Dexilant

Package Leaflet: Information for the Patient

Dexilant, 30 mg, Delayed-Release Capsules, Hard

Dexilant, 60 mg, Delayed-Release Capsules, Hard

Dexlansoprazole

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Dexilant and what is it used for
• 2. Important information before taking Dexilant
• 3. How to take Dexilant
• 4. Possible side effects
• 5. How to store Dexilant
• 6. Contents of the pack and other information

1. What is Dexilant and what is it used for

Dexilant contains the active substance dexlansoprazole, which is a proton pump inhibitor (PPI). Proton pump inhibitors reduce the amount of acid produced in the stomach. Dexilant is used in adults and adolescents aged 12 years and older for the following indications:

• Treatment of erosive oesophagitis (oesophagitis associated with damage to the oesophageal mucosa);
• Maintenance treatment of erosive oesophagitis and heartburn;
• Short-term treatment of heartburn and acid regurgitation associated with non-erosive gastro-oesophageal reflux disease (GERD, gastro-oesophageal reflux disease). This is a disease characterized by the movement of stomach acid into the oesophagus (reflux).

The action of Dexilant is to reduce the amount of acid produced in the stomach, which can lead to the healing of oesophageal damage and relief of symptoms associated with the above-mentioned diseases, as well as prevent their recurrence.

2. Important information before taking Dexilant

When not to take Dexilant

• if you are allergic to dexlansoprazole or any of the other ingredients of this medicine (listed in section 6);

Warnings and precautions

Before starting to take Dexilant or during treatment, inform your doctor:

• if you have liver problems. Your doctor may then adjust the dose of the medicine.
• if you have stomach problems. Your doctor may perform an additional examination called endoscopy (involving the insertion of a small camera through the oesophagus to observe the inside of the stomach), which will help to rule out other more serious causes of your symptoms.
• if you are taking proton pump inhibitors, such as Dexilant, especially for more than one year, as this may slightly increase the risk of hip, wrist, or spine fractures. You should inform your doctor if you have been diagnosed with osteoporosis (reduced bone density) or if your doctor has informed you that you are at risk of osteoporosis (e.g., if you are taking corticosteroid medications).
• if you are taking Dexilant for a long time (more than 1 year). Your doctor will probably ask you to come for regular check-ups to monitor your health. If you experience any new symptoms or if any of your existing symptoms worsen, you should inform your doctor.
• if you are taking other medicines, such as digoxin (used to treat heart conditions) or diuretics (‘water tablets’). Your doctor may recommend regular blood tests to monitor magnesium levels.
• if you have a vitamin B12 deficiency or risk factors for vitamin B12 deficiency, and you are being treated with Dexilant for a long time. Like all medicines that reduce stomach acid, Dexilant may lead to reduced absorption of vitamin B12.
• if you have ever had a skin reaction after taking a medicine that reduces stomach acid.
• if you have a rash on your skin, especially in areas exposed to sunlight, you should inform your doctor as soon as possible, as it may be necessary to stop taking Dexilant. You should also inform your doctor about any other side effects, such as joint pain.
• if you are taking dexlansoprazole, kidney inflammation may occur. Symptoms observed by the patient and in laboratory tests may include decreased urine output or blood in the urine and/or hypersensitivity reactions, such as fever, rash, and joint stiffness. Such symptoms should be reported to the attending physician.
• Dexilant may cause rare but severe skin reactions, which can occur on any part of the patient's body (see also section 4). These severe skin reactions may require hospital treatment and can be life-threatening; skin rash with blisters, peeling, or bleeding from any part of the skin (including lips, eyes, mouth, nose, genitals, hands, or feet). It may also cause fever, chills, body aches, shortness of breath, or swollen lymph nodes. You should then stop taking Dexilant and contact your doctor immediately. These symptoms may be the first signs of a severe skin reaction.
• about a planned specific blood test (chromogranin A level).

Children

This medicine should not be given to children under 12 years of age.

Dexilant and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. This is important because dexlansoprazole may affect the action of other medicines. Also, some medicines may affect the action of dexlansoprazole. If you are taking medicines containing the following active substances, you should consult your doctor before taking Dexilant:

• HIV protease inhibitors, such as atazanavir and nelfinavir (used to treat HIV infection),
• ketokonazole, itraconazole, rifampicin (used to treat infections),
• erlotinib (used to treat cancer),
• digoxin (heart disease treatment),
• tacrolimus (prevention of transplant rejection),
• fluvoxamine (used to treat depression and other mental disorders),
• warfarin (prevention of blood clots),
• antacids (used to treat heartburn or acid regurgitation),
• sucralfate (used to treat stomach ulcers),
• products containing St. John's Wort (Hypericum perforatum) (herbal products used to treat mild depression),
• methotrexate (used to treat cancer).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.

