Tachifenekid

Package leaflet: Information for the user

Tachifenekid 32 mg/ml + 9.6 mg/ml oral suspension

Paracetamol/ibuprofen
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Tachifenekid is and what it is used for
2. What you need to know before taking Tachifenekid
3. How to take Tachifenekid
4. Possible side effects
5. How to store Tachifenekid
6. Contents of the pack and other information

1. What Tachifenekid is and what it is used for

Tachifenekid contains paracetamol and ibuprofen.
Paracetamol works by blocking pain signals directed to the brain. Ibuprofen belongs to a class of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It relieves pain and reduces inflammation (swelling, redness, or pain).
Tachifenekid is used for the short-term treatment of mild to moderate acute pain not expected to be relieved by paracetamol or ibuprofen alone in children aged 2 to 12 years.
If you have any questions about this medicine, consult your doctor or pharmacist.
Consult your doctor if your child does not feel better or feels worse after 3 days.

2. What you need to know before taking Tachifenekid

Excipients with known effects:

1. Liquid maltitol (E965) 250 mg/ml
2. Propylene glycol (E1520) 9.6 mg/ml
3. Sodium benzoate (E211) 1 mg/ml
4. Sodium 1.23 mg/ml
5. Glycerol (E422) 150 mg/ml

1 ml of oral solution contains 9.6 mg of propylene glycol and 1 mg of sodium benzoate.

• Do not use Tachifenekid: if your child is allergic to the active substances or to any of the other components of this medicine (listed in section 6);
• if your child has (or has previously had) rectal (anal) bleeding, tarry black stools, or diarrhoea with bleeding;
• if your child suffers from peptic ulcer (e.g. gastric or duodenal ulcer), or has suffered from it recently or in the past;
• together with other medicines containing paracetamol or ibuprofen;
• if your child suffers from severe heart failure, liver failure, or kidney failure;
• if your child suffers from cerebrovascular bleeding or any other active bleeding;
• if your child has blood production disorders;
• if your child develops asthma, urticaria, or allergic-type reactions after taking acetylsalicylic acid or other NSAIDs.

If you are an adult, in addition to the above, do not use Tachifenekid if:

• you regularly drink large amounts of alcohol;
• you are in the last three months of pregnancy.

Warnings and precautions
What you need to know before taking Tachifenekid
With ibuprofen, signs of an allergic reaction to this medicine have been reported, including breathing problems, swelling of the face and neck area (angioedema), and chest pain. Immediately discontinue Tachifenekid and contact your doctor or emergency medical services if you notice any of these signs.
Consult your doctor or pharmacist before taking Tachifenekid.
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when taken at high doses. Do not exceed the recommended dose or duration of treatment.
Children who are dehydrated are at risk of kidney impairment. Consult your doctor or pharmacist before administering Tachifenekid to your child if:

• they suffer from high blood pressure, kidney or liver problems;
• they suffer from asthma or diabetes;
• they suffer from lupus or mixed connective tissue disease;
• they suffer from chronic inflammatory bowel disease, such as ulcerative colitis, Crohn's disease, or gastrointestinal bleeding;
• they have chickenpox;
• they suffer from liver disease, hepatitis, kidney disease, or difficulty urinating;
• they are allergic to other medicines containing acetylsalicylic acid, to other NSAIDs, or to any other substance listed at the end of this leaflet;
• they currently have an infection;
• they are due to undergo surgery;
• they suffer from or have previously suffered from other medical conditions, including:
  • heartburn, indigestion, gastric ulcer, or any other stomach problem;
  • vomiting blood or intestinal bleeding;
  • severe skin reactions, such as Stevens-Johnson syndrome;
  • asthma;
  • vision problems;
  • tendency to bleed or other blood disorders;
  • intestinal problems such as ulcerative colitis or Crohn's disease;
  • swelling of the ankles or feet;
  • diarrhoea;
  • genetic or acquired defects in certain enzymes that manifest with neurological complications;
  • skin disorders or occasionally both (e.g. porphyria);
  • smallpox;
  • autoimmune diseases such as systemic lupus erythematosus.

This product is indicated for children aged between 2 and 12 years. If you are an adult taking this product, all the above information remains valid, together with the following additional warnings:
Inform your doctor or pharmacist if:

• you use drugs;
• you are pregnant or planning to become pregnant;
• you are breastfeeding or planning to breastfeed.

During treatment with Tachifene, inform your doctor immediately if:
You suffer from serious illnesses, including severe kidney impairment or sepsis (when bacteria and their toxins circulate in the blood causing organ damage), malnutrition, chronic alcoholism, or if you are also taking flucloxacillin (an antibiotic). In patients with these conditions, a serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported when paracetamol is used regularly over a prolonged period or when paracetamol is taken in combination with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep rapid breathing, drowsiness, nausea, and vomiting.
Do not drink alcohol during treatment with this medicine. The combination of alcohol and Tachifenekid may cause liver damage.
This product belongs to a class of medicines (NSAIDs) that may impair fertility in women. This effect is reversible upon discontinuation of the drug.

Special caution with Tachifenekid:
Skin reactions
Serious skin reactions have been reported with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).
Stop using Tachifenekid and contact your doctor immediately if you notice any symptoms related to these serious skin reactions described in section 4.

Other medicines and Tachifenekid
Inform your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines.
Tachifenekid may affect or be affected by other medicines, for example:

• medicines with anticoagulant effects (i.e. substances that thin the blood and prevent clot formation, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• medicines for epilepsy or seizures;
• chloramphenicol, an antibiotic used to treat eye and ear infections;
• probenecid, a medicine used to treat gout;
• zidovudine, a medicine used to treat HIV (the virus that causes acquired immunodeficiency syndrome);
• medicines used to treat tuberculosis, such as isoniazid;
• acetylsalicylic acid, salicylates, or other NSAIDs;
• medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan);
• diuretics;
• lithium, a medicine used to treat certain types of depression;
• methotrexate, a medicine used to treat arthritis and some types of cancer;
• corticosteroids, such as prednisone and cortisone;
• metoclopramide, propantheline;
• tacrolimus or cyclosporine, immunosuppressive drugs used after organ transplants;
• sulfonylureas, medicines used to treat diabetes;
• certain antibiotics (such as quinolones);
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that require urgent treatment (see section 2).

These medicines may be affected by Tachifenekid or may affect its effectiveness.
Dosage adjustments or substitution with other medicines may be necessary.
Many other medicines may also affect or be affected by treatment with Tachifenekid.
Therefore, always consult your doctor or pharmacist before using Tachifenekid with other medicines.
Your doctor or pharmacist can provide further information about these and other medicines to be cautious about or avoid while taking this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during the last three months of pregnancy.
This may cause kidney or heart problems in the unborn baby. It may affect your or your baby's tendency to bleed and may cause delayed or prolonged labour.
During the first six months of pregnancy, this product should not be administered unless strictly necessary and under medical advice.
If treatment is needed during this period or while trying to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from the 20th week of pregnancy onwards, this product may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
This product may impair female fertility and is not recommended for women wishing to conceive.

Driving and using machines
Exercise caution when driving or operating machinery until you know how Tachifenekid affects you.

Tachifenekid contains liquid maltitol, sodium benzoate, sodium, and propylene glycol

• Liquid maltitol: if your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
• Sodium benzoate: this medicine contains 1 mg of sodium benzoate per ml.
• Sodium: Tachifenekid contains up to 38 mg of sodium (the main component of table salt) per dose. This corresponds to 1.9% of the maximum daily recommended dietary intake for an adult.
• Propylene glycol: this medicine contains approximately 9.6 mg of propylene glycol per ml, equivalent to a maximum of 16 mg/kg/day.

If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3 How to use Tachifenekid
Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
In children up to 10 years of age, it is essential to follow the dosage based on body weight rather than age, which is only approximate and provided for informational purposes.

