Dexilant

Package leaflet: Information for the patient

Dexilant, 30 mg, modified-release capsules, hard
Dexilant, 60 mg, modified-release capsules, hard
dexlansoprazole
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Dexilant is and what it is 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 Dexilant is and what it is 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 reflux esophagitis (inflammation of the esophagus associated with damage to its lining);
• Maintenance treatment of erosive reflux esophagitis and heartburn;
• Short-term treatment of heartburn and regurgitation of gastric acid associated with non-erosive symptomatic gastro-oesophageal reflux disease (GERD). This is a condition characterized by the backflow of hydrochloric acid from the stomach into the esophagus (reflux).

The action of Dexilant is based on reducing the amount of acid secreted in the stomach, which may promote healing of esophageal damage and relieve symptoms associated with the above-mentioned conditions, as well as prevent their recurrence.

2. Important information before taking Dexilant

When NOT to take Dexilant

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

Warnings and precautions
Before starting or while taking Dexilant, inform your doctor:

• if the patient has liver problems. The doctor may then adjust the dose of the medicine.
• if the patient has stomach problems. The doctor may perform an additional examination called endoscopy (inserting a small camera through the oesophagus to observe the inside of the stomach), which may help exclude other, more serious causes of the patient's symptoms.
• if the patient is taking proton pump inhibitors, such as Dexilant, especially for longer than one year, as there may be a slight increase in the risk of fractures of the hip, wrist, or spine. Inform your doctor if osteoporosis (reduced bone density) has been diagnosed or if your doctor has informed you that you are at risk of developing osteoporosis (for example, if you are taking steroid medicines).
• if the patient is taking Dexilant for a longer period (more than 1 year). The doctor will likely ask the patient to have regular check-ups to monitor their health. If any new symptoms occur or if any existing symptoms worsen, inform the doctor immediately.
• if the patient is taking other medicines such as digoxin (used for heart conditions) or diuretics ("water tablets"). The doctor may recommend regular blood tests to monitor magnesium levels.
• if the patient has ever had vitamin B deficiency or has risk factors indicating possible reduced vitamin B levels, and the patient is being treated long-term with Dexilant. Like all medicines that reduce (inhibit) gastric acid secretion, Dexilant may lead to reduced absorption of vitamin B₁₂.
• if the patient has ever experienced a skin reaction due to taking a medicine similar to Dexilant that reduces stomach acid secretion.
• if the patient develops a skin rash, especially in areas exposed to sunlight, they should inform the doctor as soon as possible, as discontinuation of Dexilant may be necessary. Also report any other adverse reactions such as joint pain.
• interstitial nephritis (inflammation of the kidneys) may occur during treatment with dexlansoprazole. Symptoms observed by the patient and in laboratory results may include reduced urine volume or blood in the urine and (or) hypersensitivity reactions such as fever, rash, and joint stiffness. Such symptoms should be reported to the treating physician.
• Dexilant may cause rare but serious skin reactions, which may occur on any part of the patient's body (see also section 4). These serious skin reactions may require hospital treatment and may be life-threatening; skin rash with blisters, peeling or bleeding from any part of the skin (including lips, eyes, mouth, nose, genital organs, palms or soles). Fever, chills, body aches, shortness of breath, or swollen lymph nodes may also occur. In such cases, stop taking Dexilant immediately and contact your doctor without delay. These symptoms may be early signs of a serious skin reaction.
• about a planned specific blood test (chromogranin A level).

