Loperamide Combix 2 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Loperamida Combix 2 mg hard capsules EFG

loperamide hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for administration provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve within 2 days.

Contents of the leaflet

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

1. What Loperamida Combix is and what it is used for

Loperamida Combix is an antidiarrheal medicine that reduces intestinal movements and secretions, resulting in a decrease in liquid stools.

This medicine is indicated for the symptomatic treatment of acute nonspecific (occasional) diarrhea in adults and children aged 12 years and older.

You should consult a doctor if symptoms worsen or do not improve after 2 days.

2. What you need to know before taking Loperamida Combix

Do not take Loperamida Combix

• In children under 12 years of age.
• If you are allergic (hypersensitive) to loperamide hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• If you have high fever (above 38°C) or blood in your stools.
• If you have ulcerative colitis (inflammation of the intestine).
• If you have severe diarrhoea following antibiotic treatment.
• If your diarrhoea is due to an infection caused by organisms such as Salmonella, Shigella, and Campylobacter.
• Treatment must be stopped immediately and you should consult your doctor if constipation, abdominal distension (bloating), or ileus (lack of intestinal movements) occurs.

Warnings and precautions

Talk to your doctor or pharmacist before taking Loperamida Combix:

• If you have severe diarrhoea, your body loses more fluids, sugars, and salts than normal. You will need to replace fluids by drinking more than usual. Ask your pharmacist about rehydration preparations to replace sugars and salts.
• Treatment with this medicine is only symptomatic, so diarrhoea should be treated by addressing its underlying cause.
• If you have AIDS and your stomach swells, stop taking this medicine immediately and consult your doctor.
• If you have liver disease, consult your doctor before taking this medicine, as it could cause toxicity in the central nervous system.
• If you are taking any narcotic-type painkillers, consult your doctor or pharmacist before taking this medicine, as it may interact with them.

Do not use this medicine for any purpose other than that indicated (see section 1), and never take more than the recommended dose (see section 3). Serious heart problems (with symptoms including rapid or irregular heartbeat) have been reported in patients who have taken excessive amounts of loperamide.

If there is no improvement within 48 hours, or if fever, constipation, or other symptoms appear, stop treatment and consult your doctor.

Patients with diarrhoea should drink plenty of fluids to prevent dehydration, which may manifest as dry mouth, excessive thirst, reduced urine output, wrinkled skin, dizziness, or lightheadedness. This is especially important in children and the elderly.

Children and adolescents

Do not use in children and adolescents under 12 years of age.

Other medicines and Loperamida Combix

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

It is especially important to inform them if you are taking medicines containing:

• Ritonavir, saquinavir (used to treat HIV).
• Quinidine (used to treat abnormal heart rhythms).
• Oral desmopressin (used to treat central diabetes insipidus and nocturnal urinary incontinence in children).
• Itraconazole or ketoconazole (used to treat fungal infections).
• Gemfibrozil (used to lower cholesterol).
• St. John's wort (used to improve mood).
• Valerian (used to treat mild anxiety).
• Opioid analgesics (used to treat severe pain), as they may increase the risk of severe constipation and central nervous system depression (e.g. drowsiness or reduced consciousness).
• Broad-spectrum antibiotics, as loperamide may worsen or prolong antibiotic-associated diarrhoea and increase blood levels of loperamide.

Pregnancy and breastfeeding

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

Pregnant women should not take this medicine unless prescribed by a doctor, as there is no clinical experience with its use in pregnancy.

Do not take loperamide if you are breastfeeding. Small amounts of the medicine may pass into breast milk.

Driving and using machines

You may drive and operate tools or machinery unless you feel tired, dizzy, or drowsy. Do not drive or operate machinery under such circumstances.

Loperamida Combix contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Loperamida Combix contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per hard capsule; i.e., it is essentially “sodium-free”.

3. How to take Loperamida Combix

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult 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.

The maximum dose for adults is 8 capsules (16 mg) per day.

Children 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:

Take the capsules with a full glass of water.

Patients with liver disease

They should consult their doctor.

Elderly and patients with kidney disease

Follow the same instructions described for adults and children over 12 years of age.

Use in children and adolescents

Children under 12 years of age must not take this medicine. It is contraindicated.

If you take more Loperamida Combix than you should

Taking too many capsules may cause abnormal coordination, stupor, pupillary constriction, increased muscle tone, breathing difficulty (children are more sensitive to these effects than adults), and reduced urine output.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Loperamida Combix

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Adverse effects of unknown frequency (cannot be estimated from available data):

Upper abdominal pain, abdominal pain radiating to the back, tenderness when touching the abdomen, fever, rapid pulse, nausea, vomiting, which may be symptoms of inflammation of the pancreas (acute pancreatitis).

If you experience any of these symptoms, stop using the medicine and seek medical help immediately.

Very rare adverse effects (may affect up to 1 in 10,000 people):

• Swelling of the face, lips, tongue, or throat that may cause difficulty swallowing or breathing (angioedema).
• Allergic reactions (including anaphylactic shock).
• Fatigue.
• Decreased amount of urine.
• Loss or reduction of consciousness.
• Abnormal coordination – increased muscle tension (hypertonia).
• Stupor – constriction of the pupil (miosis).
• Loss of intestinal motility (ileus, including paralytic ileus).
• Itching or hives.
• Somnolence.
• Abnormal dilation of the colon (megacolon).
• Bullous rash (including Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme).

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Loperamide Combix

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after “EXP”. The expiry date is the last day of the month indicated.

Do not store above 30 °C.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point located at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Loperamida Combix

• The active substance is loperamide hydrochloride. Each hard capsule contains 2 mg of loperamide hydrochloride.
• The other components (excipients) are:

Capsule contents: lactose monohydrate, rice starch, talc and magnesium stearate.

Capsule shell: gelatin, titanium dioxide (E171) and sodium lauryl sulfate.

Appearance of the product and contents of the container

Loperamida Combix are hard gelatin capsules, with white opaque cap and body, containing white or almost white powder inside, and approximate dimensions of 14.3 mm in length and 5.3 mm in width.

This medicine is available in PVC/PVDC-Aluminum blisters packed in cardboard boxes containing 10 and 20 hard capsules.

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2. Edificio 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France
ZAC Les Hautes Patures
Parc d'activités des Peupliers
25 Rue des Peupliers
92000 Nanterre
France

or

Centre Specialites Pharmaceutiques
Z.A.C. des Suzots
35 Rue de la Chapelle
63450 Saint Amant Tallende
France

or

Pharmex Advanced Laboratories S.L.
Ctra. A-431 km. 19
14720 Almodóvar del Río,
Córdoba
Spain

or

Netpharmalab Consulting Services
Carretera de Fuencarral 22,
Alcobendas,
28108 Madrid
Spain

or

Flavine Pharma France
3 Voie d’Allemagne
13127 Vitrolles
France

Date of the most recent revision of this leaflet: October 2025

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