Tachinotte syrup fever flu cold cough

TACHINOTTE syrup

Paracetamol + Promethazine hydrochloride + Dextromethorphan hydrobromide

1. What Tachinotte is and what it is used for

Tachinotte is an oral syrup containing three active ingredients: acetaminophen, promethazine hydrochloride and dextromethorphan hydrochloride. Paracetamol works by reducing fever and relieving pain.
Promethazine hydrochloride is used to improve night's sleep.

Dextromethorphan hydrochloride works by calming the cough.

Tachinotte is used in adults and teenagers from 12 years onwards for the treatment of cold and flu symptoms accompanied by cough. Tachinotte is specific to facilitate night's rest.

Talk to your doctor if you don't feel better or feel worse after 3 days of treatment.

2. What you need to know before you take Tachinotte

Don't take Tachinotte

• if you are allergic to paracetamol or promethazine hydrochloride or dextromethorphan hydrobromide or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to other substances similar to paracetamol or promethazine hydrochloride or dextromethorphan hydrobromide
• if you are under 12 years of age
• if you suffer from impaired kidney function (kidney failure)
• if you suffer from impaired liver function (liver failure)
• if you have severe liver disease (severe hepatocellular insufficiency)
• if I am aware of a strong deficiency of glucose-6-phosphate dehydrogenase (a substance normally present in the human body, the deficiency of which can cause blood disease)
• if it is affected by severe hemolytic anemia (disease due to the destruction of some blood cells, red blood cells).

Warnings and precautions

Talk to your doctor or pharmacist before taking Tachinotte:

• if you suffer from asthma or breathing problems, as it may have decreased breathing capacity
• if you have glaucoma (increased internal pressure in the eye)
• if you suffer from prostatic hypertrophy (enlarged prostate)
• if you suffer from urinary retention (inability of the urinary bladder to empty completely)
• if you have epilepsy
• if I am aware of heart and / or blood vessel disease
• if you are being treated concomitantly with any other medication (see "Others

medicines and Tachinotte ").

In case of allergic reactions stop treatment immediately.

Use of high doses and / or for prolonged periods

The use of high and / or prolonged doses of this medicine can cause serious liver problems (liver disease) and kidney and blood changes. After three consecutive days of use, without appreciable results, consult your doctor.

Older

If you are elderly, take this medicine with caution and do not exceed the recommended doses, as it is more sensitive to the effect of this medicine.

Children and adolescents
Do not give Tachinotte syrup to children under the age of 12 (see paragraph "Do not take Tachinotte").

Other medicines and Tachinotte

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

In particular, tell your doctor if you are taking or have recently taken:

medicines that contain acetaminophen . During treatment with acetaminophen, before taking any other medicine, check that it does not contain acetaminophen, since if acetaminophen is taken in doses

high serious and undesirable effects may occur;

• anti-hypertensive medicines (medicines to lower blood pressure), as their effect may increase;
• ear-toxic medicines such as aminoglycosides (a class of antibiotics), as Tachinotte could mask the first signs of ear toxicity;
• anti-inflammatory medicines; concomitant use of Tachinotte and anti-inflammatory drugs is not recommended;
oral anticoagulants (medicines used to make the blood more fluid). In this case the doctor will reduce the dose of the anticoagulant you are taking;
• rifampicin (an antibiotic);
• cimetidine (a medicine used to treat stomach ulcer);
• antiepileptics (medicines used to treat epilepsy), e.g. glutetimide, phenobarbital, carbamazepine.
• medicines to treat depression such as uoxetine, paroxetine, sertraline and bupropion (see section 2. "Do not take Tachinotte");
• medicines to treat severe pain or to reduce withdrawal symptoms in addictive cases (methadone);
• medicines to treat psychiatric diseases (haloperidol, thioridazine, perphenazine);
• medicines to treat heart rhythm disorders (amiodarone, quinidine, propafenone);
• medicines to treat heart rhythm abnormalities (flecainide);
• medicines to reduce the level of calcium in the blood and treat dysfunction of the body due to a reduced secretion of the hormone that regulates these levels in the blood (hyperparathyroidism) such as cinacalcet;
• medicines used to prevent the development of fungi (fungi) (terbinafine).

Avoid to take the following medicines at the same time as Tachinotte as it may increase their sedative effect (physical and mental relaxation):

• hypnotic medicines (medicines to induce sleep)
• sedatives and tranquilizers (medicines that induce physical and mental relaxation)

Interference with exams

If those taking the drug have to carry out tests, take into account that the administration of this medicine can interfere with the determination of uricemia and blood glucose and with false pregnancy immunoassays, falsifying the results.

Tachinotte with alcohol
Avoid taking alcohol at the same time as Tachinotte as it could increase their sedative effect (physical and mental relaxation).

Pregnancy, breastfeeding and fertility

If you are pregnant, breastfeeding or planning to become pregnant, or breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.

If you are pregnant or breastfeeding, take Tachinotte only after consulting your doctor, who will assess the benefit of the mother and the risks to the baby.
As stated in the section "Other medicines and Tachinotte" , this medicine may interfere with immunological pregnancy tests by falsifying the results.

Driving and using machines
Avoid from driving or carrying out activities that require prompt vigilance, as this medicine can make you sleepy.

Tachinotte contains sorbitol, sodium and parahydroxybeanzoates

Sorbitol : if your doctor has diagnosed you have an intolerance to some sugars, contact him before taking this medicine.
Sodium : this medicine contains 1, 03 mmol (or 23.6 mg) of sodium for the 20 ml dose. To be taken into consideration in people with reduced kidney function or on a low sodium diet. Parahydroxybenzoates : can cause allergic reactions (even delayed)

3. How to take Tachinotte

Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are not sure, consult your doctor or pharmacist.

