Prospecto:Information for the Patient

Humatin 250 mg Hard Capsules

paramomycin

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• 1. If you have any doubts, consult yourdoctor, pharmacist, or nurse.

-This medication has been prescribedonlyto you, and you should not give it to other people even iftheyhave the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor, pharmacist, or nurse,evenifthey are not listed in this prospectus. See section 4.

1.What is Humatin 250 mg Hard Capsules and what is it used for

2.What you need to knowbeforestarting totake Humatin 250 mg Hard Capsules

3.How to take Humatin 250 mg Hard Capsules

4.Possible adverse effects

5Storage of Humatin 250 mg Hard Capsules

6.Contents of the package and additional information

Humatin250 mghard capsules contain paromomycin which belongs to a group of antibiotics called aminoglycoside antibiotics. It is used in the treatment of intestinal infections and hepatic coma.

Humatin 250 mg hard capsules (paromomycin) is indicated in children and adults for the treatment of:

• Acute and chronic non-invasive intestinal amebiasis.

Additionally, it is indicated in adults for:

• Adjunctive treatment of hepatic coma by reducing ammonia-producing bacteria in the gastrointestinal tract.

Do not take Humatin250 mghard capsules

• if you are allergic to the active ingredient or to any of the other components of this medicine (listed in section 6).
• if you have previously been treated with paromomicina and have developed hypersensitivity reactions
• if you have had an allergic reaction to any other aminoglucósido antibiotic, as you may also be allergic to paromomicina
• if you have pre-existing ear damage (dizziness, vertigo, ringing in the ears, buzzing or hearing loss)
• if you have pathological muscle weakness (myasthenia gravis)
• if you have constipation or intestinal obstruction
• during pregnancy and lactation

Due to the possible risk of damage to renal and auditory function, the active ingredient paromomicina contained in Humatin 250 mg hard capsules should not be administered without passing through the gastrointestinal tract (parenteral route).

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to take Humatin 250 mg hard capsules if:

• you have renal insufficiency
• you are being treated long-term (for example, treatment of hepatic coma by reducing ammonia-producing bacteria in the gastrointestinal tract)
• you have gastrointestinal ulcers or bleeding in the intestines

In the aforementioned patient groups, auditory function should be regularly monitored.

If signs of ototoxicity (dizziness, vertigo, ringing in the ears, buzzing or hearing loss) or nephrotoxicity appear, it may be necessary to reduce the dose or even consider suspending treatment.

The prolonged and/or repeated use of Humatin 250 mg hard capsules may cause a new or second infection with bacteria or fungi resistant to paromomicina. Be aware of the signs of a possible subsequent infection with these pathogens (infection of mucous membranes with inflammation and white deposits on mucous membranes).

These infections should be treated accordingly.

If you experience intense, persistent, sometimes bloody diarrhea and abdominal cramps similar to a muscle spasm during or after treatment with Humatin 250 mg hard capsules, inform your doctor because this is due to a severe inflammation of the intestinal mucous membranes (pseudomembranous enterocolitis) usually caused by Clostridioides difficile and should be treated immediately. This life-threatening intestinal disease caused by antibiotic treatment.

Other medicines and Humatin 250 mg hard capsules250 mghard capsules

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

When taking paromomicina, only a very small amount is absorbed into the bloodstream through the gastrointestinal tract, so it is unlikely to expect interactions with other medicines in the body. In theory, the same interactions may occur as with systemically administered aminoglucósides.

With the simultaneous use of certain muscle relaxants (non-depolarizing muscle relaxants), the blockade of transmission of stimuli between nerve and muscle may be deepened and prolonged.

Due to the increased risk of side effects, special monitoring should be performed on patients being treated simultaneously or subsequently with other medicines that may be harmful to renal or auditory function, such as: amphotericin B, colistin, ciclosporin, cisplatino, vancomycin or certain diuretics such as etacrinate acid and furosemide.

Pregnancy, lactation and fertilityand fertility

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

Humatin 250 mg hard capsules should not be used during pregnancy and lactation.

Driving and operating machines

No data are available on the influence of paramomicina on the ability to drive and operate machines.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.If in doubt, consult your doctor or pharmacist again.

