Acupan

Main information

  • Trade name:
  • Acupan 30 mg Tablet
  • Dosage:
  • 30 mg
  • Pharmaceutical form:
  • Tablet
  • Units in package:
  • Blister pack, 1x10, 10 tablets
  • Class:
  • Prescription
  • Prescription type:
  • Prescription
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • Orgapharm SAS

Documents

Localization

  • Available in:
  • Acupan 30 mg Tablet
    New Zealand
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • ACUPAN is indicated for the relief of acute pain, including post-operative, dental, musculo-skeletal and acute traumatic pain.

Other information

Status

  • Source:
  • Medsafe - Medicines Safety Authority - New Zealand
  • Authorization number:
  • 2482
  • Authorization date:
  • 15-05-1980
  • Last update:
  • 09-05-2018

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

ACUPAN

Consumer Medicine Information

ACUPAN™

Nefopam hydrochloride

30 mg tablets

What is in this leaflet

This leaflet answers some common questions about ACUPAN tablets. However,

it does not contain all the available information. It does not take the place of

talking to your doctor or pharmacist. If you have any questions about

ACUPAN that are not answered by this leaflet, ask your doctor or

pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you

taking ACUPAN against the benefits before prescribing it to you. If you are

worried about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with your medicine as you may want to read it again.

What ACUPAN is used for

The name of your medicine is ACUPAN. ACUPAN belongs to a group of

medicines called analgesics, commonly known as pain killers or pain relievers. It

contains nefopam hydrochloride as the active ingredient. 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 ACUPAN does not stop

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

ACUPAN is used to relieve both short term pain and long lasting pain (for

example pain after an operation, dental pain, joint or muscle pain or after an

injury). ACUPAN should not be used to treat the pain from a heart attack.

Ask your doctor if you have any questions about why this medicine has

been prescribed for you.

Your doctor may have prescribed ACUPAN for another purpose.

ACUPAN

Before you take ACUPAN

When you must not take it

Do not take ACUPAN if you have an allergy to:

Any medicine containing nefopam

Any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

Shortness of breath

Wheezing or difficulty breathing

Swelling of the face, lips, tongue, or other parts of the body

Rash, itching, or hives on the skin.

Do not use this medicine for the treatment of a heart attack.

Do not use this medicine if you:

have a history of epilepsy (fits)

are taking a medicine called a monoamine oxidase inhibitor (MAOI) to

treat depression.

Do not give this medicine to a child under 12 years old.

Safety and effectiveness in children younger than 12 years have not been

established.

Do not use ACUPAN after the expiry date printed on the pack has passed

or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

Before you start to take ACUPAN

Tell your doctor if you:

have allergies to any other medicines, foods, preservatives or dyes

have any heart problems

have an eye condition called glaucoma

have any liver or kidney problems, including difficulty passing urine

are pregnant or plan to become pregnant

are breastfeeding.

If you are not sure whether to start taking this medicine, talk to your doctor.

ACUPAN

Taking Other Medicines

Tell your doctor or pharmacist if you are taking any other medicines,

including any that you buy without a prescription from your pharmacy,

supermarket or health-food shop.

Some medicines may be affected by ACUPAN. These include:

Monoamine oxidase inhibitors (known as MAOIs) for depression

Tricyclic antidepressants for depression

Anticholinergics for relief of stomach cramps or spasms

Sympathomimetic agents (e.g. pseudoephedrine)

Alcohol and other central nervous system depressants.

You may need different amounts of your medicines, or you may need to take

different medicines. Your doctor or pharmacist has more information on

medicines to be careful with or to avoid while taking ACUPAN.

How to take ACUPAN

Carefully follow all directions given to you by your doctor or pharmacist.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack ask your doctor or

pharmacist for help.

How much to take

Adults: The usual dose is 1 – 3 tablets three times a day. The recommended

starting dose is 2 tablets three times a day.

ACUPAN may be taken with or without food. Your doctor will prescribe the

correct dose for you.

Take ACUPAN only as directed by your doctor or pharmacist. Do not

change the dose or stop taking ACUPAN unless your doctor tells you to do

so.

If you forget to take your medicine

If you miss a dose and remember within an hour of the missed dose, take it right

away. If you do not remember until later, skip the missed dose and go back to

taking it as you would normally.

