Patient Information Leaflet: Information for the patient

LOPEMID 2 mg, hard capsules

Loperamide hydrochloride
Please read this entire 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 for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What LOPEMID is and what it is used for
What you need to know before taking LOPEMID
How to take LOPEMID
Possible side effects
How to store LOPEMID
Contents of the pack and other information

1. What LOPEMID is and what it is used for

LOPEMID contains the active substance loperamide, which belongs to a class of medicines called antidiarrhoeals and antipropulsives, which help reduce diarrhoea by decreasing intestinal motility.
This medicine is indicated:

for the treatment of both occasional and persistent diarrhoea (acute and chronic diarrhoea);
to reduce diarrhoea and increase stool consistency following a bowel surgery known as ileostomy (a procedure in which a segment of the intestine is brought out through the abdominal wall).

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

2. What you need to know before taking LOPEMID

Do not take LOPEMID

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
if you have high fever and blood in your stools (signs of acute dysentery);
if you suffer from an intestinal inflammation called ulcerative colitis;
if you have diarrhea caused by antibiotic use (pseudomembranous colitis);
if you have an intestinal infection caused by bacteria such as Salmonella, Shigella, and Campylobacter;
if taking this medicine may expose you to the risk of complications that could lead to intestinal paralysis (ileus, megacolon, and toxic megacolon). If during treatment you develop constipation (stippsis), ileus, or abdominal swelling (abdominal distension), stop treatment with this medicine immediately and consult your doctor.

Do not administer Lopemid to children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking LOPEMID.
This medicine improves the symptoms of diarrhea (symptomatic treatment),
but does not treat its underlying cause. Therefore, when the cause of diarrhea can be identified, it is necessary to treat it with a specific therapy, which your doctor will prescribe.
Diarrhea causes a significant loss of fluids and electrolytes, especially in children. For this reason, it is important to drink plenty of fluids and/or use electrolyte replacement solutions.
Take this medicine with caution and under medical supervision if you have liver problems (impaired hepatic function, liver dysfunction), as toxic effects affecting the central nervous system may occur.
Do not take this medicine for uses other than those indicated (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 in Lopemid, serious heart problems (with symptoms including rapid or irregular heartbeat) have been reported.

Stop taking Lopemid immediately and consult your doctor if:

you do not see any improvement in your condition within 48 hours of taking Lopemid
you have AIDS and notice abdominal swelling
you experience difficulty in defecation (constipation), abdominal swelling, and/or abdominal pain.

Contact your doctor if you do not feel better or if you feel worse after 2 days of treatment, or if the condition recurs repeatedly.
Children aged 2 to 6 years
Administer Lopemid to children aged 2 to 6 years only under medical supervision.
Other medicines and LOPEMID
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
This is particularly important if you are taking:

Quinidine (a medicine used for heart rhythm disorders)
Ritonavir (a medicine used to treat AIDS)
Ketoconazole and itraconazole (medicines used for fungal infections)
Gemfibrozil (a medicine that lowers blood lipid levels)
Desmopressin (a medicine used, for example, in type 1 diabetes)
Other medicines with effects similar to Lopemid that slow intestinal activity (e.g. anticholinergics)
Medicines that increase intestinal peristalsis
Medicines that inhibit CYP450 or P-glycoprotein.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant, especially during the first trimester, use this medicine only if clearly needed and under direct medical supervision.
Do not take Lopemid while breastfeeding, as a small amount of the medicine may pass into breast milk.
Driving and using machines
LOPEMID may cause tiredness, dizziness, or drowsiness. If this occurs, avoid driving or operating machinery.
Lopemid 2mg capsules contain lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take LOPEMID

