LINEASUL TISANA

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

LINEASUL Herbal Tea

Cassia angustifolia Vahl. and Rhamnus frangula L.

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 4 days.

Contents of this leaflet:

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

1. What LINEASUL is and what it is used for

LINEASUL is a herbal medicine used for the short-term treatment of occasional constipation.

LINEASUL is a combination of herbal laxatives, which means that they stimulate intestinal activity, thereby promoting bowel evacuation.

You should consult a doctor if your condition worsens or does not improve after 4 days.

2. Taking LINEASUL

Do not take LINEASUL:

• If you are allergic to the active substances or to any of the other components of this medicine (listed in section 6).
• If you have abdominal pain of unknown origin.
• If you are currently suffering or have recently suffered from diarrhoea or vomiting with significant loss of fluids or minerals.
• If you have sudden changes in bowel habits that persist for more than 2 weeks.
• If you have intestinal obstruction or stenosis, atony, appendicitis, or inflammatory bowel diseases (such as Crohn's disease, ulcerative colitis).
• If you have nephritis (inflammation of the kidneys).
• If you have hepatitis (inflammation of the liver).
• Do not administer this medicine to children under 12 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take LINEASUL:

• If you are taking other medicines such as cardiotonic glycosides, antiarrhythmic drugs, drugs that induce QT interval prolongation, diuretics, corticosteroids, or liquorice root.

• Must not be used daily over a prolonged period.

• Abuse may cause diarrhoea, resulting in loss of fluid and electrolytes (mainly a decrease in potassium).

• Long-term abuse may worsen constipation.

• Chronic use may lead to pigmentation of the colon (pseudomelanosis coli), which is harmless and resolves upon discontinuation of treatment.

• If you need to take laxatives frequently, the underlying cause of constipation should be investigated.

Children and adolescents

Do not administer to children under 12 years of age.

Use of LINEASUL with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

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

Administration is not recommended in patients treated with cardiotonic glycosides (drugs regulating cardiac activity) and antiarrhythmic drugs (e.g.: quinidine), as their absorption may be altered.

The effect of this medicine on intestinal transit could alter the levels of other medicines taken concomitantly by oral route.

Taking LINEASUL with food and drink

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

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

This preparation is excreted in small amounts in breast milk; although there are no data on possible laxative effects in infants, its use is not recommended under these circumstances.

Driving and use of machines:

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

3. How to take LINEASUL

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor or pharmacist.

LINEASUL is administered orally.

The recommended dose is: 1 sachet per day, prepared as an infusion (herbal tea), preferably before going to bed.

The lowest effective dose should be used. Generally, it will be sufficient to take one infusion (prepared with one tea bag) two or three times per week during treatment.

Each 1.4 g tea bag contains approximately 15.8 mg hydroxyanthracene glycosides expressed as sennoside B and 11.9 mg hydroxyanthracene glycosides expressed as glucofrangulins A.

The recommended maximum daily dose of hydroxyanthracene derivatives is 30 mg, equivalent to one sachet per day.

The laxative effect usually occurs 6 to 12 hours after oral administration.

Treatment should be short-term, with a maximum recommended duration of 6 days.

If symptoms persist after 4 days of treatment, consult your doctor or pharmacist.

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

Use in children and adolescents

Do not administer to children under 12 years of age.

The recommended dose for adolescents is the same as for adults.

If you take more LINEASUL than you should

Ingestion of doses much higher than recommended may cause excessive intestinal activity, resulting in abdominal pain, spasms, and severe diarrhea with loss of water and electrolytes. If the electrolyte imbalance is severe, it may lead to confusion, cardiac arrhythmia, muscle cramps, fatigue, or weakness, which may be more pronounced in elderly patients. However, the risk of intoxication from consuming herbal infusions is limited.

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

If you forget to take LINEASUL

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

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 pattern of defecation is temporarily interrupted. Constipation may also be defined by infrequent or hard stools, accompanied by pain 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 to prevent constipation, which may help you avoid the need for laxatives:

• Modify your diet by including fiber-rich foods such as fruits, vegetables, legumes, etc.

• Drink plenty of water.

• Avoid a sedentary lifestyle by engaging in regular physical exercise.

• When you feel the urge to defecate, do not delay it.

• Try to establish a regular time for bowel movements each day.

• Allow yourself enough time so that defecation can occur without rushing.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

• Hypersensitivity reactions (allergy) may occur.
• At the beginning of treatment, and depending on the dose, some discomforts may appear such as flatulence (gas), intestinal spasms, or pain, which disappear after a few days without the need to discontinue treatment.
• A yellowish or reddish-brown discoloration of the urine may occur (depending on the pH), which has no clinical significance.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of LINEASUL

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This helps protect the environment.

6. Contents of the pack and other information

Composition of LINEASUL

The active substances are:

• 700 mg of leaves of Cassia angustifolia Vahl.*
• 168 mg of bark of Rhamnus frangula L. *

(*) Containing approximately 15.8 mg hydroxyanthracene glycosides expressed as sennoside B and 11.9 mg hydroxyanthracene glycosides expressed as glucofrangulins A.

The other excipients are: 530 mg of leaves of Melissa officinalis L.

Appearance of the medicine and contents of the pack

This medicine is presented in cartons containing 25 tea bags for infusion.

How to prepare the infusion

Place one tea bag in about 150 ml of water just below boiling point and let it steep for 3 to 5 minutes. Sugar or another sweetener may be added.

Marketing Authorization Holder and Manufacturer:

Laboratorios RINTER CORONA, S.L.

Parque Industrial el Bierzo, C/ Burdeos, parcela 8

24400-Ponferrada (LEÓN)

Date of the most recent revision of this leaflet: March 2014

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/