ACUPAN

Do not take more than one dose at the same time to make up for the

forgotten dose.

While you are taking ACUPAN

Things you must do

Tell all doctors, dentists and pharmacists who are treating you that you are

taking ACUPAN.

Tell your doctor immediately if you become pregnant while taking

ACUPAN.

Do not drive or operate heavy machinery until you know how ACUPAN

affects you.

ACUPAN may cause blurred vision or make you feel drowsy, dizzy, light-headed

or less alert than usual.

ACUPAN may cause a dry mouth in some people. For temporary relief chew

sugarless gum, suck on an ice cube or use a saliva substitute.

Talk to your dentist if a dry mouth continues.

Continued dry mouth may increase the chance of dental disease, including tooth

decay, gum disease and fungal infections.

Things you must not do

Do not give ACUPAN to anyone else even if they have the same condition

as you.

Do not take ACUPAN to treat any other complaints unless your doctor tells

you to.

Side Effects

All medicines can cause unwanted side effects. Sometimes they are serious,

most of the time they are not.

Talk to your doctor if any of the following side effects occur and they worry

you:

More common: Nausea, nervousness, dry mouth, lightheadedness and difficulty

passing urine.

ACUPAN

Less common: Vomiting, blurred vision, drowsiness, sweating, insomnia,

headache, confusion, seeing, feeling or hearing things that are not there, rapid

heartbeat and worsening of chest pain.

Rarely a temporary harmless pink discolouration of the urine may occur.

Tell your doctor immediately, or go to the Emergency Department at your

nearest hospital if you notice any of the following:

Signs of allergy such as rash or hives, swelling of the face, lips, tongue or throat,

wheezing or difficulty breathing or swallowing.

These symptoms are usually rare but may be serious and need urgent medical

attention.

Tell your doctor or pharmacist if you notice anything else that is making

you feel unwell.

Other side effects not listed above may also occur in some people.

If you take too much (Overdose)

Immediately telephone your doctor or the National Poisons Information

Centre (0800 POISON or 0800 764 766) for advice, or go to the Emergency

Department your nearest hospital if you think that you or anyone else may

have taken too much ACUPAN. Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical attention. Symptoms of an overdose include

agitation, seeing, feeling or hearing things that are not there, fits or seizures, fast

heartbeat and coma.

After taking ACUPAN

Storage

Keep ACUPAN in a cool dry place where the temperature stays below 25°C.

Do not store it or any other medicine in the bathroom or near a sink. Do not

leave it on a window sill or in the car.

Keep all medicines where children cannot reach them.

A locked cupboard at least 1.5 metres above the ground is a good place to store

medicines.

ACUPAN

Disposal

If your doctor tells you to stop taking this medicine, or it has passed its expiry

date, ask your pharmacist what to do with any tablets left over.

Product Description

What it looks like

ACUPAN are white, round tablets with APN marked on one side. It comes in a

blister pack containing 90 tablets.

Ingredients

Each ACUPAN tablet contains nefopam hydrochloride as the active ingredient.

ACUPAN also contains the following inactive ingredients:

Magnesium stearate

Calcium hydrogen phosphate

Hydrogenated vegetable oil

Microcrystalline cellulose

Pregelatinised maize starch

Colloidal silicon dioxide

Hypromellose

Titanium dioxide

ACUPAN contains no preservatives, sugar, gluten or lactose.

Supplier

iNova Pharmaceuticals (New Zealand) Limited

c/- Simpson Grierson

88 Shortland Street,

Auckland 1141

Telephone: Toll-free 0508 375 394

ACUPAN

Date of Preparation

29 January 2018

TM: Trademark

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28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fenfluramine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0177/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Opinion/decision on a Paediatric investigation plan (PIP): Mexiletine (hydrochloride), decision type: , therapeutic area: , PIP number: P/0210/2018

Europe - EMA - European Medicines Agency

28-11-2018

Econor (Elanco GmbH)

Econor (Elanco GmbH)

Econor (Active substance: Valnemulin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)8038 of Wed, 28 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/42/T/54

Europe -DG Health and Food Safety

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-guanidino-1-hexanone hexahydrochloride, decision type: , therapeutic area: , PIP number: P/0134/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Europe - EMA - European Medicines Agency

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

21-11-2018

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Takeda Pharma A/S)

EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18

Europe -DG Health and Food Safety

15-11-2018

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Samsung Bioepis NL B.V.)

