Kelemata herbal tea

PACKAGE LEAFLET

KELEMATA HERBAL TEA

Senna leaves
2 g “TEA” 10 sachets
Before use, carefully read all the information on the packaging
WHAT KELEMATA TEA IS AND WHAT IT IS USED FOR
Pharmacotherapeutic category
KELEMATA TEA is a laxative.
Therapeutic indications
Short-term treatment of occasional constipation.
BEFORE USING KELEMATA TEA
Do not use KELEMATA TEA in the following cases:
Hypersensitivity to the active substance or to any of the excipients.
Presence of acute or unknown origin abdominal pain, nausea or vomiting, intestinal obstruction or stenosis, rectal bleeding of unknown origin, severe state of dehydration.
Pregnancy and breastfeeding
Generally contraindicated during pregnancy and breastfeeding.
Children
Contraindicated in children under 10 years of age. In children under 12 years of age, this medicine may be used only after consulting a doctor.
Elderly and patients in poor health
It is advisable to consult a doctor before using this medicine.
Precautions for use
The treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of medication, and monitoring during therapy.
Consult a doctor when the need for a laxative arises from a sudden change in previous bowel habits (characteristic frequency of bowel movements) lasting more than 2 weeks, when constipation is persistent, or when use of the laxative fails to produce an effect.
Interaction with other medicines, foods and other forms of interaction
"Inform your doctor or pharmacist if you have recently taken any other medicines, including those without a prescription."
Laxatives may reduce intestinal transit time, and thus the absorption, of other medicines taken simultaneously by oral route. Therefore, avoid taking laxatives and other medicines at the same time: wait at least 2 hours after taking a medicine before taking the laxative.
Milk or antacids may alter the effect of the medicine; wait at least one hour before taking the laxative.
What to do during pregnancy and breastfeeding
"Ask your doctor or pharmacist for advice before taking any medicine."
Effects on ability to drive and use machines
KELEMATA TEA does not affect the ability to drive vehicles or operate machinery.
Special warnings
Abuse of laxatives (frequent or prolonged use, or excessive doses) may cause persistent diarrhoea, resulting in loss of water, mineral salts (especially potassium), and other essential nutrients.
In severe cases, dehydration or hypokalaemia (reduced potassium levels in the blood) may occur, which can lead to cardiac or neuromuscular dysfunction, particularly if concomitant treatment with cardiac glycosides, diuretics or corticosteroids is being administered.
Abuse of laxatives, especially stimulant (contact) laxatives, may lead to dependence (and therefore possible need to progressively increase the dose), chronic constipation, and loss of normal intestinal function (intestinal atony).
It should first be noted that, in most cases, a balanced diet rich in water and fibre (bran, vegetables and fruit) can durably resolve constipation.
Many people believe they suffer from constipation if they cannot defecate every day. This is a mistaken belief, as this condition is entirely normal for many individuals. Constipation should instead be considered when bowel movements are reduced compared to personal habits and are associated with the passage of hard stools.
If episodes of constipation recur frequently or if you have noticed any recent change in their characteristics, consult a doctor.
HOW TO USE KELEMATA TEA
Dosage and method
ORAL USE.
Prepare the tea as follows: place 1 sachet of KELEMATA TEA in a teacup; pour over boiling water and let steep for 10–15 minutes.
The sachet must never be boiled. The tea should be taken cold or lukewarm, optionally sweetened. A diet rich in fluids enhances the effect of the medicine.
The correct dose is the lowest dose sufficient to produce easy evacuation of soft stools. It is advisable to initially use the lowest recommended doses. If necessary, the dose may be increased, but must never exceed the maximum indicated dose.
Caution: Do not exceed the indicated doses without medical advice.
When and for how long:
Should preferably be taken in the evening before a meal. Laxatives should be used as infrequently as possible and for no longer than 7 days. Use for longer periods requires a doctor's prescription following adequate evaluation of the individual case.
Consult your doctor or pharmacist for any doubts regarding the use of this medicine.
What to do if you forget to take KELEMATA TEA
None. Do not take a double dose compared to the recommended usage.
If you take an excessive dose of KELEMATA TEA
Excessive doses may cause abdominal pain and diarrhoea; rehydration should be considered.
Also refer to the section “Special warnings” regarding laxative abuse.
Contact your doctor immediately or go to the nearest hospital.
"In case of accidental ingestion/overdose of KELEMATA TEA,
"notify your doctor immediately or go to the nearest hospital."
**Report any adverse reactions experienced while taking KELEMATA TEA,
"
POSSIBLE ADVERSE REACTIONS
"Like all medicines, it may cause adverse reactions, although not all people experience them."
