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NEFOPAM HYDROCHLORIDE 30 MG FILM-COATED TABLETS - Patient leaflet, side effects, dosage

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Sources: Original (products.mhra.gov.uk)

Patient leaflet - NEFOPAM HYDROCHLORIDE 30 MG FILM-COATED TABLETS

Nefopam Hydrochloride 30 mg 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 or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm then, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Nefopam Hydrochloride 30 mg film-coated tablets (referred to as Nefopam Tablets throughout this leaflet).

What is in this leaflet:

  • 1. What Nefopam Tablets is and what it is used for

  • 2. What you need to know before you take Nefopam Tablets

  • 3. How to take Nefopam Tablets

  • 4. Possible side effects

  • 5. How to store Nefopam Tablets

  • 6. Contents of the pack and other information

1. what nefopam tablets is and what it is used for

Nefopam Tablets 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 Tablets does not stop the pain from happening, but you will not be able to feel the pain as much.

Nefopam Tablets is used to relieve of 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 Tablets should not be used to treat the pain from a heart attack.

2. what you need to know before you take nefopam tablets:do not take nefopam tablets: if you are a child under 12 years old

  • if you have ever had an allergic reaction to nefopam hydrochloride or any of the ingredients resulting in a skin rash, swelling of the face or difficulty in breathing (see section 6. Contents of the pack and other information)
  • if you are taking monoamine oxidase inhibitors (MAOIs) to treat your depression
  • if you have, or have ever had, epilepsy (fits).

Warnings and precautions

If the answer to any of the following is ’yes', you must tell your doctor- your doctor may decide to alter your treatment.

  • Are you pregnant or breast feeding?
  • Do you have severe problems with your liver or kidneys?
  • Do you have, or have you had in the past difficulty passing urine?
  • Are you taking other medicines?
  • Have you previously been diagnosed with glaucoma (increased pressure in the eye)

Other medicines and Nefopam tablets

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without prescription and medicines listed below:

  • Monoamine oxidase inhibitors (known as MAOIs) for depression.

You must tell your doctor if you are taking this medicine.

  • Tricyclic antidepressants for depression
  • Anticholinergics
  • Sympathomimetics

Tell your doctor or dentist if you are taking any of these medicines.

Pregnancy and breast-feeding

Nefopam Tablets should not be taken during pregnancy or while breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine. Please contact your doctor if you become pregnant during your treatment.

Driving and using machines

Nefopam Tablets can cause drowsiness. Do not drive or operate heavy machinery unless you know how Nefopam Tablets affects you.

3. how to take nefopam tabletsdosage for adults:always take nefopam tablets exactly as your doctor has told you.

The usual 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.

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 Swallow your tablets with water.

Dosage for children:

Over 12 years – as per adults (see above).

Under 12 years – Nefopam Tablets should not be taken by children under 12.

Dosage for older patients:

In older 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 Tablets depending upon your condition.

If you take more Nefopam Tablets than you should

If you accidentally take more tablets than your prescribed dose, tell your doctor or pharmacist immediately and if necessary contact your nearest hospital casualty department. Remember to take the pack and any remaining medicines with you.

If you forget to take Nefopam Tablets

If you forget to take Nefopam Tablets, take it as soon as you remember. Do not take more than one dose at the same time to make up for the forgotten dose.

If you stop taking Nefopam Tablets

Do not stop taking Nefopam Tablets without first checking with your doctor.

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

4. possible side effects

Like all medicines Nefopam Tablets can cause side effects, although not everybody gets them.

Please stop taking this medicine and contact your doctor as soon as possible if you experience the following rare reactions:

  • swelling of the skin and soft tissue around the eyes, nose and throat (angioedema), or allergic reactions (anaphylaxis).
  • feeling sick
  • 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
  • convulsions, tremor
  • confusion
  • hallucinations (seeing things that aren’t there).
  • being sick
  • abdominal pain or diarrhoea
  • blurred vision
  • drowsiness
  • sweating
  • trouble sleeping
  • headaches
  • awareness of your heartbeat (palpitations), or a fast heartbeat (tachycardia).
  • confusion

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website:www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store nefopam tablets

Keep your tablets in the original package and out of the sight and reach of children.

Do not use Nefopam Tablets after the expiry date shown on the carton, even if there are some tablets left. Ask your doctor to replace them with a new prescription and take any unused tablets back to the pharmacy.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to threw away medicines you no longer use.

These measures will help to protect the environment.

