Biochetasi

Package leaflet: Information for the patient

Biochetasi effervescent tablets

Biochetasi effervescent granules
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

1. What Biochetasi is and what it is used for
2. What you need to know before taking Biochetasi
3. How to take Biochetasi
4. Possible side effects
5. How to store Biochetasi
6. Package contents and other information

1. What Biochetasi is and what it is used for

Biochetasi contains the active substances sodium citrate, potassium citrate, thiamine diphosphate free ester (vitamin B),
riboflavin 5-monophosphate monosodium salt (vitamin B), vitamin B hydrochloride, citric acid.
Biochetasi is indicated for:

• excessive stomach acidity (gastric hyperacidity);
• difficult digestion;
• liver function insufficiency;
• conditions involving excess ketone bodies (substances derived from fat metabolism) in the blood (ketonemic states);
• nausea during pregnancy.

Consult your doctor if you do not feel better or feel worse after a short period of treatment, if the disorder recurs repeatedly, or if you notice any recent change in its characteristics.

2. What you need to know before taking Biochetasi

Do not take Biochetasi

• if you are allergic to the active substances, to substances that are chemically very similar, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Biochetasi.
Other medicines and Biochetasi
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Inform your doctor if you are taking:
propanteline bromide (a medicine used for abdominal pain)
levodopa (a medicine used in the treatment of Parkinson's disease);
antacids (medicines used to treat stomach disorders).
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Biochetasi may be used during pregnancy and breastfeeding.
Driving and using machines
Biochetasi does not impair the ability to drive or operate machinery.
Biochetasi effervescent tablets contain sucrose, sodium, and aspartame
Biochetasi effervescent tablets contain sucrose. If your doctor has diagnosed you with an intolerance to
certain sugars, contact him or her before taking this medicine.
This medicine contains 10.3 mmol (or 238 mg) of sodium (a main component of table salt) per effervescent tablet. This corresponds to 11.9% of the maximum daily recommended dietary intake for an adult.
Biochetasi effervescent tablets contain aspartame. This medicine is a source of phenylalanine.
It may be harmful if you have phenylketonuria.
Biochetasi effervescent granules contain sorbitol, glucose, sucrose, sodium, and fructose
Biochetasi effervescent granules contain 125 mg of sorbitol and 650 mg of fructose. Sorbitol is a source of fructose. If your doctor has told you (or your child) that you (or your child) are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients are unable to metabolize fructose, speak to your doctor before you (or your child) take this medicine.
Biochetasi effervescent granules contain glucose and sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
Biochetasi effervescent granules contain glucose, sucrose, and fructose, which may be harmful to teeth.
This medicine contains approximately 1.7 g of sucrose and 1.4 g of glucose per dose (sachet). This should be taken into account in patients with diabetes mellitus.
This medicine contains 6.2 mmol (or 142 mg) of sodium (a main component of table salt) per sachet. This corresponds to 7.1% of the maximum daily recommended dietary intake for an adult.

3. How to take Biochetasi

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Do not exceed the recommended doses and use Biochetasi only for short-term treatment.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment, if the condition recurs repeatedly, or if you notice any recent changes in its characteristics.

Adults and children over 12 years of age
The recommended dose is 2 effervescent tablets or 2 sachets of effervescent granules, taken 3 times daily.
The tablets or sachets of effervescent granules must be dissolved in half a glass of water.

Use in children under 12 years of age
The recommended dose in children under 12 years of age is 1 effervescent tablet or 1 sachet of effervescent granules, taken 3 times daily.
The tablets or sachets of effervescent granules must be dissolved in half a glass of water.

If you take more Biochetasi than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.

If you forget to take Biochetasi
Do not take a double dose to make up for the forgotten dose.

