SINDIAR 2 mg HARD CAPSULES

2. What you need to know before taking Sindiar

Do not takeSindiar:

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

Treatment of diarrhea with Sindiar is 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 without consulting a doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Sindiar.

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

Patients with diarrhea should drink plenty of fluids to avoid dehydration, which is manifested by: 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 medicine for a use other than that indicated (see section 1) and never take more than the recommended amount (see section 3). Serious 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 of Sindiar.

Taking Sindiar with other medicines:

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

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

Pregnancyand breastfeeding

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

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

Breastfeeding women should not use this medicine without consulting their doctor.

Driving and using machines

Although effects are not expected, if fatigue, dizziness, or drowsiness occur, it is recommended that you do not drive or operate machinery.

3. How to take Sindiar

Follow exactly the administration instructions of the medicine contained in this leaflet or as 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 an initial dose, followed by 1 capsule (2 mg) after each diarrheal stool. Do not take more than 8 capsules (16 mg) per day.

Adolescents over 12 years

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

.

Elderly patients

No dose adjustment is necessary.

Patients with renal insufficiency

No dose adjustment is necessary.

Patients with hepatic insufficiency

They should consult their doctor before taking this medicine.

The maximum treatment duration will be 2 days.

Method of administration

This medicine is administered orally.

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

Do not exceed the recommended dose.

If you think the effect 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 for help. Symptoms may include: increased heart rate, irregular heartbeats, cardiac arrhythmias (these symptoms can have potentially serious and life-threatening consequences), muscle stiffness, uncoordinated movements, drowsiness, difficulty urinating, or weak breathing.

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

If you have taken more Sindiar than you should, consult your doctor or contact the Toxicology Information Service. Telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Sindiar

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The side effects described are:

• Uncommon (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.
• Frequency not known (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 pancreatitis (acute pancreatitis).

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

If you think any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: https://www.notificaram.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sindiar

Keep out of sight and reach of children.

Store below 30°C.

Do not use this medicine after the expiration date stated on the carton after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicine in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Sindiar composition

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

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

Product appearance and package contents

Sindiar is available in packages containing 10 and 20 hard capsules.

Marketing authorization holder and manufacturer

Marketing authorization holder

TEVA PHARMA S.L.U.

C/ Anabel Segura 11

Edificio Albatros B, 1ª planta

28108 Alcobendas. Madrid (Spain)

Manufacturer

Teva Pharma S.L.U.

Polígono Industrial Malpica, c/C nº 4,

50016 Zaragoza.

Spain

This leaflet was approved in May 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/