Ranisan 75 mg

Package leaflet: Information for the user

RANISAN 75 mg
( Ranitidine hydrochloride )
75 mg coated tablets
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the
physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible side effects not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 5 days, or if the patient feels worse, consult a doctor.

Contents of the leaflet:

1. What RANISAN 75 mg is and what it is used for
2. Important information before taking RANISAN 75 mg
3. How to take RANISAN 75 mg
4. Possible side effects
5. How to store RANISAN 75 mg
6. Contents of the pack and other information

1. What RANISAN 75 mg is and what it is used for

RANISAN contains ranitidine, a specific, rapidly-acting histamine H₂-receptor antagonist. It inhibits both basal and postprandial secretion of hydrochloric acid and reduces pepsin secretion in gastric juice.
The medicine is indicated for symptomatic treatment of heartburn and indigestion (dyspepsia) not associated with gastrointestinal disease in adults and adolescents aged above 16 years.

2. Important information before taking RANISAN 75 mg

When not to take RANISAN 75 mg:

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• in children and adolescents under 16 years of age.

Warnings and precautions
Before starting treatment with RANISAN 75 mg, discuss this with your doctor or pharmacist.
Treatment with an H(_2)-receptor antagonist may mask symptoms associated with stomach cancer and thus delay diagnosis of this disease. Therefore, in patients with gastric ulcer or when the indication relates to dyspeptic symptoms, malignancy must always be ruled out before initiating ranitidine therapy (this particularly applies to middle-aged and elderly individuals, or patients in whom new symptoms have appeared or the nature of existing symptoms has changed).
Ranitidine is excreted by the kidneys, and therefore in patients with impaired renal function, plasma concentrations of the drug are increased. In such patients, the drug should be dosed individually depending on the degree of renal impairment (see also Dosage in renal impairment).
Patients receiving nonsteroidal anti-inflammatory drugs (NSAIDs) concomitantly with ranitidine should be monitored regularly. This especially applies to elderly patients and those with a history of peptic ulcer disease.
There have been rare reports suggesting that ranitidine may trigger acute attacks of porphyria.
Therefore, the use of this medicine should be avoided in patients with a history of acute porphyria.
Smoking promotes recurrence of duodenal ulcer disease; therefore, patients are advised to stop smoking.
An increased risk of community-acquired pneumonia has been observed in certain patient groups receiving ranitidine, such as elderly individuals, patients with diabetes, chronic lung disease, or immunodeficiency.

RANISAN 75 mg and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.
Ranitidine may affect the absorption, metabolism, and renal excretion of certain other medicines. Therefore, dosage adjustments or discontinuation of treatment may be required. This may apply to the following medicines:

• nonsteroidal anti-inflammatory drugs (pain-relieving and anti-inflammatory medicines),
• coumarin derivatives, e.g. warfarin (anticoagulants),
• triazolam, midazolam (sedatives, hypnotics),
• ketoconazole (antifungal medicine),
• atazanavir and delavirdine (medicines used in the treatment of HIV infection),
• gefitinib (medicine used in oncology),
• glipizide (antidiabetic medicine),
• in the case of high-dose ranitidine, also procainamide and N-acetylprocainamide (medicines used in cardiac arrhythmias).

Other medicines and RANISAN 75 mg
If you are taking a medicine containing erlotinib, used to treat certain types of cancer, talk to your doctor before using RANISAN 75 mg. Ranitidine contained in RANISAN 75 mg may reduce the amount of erlotinib in the blood. Therefore, when erlotinib is administered concomitantly, your doctor may adjust treatment accordingly.
No interactions have been observed between ranitidine and amoxicillin or metronidazole.
If high doses of sucralfate (2 g) are administered simultaneously with RANISAN 75 mg, the absorption of ranitidine may be reduced. Therefore, sucralfate should be taken at least two hours after ranitidine.
Inform your doctor about all medicines currently taken or recently taken, including those available without a prescription.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
This medicine may be used during pregnancy only if clearly necessary.
Ranitidine passes into breast milk; therefore, it should be administered during breastfeeding only if clearly necessary.
There is no data available on the effect of ranitidine on fertility in humans. Studies conducted in animals have not shown any effect on fertility in either sex.

Driving and using machines
If adverse effects such as dizziness or blurred vision occur, psycho-physical performance may be impaired.

