LOPEMID 2 mg Hard Capsules

Зміст інструкції

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

LOPEMID 2 mg, hard capsules

Loperamide hydrochloride
Read this leaflet carefully before you start taking this medicine because
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 for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LOPEMID is and what it is used for

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

• for the treatment of both occasional and persistent diarrhoea (acute and chronic diarrhoea);
• to reduce diarrhoea and to increase the consistency of stools after surgery on the intestine called “ileostomy” (which consists of the externalization of a section of the intestine on the abdominal surface).

Consult your doctor if you do not feel better or if you feel worse after the days of therapy
prescribed by your doctor.

2. What you need to know before taking LOPEMID

Do not take LOPEMID

• if you are allergicto the active ingredient or any of the other ingredients of this medicine (listed in section 6)
• in case of high fever and blood in the stool (signs of acute dysentery);
• if you suffer from an inflammation of the intestine called ulcerative colitis;
• if you suffer from diarrhoea caused by the use of antibiotics (pseudomembranous colitis);
• if you have an intestinal infection caused by bacteria such as Salmonella, Shigella and Campylobacter;
• 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 (abdominal distension) during treatment, immediately stop treatment with this medicine and consult your doctor.

Do not administer Lopemid to children under 2 years of age.

Warnings and precautions
Consult your doctor or pharmacist before taking LOPEMID.
The use of this medicine improves the symptoms of diarrhoea (symptomatic treatment),
but does not cure the cause. Therefore, when it is possible to establish the cause of the diarrhoea, it is
necessary to treat it with specific therapy as indicated by your doctor.
Diarrhoea causes a marked loss of fluids and mineral salts, especially in
children. For this reason, it is important to take a high amount of fluids and/or
preparations based on mineral salts.
Take this medicine with caution and under the supervision of your doctor if you have liver disorders (impaired liver function, hepatic dysfunction), because
toxic effects affecting the central nervous system may occur.
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 Lopemid, serious heart problems (with symptoms including a rapid or irregular heartbeat) have been reported.

Immediately stop treatment with Lopemid and consult your doctor if:

• you do not observe an improvement in your condition within 48 hours of taking Lopemid
• If you suffer from AIDS and notice abdominal bloating
• If you experience difficulty in defecation (constipation), bloating and/or abdominal pain.

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 2 to 6 years of age
Administer Lopemid to children from 2 to 6 years of age only under medical supervision.

Other medicines and LOPEMID
Tell your doctor or pharmacist if you are taking, have recently taken or
may take any other medicine.
This is particularly important if you are taking:

• Quinidine (a drug used in heart rhythm disorders)
• Ritonavir (a drug used to treat AIDS)
• Ketoconazole and itraconazole (drugs used in fungal infections)
• Gemfibrozil (a drug that lowers fat levels in the blood)
• Desmopressin (a drug used for example in type 1 diabetes)
• Other drugs with effects similar to those of Lopemid that slow down intestinal activity (e.g. anticholinergics)
• Drugs that accelerate intestinal peristalsis
• Drugs that inhibit CYP450 or P-glycoprotein.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy or if you are
breastfeeding with breast milk, ask your doctor or pharmacist for advice before using
this medicine.

If you are pregnant, especially during the first trimester, use the medicine only in
case of actual need and under the direct control of the doctor.
Do not take Lopemid during breastfeeding as a small amount of
medicine may pass into breast milk
Driving and operating machinery
LOPEMID may cause fatigue, dizziness or lightheadedness. If this should occur
avoid driving vehicles and using machinery.

Lopemid 2mg capsules contains lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before
taking this medicine

3. How to take LOPEMID

Take this medicine following the instructions of your doctor exactly. If you have any
doubts, consult your doctor or pharmacist.
Take the capsules with a little water.
During treatment with this medicine, you should reduce the dose as soon as you notice an
improvement in your health condition (normalization of bowel movements).
Stop treatment with this medicine if you experience constipation
(See section Warnings and precautions).
Caution: do not take this medicine for more than two days.

The recommended dose is:
Adults
Acute diarrhea: the initial dose is 2 capsules (4 mg) for adults, and then 1 capsule
(2 mg) after each bowel movement.
Do not exceed the maximum dose of 8 capsules per day (16 mg).

Chronic diarrhea: The initial dose is 2 capsules (4mg) per day.
Do not exceed the maximum dose of 8 capsules per day (16 mg).
The doctor will adjust the dose according to your health condition; generally, the
maintenance dose is between 1 and 6 capsules per day.