Your doctor will establish the most suitable dose and treatment duration for you, based on your condition and response to treatment. It is administered orally. As a general rule, the recommended dose of medication and administration frequency is as follows:

Non-invasive intestinal amebiasis:

Adults, adolescents, and children who can swallow capsules, the total recommended daily dose is 25 – 35 mg/kg/day, divided into 3 doses, taken with meals, for 5 days.

Acute liver failure:

Adults: 4 g/day, divided into 2-4 doses, for 5 to 6 days.

The paromomycin sulfate capsules should only be used in adults, adolescents, and children who can swallow capsules.

The capsule should be taken whole.

Special patient groups

Patients with liver failure

Generally, no dose adjustment is necessary in patients with liver failure.

Patients with renal failure

Paromomycin absorbed into the bloodstream is primarily eliminated through the kidneys. Therefore, paromomycin should be used with caution in patients with renal failure.

If you take more Humatin 250 mg hard capsules than you should

Since the active ingredient of Humatin 250 mg capsules, paromomycin, is barely absorbed into the bloodstream when the mucous membrane of the gastrointestinal tract is intact, it is unlikely that symptoms of overdose will occur with a small overdose of Humatin 250 mg capsules (see, however, regarding the possibility of hearing damage in section 2).

If you suspect an overdose, inform your doctor so that they can decide how to proceed.

If you forgot to take Humatin 250 mg hard capsules

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

Continue taking the medication at the next scheduled time according to the usual dosing schedule.

If you do not notice your mistake until the next day, do not take a double dose to compensate for the missed doses and continue taking the same number of Humatin 250 mg capsules as prescribed. In this case, it may be necessary to extend the treatment by one day. In this case, talk to your doctor. You should also talk to your doctor if you forgot to take a dose or took too little.

If you interrupt treatment with Humatin 250 mg hard capsules

Treatment with Humatin 250 mg hard capsules should never be initiated on your own, and should not be interrupted without medical advice. Do not change the prescribed dose on your own. It is imperative that you strictly adhere to the dose prescribed by your doctor. The success of treatment with Humatin 250 mg hard capsules depends on completing the entire treatment.

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

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

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

Frequent (may affect up to 1 in 10 people):

• soft stools,
• diarrhea

Rare (may affect up to 1 in 1,000 people):

• anorexia,
• nausea,
• vomiting,
• abdominal cramps,
• abdominal or stomach pain,
• digestive disorders with fatty stools (malabsorption syndrome)
• allergic reactions such as urticaria

Very Rare (may affect up to 1 in 10,000 people):

• inflammation of the pancreas (pancreatitis).
• headache,
• dizziness,
• increase in the number of certain white blood cells in the blood (eosinophilia)
• blood in the urine (hematuria)

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use: www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

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

Store at room temperature.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE point of the pharmacy.In case of doubt, please ask your pharmacisthow to dispose ofthecontainers and medicines you no longerneed. By doing so, you will help protect the environment.

Composition of Humatin250 mghard capsules

• The active ingredient is paramomicina. Each hard capsule contains 250 mg of paromomicina.
• The other components(excipients)are:

Contents of the capsule: magnesium stearate, anhydrous colloidal silica

Composition of the capsule: gelatin, titanium dioxide (CI = 77891) (E-171), yellow iron oxide (CI = 77492) (E 172), red iron oxide (CI = 77491) (E 172), black iron oxide (CI = 77499) (E 172), 1-butanol, Shellac gum, Shellac lacquer, isopropyl alcohol, ammonia, propylene glycol, antifoam C.

Appearance of the product and contents of the packaging

Humatin250 mghard capsules are presented in the form of hard capsules with a yellow body and a black cap. The packaging contains 8 capsules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Pfizer, S.L.

Avda. de Europa, 20 B.

Parque Empresarial La Moraleja.

28108 Alcobendas. Madrid

Spain.

Responsible for manufacturing:

Delpharm L'aigle.

Zone Industrielle Nº 1, Route de Crulai - L'Aigle – 61300

France

Last review date of this leaflet: February 2022

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

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