The product should be administered every 4–6 hours as needed, without exceeding 4 doses within 24 hours.
Adults or elderly patients taking this product should consult their doctor to determine the appropriate dose.
Use the lowest effective dose for the shortest duration necessary to relieve symptoms. Tachifenekid should be used only for short-term treatment. Consult a doctor if symptoms persist or worsen after 3 days.
If your doctor has prescribed a different dose, follow their instructions.

Instructions for using the syringe:

1. Shake the bottle for at least 10 seconds before use.
2. Firmly push the syringe into the dispenser (opening) on the neck of the bottle.

3. To fill the syringe, invert the bottle. While holding the syringe in place, gently pull the plunger down to draw the medicine up to the correct mark.

4. Return the bottle to an upright position, then gently rotate the syringe to detach it from the dispenser.

5. Insert the tip of the syringe into the child’s mouth (usually into the side between the cheek and gums). Press the plunger to slowly and gently administer the medicine.

6. If the table above indicates that more than 5 ml of medicine should be administered, repeat steps 2 to 5 to give the child the correct amount.
7. After use, replace the cap on the bottle and tighten it. Keep all medicines out of sight and reach of children.
8. Wash the syringe with warm water and allow it to dry.

Do not mix this medicine with food or drinks.

If you use more Tachifenekid than you should
Contact your doctor immediately if you or your child accidentally take too much of this medicine, even if you feel well. Excessive intake of paracetamol may cause severe and delayed liver damage. If you suspect that your child or someone else has taken an overdose of Tachifenekid, contact your doctor immediately or go to the nearest hospital emergency department. Do this even if no symptoms or signs of poisoning are present. Your child may require urgent medical care.
Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with traces of blood), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, tinnitus, confusion, and uncontrolled eye movements. Additionally, agitation, drowsiness, disorientation, or coma may occur. Occasionally, patients may develop seizures. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing difficulties may be reported.
Furthermore, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute kidney failure and liver damage may also occur. Asthma may be exacerbated in asthmatic patients. In addition, low blood pressure and reduced respiratory function may occur.

If you forget to give the medicine to your child
If it is almost time for the next dose, do not give the missed dose; only give the next dose at the scheduled time. Otherwise, give it as soon as you remember, and then continue with the regular dosing schedule.
Do not give your child a double dose to make up for a forgotten dose.
If you are unsure whether to skip the dose, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If any side effect worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.
If you experience any of the following serious side effects, stop using Tachifenekid and contact your doctor immediately or go to the nearest hospital emergency department:

• Flat, red spots, target-shaped or circular, on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes.

These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].

• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• Widespread, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (generalized acute exanthematous pustulosis).

Common:

• vomiting blood or material resembling coffee grounds;
• rectal bleeding, sticky and black stools (bowel movements), or diarrhoea with blood;
• swelling of the face, lips, or tongue, which may cause difficulty swallowing or breathing.

Very rare:

• asthma, wheezing, shortness of breath;
• sudden or severe itching, skin rash, urticaria;
• severe rash with blisters and bleeding from the lips, eyes, mouth, nose, and genitals (Stevens-Johnson syndrome). Very rare cases of severe skin reactions have been reported;
• worsening of existing severe skin infections (you may notice a rash, blistering, and skin discoloration, fever, drowsiness, diarrhoea, and malaise) or worsening of other infections including chickenpox or shingles, or a serious infection with destruction (necrosis) of subcutaneous tissue and muscles, blistering, and skin peeling;
• fever, general feeling of illness, nausea, stomach ache, headache, and neck stiffness.

Other possible side effects are:
Common (may affect up to 1 in 10 people):

• nausea or vomiting;
• loss of appetite;
• heartburn or pain in the upper stomach;
• cramps, flatulence, constipation or diarrhoea, minor gastrointestinal blood loss;
• skin rashes, skin itching;
• headache;
• dizziness;
• feeling nervous;
• ringing or buzzing in the ears;
• unusual weight gain, swelling and fluid retention, swelling of the ankles or legs (oedema).