KELEMATA TEA may cause adverse reactions. Following the instructions reduces the risk of such effects.
Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation.
With use of the product, urine may sometimes turn slightly yellow-brown or red. This discoloration is simply due to the presence in urine of senna components and is not clinically significant.
Prolonged use of laxatives may lead to tolerance or various types of damage.
These effects are generally transient. If they occur, consult your doctor or pharmacist.
It is important to inform your doctor or pharmacist of any adverse reactions not described in this leaflet.
"Following the instructions in the leaflet reduces the risk of adverse reactions."
*"Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. Adverse reactions can also be reported directly via the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili ". Reporting adverse reactions helps provide more information on the safety of this medicine.
EXPIRY DATE AND STORAGE
Expiry date: See the date on the packaging.
The expiry date refers to the product in intact, correctly stored packaging.
Caution: Do not use the medicine after the expiry date stated on the packaging.
Store the medicine at a temperature below 30°C
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep the medicine out of the sight and reach of children.
Composition
Each 2.0 g sachet contains:
Active ingredient:
Senna leaves (min. 2.5% hydroxyanthracene glycosides, expressed as sennoside B) 1026 mg
Excipients:
Couch grass rhizome, guaiac wood, hyssop leaves, pellitory leaves, peppermint leaves, sarsaparilla roots, star anise fruits, lemon balm tops.
Marketing Authorisation Holder
KELEMATA S.r.l. Corso Re Umberto, 20 10128 Turin
Manufacturer
Kelemata S.r.l. Martellago (VE) plant, via Castellana, 120
A.I.C.
Batch No.
Expiry date
OVER-THE-COUNTER MEDICINE NOT SUBJECT TO MEDICAL PRESCRIPTION
1.1
KELEMATA TEA
Senna leaves
“41.02 g POWDER FOR HERBAL TEA” 80 g pack
Before use, carefully read all the information on the packaging.
WHAT KELEMATA TEA IS AND WHAT IT IS USED FOR
Pharmacotherapeutic category: KELEMATA TEA is a laxative.
Therapeutic indications: short-term treatment of occasional constipation.
BEFORE USING KELEMATA TEA
Do not use KELEMATA TEA in the following cases:
Hypersensitivity to the active substance or to any of the excipients. Presence of acute or unknown origin abdominal pain, nausea or vomiting, intestinal obstruction or stenosis, rectal bleeding of unknown origin, severe state of dehydration.
Pregnancy and breastfeeding
Generally contraindicated during pregnancy and breastfeeding.
Children
Contraindicated in children under 10 years of age. In children under 12 years of age, this medicine may be used only after consulting a doctor.
Elderly and patients in poor health
It is advisable to consult a doctor before using this medicine.
Precautions for use
The treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of medication, and monitoring during therapy.
Consult a doctor when the need for a laxative arises from a sudden change in previous bowel habits (characteristic frequency of bowel movements) lasting more than 2 weeks, when constipation is persistent, or when use of the laxative fails to produce an effect.
Interaction with other medicines, foods and other forms of interaction
Laxatives may reduce intestinal transit time, and thus the absorption, of other medicines taken simultaneously by oral route. Therefore, avoid taking laxatives and other medicines at the same time: wait at least 2 hours after taking a medicine before taking the laxative.
Milk or antacids may alter the effect of the medicine; wait at least one hour before taking the laxative.
Special warnings
Abuse of laxatives (frequent or prolonged use, or excessive doses) may cause persistent diarrhoea, resulting in loss of water, mineral salts (especially potassium), and other essential nutrients. In severe cases, dehydration or hypokalaemia (reduced potassium levels in the blood) may occur, which can lead to cardiac or neuromuscular dysfunction, particularly if concomitant treatment with cardiac glycosides, diuretics or corticosteroids is being administered. Abuse of laxatives, especially stimulant (contact) laxatives, may lead to dependence (and therefore possible need to progressively increase the dose), chronic constipation, and loss of normal intestinal function (intestinal atony).
It should first be noted that, in most cases, a balanced diet rich in water and fibre (bran, vegetables and fruit) can durably resolve constipation. Many people believe they suffer from constipation if they cannot defecate every day. This is a mistaken belief, as this condition is entirely normal for many individuals. Constipation should instead be considered when bowel movements are reduced compared to personal habits and are associated with the passage of hard stools.
If episodes of constipation recur frequently or if you have noticed any recent change in their characteristics, consult a doctor.
Effects on ability to drive and use machines: none.
HOW TO USE KELEMATA TEA
Dosage and method
ORAL USE.
