Ranitidine aurovitas

Package leaflet: Information for the patient

Ranitydyna Aurovitas, 150 mg, coated tablets
Ranitidinum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are identical.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Ranitydyna Aurovitas is and what it is used for

What is Ranitydyna Aurovitas?
Ranitydyna Aurovitas belongs to a group of medicines called histamine H₂-receptor antagonists.
It reduces the amount of stomach acid produced, preventing heartburn and acid regurgitation.
However, it maintains sufficient stomach acid levels for normal digestion.

Uses
Ranitydyna Aurovitas is used in adults and children aged 3 to 18 years for:

• Mild gastritis.
• Inflammation of the intestine (duodenum) or stomach ulcers (regardless of whether they are caused by long-term use of non-steroidal anti-inflammatory drugs, also known as NSAIDs, commonly used in the treatment of joint inflammation).
• Prevention of recurrence of stomach ulcers.
• Gastro-oesophageal reflux disease (oesophagitis due to backflow of stomach contents).
• Zollinger-Ellison syndrome (a condition in which the stomach produces excessive amounts of acid).
• Treatment of symptoms such as heartburn and acid regurgitation, which may cause pain or discomfort.

If the above conditions do not improve or worsen, you should contact your doctor.

2. Important information before using Ranitydyna Aurovitas

When not to use Ranitydyna Aurovitas

• If the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If the patient has any doubts, they should consult a doctor or pharmacist before using Ranitydyna Aurovitas.

Warnings and precautions
Before starting treatment with Ranitydyna Aurovitas, the patient should discuss it with a doctor or pharmacist.

• If the patient has impaired kidney function, the doctor may reduce the dose.
• If the patient has ever had an acute attack of porphyria (a metabolic disorder characterized, among other things, by skin disorders).
• If the patient is over 50 years of age.
• If the patient is on a low-sodium or salt-free diet.
• If the patient has previously experienced an increased risk of bleeding or if the patient is taking medicines that increase the risk of bleeding (painkillers and anti-inflammatory drugs, also known as non-steroidal anti-inflammatory drugs or NSAIDs, such as acetylsalicylic acid, ibuprofen, celecoxib, etodolac, diclofenac, meloxicam).
• If the patient has recently experienced sudden weight loss. Stomach cancer may sometimes cause the same symptoms as those for which this medicine is indicated. These symptoms may initially improve during treatment with this medicine. However, use of this product does not cure stomach cancer.
• If the patient has diabetes, lung disease, heart failure, or weakened immunity. The patient may have an increased risk of developing pneumonia.

Ranitydyna Aurovitas and other medicines
The patient should inform the doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may affect how Ranitydyna Aurovitas works or may increase the risk of adverse effects. Ranitydyna Aurovitas may also affect the way other medicines work, including:

• Procainamide or N-acetylprocainamide (a medicine used in the treatment of heart diseases)
• Warfarin (an anticoagulant medicine)
• Medicines used to treat pain and inflammatory conditions (non-steroidal anti-inflammatory drugs - NSAIDs)
• Triazolam (a medicine for insomnia)
• Midazolam (a sedative medicine)
• Glipizide (a medicine that lowers blood sugar levels)
• Ketoconazole (an antifungal medicine)
• Atazanavir or delavirdine (medicines used in the treatment of HIV infection)
• Gefitinib (a medicine for lung cancer)
• Medicines that neutralize gastric acid and sucralfate (another medicine used to treat disorders such as stomach and intestinal ulcers). Concomitant use of these medicines may reduce the absorption of ranitidine into the bloodstream (making it less effective). Therefore, these medicines should be taken approximately 2 hours after taking ranitidine.
• If the patient is taking erlotinib, a medicine used to treat certain types of cancer, they should talk to their doctor before taking Ranitydyna Aurovitas. The ranitidine contained in Ranitydyna Aurovitas may reduce the amount of erlotinib in the blood, which may require the doctor to adjust the therapeutic dose if erlotinib is being used concurrently.

