PANKREOFLAT 172 MG/80 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Pankreoflat 172 mg/80 mg Coated Tablets

Pancreatin / Dimeticone

Read all of 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 as indicated by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or more information, ask your pharmacist.

• If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 10 days.

Contents of the Package Leaflet

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

1. What is Pankreoflat and what is it used for

Pankreoflat belongs to a group of medicines 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 those individuals whose body is not able to produce these enzymes in sufficient quantity. Additionally, dimeticone acts on excess gases accumulated in the digestive tract, facilitating their elimination and relieving the discomfort they cause.

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

2. What you need to know before taking Pankreoflat

Do not take Pankreoflat

• If you are allergic (hypersensitive) to pancreatin (lipase, amylase, protease) of porcine origin, dimeticone, cow's milk protein, or any of the other components of this medicine (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 particularly careful with Pankreoflat:

• If your symptoms worsen or persist after 10 days, you should stop treatment and consult a doctor.
• If allergy symptoms (hypersensitivity) appear, treatment should be stopped and your doctor informed.
• If you have lactose intolerance or a milk protein allergy, do not use this medicine.
• If you have or have a history of hyperuricemia (elevated uric acid in the blood), gout, or kidney failure, you should use Pankreoflat with caution.

In any case, immediately inform your doctor so that he can decide whether to continue or not with the treatment or adjust it to your specific case, for example, by changing the recommended dose.

Children

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

Taking Pankreoflat with other medicines

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

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

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

Taking Pankreoflat with food, drinks, and alcohol

It is not recommended to consume alcoholic beverages while being treated with Pankreoflat, as they may decrease the activity of the medicine.

Intake of foods that increase gas formation and carbonated beverages should be avoided.

Pregnancy, breastfeeding, and fertility

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 possible benefit/risk should be assessed in case of prescribing and/or dispensing this medicine to a woman during pregnancy or breastfeeding, consulting with your doctor and/or pharmacist.

Driving and using machines

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

Important information about some of the components of Pankreoflat

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

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

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

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

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

3. How to take Pankreoflat

Follow exactly the administration instructions of Pankreoflat contained in this leaflet 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 at 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 or breaking, with sufficient liquid (water), during or after main meals.

Use in children

It should not be administered to children under 12 years old without medical supervision. Pankreoflat is not recommended in cases of infant 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 Toxicology Information Service. Phone: 91. 562.04.20, indicating the medicine and the amount ingested.

If you forget 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 make up for forgotten doses.

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

4. Possible side effects

The side effects observed are described below according to their frequency of occurrence:

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

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

The side effects reported are usually mild.

The possible side effects described below are classified according to their frequency of occurrence:

Very common side effects(occur in at least 1 in 10 patients)

• Abdominal pain, nausea, vomiting, diarrhea.

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

• Constipation.

Very rare side effects(occur in less than 1 in 10,000 patients):

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

Side effects with unknown frequency:

• Hypersensitivity reactions 1
• Anaphylactic reactions (a type of allergic reaction that can manifest with the appearance of a skin rash, itching, and/or localized edema)
• Angioedema (allergic reaction characterized by the appearance of skin and mucous membrane swelling)
• Anaphylactic shock (severe allergic reaction that can manifest with difficulty breathing, or decreased blood pressure)
• Mouth ulcers.

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 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

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

5. Storage of Pankreoflat

Store below 30°C.

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

Do not use this medicine after the expiration date stated on the packaging, after EXP. 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 medicines you no longer need at the SIGRE collection point in your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and further information

Composition of Pankreoflat

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

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

Appearance of the product and pack contents

Pankreoflat are white, oblong, coated tablets.

Pack sizes of 20 and 50 coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Date of the last revision of this leaflet: July 2019

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