35 mg / 450 mg tablets
orphenadrine citrate and paracetamol
What Norgesic is and what it is used for
Norgesic is a combination preparation that has a muscle-relaxing, analgesic, and antipyretic effect.
Norgesic is used to relieve muscle pain in connection with sprains, sprains, muscle injuries, certain infectious diseases, connective tissue inflammation, spinal cord injuries, sore throats, skeletal injuries, and stress headaches. Norgesic is also used for menstrual problems.
What you need to know before using Norgesic
Do not use Norgesic:
- if you are allergic to orphenadrine citrate or paracetamol or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Norgesic:
- if you have palpitations
- if you have an enlarged prostate
- if you have glaucoma ( glaucoma )
If you have a shallow anterior chamber of the eye and a narrow ventricular angle, the treatment may trigger an attack of acute glaucoma caused by pupil dilation, but this condition is very uncommon.
Never take more Norgesic than your doctor has recommended. If you are taking other painkillers that contain paracetamol, do not use Norgesic without first talking to a doctor or pharmacist.
Higher doses than those recommended do not provide better pain relief but carry the risk of very serious liver damage. The symptoms of liver damage usually come only after a few days. Therefore, you must contact a doctor as soon as possible if you have taken too large a dose.
The risk of this type of liver damage increases with alcohol abuse. Always tell your doctor if you have alcohol problems or liver damage. The intoxicating effect of alcohol does not increase with the addition of Norgesic.
Do not use Norgesic without a doctor’s prescription if you have alcohol problems or liver damage, nor use Norgesic with alcohol.
Other medicines and Norgesic
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines.
Norgesic may affect or be affected if taken at the same time as certain other medicinal substances:
- warfarin (blood-thinning drug). Single doses of Norgesic are not considered to affect the effect of warfarin .
- chloramphenicol (drug for bacterial infections)
- probenecid (anti- gout medicine )
- phenytoin , phenobarbital and carbamazepine (antiepileptic medicines )
- antihistamines (medicines for allergies )
- antispasmodics (medicines for certain intestinal problems)
- tricyclic antidepressants (antidepressants)
- MAO inhibitors (antidepressants and Parkinson’s disease )
- phentiazines (medicines for mental illness)
- dopaminergic antiparkinsonian drugs including amantidine (medicines used to treat Parkinson’s disease)
- antiarrhythmic drugs such as disopyramide (medicines for irregular heartbeat).
- alcohol may reduce the effect of Norgesic
- Norgesic may reduce the motility of the gastrointestinal tract and thereby affect the uptake of other oral drugs.
- opioids (morphine-like drugs) as they may cause drowsiness and impaired breathing
Pregnancy and breastfeeding
Use during pregnancy and lactation is not recommended.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
During treatment with Norgesic, the ability to react may be reduced. This should be taken into account when sharper attention is required, for example when driving a car.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. How to use Norgesic
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by your doctor who adjusts it individually for you.
The usual dose for adults is 2 tablets 3 times daily.
If you have the impression that the effect of Norgesic is too strong or too weak, talk to your doctor or pharmacist.
Note! Higher doses than those recommended carry a risk of very serious liver damage.
If you have used too much Norgesic
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
The symptoms of liver damage usually come only after a few days. Therefore, you must contact a doctor as soon as possible if you have taken too large a dose.
If you forget to use Norgesic:
Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, Norgesic can cause side effects, although not everybody gets them.
Stop taking Norgesic and contact a doctor immediately if you get any of the following symptoms ( angioedema )
- swelling of the face, tongue or throat
- difficulty swallowing
- hives and difficulty breathing.
Common (may affect up to 1 in 10 people): Fatigue, dizziness, nausea, blurred vision, and dry mouth.
Rare (may affect up to 1 in 1,000 people): Hives, itching, angioedema, liver damage, increased amounts of creatinine (a substance that reflects kidney function).
Very rare (may affect up to 1 in 10,000 people): Severe skin reactions, hallucinations, confusion, tremors, difficulty adjusting the eye, palpitations, constipation, and difficulty urinating.
Liver damage when using paracetamol has occurred in connection with alcohol abuse. With long-term use, the risk of kidney damage can not be completely ruled out.
How Norgesic should be stored
Keep this medicine out of the sight and reach of children and adolescents.
Do not use this medicine after the expiry date which is stated on the carton after EXP. Dat or EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substances are: orphenadrine citrate and paracetamol .
- The other ingredients are: microcrystalline cellulose, pregelatinized maize starch, magnesium stearate and colloidal silica.
What the medicine looks like and contents of the pack
Tablets packed in 30 pcs in a blister pack or 100 pcs in the blister pack.
Marketing Authorisation Holder
Meda AB, Box 906, 170 09 Solna
Tel: 08-630 19 00
Email: info@medasverige.se
Manufacturer
MEDA Pharma GmbH & Co. KG
Benzstraße 1
61352 Bad Homburg
Germany
CANA SA Pharmaceuticals Laboratories
Irakliou Ave. 446
Heraklion Attiki 14122
Greece
Fine Foods & Pharmaceuticals NTMSpA
Via Grignano 43
24041 Brembate
Italy