Driving and using machines

Patients taking Dexilant may occasionally experience side effects such as dizziness, fatigue, and vision disturbances. If you experience any of these side effects, you should be cautious due to impaired reaction ability. The patient should decide whether they are able to drive a vehicle or perform other activities that require attention. Due to the way the medicine works and its side effects, taking the medicine by the patient is one of the factors that affect the ability to perform such activities safely. A description of side effects can be found later in this leaflet. You should read this leaflet carefully. If you have any questions, consult your doctor.

Dexilant contains sucrose

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine. Dexilant contains sodium. The medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means the medicine is considered "sodium-free".

3. How to take Dexilant

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The capsules should be swallowed whole with a glass of water. The capsules can be taken with or without food. If you have problems swallowing the capsules whole, you can open the capsule and sprinkle the contents onto a spoonful of applesauce or mashed banana. You should swallow the mixture immediately. Do not chew or suck the mixture. Do not store for later use.

For adults, the following doses of Dexilant are recommended:

• Treatment of erosive oesophagitis:take 60 mg once a day for 4 weeks. Your doctor may recommend taking the medicine for another 4 weeks.
• Maintenance treatment of erosive oesophagitis and heartburn in patients who require long-term suppression of gastric acid secretion:take 30 mg once a day for up to 6 months.
• Treatment of heartburn and acid regurgitation associated with non-erosive gastro-oesophageal reflux disease:take 30 mg once a day for up to 4 weeks.

For adolescents aged 12 to 17 years, the following doses of Dexilant are recommended:

• Treatment of erosive oesophagitis:take 60 mg once a day for 4 weeks. Your doctor may recommend taking the medicine for another 4 weeks.
• Maintenance treatment of erosive oesophagitis and heartburn in patients who require long-term suppression of gastric acid secretion:take 30 mg once a day. Your doctor will determine the total duration of treatment.
• Treatment of heartburn and acid regurgitation associated with non-erosive gastro-oesophageal reflux disease:take 30 mg once a day for up to 4 weeks.

Elderly patients and patients with impaired liver function:

Your doctor may recommend taking a lower dose of the medicine. Your doctor will inform you how long to take Dexilant. If necessary, your doctor may decide to use a different dose.

Taking a higher dose of Dexilant than recommended

In case of accidental overdose, contact your doctor immediately. In patients who have taken too high doses of dexlansoprazole, the following symptoms have been observed:

• high blood pressure, hot flushes, bruising, sore throat, and weight loss.

Missing a dose of Dexilant

If you forget to take a dose, take it as soon as you remember. If it is time for your next dose, take it as usual. Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Dexilant

You should not stop treatment too early, even if your symptoms have disappeared. If you do not complete the prescribed treatment period, your disease may not be fully cured and may recur. Before stopping treatment, consult your doctor. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dexilant can cause side effects, although not everybody gets them. In clinical trials, side effects after taking Dexilant were mostly mild or moderate.

Stop taking the medicine and contact your doctor immediately or go to the nearest hospital emergency department if you experience any of the following side effects:

• hypersensitivity reaction or severe allergic reaction (frequency not known), with symptoms such as rash, facial swelling, throat constriction, and difficulty breathing;
• anaphylactic shock or severe, severe, and sudden allergic reaction (frequency not known) including symptoms such as shortness of breath, confusion, paleness, significant skin rash, throat constriction, weakness, difficulty breathing, and loss of consciousness.

The most common side effects (common – may affect up to 1 in 10 people) were:

Diarrhea, stomach pain, headache, nausea, abdominal discomfort, bloating, constipation, mild gastric polyps.

In some patients taking Dexilant, other side effects have occurred:

Uncommon (may affect up to 1 in 100 people):

• difficulty sleeping,
• depression,
• dizziness,
• change in taste,
• high blood pressure,
• hot flushes,
• cough,
• vomiting,
• dry mouth,
• abnormal liver test results,
• hives,
• itching,
• rash,
• feeling weak,
• changes in appetite,
• fracture of the hip, wrist, or spine.

