Treo Comp 500 mg/50 mg/30 mg effervescent tablet aspirin/caffeine/codeine phosphate hemihydrate
What Treo Comp Is And What It Is Used For
Treo Comp contains three active substances.
Acetylsalicylic acid relieves pain by counteracting the formation of special substances, prostaglandins. The antipyretic effect is due to acetylsalicylic acid increasing the body’s heat output.
Caffeine enhances the pain-relieving effect of acetylsalicylic acid. Caffeine also has an analgesic effect through its constricting effect on dilated blood vessels in the brain, e.g. in the case of migraine. Caffeine also has a refreshing effect.
Codeine belongs to a group of drugs called opioid analgesics that work by relieving pain. It can be used alone or with other pain relievers, such as paracetamol.
Treo Comp is used against pain and aches of various kinds.
What You Need To Know Before Using Treo Comp
Do Not Use Treo Comp
- If you have had a hypersensitivity reaction such as Asthma, breathing difficulties, hay fever, or hives when using acetylsalicylic acid or other anti-inflammatory drugs.
- If you have a stomach ulcer
- If you suffer from haemophilia
- If you have a reduced number of blood platelets ( thrombocytopenia )
- If you suffer from biliary tract problems
- If you have cirrhosis
- If you suffer from severe heart failure
- If you suffer from severe kidney disease
- If you know that you convert codeine to morphine very quickly
- If you are breast-feeding
- During the last three months of pregnancy.
Warnings And Precautions
In general, a higher dose than recommended can entail risks. Therefore, do not use several different painkillers at the same time without consulting a doctor.
There is a risk of developing addiction with high doses and long-term use. Do not use Treo painkiller for more than 3 days. Talk to your doctor if the pain has not improved after 3 days.
Long-term use of Treo painkiller for headaches can worsen the headache. If you have or think you have such a headache, you should seek medical advice and stop treatment.
Suppose you are treated with drugs that inhibit blood clotting (blood thinners) or diuretics, have asthma, kidney disease, liver disease, heart failure, have had stomach ulcers, know that you are hypersensitive to acetylsalicylic acid, ibuprofen, or other anti-inflammatory agents. In that case, you should consult a doctor before treatment with Treo Comp begins.
Due to the caffeine content, Treo Comp can make it difficult to fall asleep if taken close to bedtime.
People under 18 with a fever should not use Treo Comp without consulting a doctor (because Aspirin treo comp has been associated with Reye’s syndrome, a rare disease affecting the liver and brain).
Treo Comp, like many anti-inflammatory drugs (so-called NSAIDs ), can make it difficult to get pregnant and is therefore not recommended for women trying to get pregnant. The effect is temporary, i.e., it stops when you stop using these drugs.
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, which means they can be affected differently. Some people cannot form morphine, or it is formed in very small amounts, so you do not get sufficient pain relief. Other people have an increased risk of serious side effects because they can form much morphine. If you experience the following side effects, you must stop taking this Treo medicine and contact your doctor immediately:
- Slow or shallow breathing
- Confusion
- Sleepiness
- Small pupils
- Nausea or vomiting
- Constipation
- Loss of appetite
Children And Young People
Treo Comp is not approved for treating children under 18 years of age.
Other Medicines And Treo Comp
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 remedies.
Simultaneous use of Treo Comp and certain medicines increase the risk of effects on the nervous system, e.g. drowsiness, difficulty breathing ( respiratory depression ), and coma can be life-threatening. Examples of these medicines are:
- Anaesthetic (in dental surgery and general surgery )
- Sedatives and hypnotics (eg benzodiazepines and barbiturates )
- Certain drugs for mental illness (e.g. for depression or psychosis )
- Certain anti-allergy agents (soothing antihistamines )
- Other strong painkillers ( opioids )
- Muscle relaxant drugs.
Because of this, the simultaneous use of Treo Comp and the above medicines should only be considered by the doctor when other treatment options are impossible. If the doctor prescribes Treo Comp at the same time as one of the above medicines, the dose and duration of treatment must be limited by the doctor. Tell your doctor if you are taking any of the above medicines, and follow your doctor’s dosage recommendations. It may be helpful to inform friends or relatives about the signs and symptoms listed above. Contact your doctor if you experience any of these symptoms.
Treatment with Treo Comp can affect or be affected by certain medicinal substances against
- Blood clots (e.g., warfarin )
- Rejection of organs after transplantation (ciclosporin, tacrolimus)
- High blood pressure (e.g. diuretics )
- Pain and inflammation (e.g. corticosteroids )
- Gout (probenecid)
- Cancer and rheumatoid arthritis (methotrexate)
- Certain medicines for glaucoma also called glaucoma (e.g. acetazolamide)
- Heart rhythm disturbances ( digoxin )
- Epilepsy ( phenytoin, valproic acid, carbamazepine, phenobarbital, primidone)
- Diabetes type II (sulphonylureas)
- High blood fats ( nicotinic acid )
- Infection ( ciprofloxacin , norfloxacin)
- Allergy (phenylpropanolamine)
- Heart rhythm disorders ( quinidine )
- Fungal infections (terbinafine)
- Mental illness (e.g., lithium, clozapine)
- Depression (selective serotonin reuptake inhibitors ( SSRIs ) such as fluvoxamine)
- Tuberculosis (rifampicin)
Use Of Treo Comp With Acohol
Simultaneous use of Treo Comp and alcohol should be avoided due to the risk of reduced respiratory function.
