Leaflet: information for the user

Pankreoflat 172 mg/80 mg coated tablets

Pancreatina / Dimeticona

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

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

-You should consult a doctor if you get worse or do not improve after 10 days.

Pankreoflat belongs to a group of medications known as pancreatic enzymes and their combinations.

Thanks to its activity on fats, carbohydrates, and proteins, pancreatic enzymes facilitate digestion and promote the absorption of food in individuals whose body is unable to produce sufficient amounts of these enzymes. Additionally, dimethicone acts on excess gases accumulated in the digestive tract, facilitating their elimination and alleviating the discomfort they cause.

Pankreoflat is indicatedfor the relief of symptoms of digestive alterations in which aerophagia(swallowing air), flatulence (accumulation of gases in the digestive system), such as stomach heaviness and slow digestions related to pancreatic enzyme insufficiency in adults and adolescents over 12 years old.

Do not take Pankreoflat

• If you are allergic (hypersensitive) to porcine pancreatic enzymes (lipase, amylase, protease), dimethicone, cow's milk protein, or any of the other components of this medication (listed in section 6).
• If you have acute pancreatitis (acute inflammation of the pancreas).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pankreoflat.

Be especially careful with Pankreoflat:

• If symptoms worsen, or if they persist after 10 days, discontinue treatment and consult a doctor.
• If symptoms of allergy (hypersensitivity) appear, discontinue treatment and inform your doctor.
• If you have lactose intolerance or milk protein allergy, do not use this medication.
• If you have hyperuricemia (elevated uric acid in the blood), gout, or renal insufficiency, use Pankreoflat with caution.

In any case, immediately inform your doctor so that he can decide whether to continue or discontinue treatment, or adjust it to your specific case, for example, by changing the recommended dose.

Children

Pankreoflat is not recommended for the treatment of infantile colic due to a lack of information in this patient population.

Taking Pankreoflat with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, as it may be necessary to discontinue treatment or adjust the dose of one of them.

Antacids such as calcium carbonate or magnesium hydroxide may reduce the therapeutic effects of Pankreoflat.

If you are taking iron supplements, space your administration at least 2 hours apart from Pankreoflat.

Taking Pankreoflat with food, drinks, and alcohol

It is not recommended to consume alcoholic beverages while taking Pankreoflat, as they may reduce the activity of the medication.

Avoid consuming foods that increase gas formation and carbonated beverages.

Pregnancy, breastfeeding, and fertility

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

The potential benefit/risk of prescribing and/or dispensing this medication to a woman during pregnancy or breastfeeding should be evaluated by consulting with your doctor and/or pharmacist.

Driving and operating machinery

Given the characteristics of this medication, it is unlikely that its administration will affect your ability to drive and operate hazardous machinery.

Important information about some components of Pankreoflat

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication may cause allergic reactions in patients with cow's milk protein allergy.

This medication may produce allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for Pankreoflat as contained in this prospectus or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Adults and adolescents over 12 years old: the recommended dose is 1 to 2 coated tablets with each main meal. The dose should be adjusted individually according to symptoms and the fat content of the diet.

The tablets should be taken whole, without chewing, breaking, with sufficient liquid (water), during or after the main meals.

Use in children

Pankreoflat should not be administered to children under 12 years old without medical supervision. Pankreoflat is not recommended in cases of infantile colic.

If you take more Pankreoflat than you should

If you have taken more Pankreoflat than you should, consult your doctor immediately, go to the nearest hospital or call the Toxicological Information Service. Telephone: 91. 562.04.20, indicating the medication and the amount ingested.

If you forgot to take Pankreoflat:

In case you forget to take a dose, wait until the next meal and take the usual number of tablets. 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.

Adverse effects observed are described below according to the frequency of presentation:

Very common (appear in at least 1 in 10 patients), common (occur between 1 and 10 in 100 patients), uncommon (occur between 1 and 10 in 1,000 patients), rare (occur between 1 and 10 in 10,000 patients), very rare (occur in fewer than 1 in 10,000 patients).

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

Adverse effects reported are usually mild.

The possible adverse effects described below are classified according to their frequency of appearance in:

Very common adverse effects(appear in at least 1 in 10 patients)

• Abdominal pain, nausea, vomiting, diarrhea.

Uncommon adverse effects(occur between 1 and 10 in 1,000 patients)

• Constipation.

Very rare adverse effects(occur in fewer than 1 in 10,000 patients):

• Weight loss.
• Hyperuricemia (elevated levels of uric acid in the blood), hyperuricosuria (elevated levels of uric acid in urine).
• Abdominal distension (feeling of bloating in the abdomen), colon stenosis (narrowing of the large intestine), intestinal obstruction, perianal irritation, dyspepsia (feeling of heavy digestion, abdominal bloating, early satiety),
• Pruritus (itching sensation on the skin), skin rash, urticaria.
• Edema, pain.

Adverse effects of unknown frequency:

• Hypersensitivity reactions1
• Anaphylactic reactions (type of allergic reaction that may manifest as a skin rash, itching, and/or localized edema)
• Angioedema (allergic reaction characterized by skin and mucous membrane swelling)
• Anaphylactic shock (severe allergic reaction that may manifest as difficulty breathing, or decreased blood pressure)
• Mouth ulceration.

1. The following hypersensitivity symptoms have been observed (urticaria, angioedema, anaphylactic shock, asthma in patients with a history of intolerance or allergy to milk proteins).

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 that does not appear 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 toproviding more information on the safety of this medicine.

Store below 30°C.

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

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Pankreoflat

• The active principles are pancreatin and dimethicone. Each coated tablet contains 80 mg of dimethicone, and pancreatin in an amount equivalent to 6,000 U Ph. Eur. of amylase, 6,000 U Ph. Eur. of lipase, and 400 U Ph. Eur. of protease.

• The other components are: skimmed milk powder containing lactose in its composition, hydroxypropylmethylcellulose (E464), gum arabic (E414), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sorbic acid (E200), sucrose, hydroxypropylcellulose (E463), magnesium stearate, polyvinylpyrrolidone/acetate copolymer, shellac (E904), acetylated monoglycerides, silicon dioxide (E551), talc (E553b), povidone (E1201), polyethylene glycol (E1521), sodium caramel (E466), titanium dioxide (E171), and carnauba wax.

Appearance of the product and contents of the packaging

Pankreoflat are white, oblong, coated tablets.

Packaging with 20 and 50 coated tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for Manufacturing

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Last review date of this leaflet: July 2019

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