The patient should contact their doctor or pharmacist if they are using any of the medicines listed above.
Ranitydyna Aurovitas with food and drink
Ranitydyna Aurovitas can be taken with or without food.
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.
Ranitydyna Aurovitas should not be used during pregnancy or breastfeeding without prior consultation with a doctor. This is because the active substance of the medicine (ranitidine) crosses the placenta and is also excreted in human milk.
Before taking any medicine, the patient should discuss it with a doctor or pharmacist. The doctor will weigh the benefits and risks to both mother and child associated with the use of Ranitydyna Aurovitas.
Driving and operating machinery
There is no data available on the effect of Ranitydyna Aurovitas on the ability to drive motor vehicles and operate machinery. If side effects such as disorientation, visual disturbances, hallucinations, or movement disorders occur, these abilities may be impaired.

3. How to use Ranitydyna Aurovitas

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
It is not necessary to take Ranitydyna Aurovitas with food.
The usual dose for adults is 300 mg per day, taken as:

• 1 tablet of Ranitydyna Aurovitas 300 mg once daily, in the evening before bedtime.
• 1 tablet of Ranitydyna Aurovitas 150 mg twice daily, one tablet in the morning and one in the evening, with approximately 12 hours between doses.
• The doctor will determine the exact dose appropriate for the patient based on their symptoms.
• If symptoms of oesophagitis do not improve, the doctor may recommend a dose of 2 tablets of 300 mg or 4 tablets of 150 mg per day for up to eight weeks.
• In some patients (such as those with Zollinger-Ellison syndrome associated with excessive gastric acid secretion), the usual dose is 3 tablets of 150 mg per day. This dose may be increased to 600–900 mg per day.
• For the treatment of gastric ulcers caused by long-term use of non-steroidal anti-inflammatory drugs (NSAIDs), the usual dose is 1 tablet of Ranitydyna Aurovitas 150 mg twice daily for up to 12 weeks.
• If the patient has impaired kidney function, the doctor may reduce the dose of Ranitydyna Aurovitas.
• Tablets should not be crushed or chewed. Swallow the tablet whole.

Use in children and adolescents under 18 years of age

• For children aged 12 years and older, the usual dose is similar to that for adults.
• This medicine is not suitable for children aged 3–11 years, as the tablet cannot be divided to adjust the dose according to body weight, nor can it be crushed to facilitate swallowing. Other appropriate medicines may be available for children aged 3–11 years.

Peptic ulcer disease treatment
The usual dose in children is 2 mg/kg body weight/day, given in two divided doses, for four weeks. Each dose should be taken at least 12 hours apart from the previous dose. Alternatively, the dose may be increased to 4 mg/kg body weight/day, in two divided doses, taken approximately 12 hours apart. Treatment may also be extended up to eight weeks.
Oesophagitis, heartburn, and (or) gastric content regurgitation treatment
The usual dose is 2.5 mg/kg body weight/day, given in two divided doses for two weeks, each dose taken approximately 12 hours apart. The dose may be increased to 5 mg/kg body weight/day, in two divided doses, taken approximately 12 hours apart.

Taking more Ranitydyna Aurovitas than prescribed
If a patient takes more Ranitydyna Aurovitas than prescribed, they should contact a doctor or pharmacist immediately. If possible, the patient should show the medicine packaging. Overdose may cause side effects listed in section 4, "Possible side effects". In addition, in adult patients, overdose may cause drowsiness and nausea. In children, overdose may cause vomiting, irritability, and insomnia.

If you forget to take Ranitydyna Aurovitas
If a dose is missed, take it as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. Do not take a double dose to make up for a missed dose.

Stopping Ranitydyna Aurovitas
It is important to continue taking Ranitydyna Aurovitas until the doctor determines that treatment can be stopped, even if the patient feels better. If treatment is not completed as directed by the doctor, it may be ineffective and symptoms may return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects in children may be similar to those observed in adults.