Take this medicine exactly as directed by your doctor. If you
have any doubts, consult your doctor or pharmacist.
Take the capsules with a glass of water.
During treatment with this medicine, reduce the dose as soon as you notice an
improvement in your condition (normalization of stools).
Stop treatment with this medicine if constipation occurs
(See section Warnings and precautions).
Warning: do not take this medicine for more than two days.
Recommended dose:
Adults
Acute diarrhoea: The initial dose is 2 capsules (4 mg) for adults, followed by 1 capsule
(2 mg) after each episode of diarrhoea.
Do not exceed the maximum daily dose of 8 capsules (16 mg).
Chronic diarrhoea: The initial dose is 2 capsules (4 mg) daily.
Do not exceed the maximum daily dose of 8 capsules (16 mg).
Your doctor will adjust the dose according to your health condition; generally, the
maintenance dose ranges between 1 and 6 capsules per day.
Children aged 6 to 17 years
Acute diarrhoea: The initial dose is 1 capsule (2 mg) for children, followed by 1 capsule
(2 mg) after each episode of diarrhoea.
Chronic diarrhoea: The initial dose is 1 capsule (2 mg) daily.
In both acute and chronic diarrhoea, the maximum dose will be determined by the
doctor according to the child's body weight, usually 3 capsules for every 20 kg of body
weight. It is recommended not to exceed 8 capsules per day.
Use in patients with liver problems
Take this medicine with caution if you have liver problems (See section Warnings and
precautions).
If you take 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 may have potentially serious and life-threatening
consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty
urinating, or weak breathing.
Compared to adults, children's reactions to high doses of Lopemid are stronger. If a child
takes an excessive amount or shows any of the above symptoms, contact your doctor
immediately.
In case of overdose of this medicine, contact your doctor or the nearest hospital
immediately.
If an excessive dose of LOPEMID is accidentally ingested, you may experience drowsiness,
muscle rigidity or uncoordinated movements, constricted pupils, breathing difficulties,
stupor, depression of the central nervous system, difficulty or inability to defecate
(constipation or intestinal obstruction), and reduced urine output (urinary retention).
These effects are more likely to occur in children.
Contact your doctor immediately or go to the nearest hospital, as appropriate treatment
must be started promptly.
If you forget to take LOPEMID
Do not take a double dose to make up for a missed dose.
If you have any doubts about how to use 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 contact your doctor immediately if you notice:

Severe allergic reactions (anaphylactic or anaphylactoid reactions) which may present as skin rashes, swelling of the hands, feet, face, eyes, lips, throat, breathing difficulties, or a sudden drop in blood pressure (angioedema);
Abdominal swelling associated with pain, nausea, vomiting, inability to pass stools, signs of intestinal obstruction or megacolon;
Severe skin rashes with redness, peeling and/or blistering (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 patients)
Headache, difficulty passing stools (constipation), nausea, abdominal gas
Uncommon (may affect up to 1 in 100 patients)
Dizziness, abdominal pain, abdominal discomfort, dry mouth, vomiting, skin rash
Rare (may affect up to 1 in 1,000 patients)
Indigestion, abdominal swelling (abdominal distension)

Chronic Diarrhea
Other side effects may occur with the following frequencies:
Common: (may affect up to 1 in 10 patients)
Dizziness, difficulty passing stools (constipation), nausea, abdominal gas
Uncommon (may affect up to 1 in 100 patients)
Headache, abdominal pain, abdominal discomfort, dry mouth, indigestion (dyspepsia), abdominal distension

With the use of loperamide-containing medicines, the following side effects may also occur:

Urticaria, pruritus
Drowsiness, loss of consciousness, stupor, reduced level of consciousness, increased muscle tone (hypertonia), coordination disturbances
Decreased pupil size (miosis)
Intestinal obstruction, including due to paralysis of intestinal muscles (ileus, including paralytic ileus), colon abnormalities even following ulcerative colitis (megacolon, including toxic megacolon), severe oral cavity pain (glossodynia)
Inability to completely empty the bladder of urine (urinary retention)
Fatigue

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

5. How to store LOPEMID

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

6. Package contents and other information

What LOPEMID contains
LOPEMID 2 mg, 30 hard capsules
Active substance: loperamide hydrochloride
Each hard capsule contains: Loperamide hydrochloride 2 mg
Other components: microcrystalline cellulose, monohydrate lactose, talc.
Capsule shell constituents: gelatin, titanium dioxide.
Description of the appearance of LOPEMID and package contents
LOPEMID is presented as 2 mg hard capsules, in packages containing 30 capsules.
Marketing Authorization 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)