Adults and adolescents over 16 years of age

The recommended dose is 20 ml of syrup once a day. Fill the measuring cup up to the top mark corresponding to 20 ml (or 4 coffee spoons).

Children and teenagers

Children from 0 to 12 years old

Do not give Tachinotte syrup to children under the age of 12 (see paragraph "Do not take Tachinotte").
Teens from 12 to 16 years
< / em> The recommended dose is 10 ml of syrup once a day. Fill the measuring cup to the lower mark corresponding to 10 ml (or 2 coffee spoons).

Warning: do not exceed the indicated doses without medical advice, especially if you are elderly.

Method of administration

The product should only be taken on a full stomach before going to bed to improve the quality of the night's sleep.

Duration of treatment

Do not exceed 3 days of treatment. After 3 days of continuous use without appreciable results, consult your doctor.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change in its characteristics.

If you take more Tachinotte than you should

In case of accidental ingestion of an overdose of Tachinotte, notify your doctor immediately or contact the nearest hospital with this leaflet.

Symptoms

In case of accidentally taking very high doses of this medicine, the symptoms that it could generally manifest include:

• nausea, vomiting, abdominal pain, which occurs early
• liver damage, which typically occurs 2-4 days after taking an overdose
• respiratory depression (reduction / blocking of respiratory activity)
• drowsiness
• convulsions

  Treatment

  The doctor will perform the appropriate support therapy based on the nature and severity of the symptoms.

  Note for the healthcare professional : in case of intoxication with paracetamol, the appropriate recommended therapy is gastric lavage using specific antidotes such as acetylcysteine ​​or methionine. More than 10 hours after ingestion, hemoperfusion may be necessary. In case of intoxication with dextromethorphan, the specific antidote to be used is intravenous naloxone. In case of intoxication with promethazine the specific antidote to be used is sodium thiopentone.

  If you forget to take Tachinotte

  Do not take a double dose to make up for a forgotten dose.

  If you stop taking Tachinotte

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

  4. Possible and undesirable effects

  Like all medicines, this medicine can cause unwanted effects, although not everybody gets them.

  If you experience the following unwanted effects STOP treatment with this medicine and contact immediately your doctor:

  Allergic reactions with :
  - swelling of the throat (edema of the larynx)
  - swelling of the hands, feet, ankles, face, lips, tongue and / or throat ( angioedema)
  - severe allergic reaction (ana lactic shock).

  In addition, those taking the drug may experience the following undesirable effects, for which insufficient data are available to establish the frequency.

  Effects that affect the blood

  • reduction in the number of platelets in the blood (thrombocytopenia)
  • reduction in the number of white blood cells in the blood

  (leukopenia / agranulocytosis)

  • reduction of hemoglobin in the blood, a substance that carries oxygen in the blood (anemia).

  Effects affecting the mind and nervous system

  • vertigo
  • excitation
  • tremors
  • irritability
  • drowsiness
  • exhaustion

    Effects affecting the mouth, stomach and intestines

    • dry mouth due to lack of saliva (dry mouth)
    • stomach and intestine disorders, such as vomiting, diarrhea and

    abdominal pain.

    constipation.

    Effects affecting the liver

    • abnormal liver function
    • inflammation of the liver (hepatitis).

    Effects affecting the skin and subcutaneous tissue

    • red spots, blisters, skin rashes that include erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis
    • light intolerance (photosensitivity).

    Very rare cases of severe skin reactions have been reported.

    Effects affecting the kidneys and urinary tract

    • reduced kidney function (acute renal failure)
    • in inflammation of the kidneys (interstitial nephritis)
    • blood in the urine (hematuria)
    • cessation or reduction of urine production (anuria)
    • inability of the urinary bladder to empty completely (urinary retention).

    When you experience these unwanted effects, consult your doctor or pharmacist.

    Reporting of unwanted e ects

    If you experience any unwanted effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report unwanted e ects directly through the national reporting system at the address www.agenziafarmaco.gov.it / it / responsible. By reporting the e ects

    side effects you can help provide more information on the safety of this medicine.

    5. How to store Tachinotte

    Keep this medicine out of the sight and reach of children. Store in the original package to protect the medicine from light. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
    Do not throw any medicines into waste water and household waste. Ask your pharmacist how to get rid of medicines you no longer use. This will help protect the environment.

    6. Contents of the pack and other information

    What Tachinotte contains

    • the active ingredients are: paracetamol, promethazine hydrochloride and dextromethorphan hydrobromide (100 ml of syrup contain 2.5 g of acetaminophen, 100 mg of promethazine hydrochloride and 75 mg of dextromethorphan hydrochloride)
    • the other ingredients are : sorbitol 70% not crystallizable; macrogol 1500; propylene glycol; ascorbic acid; sodium citrate; sodium benzoate; Saccharin sodium ; anhydrous citric acid; methyl parahydroxybenzoate; propyl parahydroxybenzoate; mint-lemon aroma; quinoline yellow (E 104); patent blue V (E 131); purified water. See also section 2 "Tachinotte contains sorbitol, sodium and parahydroxybenzoates".

    Description of what Tachinotte looks like and contents of the pack

    Tachinotte comes in the form of a sugar-free syrup contained in a 120 ml glass bottle with measuring cup and closure cap.

    Marketing authorization holder

    Chemical Companies United Angelini Francesco - A.C.R.A.F. S.p.A. Viale Amelia 70, 00181 ROME

    Maker

    - A.C.R.A.F. S.p.A. , via Vecchia del Pinocchio 22, 60131 Ancona
    - Farmaclair, Avenue du General de Gaulle, 440 - Herouville St. Clair – FRANCIA - Alfa Wassermann S.p.A., Contrada Sant'Emidio, Alanno (PE)