RENAZOL 15 mg Capsules

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Renazol, 15 mg, Gastro-Resistant Capsules, Hard
   1. Read the Package Leaflet Carefully Before Taking the Medication, as it Contains
   2. Table of Contents of the Leaflet
3. What is Renazol and What is it Used For
4. Important Information Before Taking Renazol
   1. When Not to Take Renazol
   2. Warnings and Precautions
   3. Using Renazol in Patients with Kidney or Liver Function Disorders:
   4. Using Renazol in Elderly Patients:
   5. Children and Adolescents
   6. Other Medications and Renazol
   7. Renazol with Food and Drink
   8. Pregnancy, Breastfeeding, and Fertility
   9. Driving and Operating Machinery
5. How to Take Renazol
   1. Dosing in Patients with Liver Function Disorders:
   2. Overdose of Renazol:
   3. Missing a Dose of Renazol:
6. Possible Side Effects
7. How to Store Renazol
8. Package Contents and Other Information
   1. What Renazol Contains
   2. What Renazol Looks Like and What the Package Contains
   3. Marketing Authorization Holder:
   4. Manufacturer:
   5. Date of Last Revision of the Leaflet:

Package Leaflet: Information for the Patient

Renazol, 15 mg, Gastro-Resistant Capsules, Hard

Lansoprazole

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains

Important Information for the Patient.

• This leaflet should be kept in case it needs to be read again.
• A pharmacist should be consulted if advice or additional information is needed.
• If any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed.
• If there is no improvement or the patient feels worse after 2 weeks, the doctor should be contacted.
• The medication Renazol should not be taken for more than 2 weeks without consulting a doctor.

Table of Contents of the Leaflet

• 1. What is Renazol and What is it Used For
• 2. Important Information Before Taking Renazol
• 3. How to Take Renazol
• 4. Possible Side Effects
• 5. How to Store Renazol
• 6. Package Contents and Other Information

1. What is Renazol and What is it Used For

The active substance of the medication Renazol is lansoprazole, which blocks the enzyme that produces stomach acid. This reduces the amount of acid in the stomach and decreases the irritating effect of acidic stomach contents on the esophagus in patients with gastroesophageal reflux disease. The medication starts working within 1 to 2 hours after administration and lasts for approximately 24 hours. Renazol is used in adults for short-term treatment of symptoms of gastroesophageal reflux disease (such as heartburn and acid regurgitation). Gastroesophageal reflux disease is a condition where stomach contents flow back into the esophagus, potentially leading to inflammation and pain. This can cause symptoms such as a burning sensation in the chest and throat (heartburn) and a sour taste in the mouth (due to acid regurgitation). To achieve symptom improvement, it may be necessary to take the capsules for 2-3 consecutive days. If there is no improvement or the patient feels worse after 2 weeks, the doctor should be consulted.

2. Important Information Before Taking Renazol

When Not to Take Renazol

• if the patient is allergic to lansoprazole or any of the other ingredients of this medication (listed in section 6)

-if the patient is taking a medication containing atazanavir (used to treat HIV infection (human immunodeficiency virus) .

• if the patient is under 18 years of age.

Warnings and Precautions

A doctor should be consulted if:

• symptoms of indigestion or heartburn have not improved after 2 weeks of treatment
• the patient has had stomach ulcers or surgery in the gastrointestinal tract
• the patient has liver function disorders (see section 3, How to Take Renazol)
• the patient is over 55 years old and has experienced new symptoms or a change in existing symptoms
• the patient is pregnant or breastfeeding
• if the patient has ever had a skin reaction after taking a medication similar to Renazol, which reduces stomach acid production.

Before taking the medication, the doctor should be informed:

• about any planned specific blood test (chromogranin A levels).

If a skin rash occurs, especially in areas exposed to sunlight, the doctor should be informed as soon as possible, as it may be necessary to stop taking Renazol. Any other side effects, such as joint pain, should also be reported. Renazol may mask the symptoms of other diseases. The doctor should be informed immediatelyif any of the following symptoms occur (before or after taking this medication):

• unexplained weight loss
• difficulty swallowing
• vomiting food, especially if it happens repeatedly
• bloody vomiting, which may look like coffee grounds
• blood in the stool, black or tarry stools
• stomach pain
• chest pain
• pale skin and weakness (suspected anemia)
• severe, persistent diarrhea (lansoprazole treatment may slightly increase the risk of gastrointestinal infections caused by bacteria Salmonellaand Campylobacter).

