Ranisan 75 mg

Package Leaflet: Information for the Patient

RANISAN 75 mg

(Ranitidine Hydrochloride)

75 mg Film-Coated Tablets

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 your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 5 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet:

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

RANISAN contains ranitidine, which is a specific, fast-acting histamine H-receptor antagonist. It inhibits both basal and postprandial secretion of hydrochloric acid and reduces the secretion of pepsin in gastric juice.
The medicine is used for symptomatic treatment of heartburn and indigestion (dyspepsia) not associated with gastrointestinal disease in adults and adolescents over 16 years of age.

2. Important information before taking RANISAN 75 mg

When not to take RANISAN 75 mg:

• if you are allergic to the active substance or 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 to take RANISAN 75 mg, discuss it with your doctor or pharmacist.
Treatment with H-receptor antagonists may mask symptoms associated with gastric cancer and thus delay diagnosis of the disease. Therefore, in patients with gastric ulcers and if the indication is related to dyspeptic symptoms, it is necessary to exclude the malignant nature of the disease (especially in middle-aged and elderly patients, or patients who have developed new symptoms or a change in symptom characteristics) before starting treatment with ranitidine.
Ranitidine is excreted by the kidneys, and therefore, in patients with impaired renal function, the plasma concentration of the medicine is increased. In these patients, the medicine should be dosed individually, depending on the degree of renal impairment (see also Dosage in renal impairment).
Patients treated with non-steroidal anti-inflammatory drugs and ranitidine should be regularly monitored. This applies especially to elderly patients and patients with a history of peptic ulcer disease.
There are rare reports suggesting that ranitidine may cause acute attacks of porphyria.
Therefore, the medicine should be avoided in patients with a history of acute porphyria.
Smoking promotes recurrence of duodenal ulcer disease, so patients are advised to quit smoking.
It has been found that in certain patient groups taking ranitidine, such as the elderly, patients with diabetes or chronic pulmonary disease, or patients with impaired immunity, there may be an increased risk of developing community-acquired pneumonia.

RANISAN 75 mg and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have 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, it may be necessary to modify their doses or discontinue treatment. This may apply to the following medicines:

• non-steroidal anti-inflammatory drugs (pain-relieving and anti-inflammatory medicines),
• warfarin (anticoagulant medicines),
• triazolam, midazolam (sedative and hypnotic medicines),
• ketoconazole (antifungal medicine),
• atazanavir and delavirdine (medicines used to treat HIV infection),
• gefitinib (oncology medicine),
• glipizide (antidiabetic medicine),
• in the case of high doses of ranitidine, also procainamide and N-acetylprocainamide (medicines used to treat arrhythmias).

Other medicines and RANISAN 75 mg

In the case of taking a medicine containing erlotinib, used to treat certain types of cancer, you should discuss it with your doctor before taking RANISAN 75 mg. Ranitidine contained in RANISAN 75 mg may decrease the amount of erlotinib in the blood. Therefore, in the case of concomitant administration of erlotinib, your doctor may adjust the treatment accordingly.
No interactions have been found between ranitidine and amoxicillin or metronidazole.
If large doses of sucralfate (2 g) are administered concomitantly with RANISAN 75 mg, the absorption of ranitidine may be reduced. Therefore, sucralfate should be taken at least 2 hours after ranitidine.
Tell your doctor about all medicines you are currently taking or have recently taken, including those that are available without a prescription.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
The medicine may be used during pregnancy only if necessary.
Ranitidine passes into breast milk, so it may be administered during breastfeeding only if necessary.
There are no data on the effect of ranitidine on human fertility. In animal studies, no effect on fertility of either sex was found.

Driving and using machines

If you experience side effects such as dizziness or blurred vision, your ability to drive or operate machinery may be impaired.

3. How to take RANISAN 75 mg

This medicine should always be taken exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.
The recommended dose is:
Take the medicine orally. Swallow the tablets whole with water.
Adults and children over 16 years:
1 film-coated tablet of 75 mg per day. If symptoms persist for more than 1 hour after taking the medicine, you can take another tablet (the maximum daily dose is 2 tablets).
Do not take the medicine for more than 5 days without consulting your doctor.
If symptoms persist for 14 days or worsen, you should verify the diagnosis.
If you feel that the effect of the medicine is too strong or too weak, you should consult your doctor.

Taking more than the recommended dose of RANISAN 75 mg

In case of ranitidine overdose, symptomatic and supportive treatment is recommended.
If you have taken more than the recommended dose of the medicine, you should immediately consult 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, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported in patients taking ranitidine:

• Allergic reactions, which may include:
• skin rash (hives) or redness,
• swelling, mainly of the face, lips, tongue, or throat (angioedema),
• wheezing, coughing, or difficulty breathing, chest pain,
• sudden feeling of weakness or dizziness (which may lead to falls or loss of consciousness).
• Kidney problems, which may include:
• back pain, fever, pain when urinating, abnormal blood or urine test results (acute interstitial nephritis).
• Severe stomach pain, which may be a sign of pancreatitis.
• Slow or irregular heartbeat.

You should immediately contact your doctor if you experience any of the above symptoms. Stop taking RANISAN 75 mg.
Uncommon side effects(affecting less than 1 in 100 patients, but more than 1 in 1,000 patients taking the medicine):

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

Rare side effects(affecting less than 1 in 1,000 patients, but more than 1 in 10,000 patients taking the medicine):

• Skin rash.

Rare side effects that may appear in blood test results:

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

Very rare side effects(affecting less than 1 in 10,000 patients taking the medicine):

• Usually transient changes in blood cell counts. You may feel tired, short of breath, be more prone to infections, or bruise more easily.
• Transient 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.
• Accelerated heartbeat.
• Vasculitis.
• Diarrhea.
• Usually transient hepatitis with or without jaundice.
• Exfoliative dermatitis, alopecia.
• Transient impotence, breast symptoms in men (such as gynecomastia and galactorrhea).

Side effects with unknown frequency(the frequency cannot be estimated from the available data):

• Dyspnea.

If any of the side effects get worse or if you notice any side effects not listed in this leaflet, you should tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. 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: 22 49-21-301,
fax: 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 this medicine.

5. How to store RANISAN 75 mg

Keep the medicine out of the sight and reach of children.
There are no special precautions for storage temperature.
Store in a dry place. Protect from light.
Do not use this medicine after the expiry date stated on the carton after EXP. 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 RANISAN 75 mg contains

• The active substance is ranitidine in the form of ranitidine hydrochloride.
• The other ingredients are: microcrystalline cellulose, corn starch, copovidone, povidone 25, magnesium stearate. The coating contains: 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 available in the form of light pink film-coated tablets, lens-shaped, 7 mm in diameter.
RANISAN 75 mg film-coated tablets are packaged in aluminum/aluminum blisters, 1 blister of 10 tablets in a cardboard box.

Marketing authorization holder and manufacturer:

PRO.MED.CS. Praha a.s
Telćská 1
140 00 Praha 4
Czech Republic
For more detailed information, please contact your local representative of the marketing authorization holder.

Date of last revision of the leaflet: