Ranigast fast

Patient Information Leaflet

Ranigast Fast, 150 mg, effervescent tablets
Ranitidine
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 14 days, or if your condition worsens, consult your doctor.

Table of contents

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

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

• Symptomatic treatment of gastric (dyspeptic) discomfort not associated with organic gastrointestinal disease, such as: heartburn, indigestion, acid dyspepsia.

2. Important information before using Ranigast Fast

When not to use Ranigast Fast:

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

Warnings and precautions
Before starting treatment with Ranigast Fast, discuss this with a doctor or pharmacist.
Treatment with ranitidine may mask symptoms of stomach cancer and thus delay diagnosis of this disease. Therefore, consult a doctor:

• if the patient has not previously experienced gastrointestinal (dyspeptic) symptoms, or if such symptoms have recently changed—particularly in middle-aged or elderly individuals,
• if the patient has dyspeptic symptoms and has recently lost weight.

Patients who have previously experienced acute attacks of porphyria should avoid using this medicine, as ranitidine may trigger an acute attack of porphyria.
Before starting treatment with Ranigast Fast, discuss the following with a doctor:

• if the patient has impaired kidney and/or liver function. In patients with impaired kidney function, the doctor will adjust the dose accordingly, individually for each patient.
• if the patient is taking nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen; particularly relevant for elderly individuals and those with a history of peptic ulcer disease. Ranigast Fast should be used together with NSAIDs only under medical supervision.
• if the patient is taking other medicines, including those available without a prescription.
• if the patient is under continuous medical supervision for other reasons.
• if the patient has diabetes, lung diseases, or immune system disorders.
• if the patient has difficulty swallowing or suffers from chronic abdominal pain.

Children and adolescents
Ranigast Fast must not be used in children and adolescents under 16 years of age.

Ranigast Fast and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Ranigast Fast may affect the rate and extent of absorption of the following medicines:

• ketoconazole (a medicine used to treat fungal infections),
• atazanavir, delavirdine (medicines used in viral infections),
• gefitinib (a medicine used in cancer treatment),
• benzodiazepines such as midazolam, triazolam—used in insomnia,
• glipizide (a medicine used in diabetes treatment),
• procainamide, N-acetylprocainamide (medicines used in cardiac arrhythmias),
• sucralfate (a protective medicine used in peptic ulcer disease).
  Ranigast Fast may enhance the effect of coumarin-derived anticoagulants such as warfarin; therefore, prothrombin time must be closely monitored during concomitant therapy with these medicines.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Ranitidine crosses the placenta; therefore, Ranigast Fast should not be used during pregnancy.
Breastfeeding
Ranitidine passes into breast milk; therefore, Ranigast Fast should not be used during breastfeeding.
There is no data available on the effect of ranitidine on human fertility. Animal studies have shown no effect on fertility in either sex.

Driving and operating machinery
If adverse effects such as dizziness or blurred vision occur, the patient should not drive or operate machinery, as Ranigast Fast may impair psychophysical performance.

The medicine contains sorbitol, sodium, and aspartame

• The medicine contains 820 mg of sorbitol per tablet. Sorbitol is a source of fructose. If the patient has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance—a rare genetic disorder in which the patient's body cannot break down fructose—the patient should consult a doctor before taking this medicine or giving it to a child.
• The medicine contains 211 mg of sodium (the main component of table salt) per tablet. This corresponds to 11% of the maximum recommended daily intake of sodium in the adult diet.
• The medicine contains 20 mg of aspartame per tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria—a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.

3. How to use Ranigast Fast

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Do not use Ranigast Fast for longer than 14 days without consulting a doctor.
If symptoms persist after 14 days of treatment, medical advice should be sought immediately.

Recommended dosage:
Adults and adolescents aged above 16 years:
One tablet (150 mg) once daily.
Maximum: one tablet twice daily.

Patients with renal impairment
Patients with renal impairment 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 used in children and adolescents under 16 years of age.

Method of administration:
Dissolve the tablet in ½ glass of water, wait until it is completely dissolved, and then drink the prepared solution.

Use of a higher than recommended dose of Ranigast Fast
If more than the recommended dose is taken, contact a doctor immediately.

Missed dose of Ranigast Fast
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The frequency of the adverse reactions listed below has been defined 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 1,000 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 contact your doctor or nearest hospital immediately if any of the following serious adverse reactions occur:

• Severe allergic reactions:
• very rare: anaphylactic shock (manifesting as rash, burning and itching of the tongue, palms and soles, severe swelling of the face, lips or throat, difficulty breathing, speaking or swallowing, sudden drop in blood pressure, slow or rapid pulse, paleness, restlessness, sweating, dizziness, loss of consciousness, respiratory arrest and cardiac arrest);
• rare: angioedema (manifesting as sudden swelling of the face, limbs or joints without itching or pain), bronchospasm, low blood pressure, chest pain.
• Severe skin reactions (very rare): rash with swelling, blisters or peeling of the skin, bleeding from the eyes, nose, mouth or genital organs, rapid deterioration of the patient's general condition.
• Other severe reactions (very rare): yellowing of the skin and whites of the eyes (due to liver damage); kidney function disorders manifesting as painful urination, pain in the lower back and fever; acute pancreatitis manifesting as severe pain in the upper and middle part of the abdomen, accompanied by vomiting and high fever.

Other adverse reactions:
Uncommon:

• abdominal pain, constipation, nausea.

Rare:

• transient liver function disorders (abnormal liver function tests, i.e. liver enzymes: AspAT and AlAT, detected in laboratory tests),
• skin rash (itchy red bumps on the skin),
• allergic reactions,
• increased plasma creatinine concentration.

Very rare:

• diarrhoea,
• 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 suppression of blood cell production in the bone marrow,
• slowed heart function, increased heart rate, irregular heartbeat (atrioventricular block),
• headache (sometimes severe),
• dizziness,
• transient tremors, slow, irregular hand movements (so-called involuntary movements),
• agitation,
• disorientation (disturbances in orientation regarding time, place, situation or self),
• depression,
• hallucinations (perception of non-existent objects or people); especially in severely ill patients, elderly patients and patients with kidney disease,
• blurred vision,
• alopecia,
• vasculitis (manifesting as pain and swelling of the legs, redness and increased skin temperature),
• breast enlargement in men (gynecomastia),
• galactorrhea,
• transient impotence in men,
• joint and muscle pain,
• acute inflammation of the kidneys.

Frequency not known:

• shortness of breath.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warszawa
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows the collection of further information on the safety of the medicine.

5. How to store Ranigast Fast

Keep the medicine out of the sight and reach of children.
Store 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 stated month.
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 Ranigast Fast contains

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

What Ranigast Fast looks like and contents of the pack
Ranigast Fast is a round, almost white or slightly yellow effervescent tablet, with small yellow specks;
with slightly rough surface and bevelled edges.
The packaging consists of a polypropylene bottle closed with a polyethylene plug equipped
with a moisture absorber (silica gel), placed in a cardboard box together with the package leaflet.
The pack contains 10 effervescent tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA SA
ul. Pelplińska 19
83-200 Starogard Gdański
Manufacturer
NP Pharma Sp. z o.o.
ul. Podstoczysko 30
07-300 Ostrów Mazowiecka

For further information, please contact the representative of the Marketing Authorisation Holder:
POLPHARMA Biuro Handlowe Sp. z o.o.
ul. Bobrowiecka 6
00-728 Warszawa
tel. 22 364 61 01