PankreoFlat 172 mg/80 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pankreoflat 172 mg/80 mg coated tablets

Pancreatin / Dimethicone

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

Always follow exactly the instructions for use 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 further 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 your condition worsens or if you do not improve after 10 days.

Leaflet contents

1. What Pankreoflat is and what it is used for
2. What you need to know before taking Pankreoflat
3. How to take Pankreoflat
4. Possible adverse effects
5. How to store Pankreoflat
6. Package contents and additional information

1. What Pankreoflat is and what it is used for

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

Due to its activity on fats, carbohydrates, and proteins, pancreatic enzymes aid digestion and promote food absorption in individuals whose bodies are unable to produce sufficient quantities of these enzymes. In addition, dimethicone acts on excess gas accumulated in the digestive tract, facilitating its elimination and relieving the discomfort it causes.

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

2. What you need to know before starting to take Pankreoflat

Do not take Pankreoflat

• If you are allergic (hypersensitive) to porcine-source pancreatin (lipase, amylase, protease), dimethicone, cow's milk protein, or to 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

Talk to your doctor or pharmacist before starting to take Pankreoflat.

Take special care with Pankreoflat:

• If your symptoms worsen or persist beyond 10 days, you must stop treatment and consult a doctor.
• If symptoms of allergy (hypersensitivity) occur, treatment must be stopped and your doctor must be informed.
• If you have lactose intolerance or allergy to milk proteins, do not use this medicine.
• If you have or have a history of hyperuricemia (elevated blood uric acid), gout, or renal impairment, use Pankreoflat with caution.

In any case, inform your doctor immediately so that they can decide whether or not to continue or adjust treatment according to your individual situation, for example, by changing the recommended dose.

Children

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

Taking Pankreoflat with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, as it may be necessary to interrupt treatment or adjust the dose of one or more of them.

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

If you are taking iron supplements, you should separate their administration from that of Pankreoflat by at least 2 hours.

Taking Pankreoflat with food, drinks, and alcohol

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

You should avoid consuming foods that increase gas formation and carbonated drinks.

Pregnancy, breastfeeding, and fertility

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

The potential benefit/ risk should be evaluated if prescribing and/or dispensing this medicine to a woman during pregnancy or breastfeeding; discuss this with your doctor and/or pharmacist.

Driving and use of machines

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

Important information about some of the components of Pankreoflat

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

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

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

This medicine may cause 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; therefore, it is essentially “sodium-free”.

3. How to take Pankreoflat

Follow exactly the instructions for use of Pankreoflat provided in this leaflet or those indicated by your doctor or pharmacist.

If in doubt, consult your doctor or pharmacist.

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

The tablets must be taken whole, without chewing or dividing, with sufficient liquid (water), during or immediately after main meals.

Use in children

Pankreoflat must not be administered to children under 12 years of age without medical supervision. Pankreoflat is not recommended for 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 Toxicology Information Service at telephone number: 91.562.04.20, indicating the medication and the amount ingested.

If you forget to take Pankreoflat:

If you forget to take a dose, wait until your next meal and take your usual number of tablets. 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 adverse effects

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

Very common (occur in at least 1 out of every 10 patients), common (occur in 1 to 10 out of every 100 patients), uncommon (occur in 1 to 10 out of every 1,000 patients), rare (occur in 1 to 10 out of every 10,000 patients), very rare (occur in fewer than 1 out of every 10,000 patients).

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

The reported adverse effects are generally mild in nature.

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

Very common adverse effects (occur in at least 1 out of every 10 patients)

• Abdominal pain, nausea, vomiting, diarrhoea.

Uncommon adverse effects (occur in 1 to 10 out of every 1,000 patients)

• Constipation.

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

• Weight loss.
• Hyperuricaemia (increased levels of uric acid in blood), hyperuricosuria (increased 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 of the skin), skin rash, urticaria.
• Oedema, pain.

Adverse effects with unknown frequency:

• Hypersensitivity reactions 1
• Anaphylactic reactions (type of allergic reaction that may present with skin rash, itching and/or localized oedema)
• Angioedema (allergic reaction characterized by swelling of the skin and mucous membranes)
• Anaphylactic shock (severe allergic reaction that may manifest as difficulty breathing or decreased blood pressure)
• Mouth ulceration.

1. The following symptoms of hypersensitivity have been observed (urticaria, angioedema, anaphylactic shock, asthma in patients with 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 they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse 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 expiry date stated on the packaging, following EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, 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 pack and other information

Composition of Pankreoflat

• The active substances are pancreatin and dimethicone. Each coated tablet contains 80 mg of dimethicone 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, hydroxypropylmethylcellulose (E464), gum arabic (E414), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), sorbic acid (E200), sucrose, hydroxypropylcellulose (E463), magnesium stearate, polyvinylpyrrolidone/vinyl acetate copolymer, shellac gum (E904), acetylated monoglycerides, silicon dioxide (E551), talc (E553b), povidone (E1201), polyethylene glycol (E1521), sodium carmellose (E466), titanium dioxide (E171) and carnauba wax.

Nature and contents of the pack

Pankreoflat are white, oblong coated tablets.

Packs containing 20 and 50 coated tablets.

Only some 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 most recent review of this leaflet: July 2019

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