Treo – Acetylsalicylic acid/caffeine uses, dose and side effects

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500 mg/50 mg effervescent tablet
acetylsalicylic acid/caffeine

What Treo is and what it is used for

Treo contains a combination of aspirin and caffeine.

Treo has an analgesic, antipyretic, and anti-inflammatory effect. 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.

With water, Treo provides a clear solution that is gentler on the stomach than regular solid tablets with acetylsalicylic acid. Treo starts working within 30 minutes. The effect is greatest after 1-2 hours.

This medicine is used for temporary mild to moderate pain conditions, e.g. headaches, migraine headaches, toothaches, muscle, and joint pains, menstrual pains, and in cases of fever in cold diseases.

What you need to know before using Treo

Do not use Treo

– if you are allergic to acetylsalicylic acid, caffeine, or any other ingredient in this medicine (listed in section 6).

– if you have had any hypersensitivity reaction such as asthma, breathing difficulties, hay fever, or hives when taking acetylsalicylic acid or certain other anti-inflammatory medicines

– if you have a stomach ulcer

– if you have hemophilia or a reduced number of blood platelets ( thrombocytopenia )

– if you have cirrhosis of the liver

– if you have severe heart failure

– if you have severe kidney disease

– if you are pregnant during the last three months of pregnancy.

Warnings and precautions

Higher doses than those recommended may entail serious risks. Do not use different types of pain relievers at the same time without a doctor’s prescription.

Talk to your doctor or pharmacist before using Treo:

– if you have asthma

– if you have mild to moderate heart failure

– if you have kidney disease or liver disease, especially during simultaneous treatment with diuretics

– if you are treated with medicines that inhibit blood clotting

– if you have had a stomach ulcer

– if you are hypersensitive to aspirin, ibuprofen, or other anti-inflammatory agents.

Due to the caffeine content, Treo can make it difficult to fall asleep if you take it close to bedtime.

Treo is intended for temporary discomfort.

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.

Children and young people

Treo should not be used by children under 14 years of age.

Medicines containing acetylsalicylic acid should not be given to people under the age of 18 with fever without consulting a doctor due to the risk of developing Reye’s syndrome, a rare but serious medical condition.

Other medicines and Treo

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.

Treatment with Treo 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 )
  • depression (selective serotonin reuptake inhibitors ( SSRIs ) such as fluvoxamine)
  • manic depressive disorder, schizophrenia (lithium, clozapine)
  • epilepsy ( phenytoin , valproic acid , carbamazepine)
  • diabetes type II (sulphonylureas)
  • high blood fats ( nicotinic acid )
  • infection ( ciprofloxacin , norfloxacin)
  • allergy (phenylpropanolamine)

Using Treo with food and drink

Treo in combination with alcohol may increase the risk of bleeding in the gastrointestinal tract.

Pregnancy, breastfeeding, and fertility

Pregnant women should not use Treo during the last three months of pregnancy. Ingestion of Treo should be avoided by women planning a pregnancy or who are pregnant. Treatment during any part of the pregnancy must only take place after a doctor’s prescription.

Acetylsalicylic acid and caffeine pass into breast milk but probably do not affect children who are breastfed. However, talk to your doctor if you use Treo more than occasionally during breastfeeding.

Treo, 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 types of drugs.

Driving ability and use of machinery

In some people, Treo can impair the ability to react, e.g. due to side effects such as dizziness and fatigue. This should be considered 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 contains sodium

Consult a doctor or pharmacist if your need for Treo 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

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.

Adults and adolescents over 14 years of age: 1-2 tablets 1-3 times per day or as prescribed by a doctor, maximum of 6 tablets per day.

More than 2 effervescent tablets at a time do not provide a better pain-relieving effect. Contact the doctor if the symptoms worsen or do not improve within 3 days for fever and migraine and within 5 days for pain.

Use for children

Treo should not be given to children under 14 years of age.

Warning: Not to be given to people under 18 years of age with fever

without consulting a doctor due to the risk of developing Reye’s syndrome, a rare but serious medical condition.

One effervescent tablet should be dissolved in a ½ glass of water.

If you have used too much Treo

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.

Symptoms of overdose may include headache, dizziness, convulsions, vomiting, ringing in the ears, palpitations ( tachycardia ), abdominal pain, irritation, restlessness, and shortness of breath.

If you forget to use Treo

Do not take a double dose to make up for a missed tablet.

If you have any further questions about this medicine, ask your doctor or pharmacist.

Possible side effects

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

Common (may affect up to 1 in 10 people): Increased risk of bleeding, especially from the lining of the gastrointestinal tract. Palpitations, anxiety, insomnia, tremors. Stomach upset, e.g. heartburn, nausea.

Uncommon (may affect up to 1 in 100 users): Hypersensitivity reaction, 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. Fatigue, dizziness, tinnitus, sweating.

Rare (may affect up to 1 in 1,000 people): Severe bleeding from the gastrointestinal tract. Liver effects, severe skin reactions, kidney effects.

Decreased number of blood platelets. Dissolution of red blood cells in hereditary deficiency of a special metabolic enzyme ( glucose -6-phosphate dehydrogenase).

Smaller blood losses can in some cases lead to anemia.

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

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

Stored in original packaging. Moisture sensitive.

Keep this medicine out of the sight and reach of children.

Use before the expiry date stated on the packaging. 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, and caffeine 50 mg.

– Other ingredients are sodium carbonate, citric acid, sodium bicarbonate, povidone, simethicone, sodium dihydrogen citrate, sodium citrate, mannitol, and docusate sodium.

Appearance and package sizes of the medicine

Treo effervescent tablets are 20 mm in diameter, white, and flat.

Aluminum tubes, 10 pcs, 20 pcs

Aluminum tube with outer carton, 60 pcs (3×20)

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Manufacturer

HERMES PHARMA GmbH

Hans-Urmiller-Ring 52

82515 Wolfratshausen

Germany

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