Ranigast Pro

Package Leaflet: Information for the User

Ranigast PRO, 75 mg, Film-Coated Tablets

Ranitidine

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

Important Information for the Patient.
This medication should always be taken exactly as described in the patient information leaflet or as advised by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 14 days, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is Ranigast PRO and what is it used for

Ranitidine, the active substance of Ranigast PRO, inhibits the secretion of hydrochloric acid in the stomach.
The indication for use of the medication is the symptomatic treatment of gastrointestinal disorders not related to organic gastrointestinal disease: dyspepsia, heartburn, hyperacidity, epigastric pain. The medication quickly relieves heartburn and dyspepsia. One tablet acts for approximately 6-8 hours.

2. Important information before taking Ranigast PRO

When Not to Take Ranigast PRO

• if the patient is allergic to ranitidine or any of the other ingredients of this medication (listed in section 6),
• in children under 16 years of age.

Warnings and Precautions

Before starting treatment with Ranigast PRO, the patient should discuss it with their doctor or pharmacist:

• if the patient has liver or kidney function disorders,
• if the patient has had acute porphyria,
• if the patient has weight loss along with dyspepsia,
• if the patient has not had gastrointestinal (dyspeptic) symptoms before, or if they have changed recently - especially in people of middle or advanced age,
• if the patient is taking non-steroidal anti-inflammatory drugs (NSAIDs) - especially in elderly people and those with a history of peptic ulcer disease,
• if the patient is taking other medications, including those available without a prescription,
• if the patient is under regular medical supervision for other reasons,
• if the patient has diabetes, respiratory diseases, and immune system disorders,
• if the patient has difficulty swallowing or chronic abdominal pain. Treatment with ranitidine may mask the symptoms of stomach cancer.

Ranigast PRO and Other Medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
Ranigast PRO may affect the rate and extent of absorption of medications such as:

• ketokonazole (an antifungal medication),
• atazanavir, delavirdine (medications used to treat viral infections),
• gefitinib (a medication used to treat cancer),
• benzodiazepines, such as midazolam, triazolam - used for insomnia,
• glipizide (a medication used to treat diabetes),
• procainamide, N-acetylprocainamide (medications used to treat heart rhythm disorders).

Sucralfate (a medication used to treat stomach ulcers) in doses above 2 g reduces the absorption of ranitidine.
Ranitidine does not enhance the effects of medications such as: amoxicillin (an antibiotic) and metronidazole (an antifungal and anti-protozoal medication), diazepam (a sedative and anxiolytic medication, also used to treat epilepsy), lidocaine (a local anesthetic, also used to treat heart rhythm disorders), phenytoin (an antiepileptic medication), propranolol (a medication used to treat hypertension and coronary heart disease) and theophylline (a medication used to treat asthma).
Ranigast PRO may enhance the effects of anticoagulant medications, such as warfarin, so it is necessary to closely monitor prothrombin time during concurrent treatment with these medications.

Ranigast PRO with Food and Drink

Food does not have a significant effect on the absorption of ranitidine, so the medication can be taken independently of meals.

Pregnancy, Breast-Feeding, and Fertility

If the patient is pregnant or breast-feeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.
Pregnancy
The medication should be used in pregnant women only when, in the doctor's opinion, it is absolutely necessary.
Breast-Feeding
Ranitidine passes into breast milk, so in breast-feeding women, the medication can be used only when, in the doctor's opinion, it is absolutely necessary.
There are no data on the effects of ranitidine on human fertility. In animal studies, no effects on fertility were observed.

Driving and Using Machines

There is no information on contraindications for driving vehicles and operating machinery during treatment with ranitidine. However, some patients have experienced side effects such as dizziness and headache or blurred vision, which may impair physical and mental performance. If such side effects occur, the patient should not drive vehicles or operate machinery.

Ranigast PRO Contains Orange Yellow S (E110)

The medication may cause allergic reactions.

3. How to Take Ranigast PRO

This medication should always be taken exactly as described in the patient information leaflet or as advised by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Adults and Adolescents Over 16 Years of Age
In case of dyspepsia symptoms, the patient should take 1 film-coated tablet of 75 mg.
If symptoms persist for more than 1 hour after taking the medication or recur, the patient can take another 75 mg tablet.
The patient should not take more than 150 mg per day.
The tablet should be swallowed whole, with a small amount of water.
The medication should not be taken for more than 2 weeks without medical supervision. If symptoms do not improve after 2 weeks of treatment, the patient should consult their doctor immediately.
Dosing in Patients with Renal Impairment
In patients with renal impairment (creatinine clearance less than 50 ml/min), the elimination of ranitidine may be reduced, which may lead to an increase in its concentration in the blood serum.
Hemodialysis reduces the concentration of ranitidine in the blood serum. In patients undergoing chronic dialysis, ranitidine should be administered immediately after dialysis.