Pregnancy, Breastfeeding, And Fertility
Talk to your doctor or pharmacist before taking Treo Comp.
Ingestion of Treo Comp should be avoided by women who are trying to conceive or are pregnant. Treatment during any part of the pregnancy must only take place after a doctor’s prescription.
Do not take Treo Comp if you are breastfeeding. Codeine and morphine pass into breast milk.
Driving Ability And Use Of Machinery
During treatment with Treo Comp, the ability to react may be reduced. This should be taken into account at times when increased attention is required, e.g. when driving.
You are responsible for assessing whether you can drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and side effects.
A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Treo Comp Contains Sodium
Consult a doctor or pharmacist if your need for Treo comp is more than 1 effervescent tablet daily for a longer period, especially if you have been prescribed a low-salt (low-sodium) diet.
Treo medicine contains 276 mg of sodium (the main ingredient in common/table salt) per effervescent tablet. This corresponds to 14% of adults recommended daily sodium intake.
How To Use Treo Comp
Always use Treo Comp as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Note! Higher doses than those recommended can involve serious risks.
The usual dose for adults is 1-2 effervescent tablets every 6 – 8 hours. The doctor must determine the dose and adjusts it individually for the patient.
Aspirin treo comp starts working within 30 minutes. The effect is greatest after 1-2 hours. One effervescent tablet should be dissolved in a ½ glass of water. With water, Treo Comp provides a clear solution gentler on the stomach than regular solid tablets with acetylsalicylic acid.
If You Have Used Too Much Treo Comp
If you have ingested too much medicine or, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If You Forget To Use Treo Comp
Do not take a double dose to make up for a missed dose.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible Treo Comp Side Effects
Treo Comp can cause side effects like all medicines, although not everybody gets them.
Common treo comp side effects (may affect up to 1 in 10 users):
- Stomach upset, e.g.
- Heartburn
- Nausea
- Constipation
- Increased risk of bleeding, especially from the mucosa of the gastrointestinal tract
- Palpitations
- Anxiety
- Insomnia
- Tremors
- Fatigue
Uncommon (may affect up to 1 in 100 users):
- Hypersensitivity reactions are usually in the form of hives, hay fever, or asthma. The risk of a hypersensitivity reaction increases in patients with allergies or asthma
- Stomach ulcers and stomach bleeding with regular use
- Bile tract problems
- Dizziness
- Tinnitus
- Sweating
Rare (may affect up to 1 in 1,000 people):
- Severe bleeding from the gastrointestinal tract
- Decreased number of blood platelets
- Dissolution of red blood cells in hereditary deficiency of a special metabolic enzyme ( glucose -6-phosphate dehydrogenase)
- Liver effects
- Severe skin reactions
- Kidney effects
- Very severe hypersensitivity reaction with fever, rash, swelling, and sometimes a drop in blood pressure (anaphylactic shock ).
Very rare (affects less than 1 in 10,000 users):
- Pancreatitis
- Smaller blood losses can, in some cases, lead to anaemia.
- Dizziness and ringing in the ears can be symptoms of overdose.
- Elderly people may sometimes experience dizziness, restlessness, fatigue, or constipation.
- Acetylsalicylic acid may increase the risk of Reye’s syndrome in children and adolescents with diseases caused by viruses, especially chickenpox and influenza. Reye’s syndrome is very rare. The symptoms consist of signs of swelling in the brain and liver damage, sometimes with low blood sugar.
How To Store Treo Comp
- Store in well-sealed original packaging. Moisture sensitive.
- Keep this medicine out of sight and reach of children.
- Use before the expiry date, which is stated on the tube after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents Of The Packaging And Other Information
Contents Declaration
- The active substances are acetylsalicylic acid 500 mg, caffeine 50 mg, and codeine phosphate hemihydrate 30 mg.
- Other ingredients are sodium bicarbonate, citric acid, docusate sodium, sodium carbonate, povidone, sodium dihydrogen citrate, sodium citrate, and mannitol.
Appearance And Package Sizes Of The Medicine
- Soda tablets, white, flat, Ø 20 mm.
- Aluminium tube with outer carton, 20 pcs, 60 pcs (3×20) and 100 pcs (5×20)
- Not all pack sizes may be marketed.
Marketing Authorisation Holder
HERMES PHARMA GmbH
Hans-Urmiller-Ring 52
82515 Wolfratshausen
Germany