Children from 6 to 17 years
Acute diarrhea: the initial dose is 1 capsule (2mg) for children, and then 1 capsule
(2 mg) after each bowel movement.

Chronic diarrhea: The initial dose is 1 capsule (2mg) per day.
In both cases of acute and chronic diarrhea, the maximum dose will be calculated by
the doctor based on the child's body weight; generally, 3 capsules will be administered for
every 20 kg of body weight. It is recommended not to exceed 8 tablets
per day.

Use in patients with liver problems
Take this medicine with caution if you suffer from liver problems (See the
section Warnings and precautions).

If you use more LOPEMID than you should
If you have taken too much Lopemid, contact your doctor or hospital immediately for
advice. Symptoms may include: increased heart rate, irregular heartbeat, changes in
heart rhythm (these symptoms can have potentially serious and life-threatening
consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty
urinating or shallow breathing.
Compared to adults, children's reaction to high doses of Lopemid is stronger. If a
child takes an excessive amount or experiences some of the above symptoms,
contact your doctor immediately.
In case of ingestion/taking of an excessive amount of this medicine, contact your doctor or the
nearest hospital immediately.
In case of accidental ingestion/taking of an excessive dose of LOPEMID, you may
experience drowsiness, muscle stiffness or uncoordinated movements, constricted pupils,
difficulty breathing, stupor, depression of the nervous system, difficulty or
inability to evacuate (constipation or intestinal obstruction) and decreased diuresis
(urinary retention). These effects are more likely to occur in children.
Immediately notify your doctor or go to the nearest hospital, as
appropriate therapy is necessary.

If you forget to use LOPEMID
Do not take a double dose to make up for a missed dose.
If you have any questions about using this medicine, consult your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although
not everyone experiences them.
Stop taking Lopemid and consult your doctor immediately if you notice:

• Severe allergic reactions (anaphylactic or anaphylactoid reactions) that may manifest with skin rashes, swelling of the hands, feet, face, eyes, lips, throat, difficulty breathing, or a sudden drop in blood pressure (angioedema);
• Abdominal swelling associated with pain, nausea, vomiting, inability to defecate, signs of intestinal obstruction or megacolon;
• Severe skin rashes with redness, exfoliation and/or blister formation (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis).

Acute Diarrhea
Other side effects may occur with the following frequencies:

Common:(may affect up to 1 in 10 people)
Headache, Difficulty defecating (constipation), nausea, presence of gas
in the abdomen

Uncommon(may affect up to 1 in 100 people)
Dizziness, Abdominal pain, abdominal discomfort, dry mouth, vomiting, skin
rash

Rare(may affect up to 1 in 1000 people)
Indigestion, Abdominal bloating (abdominal distension)

Chronic Diarrhea
Other side effects may occur with the following frequencies:

Common:(may affect up to 1 in 10 people)
Dizziness, Difficulty defecating (constipation), nausea, presence of gas in the abdomen

Uncommon(may affect up to 1 in 100 people)Headache,
Abdominal pain, abdominal discomfort, dry mouth, indigestion (dyspepsia),
abdominal distension
The following side effects may also occur with the use of loperamide-based medicines:

• Urticaria, itching
• Somnolence, loss of consciousness, stupor, decreased level of consciousness, increased muscle tone (hypertonia), coordination disorders
• Pupil constriction (miosis)
• Intestinal obstruction, even due to paralysis of the intestinal muscles (including paralytic ileus), colon malformation even following ulcerative colitis (including toxic megacolon), severe oral cavity pain (glossodynia).
• Inability to completely empty the bladder (urinary retention)
• Fatigue

Reporting of side effects
If you experience any side effects, including those not listed in this
leaflet, please inform your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can
contribute to providing more information on the safety of this medicine.

5. How to store LOPEMID

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date that is reported on the packaging
after Exp. The expiry date refers to the last day of that month.
The expiry date refers to the product in intact packaging, correctly
stored.
Store at room temperature.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use.
This will help protect the environment .

6. Contents of the pack and other information

What LOPEMID contains
LOPEMID 2 mg, 30 hard capsules
The active ingredient is: loperamide hydrochloride
1 hard capsule contains: Loperamide hydrochloride 2 mg

The other ingredients are: microcrystalline cellulose, lactose monohydrate, talc.
Envelope constituents: gelatin, titanium dioxide.

Description of the appearance of LOPEMID and contents of the pack
LOPEMID is presented in 2mg hard capsules, in packs of 30 capsules

Marketing Authorisation Holder
VISUFARMA S.p.A.
Via Canino, 21
Rome
Italy

Manufacturer
SPECIAL PRODUCT’S LINE S.P.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)