Prospect: information for the user

LINEASUL Tisana

Cassia angustifoliaVahl. andRhamnus frangulaL.

1.What it isLINEASULand for what it is used

2.What you need to know before starting to takeLINEASUL

3.How to takeLINEASUL

4.Possible adverse effects

5.Storage ofLINEASUL

6.Contents of the package and additional information

LINEASULis a plant-based medicationused for the short-term treatment of occasional constipation.

LINEASULis an association of plant laxatives, that is, it stimulates intestinal activity, promoting the evacuation of feces.

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

Do not take LINEASUL:

• If you are allergic to the active ingredients or any of the other components of this medication (listed in section 6).
• If you have unknown abdominal pain.
• If you are experiencing or have recently experienced diarrhea or vomiting with significant loss of liquids 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 disease of the colon (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 medication to children under 12 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take LINEASUL:

• If you are taking other medications such as cardiac glycosides, antiarrhythmics, medications that induce prolongation of the QT interval, diuretics, corticosteroids, or licorice root.

• Should not be used daily for a prolonged period of time.
• Abuse may cause diarrhea, resulting in a loss of fluid and electrolytes (mainly a decrease in potassium).
• Long-term abuse may exacerbate constipation.
• Chronic use may cause colon pigmentation (pseudomelanosis colonica), which is harmless and will disappear upon discontinuation of treatment.
• 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 old.

Use of LINEASUL with other medications

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

Prolonged use of laxatives may 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).

Administration is not recommended in patients receiving treatment with cardiac glycosides (medications that regulate heart activity) and antiarrhythmic medications (e.g., quinidine), as their absorption may be modified.

The action of this medication on intestinal transit may modify the levels of other medications taken concurrently by mouth.

Taking LINEASUL with food and beverages

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

Pregnancy, breastfeeding, and fertility

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

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

Driving and operating machines:

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

Follow exactly the medication administration instructions contained in this leaflet or those 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 going to bed.

The smallest effective dose should be taken. Generally, it will be sufficient to take an infusion (prepared with a sachet) two or three days a week of treatment.

Each 1.4 g sachet 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 usually occurs 6 to 12 hours after oral administration.

The treatment will be of short duration, with a maximum recommended duration of 6 days.

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

If you estimate that the action ofLINEASULis too strong or too weak, inform your doctor or pharmacist.

Use in children and adolescents

Do not administer to children under 12 years old.

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

If you take moreLINEASULthan you should

The ingestion of much higher doses than the recommended doses of the product may cause an 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 intoxication by consuming teas is limited.

If you have taken moreLINEASULthan 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 LINEASUL

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 bowel routine 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 avoid the use of laxatives:

• You should change your eating habits. Consume foods rich in fiber, fruits, vegetables, legumes, etc.

• Drink a large amount of water.
• Avoid sedentary behavior 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, this medication can produce adverse effects, although not all people will experience them.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

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

Composition ofLINEASUL

The active principles are:

• 700 mg of Leaves ofCassia angustifoliaVahl.*
• 168 mg of Bark ofRhamnus frangula L.*

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

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

Appearance of the product and contents of the packaging

This medicine 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 rest for 3 to 5 minutes. Sugar or another sweetener can be added.

Holder of the marketing authorization and responsible for manufacturing:

Laboratorios RINTER CORONA, S.L.

Parque Industrial el Bierzo, C/ Burdeos, parcela 8

24400-Ponferrada (LEÓN)

Last review date of this leaflet:March 2014

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