Overdose of Ranigast PRO

In the event of an overdose of Ranigast PRO, transient side effects may occur, such as those that occur during treatment with ranitidine (see section 4 "Possible side effects").
Sometimes, hypotension and gait disturbances may occur.
In case of poisoning, the patient should immediately consult a doctor, who will provide appropriate treatment.

Missed Dose of Ranigast PRO

If the patient misses a dose, they should take it as soon as possible. If it is almost time for the next dose, the patient should not take a double dose to make up for the missed dose.

Stopping Treatment with Ranigast PRO

If the patient has any further doubts about taking this medication, they should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medications, Ranigast PRO can cause side effects, although not everybody gets them.
Side effects have been classified according to their frequency of occurrence:
The frequency of possible side effects listed below is defined using the following convention:

• very common (occurring in more than 1 in 10 patients)
• common (occurring in less than 1 in 10 patients)
• uncommon (occurring in less than 1 in 100 patients)
• rare (occurring in less than 1 in 1,000 patients)
• very rare (occurring in less than 1 in 10,000 patients)
• not known (frequency cannot be estimated from the available data). In patients taking ranitidine, the following side effects have been observed:

Very Rarely:headache (sometimes severe) and dizziness, transient involuntary movement disorders, transient confusion, depression, and hallucinations (especially in severely ill patients, elderly patients, and patients with kidney disease), bradycardia, tachycardia, atrioventricular block (conduction disorders in the heart muscle cells), vasculitis, usually transient hepatitis (cellular, canalicular, or mixed) with or without jaundice, acute pancreatitis, diarrhea, arthralgia and myalgia, usually transient leukopenia (reduced white blood cell count) and thrombocytopenia (reduced platelet count), agranulocytosis (a disease characterized by high fever, sore throat, oral, nasal, genital, and anal ulcers) or pancytopenia (deficiency of white blood cells, red blood cells, and platelets), sometimes with aplastic or hypoplastic bone marrow (bone marrow atrophy), gynecomastia (breast enlargement in men), transient impotence, galactorrhea, erythema multiforme, hair loss, anaphylactic shock (its symptoms include: shortness of breath, difficulty breathing due to laryngeal edema, difficulty exhaling, wheezing, skin itching and redness, headache, feeling of "pressure", dizziness, accelerated or slowed (rarely) heart rate, itching, urticaria of varying severity, erythema of the whole body, significant weakness, up to loss of consciousness; in severe cases, it can be life-threatening), blurred vision (accommodation disorders), nephritis.
Rarely:rash, urticaria, angioedema (swelling of the face, lips, tongue, and throat, making breathing difficult, accompanied by itching, skin redness, urticaria, and severe bronchospasm), fever, bronchospasm, transient changes in liver enzyme activity in diagnostic tests, hypotension, chest pain.
Uncommonly:abdominal pain, constipation, nausea (these symptoms usually subside during treatment).
Not Known:dyspnea.

Reporting Side Effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medication.

5. How to Store Ranigast PRO

The medication should be stored out of sight and reach of children.
Do not store above 25°C.
Do not use this medication after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the month stated.
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Ranigast PRO Contains

• The active substance is: ranitidine in the form of hydrochloride. Each tablet contains 75 mg of ranitidine.
• The other ingredients are: Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, anhydrous colloidal silica. Tablet coating: hypromellose (Methocel E15), orange yellow S (E110), titanium dioxide, triacetin, talc.

What Ranigast PRO Looks Like and Contents of the Pack

Ranigast PRO is a film-coated tablet with a diameter of 7 mm, biconvex, orange in color.
The pack contains 10 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Polpharma S.A.
Pelplińska 19
83-200 Starogard Gdański
For more detailed information, please contact the representative of the marketing authorization holder:
POLPHARMA Sales Office Ltd.
Bobrowiecka 6
00-728 Warsaw
phone: 22 364 61 01

Date of Last Revision of the Leaflet: