Leaflet: information for the user

CENAT Granulated

Plantago ovata seeds / Plantago ovata seed husks

(Ispaghula husk)

Read the entire leaflet carefully as it contains important information for you.

This medicine can be obtained without a prescription. However, for the best results, it must be used properly.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If symptoms worsen or persist after 7 days, you must consult a doctor.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Cenat belongs to a group of medications called volume-increasing laxatives. These medications act by facilitating the absorption of water by the intestinal bolus, forming a gel that increases the volume and fluidity of the feces..

Cenat is used for :

• Chronic habitual constipation, or as a result of prolonged bed rest after surgical operations, for example, after rectal or anal surgery, due to changes in diet, travel, or prolonged treatment with drastic laxatives.
• Conditions that alternate between episodes of diarrhea and constipation (irritable colon, diverticulosis). Regulation of bowel evacuation in patients with an artificial anus (colostomy).
• Symptomatic treatment of functional diarrhea and as an additional measure in cases of Crohn's disease.
• Proctological processes (rectal) such as hemorrhoids, anal fissures (or abscesses), in which it reduces the pain of defecation and facilitates the evacuation of the feces, which are richer in water.
• To complete the daily intake of fiber when it is insufficient (weight loss diets and certain metabolic disorders).

Do not take Cenat

• If you have hypersensitivity (allergy) toPlantago ovataorIspaghula huskor to any of the other components of the specialty.
• If you experience nausea, vomiting, or other abdominal symptoms of unknown diagnosis.

• If you have intestinal obstruction or have been diagnosed with stenosis (narrowing) of the digestive tract.

Be especially careful with Cenat

• Consult your doctor if you have difficulty breathing or swallowing.
• Maintain adequate hydration with the intake of 1-2 liters of water per day during treatment with Cenat.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

Because Cenat may delay the absorption of certain medications, you should take Cenat half an hour or one hour before or after the administration of other medications such as: coumarin derivatives (oral anticoagulants), digitalis-based medications, lithium, vitamins such as B12, calcium, magnesium, iron, or zinc.

Due to the risk of intestinal obstruction, do not take Cenat if you are taking anti-diarrheal medications or intestinal motility inhibitors (difenoxilato, loperamide, opioids).

Use of Cenat with food and beverages

As a general rule, Cenat should be administered after meals.

In the case of using Cenat as a complementary treatment for obesity, it is useful to take it before main meals.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Driving and operating machines

No expected effects of this medication on the ability to drive and use machinery.

Important information about some of the components of Cenat

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

Follow exactly the administration instructions for Cenat indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Cenat is administered orally.

Considering the safety of dietary fiber administration, it is not considered that there is a limitation to the treatment.

Take the granule without chewing and with a sufficient amount of liquid (a full glass) to avoid a blockage in the throat.

Drink 1 to 2 liters of water per day during the Cenat treatment.

If symptoms worsen or persist after 7 days, you must consult your doctor.

If you estimate that the action of Cenat is too strong or too weak, inform your doctor or pharmacist.

Adults and children over 12 years old

Take 2 teaspoons of granule (10 g of granule), dessertspoon, at night after dinner. If necessary, you can take an additional teaspoon in the morning (which would be equivalent to a total of 15 g of granule per day).

In case of diarrhea, take an initial dose of two teaspoons 3 times a day (30 g of granule/day) for 2 or 3 days and then reduce the dose to a full teaspoon 3 times a day (15 g/day).

You should try to have the last daily dose of Cenat after dinner, but not just before going to bed, and take it in an upright position.

As a complementary treatment for obesity, take Cenat 30 minutes before main meals to provoke a feeling of satiety.

Children from 6 to 12 years old

Administer half of the doses indicated for adults and children over 12 years old.

If you take more Cenat than you should

If you have taken more Cenat than you should, consult your doctor or pharmacist.

Overdosing onPlantago ovatamay cause abdominal discomfort and flatulence and could even cause intestinal obstruction.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 915 62 04 20, indicating the medication and the amount ingested.

If you forgot to take Cenat

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

Like all medications, Cenat may produce adverse effects, although not everyone will experience them.

The adverse effects of this medication are generally mild and transient. At the beginning of treatment and depending on the dose, some discomforts such as flatulence and feeling of fullness may appear, which disappear in a few days without the need to discontinue medication.

In certain cases, abdominal distension may appear and exceptionally isolated cases of intestinal, throat, or esophagus obstruction may occur, especially if the granule is ingested without sufficient water.

Occasionally, allergic reactions of hypersensitivity to Plantago ovata may occur, mainly due to inhalation of dust, and isolated cases of anaphylactic reactions may exist. Due to the granule presentation of Cenat, this problem is very unlikely.

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.

Store in the original packaging. Keep the bottle perfectly closed. Keep out of the reach and sight of children.

Expiration Date

Do not use Cenat after the expiration date (Exp.) shown on the bottle. The expiration date is the last day of the month indicated. Do not dispose of medications through drains or trash. Ask your pharmacist how to dispose of containers and unused medications. This will help protect the environment.

Composition of Cenat granulated

• The active principles are Seeds ofPlantago ovata, Seed husks ofPlantago ovata (Ispaghula Husk).
• The other components are: Carum carvi essential oil; Salvia officinalis essential oil; Peppermint essential oil; Arabic gum; Talc; Yellow iron oxide (E-172); Red iron oxide (E-172); Titanium dioxide (E-171); Solid paraffin; Liquid paraffin; Sucrose.

Appearance of the product and contents of the packaging

Cenat is presented in bottles containing 250 or 400 g of oral granulated for administration.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cooper Consumer Health B.V.

Verrijn Stuartweg 60,

1112 AX Diemen,

Netherlands

Responsible for manufacturing

MADAUS GMBH

Lütticher Strasse, 5

(Troisdorf) – 53842

Germany

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 Barcelona

Spain

Last review date of this leaflet:September 2022.