Linex 16 capsules

The distribution of this drug over the Internet is strictly prohibited and regulated by the laws of the Republic of Serbia, while its presentation on the Internet is allowed, solely for the purpose of informing the general and professional public about its purpose and better familiarization with the basic characteristics of the drug itself.

YOU CAN VIEW THE REGULATION ON THE METHOD OF ADVERTISING MEDICINE, REGARDING MEDICINE ("Sl. Gl. RS", no. 79/2010) HERE.

Linex®, capsule, hard, 1.2 x 107 CFU/capsule

INN: lactic acid bacteria
Read this leaflet carefully before you start taking this medicine because it contains information
that are important to you.
Always take this medicine exactly as stated in this leaflet or as explained to you by your doctor
or a pharmacist.
 Save the instructions. You may need to read it again.
 If you have additional questions or need advice, contact your pharmacist.
 If you experience any side effects, contact your doctor or pharmacist. This
includes any side effects not listed in this guide. See section 4.
 If you do not feel better or feel worse after two days, you must contact your doctor.
In this guide you will read:
1. What is the medicine Linex and what is it intended for
2. What you need to know before taking Linex
3. How to use the medicine Linex
4. Possible side effects
5. How to store the medicine Linex
6. Contents of the package and other information
1. What is the medicine Linex and what is it intended for
The drug Linex is a probiotic, which means that it contains lactic acid bacteria that help in the right amount
in establishing and maintaining a balanced and healthy intestinal microflora. The medicine Linex contains three types of mercury
lyophilized lactic acid bacteria that regulate the physiological balance of intestinal microflora, and resistant
are to certain antibiotics and chemotherapeutics.
Lactic acid bacteria are normally present in the small and large intestine where they maintain the acid-base balance
the balance required for the normal function of digestive enzymes (normal digestion), the human immune system and
motility (intestinal peristalsis). When the amount of lactic acid bacteria is not appropriate, it is impaired
the balance of the internal intestinal bacterial flora, which leads to various digestive diseases.
The lactic acid bacteria in Linex are lyophilized (ie dried at a low temperature). This
allows the medicine to be stored at room temperature without effects on the formation or activation of bacteria.
The drug Linex is used as a preventive and supportive therapy for diarrhea, flatulence and other digestive issues
disorders caused by microflora imbalance.
This imbalance can occur due to:
- viral and bacterial infections of the digestive tract in infants, children and adults (e.g. rotavirus infections,
traveler's diarrhea),
- therapy with broad-spectrum antibiotics and chemotherapeutic agents,
- radiation therapy of organs in the abdomen and pelvis.
The use of probiotics or lactic acid bacteria effectively reduces the frequency and severity of mild to moderate
digestive disorders caused by an imbalance of intestinal microflora.
2. What you need to know before taking Linex
You must not use Linex:
2 out of 5
- if you are allergic (hypersensitive) to the active substances or to any of the auxiliary substances included in
the composition of the drug.
When taking Linex, take special care:
Before taking Linex, consult your doctor if:
- you have a body temperature over 38 ºC,
– notice traces of blood or mucus in the stool,
- diarrhea lasts longer than two days,
- you have severe diarrhea accompanied by dehydration and weight loss,
- is diarrhea accompanied by severe stomach pain,
- you have another chronic disease (e.g. diabetes, cardiovascular disease) or people with reduced
immunity (eg HIV infection).
If any of the above apply to you, consult your doctor before taking this medicine.
Warning for all age groups:
If you are treating diarrhea yourself, the first and most important measure is to replace lost fluids and electrolytes.
Warning for infants and children under 6 years of age:
Diarrhea in infants and children under the age of 6 should not be treated without medical supervision.
If you are not sure about any of the above, ask your doctor or pharmacist.
Administration of other drugs
Tell your doctor and pharmacist if you are taking or have recently taken any other medicines, including those
which can be obtained without a prescription.
So far, no clinically significant interaction with other drugs has been established.
In laboratory tests, the natural resistance of bacteria from the medicine Linex, capsules, was established, they claim
certain antibiotics and chemotherapeutics. The drug Linex capsules, they claim, can be taken with antibiotics and
chemotherapeutic agents, but, if possible, not at the same time. For better effectiveness of the drug, it is recommended to take it
medication Linex capsules, hard, at least 3 hours after taking antibiotics or chemotherapeutics.
Taking Linex with food or drinks
In order to avoid the harmful effects of acidic gastric juice on lactic acid bacteria, it is recommended to take
medication Linex capsules, hard, during meals. The drug Linex capsules, they claim, should not be taken with alcohol or
hot drinks.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you are pregnant or are planning to become pregnant, consult your doctor or pharmacist
before taking this medicine.
Treatment of diarrhea during pregnancy and breastfeeding should be carried out under the supervision of a doctor.
Given that there is not enough data on the safety of Linex capsules during pregnancy and breastfeeding, no
the use of this medicine is recommended.
The influence of the drug Linex on the driving of motor vehicles and the operation of machines
3 out of 5
No studies have been conducted on the effect of Linex on the ability to drive a motor vehicle or operate a vehicle
machines.
Important information about some of the ingredients of Linex
This medicine contains lactose. In case of intolerance to some of the sugars, consult your doctor before use
of this medicine.
The medicine Linex may contain residues of milk proteins that can cause allergic reactions.
3. How to administer the drug Linex
Always take Linex exactly as your doctor has explained it to you. If you're not quite sure, check
with your doctor or pharmacist.
Always take Linex exactly as your doctor has explained it to you. If you're not quite sure, check
with your doctor or pharmacist.
For oral use.
The drug is intended for adults, children and infants.
Instructions for proper use:
– Linex should be taken orally.
- If the child is unable or unable to swallow the capsule, it is necessary to open the capsule, empty the contents into
teaspoon and mix with a little liquid.
- In order to avoid the harmful effects of acidic gastric juice on lactic acid bacteria, it is recommended
taking Linex capsules during meals. Lek Linex capsules should not be taken with alcohol or hot water
drinks.
Usual doses and duration of therapy:
Infants and children up to 2 years of age: 1 capsule, hard, three times a day (eg morning, noon and evening)
Children aged 2 to 12 years: 1-2 capsules, hard, three times a day (eg morning, noon and evening)
Adults and children over 12 years: 2 capsules, hard, three times a day (eg morning, noon and evening)
The drug Linex can be taken until the symptoms improve.
If you or your child's symptoms of diarrhea (diarrhea) do not improve after two days from the start
before taking capsules, hard, it is necessary to consult a doctor.
If you are treating diarrhea yourself, the first and most important measure is to replace lost fluids and electrolytes.
If you have taken more Linex than you should
If side effects occur, inform 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 missed dose.
Take the medicine when it is time for the next dose, and then continue according to the established schedule.
If you suddenly stop taking Linex
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
The drug Linex, like other drugs, can have side effects, although they may not occur in everyone.
4 out of 5
Side effects after taking lactic acid bacteria are very rare (can occur in at most 1
per 10,000 patients taking the drug). Hypersensitivity reactions may occur.
If any side effect becomes serious or you notice any side effect not listed in
this instruction, please inform your doctor or pharmacist about it.
Reporting adverse reactions
If you experience any unwanted reaction, you should inform your doctor, pharmacist or
nurse. This includes any possible side effects that are not listed in this guide.
By reporting side effects, you can help evaluate the safety of this medicine. Doubt on
You can report adverse reactions to the Agency for Medicines and Medical Devices of Serbia (ALIMS):
Agency for Medicines and Medical Devices of Serbia
National Center for Pharmacovigilance
Vojvode Stepe 458, 11221 Belgrade
Republic of Serbia
website: www.alims.gov.rs
e-mail: nezeljene.reakcije@alims.gov.rs
5. How to store the medicine Linex
Keep the medicine out of the sight and reach of children.
You must not use the medicine Linex after the expiration date indicated on the package after: ("Valid by") Date
of use expires on the last day of the specified month.
Store at a temperature of up to 25ºC, in the original packaging.
Unused medicines are handed over to the pharmacy where the notice that they are collected is displayed
unused medicines from citizens. Do not dispose of used medicines in the sewer or together with
communal waste. These measures will help preserve the environment.
6. Contents of the package and other information
What does Linex contain?
The active substances are:
One hard capsule contains at least 1.2 x 107 CFU at least 4.5 x 106 CFU Lactobacillus acidophilus (L.
Gasseri), at least 3.0 x 106 CFU Bifidobacterium infantis and at least 4.5 x 106 CFU Enterococcus faecium)
Auxiliary substances are:
The core of the capsule, they claim:
Lactose
dextrin,
Starch, potato
Magnesium stearate
Capsule shell:
Gelatin
Titanium dioxide (E171)
What Linex looks like and the contents of the package
White, opaque gelatin capsules, with a white body and cap, filled with white powder.
5 out of 5
The inner package is an Al/Al blister with 8 capsules, hard.
The outer packaging is a collapsible cardboard box containing two Al/Al blisters with 8 capsules each, hard
(a total of 16 capsules, hard) and Instructions for the medicine.
License holder and manufacturer
License holder
REPRESENTATIVE OFFICE OF SANDOZ PHARMACEUTICALS DD BELGRADE
Kneginje Zorke 2, Belgrade
Manufacturer:
LEK PHARMACEUTICAL COMPANY DD,
Verovškova 57, Ljubljana, Slovenia
This instruction was last approved:
March, 2017
Mode of administration of the drug:
The drug is issued without a doctor's prescription.
License number and date:
515-01-02588-16-001 from 31.03.2017