Package Insert: Information for the Patient

Sindiar2 mg Hard Capsules

Loperamide Hydrochloride

Read this entire package insert carefully before starting to take this medication, as it contains important information for you

Follow exactly the medication administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

• Conserve this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

- You should consult a doctor if your condition worsens or does not improve after 2 days of treatment.

1. What is Sindiar and what it is used for

2. What you need to know before starting to take Sindiar

3. How to take Sindiar

4. Possible adverse effects

5. Storage of Sindiar

6. Contents of the pack and additional information

Loperamide is an anti-diarrheal that reduces intestinal movements and secretions, resulting in a decrease in liquid stools.

This medication is indicated for the symptomatic treatment of acute non-specific diarrhea in adults and individuals over 12 years old.

Consult a doctor if symptoms worsen or do not improve after 2 days.

Do not takeSindiar:

• if you are allergic to loperamide or to any of the other ingredients of this medication (listed in section 6).

The treatment of diarrhea withSindiaris only symptomatic and should not be used in cases of:

• Presence of blood in the stool and high fever (above 38°C).
• Patients diagnosed with acute ulcerative colitis or pseudomembranous colitis associated with broad-spectrum antibiotic treatment.

It is not recommended for use in children under 12 years old, without consulting a doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sindiar.

If you do not observe clinical improvement in 48 hours or if fever, constipation, or other symptoms appear, discontinue treatment and consult your doctor.

Patients with diarrhea should drink plenty of liquids to avoid dehydration, which manifests as: dry mouth, excessive thirst, decreased urine output, wrinkled skin, dizziness, and drowsiness. This is especially important in children and the elderly.

Do not take this medication for a use other than indicated (see section 1) and never take more than the recommended amount (see section 3). Severe heart problems (whose symptoms include rapid or irregular heartbeats) have been reported in patients who have taken an excessive amount of loperamide, the active ingredient in Sindiar.

Taking Sindiar with other medications:

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

If you are taking any antibiotic or narcotic analgesic, consult your doctor or pharmacist before taking this medication, as it may interact with them.

Pregnancyand lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

The safety of this medication for use in pregnant women has not been established.

Women who are breastfeeding should not use this medication without consulting their doctor.

Driving and operating machinery

Although no effects are expected, if you experience fatigue, dizziness, or drowsiness, it is best not to drive or operate machinery.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults

2 capsules (4 mg) as the initial dose, followed by 1 capsule (2 mg) after each diarrheal stool. Do not take more than 8 capsules (16 mg) per day.

Older adolescents (over 12 years)

1 capsule (2 mg) as the initial dose, followed by 1 capsule (2 mg) after each diarrheal stool. In children, the maximum daily dose should be related to body weight:

.

Older adults

No dose adjustment is required.

Patients with renal insufficiency

No dose adjustment is required.

Patients with hepatic insufficiency

They should consult their doctor before taking this medication.

The maximum duration of treatment will be 2 days.

Administration form

This medication is administered orally.

Take the capsule, without chewing or crushing, with a sufficient amount of water (a glass of water).

Do not exceed the recommended dose.

If you estimate that the action of Sindiar is too strong or too weak, inform your doctor or pharmacist.

If you take more Sindiar than you should

If you have taken too much Sindiar, contact a doctor or hospital as soon as possible to seek help. Symptoms may include: increased heart rate, irregular heartbeats, heart rhythm disturbances (these symptoms may have potentially serious and life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, or weak breathing.

Children react more severely to high doses of Sindiar than adults. If a child takes an excessive amount or exhibits any of the above symptoms, call a doctor immediately.

If you have taken moreSindiardthan you should, visit your doctor or contact the Toxicological Information Service. Phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Sindiar

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medicationmay produce adverse effects, although not all people will experience them.

The described adverse effects are:

• Rare (less than 1 in 100 but more than 1 in 1,000): hypersensitivity reactions (skin rashes), urinary retention.
• Very rare (less than 1 in 10,000): toxic megacolon (constipation, abdominal distension, nausea, and vomiting), paralytic ileus (persistent constipation), particularly when the established recommendations have not been followed.
• Unknown frequency (cannot be estimated from available data): upper abdominal pain, abdominal pain radiating to the back, abdominal tenderness, fever, rapid pulse, nausea, vomiting, which may be symptoms of acute pancreatitis.

Also, discomfort that is usually difficult to differentiate from diarrhea symptoms such as: abdominal pain and/or abdominal distension, nausea, and vomiting, fatigue, drowsiness, or dizziness, and dry mouth.

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es

By reporting adverse effects, you can contribute to providing more information about the safety of this medication

Keep out of sight and reach of children.

Store below 30°C.

Do not usethis medicationafter the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment

Composition of Sindiar

• The active ingredient is loperamide hydrochloride. Each capsule contains loperamide (hydrochloride) 2 mg.

-The other components (excipients) are: mannitol, magnesium stearate, and talc.

Appearance of the product and content of the packaging

Sindiar is presented in packaging containing 10 and 20 hard capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

TEVA PHARMA S.L.U.

C/ Anabel Segura 11

Edificio Albatros B, 1st floor

28108 Alcobendas. Madrid (Spain)

Responsible for manufacturing

Teva Pharma S.L.U.

Polígono Industrial Malpica, c/C nº 4,

50016 Zaragoza.

Spain

This leaflet was approved in May 2022

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/