Children
This medicine must not be given to children under 12 years of age.
Dexilant and other medicines
Inform your doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. This is important because dexlansoprazole may affect the action of other medicines. Likewise, some medicines may affect the action of dexlansoprazole.
If the patient is taking medicines containing the following active substances, consult your doctor before using Dexilant:

• HIV protease inhibitors such as atazanavir and nelfinavir (used in the treatment of HIV infection),
• ketoconazole, itraconazole, rifampicin (used in the treatment of infections),
• erlotinib (used in the treatment of cancer),
• digoxin (treatment of heart conditions),
• tacrolimus (prevention of transplant rejection),
• fluvoxamine (used in the treatment of depression and other psychiatric disorders),
• warfarin (prevention of blood clots),
• acid-neutralising medicines (used in the treatment of heartburn or acid regurgitation),
• sucralfate (used in the treatment of stomach ulcers),
• products containing St John's wort (Hypericum perforatum) (herbal products used in the treatment of mild depression),
• methotrexate (used in the treatment of cancer).

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Driving and operating machinery
Patients taking Dexilant may occasionally experience adverse effects such as dizziness, fatigue, and visual disturbances. If the patient experiences any of these adverse effects, caution should be exercised due to impaired reaction ability. The patient should personally decide whether they are able to drive a motor vehicle or perform other tasks requiring concentration. Due to the mechanism of action of the medicine and its adverse effects, taking the medicine is one of the factors affecting the ability to safely perform such activities.
A description of adverse reactions can be found later in this leaflet.
Please read this leaflet carefully.
If you have any questions, consult your doctor.
Dexilant contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
Dexilant contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. the medicine is considered "sodium-free".

3. How to take Dexilant

This medicine should always be taken as instructed by your doctor or pharmacist. If you have any
doubts, consult your doctor or pharmacist.
The capsules should be swallowed whole with a glass of water. The capsules may be taken with or
without food. If you have difficulty swallowing the Dexilant capsules, you may open the capsule
and mix its contents with a spoonful of applesauce or apple puree. The mixture should be swallowed
immediately. Do not chew or suck the mixture. Do not store the mixture for later use.

Recommended doses for adults:

• Treatment of erosive reflux esophagitis: take 60 mg once daily for 4 weeks. Your doctor may recommend continuing treatment for another 4 weeks.
• Maintenance treatment of erosive reflux esophagitis and heartburn in patients who require prolonged suppression of gastric acid secretion: take 30 mg once daily for up to 6 months.
• Treatment of heartburn and acid regurgitation associated with non-erosive symptomatic gastroesophageal reflux disease (GERD): take 30 mg once daily for up to 4 weeks.

Recommended doses for adolescents aged 12 to 17 years:

• Treatment of erosive reflux esophagitis: take 60 mg once daily for 4 weeks. Your doctor may recommend continuing treatment for another 4 weeks.
• Maintenance treatment of erosive reflux esophagitis and heartburn in patients who require prolonged suppression of gastric acid secretion: take 30 mg once daily. Your doctor will determine the total duration of treatment.
• Treatment of heartburn and acid regurgitation associated with non-erosive symptomatic gastroesophageal reflux disease (GERD): take 30 mg once daily for up to 4 weeks.

Elderly patients and patients with impaired liver function:
Your doctor may recommend a lower dose.
Your doctor will inform you how long you should take Dexilant.
If necessary, your doctor may decide to use a different dose.

Accidental overdose of Dexilant
If you or someone else has taken more Dexilant than recommended (overdose), contact your doctor immediately.
The following symptoms have been observed in patients who have taken excessive doses of dexlansoprazole:

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

Missed dose of Dexilant
If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at the regular time. Do not take a double dose to make up for a missed dose.

Stopping Dexilant treatment
Do not stop treatment too early, even if your symptoms improve. If the prescribed treatment period is not completed, the condition may not be fully cured and may recur. Consult your doctor before stopping treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this product may cause adverse reactions, although not everyone experiences them.
In clinical trials, adverse reactions following the use of Dexilant were mostly mild or moderate.
The patient should stop taking the medicine and immediately contact a doctor or go to the nearest
hospital emergency department if any of the following adverse reactions occur:

• hypersensitivity reaction or serious allergic reaction (frequency unknown), with the following symptoms: rash, facial swelling, throat tightness, and difficulty breathing;
• anaphylactic shock or severe, serious and sudden allergic reaction (frequency unknown), including symptoms such as: shortness of breath, confusion, pale skin, extensive skin rash, throat tightness, weakness, difficulty catching breath, and loss of consciousness.

