Entocord 2 mg comprimido y disolvente para suspension rectal
Introduction
Patient Information Leaflet
Entocord 2 mg Rectal Suppository and Suspension
budesonide
Read this leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
1. What Entocord is and what it is used for
2. What you need to know before using Entocord
3. How to use Entocord
4. Possible side effects
5. Storage of Entocord
6. Contents of the pack and additional information
1. What is Entocord and what is it used for
Entocord (budesónida) belongs to a group of medications known as glucocorticosteroids (a type of cortisone) that are used to reduce inflammation.
Entocord is used in the treatment of ulcerative colitis, a disease caused by inflammation of the intestinal wall, which affects the rectum and the sigmoid and descending colon.
2. What you need to know before starting to use Entocord
No use Entocord
If you are allergic to budesonide or any of the other components of this medication (listed in section 6).
Warnings and precautions
Consult your doctor, pharmacist, or nurse before starting to use Entocord.
You must inform your doctor of the following situations at all times:
- If you have other health problems, such as liver disease.
- If you are experiencing or contracting any infection, particularly chickenpox or measles.
- If you have diabetes (including family history), osteoporosis, stomach ulcers, or high blood pressure.
- If you have any eye disease such as glaucoma (including family history) or cataracts.
- If your symptoms worsen while using Entocord.
Do not interrupt treatment with Entocord until your doctor tells you to.
Contact your doctor if you experience blurred vision or other visual disturbances.
Entocord has been prescribed specifically for your current condition. Do not use it for other problems unless your doctor tells you to.
If you were previously treated with "cortisone" tablets (such as prednisone, prednisolone, or methylprednisolone) and your medication has been changed to Entocord, temporary symptoms that may have previously bothered you may reappear, such as skin rashes, muscle and joint pain. If any of these symptoms bother you or if you experience symptoms such as headaches, fatigue, nausea, or vomiting, please contact your doctor.
Children and adolescents
There are no long-term treatment data in children and adolescents; regular height monitoring is recommended.
Other medications and Entocord
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or may need to take any other medication.
Certain medications may interact with Entocord; in these cases, it may be necessary to adjust the dose or discontinue treatment with one of the medications.
It is essential to inform your doctor if you are taking any of the following medications: ketoconazole, itraconazole (medications used to treat fungal infections), carbamazepine (antiepileptic), or in women, estrogens and some contraceptives.
Some medications may increase the effects of Entocord, and your doctor may wish to closely monitor you if you are taking these medications (including some medications for HIV treatment: ritonavir (and other HIV protease inhibitors, cobicistat).
Diagnostic tests for pituitary gland activity may show false low results due to adrenal function suppression.
Pregnancy and breastfeedingIf you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor, pharmacist, or nurse before using this medication.
Driving and operating machineryEntocord does not affect the ability to drive vehicles or operate machinery.
Entocord contains parahydroxybenzoate of methyl and propyl
It may cause allergic reactions (possibly delayed) because it contains parahydroxybenzoate of methyl and propyl.
If you are an athlete, you should be aware that this medication contains a component that may result in a positive analytical control test for doping.
3. How to use Entocord
Remember to use your medication.
Your doctor will indicate the duration of your treatment with Entocord. Do not stop treatment before your doctor tells you to.
Before using Entocord for the first time, it is essential to read the Instructions for Use that are described below. These instructions will tell you how to prepare and use Entocord. Follow the instructions carefully.
Instructions for use/manipulation Entocord should be administered at night before going to bed. Entocord consists of: a tablet, a 115 mL solvent bottle, and a pre-packaged individual rectal catheter. To reconstitute the medication, the tablet must be dissolved in the solvent before use. To administer Entocord correctly, follow the instructions carefully: | |||
How to prepare Entocord | |||
| (Fig. 1). | ||
| (Fig. 2). | ||
4.Remove the protective cap from the bottle. 5.Remove the catheter from its packaging and screw it onto the bottle (Fig. 4). 6.The enema is ready and should be used immediately. How to administer Entocord The packaging includes plastic gloves to protect your hand during medication administration (see illustrations below).
Get into a comfortable sleeping position. Try to retain Entocord for as long as possible, preferably all night. | (Fig. 3). (Fig. 4). | ||
1. Insert your hand into the plastic glove | 2. Empty the bottle contents into the rectum | 3. After use, remove the plastic glove, wrapping it around the bottle |
Once the rectal suspension is prepared, it must be administered immediately. Do not store it in the bottle.
The dosage is adapted to each individual. Follow your doctor's instructions carefully. These instructions may be different from the information contained in this prospectus.