Allergic reactions: These occur rarely in patients taking Ranitydyna Aurovitas. Symptoms may include:

• Skin rash with intense itching and hives
• Facial and oral cavity swelling (angioedema)
• Chest pain, shortness of breath, unexplained fever, wheezing or breathing difficulties
• Feeling faint, especially when standing up
• Fainting

If any of the above symptoms occur, immediately inform your doctor or pharmacist and discontinue treatment with Ranitydyna Aurovitas without delay.

Severe skin reactions: These occur very rarely in patients taking Ranitydyna Aurovitas. Symptoms include:

• Skin rash which may lead to blistering and may appear as small spots (central dark spots surrounded by a lighter area, with a dark ring around the edge). If any of these symptoms occur, immediately inform your doctor or pharmacist and discontinue treatment with Ranitydyna Aurovitas without delay.

Adverse effects occurring not very commonly (may affect up to 1 in 100 people):

• Abdominal pain
• Constipation
• Nausea

Adverse effects occurring rarely (may affect up to 1 in 1,000 people):

• Allergic reactions
• Rash

Rare adverse effects that may appear in blood test results:

• Changes in liver function tests
• Increased plasma creatinine concentration (relating to kidney function tests)

Adverse effects occurring very rarely (may affect up to 1 in 10,000 people):

• Confusion or depression, or seeing or hearing things that are not there (hallucinations)
• Headache, dizziness
• Uncontrolled movements
• Blurred vision
• Slow or irregular heartbeat (bradycardia)
• Certain types of disturbances in the conduction of electrical impulses in the heart, leading to heart rhythm disorders (atrioventricular block)
• Increased heart rate (tachycardia)
• Inflammation of blood vessels (vasculitis)
• Pancreatitis
• Diarrhea
• Hepatitis, sometimes with yellowing of the whites of the eyes or yellowing of the skin (jaundice)
• Rash with irregular red patches (erythema multiforme)
• Unexpected hair loss or hair thinning (alopecia)
• Joint or muscle pain
• Kidney inflammation (interstitial nephritis)
• Inability to achieve or maintain an erection (impotence)
• Galactorrhea
• Breast tenderness and/or breast enlargement in men (gynecomastia)

Very rare adverse effects that may appear in blood test results:

• Decrease in white blood cells (leukopenia)
• Reduced number of platelets (blood cells that help blood to clot) (thrombocytopenia)
• Decrease in the amount of certain types of blood cells

Adverse effects occurring with unknown frequency (frequency cannot be estimated from available data):

• Shortness of breath

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 4921301, fax: +48 22 4921309, e-mail: [email protected].
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Ranitydyna Aurovitas

Keep this medicine out of sight and reach of children.
No special storage instructions apply.
Do not use this medicine after the expiry date stated on the carton and blister pack following 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. This will help protect the environment.

6. Contents of the package and other information

What Ranitydyna Aurovitas contains

• The active substance is ranitidine. Each coated tablet contains 150 mg of ranitidine (as hydrochloride).
• Other ingredients are: Tablet core: microcrystalline cellulose (E 460), sodium croscarmellose (E 468), magnesium stearate (E 470b). Tablet coating: hypromellose (5 cp), titanium dioxide (E 171), triacetin.

What Ranitydyna Aurovitas looks like and contents of the pack
Coated tablet.
White to almost white, round coated tablets, embossed with the code ‘K’ on one side and ‘150’ on the other.
Ranitydyna Aurovitas coated tablets are available in blisters made of PA/Al/PVC/Al.
Pack sizes: 10, 20, 28, 30 or 60 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
Poland
Manufacturer/Importer:
Milpharm Limited
Ares Block, Odyssey Business Park, West End Road,
Ruislip HA4 6QD, United Kingdom
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate
Hal Far, Birzebbugia, BBG 3000
Malta
This medicinal product is authorised in the European Economic Area under the following names:
Czech Republic: Ranitidine Aurovitas
Italy: Ranitidina Aurobindo Italia
Netherlands: Ranitidine Aurobindo 150 mg/ 300 mg, filmomhulde tabletten
Poland: Ranitydyna Aurovitas
Spain: Ranitidina Aurovitas 150 mg/ 300 mg comprimidos recubiertos con película EFG