Prepare the tea as follows: place 1–2 teaspoons of KELEMATA TEA powder (dose variable according to individual sensitivity) in a teacup; pour over boiling water and let steep for 10–15 minutes, then strain.
Never boil the herbs. The tea should be taken cold or lukewarm, optionally sweetened. A diet rich in fluids enhances the effect of the medicine.
The correct dose is the lowest dose sufficient to produce easy evacuation of soft stools. It is advisable to initially use the lowest recommended doses. If necessary, the dose may be increased, but must never exceed the maximum indicated dose.
Caution: Do not exceed the indicated doses without medical advice.
When and for how long: should preferably be taken in the evening before a meal. Laxatives should be used as infrequently as possible and for no longer than 7 days. Use for longer periods requires a doctor's prescription following adequate evaluation of the individual case.
Consult your doctor or pharmacist for any doubts regarding the use of this medicine.
If you take an excessive dose of KELEMATA TEA
Excessive doses may cause abdominal pain and diarrhoea; rehydration should be considered.
Also refer to the section “Special warnings” regarding laxative abuse.
Contact your doctor immediately or go to the nearest hospital.
What to do if you forget to take KELEMATA TEA
None. Do not take a double dose compared to the recommended usage.
POSSIBLE ADVERSE REACTIONS
Like all medicines, KELEMATA TEA may cause adverse reactions. Following the instructions in the leaflet reduces the risk of adverse reactions.
Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation.
With use of the product, urine may sometimes turn slightly yellow-brown or red. This discoloration is simply due to the presence in urine of senna components and is not clinically significant.
Prolonged use of laxatives may lead to tolerance or various types of damage.
These adverse reactions are generally transient. However, if they occur, consult your doctor or pharmacist.
It is important to inform your doctor or pharmacist of any adverse reactions not described in this leaflet.
EXPIRY DATE AND STORAGE
Expiry date: See the date on the packaging.
The expiry date refers to the product in intact, correctly stored packaging.
Caution: Do not use the medicine after the expiry date stated on the packaging.
Store the medicine at a temperature below 30°C
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep the medicine out of the sight and reach of children.
Composition: 80 g contains
Active ingredient:
Senna leaves 41.02 g
(min. 2.5% hydroxyanthracene glycosides, expressed as sennoside B).
Excipients:
Couch grass rhizome, guaiac wood, hyssop leaves, pellitory leaves, peppermint leaves, sarsaparilla roots, star anise fruits, lemon balm tops.
Marketing Authorisation Holder
Kelémata S.r.l. Corso Re Umberto, 20 10128 Turin
Manufacturer
Kelémata S.r.l. Martellago (VE) plant, via Castellana, 120
A.I.C 000367058
Batch No.
Expiry date
OVER-THE-COUNTER MEDICINE NOT SUBJECT TO MEDICAL PRESCRIPTION
KELEMATA TEA
Senna leaves
“51.28 g POWDER FOR HERBAL TEA” 100 g pack
Before use, carefully read all the information on the packaging.
WHAT KELEMATA TEA IS AND WHAT IT IS USED FOR
Pharmacotherapeutic category
KELEMATA TEA is a laxative.
Therapeutic indications
Short-term treatment of occasional constipation.
BEFORE USING KELEMATA TEA
Do not use KELEMATA TEA in the following cases:
Hypersensitivity to the active substance or to any of the excipients.
Presence of acute or unknown origin abdominal pain, nausea or vomiting, intestinal obstruction or stenosis, rectal bleeding of unknown origin, severe state of dehydration.
Pregnancy and breastfeeding
Generally contraindicated during pregnancy and breastfeeding.
Children
Contraindicated in children under 10 years of age. In children under 12 years of age, this medicine may be used only after consulting a doctor.
Elderly and patients in poor health
It is advisable to consult a doctor before using this medicine.
Precautions for use
The treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of medication, and monitoring during therapy.
Consult a doctor when the need for a laxative arises from a sudden change in previous bowel habits (characteristic frequency of bowel movements) lasting more than 2 weeks, when constipation is persistent, or when use of the laxative fails to produce an effect.
Interaction with other medicines, foods and other forms of interaction
Laxatives may reduce intestinal transit time, and thus the absorption, of other medicines taken simultaneously by oral route. Therefore, avoid taking laxatives and other medicines at the same time: wait at least 2 hours after taking a medicine before taking the laxative.
Milk or antacids may alter the effect of the medicine; wait at least one hour before taking the laxative.
Special warnings
Abuse of laxatives (frequent or prolonged use, or excessive doses) may cause persistent diarrhoea, resulting in loss of water, mineral salts (especially potassium), and other essential nutrients. In severe cases, dehydration or hypokalaemia (reduced potassium levels in the blood) may occur, which can lead to cardiac or neuromuscular dysfunction, particularly if concomitant treatment with cardiac glycosides, diuretics or corticosteroids is being administered. Abuse of laxatives, especially stimulant (contact) laxatives, may lead to dependence (and therefore possible need to progressively increase the dose), chronic constipation, and loss of normal intestinal function (intestinal atony).
It should first be noted that, in most cases, a balanced diet rich in water and fibre (bran, vegetables and fruit) can durably resolve constipation. Many people believe they suffer from constipation if they cannot defecate every day. This is a mistaken belief, as this condition is entirely normal for many individuals. Constipation should instead be considered when bowel movements are reduced compared to personal habits and are associated with the passage of hard stools.
If episodes of constipation recur frequently or if you have noticed any recent change in their characteristics, consult a doctor.
Effects on ability to drive and use machines
None.
HOW TO USE KELEMATA TEA
Dosage and method
ORAL USE.
Prepare the tea as follows: place 1–2 teaspoons of KELEMATA TEA powder (dose variable according to individual sensitivity) in a teacup; pour over boiling water and let steep for 10–15 minutes, then strain.
Never boil the herbs. The tea should be taken cold or lukewarm, optionally sweetened. A diet rich in fluids enhances the effect of the medicine.
The correct dose is the lowest dose sufficient to produce easy evacuation of soft stools. It is advisable to initially use the lowest recommended doses. If necessary, the dose may be increased, but must never exceed the maximum indicated dose.
Caution: Do not exceed the indicated doses without medical advice.
When and for how long:
Should preferably be taken in the evening before a meal.
Laxatives should be used as infrequently as possible and for no longer than 7 days. Use for longer periods requires a doctor's prescription following adequate evaluation of the individual case.
Consult your doctor or pharmacist for any doubts regarding the use of this medicine.
If you take an excessive dose of KELEMATA TEA
Excessive doses may cause abdominal pain and diarrhoea; rehydration should be considered.
Also refer to the section “Special warnings” regarding laxative abuse.
Contact your doctor immediately or go to the nearest hospital.
What to do if you forget to take KELEMATA TEA
None. Do not take a double dose compared to the recommended usage.
POSSIBLE ADVERSE REACTIONS
Like all medicines, KELEMATA TEA may cause adverse reactions. Following the instructions in the leaflet reduces the risk of adverse reactions.
Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation.
With use of the product, urine may sometimes turn slightly yellow-brown or red. This discoloration is simply due to the presence in urine of senna components and is not clinically significant.
Prolonged use of laxatives may lead to tolerance or various types of damage.
These adverse reactions are generally transient. However, if they occur, consult your doctor or pharmacist.
It is important to inform your doctor or pharmacist of any adverse reactions not described in this leaflet.
EXPIRY DATE AND STORAGE
Expiry date: See the date on the packaging.
The expiry date refers to the product in intact, correctly stored packaging.
Caution: Do not use the medicine after the expiry date stated on the packaging.
Store the medicine at a temperature below 30°C
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep the medicine out of the sight and reach of children.
Composition: 100 g contains
Active ingredient:
Senna leaves 51.28 g
(min. 2.5% hydroxyanthracene glycosides, expressed as sennoside B).
Excipients:
Couch grass rhizome, guaiac wood, hyssop leaves, pellitory leaves, peppermint leaves, sarsaparilla roots, star anise fruits, lemon balm tops.
Marketing Authorisation Holder
Kelémata S.r.l. Corso Re Umberto, 20 10128 Turin
Manufacturer
Kelémata S.r.l. Martellago (VE) plant, via Castellana, 120
A.I.C 000367060
Batch No.
Expiry date
OVER-THE-COUNTER MEDICINE NOT SUBJECT TO MEDICAL PRESCRIPTION
Revision of the package leaflet by the Italian Medicines Agency:
1.2
KELEMATA TEA
Senna leaves
“1.3 g TEA” 20 sachets
Before use, carefully read all the information on the packaging
WHAT KELEMATA TEA IS AND WHAT IT IS USED FOR
Pharmacotherapeutic category: KELEMATA TEA is a laxative.
Therapeutic indications: short-term treatment of occasional constipation.
BEFORE USING KELEMATA TEA
Do not use KELEMATA TEA in the following cases:
Hypersensitivity to the active substance or to any of the excipients.
Presence of acute or unknown origin abdominal pain, nausea or vomiting, intestinal obstruction or stenosis, rectal bleeding of unknown origin, severe state of dehydration.
Pregnancy and breastfeeding
Generally contraindicated during pregnancy and breastfeeding.
Children
Contraindicated in children under 10 years of age. In children under 12 years of age, this medicine may be used only after consulting a doctor.
Elderly and patients in poor health
It is advisable to consult a doctor before using this medicine.
Precautions for use
The treatment of chronic or recurrent constipation always requires medical intervention for diagnosis, prescription of medication, and monitoring during therapy. Consult a doctor when the need for a laxative arises from a sudden change in previous bowel habits (characteristic frequency of bowel movements) lasting more than 2 weeks, when constipation is persistent, or when use of the laxative fails to produce an effect.
Interaction with other medicines, foods and other forms of interaction
Laxatives may reduce intestinal transit time, and thus the absorption, of other medicines taken simultaneously by oral route. Therefore, avoid taking laxatives and other medicines at the same time: wait at least 2 hours after taking a medicine before taking the laxative.
Milk or antacids may alter the effect of the medicine; wait at least one hour before taking the laxative.
Effects on ability to drive and use machines: none.
Special warnings
Abuse of laxatives (frequent or prolonged use, or excessive doses) may cause persistent diarrhoea, resulting in loss of water, mineral salts (especially potassium), and other essential nutrients.
In severe cases, dehydration or hypokalaemia (reduced potassium levels in the blood) may occur, which can lead to cardiac or neuromuscular dysfunction, particularly if concomitant treatment with cardiac glycosides, diuretics or corticosteroids is being administered.
Abuse of laxatives, especially stimulant (contact) laxatives, may lead to dependence (and therefore possible need to progressively increase the dose), chronic constipation, and loss of normal intestinal function (intestinal atony).
It should first be noted that, in most cases, a balanced diet rich in water and fibre (bran, vegetables and fruit) can durably resolve constipation.
Many people believe they suffer from constipation if they cannot defecate every day. This is a mistaken belief, as this condition is entirely normal for many individuals. Constipation should instead be considered when bowel movements are reduced compared to personal habits and are associated with the passage of hard stools.
If episodes of constipation recur frequently or if you have noticed any recent change in their characteristics, consult a doctor.
HOW TO USE KELEMATA TEA
Dosage and method: ORAL USE.
Prepare the tea as follows: place 1–2 sachets of KELEMATA TEA (dose variable according to individual sensitivity) in a teacup; pour over boiling water and let steep for 10–15 minutes.
The sachet must never be boiled. The tea should be taken cold or lukewarm, optionally sweetened. A diet rich in fluids enhances the effect of the medicine.
The correct dose is the lowest dose sufficient to produce easy evacuation of soft stools. It is advisable to initially use the lowest recommended doses. If necessary, the dose may be increased, but must never exceed the maximum indicated dose.
Caution: Do not exceed the indicated doses without medical advice.
When and for how long:
Should preferably be taken in the evening before a meal. Laxatives should be used as infrequently as possible and for no longer than 7 days. Use for longer periods requires a doctor's prescription following adequate evaluation of the individual case.
Consult your doctor or pharmacist for any doubts regarding the use of this medicine.
What to do if you forget to take KELEMATA TEA: None. Do not take a double dose compared to the recommended usage.
If you take an excessive dose of KELEMATA TEA
Excessive doses may cause abdominal pain and diarrhoea; rehydration should be considered.
Also refer to the section “Special warnings” regarding laxative abuse.
Contact your doctor immediately or go to the nearest hospital.
POSSIBLE ADVERSE REACTIONS
KELEMATA TEA may cause adverse reactions. Following the instructions reduces the risk of such effects.
Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation.
With use of the product, urine may sometimes turn slightly yellow-brown or red. This discoloration is simply due to the presence in urine of senna components and is not clinically significant.
Prolonged use of laxatives may lead to tolerance or various types of damage.
These effects are generally transient. If they occur, consult your doctor or pharmacist.
It is important to inform your doctor or pharmacist of any adverse reactions not described in this leaflet.
EXPIRY DATE AND STORAGE
Expiry date: See the date on the packaging.
The expiry date refers to the product in intact, correctly stored packaging.
Caution: Do not use the medicine after the expiry date stated on the packaging.
Store the medicine at a temperature below 30°C
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep the medicine out of the sight and reach of children.
Composition
Each 1.3 g sachet contains:
Active substance: Senna leaves (min. 2.5% hydroxyanthracene glycosides, expressed as sennoside B) 667 mg
Excipients: Couch grass rhizome, guaiac wood, hyssop leaves, pellitory leaves, peppermint leaves, sarsaparilla roots, star anise fruits, lemon balm tops.
Marketing Authorisation Holder
KELEMATA S.r.l. Corso Re Umberto, 20 10128 Turin
Manufacturer
Kelemata S.r.l. Martellago (VE) plant, via Castellana, 120
A.I.C.
Batch No.
Expiry date
OVER-THE-COUNTER MEDICINE NOT SUBJECT TO MEDICAL PRESCRIPTION
1.3

PACKAGE LEAFLET

FOGLIO ILLUSTRATIVO

PACKAGE LEAFLET

KELEMATA TEA

“16 mg FILM-COATED TABLETS” 40 Tablets
Dry Senna Extract
Please read this leaflet carefully because it contains important information for you.
This medicine can be obtained without a doctor's prescription. However, you must use it carefully
to achieve the best results.
Keep this leaflet, as you may need to read it again.
If you would like more information or advice, please consult your pharmacist.
If your symptoms worsen or do not improve after a short period of treatment, you should
contact your doctor.
In this leaflet:

1. What TISANA KELEMATA is and what it is used for
2. Before you take TISANA KELEMATA
3. How to take TISANA KELEMATA
4. Possible side effects
5. How to store TISANA KELEMATA
6. Further information

1. WHAT TISANA KELEMATA IS AND WHAT IT IS USED FOR

Pharmacotherapeutic category
TISANA KELEMATA is a laxative.
Therapeutic indications
Short-term treatment of occasional constipation.

2. BEFORE USING KELEMATA HERBAL TEA

Do not use KELEMATA HERBAL TEA in the following cases:
Hypersensitivity to the active substance or to any of the excipients. Presence of acute or unknown origin abdominal pain, nausea or vomiting, intestinal obstruction or stenosis, rectal bleeding of unknown origin, severe dehydration.
Pregnancy and breastfeeding
Generally contraindicated during pregnancy and breastfeeding.
Children
Contraindicated in children under 10 years of age. In children under 12 years, this medicine should be used only after consulting a doctor.
Elderly and individuals in poor health
It is advisable to consult a doctor before using this medicine.
Precautions for use
The treatment of chronic or recurrent constipation always requires medical supervision for diagnosis, prescription of medication, and monitoring during therapy. Consult your doctor if the need for a laxative arises from a sudden change in previous bowel habits (frequency and characteristics of bowel movements) lasting more than 2 weeks, if constipation is persistent, or if use of the laxative fails to produce an effect.
Interaction with other medicines, foods, and other forms of interaction
Laxatives may reduce intestinal transit time, and thus the absorption, of other medicines taken simultaneously by oral route. Therefore, avoid taking laxatives and other medicines at the same time: wait at least 2 hours after taking any medicine before taking the laxative. Milk or antacids may alter the effect of the medicine; wait at least 1 hour before taking the laxative.
Special warnings
Abuse of laxatives (frequent or prolonged use, or excessive doses) may cause persistent diarrhea leading to loss of water, mineral salts (especially potassium), and other essential nutrients. In severe cases, dehydration or hypokalemia (reduced potassium levels in the blood) may occur, which can lead to cardiac or neuromuscular dysfunction, especially if the patient is concurrently being treated with cardiac glycosides, diuretics, or corticosteroids. Abuse of laxatives—particularly stimulant laxatives (contact laxatives)—may lead to dependence (and thus the possible need to progressively increase the dose), chronic constipation, and loss of normal intestinal function (intestinal atony). It should first of all be remembered that, in most cases, a balanced diet rich in water and fiber (bran, vegetables, and fruit) can provide a lasting solution to constipation. Many people believe they suffer from constipation if they do not have a bowel movement every day. This is a mistaken belief, as such a condition is entirely normal for many individuals. Constipation should instead be considered present when bowel movements are reduced compared to one's usual habits and are associated with the passage of hard stools. If episodes of constipation recur frequently or if you have noticed any recent changes in their characteristics, consult your doctor.