Recommended dose for adults
It is recommended to administer one Entocord (tablet + 115 mL solvent bottle) per day (at night) for four weeks. The best time to use Entocord is at night, just before going to bed. This way, Entocord will remain in your intestine for as long as possible while you are sleeping.
The full effect is usually achieved in 2-4 weeks. However, if your symptoms have not improved after four weeks of treatment, your doctor may extend your treatment for another four weeks.
Entocord should be used regularly as prescribed. Do not forget to administer Entocord even if you start feeling better.
Patients of advanced age
The same dosage as for adults.
If you use more Entocord than you should
In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20
If you forget to use Entocord
If you occasionally forget to administer a dose of Entocord, do not compensate for the missed dose. Simply continue with the next dose as prescribed.
Do not use a double dose to compensate for missed doses.
4. Possible Adverse Effects
Like all medicines, this medicine may cause side effects, although not everyone will experience them.
If you have an allergic reaction, consult your doctor immediately.The signs may include hives on the skin or swelling of the face, lips, mouth, tongue, or throat. This may make it difficult to breathe.
Other possible side effects:
Common: may affect up to 1 in 10 people
- Abdominal or intestinal pain, such as stomach pain, flatulence, diarrhea, stomach burning, and feeling unwell.
- Muscle cramps.
- Skin reactions, such as pustular rash and skin eruption.
- Changes in behavior, such as nervousness, insomnia, mood changes, and depression.
- Palpitations.
- Low potassium levels in the blood.
- Menstrual disorders.
- Cushingoid features such as rounded face, acne, weight gain, and easy bruising.
Uncommon: may affect up to 1 in 100 people
- Uncontrollable movements or extreme restlessness, possibly accompanied by spasms or muscle twitches.
- Anxiety.
- Tremors.
Rare: may affect up to 1 in 1,000 people
- Alteration in the adrenal gland (a small gland near the kidney).
- Aggression.
- Opacity of the natural lens of the eye including the posterior part (cataracts).
- Glaucoma (increased eye pressure).
- Blurred vision.
- Alteration of skin color as a result of internal bleeding.
Very rare: may affect up to 1 in 10,000 people
- Severe allergic reaction (called anaphylaxis) that may cause difficulty breathing or shock.
- Delayed growth rate in children and adolescents.
Frequency not known: cannot be estimated from available data
- Allergic reactions that may cause swelling of the face, especially the eyelids, lips, tongue, or throat (angioedema).
Medicines like Entocord (corticosteroids) may affect the normal production of steroid hormones in your body. The effects include:
- Changes in bone mineral density (bone thinning).
- Glaucoma (increased eye pressure).
- Decreased growth rate in children and adolescents.
- Alteration in the adrenal gland (a small gland near the kidney).
Most of the side effects mentioned in this list can also be expected with treatment with other glucocorticoids.
Do not be alarmed by this list of side effects. You may not experience any of them. If you consider any of the side effects you experience to be severe or if you notice any side effect not mentioned in this prospectus, inform your doctor, pharmacist, or nurse.
Reporting of side effects:
If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not appearing 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 side effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Entocord
Keep this medication out of the sight and reach of children. Do not store the tablets and the vial of solvent at a temperature above 30°C.
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.
Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.
6. Content of the container and additional information
Composition ofEntocord
- The active principle is budesonide.Entocord (tablet and 115 mL solvent bottle) contains 2 mg of budesonide per 100 mL (0.02 mg/mL).
- Entocord is composed of: a dispersible tablet, a 115 mL solvent bottle, and an individually packaged rectal cannula.
- Each tablet contains: 2.3 mg of the active principle budesonide
- The other excipients are: lactose, colorant [riboflavin (E101)], crospovidone, anhydrous colloidal silica, and magnesium stearate.
- Each 115 mL solvent bottle contains: sodium chloride, preservatives, [methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216)], and water.
Appearance of the product and content of the container
Entocord is presented in the form of dispersible tablets and rectal suspension solvent. The containers contain a blister pack with 7 tablets, 7 115 mL solvent bottles, 7 rectal cannulas (enema applicators), and 7 plastic covers for use during enema application.
Marketing authorization holder and responsible manufacturer
Marketing authorization holder:
Tillotts Pharma GmbH
Warmbacher Str. 80
79618 Rheinfelden
Germany
Responsible manufacturer:
Lusomedicamenta, Sociedade Técnica Farmacêutica, SA
Estrada Consiglieri Pedroso, 69-B
Queluz de Baixo
2730-055 Barcarena
Portugal
For further information about this medicine, please contact the local representative of the marketing authorization holder:
Tillotts Pharma Spain, S.L.U.
Gran Via de les Corts Catalanes 680, 1st 1st
08010 Barcelona
Spain
Last review date of this leaflet:July 2023
Other sources of information
Detailed and updated 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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