Renazol should not be taken for more than 2 weeks without consulting a doctor. Renazol should not be taken as a preventive measure. If the patient has had recurring heartburn or indigestion for some time, they should remain under regular medical supervision, especially if they are over 55 years old and have been taking over-the-counter medications for indigestion or heartburn for a long time.

Using Renazol in Patients with Kidney or Liver Function Disorders:

In patients with kidney function disorders, dose adjustment is not necessary. In patients with liver function disorders, the doctor should be consulted before taking Renazol.

Using Renazol in Elderly Patients:

In elderly patients, the elimination of lansoprazole is slower, so it may be necessary to consult a doctor and adjust the dose of Renazol.

Children and Adolescents

Renazol is not recommended for children and adolescents, as the safety and efficacy of lansoprazole in this patient group have not been fully investigated.

Other Medications and Renazol

The doctor or pharmacist should be informed about all medications currently being taken or
recently taken, as well as any medications planned to be taken.
In particular, the doctor should be informed about taking medications containing the following active substances:

• atazanavir (used to treat HIV infection). Renazol should not be taken at the same time as atazanavir.
• ketokonazole, itraconazole (antifungal medications)
• rifampicin (used to treat bacterial infections)
• digoxin (used to treat heart failure)
• warfarin, acenocoumarol (anticoagulant medications)
• phenytoin (antiepileptic medication)
• theophylline (used to treat asthma)
• tacrolimus (used to prevent transplant rejection)
• fluvoxamine (used to treat depression and mental disorders)
• medications that neutralize stomach acid (used to treat heartburn and acid regurgitation)
• sucralfate (used to treat stomach ulcers)
• and herbal products containing St. John's Wort (Hypericum perforatum).

A minimum of 1-hour interval should be maintained between the administration of lansoprazole and medications that neutralize stomach acid or sucralfate.

Renazol with Food and Drink

Renazol works best when taken about 30 minutes before a meal.

Pregnancy, Breastfeeding, and Fertility

In pregnancy, during breastfeeding, or if pregnancy is suspected or planned, the doctor should be consulted before taking this medication.
There are no adequate studies on the use of lansoprazole in pregnant women. Therefore, despite animal studies not showing a direct or indirect harmful effect on pregnancy, fetal development, childbirth, or postnatal development, the use of Renazol during pregnancy is not recommended.
It is not known whether lansoprazole passes into breast milk. Animal studies have shown that lansoprazole passes into breast milk. The decision to continue or stop breastfeeding, or to continue or stop treatment with Renazol, should be made by the doctor after considering the benefits of breastfeeding for the child and the benefits of lansoprazole treatment for the mother.

Driving and Operating Machinery

Lansoprazole has a minor or moderate effect on the ability to drive and operate machinery. During treatment, side effects such as dizziness, vision disturbances, or drowsiness (see section 4, Possible Side Effects) may occur, which can affect reaction time while driving or operating machinery.
Renazol contains sucrose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medication.
Renazol contains sodium. The medication contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free).

3. How to Take Renazol

The recommended dose of the medication is 15 mg (1 capsule) per day.
This medication should always be taken according to the description in the patient leaflet or as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
The medication should be taken for at least 2-3 consecutive days. The use of Renazol should be stopped after complete relief of symptoms. It is possible to alleviate symptoms of reflux and heartburn after just one day of taking Renazol, but it should be remembered that this medication is not intended for immediate relief of symptoms.
The doctor should be consulted if symptoms do not improve after taking the medication for 2 weeks. Renazol should not be taken for more than 2 weeks without consulting a doctor.
The capsules should be taken before a meal, at the same time every day. The capsules should be swallowed whole, with plenty of water. The capsules can be opened and their contents poured out, but they should not be chewed or crushed.
Taking the medication with food slows down and reduces the absorption of lansoprazole. The best effect of the medication is achieved when taken on an empty stomach.
If there is no improvement or the patient feels worse after 2 weeks, the doctor should be contacted.
If the effect of the medication seems too strong or too weak, the doctor should be consulted.

Dosing in Patients with Liver Function Disorders:

Patients with liver function disorders should consult their doctor before taking Renazol.

Overdose of Renazol:

There is no experience with lansoprazole overdose in humans.
Doses up to 180 mg per day have been tolerated by humans without significant side effects.
In case of overdose, the side effects listed in section 4, Possible Side Effects, may occur in a more severe form.
In case of taking a higher dose of the medication than recommended, the doctor or pharmacist should be consulted immediately.

