Linomed, granules
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
LinoMed, granules
Read all of this leaflet carefully before you start using this medicine
because it contains important information for you.
This medicine is available without prescription for the treatment of minor conditions without the need for medical intervention. However, you should use LinoMed carefully to achieve the best results.
Always follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
- Keep this leaflet. 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.
- If symptoms worsen or persist beyond 4 days, you should consult a doctor.
Contents of the leaflet
- What LinoMed is and what it is used for
- What you need to know before taking LinoMed
- How to take LinoMed
- Possible side effects
- How to store LinoMed
- Contents of the pack and other information
1. What LinoMed is and what it is used for
LinoMed is a granulate prepared from a mixture of the following plant substances: whole flax seeds (Linum usitatissimum L.), coated with senna leaf powder (Cassia angustifolia Val.) and buckthorn bark powder (Rhamnus frangula), with a content equivalent to 20.5 mg of hydroxyanthracene derivatives expressed as sennoside B, for oral use.
LinoMed is indicated for the short-term symptomatic treatment of
occasional constipation.
2. What you need to know before starting to take Linomed
Do not take LinoMed if you are known to be allergic to any of the components of the medicine. You should also not use this medicine without first consulting your doctor if you have abdominal pain, cramps or inflammation, nausea or vomiting, or if you have any lesion around the anus, inflammatory bowel disease (for example, Crohn's disease, ulcerative proctocolitis). If you have been diagnosed with severe dehydration.
Do not take LinoMed, or any other laxative, without first 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 travel, changes in diet, use of certain medications, etc.)
- If constipation is accompanied by abdominal pain, fever, or swelling.
- If you suffer from severe liver disease.
Do not use this medicine in case of chronic constipation.
If a sudden change in bowel habits lasts longer than two weeks, you should see a doctor.
Take special care with LinoMed because:
The treatment of constipation should only be an adjunct to hygienic-dietary measures:
- Increasing dietary fiber and fluid intake (water).
- Physical activity and re-education of defecation function.
Prolonged use of this medicine may lead to adaptation by the body, resulting in some dependence, which would require increasing the dose to achieve the same effect, as well as functional intestinal disorders and disturbances in the body's fluid balance with loss of minerals.
This medicine contains 480 mg of sucrose per measuring spoon (4.1 g).
If you know you have a sugar intolerance or your doctor has informed you of such, consult your doctor before taking this medicine.
Use in the elderly: Elderly individuals may be more sensitive to the adverse effects of this medicine, possibly due to reduced kidney function. Lower doses than those recommended for adults may be required. In cases of habitual constipation, the use of another type of laxative is recommended, as repeated use of stimulant laxatives may lead to weakness, hypotension, and psychomotor incoordination.
Use in children: LinoMed must not be administered to children under 12 years of age.
Pregnancy
Do not take this medicine during the first trimester of pregnancy. Do not use during the remainder of pregnancy without consulting your doctor.
IMPORTANT FOR WOMEN
If you are pregnant or think you might be pregnant, consult your doctor before taking this medicine. Taking medications during pregnancy can be dangerous for the embryo or fetus and must be monitored by your doctor.
Breastfeeding
Do not use during breastfeeding without consulting your doctor.
Driving and use of machines:
No effects on the ability to drive or operate machinery have been reported.
Important information about some of the components of LinoMed
This medicine contains 480 mg of sucrose per measuring spoon (4.1 g). If your doctor has told you that you have an intolerance to certain sugars or if you are aware of such, consult your doctor before taking this medicine.
Taking other medicines:
Unless prescribed by your doctor, do not use this medicine if you are taking diuretics (medicines to increase urine production) or medicines for the heart.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription, before taking this laxative medicine.
Laxatives reduce intestinal transit time and may alter the absorption of other oral medicines taken simultaneously.
3. How to take LinoMed
Follow these instructions unless your doctor has given you different advice.
Remember to take your medicine.
LinoMed is a medicine taken by mouth.
The recommended dose for adults, elderly and adolescents over 12 years of age
is one dosing spoon of granules per day (4.1 g).
LinoMed comes as granules that must be swallowed whole, without chewing, with a glass of water (200 ml) or another liquid.
The medicine usually takes six to twelve hours to produce its laxative effect; therefore, it is recommended to take it once at night, so that the effect occurs the next morning.
This medicine should not be taken for longer than one week without consulting your doctor.
Do not exceed the recommended dose.
If defecation has not occurred within 3 days (72 hours) after starting treatment with LinoMed, or if it is accompanied by blood, treatment must be stopped immediately and you should consult your doctor.
If you feel that 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 have, consult your doctor or pharmacist.
In case of overdose or accidental ingestion, diarrhoea may occur, leading to loss of water and electrolytes. If the electrolyte imbalance is severe, it may cause confusion, cardiac arrhythmia, asthenia, cramps, abdominal pain and general weakness, which may be more severe in elderly patients. In case of poisoning or overdose, seek immediate medical attention or call the Toxicology Information Service at telephone number 915620420.
If you forget to take LinoMed:
Do not take a double dose to make up for missed doses.
4. Possible adverse effects
Like all medicines, LinoMed may have adverse effects. These are not usually seen under the recommended conditions of use. However, occasionally in sensitive individuals, diarrhea, cramps or abdominal pain, nausea and vomiting may occur.
This medicine may turn the urine brown or reddish in colour, but this is not significant.
If you notice any adverse reaction not described above, consult your doctor or pharmacist.
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist
or nurse, 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 Medicinal Products: https://www.notificaram.es.
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of LinoMed
Keep LinoMed out of the reach and sight of children.
Store LinoMed in the original packaging; no special storage conditions are required, but keep below 30°C.
Expiry
Do not use LinoMed after the expiry date stated on the packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need.
This will help protect the environment.
6. Contents of the package and other information
Each 4.1 g dose (one measuring spoon) contains the following active ingredients:
1.76 g of whole flaxseed (Linum usitatissimum L.) coated with:
0.56 g of powdered senna leaf (Cassia angustifolia Vahl.)
0.05 g of powdered buckthorn bark (Rhamnus frangula L.)
The other 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 Manufacturing Responsible Person
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
The Netherlands
This leaflet was approved in: January 2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/