Flixabi (Active substance: infliximab) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)7549 of Thu, 15 Nov 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4020/T/30

Europe -DG Health and Food Safety

13-11-2018

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Zogenix GmbH)

EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01

Europe -DG Health and Food Safety

13-11-2018

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Zogenix GmbH)

EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01

Europe -DG Health and Food Safety

1-11-2018

Dexdomitor (Orion Corporation)

Dexdomitor (Orion Corporation)

Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018

Europe -DG Health and Food Safety

31-10-2018

Evista (Daiichi Sankyo Europe GmbH)

Evista (Daiichi Sankyo Europe GmbH)

Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018

Europe -DG Health and Food Safety

30-10-2018

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Akcea Therapeutics UK Ltd)

EU/3/14/1250 (Active substance: Phosphorothioate oligonucleotide targeted to transthyretin) - Transfer of orphan designation - Commission Decision (2018)7282 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/098/13/T/01

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Freeline Therapeutics Ltd)

EU/3/18/2080 (Active substance: Recombinant adeno-associated viral vector serotype S3 containing codon-optimised expression cassette encoding human coagulation factor IX variant) - Orphan designation - Commission Decision (2018)7281 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/127/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Spark Therapeutics Ireland Ltd)

EU/3/18/2079 (Active substance: Recombinant adeno-associated viral vector containing a bioengineered capsid and a codon-optimised expression cassette to drive the expression of the SQ form of a B-domain deleted human coagulation factor VIII) - Orphan designation - Commission Decision (2018)7280 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/104/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Sellas Life Sciences Limited)

EU/3/18/2078 (Active substance: Peptides YMFPNAPYL, SGQAYMFPNAPYLPSCLES, RSDELVRHHNMHQRNMTKL and PGCNKRYFKLSHLQMHSRKHTG) - Orphan designation - Commission Decision (2018)7279 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/091/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Worphmed Srl)

EU/3/18/2077 (Active substance: Melatonin) - Orphan designation - Commission Decision (2018)7278 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/077/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Consorcio Centro de InvestigaciOn BiomEdica en Red M.P.)

EU/3/18/2075 (Active substance: Gefitinib) - Orphan designation - Commission Decision (2018)7276 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (PhaRA bvba)

EU/3/18/2074 (Active substance: Avapritinib) - Orphan designation - Commission Decision (2018)7275 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/079/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Fondazione Telethon)

EU/3/18/2073 (Active substance: Autologous CD34+ haematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the alpha-L-iduronidase cDNA) - Orphan designation - Commission Decision (2018)7274 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/113/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Loxo Oncology Limited)

EU/3/18/2071 (Active substance: 6-(2-hydroxy-2-methylpropoxy)-4-(6-(6-((6-methoxypyridin-3-yl)methyl)-3,6-diazabicyclo[3.1.1]heptan-3-yl)pyridin-3-yl)pyrazolo[1,5-a]pyridine-3-carbonitrile) - Orphan designation - Commission Decision (2018)7272 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/125/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (FGK Representative Service GmbH)

EU/3/18/2072 (Active substance: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-alpha-L-talofuranosyl)-paromamine sulfate) - Orphan designation - Commission Decision (2018)7273 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/102/18

Europe -DG Health and Food Safety

30-9-2018

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Daiichi Sankyo Europe GmbH)

Roteas (Active substance: edoxaban) - PSUSA - Modification - Commission Decision (2018)5089 of Sun, 30 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/PSUSA/10387/201710

Europe -DG Health and Food Safety

26-9-2018

Sileo (Orion Corporation)

Sileo (Orion Corporation)

Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018

Europe -DG Health and Food Safety

17-9-2018

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction.   Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the c

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction. Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the c

Reminder: the FDA is accepting applications through Sept. 30, 2018, for the #FDAInnovationChallenge for devices to help combat #opioid addiction. Submissions will be evaluated based on the feasibility, potential public health impact and novelty of the concept.

FDA - U.S. Food and Drug Administration