Effects on the ability to drive and use machinery: none.

3. HOW TO USE TISANA KELEMATA

Dosage and method
ORAL USE. Take 2-3 coated tablets with a generous glass of water. A diet rich in fluids supports the effect of the medicine. The correct dose is the lowest dose sufficient to produce easy evacuation of soft stools. It is advisable to initially use the minimum recommended doses. When necessary, the dose may subsequently be increased, but must never exceed the maximum dose indicated. Warning: Do not exceed the stated doses without medical advice.
When and for how long:
Preferably take in the evening before a meal. Laxatives should be used as infrequently as possible and for no longer than 7 days. Use for longer periods requires a doctor's prescription following an appropriate assessment of the individual case. Consult your doctor or pharmacist for any doubts regarding the use of this medicine.
If you take an excessive dose of TISANA KELEMATA
Excessive doses may cause abdominal pain and diarrhea; rehydration should be undertaken. See also the section “Special warnings” regarding laxative abuse. Immediately contact your doctor or go to the nearest hospital.
What to do if you forget to take TISANA KELEMATA
None. Do not take a double dose to make up for the missed dose.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, KELEMATA TEA may cause adverse reactions. Following the instructions contained in this leaflet reduces the risk of adverse reactions. Occasionally: isolated cramping pains or abdominal colic, more frequent in cases of severe constipation. During use of the product, urine may occasionally become slightly yellowish-brown or red in colour. This discolouration is simply due to the presence in the urine of components derived from senna and is not clinically significant. Prolonged use of laxatives may lead to dependence or various types of damage. These adverse reactions are generally transient. However, if they occur, it is advisable to consult a doctor or pharmacist. It is important to inform the doctor or pharmacist of any adverse reactions not described in this leaflet.

5. HOW TO STORE KELEMATA HERBAL TEA

Do not use the medicine after the expiry date stated on the packaging.
This medicine does not require any special storage conditions.
Keep the medicine out of the reach and sight of children.
EXPIRY DATE AND STORAGE
Expiry date: See the date printed on the packaging.
The expiry date refers to the product stored in its original, unopened packaging and kept under appropriate conditions.
Warning: do not use the medicine after the expiry date indicated on the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep the medicine out of the reach and sight of children.
Composition: each coated tablet contains:
Active substance: Senna dry extract 16.00 mg (standardized to 45% sennosides).
Excipients: Composite dry extract, Sucrose, Silica, Magnesium stearate, Corn starch, Titanium dioxide, Arabic gum, Talc, Iron oxide.
Pharmaceutical form and contents:
"16 mg coated tablets" (pack containing 40 tablets)
Marketing Authorization Holder:
Kelémata S.r.l., Corso Re Umberto, 20 – 10128 Torino
Manufacturer:
Doppel Farmaceutici S.r.l. – 20089 Quinto de Stampi – Rozzano (Mi)
Kelemata S.r.l., Martellago (Ve) plant, via Castellana, 120