• Pink discoloration of urine:this effect is harmless.

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

• • Coma
• • Confusion

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist or nurse.

Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl.

Side effects can also be reported 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 Holsten

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister pack after EXP.

The expiry date refers to the last day of the month stated.

There are no special precautions for storage.

Do not use this medicine if the packaging or any of the tablets is damaged.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Nefopam Holsten contains

• The active substance of Nefopam Holsten is nefopam hydrochloride. Each coated tablet contains 30 mg of nefopam hydrochloride.
• The other ingredients are: Tablet core: microcrystalline cellulose, povidone K30, calcium hydrogen phosphate, copovidone, corn starch, colloidal anhydrous silica, magnesium stearate. Coating: Opadry OY-S-7335: hypromellose (type 2910, 6cP), titanium dioxide (E 171).

What Nefopam Holsten looks like and contents of the pack

Nefopam Holsten is a white, round, biconvex coated tablet with a diameter of 7.1 mm.

The tablets are packaged in PVC/PE/PVDC/Aluminum blisters. The pack contains 30 tablets.

Marketing authorization holder and manufacturer: Marketing authorization holder

Holsten Pharma GmbH

Hahnstraße 31-35

60528 Frankfurt am Main

Germany

Email: [email protected]

Manufacturer

Laboratories BTT

ZI de Krafft

67150 Erstein

France

or

Holsten Pharma GmbH

Hahnstraße 31-35

60528 Frankfurt am Main

Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Estonia: Anefaltic 30 mg õhukese polümeerikattega tabletid

Latvia: Anefaltic 30 mg apvalkotās tabletes

Lithuania: Anefaltic 30 mg plėvele dengtos tabletės

Poland: Nefopam Holsten 30 mg tabletki powlekane

For more detailed information on this medicine, you should contact the marketing authorization holder.

Date of last revision of the leaflet: 12.2023