Linex Forte 14 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.

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Linex®
Forte, 2 x 109 CFU, capsules, hard
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 or your child do not feel better or feel worse after two days, you must move
to your doctor.
In this guide you will read:
1. What is the medicine Linex Forte and what is it intended for
2. What you need to know before taking Linex Forte
3. How to take Linex Forte
4. Possible side effects
5. How to store the medicine Linex Forte
6. Contents of the package and other information
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1. What is the medicine Linex Forte and what is it intended for
The drug Linex Forte is a probiotic, which means that it contains microorganisms that help regulate the balance
intestinal flora. The drug Linex Forte contains two strains of lactic acid bacteria (Lactobacillus acidophilus
(LA-5
®
) and Bifidobacterium animalis subsp. lactis (BB-12®
)) that help establish and maintain
balance and function of intestinal microorganisms (intestinal flora).
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 immune system
people and intestinal motility (peristalsis). In addition, these bacteria further prevent reproduction
harmful bacteria.
The lactic acid bacteria in Linex Forte are lyophilized (ie dried at a low temperature). This
it allows the drug to be stored at room temperature without affecting the shape or activation of bacteria.
The drug Linex Forte is used as a preventive and supportive therapy in adults, children and infants with diarrhea
(diarrhea), flatulence and other digestive disorders caused by:
- viral and bacterial infections of the digestive tract (e.g. rotavirus infections, traveler's diarrhea)
- treatment with antimicrobial drugs (e.g. antibiotics and/or other synthetic antimicrobial drugs)
- radiation treatment of abdominal and pelvic organs.
Regular application of lactic acid bacteria effectively reduces the frequency and severity of mild to moderate
digestive problems (mainly diarrhea) associated with disruption of normal intestinal microflora and
maintains normal intestinal peristalsis.
2. What you need to know before taking Linex
Forte Lek Linex Forte should not be taken:
- if you are allergic (hypersensitive) to the active substance or to any of its auxiliary substances
medicines (listed in section 6.)
Warnings and precautions
Talk to your doctor before taking LinexForte if:
- you have a body temperature over 38ºC;
- notice blood or mucus in the stool;
- diarrhea (diarrhea) lasts longer than two days;
- you have pronounced diarrhea followed by dehydration and loss of body weight;
- is diarrhea accompanied by severe abdominal pain such that medical assistance is required;
- you have serious diseases that require intensive treatment (eg structural heart diseases, the presence of
central venous catheter);
- use therapy with immunosuppressive drugs (eg during transplantation);
- you have altered bowel function (e.g. short bowel syndrome);
– you have other chronic conditions (eg diabetes, cardiovascular diseases) or
– you have conditions of reduced immune resistance (e.g. HIV infection)
If you or your child's symptoms of diarrhea (diarrhea) do not improve after two days from
before starting to take hard capsules, it is necessary to consult a doctor.
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Warning for all age groups:
In the treatment of diarrhea, the first and most important measure is the replacement of lost fluid and electrolytes (salt), which
is especially important in pre-existing diseases with more difficult fluid and electrolyte regulation.
Warning for infants and children under 6 years of age:
Diarrhea in children under 6 years of age must not be treated without medical supervision.
Therefore, the medicine Linex Forte can be used in children under 6 years old only after the previous one
consultation with a doctor.
Other medicines and the medicine LinexForte
Tell your doctor or pharmacist if you or your child are taking or may take any
other medicines, including those that can be obtained without a doctor's prescription.
So far no interaction studies with other drugs have been conducted.
The lactic acid bacteria in Linex Forte are, like other bacteria, sensitive to certain
antibiotics. If you take this medicine at the same time as antibiotics, it is recommended that the medicine Linex Forte
capsules, hard take at least three hours after taking antibiotics.
Taking Linex Forte with food, drinks and alcohol
It is preferable to take Linex Forte with a meal, as this allows for maximum effectiveness
medicine. Linex Forte should not be taken together with alcohol and hot drinks.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you are pregnant or are planning to become pregnant, contact 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. They are not reported
adverse reactions associated with the use of the drug Linex Forte, capsules, during pregnancy and breastfeeding.
There is not enough data to confirm the safety of the use of Linex capsules, they claim
pregnancy and breastfeeding. However, in case of acute diarrhea during pregnancy and breastfeeding, it is necessary to take action
preventive measures to prevent fluid and electrolyte loss or any other side effects
which could put the unborn child or the pregnant woman at risk.
Given that there is not enough data on the safety of using Linex Forte during
use of this medicine is not recommended during pregnancy and breastfeeding.
There are no data on the effect of this drug on fertility.
Driving vehicles and operating machines
No studies have been conducted on the effect of Linex Forte on the ability to drive or operate vehicles
machines.
Linex Forte hard capsules contain oligofructose.
Oligofructose is an oligosaccharide consisting of fructose, glucose, sucrose and possible lactose residues.
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In case of intolerance to certain sugars, consult your doctor before using this
medicine. Linex Forte contains milk protein residues that can cause allergic reactions.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “sodium free”.
3. How to take Linex Forte
Always take this medicine exactly as stated in this leaflet or as explained to you by your doctor
doctor. If you are not sure, check with your doctor or pharmacist.
The drug Linex Forte is intended for oral use.
- Capsules, hard, to be swallowed with liquid during meals. In children under 6 years of age and persons who
are unable or do not know how to swallow the capsule, it is necessary to open the capsule, empty the contents into
spoon and mix with a little water.
- Take the medicine Linex Forte capsules, hard during a meal considering that this way
ensures the best effect of the drug.
- Linex Forte should not be taken with alcohol or hot drinks.
Length and duration of therapy:
Adults and adolescents 12 years of age and older: one capsule, hard, one to three times a day
(depending on the severity of symptoms).
Children aged 2 to 12 years: one capsule, hard, once or twice a day (in
depending on the severity of symptoms)
Infants up to 2 years of age: one capsule, hard, once a day.
You can give Linex Forte to your child until the symptoms improve.
If there is no improvement in the symptoms of diarrhea (diarrhea) after 2 days of starting to take Linex
Forte, it is necessary to consult a doctor.
If diarrhea lasts longer than two days, parents should definitely consult a doctor. U
in the treatment of diarrhea, the first and most important measure is the replacement of lost fluids and electrolytes.
Linex Forte capsules are taken at least three hours after taking antibiotics.
If you have taken more Linex Forte than you should
If side effects occur, contact your doctor or pharmacist. No cases have been reported
overdoses.
If you forget to take Linex Forte
Do not take a double dose to make up for a missed dose.
Continue treatment according to the established schedule.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although they may not occur
in all patients taking this medicine.
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Adverse effects after taking lactic acid bacteria are very rare (they can occur in
maximum 1 in 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 guide, please inform your doctor or pharmacist.
Reporting adverse reactions
If you experience any unwanted reaction, you should inform your doctor or
pharmacist. 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 Forte
Keep the medicine out of the sight and reach of children.
You must not use the medicine Linex Forte after the expiration date indicated on the package ("Valid
to the:"). The term of use expires on the last day of the specified month.
Store at a temperature of up to 25 ºC, in the original packaging.
Unusable medicines are handed over to the pharmacy where the notice to that pharmacy is displayed
they collect unusable medicines from citizens. Unusable medicines must not be thrown away
sewage or together with municipal waste. These measures will help protect the environment.
6. Contents of the package and other information
What does Linex Forte contain?
The active substances are:
One hard capsule contains at least 2 x 109 CFU of live lyophilized lactic acid bacteria:
- Lactobacillus acidophilus (LA-5
®
): at least 1 x 109 CFU,
– Bifidobacterium animalis subsp. lactis (BB-12®
): at least 1 x 109 CFU.
Auxiliary substances are:
The contents of the capsule, they claim:
inulin; oligofluctose (glucose, fructose, sucrose); maltodextrin; magnesium stearate.
The composition of the capsule, they claim:
White capsule body: titanium dioxide (E171); hydroxypropylmethylcellulose.
Yellow capsule cap: titanium dioxide (E171); hydroxypropylmethylcellulose; iron (III)-oxide, yellow
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(E172).
What the medicine Linex Forte looks like and the contents of the package

Capsule, hard
Hard capsule No.2 with a white capsule body and a yellow capsule cap. It's a capsule
filled with light brown to light pink powder with darker dots.
The inner packaging is a blister (Al/Al) with 7 hard capsules.
The outer packaging is a collapsible cardboard box containing two blisters with 7 hard capsules each
(a total of 14 capsules, hard) and Instructions for the drug.
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 is the last one approved
September, 2022.
Mode of administration of the drug:
The drug is issued without a doctor's prescription.
License number and date:
515-01-04391-21-001 from September 29, 2022.