500 mg / 30 mg effervescent tablet
paracetamol and codeine phosphate hemihydrate
What Paracetamol / Codeine Evolan is and what it is used for
Paracetamol / Codeine Evolan contains two painkillers ( paracetamol and codeine ), which work in different ways. Paracetamol has both analgesic and antipyretic effects. Codeine belongs to a group of drugs called opioid analgesics that work by relieving pain. It can be used alone or in combination with other painkillers such as paracetamol.
Paracetamol / Codeine Evolan is used for aches and pains of various kinds.
Paracetamol and codeine contained in Paracetamol / Codeine Evolan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you use Paracetamol / Codeine Evolan
Do not use Paracetamol / Codeine Evolan
- if you are allergic to paracetamol, codeine, or any of the other ingredients of this medicine (listed in section 6)
- if you know that you are very fast converting codeine to morphine
- if you are breast-feeding
- if you suffer from biliary tract problems.
Warnings and cautions
- Never take more Paracetamol / Codeine Evolan tablets than those listed in section 3 “How to use Paracetamol / Codeine Evolan”. If you are taking other painkillers that contain paracetamol, do not use Paracetamol / Codeine Evolan without first talking to a doctor or pharmacist.
- Higher doses than those recommended do not provide better pain relief but instead entail a risk of impaired respiratory function and very serious liver damage. The symptoms of liver damage usually come only after a few days. It is therefore important that you 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.
Talk to your doctor before using Paracetamol / Codeine Evolan:
- if you have asthma. Take special care with Paracetamol / Codeine Evolan if you have asthma and at the same time are hypersensitive to acetylsalicylic acid.
- if you have alcohol problems.
- if you have liver damage.
- if you have a serious infection such as blood poisoning, this can increase the risk of so-called metabolic acidosis. Signs of metabolic acidosis include difficulty breathing (deep inhalation and rapid exhalation), nausea, and vomiting. Contact a doctor immediately if you get a combination of these symptoms.
Do not use Paracetamol / Codeine Evolan with alcohol.
If you use Paracetamol / Codeine Evolan for a long time, there is a risk of developing an addiction.
Due to their sodium content, effervescent tablets are not suitable for people on a low-salt diet.
Codeine is converted to morphine in the liver by an enzyme. It is morphine that provides pain relief. Some people have different variants of this enzyme that allow them to be affected in different ways. Some people cannot form morphine or it is formed in very small amounts, which means that you do not get enough pain relief. Other people have an increased risk of getting serious side effects because they can produce a very large amount of morphine. If you get any of the following side effects, you must stop taking this medicine and contact a doctor immediately: slow or shallow breathing, confusion, drowsiness, small pupils, nausea or vomiting, constipation, and loss of appetite.
Children and young people
Paracetamol / Codeine Evolan is not approved for the treatment of children and adolescents under 18 years of age.
Use of other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines / herbal medicines can affect or be affected by treatment with Paracetamol / Codeine Evolan, for example:
- Quinidine (medicine for irregular heartbeat)
- Neuroleptics (medicines for mental illness)
- Antidepressants
- Warfarin (a blood thinner). Contact your doctor if you take more than 2 tablets of Paracetamol / Codeine Evolan per day for 5 consecutive days. There is a risk that the effect of warfarin will be affected.
- Probenecid (medicine for gout )
- Certain medicines for epilepsy ( phenytoin, phenobarbital, and carbamazepine)
- Rifampicin (a medicine used to treat tuberculosis )
- Cholestyramine (medicine for high blood fats). Paracetamol / Codeine Evolan and cholestyramine should be taken at least 1 hour apart.
- Chloramphenicol for injection (medicine for bacterial infections). However, chloramphenicol against infection in your eye can be used.
- St. John’s wort extract (included in some (traditional) herbal and herbal remedies)
- Metoclopramide (nausea medicine).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Taking Paracetamol / Codeine Evolan should be avoided by women who are planning to become pregnant or are pregnant. Treatment during any part of the pregnancy should only be done after a doctor’s prescription.
