Label: information for the user

LinoMed, granulated

Read this label 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 ailments without the intervention of a doctor. Nevertheless, you must use LinoMed with care to obtain the best results.

Follow exactly the administration instructions of the medication contained in

this label or those indicated by your doctor or pharmacist.

- Keep this label. You may have to read it again.

- If you need advice or more information, consult your pharmacist.

- If you experience adverse effects, consult your doctor, pharmacist or nurse, even if they

are not described in this label.

-If symptoms worsen or persist after 4 days, you must consult a doctor

1. What is LinoMed and what it is used for

2. What you need to know before starting to take LinoMed

3. How to take LinoMed

4. Possible adverse effects

5. Conservation of LinoMed

6. Contents of the package and Additional information

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

LinoMed is indicated for symptomatic and short-term treatment of

occasional constipation.

Do not take LinoMed ifyou have a known allergy to any of the components of the medication. Do not use this medication without consulting your doctor if you have abdominal pain, cramps, or inflammation, if you experience nausea or vomiting, or if you have any anal injury, inflammatory bowel disease (for example, 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 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.)

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 have severe liver disease.

Do not use this medication for chronic constipation.

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

Be especially careful with LinoMed because:

The treatment of constipation should not be more than a help to the hygienic-dietary treatment:

- Enrichment of the diet with vegetable fibers and drinks (water).

- Physical activity and reeducation of defecation function.

Prolonged use of this medication may cause adaptation of the body with certain dependence that would require increasing the dosage to achieve the same results, as well as functional intestinal disorders and fluid balance anomalies in the body with mineral loss.

This medication contains 480 mg of saccharose per spoonful (4.1 g).

If you are aware that you have intolerance to certain sugars or your doctor has indicated it, consult with him before taking this medication.

Use in the elderly.The elderly may be more sensitive to the adverse effects of this medication, possibly due to a lower renal function. Smaller doses than those recommended for adults may be required. In the case of habitual constipation, the use of another type of laxative is recommended, as repeated use of stimulant laxatives may cause states of weakness, hypotension, and psychomotor discoordination.

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

Pregnancy

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

IMPORTANT FOR WOMEN

If you are pregnant or believe you may be, consult your doctor before taking this medication. The consumption of medications during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.

Breastfeeding

Do not use without consulting your doctor.

Driving and use of machines:

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

Important information about one of the components of LinoMed

This medication contains 480 mg of saccharose per spoonful (4.1 g). If your doctor has indicated that you have intolerance 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 take diuretics (urinary medications) or heart medications.

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

Laxatives decrease the time of intestinal transit and may modify the absorption of other oral medications administered simultaneously.

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, elderly, and adolescents over 12 years old

is one scoop of granulated powder per day (4.1 g).

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

The medication usually takes six to twelve hours to produce its laxative effect, so it is recommended to take a single dose at night, so that the effect occurs in the morning.

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

The recommended dose should not be increased.

If, after 3 days (72 hours), since the start of LinoMed intake, there has been no defecation, or if it is accompanied by blood, the treatment should be suspended immediately and a doctor should be consulted.

If you estimate that the action 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 losses may occur. If the electrolyte imbalance is severe, it may cause confusion, cardiac arrhythmia, fatigue, muscle cramps, abdominal pain, and general weakness, which may be more severe in the elderly. In case of poisoning or overdose, you should immediately go to a medical center or call the Toxicological Information Service, phone 915620420.

If you forgot to take LinoMed:

Do not take a double dose to compensate for the missed doses.

Like all medicationsLinoMed, LinoMed may have adverse effects. These are not usually observed under the proposed conditions of use. However, occasionally, in sensitive individuals, diarrhea, cramps, or abdominal pain, nausea, and vomiting may appear.

This medication may give urine a brown or reddish color, but this is not significant.

If any adverse reaction not previously described is observed, consult a doctor or pharmacist.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult a doctor or pharmacist

or nurse, even if it is about possible adverse effects that do not appear in this

leaflet. You can also report them directly through the Spanish System of

Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.

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

KeepLinoMedout of the reach and sight of children.

ConserveLinoMedin the original packaging, no special storage conditions are required at a temperature below 30°C.

Expiration Date

Do not useLinoMedafter the expiration date indicated on the packaging.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medicines.

By doing so, you will help protect the environment.

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

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

0.56 g of cassia leaf (Cassia angustifoliaVahl.) powder

0.05 g of buckthorn bark (Rhamnus frangulaL.) powder

The remaining components are excipients:

Talc

Sucrose

Calcium carbonate

Atomized gum arabic

Red iron oxide

Calcium lactate pentahydrate

Black iron oxide

Vanillin

Ginger oil

Marketing authorization holder and responsible manufacturer

Bioforce España A.Vogel, S.A.

Platón 6,

08021-Barcelona

Spain

Phone 93 201 99 22

Fax 93 209 03 19

Manufacturer

A: VOGEL B.V.

J.P. Broekhovenstraat 16, Elburg

Netherlands

This leaflet was approved in: January 2020

The detailed and updated information on this medication is available on

the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/