3. How to take RANISAN 75 mg

This medicine should always be taken exactly as described in the patient leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
The medicine should be taken orally. Tablets should be swallowed whole with water.
Adults and children over 16 years of age:
1 film-coated tablet of 75 mg per day. If symptoms persist for more than one hour after taking the medicine, a second tablet may be taken (maximum daily dose is 2 tablets).
Do not use this medicine for longer than 5 days without medical advice.
If symptoms persist for 14 days or worsen, the diagnosis should be reviewed.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Taking more RANISAN 75 mg than recommended
In case of ranitidine overdose, symptomatic and supportive treatment is indicated.
If you have taken more medicine than recommended, seek immediate advice from your doctor or pharmacist.
Missing a dose of RANISAN 75 mg
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Below is a list of adverse reactions observed in people treated with ranitidine. In many
cases, there was no definite causal relationship with the use of ranitidine.

• Allergic reactions, the symptoms of which may include:
• skin rash (urticaria) or redness,
• swelling, mainly of the face, lips, tongue or throat (angioedema),
• worsening of wheezing, cough or difficulty breathing, chest pain,
• sudden feeling of weakness or dizziness (which may lead to falling or loss of consciousness).
• Kidney problems, which may manifest as back pain, fever, pain during urination, abnormal blood and urine test results (acute interstitial nephritis).
• Severe abdominal pain, which may indicate pancreatitis.
• Slow or irregular heartbeat.

If any of the above symptoms occur, contact a doctor immediately.
Discontinue use of RANISAN 75 mg.

Adverse reaction occurring not very often (means occurring in fewer than 1 in 100
patients, but more frequently than in 1 in 1,000 patients taking the medicine):

• Abdominal pain.
• Constipation.
• Nausea. These symptoms usually resolve during continued treatment.

Adverse reaction occurring rarely (means occurring in fewer than 1 in 1,000
patients, but more frequently than in 1 in 10,000 patients taking the medicine):

• Skin rash.

Rare adverse effects that may appear in blood test results:

• Increased plasma creatinine concentration (usually slight; returns to normal during continued therapy).
• Transient changes in liver enzyme activity.

Adverse reaction occurring very rarely (means occurring in fewer than 1 in 10,000
patients taking the medicine):

• Usually transient changes in blood cell counts. The patient may experience fatigue, shortness of breath, increased susceptibility to infections, or easier bruising.
• Transient states of confusion, depression, and hallucinations, mainly in seriously ill patients, elderly patients, and patients with nephropathy (kidney disease).
• Headache, sometimes severe, dizziness, joint and muscle pain, transient involuntary movements.
• Transient blurred vision, probably due to accommodation disorder.
• Rapid heartbeat.
• Vasculitis.
• Diarrhea.
• Usually transient hepatitis, with or without jaundice.
• Erythema multiforme, alopecia.
• Transient impotence, symptoms and conditions affecting the breasts in men (such as gynecomastia and galactorrhea).

Adverse reaction occurring with unknown frequency (means frequency cannot be
determined from available data):

• Dyspnea (shortness of breath).

If any adverse reaction worsens or if any adverse reactions not listed in this leaflet occur, inform a doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. 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 Warsaw,
tel.: 22 49-21-301,
fax: 22 49-21-309,
e-mail: [email protected].
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store RANISAN 75 mg

Keep this medicine out of the sight and reach of children.
No special precautions regarding storage temperature are required.
Store in a dry place. Protect from light.
Do not use this medicine after the expiry date stated on the carton after: Expiry (EXP). 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. These measures will help protect the environment.

6. Contents of the packaging and other information

What Ranisan 75 mg contains

• The active substance is ranitidine in the form of ranitidine hydrochloride.
• The other ingredients are: microcrystalline cellulose, maize starch, copovidone, povidone 25, magnesium stearate.
  Coating composition: hypromellose 5, hypromellose 15, titanium dioxide, yellow iron oxide, red iron oxide, dimethicone emulsion with colloidal titanium dioxide, magnesium stearate, macrogol 6000.

What Ranisan 75 mg looks like and contents of the pack
Ranisan 75 mg is a pale pink, film-coated, biconvex tablet with a diameter of 7 mm.
Film-coated tablets Ranisan 75 mg are packed in aluminium/aluminium blisters, 1 blister containing 10 tablets per cardboard box.

Marketing Authorisation Holder and Manufacturer:
PRO.MED.CS. Praha a.s
Telčská 1
140 00 Praha 4
Czech Republic

For further information, please contact the local representative of the Marketing Authorisation Holder.