PHARMATRES TISANE

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

PHARMATRES Tisana

Cassia angustifolia Vahl. and Fucus vesiculosus L.

In this leaflet:

1. What PHARMATRES Tisana is and what it is used for
2. Before taking PHARMATRES Tisana
3. How to take PHARMATRES Tisana
4. Possible side effects
5. Storage of PHARMATRES Tisana
6. Additional information

1. What PHARMATRES Tisana is and what it is used for

PHARMATRES Tisanais a plant-based medicine for the short-term treatment of occasional constipation.

PHARMATRES Tisanais an association of vegetable laxatives, which stimulate intestinal activity, favoring the evacuation of feces.

2. Before using PHARMATRES Tisana

Do not take PHARMATRES Tisana:

• Do not administer this medicine to children under 12 years of age.
• If you are allergic (hypersensitive) to the components of PHARMATRES Tisana
• If you have abdominal pain of unknown origin.
• If you are suffering or have recently suffered from diarrhea or vomiting with significant loss of fluids or minerals.
• If you have intestinal obstruction and stenosis, atony, appendicitis, inflammatory bowel diseases (such as Crohn's disease, ulcerative colitis)
• If you have any thyroid gland disorder (hyperthyroidism)

Be careful with PHARMATRES Tisana:

• If you are taking other medicines such as cardiac glycosides, arrhythmia medications, medications that induce QT interval prolongation, diuretics, corticosteroids, or licorice root.
• If you have acute or persistent undiagnosed gastrointestinal disorders.
• If you need to take laxatives frequently, the cause of constipation should be investigated.
• The frequent use of this type of laxative should be avoided.
• If you have any kidney disease.
• If you have any thyroid gland disorder or if you are being treated with antithyroid medication (hyperthyroidism).

The prolonged use of this medicine can produce an adaptation of the body with some dependence, which would require increasing the dosage to achieve the same results. Additionally, the abuse of laxatives can cause intestinal disorders such as diarrhea with consequent loss of fluid and electrolytes (mainly a decrease in potassium). Similarly, long-term abuse can also worsen constipation.

Use of other medicines:

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription, homeopathic medicines, herbal remedies, and other health-related products.

The prolonged use of laxatives can lead to a decrease in potassium levels, which can increase the action of other medicines administered for the heart (antiarrhythmics, diuretics, corticosteroids, and/or licorice root).

The action of this medicine on intestinal transit could modify the levels of other medicines taken orally at the same time.

Taking PHARMATRES Tisana with food and drinks

Food and drinks do not influence the effect of the medicine.

Use in children:

Do not use in children under 12 years of age.

Use in the elderly:

Elderly patients may be more sensitive to the action of this medicine and therefore may require a lower dose.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking this medicine.

The use during pregnancy and breastfeeding is not recommended.

Driving and using machines:

No effects on the ability to drive and use machines have been described.

3. How to take PHARMATRES Tisana

Follow these instructions unless your doctor has given you different ones.

Consult your doctor or pharmacist if you have any doubts.

If you think the action of PHARMATRES Tisanais too strong or too weak, inform your doctor or pharmacist.

Adolescents over 12 years of age, adults, and the elderly: The recommended dose is 1 bag per day, administered as an infusion (one cup, 250 ml), preferably before bedtime.

Generally, it is sufficient to take the medicine 2 or 3 times to achieve the desired effect.

The medicine usually takes 6 to 12 hours to produce its laxative action; therefore, it is recommended to take it once at night, so that the effect occurs in the morning.

The maximum recommended treatment duration will be 6 days; if symptoms persist after this period, consult your doctor or pharmacist.

If, after 4 days of taking PHARMATRES Tisana, defecation has not occurred, the treatment should be suspended immediately and your doctor consulted.

If you think the action of PHARMATRES Tisanais too strong or too weak, inform your doctor or pharmacist.

If you take more PHARMATRES Tisana than you should:

Taking much higher doses of the product than recommended can cause excessive intestinal activity, presenting abdominal pain, spasms, and massive diarrhea with loss of water and electrolytes. If the electrolyte imbalance is severe, it can cause confusion, cardiac arrhythmia, cramps, fatigue, or weakness, which can be more pronounced in the elderly. However, the possibility of intoxication from consuming the infusions is very low.

If you have taken more PHARMATRES Tisanathan you should, consult your doctor, pharmacist, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take PHARMATRES Tisana:

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

Other information about the treatment of constipation

Although intestinal habits are not the same in all people, it can be said that there is constipation when more than 3 days pass without bowel movement or when the routine of bowel movements is temporarily interrupted. Constipation is also considered to exist if the stools are scarce or hard and pain occurs during evacuation.

Constipation often occurs due to lack of physical exercise, also due to ingesting small amounts of liquid or eating foods low in fiber. Therefore, it is essential to follow the following recommendations for the prevention of constipation, which can avoid the use of laxatives:

• You should change your eating habits. Eat foods rich in fiber, fruits, vegetables, legumes, etc.
• Drink plenty of water.
• Avoid sedentary lifestyle by doing regular physical exercise.
• When you feel the need to go to the bathroom, do not put it off until later.
• Try to have bowel movements at the same time every day.
• Make sure to dedicate enough time for bowel movements to occur without rushing.

4. Possible side effects

Like all medicines, PHARMATRES Tisanacan have side effects, although not everyone will experience them.

Occasionally, abdominal pain and spasms, bloating (gas in the abdomen), nausea, mucous stools and/or diarrhea, skin rashes, and allergic reactions may occur. The urine may turn yellow-brown in color, although this has no clinical significance. All these symptoms disappear when treatment is stopped.

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of PHARMATRES Tisana

Keep PHARMATRES Tisanaout of the reach and sight of children.

No special storage conditions are required.

Expiry date

Do not use PHARMATRES Tisanaafter the expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Additional information

Composition of PHARMATRES Tisana

Each bag contains as active ingredients:

• 0.375 g of Cassia angustifolia Vahl. leaves*
• 0.375 g of Cassia angustifolia Vahl. fruits*
• 0.750 g of Fucus vesiculosus L. thalli**

(*) Total content of hydroxyanthracene derivatives expressed as sennoside B: between 15.25 and 18.97 mg per bag

(**) Iodine content: between 297 and 363 micrograms per bag

It does not contain excipients.

Appearance of the product and packaging content

This medicine is presented in boxes containing 25 filter bags for infusion.

Marketing authorization holder and manufacturer:

Laboratorios RINTER CORONA, S.L.

Parque Industrial el Bierzo, C/ Burdeos, parcela 8

24400-Ponferrada (LEÓN)

This leaflet was approved in July 2010