Renazol

Package leaflet: Information for the patient

Renazol, 15 mg, enteric hard capsules
Lansoprazole
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• Consult your pharmacist if you need advice or further information.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
• If there is no improvement after 2 weeks, or if symptoms worsen, consult your doctor.
• Do not take Renazol for longer than 2 weeks without consulting a doctor.

Table of contents

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

1. What Renazol is and what it is used for

The active substance in Renazol is lansoprazole, which inhibits the enzyme responsible for producing hydrochloric acid in the stomach. In this way, the medicine reduces the amount of acid in the stomach and decreases the irritating effect of acidic gastric contents on the oesophagus in patients with gastro-oesophageal reflux.
The effect of the medicine begins approximately 1 to 2 hours after ingestion and lasts for about 24 hours.
Renazol is used in adult patients for short-term treatment of symptoms of gastro-oesophageal reflux disease (such as heartburn and regurgitation of acidic stomach contents – acid regurgitation).
Reflux refers to the backflow of stomach contents into the oesophagus, which may lead to inflammation and associated pain. This may result in symptoms such as a burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (due to regurgitation of acidic contents).
To achieve symptom relief, it may be necessary to take the capsules for 2–3 consecutive days.
If there is no improvement after 2 weeks, or if symptoms worsen, consult your doctor.

2. Important information before taking Renazol

When not to take Renazol

• if the patient has a known allergy to lanzoprazole or any of the other ingredients of this medicine (listed in section 6)
• if the patient is taking a medicine containing atazanavir (used in the treatment of HIV infection (human immunodeficiency virus))
• if the patient is under 18 years of age

Warnings and precautions

Consult a doctor if:

• symptoms of indigestion or heartburn have not improved despite treatment lasting for 2 weeks
• the patient has a history of peptic ulcer disease or gastrointestinal surgery
• the patient has impaired liver function (see section 3. How to take Renazol)
• the patient is over 55 years of age and has noticed new symptoms or a change in the nature of existing symptoms
• the patient is pregnant or breastfeeding
• the patient has ever experienced a skin reaction while taking a medicine similar to Renazol that reduces gastric acid secretion

Before taking this medicine, inform the doctor:

• about a planned specific blood test (chromogranin A levels)

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 Renazol may be necessary. Also report any other adverse reactions such as joint pain.

Renazol may mask symptoms of other diseases.

Contact the doctor immediately if any of the following symptoms occur (before or after taking this medicine):

• unexplained weight loss
• difficulty swallowing
• vomiting of food, especially recurrent
• vomiting blood, which may look like dark coffee grounds
• blood in stool, black or tarry stools
• stomach pain
• chest pain
• paleness and weakness (suspected anaemia)
• severe, persistent diarrhoea (treatment with lanzoprazole may slightly increase the risk of gastrointestinal infections caused by Salmonella and Campylobacter bacteria)

Do not take Renazol for longer than 2 weeks without consulting a doctor.

Do not use Renazol preventively.

If the patient has had recurrent heartburn or indigestion symptoms for some time, they should remain under regular medical supervision, especially patients over 55 years of age who are taking long-term over-the-counter medications for indigestion or heartburn.

Use of Renazol in patients with impaired kidney and/or liver function:

In renal impairment, dose adjustment is not necessary. In case of impaired liver function, contact a doctor before taking Renazol.

Use of Renazol in elderly patients:

In elderly patients, elimination of lanzoprazole is slower; therefore, consultation with a doctor and possible dose adjustment of Renazol may be necessary.

Children and adolescents

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

Other medicines and Renazol

Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.

In particular, inform the doctor if taking medicines containing the following active substances:

• atazanavir (used in the treatment of HIV infection). Renazol must not be taken at the same time as atazanavir.
• ketoconazole, itraconazole (antifungal and antifungal agents)
• rifampicin (used in bacterial infections)
• digoxin (used in heart failure)
• warfarin, acenocoumarol (anticoagulants)
• phenytoin (antiepileptic medicine)
• theophylline (used e.g. in asthma treatment)
• tacrolimus (used e.g. to prevent transplant rejection)
• fluvoxamine (used in depression and psychiatric disorders)
• acid-neutralizing medicines (used in heartburn and acid reflux into the oesophagus)
• sucralfate (used in peptic ulcer disease)
• and herbal products containing St. John's wort (Hypericum perforatum)

An interval of at least 1 hour should be maintained between administration of lanzoprazole and acid-neutralizing medicines or sucralfate.

Renazol with food and drink

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

Pregnancy and breastfeeding, and effect on fertility

During pregnancy, while breastfeeding, if pregnancy is suspected, or when planning pregnancy, consult a doctor before taking this medicine.

There are insufficient data on the use of lanzoprazole in pregnant women. Although animal studies have not shown direct or indirect harmful effects on pregnancy, embryo or foetal development, delivery or postnatal development, the use of Renazol during pregnancy is not recommended.

It is unknown whether lanzoprazole passes into human breast milk. Animal studies have shown that lanzoprazole passes into maternal milk. The decision to continue or discontinue breastfeeding or to continue or discontinue treatment with Renazol should be made by the doctor after considering the benefits of breastfeeding for the child and the benefits of treatment with lanzoprazole for the mother.