If you stop taking Biochetasi
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Frequency not known (frequency cannot be estimated from the available data):
Urticaria, nausea, skin rash, swelling of the lips (angioedema of the lips), excretion of coloured urine (chromaturia).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell 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 Biochetasi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
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 Biochetasi contains
Biochetasi effervescent tablets

• The active substances are sodium citrate, potassium citrate, free thiamine diphosphate ester, riboflavin 5-monophosphate monosodium salt, vitamin B hydrochloride, citric acid. Each effervescent tablet contains:
  o sodium citrate 425 mg
  o potassium citrate 50 mg
  o free thiamine diphosphate ester 50 mg
  o riboflavin 5-monophosphate monosodium salt 25 mg
  o vitamin B hydrochloride 12.5 mg
  o citric acid 70 mg
• Other components are tartaric acid, aspartame, orange flavour, sucrose, insoluble polyvinylpyrrolidone, polyvinylpyrrolidone, talc, precipitated silica, sodium bicarbonate.

Biochetasi effervescent granules

• The active substances are sodium citrate, potassium citrate, free thiamine diphosphate ester, riboflavin 5-monophosphate monosodium salt, vitamin B hydrochloride, citric acid. Each sachet contains:
  o sodium citrate 425 mg
  o potassium citrate 50 mg
  o free thiamine diphosphate ester 50 mg
  o riboflavin 5-monophosphate monosodium salt 25 mg
  o vitamin B hydrochloride 12.5 mg
  o citric acid 100 mg
• Other components are malic acid, sorbitol, tartaric acid, sodium bicarbonate, polyvinylpyrrolidone, orange flavour, saccharin, sodium edetate, propyl gallate, sucrose, fructose, glucose.

Description of the appearance of Biochetasi and contents of the pack
Biochetasi effervescent tablets
Each pack contains 10 or 20 effervescent tablets.
Biochetasi effervescent granules
Each pack contains 10, 16, 18 or 20 sachets of effervescent granules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)
Manufacturer
Alfasigma S.p.A. - Via Pontina km 30,400 - 00071 Pomezia (RM)

Patient information leaflet: information for the patient

Biochetasi suppositories

Please read this leaflet carefully before using this medicine, as it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

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

1. What Biochetasi is and what it is used for

Biochetasi contains the active ingredients thiamine diphosphate free ester (vitamin B1), riboflavin-5'-monophosphate sodium salt (vitamin B2), vitamin B6, sodium citrate, and potassium citrate.
Biochetasi is indicated in toxic conditions, particularly those characterized by acidosis or ketosis, namely:

• vomiting during pregnancy;
• excess acids in the body (state of acidosis or ketosis) and diabetic coma;
• liver dysfunction with impaired fat digestion;
• intoxication due to burns.

2. What you need to know before using Biochetasi

Do not use Biochetasi

• if you are allergic to the active substances, to substances that are chemically very similar, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using Biochetasi.
Other medicines and Biochetasi
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
Inform your doctor if you are taking:
propanteline bromide (a medicine used for abdominal pain)
levodopa (a medicine used in the treatment of Parkinson's disease);
antacids (medicines used to treat stomach disorders).
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Biochetasi may be used during pregnancy and breastfeeding.
Driving and using machines
Biochetasi does not affect the ability to drive or operate machinery.

3. How to use Biochetasi

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 or 2 suppositories per day.
If you use more Biochetasi than you should
In case of accidental ingestion or overdose, contact your doctor immediately or go to the nearest hospital.
If you forget to use Biochetasi
Do not use a double dose to make up for the forgotten dose.
If you stop using Biochetasi
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Frequency not known (frequency cannot be estimated from the available data):
Urticaria, nausea, rash, swelling of the lips (lip oedema), coloured urine (chromaturia).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to 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 Biochetasi

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”. The expiry date refers to the last day of that month.
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 Biochetasi contains

• The active substances are free thiamin diphosphate ester (vitamin B1), monosodium riboflavin-5’-phosphate (vitamin B2), vitamin B6, sodium citrate, potassium citrate. Each suppository contains:
  o free thiamin diphosphate ester 150 mg
  o monosodium riboflavin-5’-phosphate 50 mg
  o vitamin B6 30 mg
  o sodium citrate 250 mg
  o potassium citrate 10 mg
• The other component is solid semisynthetic glycerides.

Description of the appearance of Biochetasi and contents of the pack
Each pack contains 6 suppositories of 1.750 g.
Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del '99, n. 5 - 40133 Bologna (BO)
Manufacturer
Alfasigma S.p.A. - Via Pontina km 30,400 - 00071 Pomezia (RM)