Missing a Dose of Renazol:

If a dose of the medication is missed at the scheduled time, it should be taken as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped. A double dose should not be taken to make up for the missed dose.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.
The medication should be stopped, and the doctor or pharmacist should be consulted immediately, or the patient should go to the nearest hospital, if:

• allergic reactions, such as rash, swelling of the lips, tongue, or face, or if there are difficulties breathing, fever, or a drop in blood pressure
• severe skin reactions, which are accompanied by redness, blistering, severe inflammation, and skin peeling
• liver function disorders, which can cause yellowing of the skin or whites of the eyes.

These side effects are rare and may require medical attention.
The following side effects are common (occurring in more than 1 in 100 patients):

• vomiting, nausea, diarrhea, abdominal pain, constipation, bloating with gas, indigestion
• rash, hives, itching
• pain, dizziness
• fatigue
• mild stomach polyps.

The following side effects are uncommon (occurring in less than 1 in 100 patients):

• dry mouth or throat, loss of appetite
• hip, wrist, or spine fractures
• taste disturbances
• increased liver enzyme activity.

The following side effects are rare (occurring in less than 1 in 1,000 patients):

• pancreatitis, esophageal candidiasis, glossitis
• erythema multiforme (a disease characterized by the occurrence of reddish, swollen, and blistering rashes on the skin and mucous membranes), purpura (small, pinpoint areas of bleeding into the skin), petechiae (a process of bleeding into the surrounding tissues), hair loss, excessive sweating
• depression, hallucinations, confusion, insomnia, lethargy, drowsiness, tremors, paresthesia (tingling or burning sensation of the skin)
• hepatitis and jaundice
• changes in blood cell count
• interstitial nephritis
• palpitations, chest pain
• peripheral edema
• muscle and joint pain
• vision disturbances
• angioedema (swelling of the tissues), bronchospasm, fever.

The following side effects are very rare (occurring in less than 1 in 10,000 patients):

• colitis, oral inflammation, blackening of the tongue
• Stevens-Johnson syndrome (a disease characterized by the occurrence of blisters in the mucous membranes of the mouth, throat, genital area, and anus, accompanied by fever), toxic epidermal necrolysis (a type of severe skin damage)
• decrease in the number of certain white blood cells
• breast enlargement in men, galactorrhea
• anaphylactic shock (a type of systemic allergic reaction, the symptoms of which include: circulatory disorders, blood pressure drop, bronchospasm, and hives, and in severe cases, there is a risk to life), impotence, and general malaise
• increased cholesterol and triglyceride levels in the blood.

The following side effects have an unknown frequency:

• rash that may be accompanied by joint pain
• visual hallucinations
• decreased magnesium levels in the blood. If Renazol has been taken 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, confusion, seizures, dizziness, and heart rhythm disturbances (ventricular arrhythmias). If any of these symptoms are observed, the doctor should be informed immediately. Low magnesium levels can lead to decreased potassium or calcium levels in the blood. The doctor may recommend regular blood tests to monitor magnesium levels. Some patients may experience other side effects while taking Renazol.If any side effects occur, including any possible side effects not listed in the leaflet, the doctor should be consulted.

If any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medication.

5. How to Store Renazol

The medication should be stored out of sight and reach of children.
The medication should not be used after the expiration date stated on the package and blister after: EXP. The expiration date (EXP) means the last day of the given month.
The medication should not be stored at a temperature above 30°C. The medication should be stored in its original packaging, protected from moisture.
Medications should not be disposed of in wastewater or household waste. The pharmacist should be asked how to dispose of unused medications. This will help protect the environment.

6. Package Contents and Other Information

What Renazol Contains

• The active substance of Renazol is lansoprazole. Each capsule contains 15 mg of lansoprazole.
• The other excipients are: sucrose - granules, sodium lauryl sulfate, mannitol, meglumine, hypromellose, macrogol 6000, talc, polysorbate 80, titanium dioxide (E171), methacrylic acid, and ethyl acrylate copolymer (1:1). The composition of the capsule shell: quinoline yellow (E104), titanium dioxide (E171), gelatin, purified water.

What Renazol Looks Like and What the Package Contains

Renazol 15 mg - opaque, yellow, hard gelatin capsules, size 3, containing white or almost white microgranules.
Packaged in a blister pack of OPA/Al/PVC/Al foil containing 7 capsules. The carton contains 14 capsules (2 blisters) along with the patient leaflet.

Marketing Authorization Holder:

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer:

Laboratorios Liconsa S.A.
Avenida Miralcampo, N° 7, Poligono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain

Date of Last Revision of the Leaflet: