Treo Comp – Aspirin/caffeine/codeine phosphate hemihydrate uses, dose and side effects

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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 an invigorating 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 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 certain other anti-inflammatory drugs .
  • if you have a stomach ulcer
  • if you suffer from hemophilia
  • 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 breastfeeding
  • 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 Comp for more than 3 days. If the pain has not improved after 3 days, talk to your doctor.

Long-term use of painkillers for headaches can worsen the headache. If you have or think you have such a headache, you should seek medical advice and stop treatment.

If 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, 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.

Treo Comp should not be used by people under the age of 18 with fever without consulting a doctor (because the use of aspirin has been associated with Reye’s syndrome, a very rare disease that affects 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 who are trying to get pregnant. The effect is temporary, i.e. it stops when you stop using these types of 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 in different ways. Some people cannot form morphine or it is formed in very small amounts, which means that you do not get sufficient pain relief. Other people have an increased risk of serious side effects because they can form a very large amount of morphine. If you experience any of the following side effects, you must stop taking this medicine and contact your doctor immediately: slow or shallow breathing, confusion, sleepiness, small pupils, nausea or vomiting, constipation, and loss of appetite.

Children and young people

Treo Comp is not approved for the treatment of 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 ), coma, and can be life-threatening. Examples of these medicines are:

  • anesthetic (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 not possible. 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 carefully follow your doctor’s dosage recommendations. It may be helpful to inform friends or relatives to be aware of 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 (eg, warfarin )
  • rejection of organs after transplantation (ciclosporin, tacrolimus)
  • high blood pressure (eg diuretics )
  • pain and inflammation (eg 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 (eg, lithium, clozapine)
  • depression (selective serotonin reuptake inhibitors ( SSRIs ) such as fluvoxamine)
  • tuberculosis (rifampicin)

Use of Treo Comp with alcohol

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 are fit to 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/or 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.

This medicine contains 276 mg of sodium (the main ingredient in common/table salt) per effervescent tablet. This corresponds to 14% of the maximum recommended daily intake of sodium for adults.

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 dose must be determined by the doctor, who adjusts it individually for the patient.

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 that is 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 if, 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 side effects

Like all medicines, Treo Comp can cause side effects, although not everybody gets them.

Common (may affect up to 1 in 10 users): Stomach upset, eg. 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, usually in the form of hives, 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 anemia.

Dizziness and ringing in the ears can be symptoms of overdose.

Elderly people may in some cases experience dizziness, restlessness, fatigue, or constipation.

Acetylsalicylic acid may increase the risk of Reye’s syndrome in children and adolescents in connection 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 the 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 the 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.

Aluminum 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

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