Rare (may affect up to 1 in 1,000 people):

• hallucinations involving hearing voices or sounds,
• seizures,
• tingling or numbness,
• vision disturbances,
• feeling dizzy or spinning,
• kidney disease,
• fungal infections.

Frequency not known (frequency cannot be estimated from the available data):

• reduced number of red blood cells. This can cause pallor, weakness, intolerance to physical exertion, dizziness, fatigue, and confusion.
• bruising or bleeding due to low platelet count of unknown cause,
• severe skin reactions [Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme, and subacute cutaneous lupus]. It may also cause joint pain or flu-like symptoms, fever, swelling of the glands (e.g., under the arms), and changes in blood test results showing changes in some white blood cells or liver enzymes.
• blurred vision,
• deafness,
• liver inflammation caused by the medicine (with symptoms such as loss of appetite, headache, nausea, fatigue, fever, jaundice, pale or clay-colored stools, dark urine),
• rash that may be associated with joint pain.
• If you have taken Dexilant for more than three months, there is a possibility of decreased magnesium levels in the blood. Low magnesium levels can cause fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, rapid heartbeat. If you notice any of these symptoms, you should inform your doctor immediately. Low magnesium levels can lead to decreased potassium or calcium levels in the blood. Your doctor may recommend regular blood tests to monitor magnesium levels.
• Low sodium levels in the blood. Typical symptoms include nausea and vomiting, headache, drowsiness and fatigue, confusion, weakness or muscle cramps, irritability, seizures, coma.
• Visual hallucinations.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz2.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dexilant

Keep the medicine out of the sight and reach of children. Do not use the medicine after the expiry date stated on the blister pack and carton after "EXP". The expiry date refers to the last day of that month. Do not store above 25°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Dexilant contains

• The active substance of Dexilant is dexlansoprazole. Each delayed-release capsule contains 30 mg or 60 mg of dexlansoprazole.
• The other ingredients (excipients) are:
• Contents of the capsule:Colloidal anhydrous silica, hydroxypropylcellulose, hypromellose, low-substituted hydroxypropylcellulose, heavy magnesium carbonate, methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30% (methacrylic acid units, ethyl acrylate units, sodium lauryl sulfate, polysorbate 80), methacrylic acid and methyl methacrylate copolymer (1:1), methacrylic acid and methyl methacrylate copolymer (1:2), macrogol 8000, polysorbate 80, sucrose (see section 2 "Dexilant contains sucrose"), sucrose granules (sucrose, cornstarch), talc, titanium dioxide (E 171), triethyl citrate.
• 30 mg capsule shell:Carrageenan (E 407), titanium dioxide (E 171), hypromellose, potassium chloride, purified water, indigo carmine (E 132), iron oxide black (E 172).
• 60 mg capsule shell:Carrageenan (E 407), titanium dioxide (E 171), hypromellose, potassium chloride, purified water, indigo carmine (E 132).
• Printing ink:Iron oxide red (E 172), iron oxide yellow (E 172), indigo carmine (E 132), carnauba wax, bleached shellac, glycerol monooleate.
• Alternative printing ink (SB-5015):Iron oxide red (E 172), iron oxide yellow (E 172), indigo carmine (E 132), strong ammonia solution, bleached shellac, propylene glycol.

What Dexilant looks like and contents of the pack

Dexilant is a hard, delayed-release capsule.

• Each 30 mg capsule (size 3) is opaque, with a blue cap and gray body, with "TAP" printed on the cap and "30" printed on the body.
• Each 60 mg capsule (size 2) is opaque, with a blue cap and body, with "TAP" printed on the cap and "60" printed on the body. The capsules are packaged in blister packs of 14, 28, 56, or 98 capsules of Dexilant 30 mg or 14 or 28 capsules of Dexilant 60 mg. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder: Takeda Pharma Sp. z o.o., ul. Prosta 68, 00-838 Warsaw, Tel. +48 22 608 13 00. Manufacturers: Delpharm Novara S.r.l., Via Crosa, 86, 28065 - Cerano (NO), Italy; Takeda Oranienburg GmbH, Lehnitzstrasse 70-98, 16515 - Oranienburg, Brandenburg, Germany.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany, Lithuania, Poland: Dexilant. Portugal: Gladexa.

Date of last revision of the leaflet: 09/2024