500 mg / 30 mg tablets or effervescent tablets are
paracetamol / codeine
What Panocod is and what it is used for
Panocod contains paracetamol and codeine . Paracetamol has a pain-relieving and antipyretic effect.
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.
Panocod tablets and effervescent tablets are used for aches and pains of various kinds in adults.
What you need to know before taking Panocod
Do not take Panocod:
- if you are allergic to paracetamol, codeine, or any of the other ingredients of this medicine (listed in section 6).
- if you suffer from biliary tract problems
- if you have severe hepatic impairment
- if you have difficulty breathing
- if you are about to give birth or if there is a risk of premature birth
- if you are breast-feeding
- if you know that your body very quickly converts codeine to morphine
Warnings and cautions
Talk to your doctor or pharmacist before using Panocod:
- if you have asthma
- if you are taking benzodiazepines (sedatives, hypnotics, and medicines used to treat epilepsy )
- if you are hypersensitive to certain medicines for fever or pain ( acetylsalicylic acid, non-steroidal anti-inflammatory drugs, NSAIDs )
- if you have impaired liver function including if you have a disease called Gilbert’s syndrome
- if you have impaired kidney function
- if you are older
- if you have anemia
- if you are dehydrated or malnourished
- if you have long-term (chronic) alcohol intake, including if you have recently stopped drinking alcohol
- if you are deficient in the enzyme glucose – 6 -phosphate dehydrogenase
- if you have prostate enlargement or urethral stricture
- if you have any inflammatory bowel disease
- if you have a disease that involves an impaired respiratory function
- 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, nausea, and vomiting. Contact a doctor immediately if you get a combination of these symptoms.
Never take more Panocod than is stated in the dosing instructions. If you are taking other painkillers that contain paracetamol, do not use Panocod without first talking to your 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. Therefore, you must contact a doctor as soon as possible if you have taken too large a dose.
Concomitant use of alcohol should be avoided, as the combination can cause drowsiness, impaired respiratory function, coma, and even death. See also heading “Panocod with alcohol”.
The risk of this type of liver damage increases with alcohol abuse. Do not use Panocod without your doctor’s prescription if you have alcohol problems or liver damage. The intoxicating effect of alcohol does not increase with the addition of Panocod. Do not use Panocod with alcohol.
Liver damage can occur even at lower doses, after a short period of treatment, and when there are no other problems with the liver.
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, as 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.
If you use Panocod for a long time, there is a risk of developing an addiction.
The risk of getting used to codeine compared to morphine is small but should not be overlooked.
Prolonged use of painkillers for headaches can worsen the headache. If you have or think you may have such a headache, you should seek medical advice and stop treatment.
Due to its sodium salt content, Panocod effervescent tablets should not be used if a low-salt diet is prescribed and may also be unsuitable for those with high blood pressure or poor heart/kidney function.
Children
Panocod is not approved for the treatment of children under 18 years.
Other medicines and Panocod
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The treatment can be affected if this medicine is taken at the same time as certain other medicines / herbal medicines. The treating physician, therefore, needs to know about other concomitant medications.
Concomitant use of Panocod with certain medicines increases the risk of drowsiness, difficulty breathing ( respiratory depression ), coma and may be life-threatening. Examples of these drugs are:
- other strong painkillers
- sedatives, hypnotics, and antiepileptic drugs (eg certain antihistamines, benzodiazepines, and barbiturates )
- anesthetics for anesthesia before e.g. an operation
- certain medicines for mental illness (phenothiazines)
- muscle relaxants
The following medicines may affect or be affected by treatment with Panocod:
- Quinidine (used to treat heart rhythm disorders)
- Neuroleptics (which are a group of drugs for certain mental illnesses)
- Antidepressants ( fluoxetine, paroxetine, bupropion) (used for depression)
- Cinacalcet (a drug for diseases of the parathyroid gland)
- Warfarin and other antivitamin-K drugs (blood thinners). Contact your doctor if you take more than 2 effervescent tablets/tablets of Panocod per day for 5 consecutive days. There is a risk that the effect of warfarin will be affected.
- Chloramphenicol for injection (medicine for bacterial infections). However, chloramphenicol against infection in your eye can be used.
- Probenecid (used for gout )
- Some medicines for epilepsy ( phenytoin, phenobarbital, carbamazepine, topiramate)
- Rifampicin (a medicine used to treat tuberculosis )
- Cholestyramine (medicines for high blood fats), Panocod, and cholestyramine should be taken at least one hour apart.
- St. John’s wort extract (included with some herbal remedies)
- Metoclopramide, domperidone (anti-nausea medicine)
- Flucloxacillin (anti-infective drug )
- Cough suppressants b
- Medicines for high blood pressure
- Tricyclic antidepressants (imipramine, amitriptyline)
- MAO inhibitors (antidepressants, such as tranylcypromine). Panocod should not be taken within two weeks after stopping treatment with an MAOI.
- Medicines for diarrhea.
- Buprenorphine, methadone (medicines used to treat pain or to treat patients who have developed an opioid addiction )
- Naltrexone (used as adjunctive therapy in alcohol dependence or medicines for obesity, for example).
- Some so-called chelating resin. Panocod and chelating resin should be taken at least two hours apart.
Do not take other medicines containing paracetamol at the same time!
Panocod with alcohol
Concomitant use of alcohol should be avoided due to the risk of impaired respiratory function. See also section “Warnings and precautions”.
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.
Pregnancy
If necessary, Panocod can be used during pregnancy. However, you should use the lowest possible dose that relieves your pain and/or fever and use it for the shortest possible time. Contact your doctor or midwife if the pain and/or fever do not decrease or if you need to take the medicine more often. Panocod should be avoided during the last three months of pregnancy and childbirth.
Breast-feeding
Do not take Panocod if you are breastfeeding. Codeine and morphine pass into breast milk.
Driving and using machines
During treatment with Panocod, the ability to react may be reduced, and you may become tired and drowsy, which should be borne in mind at times when sharper attention is required, e.g. while driving and precision work.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. 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.
Panocod effervescent tablets contain sorbitol
This medicine contains 50 mg of sorbitol in each effervescent tablet.
Sorbitol is a source of fructose. If you have been told by your doctor that you have an intolerance to some sugars, or 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.
Panocod tablets and effervescent tablets contain sodium:
Panocod tablets: This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
Panocod effervescent tablets: Each effervescent tablet contains 388 mg of sodium (the main ingredient in table salt/table salt). The maximum daily dose (8 effervescent tablets) is 155% of the maximum recommended daily sodium intake for adults. Consult your doctor or pharmacist if you need 2 or more effervescent tablets daily for a long period, especially if you have been prescribed a low-salt (sodium-poor) diet.
How to take Panocod
Always take 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.
Dose one is determined by the doctor, who adjusts it individually for you.
The usual dose for adults is 1-2 tablets or effervescent tablets 1-4 times daily, a maximum of 8 tablets or effervescent tablets per day.
Effervescent tablet one is dissolved in half a glass of water.
If you take more Panocod than you should
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
In case of severe overdose, the hospital should be contacted immediately (risk of liver damage). There is a risk of liver damage even if you feel well. An antidote must be inserted by a doctor as early as possible if any liver damage is to be prevented.
If you forget to take Panocod
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, this medicine can cause side effects, although not everybody gets them.
Stop taking Panocod and contact a doctor immediately if you get any of the following symptoms:
- Swelling of the face, tongue, or throat; difficulty swallowing; hives and difficulty breathing. This may be a sign of angioedema occurring in up to 1 in 1000 users
- An infection with symptoms such as fever with severely deteriorating general condition or fever with local infection symptoms such as sore throat/throat/mouth or difficulty urinating. This may indicate a lack of white blood cells ( agranulocytosis ) which occurs in an unknown number of users.
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, renal impairment.
Very rare (may affect up to 1 in 10,000 people ): Inflammation of the pancreas, allergic shock (anaphylactic shock ), decreased platelet count ( thrombocytopenia ), decrease in white blood cell count ( leukopenia, neutropenia ), severe skin reactions.
Has been reported ( occurs in an unknown number of users ): Inflammation of the liver that can lead to liver failure, respiratory cramps, hypersensitivity, confusion, feeling of discomfort or sadness ( dysphoria ), agitation, risk of dependence on the drug with long-term use, seizures, headache, drowsiness, dizziness, decreased consciousness ( sedation ), pupil contraction ( miosis ), difficulty breathing, vomiting, dry mouth, itching, difficulty urinating.
Severe skin reactions have been reported in very rare cases.
Liver damage when using paracetamol has occurred in connection with alcohol abuse. With long-term treatment, the risk of kidney damage can not be completely ruled out.
How to store Panocod
Keep this medicine out of the sight and reach of children.
Effervescent tablets should be stored in the original packaging. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the carton after 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
Panocod tablets:
- The active substances are paracetamol 500 mg and codeine 30 mg per tablet.
- The other ingredients are stearic acid, magnesium stearate, polyvidone, microcrystalline cellulose, starch, talc, potassium sorbate, corn starch, and croscarmellose sodium.
Panocod effervescent tablets:
- The active substances are paracetamol 500 mg and codeine 30 mg per effervescent tablet.
- The other ingredients are sorbitol, saccharin sodium, citric acid, sodium bicarbonate, sodium lauryl sulfate, sodium carbonate (anhydrous), polyvidone, and dimethicone.
Each effervescent tablet contains 388 mg of sodium.
What the medicine looks like and the contents of the pack
Panocod tablets are available in pressure packs of 20, 50, and 100 tablets, single-dose packs of 2×49 tablets, and glass jars of 2×150 tablets.
The tablets are white, oblong, and marked with 72M, dimensions 17.2×7.3 mm.
Panocod effervescent tablets are available in strip packs of 20, 48, 60, and 100 tablets.
The effervescent tablets are white, scored on one side, dimensions 20×5.5 mm.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Sanofi AB
Box 30052
104 25 Stockholm