OUTER LABELLING
CARDBOARD BOX
Psyllium seed
Psyllii semen
Sachet composition:
Psyllium seed (Psyllii semen) – 5.0 g
Herbs, 5.0 g per sachet
30 saszetek po 5,0 g Kod kreskowy EAN UCC: 5909990022144
Indications for use:
Constipation. Conditions requiring bowel movement.
Method of administration: Oral.
Posology: Adults and adolescents over 12 years: Pour contents of sachet into a glass, fill up with boiled water. Set aside to swell up. Use 2 times a day after a meal and wash down with plenty of water.
Children from 6 to 12 years: Half the adult dose.
Contraindications:
Sudden changes of bowel habits, lasting longer than 2 weeks, undiagnosed rectal bleeding and lack of bowel movement after laxative use. Irregular constrictions in the gastrointestinal tract, diseases of the esophagus and gullet, possible or actual bowel obstruction or atony, undiagnosed abdominal pain, nausea, vomiting, colonic hypertrophy (megacolon), issues with swallowing or the throat, known hypersensitivity to psyllium seed.
Warnings and precautions:
Due to insufficient data, not recommended for children under 6 years. Do not use shortly before bedtime. If constipation persists after 3 days, consult a doctor or pharmacist. The product should be used to relieve constipation which did not subside after change of eating habits. Unless advised otherwise by a doctor, psyllium seed should not be used by patients with fecal impaction and symptoms such as abdominal pain, nausea, vomiting, as they can indicate possible or actual bowel obstruction. In case of abdominal pain or any other bowel movement disorder, use should be discontinued and doctor's advice be sought. It is necessary to use the product with a sufficient amount of fluid (at least 30 ml per 1 g). Use with insufficient amount of fluids may cause bowel obstruction and obstruction of the throat or esophagus, which may result in choking. If chest pain, vomiting, issues with swallowing or breathing occur following use, immediately consult a doctor. Use by elderly and/or weakened patients should be conducted under a doctor's supervision. Use of psyllium seed with medicine inhibiting peristalsis (e.g. opioids) requires a doctor's supervision in order to reduce the risk of bowel obstruction.
Interactions:
Use of psyllium seed may decrease absorption of concomitantly used medicine, such as mineral compounds, vitamins (B12), cardiac glycosides, coumarin derivatives, carbamazepine and lithium. Therefore, the product should be not be used ½ – 1 hour before or after other medicine. Use by diabetic patients requires a doctor's supervision, as the diabetic therapy may need adjusting. Concomitant use with thyroid hormones requires a doctor's supervision, as the hormon dose may need adjusting.
Pregnancy and lactation:
Use can be considered during pregnancy and lactation, if deemed necessary and change of eating habits is unsuccessful. In that case, treatment should begin with bulk-forming laxatives.
Impact on ability to drive vehicles and operate machinery:
None.
Adverse effects:
Flatulence may occur, which usually subsides during treatment. Abdominal distension may also occur, along with risk of obstruction of the bowels or throat, as well as fecal impaction, especially with use with insufficient fluid intake. Frequency of occurrence is unknown.
During oral use, skin contact or inhalation of powdered product, patients may experience hypersensitivity reactions, such as catarrh, conjunctivitis, bronchospasm, anaphylaxis in some cases, as well as skin symptoms, such rash and/or itching. Persons in continuous contact with powdered psyllium seed should take special caution. Frequency of occurrence is unknown.
Reporting adverse effects:
In case of any adverse effect, including those not stated on the packaging, notify a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Adverse Drug Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: 22 49-21-301, fax: 22 49-21-309, e-mail: ndl@urpl.gov.pl.
Adverse effects can also be reported to the marketing authorisation holder. Reporting adverse effects allows for more safety information to be gathered on a medicinal product.
Overdose:
Overdose may result in abdominal discomfort, flatulence and bowel obstruction. In case of overdose, appropriate fluid intake and emergency treatment should be provided.
Dose omission:
Do not use double doses to supplement omitted doses.
Storage:
Store closed in max. 30 °C, keep away from children.
Marketing authorisation holder:
- Labofarm Sp. z o.o.
ul. Lubichowska 176 b
83-200 Starogard Gdański
tel. 58 561 20 08
e-mail: poczta@labofarm.com.pl
Marketing authorisation number: IL-6249/LN
Batch number:
Expiry date:
Do not use after expiry date.
Non-prescription medicinal product – OTC
Date of information approval: 2016.10.25
PL