Ranigast Fast

Package Leaflet: Information for the User

Ranigast Fast, 150 mg, Effervescent Tablets

Ranitidine

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

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after 14 days there is no improvement or you feel worse, consult a doctor.

Table of Contents of the Leaflet

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

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

Ranigast Fast contains the active substance ranitidine, which inhibits the secretion of hydrochloric acid and pepsin in the stomach.
A dose of 150 mg of ranitidine inhibits the secretion of hydrochloric acid in the stomach for about 12 hours.
Indications for use:

• symptomatic treatment of gastrointestinal disorders (dyspeptic) not related to organic disease of the gastrointestinal tract, such as: heartburn, indigestion, hyperacidity.

2. Important information before taking Ranigast Fast

When not to take Ranigast Fast:

• if you are allergic to ranitidine or any of the other ingredients of this medicine (listed in section 6),
• if you have porphyria (a disease characterized by abnormal production of heme, a component of hemoglobin),
• if you have phenylketonuria (a rare, inherited disorder of metabolism).

Warnings and precautions

Before starting treatment with Ranigast Fast, discuss it with your doctor or pharmacist.
Treatment with ranitidine may mask the symptoms of stomach cancer and thus delay diagnosis of this disease, so you should consult a doctor:

• if you have never had gastrointestinal disorders (dyspeptic) or have had them, but they have recently changed - especially if you are middle-aged or elderly,
• if you have dyspeptic disorders and have recently lost weight.

Patient who have had acute porphyria attacks in the past should avoid taking this medicine, as ranitidine may trigger an acute porphyria attack.
Before starting treatment with Ranigast Fast, discuss it with your doctor:

• if you have kidney and/or liver function disorders. In patients with kidney function disorders, the doctor will reduce the dose of the medicine, individually for each patient.
• if you are taking non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen; especially if you are elderly and have a history of stomach ulcers. Ranigast Fast should be taken with NSAIDs under medical supervision.
• if you are taking other medicines, including those available without a prescription.
• if you are under constant medical supervision for other reasons.
• if you have diabetes, lung disease, or immune system disorders.
• if you have difficulty swallowing or chronic abdominal pain.

Children and adolescents

Ranigast Fast should not be taken by children and adolescents under 16 years of age.

Ranigast Fast and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Ranigast Fast may affect the speed and extent of absorption of medicines such as:

• ketokonazole (a medicine used to treat fungal infections),
• atazanavir, delavirdine (medicines used to treat viral infections),
• gefitinib (a medicine used to treat tumors),
• benzodiazepines, such as midazolam, triazolam - used for insomnia,
• glipizide (a medicine used to treat diabetes),
• procainamide, N-acetylprocainamide (medicines used to treat heart rhythm disorders),
• sucralfate (a protective medicine used to treat stomach ulcers). Ranigast Fast may enhance the effect of anticoagulant medicines of the coumarin type, such as warfarin, so it is necessary to closely monitor prothrombin time during concomitant treatment with these medicines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Ranitidine passes through the placenta, so Ranigast Fast should not be taken during pregnancy.
Breastfeeding
Ranitidine passes into breast milk, so Ranigast Fast should not be taken during breastfeeding.
There is no data on the effect of ranitidine on human fertility. In animal studies, no effect on fertility was found.

Driving and using machines

If you experience side effects such as dizziness or blurred vision, do not drive or operate machinery, as Ranigast Fast may impair your physical and mental abilities.

The medicine contains sorbitol, sodium, aspartame

• The medicine contains 820 mg of sorbitol in each tablet. Sorbitol is a source of fructose. If you have previously been diagnosed with intolerance to some sugars or previously diagnosed with hereditary fructose intolerance, a rare genetic disease in which the patient's body does not break down fructose, you should consult your doctor before taking the medicine or giving it to a child.
• The medicine contains 211 mg of sodium (the main component of common salt) in each tablet. This corresponds to 11% of the maximum recommended daily intake of sodium in the diet for adults.
• The medicine contains 20 mg of aspartame in each tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disease in which phenylalanine accumulates in the body due to its improper excretion.

3. How to take Ranigast Fast

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Do not take Ranigast Fast for more than 14 days without consulting a doctor.
If your symptoms do not improve after 14 days of treatment, consult a doctor immediately.
Recommended dosage:
Adults and adolescents over 16 years of age:
One tablet (150 mg) once a day.
Maximum 1 tablet twice a day.
Patient with kidney failure
Patient with kidney failure may take a maximum of 150 mg of ranitidine (1 tablet) per day.
Children and adolescents under 16 years of age
Ranigast Fast should not be taken by children and adolescents under 16 years of age.
Method of administration:
The tablet should be dissolved in ½ glass of water, wait for it to dissolve completely, and then drink the prepared solution.

