Ranimax Teva

Package Leaflet: Information for the User

Ranimax Teva, 150 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 Package Leaflet or as Directed by a Doctor, Pharmacist, or Nurse.

• This Package 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 Undesirable Effects, Including any Possible Undesirable Effects not Listed in the Package Leaflet, the Doctor, Pharmacist, or Nurse Should be Informed. See Section 4.
• If there is no Improvement or the Patient Feels Worse, the Doctor Should be Contacted.

Package Leaflet Contents:

• 1. What is Ranimax Teva and What is it Used for
• 2. Important Information Before Taking Ranimax Teva
• 3. How to Take Ranimax Teva
• 4. Possible Undesirable Effects
• 5. How to Store Ranimax Teva
• 6. Package Contents and Other Information

1. What is Ranimax Teva and What is it Used for

A Medication that Inhibits the Secretion of Hydrochloric Acid in the Stomach. It Causes the Rapid Relief of Symptoms Associated with Excessive Secretion of Hydrochloric Acid: Hyperacidity, Heartburn, and Epigastric Pain. Ranimax Teva is Indicated for the Symptomatic Treatment of Recurring Dyspeptic Symptoms not Associated with Organic Gastrointestinal Disease, such as Heartburn, Hyperacidity, and Epigastric Pain.

2. Important Information Before Taking Ranimax Teva

When Not to Take Ranimax Teva

• If the Patient is Allergic to Ranitidine or any of the Other Ingredients of this Medication,
• If the Patient has a History of Liver Cirrhosis with Portal Hypertension,
• In Children Under 16 Years of Age.

Warnings and Precautions

Care Should be Exercised in Patients:

• Who have not Previously Experienced Dyspeptic Symptoms or have Experienced a Change in Symptoms, as well as those who have Experienced Weight Loss, as Dyspeptic Symptoms may be a Sign of a Serious Gastrointestinal Disease,
• With a History of Gastric or Duodenal Ulcer,
• With Liver or Kidney Failure,
• With Porphyria,
• With Concomitant Diseases Treated with Other Medications.

Sudden Onset of Chest Tightness, Wheezing, Rash, Itching of the Eyes and Face may be a Sign of Allergy to the Medication. Smoking Reduces the Effectiveness of the Medication. Consult a DoctorEven if the Above Warnings Refer to Situations that Occurred in the Past.

Use of Ranimax Teva in Children

Ranimax Teva Should not be Used in Children Under 16 Years of Age.

Ranimax Teva and Other Medications

Inform the Doctor About all Medications Taken Recently, Including those Available Without a Prescription.
The Medication may Cause:

• Reduced Absorption of Ketoconazole (an Antifungal Medication), Atazanavir (an Antiviral Medication Used to Treat HIV), Delavirdine (an Antiviral Medication Used to Treat HIV), Gefitinib, and Erlotinib (a Medication Used to Treat Non-Small Cell Lung Cancer). If the Patient is Taking Erlotinib, a Medication Used to Treat Certain Types of Cancer, the Doctor Should be Informed Before Taking Ranimax Teva. Ranitidine in Ranimax Teva may Decrease Erlotinib Levels in the Blood and May Require Dose Adjustment by the Doctor),
• Other Medications whose Absorption Depends on Gastric Acid Secretion (a Minimum of 2 Hours Should be Allowed Between Administration of these Medications and Ranitidine),
• Increased Absorption of Triazolam (a Benzodiazepine Used to Treat Insomnia), Midazolam (a Psychotropic Medication), and Glipizide, an Antidiabetic Medication.
• Changes in Prothrombin Time During Concomitant Use with Warfarin.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, Thinks they may be Pregnant or are Planning to have a Child, they Should Consult a Doctor or Pharmacist Before Taking this Medication.
Pregnancy
Consult a Doctor Before Taking any Medication
The Medication Should Only be Used During Pregnancy if Clearly Necessary.
Breastfeeding
Consult a Doctor Before Taking any Medication
The Use of Ranimax Teva is not Recommended During Breastfeeding.

Driving and Operating Machinery

The Medication Does not Usually Impair the Ability to Drive or Operate Machinery. However, if Symptoms such as Dizziness, Drowsiness, Confusion, or Blurred Vision Occur, the Patient Should Consult a Doctor Regarding the Ability to Drive During Treatment.

Important Information About Some Ingredients of Ranimax Teva:

The Medication Contains Lactose. If the Patient has been Diagnosed with Intolerance to some Sugars, they Should Consult a Doctor Before Taking the Medication.

3. How to Take Ranimax Teva

Adults and Adolescents Over 16 Years:
In Case of Recurring Dyspeptic Symptoms, 1 Tablet of 150 mg Should be Taken, if Necessary 2 Times a Day.
No More than 2 Tablets of the Medication Should be Taken per Day.
The Medication Should not be Taken Without Consulting a Doctor for More than 2 Weeks. If Symptoms do not Improve After 2 Weeks of Treatment, the Doctor Should be Consulted Immediately.

Overdose of Ranimax Teva

In Case of Overdose, the Doctor or Pharmacist Should be Consulted Immediately.
Overdose of the Medication Causes an Increase in Undesirable Effects Observed During Therapeutic Dose Administration (see Section 4. Possible Undesirable Effects). In Case of Overdose, Symptomatic and Supportive Treatment is Recommended. The Medication can be Removed from the Blood by Hemodialysis.

Missed Dose of Ranimax Teva

In Case of a Missed Dose, the Normal Recommended Dose Should be Taken as Soon as Possible. The Next Dose Should be Taken According to the Previous Doctor's Instructions. A Double Dose Should not be Taken to Make up for a Missed Dose.

4. Possible Undesirable Effects

Like all Medications, Ranimax Teva can Cause Undesirable Effects, Although they may not Occur in Everyone. If any of the Following Symptoms Occur, the Medication Should be Stopped and the Doctor or the Nearest Hospital Should be Notified.
Uncommon (Occurring in 1 to 10 in 1,000 Patients);
Rare (Occurring in 1 to 10 in 10,000 Patients);
Very Rare (Occurring Less Frequently than 1 in 10,000 Patients);
Unknown (Frequency Cannot be Determined from Available Data).
The Most Commonly Observed Undesirable Effects of Ranitidine are:

Uncommon (Occurring in 1 to 10 in 1,000 Patients)

• Abdominal Pain, Constipation, Nausea or Vomiting (these Symptoms Usually Resolved During Treatment);

Rare (Occurring in 1 to 10 in 10,000 Patients)

• Hypersensitivity Reactions (Urticaria, Angioedema, Bronchospasm, Fever, Hypotension, Chest Pain), Transient and Reversible Changes in Liver Enzyme Activity in Diagnostic Tests; Rash; Increased Creatinine Levels in the Blood (usually Mild, these Symptoms Resolved During Treatment).

Very Rare (Occurring Less Frequently than 1 in 10,000 Patients)

• Blood Cell Changes (Leukopenia, Thrombocytopenia). These Changes are Usually Reversible; Agranulocytosis or Pancytopenia, Sometimes with Bone Marrow Damage; Anaphylactic Shock; Reversible Confusion, Depression, and Hallucinations; Headache (Sometimes Severe), Dizziness, and Transient Involuntary Movement Disorders; Reversible Blurred Vision;

Bradycardia, Atrioventricular Block, Tachycardia; Vasculitis; Acute Pancreatitis; Diarrhea, Hepatitis (Liver, Bile Ducts, or Mixed) with or without Jaundice, Usually Reversible; Erythema Multiforme, Alopecia; Acute Interstitial Nephritis; Reversible Impotence, Gynecomastia; Musculoskeletal Symptoms such as Arthritis and Myalgia

Unknown (Frequency Cannot be Determined from Available Data)

• Increased Creatinine and Granulocytopenia; Rash; Reports of Stevens-Johnson Syndrome (this Undesirable Effect has been Reported After a Single Dose); Dyspnea, Taste Disorders, Confusion, Restlessness, Visual and Auditory Hallucinations; Epigastric Pain, Bloating or Belching, Isolated Cases of Transient Hypergastrinemia; Pruritus; Decreased Libido in Men; Upper Respiratory Tract Infections, Common Cold, and Flu-like Symptoms.

Undesirable Effects from the Nervous System are More Severe During High-Dose Administration of the Medication, in Patients Over 65 Years of Age, and in Patients with Chronic Renal and/or Liver Failure.
Reporting Undesirable Effects
If any Undesirable Effects Occur, Including those not Listed in the Package Leaflet, the Doctor or Pharmacist Should be Informed.
Undesirable Effects can be Reported Directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Aleje Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: ndl@urpl.gov.pl.
Reporting Undesirable Effects will Help to Gather More Information on the Safety of the Medication.

5. How to Store Ranimax Teva

The Medication Should be Stored in a Place Inaccessible to Children.
The Medication Should not be Used After the Expiration Date Stated on the Packaging.
Store at a Temperature Below 25°C.
Store in the Original Packaging to Protect from Light and Moisture.

6. Package Contents and Other Information

What Ranimax Teva Contains

One Tablet Contains 150 mg of Ranitidine in the Form of Hydrochloride (Equivalent to 168 mg of Ranitidine Hydrochloride).
Excipients: Corn Starch, Microcrystalline Cellulose, Povidone, Magnesium Stearate, Hypromellose, Titanium Dioxide (E171), Macrogol 6000, Lactose Monohydrate.

What Ranimax Teva Looks Like and What the Package Contains

150 mg Tablets - 1 Package Contains 10, 20, or 30 Tablets.

Marketing Authorization Holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel.: (22) 345 93 00

Manufacturer:

Polfarmex S.A., ul. Józefów 9, 99-300 Kutno
Date of Last Update of the Package Leaflet: