Trinell Pro film-coated tablet

Why do we recommend this preparation?

Owing to its triple composition, Béres Trinell Pro film-coated tablet is a quick and efficacious pain relief for mild and moderate pain.

 

In what cases is the preparation recommended?

  • Menstrual pain,
  • Headache,
  • Migraine,
  • Toothache,
  • Rheumatic pain,
  • Cold-related pain and fever
  • Post-operative pain

 

The recommended dose:
Depending on the strength of pain, a single dose for adults is 1 film-coated tablet. The single dose can be repeated 3 times within 24 hours if necessary. If you have taken a film-coated tablet, do not take the next one within 4 hours. The maximum daily dose is 4 film-coated tablets.

 

Pack sizes:
10 and 20 film-coated tablets

 

Important to know
Take the medicine after a meal.

 

Quantities of active substances per film-coated tablet

 

Name of active substance Active substance content

Acetaminophen

500 mg

propyphenazone

300 mg

caffeine 75 mg

 

 

Béres Trinell Pro film-coated tablet

paracetamol, propyphenazone, caffeine

 

 

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

This medicine is available without prescription. However, you still need to use it carefully to get the best results from it.

- Keep this leaflet. You may need to read it again.

- Ask your pharmacist if you need more information or advice.

- You must talk to a doctor if you do not feel better of if you feel worse after three days.

- If any of the side effects get severe talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

 

In this leaflet:

1. What Béres Trinell Pro film-coated tablet is and what it is used for

2. What you need to know before you take Béres Trinell Pro film-coated tablets

3. How to take Béres Trinell Pro film-coated tablets

4. Possible side effects

5. How to store Béres Trinell Pro film-coated tablets

6. Further information

 

 

1.       WHAT Béres Trinell Pro film-COATED TABLET IS AND WHAT IT IS USED FOR

 

 

Béres Trinell Pro is a fever reducer and pain reliever. It is recommended to alleviate mild and moderate pain, e.g. menstrual pain, headache, migraine, toothache, rheumatic pain and post-operative pain, as well as to alleviate pain and reduce fever caused by colds.

 

 

 

2          What you need to know before you take Béres Trinell Pro film-coated tablets

 

Do not take Béres Trinell Pro film-coated tablets  

  • with other fever reducers and painkiller (containing phenylbutazone, acetyl salicylic acid, pyrazolone or similar compounds, e.g. phenazone, propyphenazone, aminophenazone, metamizole
  • if you are hypersensitive to any of the compounds of the preparation
  • if you have hereditary glucose-6-phosphate dehydrogenase deficiency
  • if you have severe liver or kidney disorders
  • if you have porphyrin metabolism disorder (porphyria)
  • if you have low white blood cell counts
  • excessive or chronic alcohol consumption
  • below 12 years of age

 

Take special care with Béres Trinell Pro film-coated tablet

If you have asthma, if you are hypersensitive to pain relievers or antirheumatic substances, or if you have other diseases or allergy, talk to your doctor before starting to take Béres Trinell Pro. 

 

Taking other medicines

Tell your doctor or pharmacist if you are taking, have recently taken any other medicines including non-prescription preparations. Medicines taken together might interact with each other. Talk to your doctor if you take sleeping pills, preparations influencing the emptying of the stomach (metoclopramide), antibiotics (chloramphenicol), antiallergic medicines, anticoagulants or oral contraceptives.

 

Béres Trinell Pro film-coated tablets with food and drinks

Do not drink alcohol when you take this medicine.

 

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicines. Béres Trinell Pro should not be taken in the first 3 months and the last 6 weeks of pregnancy. At other times, talk to your doctor before taking this medicine. Béres Trinell Pro is contraindicated during breast-feeding.

 

Driving and using machines

No studies have been conducted on the effects of the medicine on the abilities necessary for driving and using machines.

 

 

3.         How to take Béres Trinell Pro film-coated tablet

 

Always take Béres Trinell Pro film-coated tablets as the doctor has told you. Check with your doctor or pharmacist if you are not sure.

Its usual dose:

Depending on the strength of pain a single dose for  adults is 1 film-coated tablet. The single dose can be repeated 3 times within 24 hours if necessary. If you have taken a film-coated tablet, do not take the next one within 4 hours. The maximum daily dose is 4 film-coated tablets. 

 

When in pain, take the tablet whole with abundant liquid (e.g. water, tea, fruit juice, etc.).

Do not take this medicine in a dose higher than described in this leaflet, and longer than a week, unless your doctor tells you to do so. Talk to your doctor if you have a fever or if you are in pain for longer than 3 days.

 

If you take more Béres Trinell Pro film-coated tablets than you should

If you overdosed the product accidentally or if you suspect the conscious overdosing of this medicine, the administration of the product must be stopped, talk to a doctor or call the out-of-hours service straight away. If you cannot reach your doctor, go to the nearest hospital casualty department straight away and take the medicine’s box with you! The long-term administration of high doses may cause severe, irreversible liver damage and renal function damage.

Symptoms of paracetamol overdose: feeling sick, vomiting, loss of appetite, malaise, and abdominal pain. Overdose may cause liver damage leading to death.

Symptoms of caffeine overdose: agitation, shaking, ringing in the ear, abnormal heart rhythm.

 

If you forget to take Béres Trinell Pro film-coated tablet

If you forget to take a dose, take one as soon as you remember, except if there is less than 4 hours left for the due dose. Continue as started.

Do not take two doses at the same time to make up for the missed dose under any circumstances.

 

If you stop taking the medicine

In general, no harmful effects develop when stopping the treatment.

 

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

 

 

4.         Possible side effects

 

Like all medicines, Béres Trinell Pro film-coated tablets can cause side effects, although not everybody gets them.

 

Based on their frequency, Béres Trinell Pro film-coated tablet’s side effects can be classified as follows:

 

Rare: affects more than 1 in 10,000, but less than 1 in 1000 users.

Very rare: affects fewer than 1 in 10,000 users, unknown frequency (cannot be determined based on the data available)

 

Rare: allergy symptoms, skin reactions (hives, itchy skin) may occur.

Very rare: breathing related (difficulty breathing, asthma) and vasculatory system related problems in those who are sensitive to it.

Unknown frequency: severe hypersensitivity reaction (anaphylactic shock),

Rare: haematological deviations (e.g. reduction in the complete blood cell count, low red blood cell count, low white blood cell count), increased irritation of the gastrointestinal system, fast heartbeat, elevated irritability may occur.

 

Symptoms caused by overdose – liver and kidney insufficiency, central nervous system related complaints – may occur only in case of taking a multiple of the recommended daily dose.

 

If any of the side effects get severe talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

 

 

5.         How to store Béres Trinell Pro film-coated tablets

 

Store at or below 25 °C.

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

Do not take Béres Trinell Pro film-coated tablets after the expiry date printed on the packaging.

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.

 

 

6.         Further information

 

What Béres Trinell Pro contains

- Active substances: each film-coated tablet contains 500 mg paracetamol, 300 mg propyphenazone, 75 mg caffeine.

- Other ingerdients:

Tablet core: colloidal anhydrous silica, talc, magnesium stearate, sodium starch glycolate (type A), anhydrous calcium hydrogen phosphate, hydroxypropyl cellulose, and microcrystalline cellulose.

Tablet coating: hypromellose (E 464), microcrystalline cellulose (E 460), macrogol stearate (E 431), titanium dioxide (E 171).

 

What Béres Trinell Pro film-coated tablets look like and the contents of the pack

4, 10, 20 white oblong film-tablets scored on both sides in a colourless, transparent plastic/aluminium blister packaging and a box. The scoreline is only to facilitate breaking for ease of swallowing and not to divide the tablet into equal doses.

 

Not all pack sizes may be marketed.

 

Marketing authorisation holder:

Béres Gyógyszergyár Zrt., 1037 Budapest, Mikoviny u. 2-4.

Tel: +36-1-430-5500

Fax: +36-1-250-7251

E-mail: info@beres.hu

 

Manufacturer

Béres Gyógyszergyár Zrt, 5005 Szolnok, Nagysándor József út 39.

 

 

OGYI-T-9400/01                    4          Béres Trinell Pro film-coated tablets

OGYI-T-9400/02                    10        Béres Trinell Pro film-coated tablets

OGYI-T-9400/03                    20        Béres Trinell Pro film-coated tablets

 

 

This leaflet was approved in: February, 2012.

Registration category:Over-the-counter medicinal product

For risks and side effects, please read the patient information leaflet or consult your doctor, pharmacist!

GOOD TO KNOW – Useful information prior to administration

Gluten-free - Suitability for people with coeliac disease

Lactose-free - Suitability for lactose intolerant people

Suitability for people with diabetes

Suitability for vegetarians

Suitability for pregnant women and nursing mothers

Suitability for people with high blood pressureComment: Its administration requires close attention, owing to its caffeine content!



© Copyright 2012 Béres Pharmaceuticals Ltd.

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