Driving and operating machinery

Lanzoprazole has no or negligible influence on the ability to drive vehicles and operate machinery. However, during treatment, adverse reactions such as dizziness, visual disturbances, or drowsiness (see section 4 "Possible side effects") may occur, which could impair reaction time while driving or operating machinery.

Renazol contains sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.

Renazol contains sodium. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Renazol

The recommended dose of the medicine is 15 mg (1 capsule) per day.
This medicine should always be used according to the instructions in the patient information leaflet or as directed by a physician or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine should be taken for at least 2–3 consecutive days. Treatment with Renazol should be discontinued after complete resolution of symptoms. Relief of reflux and heartburn symptoms may occur as early as one day after starting Renazol; however, bear in mind that this medicine is not intended for immediate symptom relief.
Consult a doctor if symptoms do not resolve after taking this medicine for a full 2 weeks. Do not take Renazol for longer than 2 weeks without consulting a doctor.
Capsules should be taken before a meal, at the same time each day. Swallow the capsules whole with plenty of water. The capsules may be opened and their contents sprinkled, but they should not be chewed or crushed.
Concurrent food intake slows down and reduces the absorption of lanzoprazole. Optimal effect is achieved when the medicine is taken on an empty stomach.
If there is no improvement after 2 weeks, or if the patient feels worse, contact a doctor.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.

Dosage in patients with impaired liver function:
Patients with impaired liver function should consult a doctor before using Renazol.

Taking more than the recommended dose of Renazol
There is currently no experience regarding overdosage of lanzoprazole in humans.
Doses up to 180 mg per day have been tolerated in humans without significant adverse effects.
In case of overdose, adverse effects listed in section 4, "Possible side effects", may occur in a more severe form.
If you have taken more than the recommended dose of the medicine, seek medical advice immediately from your doctor or pharmacist.

Missed dose of Renazol
If a dose of the medicine is missed at the scheduled time, take it as soon as possible.
However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a missed one.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
You should stop taking the medicine and immediately contact a doctor or go to
the nearest hospital if any of the following occur:

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

These adverse effects are rare and may require medical attention.
The following adverse effects occur frequently (in more than 1 in 100 patients):

• vomiting, nausea, diarrhoea, abdominal pain, constipation, bloating with passing wind, indigestion
• rash, urticaria, itching
• pain, dizziness
• fatigue
• mild gastric polyps.

The following adverse effects occur less frequently (in less than 1 in 100 patients):

• dryness of the mouth or throat, loss of appetite
• fracture of the hip, wrist or spine
• taste disturbances
• increased liver enzyme activity.

The following adverse effects occur rarely (in less than 1 in 1,000 patients):

• pancreatitis, oesophageal candidiasis, glossitis
• erythema multiforme (a condition characterised by erythematous, oedematous and blistering skin lesions affecting the skin and mucous membranes), petechiae (small, pinpoint haemorrhagic spots), purpura (extravasation of blood into surrounding tissues), hair loss, excessive sweating
• depression, hallucinations, confusion, insomnia, restlessness, somnolence, drowsiness, tremor, paraesthesia and burning sensation of the skin, motor restlessness
• hepatitis and jaundice
• changes in blood cell counts
• interstitial nephritis
• palpitations, chest pain
• peripheral oedema
• muscle and joint pain
• visual disturbances
• tissue swelling (angioedema), bronchospasm, fever.

The following adverse effects occur very rarely (in less than 1 in 10,000 patients):

• colitis, oral mucosal inflammation, black discoloration of the tongue
• Stevens-Johnson syndrome (a condition characterised by blistering of the mucous membranes of the mouth, throat, genital and anal areas and conjunctiva, accompanied by fever), toxic epidermal necrolysis (a type of severe skin damage)
• decreased number of certain white blood cells
• breast enlargement in males, galactorrhea
• anaphylactic shock (a type of systemic allergic reaction presenting with circulatory disturbances, hypotension, bronchospasm and urticaria; in severe cases, life-threatening), impotence and general malaise
• increased blood cholesterol and triglyceride levels.

The following adverse effects have unknown frequency:

• rash which may be accompanied by joint pain
• visual hallucinations
• decreased magnesium levels in blood. If Renazol has been taken for longer than three months, there may be a risk of decreased magnesium levels in blood. Low magnesium levels may present as fatigue, involuntary muscle cramps, delirium, seizures, dizziness, cardiac disturbances (ventricular arrhythmias). If any of the above symptoms are observed, the doctor should be informed immediately. Low magnesium levels may lead to decreased potassium or calcium levels in blood. The doctor may recommend regular blood tests to monitor magnesium levels. In some individuals, other adverse effects may occur during treatment with Renazol. If any adverse effects occur, including any possible adverse symptoms not listed in this leaflet, consult a doctor.

If any adverse effects occur, including any not listed in this leaflet, you should inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting of adverse effects helps to provide more information on the safety of the medicine.

5. How to store Renazol

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and
blister after: EXP. The expiry date (EXP) refers to the last day of the specified month.
Do not store above 30°C. Store in the original packaging and protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures help
protect the environment.

6. Contents of the pack and other information

What Renazol contains

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

What Renazol looks like and contents of the pack
Renazol 15 mg – opaque, yellow, hard gelatin capsules, size 3, containing white or almost white microgranules.
Packed in an OPA/Al/PVC/Al foil blister containing 7 capsules. A cardboard box contains 14 capsules (2 blisters) together with the package leaflet.
Marketing Authorisation 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