Package leaflet: Information for the user

Nefopam Holsten, 30 mg, coated tablets
Nefopami hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not pass it on to others. It may harm other people, even if their symptoms are the same as yours.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

What Nefopam Holsten is and what it is used for
What you need to know before taking Nefopam Holsten
How to take Nefopam Holsten
Possible side effects
How to store Nefopam Holsten
Contents of the pack and other information

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

The active substance in Nefopam Holsten is nefopam hydrochloride – an analgesic that acts on the central nervous system. This medicine is not related to morphine-type painkillers (opioid analgesics) or aspirin.

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

muscle pain;
postoperative pain;
joint pain;
pain caused by cancer;
toothache.

This treatment only relieves pain. It does not treat the underlying cause of the disease.

2. Information before using Nefopam Holsten

When not to use Nefopam Holsten:

if the patient is allergic to nefopam or any of the other ingredients of Nefopam Holsten (listed in section 6);
if the patient is taking medicines from the group of monoamine oxidase inhibitors (medicines that may be used to treat symptoms of depression, panic anxiety, social phobia, Parkinson's disease);
if the patient has experienced seizures (epilepsy);
if the patient has impaired liver or kidney function.

Warnings and precautions
Before taking the medicine, inform your doctor or pharmacist:

if the patient experiences anxiety;
if the heartbeat is faster than usual (tachycardia) or if the patient has had a myocardial infarction; in such a case, the doctor will consult a cardiologist;
if the patient has glaucoma (increased pressure inside the eye);
if the prostate gland volume is enlarged (hypertrophy) or if the patient has difficulty urinating (urinary retention);
if the patient is taking other medicines. Please also refer to the section "Nefopam Holsten and other medicines";
if the patient is elderly; dose reduction may be necessary. The recommended dose is 1 tablet three times daily. Nefopam Holsten is not recommended for children. Cases of dependence and abuse of nefopam have been reported during its use.

Consult your doctor if any of the above conditions have occurred in the past or are currently present.
Children
Nefopam Holsten is not recommended for children.
Nefopam Holsten and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken.
Nefopam is contraindicated if the patient is taking medicines from the group of monoamine oxidase inhibitors, such as selegiline, tranylcypromine or others (medicines used to treat symptoms of depression, panic anxiety, social phobia, Parkinson's disease).
Adverse effects of Nefopam Holsten may be intensified if the patient takes 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 reduced alertness. These include morphine derivatives (analgesics, cough medicines), barbiturates, benzodiazepines, anxiolytics, hypnotics, some antidepressants, some antihistamines, some antihypertensives, and baclofen.
Nefopam may interfere with certain tests for benzodiazepines and opioids. These tests may yield false-positive results in patients taking Nefopam Holsten.
The severity and frequency of adverse effects increase if Nefopam Holsten is used concomitantly with other analgesics 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 woman's clinical condition justifies treatment with nefopam.
Nefopam Holsten passes into breast milk. Nefopam Holsten should not be used during breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor before using this medicine.
Driving and operating machinery
Do not drive or operate machinery if any of the following symptoms occur:

dizziness;
nausea;
drowsiness;
vision problems.

3. How to use Nefopam Holsten

This medicine should always be taken exactly as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Adults:
The usual dose is 1 tablet three times daily, with an initial dose of 2 tablets. Approximately 6 hours after
the first dose, treatment may be continued with 1 tablet three times daily.
If pain persists, contact your doctor. An increased dose of up to 2 tablets three times daily may be
recommended. Never take more than 3 tablets at once. Therefore, never take more than 3 tablets three
times daily (= 9 tablets total).
Taking tablets with the three daily meals will ensure regular dosing. This helps the patient remember
to take Nefopam Holsten.
Use in children:
Nefopam Holsten is not recommended for use in children.
Taking more than the recommended dose of Nefopam Holsten
If you have taken more Nefopam Holsten than recommended, inform your doctor or pharmacist, or
contact the emergency department of your nearest hospital. Remember to bring the medicine packaging
and any remaining tablets with you.
Poisoning with Nefopam Holsten may result in psychiatric or
neurological symptoms (seizures, hallucinations, and agitation) as well as cardiovascular symptoms (increased
heart activity or tachycardia).
If heart rate increases significantly after taking too much Nefopam Holsten, hospitalization may be
necessary. Inform your doctor immediately. The doctor may administer diazepam and supportive
treatment.
Missed dose of Nefopam Holsten
If you miss a dose of Nefopam Holsten, take the next dose at the time of your next meal. Do not take a
double dose to make up for a missed dose.
Stopping treatment with Nefopam Holsten
Never stop taking Nefopam Holsten without medical advice. It is very likely that pain will return. Always
consult your doctor before stopping treatment.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.

Adverse reactions which may require immediate medical attention:

Allergic reactions – these are common (may occur in up to 1 in 10 people). If an allergic reaction occurs (itching, hives, skin redness, malaise, etc.), contact a doctor immediately.
Fainting – these are rare (may occur in up to 1 in 1000 people). Inform the patient's family that this adverse reaction may occur and that medical help should be sought immediately if it does.

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

Somnolence (drowsiness). If this adverse reaction occurs, driving or operating machinery must be strictly avoided.
Sweating.
Nausea.
Vomiting.

Common adverse reactions (may affect 1 to 10 in 100 people):

Faster heartbeat than usual (tachycardia).
Palpitations (irregular heartbeat).
Low blood pressure (hypotension).
Dry mouth.
Abdominal pain.
Diarrhea.
Systemic vertigo (sensation that the person or their surroundings are moving or spinning).
Dizziness.
Paraesthesia (false sensations, disturbances of feeling).
Tremor.
Urinary retention.

Rare adverse reactions (may affect up to 1 in 1000 people):

Itching.
Urticaria (hives).
Pink-red skin discoloration (flushing).
Malaise.
Hypersensitivity after surgery. This adverse reaction should be reported immediately to medical staff.
Hallucinations.
Seizures.
Agitation.
Irritability. If these symptoms occur, discontinue use of this medicine and contact a doctor or pharmacist immediately.
Abuse and/or dependence. If there is a history of drug abuse or addiction problems, inform the treating physician.
Postoperative disorientation.
Visual disturbances.
Insomnia.
Impaired kidney function. If reduced kidney function is detected in blood and urine tests, the doctor will provide appropriate advice.
Pink discoloration of urine: this effect is harmless.

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

Coma.
Confusion.

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

5. How to store Nefopam Holsten

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister foil after EXP.
The expiry date refers to the last day of the stated month.
No special storage instructions are required for this medicine.
Do not use this medicine if the packaging or any of the tablets are damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the package and other information

What Nefopam Holsten contains

The active substance in Nefopam Holsten is nefopam hydrochloride. Each coated tablet contains 30 mg of nefopam hydrochloride.
Other ingredients are:
Tablet core: microcrystalline cellulose, povidone K30, calcium hydrogen phosphate, copovidone, pregelatinized corn starch, colloidal anhydrous silica, magnesium stearate.
Coating: hypromellose (type 2910, 6 cP), 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 packed in blisters made of PVC/PE/PVDC/Aluminium. The pack contains 30 tablets.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Holsten Pharma GmbH
Hahnstraße 31-35
60528 Frankfurt am Main
Germany
E-mail: [email protected]

Manufacturer
Holsten Pharma GmbH
Hahnstraße 31-35
60528 Frankfurt am Main
Germany

This medicinal product is authorised 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 medicinal product, please contact the Marketing Authorisation Holder.