Do not take Paracetamol / Codeine Evolan if you are breastfeeding. Codeine and morphine pass into breast milk.
Driving and using machines
Paracetamol / Codeine Evolan can impair the ability to react and make you tired and drowsy, which you should keep in mind at times when sharpened attention is required, for example when driving a car and precision work.
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.
Paracetamol / Codeine Evolan contains lactose, sodium and sorbitol
Among the other ingredients in Paracetamol / Codeine Evolan, an effervescent tablet is a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains 316 mg sodium (the main ingredient in table salt/table salt) per effervescent tablet. This corresponds to 16% of the maximum recommended daily sodium intake for adults. Consult your doctor or pharmacist if you need 1 or more effervescent tablets daily for an extended period, especially if you have been prescribed a low-salt (sodium-poor) diet.
This medicine contains 80 mg sorbitol per effervescent tablet. Sorbitol is a source of fructose. If you (or your child) cannot tolerate certain sugars, or if you (or your child) have been diagnosed with hereditary
fructose intolerance, a rare, inherited disease that prevents you from breaking down fructose, talk to your doctor before using this medicine.
How to use Paracetamol / Codeine Evolan
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Note! Higher doses than those recommended can pose serious risks.
The recommended dose for adults: 1-2 effervescent tablets 1-4 times a day. Take a maximum of 8 tablets per day.
Use for children and adolescents
Paracetamol/codeine Evolan is not approved for the treatment of children and adolescents under 18 years of age.
Dissolve the effervescent tablets in a glass of water.
If you use more Paracetamol / Codeine Evolan than you should
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, always contact a doctor or hospital for risk assessment and advice. There is a risk of liver damage even if you feel well. To prevent possible liver damage, the antidote must be inserted by a doctor as early as possible.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Paracetamol / Codeine Evolan and contact a doctor immediately if you get any of the following symptoms ( angioedema ). A rare side effect (may affect up to 1 in 1,000 people).
- swelling of the face, tongue, or throat
- difficulty swallowing
- hives, and difficulty breathing.
Common (may affect up to 1 in 10 people) : Fatigue, nausea, constipation.
Uncommon (may affect up to 1 in 100 people): Bile duct cramps may occur in people who are prone to this.
Rare (may affect up to 1 in 1,000 people): Skin rash, liver damage, impaired kidney function, allergic reactions such as hives, swelling of the face, lips, tongue, or throat, sometimes with shortness of breath or difficulty swallowing ( angioedema ).
Very rare (may affect up to 1 in 10,000 people): Inflammation of the pancreas.
Very rare cases of severe skin reactions have been reported.
In case of allergic reactions, you should stop taking Paracetamol / Codeine Evolan and consult a doctor.
If you use Paracetamol / Codeine Evolan for a long time, the risk of kidney damage can not be completely ruled out.
Liver damage can occur with the use of paracetamol in connection with alcohol abuse.
How to store Paracetamol / Codeine Evolan
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. data. The expiration date is the last day of the specified month.
Store in the original package. Close the tube tightly. Moisture sensitive.
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 paracetamol 500 mg and codeine phosphate hemihydrate 30 mg per tablet.
- The other ingredients are povidone, sodium bicarbonate, anhydrous citric acid, sorbitol, lactose monohydrate, saccharin sodium, ascorbic acid, L-leucine, flavoring (lemon).
What the medicine looks like and the contents of the pack
Effervescent tablet one is white, round, flat with a break notch on one side. Diameter 23 mm.
Plastic pipe with desiccant in the plastic lid. Pack sizes: 20 tablets and 100 (5 × 20) tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Evolan Pharma AB
Box 120
182 12 Danderyd
Manufacturer:
SMB Technology SA
Rue du Parc Industriel 39
6900 Marche-en-Famenne
Belgium