Most frequently reported adverse reactions (common – may occur in up to 1 in
10 patients) were:

• diarrhoea, abdominal pain, headache, nausea, abdominal discomfort, flatulence (gas), constipation, benign gastric polyps.

Other adverse reactions occurred in some patients treated with Dexilant:
Uncommon (may occur in up to 1 in 100 patients):

• difficulty sleeping,
• depression,
• dizziness,
• altered taste,
• high blood pressure,
• hot flushes,
• cough,
• vomiting,
• dry mouth,
• abnormal liver function tests,
• urticaria,
• itching,
• rash,
• feeling of weakness,
• changes in appetite,
• fracture of hip, wrist or spine.

Rare (may occur in up to 1 in 1000 patients):

• hallucinations involving hearing voices or sounds,
• seizures,
• tingling or numbness,
• visual disturbances,
• sensation of dizziness or spinning,
• kidney disorders,
• fungal infections.

Frequency unknown (frequency cannot be estimated from available data):

• decreased number of red blood cells. This may cause pallor, weakness, intolerance to physical exertion, dizziness, fatigue, and confusion.
• development of 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 syndrome), erythema multiforme, and subacute cutaneous lupus erythematosus]. Joint pain or flu-like symptoms, fever, swollen glands (e.g. under the arms) may also occur, and blood tests may show changes in certain white blood cells or liver enzymes.
• blurred vision,
• deafness,
• drug-induced hepatitis (with symptoms such as loss of appetite, headache, nausea, fatigue, fever, jaundice, pale or clay-coloured stools, dark urine),
• rash associated with joint pain.
• If Dexilant has been taken for longer than three months, there may be a risk of low magnesium levels in the blood. Low magnesium levels may present as fatigue, involuntary muscle contractions, disorientation, seizures, dizziness, and rapid heartbeat. If any of these symptoms occur, inform your doctor immediately. Low magnesium levels may 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 of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration 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. Adverse reactions can also be reported to the marketing authorization holder. By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Dexilant

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP". The expiry date refers to the last day of that month.
Do not store above 25 °C.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Package contents and other information

What Dexilant contains

• The active substance is dexlansoprazole. Each delayed-release capsule contains 30 mg or 60 mg of dexlansoprazole.
• The other ingredients (excipients) are:
• Capsule contents: Anhydrous colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, low-substituted hydroxypropyl cellulose, 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), polyethylene glycol 8000, polysorbate 80, sucrose (see section 2 "Dexilant contains sucrose"), sucrose spheres (sucrose, corn starch), talc, titanium dioxide (E 171), triethyl citrate.
• Capsule coating 30 mg: Carrageenan (E 407), titanium dioxide (E 171), hypromellose, potassium chloride, purified water, indigotine (E 132), iron oxide black (E 172).
• Capsule coating 60 mg: Carrageenan (E 407), titanium dioxide (E 171), hypromellose, potassium chloride, purified water, indigotine (E 132).
• Printing ink (gray no. 3K): iron oxide red (E 172), iron oxide yellow (E 172), indigotine (E132), carnauba wax, purified shellac, glyceryl monooleate.
• Alternative printing ink (SB-5015): iron oxide red (E 172), iron oxide yellow (E 172), indigotine (E132), 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, printed with "TAP" on the cap and "30" on the body.
• Each 60 mg capsule (size 2) is opaque with a blue cap and body, printed with "TAP" on the cap and "60" on the body. Capsules are packed in plastic-aluminum blisters containing 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Takeda Pharma Sp. z o.o.
Prosta 68
00-838 Warsaw
Poland
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 authorised for sale in the European Economic Area under the following names:
Germany, Lithuania, Poland: Dexilant.
Portugal: Gladexa.