LINOMED, GRANULADO

Introduction

Package Leaflet: Information for the User

LinoMed, Granules

Read the entire package leaflet carefully before starting to use this medication

because it contains important information for you.

This medication can be purchased without a prescription for the treatment of minor conditions without the intervention of a doctor. Nevertheless, you should use LinoMed with care to obtain the best results.

Follow the administration instructions of the medication contained in

this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet. 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 it

is a side effect not described in this package leaflet.

• If the symptoms worsen or persist after 4 days, you should consult a doctor

Contents of the Package Leaflet

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

1. What is LinoMed and what is it used for

LinoMed is a granule prepared with a mixture of the following plant substances: whole flax seeds (Linum usitatissimumL.), coated with senna leaf powder (Cassia angustifoliaVahl.) and frangula bark powder (Rhamnus frangula), with an equivalent content of 20.5 mg of hydroxyanthracene derivatives expressed as sennosides B, for oral use.

LinoMed is indicated for the symptomatic and short-term treatment of

occasional constipation.

2. What you need to know before taking LinoMed

Do not take LinoMed ifyou have a known allergy to any of the components of the medication. You should also not use this medication without consulting your doctor first if you have abdominal pain, cramps, or inflammation, if you suffer from nausea or vomiting, or if you have any injury in the anal area, inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis). If you have been diagnosed with severe dehydration.

Do not take LinoMed, or any other laxative, without consulting your doctor first, in

the following cases:

• If there is a sudden change in your bowel habits that cannot be explained

by a change in lifestyle (such as a trip, changes in diet, consumption of certain medications, etc.)

If constipation is accompanied by pain, fever, or abdominal swelling.

• If you suffer from severe liver disease.

Do not use this medication in case of chronic constipation.

If a sudden change in bowel habits lasts more than two weeks, you should consult a doctor.

Be especially careful with LinoMed because:

The treatment of constipation should not be more than an aid to hygienic-dietary treatment:

• Enrichment of the diet with vegetable fibers and beverages (water).
• Physical activity and re-education of the defecatory function.

Prolonged use of this medication can produce adaptation of the body with some dependence, which would require increasing the dosage to achieve the same results, as well as functional intestinal disorders and anomalies in the body's fluid balance with mineral loss.

This medication contains 480 mg of sucrose per measuring spoon (4.1 g).

If you know that you are intolerant to certain sugars or your doctor has indicated so, consult with them before taking this medication.

Use in the elderly.The elderly may be more sensitive to the adverse effects of

this medication, possibly due to decreased kidney function. Lower doses than those recommended for adults may be required. In case of habitual constipation, it is recommended to use another type of laxative, as repeated use of stimulant laxatives can cause weakness, hypotension, and psychomotor discoordination.

Use in children.LinoMed should not be administered to children under 12 years of age.

Pregnancy

Do not take this medication during the first trimester of pregnancy. Do not use during the rest of pregnancy without consulting your doctor.

IMPORTANT FOR WOMEN

If you are pregnant or think you may be pregnant, consult your doctor before taking this medication. The use of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Breastfeeding

Do not use during breastfeeding without consulting your doctor.

Driving and using machines:

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

Important information about some of the components of LinoMed

This medication contains 480 mg of sucrose per measuring spoon (4.1 g). If your doctor has indicated that you are intolerant to certain sugars or if you are aware of it, consult with your doctor before taking this medication.

Taking other medications:

Unless your doctor prescribes it, do not use this medication if you are taking diuretics (medications to urinate) or heart medications.

Inform your doctor or pharmacist if you are taking or have recently taken any medication, including those purchased without a prescription, before taking this laxative medication.

Laxatives reduce intestinal transit time and can modify the absorption of other oral medications administered simultaneously.

3. How to take LinoMed

Follow these instructions unless your doctor has given you other instructions.

Remember to take your medication.

LinoMed is a medication that is administered orally.

The recommended dose for adults, the elderly, and adolescents over 12 years

is one measuring spoon of granules per day (4.1 g).

LinoMed is presented in the form of granules that should be swallowed whole, without chewing, with a glass of water (200 ml) or another liquid.

The medication usually takes between six and twelve hours to produce its laxative effect; therefore, it is recommended to take it once at night, so that the effect occurs in the morning.

This medication should not be taken for more than one week without consulting a doctor.

Do not exceed the recommended dose.

If, after 3 days (72 hours) from the start of taking LinoMed, defecation has not occurred, or if it is accompanied by blood, you should stop treatment immediately and consult your doctor.

If you think the effect of LinoMed is too strong or too weak, inform your doctor or pharmacist.

If you take more LinoMed than you should:

If you have taken more LinoMed than you should, consult your doctor or pharmacist.

In case of overdose or accidental ingestion, diarrhea with water and electrolyte loss may occur. If the electrolyte imbalance is severe, it can cause confusion, cardiac arrhythmia, asthenia, cramps, abdominal pain, and general weakness, which can be more severe in the elderly. In case of poisoning or overdose, you should immediately go to a medical center or call the Toxicology Information Service, phone 915620420.

If you forget to take LinoMed:

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

4. Possible side effects

Like all medications, LinoMedcan have side effects. They are not usually observed under the proposed use conditions. However, occasionally, in sensitive individuals, diarrhea, cramps, or abdominal pain, nausea, and vomiting may appear.

This medication can give the urine a brown or reddish color, but it is not significant.

If you observe any adverse reaction not described above, consult your doctor or pharmacist.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of LinoMed

Keep LinoMedout of the reach and sight of children.

Store LinoMedin its original packaging; it does not require special storage conditions at a temperature below 30°C.

Expiration date

Do not use LinoMedafter the expiration date indicated on the packaging.

Medications should not be thrown down the drain or into the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need.

In this way, you will help protect the environment.

6. Contents of the packaging and additional information

Each dose of 4.1 g (one measuring spoon) contains as active ingredients:

1.76 g of whole flax seeds (Linum usitatissimumL.) coated with:

0.56 g of senna leaf powder (Cassia angustifoliaVahl.)

0.05 g of frangula bark powder (Rhamnus frangulaL.)

The other components are excipients:

Talc

Sucrose

Calcium carbonate

Atomized arabic gum

Red iron oxide

Pentahydrate calcium lactate

Black iron oxide

Vanillin

Ginger oil

Marketing authorization holder and manufacturer

Bioforce España A.Vogel, S.A.

Platón 6,

08021-Barcelona

Spain

Tel 93 201 99 22

Fax 93 209 03 19

Manufacturer

A: VOGEL B.V.

J.P. Broekhovenstraat 16, Elburg

Netherlands

This package leaflet was approved in: January 2020

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