Uncommon (may affect up to 1 in 100 people):

• reduced number of red blood cells, nosebleeds, and heavy menstrual periods;
• allergic reactions: skin rash, fatigue, joint pain (e.g., serum sickness, lupus erythematosus, Schönlein-Henoch purpura, angioedema);
• breast tissue enlargement in men; low blood sugar levels;
• insomnia;
• mood changes, such as depression, confusion, nervousness;
• eye problems, such as blurred vision (reversible), eye inflammation and redness, itching;
• thickening of mucus;
• wheezing due to interruption of airflow in children during tonsillectomy;
• low levels of oxygen in the blood;
• severe stomach pain or tenderness; peptic/gastrointestinal ulcer;
• inflammation of the intestine and worsening of colonic inflammation (colitis) and digestive tract (Crohn’s disease), and complications associated with diverticulosis of the large intestine (perforation or fistula);
• inability to completely empty the bladder (urinary retention);
• abnormalities in laboratory test results (blood tests and liver and kidney enzymes);
• postoperative bleeding after tonsillectomy.

Rare (may affect up to 1 in 1,000 people):

• tingling in hands and feet;
• abnormal dreams, hallucinations;
• kidney tissue damage (particularly with long-term use);
• high levels of uric acid in the blood (hyperuricaemia).

Very rare (may affect up to 1 in 10,000 people):

• low potassium levels – weakness, fatigue, muscle cramps (hypokalaemia);
• signs of anaemia, such as tiredness, headaches, breathlessness, and paleness;
• increased tendency to bleed or bruise easily, reddish or purplish spots under the skin;
• severe or persistent headache;
• sensation of dizziness (vertigo);
• rapid or irregular heartbeat, also known as palpitations;
• increased blood pressure and possible heart problems;
• inflammation of the oesophagus;
• yellowing of the skin and/or eyes, also known as jaundice;
• liver damage (particularly with long-term use);
• hair loss;
• increased sweating;
• signs of frequent or concerning infections, such as fever, severe chills, sore throat, or mouth ulcers.

Not known (frequency cannot be estimated from the available data):

• a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell);
• a widespread, red, scaly rash, with bumps under the skin and blisters, mainly affecting skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute exanthematous pustulosis). Stop using Tachifenekid if you develop these symptoms and contact your doctor immediately. See also section 2.
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome;
• a serious condition that may make the blood more acidic (called metabolic acidosis), in patients with a serious illness who are using paracetamol (see section 2).

The list above includes serious side effects requiring medical attention. Serious side effects are rare when low doses of this medicine are taken for a short period of time.
Reporting of side effects
If your child experiences any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tachifenekid

Keep this medicine out of the sight and reach of children.
Store below 25°C.
The shelf life after opening is 3 months, if stored at a temperature equal to or below 25°C.
Do not use this medicine after the expiry date stated on the carton and bottle after “EXP”.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the packaging is torn or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tachifenekid contains
The active substances are: paracetamol 32 mg and ibuprofen 9.6 mg per ml of product.
The other components are monohydrate citric acid (E330), glycerol (E422), liquid maltitol (E965),
polysorbate 80 (E433), sodium benzoate (E211), dihydrate sodium citrate (E331), sucralose (E955), Vivapur MCG
591P (microcrystalline cellulose and sodium carmellose), xanthan gum (E415), flavouring agent,
strawberry flavour, sweet flavour, vanilla flavour and carmine (E120).
Description of the appearance of Tachifenekid and package contents
Tachifenekid is a viscous pink suspension.
Each package contains a 100 ml or 200 ml bottle fitted with a child-resistant closure and a 5 ml dosing syringe to be used as an administration device.
Marketing Authorization Holder
Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A
Viale Amelia 70
00181 Rome, Italy.
Manufacturer
SAG Manufacturing S.L.U. Carretera N-I, Km 36, San Agustin de Guadalix, 28750 Madrid, Spain.
This medicinal product is authorized in the European Economic Area Member States under the following
names:
Italy: Tachifenekid
Malta: Tachifenekid 32 mg/ml + 9.6 mg/ml oral suspension