Package leaflet: Information for the user

DIARSTOP

1.5 mg hard capsules
Loperamide hydrochloride
Please read all of this leaflet carefully before you take this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after two days of treatment.

Contents of this leaflet:

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

1. WHAT DIARSTOP IS AND WHAT IT IS USED FOR

DIARSTOP is an antidiarrheal agent used for the symptomatic treatment of acute diarrhoea, capable of slowing intestinal motility. Consult your doctor if you do not feel better or if you feel worse after two days of treatment.

2. WHAT YOU NEED TO KNOW BEFORE TAKING DIARSTOP

Do not take DIARSTOP

If you are allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6).
If you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding").
If it is necessary to maintain normal intestinal motility.

Warnings and precautions
Talk to your doctor or pharmacist before taking DIARSTOP, even if acute diarrhoea has occurred in the past. Since diarrhoea may cause significant loss of fluids and electrolytes, it is advisable to drink plenty of fluids to replace these losses. It may be helpful to take aqueous solutions containing sugar and salts.
Do not use this medicine for purposes other than those indicated (see section 1) and never take a dose higher than that recommended (see section 3). In patients who have taken an excessive dose of loperamide, the active substance in DIARSTOP, serious heart problems (with symptoms such as rapid or irregular heartbeat) have been reported.

Children
DIARSTOP must not be given to children under 12 years of age.

Other medicines and DIARSTOP
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Interactions may occur with medicines that reduce intestinal motility (e.g. anticholinergics), as they may enhance the effects of loperamide. Concomitant use with cytochrome CYP450 inhibitors and P-glycoprotein inhibitors is not recommended.

Pregnancy and breastfeeding
DIARSTOP is contraindicated during pregnancy and breastfeeding.
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
DIARSTOP does not impair the ability to drive or use machinery.

DIARSTOP contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars (such as lactose), contact your doctor before taking this medicine.

3. HOW TO TAKE DIARSTOP

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
DIARSTOP can be used in adults and children over 12 years of age.
The capsules must not be chewed, but swallowed whole with a small amount of water or another drink.
The recommended initial dose is 2 capsules, taken one after the other at the same time.
After the initial dose, take 1 capsule after each loose (unformed) bowel movement.
As your stools gradually return to normal, reduce the dose and stop treatment if constipation occurs or diarrhea resolves. Do not take more than 8 capsules per day.
Warning: Do not exceed the recommended doses. Do not use for more than two days.
Consult your doctor and stop taking the capsules if the condition recurs repeatedly or if you have noticed any recent changes in its characteristics.

If you take more DIARSTOP than you should
If you have taken too much DIARSTOP, 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 or life-threatening consequences), muscle rigidity, uncoordinated movements, drowsiness, difficulty urinating, or weak breathing.

Children react more strongly than adults to high doses of DIARSTOP. If a child has taken an excessive amount or shows any of the symptoms listed above, contact your doctor immediately.

In cases of overdose, including cases due to impaired liver function, constipation and effects due to depression of the Central Nervous System may occur, such as: stupor, miosis (pupil constriction), increased muscle tone, and slowed breathing.
In case of accidental ingestion of an excessive dose of DIARSTOP, seek immediate medical attention from your doctor or the nearest hospital.

In case of overdose, treatment measures may include: gastric lavage, induction of vomiting, use of enema, or administration of laxatives. Emergency measures may include naloxone injection, repeated if necessary after 1–3 hours, with monitoring of the patient for at least 48 hours to detect any worsening of Central Nervous System depression.

Children are more sensitive than adults to the effects of loperamide overdose. Therefore, keep this product out of children's reach, as accidental ingestion—especially in children under 4 years of age—may cause constipation and Central Nervous System depression, including drowsiness and slowed breathing. In such cases, the patient should be closely observed for 48 hours.

If you forget to take DIARSTOP
Do not take a double dose to make up for a missed dose. Resume the normal dosing schedule as indicated.

If you stop taking DIARSTOP
No effects due to discontinuation of treatment have been reported.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, DIARSTOP can cause adverse reactions, although not everybody experiences them.
Rarely, mild abdominal pain and dry mouth have been reported.
Following the instructions contained in this leaflet reduces the risk of adverse reactions.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE DIARSTOP

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
No special storage precautions are required.
Do not use this medicine if the packaging shows visible signs of deterioration.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.
It is important that you always keep the information about the medicine available; therefore, retain both the carton and the package leaflet.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What DIARSTOP contains
Each capsule contains:

The active substance is: loperamide hydrochloride: 1.5 mg.
The other components are: monohydrate lactose, maize starch, talc, magnesium stearate. The grey-green capsule consists of: gelatin, glycerin, erythrosine (E 127), indigo carmine (E 132), iron oxide yellow (E 172), iron oxide black (E 172), titanium dioxide.

Description of the appearance of DIARSTOP and contents of the pack
DIARSTOP is presented as hard capsules.
Pack sizes:
20 hard capsules.
12 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorization Holder
GIULIANI S.p.A., via Palagi 2, 20129 Milan, Italy.

Manufacturer
COSMO S.p.A., via C. Colombo 1, 20020 Lainate (Milan), Italy.