LOPERAMIDE EXAL 2 мг Капсулы

Содержание инструкции

1. Loperamide Hexal 2 mg hard capsules
   1. What is Loperamide Hexal and what is it used for
   2. What you need to know before taking Loperamide Hexal
   3. How to take Loperamide Hexal
   4. Possible side effects
   5. How to store Loperamide Hexal
   6. Contents of the pack and other information

Loperamide Hexal 2 mg hard capsules

Generic medicine

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Loperamide Hexal is and what it is used for
• 2. What you need to know before you take Loperamide Hexal
• 3. How to take Loperamide Hexal
• 4. Possible side effects
• 5. How to store Loperamide Hexal
• 6. Contents of the pack and other information

1. What is Loperamide Hexal and what is it used for

Loperamide Hexal contains the active ingredient loperamide which belongs to the class of medicines called
antidiarrheals and antiperistaltics, which help to reduce diarrhea by decreasing the motility of the intestine.
This medicine is indicated:

• for the treatment of both occasional and persistent diarrhea (acute and chronic diarrhea);
• to reduce diarrhea and to increase the consistency of stools after intestinal surgery (ileostomy).

2. What you need to know before taking Loperamide Hexal

Do not take Loperamide Hexal

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding;
• if you suffer from an intestinal disease, acute dysentery, characterized by the presence of blood in the stool and high fever;
• if you have inflammation of the intestine characterized by the presence of lesions (acute ulcerative colitis);
• if you have an intestinal infection (bacterial enterocolitis caused by invasive organisms, such as Salmonella, Shigella and Campylobacter);
• if you have a severe form of diarrhea (pseudomembranous colitis) caused by the use of medicines used for the treatment of infections caused by bacteria (antibiotics);
• if the use of this medicine may expose you to the risk of complications, which may cause blockage of intestinal activity (ileus, megacolon and toxic megacolon). If you experience constipation, ileus or abdominal bloating during treatment, stop taking this medicine immediately and consult your doctor.
• if you are using medicines that reduce bowel movements.

Loperamide Hexal should not be used in children under 6 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Loperamide Hexal.
Pay particular attention:

• if you have diarrhea your body loses fluids and mineral salts: to restore normal levels, it may be helpful to take sugary-salty aqueous solutions;
• treatment with Loperamide Hexal is only symptomatic and does not eliminate the cause of your condition;
• if you have reduced liver function, consult your doctor or pharmacist before taking Loperamide Hexal.

The use of this medicine improves the symptoms of diarrhea (symptomatic treatment), but does not cure the
cause. Therefore, when it is possible to establish the cause of the diarrhea, it is necessary to treat it with a specific
therapy that will be indicated by your doctor.
Do not take this medicine for more than 2 days.
Stop treatment with this medicine immediately and consult your doctor if:

• you do not notice an improvement in your condition within 48 hours of taking Loperamide Hexal;
• you suffer from AIDS and during treatment with this medicine you experience abdominal bloating;
• if you experience constipation, ileus or abdominal bloating during treatment

If you are taking Loperamide Hexal to treat diarrhea caused by bacteria or viruses (infectious colitis) you
have a greater risk of developing other disorders associated with blockage of intestinal activity (toxic
megacolon).
Do not take this medicine for uses other than those intended (see section 1) and never take
a dose higher than the recommended one (see section 3). In patients who have taken an excessive dose of loperamide, the active ingredient of Loperamide Hexal, serious heart problems have been reported
(with symptoms including a rapid or irregular heartbeat).
Take this medicine with caution and under the control of a doctor if you have liver problems (impaired
liver function, hepatic dysfunction), because toxic effects that
affect the central nervous system may occur.
Consult your doctor if you do not feel better or if you feel worse after 2 days of treatment or if the disorder
occurs repeatedly.

Children from 6 to 12 years
Loperamide Hexal must be used under medical supervision.
Other medicines and Loperamide Hexal
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Take this medicine with caution and inform your doctor if you are taking:

• desmopressin, a medicine used to treat diabetes;
• other medicines that slow down bowel activity (e.g. anticholinergics);
• medicines that promote intestinal activity;
• quinidine, a medicine used to treat some heart disorders;
• ritonavir, a medicine used to treat AIDS;
• itraconazole and ketoconazole, medicines used to treat fungal infections;
• gemfibrozil, a medicine used to reduce fat levels in the blood;
• other medicines (cytochrome CYP 450 inhibitors and P-glycoprotein inhibitors).

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, do not take Loperamide Hexal.

Driving and using machines
During treatment with Loperamide Hexal you may experience fatigue, dizziness or drowsiness. If this
occurs, avoid driving vehicles and using machinery.
Loperamide Hexal contains lactose, a type of sugar. If your doctor has diagnosed you with intolerance
to some sugars, contact him before taking this medicine.
Loperamide hexal contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially “sodium-free”.

3. How to take Loperamide Hexal

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
Take this medicine with a little water.
During treatment with this medicine, you must reduce the dose as soon as you notice an
improvement in your health condition (normalization of stools).
Stop treatment with this medicine if you should experience constipation (See paragraph
Warnings and precautions).
Do not take this medicine for more than 2 days.

Adults
Treatment of occasional diarrhoea:
The recommended initial dose is 2 capsules (4 mg). Afterwards, the maintenance dose will be 1 capsule (2
mg) to be taken after each bowel movement.
Do not exceed the recommended maximum dose of 8 capsules per day (16 mg).

Treatment of persistent (chronic) diarrhoea:
The recommended initial dose is 2 capsules. The doctor will adjust the dose according to your health
condition, generally the maintenance dose is between 1 and 6 capsules per day.
Do not exceed the recommended maximum dose of 8 capsules per day.

Children and adolescents (from 6 to 17 years of age)
Treatment of occasional diarrhoea and persistent (chronic) diarrhoea:
The recommended initial dose is 1 capsule. In the treatment of persistent diarrhoea, the doctor will adjust the
dose according to the child's health condition. Generally the maintenance dose is between 1 and
6 capsules per day.
The maximum dose is calculated based on body weight. For every 20 kg of body weight, 3 capsules should be administered
do not exceed 8 capsules per day.

In children from 6 to 12 years of age, Loperamide Hexal must be used under medical supervision.
Children under 6 years
This medicine should not be administered to children under 6 years of age.

Patients with liver problems
Take this medicine with caution if you suffer from liver problems (See paragraph “Warnings and
precautions”).

If you take more Loperamide Hexal than you should
In case of ingestion/taking of an excessive amount of this medicine, seek immediate medical attention
or go to the nearest hospital.
In case of overdose, the following effects may occur:

• increased heart rate, irregular heartbeat, changes in heartbeat (these symptoms may have potentially serious and life-threatening consequences),
• depression of the central nervous system, also associated with detachment from reality (stupor) and coordination difficulties. Children may experience these effects more markedly than adults;
• drowsiness;
• reduction in the size of the pupil, the black part of the eye (miosis);
• muscle disorders (hypertonia);
• difficulty breathing (respiratory depression);
• reduced need to urinate (urinary retention);
• intestinal disorders (ileus);
• difficulty or inability to defecate (constipation or intestinal obstruction).

These effects are more likely to occur in children, especially under 4 years of age.
Compared to adults, children's reaction to high doses of Loperamide Hexal is stronger. If a child
takes an excessive amount or exhibits some of the aforementioned symptoms, contact a
doctor immediately.
In case of accidental ingestion in children under 4 years of age, constipation and
depression of the central nervous system associated with drowsiness and difficulty breathing (bradypnea) may occur. In
these cases, the patient should be kept under close observation for 48 hours.
Treatment of overdose includes gastric lavage, induction of vomiting, or administration of
medicines that promote bowel emptying (laxatives). In addition, if you experience symptoms of
overdose, you may be given naloxone, a medicine used as an antidote. In these cases
you must be monitored for at least 48 hours.

If you forget to take Loperamide Hexal
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you are taking this medicine to treat occasional diarrhoea (acute diarrhoea), you may experience
the following side effects:

Common(may affect up to 1 in 100 people)

• headache;
• constipation, nausea, flatulence.

Uncommon(may affect up to 1 in 1,000 people)

• dizziness;
• abdominal pain, especially in the upper part of the abdomen, abdominal discomfort;
• dry mouth;
• vomiting;
• skin irritation (rash).

Rare(may affect up to 1 in 10,000 people)

• abdominal bloating.

If you are taking this medicine to treat persistent diarrhoea (chronic diarrhoea), you may
experience the following side effects:

Common(may affect up to 1 in 100 people)

• dizziness;
• constipation, nausea, flatulence.

Uncommon(may affect up to 1 in 1,000 people)

• headache;
• abdominal pain, abdominal discomfort;
• dry mouth;
• digestive disorders (dyspepsia).

In addition, the following side effects have been reported (post-marketing surveillance)
Seek immediate medical attention:

Not known(frequency cannot be estimated from available data)

• allergic (hypersensitivity) reactions, including severe ones (anaphylactic reaction, including shock and anaphylactoid reaction);
• drowsiness, loss of consciousness, mental disorders, also associated with detachment from reality (stupor), decreased level of consciousness, muscle disorders (hypertonia) and loss of muscle coordination making it difficult to perform certain movements;
• reduction in the size of the pupil, the black part of the eye (miosis);
• intestinal disorders, also associated with reduced bowel function (ileus, paralytic ileus, megacolon, toxic megacolon);
• pain and burning sensation in the mouth (glossodynia);
• severe skin disorders that can manifest with the formation of blisters (Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme), skin irritation (urticaria), itching;
• swelling of the face due to fluid accumulation, especially around the mouth and eyes (angioedema);
• reduced need to urinate (urinary retention);
• fatigue
• Upper abdominal pain, abdominal pain that spreads to the back, abdominal tenderness to the touch, fever, rapid pulse, nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis).

If you experience any of these symptoms, stop using the medicine and contact
your doctor immediately.

Additional side effects in children and adolescents
Children and adolescents may experience the same side effects as reported for adults.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of
this medicine.

5. How to store Loperamide Hexal

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad.” The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Loperamide Hexal contains

• The active ingredient is: loperamide hydrochloride. Each capsule contains 2 mg of loperamide hydrochloride, corresponding to 1.8 mg of loperamide.
• The other ingredients are: lactose, corn starch, magnesium stearate, talc. Capsule shell: gelatin, black iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172), patent blue V (E131).

Description of the appearance of Loperamide Hexal and contents of the pack
Pack of 8, 15 or 30 hard capsules.

Marketing Authorisation Holder
Sandoz S.p.A. - Largo U. Boccioni, 1 - 21040 Origgio (VA) - Italy

Manufacturer
Salutas Pharma GmbH - Otto-Von-Guericke-Allee, 1 - 39179 Barleben (Germany)