LINEASUL TISANA

Introduction

Leaflet: information for the user

LINEASUL Tea

Cassia angustifoliaVahl. and Rhamnus frangulaL.

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions of the medication contained in this leaflet or as indicated 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 side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 4 days.

Contents of the leaflet:

1. What is LINEASUL and what is it used for
2. What you need to know before taking LINEASUL
3. How to take LINEASUL
4. Possible side effects
5. Storage of LINEASUL
6. Package contents and additional information

1. What is LINEASUL and what is it used for

LINEASUL is a plant-based medication used for the short-term treatment of occasional constipation.

LINEASUL is an association of vegetable laxatives, which stimulate intestinal activity, favoring the evacuation of feces.

You should consult a doctor if it worsens or does not improve after 4 days

2. Taking LINEASUL

Do not take LINEASUL:

• If you are allergic to the active ingredients or to any of the other components of this medication (listed in section 6).
• 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 sudden changes in bowel habits that persist for more than 2 weeks.
• If you have intestinal obstruction and stenosis, atony, appendicitis, inflammatory bowel diseases (such as Crohn's disease, ulcerative colitis).
• If you have nephritis (kidney inflammation).
• If you have hepatitis (liver inflammation).
• Do not administer this medication 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 medications such as cardiac glycosides, anti-arrhythmic medications, medications that induce QT interval prolongation, diuretics, corticosteroids, or licorice root.

• It should not be used daily for a prolonged period.
• Abuse can cause diarrhea, with consequent loss of fluid and electrolytes (mainly a decrease in potassium).
• Long-term abuse can also worsen constipation.
• Chronic use can cause pigmentation of the colon (pseudomelanosis coli), which is harmless and will disappear when treatment is discontinued.
• If you need to take laxatives frequently, the cause of constipation should be investigated.

Children and adolescents

Do not administer to children under 12 years of age.

Using LINEASUL with other medications

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

Prolonged use of laxatives can cause a decrease in potassium levels, which can increase the effect of other medications administered for the heart (anti-arrhythmics, diuretics, corticosteroids, and/or licorice root).

It is not recommended to administer it to patients with treatment based on cardiac glycosides (medications that regulate heart activity) and anti-arrhythmic medications (e.g., quinidine), as their absorption may be modified.

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

Taking LINEASUL with food and drinks

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

This preparation is eliminated in small amounts in breast milk, and although there are no data on the possible laxative effects it may have on infants, its use is not recommended in these circumstances.

Driving and using machines:

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

3. How to take LINEASUL

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor or pharmacist.

LINEASUL is administered orally.

The recommended dose is: 1 bag per day, prepared as a tea, preferably before bedtime.

The minimum effective dose should be taken. In general, it will be sufficient to take one infusion (prepared with one bag) two or three days a week during treatment.

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

The maximum recommended daily dose of hydroxyanthracene derivatives is 30 mg, which corresponds to taking one bag per day.

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

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

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

If you think the effect of LINEASULis 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 moreLINEASULthan you should

Taking much higher doses than recommended may 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 tea is limited.

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

If you forget to take LINEASUL

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

Other information about the treatment of constipation

Although bowel habits are not the same in all people, constipation can be said to exist 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 cause pain during evacuation.

Constipation often occurs due to lack of physical exercise, low fluid intake, or a diet poor in fiber. Therefore, it is essential to follow these recommendations to prevent 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 a sedentary lifestyle by engaging in regular physical exercise.
• 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 sufficient time for bowel movements to occur without rushing.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

• Hypersensitivity reactions (allergy) can occur.
• At the start of treatment and depending on the dose, some discomfort such as flatulence (gas), intestinal spasms, and pain may appear, which disappear after a few days without needing to discontinue treatment.
• A yellowish or reddish-brown coloration of the urine (depending on the pH) may appear, which is clinically insignificant.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of LINEASUL

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

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of LINEASUL

The active ingredients are:

• 700 mg of Cassia angustifoliaVahl leaves.*
• 168 mg of Rhamnus frangulaL. bark.*

(*) With an approximate content of 15.8 mg hydroxyanthracene derivatives expressed as sennoside B and 11.9 mg hydroxyanthracene derivatives expressed as glucofrangulins A.

The other excipients are: 530 mg of Melissa OfficinalisL. leaves.

Appearance of the product and package contents

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

How to prepare the infusion

Insert one bag into 150 ml of boiling water, let it steep for 3 to 5 minutes. Sugar or another sweetener can 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 last revision of this leaflet: March 2014

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/