Description and Composition of Linex
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Linex is a probiotic. It contains three kinds of viable lyophilised lactic acid bacteria which maintain physiological balance of intestinal microorganisms intestinal microflora) and are resistant to antibiotics and chemotherapeutics.
Each hard capsule of Linex contains not less than 1.2 x 107 colony-forming units (CFU) of viable lyophilised lactic acid bacteria of the following species:
- Lactobacillus acidophilus (species L. gasseri)
- Bifidobacterium infantis and
- Enterococcus faecium.
The other ingredients are:
Capsule content: magnesium stearate, lactose, dextrin, potato starch
Capsule shell: gelatine, titanium dioxide (E171).
Lactic acid bacteria are naturally present in the small and large intestine where they keep the acid-alkaline balance, needed for the normal functioning of digestive enzymes, immune system and intestinal motility (peristaltic). When the amount of lactic acid bacteria is inadequate the balance of bacterial microflora is destroyed resulting in various gastrointestinal disturbances.
Bacteria in Linex are lyophilised (i.e. freeze-dried). This enables storage of Linex at room temperature preserving the form and activity of bacteria.
Linex can be used for prophylaxis and as a supportive treatment in diarrhoea, bloating and other gastrointestinal disturbances caused by impaired balance of intestinal microflora.
This occurs in:
- viral and bacterial infections of the gastrointestinal tract in infants, children and adults (such as rotavirus infections, travel diarrhoea).
- treatment with broad-spectrum antibiotics and chemotherapeutics
- radiation therapy of abdominal and pelvic organs.
Administration of probiotics or lactic acid bacteria effectively reduces the incidence and severity of mild to moderate gastrointestinal disturbances caused by destruction of normal intestinal microflora.
Contraindications of Linex
Do not take Linex:
- If you are allergic (hypersensitive) to the active substance or any of the other ingredients of Linex
- If your body temperature is above 38 degree Celsius
- If You noticed occult blood or mucus in the stool.
- if diarrhoea lasts for more than two days.
- if you have severe diarrhoea accompanied by dehydration and loss of body weight
- If diarrhoea is accompanied by an intense abdominal pain
- if you have other chronic diseases (eg, diabetes cardiovascular diseases) or conditions characterised by decreased immune system resistance leg., HIV infection)
In such cases you should consult your doctor prior to the start of treatment
Important warning for all age groups
In the treatment of diarrhoea, the first and most important measure is to replace the lost fluid and salts
Important warning for infants and children below 6 year of age:
Diarrhoea in infants and children below 6 years of age should be treated under medical supervision. Therefore, Linex may be used in children below six years of age and infants ONLY after prior consultation with a doctor.
Consult your doctor or pharmacist if there is anything you are not sure about
Drug Interactions with Linex
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription.
Interaction studies of Linex and other medicines have not been performed.
In laboratory studies, natural resistance of bacteria to certain antibiotics and chemotherapeutics has been demonstrated.
Linex can be taken together with antibiotics and chemotherapeutics, however, not at the same time. To improve effectiveness, it is recommended to take Linex capsules not earlier than three hours after administration of antibiotics or Chemotherapeutic
Taking Linex with food and drink
It is preferable to take Linex during meals. You should not take Linex with alcohol or hot beverages.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. Treatment of diarrhoea during pregnancy and breast-feeding should be performed under the supervision of a physician.
Since there are inadequate data concerning the safety of Linex during pregnancy and breastfeeding, the use of the medicine during these periods is not recommended.
Driving and using machines
No adverse effects of Linex on the ability to drive or operate machinery have been observed.
Important information about some of the ingredients of Linex
Linex contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine
Linex may contain residues of milk proteins which can cause allergic hypersensitivity reactions.
How to Take Linex
Aways take linex exactly according to instructions for correct administration, dosage and treatment duration given below. You should check with your pharmacist if you are not sure
Instruction for Correct Administration
Linex is intended for for oral use (taken by mouth)
It is preferable to take capsules during meals since in this manner better effectiveness of the medicine wil be Secured.
You should not take Linex capsules together with alcohol or hot beverages.
In children and infants who are not able or do not know how to swallow, the capsule should be opened and the contents (powder) empted onto a spoon. To powder add only the mount of liquid needed to a child or infant to swallow
Dosage and duration of treatment
Infants and children up to 2 years of age: one capsule three times a day (e.g., in the morning, at midday, and in the evening
Children aged 2 to 12 years: one to two capsules three times a day (eg. in the morning. midday, and in the evening)
Adults and children over 12 years of age: two capsules three times a day (eg. in the morning, at midday, and in the evening.
Linex” can be taken until symptoms improve.
If the condition (diarrhoea) does not improve after two days of treatment with Linex you must visit your doctor. In the treatment of diarrhoea, it is absolutely necessary to replace the lost fluid and salt.
What to do If you take larger dose of Linex than you should
If undesirable effects occur for an overdose, consult your doctor or pharmacist. No cases of overdose have been reported
If you forget to take Linex:
Do not take a double dose to make up for a forgotten dose.
Take the medicine when it is time for your next dose and go back to your regular dosing schedule.
If you have any further questions on the use of this product ask your doctor or pharmacist.
Possible Side Effects of Linex
Like all medicines, Linex can cause side effects although not everybody gets them
Undesirable side effects during the use of lactic acid bacteria are very rare (occuring in less than one out of 10,000 patients). Hypersensitivity reactions may occur
If any of the side effects gets serious, or if you notice any side effects not listed in this here, please tel your doctor or pharmacist
How to Store Linex
Keep the medicine out of the reach of children.
Blister packs made of aluminium foil: store at temperature below 25 degree Celsius, in the original packaging.
Bottles: store at a temperature below 25°C, in tightly closed bottle.
Do not use Linex after the expiry date Which is stated on the packaging after “EXP”. The expiry date refers to the last day of that month.
What Linex looks like and contents of the pack
Linex is available in the form of white, hard, gelatine capsules. Capsules contain white odourless powder.
Linex is available in boxes containing a bottle with 16 hard capsules,
in boxes containing blister packs made of aluminium foil with 16 and 32 hard capsules (2×8 or 4×8).
Not all pack size may be marketed.
Availability of Linex
The medicine is available without prescription in pharmacies and specialised stores Marketing.
Authorisation holder and manufacturer
Marketing Authorisation Holder
Novartis Nigeria Limited
Landmark House
Plot 52-54 Isaac John Street
Ikeja GRA, Lagos
Manufacturer
Lek Pharmaceuticals d.d.
Verovskova 57
Ljubljana, Slovenia.
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