6. contents of the pack and other informationdescription and contents of nefopam tablets the active substance is nefopam hydrochloride. each film-coated tablet contains nefopam hydrochloride 30 mg

  • The other ingredients are: Calcium hydrogen phosphate dehydrate, Microcrystalline cellulose, Hypromellose, Colloidal anhydrous silica, Magnesium stearate

What Nefopam Tablets looks like and contents of the pack

Nefopam Tablets are white round film-coated tablets, marked with ‚30N‘ on one side and smooth on other side.

Nefopam Tablets is available in Blister packs of PVC- Aluminium foil, containing 10 tablets in a 10, 20, 30, 50, 60, 90 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:

The Marketing Authorisation Holder for your tablet is:

RIA Generics Limited.,

36 Ingleby Way,

Wallington, Surrey, England

SM6 9LR, United Kingdom

Manufacturer:

Wave Pharma Limited,

4th Floor Cavendish House, 369 Burnt Oak,

Edgware, Middlesex, HA85AW, UK

If you would like this leaflet in different format information or want to report any side effects please contact marketing authorisation holder listed above.

This leaflet was last revised in December 2019.

Page 6 of 6

Sources: Original (products.mhra.gov.uk)

The drug is classified in the ATC tree:

N NERVOUS SYSTEM DRUGS

N02 ANALGESICS

N02B OTHER ANALGESICS AND ANTIPYRETICS in ATC

N02BG Other analgesics and antipyretics in ATC

N02BG06 nefopam

Frequently Asked Questions

What is Nefopam Hydrochloride used for?

Nefopam Hydrochloride is primarily used to relieve moderate pain. It can be prescribed for various types of pain, including post-surgical pain, and is often used when other pain relief options are insufficient.

How does Nefopam work in the body?

Nefopam works by inhibiting the reuptake of certain neurotransmitters in the brain, which helps to block pain signals. It affects serotonin, norepinephrine, and dopamine pathways.

What are the common side effects of Nefopam Hydrochloride?

Common side effects may include nausea, dizziness, dry mouth, and sweating. If you experience severe side effects or allergic reactions, seek medical attention promptly.

Can Nefopam be taken with other medications?

Always consult your healthcare provider before combining Nefopam with other medications, especially antidepressants or other pain relievers, to avoid potential interactions.

Is Nefopam Hydrochloride safe during pregnancy?

The safety of Nefopam during pregnancy has not been well-studied. Consult your doctor if you are pregnant or planning to become pregnant before using this medication.

How should I take Nefopam Hydrochloride tablets?

Nefopam tablets should be taken orally with water. Follow your doctor's instructions regarding dosage and frequency to ensure safe and effective treatment.

What should I do if I miss a dose of Nefopam?

If you miss a dose of Nefopam, take it as soon as you remember. If it's close to your next scheduled dose, skip the missed dose and continue with your regular dosing schedule.

Can I drive after taking Nefopam Hydrochloride?

Nefopam may cause drowsiness or dizziness in some individuals. It's important to assess how you feel before driving or operating heavy machinery after taking this medication.

What happens if I take too much Nefopam?

Overdose symptoms may include confusion, agitation, fever, hallucinations, or seizures. If you suspect an overdose, seek emergency medical help immediately.

Is it safe to drink alcohol while taking Nefopam?

Drinking alcohol while taking Nefopam is not recommended as it may increase the risk of side effects like drowsiness and dizziness.

How long does it take for Nefopam Hydrochloride to start working?

Most patients begin to feel relief from pain within 30 minutes to 1 hour after taking Nefopam, although this can vary by individual.

Can children use Nefopam Hydrochloride tablets?

Nefopam is generally not recommended for children under 12 years old. Consult your pediatrician for appropriate pain management options for children.

How long can I take Nefopam Hydrochloride safely?

Your doctor will determine the appropriate duration based on your specific condition. Long-term use should be monitored closely due to potential side effects.

Are there any alternatives to Nefopam for pain relief?

Yes, there are many alternatives including NSAIDs like ibuprofen or acetaminophen. Speak with your healthcare provider about which option might be best for you.

Will Nefopam affect my mood or mental health?

Some patients report mood changes while taking Nefopam; however, it is not classified as an antidepressant and its main function is pain relief.

Should I stop taking other pain medications when using Nefopam?

Do not stop any prescribed medication without first consulting with your healthcare provider; they can help you establish a safe plan.

Does Nefopam cause weight gain or loss?

Weight changes are not commonly associated with Nefopam use; however, any unexpected changes should be discussed with your doctor.

Can I use Nefopam for chronic pain conditions like arthritis?

Nefopam may help manage certain types of chronic pain; however, always discuss with your healthcare provider before starting any new medication for chronic conditions.

What should I do if I experience unusual side effects while taking Nefopam?

Contact your doctor immediately if you experience unusual symptoms such as increased heart rate, severe headaches, or any significant changes in your health while on this medication.