Overdose of Ranigast Fast

In case of taking a higher dose of the medicine than recommended, consult a doctor.

Missed dose of Ranigast Fast

Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of the side effects listed below was determined as follows:
Very common(occurring in more than 1 in 10 patients)
Common(occurring in 1 to 10 in 100 patients)
Uncommon(occurring in 1 to 10 in 1000 patients)
Rare(occurring in 1 to 10 in 10,000 patients)
Very rare(occurring in less than 1 in 10,000 patients)
Frequency not known(cannot be estimated from the available data).

You should immediately consult a doctor or the nearest hospital if you experience any of the following serious side effects:

• Severe allergic reactions:
• very rarely: anaphylactic shock (manifested by: rash, burning and itching of the tongue, hands and feet, severe swelling of the face, lips or throat, difficulty breathing, speaking or swallowing, sudden drop in blood pressure, slow or fast heart rate, paleness, anxiety, sweating, dizziness, loss of consciousness, respiratory and cardiac arrest);
• rarely: angioedema (manifested by sudden swelling of the face, limbs or joints without itching and pain), bronchospasm, decreased blood pressure, chest pain.
• Severe skin reactions (very rarely): rash with swelling, blisters or peeling of the skin, bleeding from the eyes, nose, mouth or genitals, rapid deterioration of the patient's condition.
• Other severe reactions (very rarely): yellowing of the skin and whites of the eyes (caused by liver damage); kidney function disorders manifested by painful urination, back pain and fever; acute pancreatitis manifested by severe pain in the upper and middle abdomen, accompanied by vomiting and high fever.

Other side effects:

Uncommon:

• abdominal pain, constipation, nausea.

Rare:

• transient liver function disorders (abnormal liver test results, i.e. liver enzymes: AspAT and AlAT, found in laboratory tests),
• skin rash (itching, red bumps on the skin),
• allergic reactions,
• increased creatinine levels in the blood.

Very rare:

• diarrhea,
• transient decrease in white blood cell count (increased susceptibility to infections); decrease in platelet count (increased risk of bleeding and bruising); decrease in all blood cells: red blood cells, white blood cells, and platelets; sometimes partial or complete inhibition of blood cell production in the bone marrow,
• slow heart rate, accelerated heart rate, irregular heartbeat (atrioventricular block),
• headache (sometimes severe),
• dizziness,
• transient tremors, slow, uncoordinated movements of the hands (involuntary movements),
• agitation,
• disorientation (disorders of orientation regarding time, place, situation, or one's own person),
• depression,
• hallucinations (perception of non-existent objects, people); especially in seriously ill patients, elderly patients, and patients with kidney disease,
• blurred vision,
• hair loss,
• vasculitis (manifested by pain and swelling of the legs, redness and increased skin temperature),
• breast enlargement in men (gynecomastia),
• lactation,
• transient impotence in men,
• joint and muscle pain,
• acute kidney inflammation.

Frequency not known:

• shortness of breath.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your 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 gather more information on the safety of the medicine.

5. How to store Ranigast Fast

Keep the medicine out of sight and reach of children.
Store in a temperature below 25°C. Keep the tube tightly closed.
Do not use this medicine after the expiry date stated on the carton and tube. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ranigast Fast contains

• The active substance of the medicine is ranitidine in the form of ranitidine hydrochloride. Each effervescent tablet contains 150 mg of ranitidine.
• Other ingredients are: sodium bicarbonate, anhydrous citric acid, sorbitol, aspartame, sodium saccharin, macrogol 6000, orange flavor.

What Ranigast Fast looks like and what the pack contains

Ranigast Fast is a round, almost white or slightly yellow effervescent tablet, with small yellow dots;
with a slightly rough surface, with obliquely cut edges.
The packaging of the medicine consists of a polypropylene tube closed with a polyethylene plug, equipped with a moisture absorber (silicon gel), placed in a cardboard box with a leaflet.
The packaging contains 10 effervescent tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Pharmaceutical Works POLPHARMA SA
Pelplińska 19
83-200 Starogard Gdański

Manufacturer

NP Pharma Sp. z o.o.
Podstoczysko 30
07-300 Ostrów Mazowiecka
To obtain more detailed information, please contact the representative of the marketing authorization holder:
POLPHARMA Sales Office Sp. z o.o.
Bobrowiecka 6
00-728 Warsaw
phone 22 364 61 01

Date of last revision of the leaflet: