PHARMATRES HERBAL TEA

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

PHARMATRES Herbal Tea

Cassia angustifolia Vahl. and Fucus vesiculosus L.

In this leaflet:

1. What PHARMATRES Herbal Tea is and what it is used for
2. Before taking PHARMATRES Herbal Tea
3. How to take PHARMATRES Herbal Tea
4. Possible side effects
5. How to store PHARMATRES Herbal Tea
6. Further information

1. What Pharmatres Herbal Tea is and what it is used for

PHARMATRES Herbal Tea is a herbal medicinal product used for the short-term treatment of occasional constipation.

PHARMATRES Herbal Tea is a combination of herbal laxatives, which means that it stimulates intestinal activity, thereby promoting the evacuation of stools.

2. Before using Pharmatres Herbal Tea

Do not take PHARMATRES Herbal Tea:

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

Take special care with PHARMATRES Herbal Tea:

• If you are taking other medicines such as cardiac glycosides, antiarrhythmic drugs, drugs that induce QT interval prolongation, diuretics, corticosteroids, or liquorice root.
• If you have acute or persistent undiagnosed 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 kidney disease.
• If you have any thyroid gland disorder, or if you are undergoing treatment with antithyroid medication (hyperthyroidism).

Prolonged use of this medicine may lead to adaptation by the body with some dependence, requiring higher doses to achieve the same effect. In addition, abuse of laxatives may cause intestinal disorders such as diarrhoea, resulting in fluid and electrolyte loss (particularly a decrease in potassium). Likewise, long-term abuse may also worsen constipation.

Use with other medicines:

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

Prolonged use of laxatives may reduce potassium levels, which could enhance the effects of other medicines used for heart conditions (antiarrhythmics, diuretics, corticosteroids, and/or liquorice root).

The effect of this medicine on intestinal transit could alter the absorption and thus the levels of other medicines taken orally at the same time.

Taking PHARMATRES Herbal Tea with food and drinks:

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

Use in children:

Do not use in children under 12 years of age.

Use in 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.

Use during pregnancy and breastfeeding is not recommended.

Driving and use of machines:

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

3. How to take Pharmatres Herbal Tea

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

Consult your doctor or pharmacist if you have any doubts.

If you feel that the effect of PHARMATRES Herbal Tea is too strong or too weak, inform your doctor or pharmacist.

Adolescents over 12 years, adults and elderly: The recommended dose is 1 tea bag per day, taken as an infusion (one cup, 250 ml), preferably before going to bed.

In general, taking the medicine 2 or 3 times is sufficient to achieve the desired effect.

The medicine usually takes 6 to 12 hours to produce its laxative effect; therefore, a single evening dose is recommended so that the effect occurs in the morning.

The maximum recommended duration of treatment is 6 days. If symptoms persist after this period, consult your doctor or pharmacist.

If no bowel movement has occurred within 4 days after starting treatment with PHARMATRES Herbal Tea, treatment must be stopped immediately and you should consult your doctor.

If you feel that the effect of PHARMATRES Herbal Tea is too strong or too weak, inform your doctor or pharmacist.

If you take more PHARMATRES Herbal Tea than you should:

Taking much higher doses than recommended may cause excessive intestinal activity, resulting in abdominal pain, spasms, and severe diarrhoea with loss of water and electrolytes. If the electrolyte imbalance is severe, confusion, cardiac arrhythmia, cramps, fatigue or weakness may occur, which may be more pronounced in elderly patients. However, the likelihood of poisoning from herbal teas is very low.

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

If you forget to take PHARMATRES Herbal Tea:

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

Additional information on constipation treatment

Although bowel habits vary among individuals, constipation can be considered present when more than 3 days pass without a bowel movement, or when the usual bowel routine is temporarily interrupted. Constipation is also considered present when stools are small or hard, or when pain occurs during defecation.

Constipation frequently occurs due to lack of physical activity, insufficient fluid intake, or consumption of low-fiber meals. Therefore, it is important to follow these recommendations for preventing constipation, which may help you avoid using laxatives:

• Change your eating habits. Eat fiber-rich foods such as fruits, vegetables, legumes, etc.
• Drink plenty of water.
• Avoid a sedentary lifestyle by exercising regularly.
• When you feel the need to go to the bathroom, do not delay.
• Try to have bowel movements at the same time every day.
• Allow yourself enough time so that defecation can occur without rushing.

4. Possible adverse effects

Like all medicines, PHARMATRES Tisana may have adverse effects, although not everyone will experience them.

Occasionally, abdominal pain and spasms, flatulence (gas in the abdomen), nausea, mucous stools and/or diarrhoea, skin rashes, and allergic reactions may occur. A yellow-red-brown discoloration of the urine 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 experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Pharmatres Herbal Tea

Keep PHARMATRES Herbal Tea out of the reach and sight of children.

No special storage conditions are required.

Expiry

Do not use PHARMATRES Herbal Tea after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional Information

Composition of PHARMATRES Herbal Tea

Each tea bag contains the following active substances:

• 0.375 g of Leaves of Cassia angustifolia Vahl.*
• 0.375 g of Fruits of Cassia angustifolia Vahl.*
• 0.750 g of Stems of Fucus vesiculosus L. **

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

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

Does not contain excipients.

Appearance of the medicinal product and contents of the container

This medicine is supplied in boxes containing 25 filter tea 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