PROSPECTO: INFORMATION FOR THE USER

PHARMATRES Tisana

Cassia angustifolia Vahl. and Fucus vesiculosus L.

In this prospectus:

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

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

PHARMATRES Tisanais an association of plant laxatives, that is, they stimulate intestinal activity, promoting the evacuation of feces.

Do not take PHARMATRES Tisana:

• Do not administer this medication to children under 12 years old.
• If you are allergic (hypersensitive) to the components of PHARMATRES Tisana
• If you have an unknown abdominal pain.
• If you are experiencing or have recently experienced diarrhea or vomiting with significant loss of liquids or minerals.
• If you have intestinal obstruction and stenosis, atony, appendicitis, inflammatory diseases of the colon (such as Crohn's disease, ulcerative colitis)
• If you have any thyroid gland disorder (hyperthyroidism)

Be especially careful with PHARMATRES Tisana:

• If you are taking other medications such as cardiac glycosides, antiarrhythmics, medications that induce prolongation of the QT interval, diuretics, corticosteroids, or licorice root.
• If you have undiagnosed acute or persistent gastrointestinal disorders.
• If you need to take laxatives frequently, the cause of constipation should be investigated.
• 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).

Prolonged use of this medication may cause the body to adapt with certain dependence that would require an increase in dosage to achieve the same results. Additionally, long-term abuse of laxatives can cause intestinal disorders such as diarrhea with the consequent loss of liquid and electrolytes (mainly a decrease in potassium). Furthermore, long-term abuse can also exacerbate constipation.

Use of other medications:

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

Prolonged use of laxatives can cause a decrease in potassium levels that may increase the action of other medications taken for the heart (antiarrhythmics, diuretics, corticosteroids, and/or licorice root).

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

PHARMATRES Tisana with food and beverages:

Foods and beverages have no influence on the effect of the medication.

Use in children:

Do not use in children under 12 years old.

Use in the elderly:

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

Pregnancy and breastfeeding:

Consult your doctor or pharmacist before taking this medication.

Use during pregnancy and lactation is not recommended.

Driving and operating machinery:

No effects on the ability to drive and operate machinery have been described.

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 ofPHARMATRES Tisanais too strong or weak, inform your doctor or pharmacist.

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

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

The medication usually takes 6 to 12 hours to produce its laxative effect, so it is recommended to take a single dose at night, so that the effect occurs in the morning.

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

If, after 4 days, since the start of takingPHARMATRES Tisana, there has been no defecation, treatment should be stopped immediately and your doctor consulted.

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

If you take more PHARMATRES Tisana than you should:

The ingestion of much larger doses than the recommended doses of the product may cause a condition of excessive intestinal activity presenting abdominal pain, spasms, and a massive diarrhea with loss of water and electrolytes. If the electrolyte imbalance is severe, it may cause confusion, cardiac arrhythmia, cramps, fatigue, or weakness, which may be more pronounced in the elderly. However, the possibility of poisoning from the consumption of herbal teas is very low.

If you have taken morePHARMATRES Tisanathan you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forgot to take PHARMATRES Tisana:

Do not take a double dose to compensate for the missed doses.

Other information about the treatment of constipation:

Although intestinal habits are not the same in everyone, it can be said that there is constipation when more than 3 days pass without evacuating the intestine or when the routine of bowel movements is temporarily interrupted. It is also considered that there is constipation if the stools are scarce or hard and there is pain during evacuation.

Constipation often occurs due to lack of physical exercise, also due to consuming a small amount of liquid or eating poor fiber-rich foods. Therefore, it is essential to follow the following recommendations for the prevention of constipation, which may prevent the use of laxatives:

• You should change your eating habits. Eat foods rich in fiber, fruits, vegetables, legumes, etc.
• Drink a large amount of water.
• Avoid a sedentary lifestyle by exercising regularly.
• When you feel the need to go to the bathroom, do not leave it for later.
• Try to have bowel movements at the same time every day.
• Make sure to spend enough time for bowel movements without rushing.

Like all medications,PHARMATRES Tisanamay have adverse effects, although not everyone will experience them.

Occasionally, they may cause abdominal pain and spasms, flatulence (presence of gas in the abdomen), nausea, mucous stools, and/or diarrhea, skin rashes, allergic reactions. A yellow-brown urine discoloration may appear, although this has no clinical significance. All these symptoms disappear when treatment is discontinued.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

KeepPHARMATRES Tisanaout of the reach and sight of children.

No special storage conditions are required.

Expiration Date

Do not usePHARMATRES Tisanaafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition ofPHARMATRES 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

No excipients are present.

Product appearance and packaging contents

This medication is presented in cases containing 25 filter bags for infusion.

Manufacturer and Responsible for Production:

Laboratorios RINTER CORONA, S.L.

Parque Industrial el Bierzo, C/ Burdeos, parcela 8

24400-Ponferrada (LEÓN)

This leaflet was approved in July 2010