FAMOTIDINE ALKALOID 20mg x 20 tabl
FAMOTIDINE tablets 40 mg. * 10 ALKALOID
Leaflet: Patient information
FAMOTIDINE ALKALOID® 40 mg film-coated tablets
(famotidipine)
FAMOTIDINE ALKALOID® 40 mg film-coated tablets
(famotidine)
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Don't leave it to other people. It can harm them even though the signs of their illness are the same as yours.
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. See point 4.
What this leaflet contains:
1. What Famotidine Alkaloid is and what it is used for
2. What you need to know before you take Famotidine Alkaloid
3. How to take Famotidine Alkaloid
4. Possible side effects
5. How to store Famotidine Alkaloid
6. Contents of the package and additional information
1. What Famotidine Alkaloid is and what it is used for
Famotidine Alkaloid (famotidine) belongs to a group of drugs called H2-blockers, which work by reducing the amount of acid produced in the stomach and thus help to improve the condition.
Your doctor has prescribed Famotidine Alkaloid to work on the acid state of your stomach. The amount of acid in your stomach can cause:
- development of a stomach or duodenal ulcer (the upper part of the small intestine, starting after the stomach);
- gastro-oesophageal reflux - a condition caused by the return of gastric juice and food back from the stomach (reflux) into the esophagus (oesophagus).
Your doctor may have prescribed Famotidine Alkaloid to treat a rare condition called Zollinger-EHison syndrome, in which the stomach produces too much acid.
Famotidine helps reduce the amount of acid produced in the stomach, helps ulcers heal and relieves symptoms. Famotidine is also used to reduce the likelihood of duodenal ulcer recurrence and gastroesophageal reflux symptoms.
2. What you need to know before you take Famotidine Alkaloid
Do not take Famotidine Alkaloid
if you are allergic to famotidine or any of the excipients of this medicine (listed in section 6).
if you are allergic to other medicines of this group, such as ranitidine, cimetidine
Warnings and precautions
Talk to your doctor or pharmacist before taking Famotidine Alkaloid
if you feel pain when swallowing or have a feeling of food stuck in the throat.
if you have kidney problems;
if you have liver problems;
if you have other stomach problems (eg tumors);
if you have problems with your immune system.
Your doctor may decide that you need further tests.
Your doctor will tell you not to stop treatment suddenly if your ulcer has been there for a long time and after treatment the symptoms have gone away. In case of long-term treatment with high doses, the doctor will prescribe a blood count and liver function test.
Children
The efficacy and safety of famotidine in children have not been established.
Other medicines and Famotidine Alkaloid
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Caution is required if atazanavir is taken together with famotidine due to the occurrence of a reduced concentration of atazanavir, which may lead to loss of therapeutic effect and development of resistance. Ketoconazole and itraconazole (used to treat infections caused by fungi) and probenecid (used to treat gout) may affect or be affected by treatment with Famotidine Alkaloid. Therefore, the physician should be informed about the use of this concomitant medication. If ketoconazole intake is necessary, the difference between the two intakes should be at least 2 hours.
If you are taking antacids (used to reduce stomach acid) you should wait 1-2 hours after taking Famotidine Alkaloid and if you are taking sucralfate (used to treat an ulcer) you should wait 2 hours before or after taking Famotidine Alkaloid.
Calcium carbonate when used as a medicine to control high levels of phosphate in the blood (hyperphosphatemia) in patients on dialysis.
Famotidine Alkaloid with food, drink and alcohol
Lifestyle changes to reduce stress, stop smoking, limit alcohol intake, and make dietary changes (eg, avoiding caffeine and certain spices) may increase the effectiveness of this medication.
With simultaneous use with alcohol, famotidine does not change the concentration of alcohol in the blood.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Famotidine is not recommended for use during pregnancy. Famotidine passes into breast milk. Treatment with this product is not recommended during breastfeeding.
Driving and using machines
Adverse drug reactions such as dizziness and headache have been observed in some patients while taking famotidine. Do not drive or operate machinery until you are sure how the medicine works for you and if you have any of these symptoms (see section 4. Possible side effects).
Famotidine Alkaloid contains lactose.
If your doctor has told you that you have an intolerance to some sugars, consult him before taking this product.
3. How to take Famotidine Alkaloid
Always take Famotidine Alkaloid exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Famotidine Alkaloid is taken by mouth, usually in the evening before going to bed.
For the treatment of duodenal ulcer: The recommended dose is one tablet (40 mg) taken with a little water, in the evening before going to bed, for 4 to 8 weeks.
For the treatment of benign active gastric ulcer: one tablet (40 mg) in the evening at bedtime for 4 to 8 weeks.
To reduce the likelihood of duodenal ulcer recurrence: The recommended dose is half a tablet (20 mg) in the evening before going to bed to prevent ulcer recurrence.
To treat conditions in which the stomach produces an excessive amount of acid - Zollinger-Ellison syndrome:
Your doctor may recommend that you take half a tablet (20 mg) every six hours (80 mg daily). Some patients require higher doses to control the condition. Your doctor will assess the need for a higher dose.
To treat gastro-oesophageal reflux, a condition caused by stomach juice and food coming back up from the stomach (reflux) into the gullet (oesophagus):
For the treatment of gastro-oesophageal reflux: half a tablet (20 mg) in the morning and half a tablet (20 mg) in the evening before going to bed, for 6-12 weeks.
For the treatment of severe symptoms (associated with the presence of erosions or ulcerations of the esophagus): one tablet (40 mg) in the morning and one tablet (40 mg) at bedtime, for 6 to 12 weeks.
To reduce the likelihood of recurrence of symptoms: half a tablet (20 mg) in the morning and half a tablet (20 mg) in the evening before going to bed.
Use in children
Famotidine Alkaloid should not be prescribed to children.
The tablet can be divided into equal doses.
If you have taken more Famotidine Alkaloid than you should
If you have accidentally taken too many tablets at once or if a child has swallowed tablets, contact your doctor immediately.
If you forget to take Famotdine Alkaloid
If you miss a dose, take it as soon as you notice the missed dose. If it is almost time for the next dose, skip the missed dose and continue with the prescribed regimen. Do not take a double dose to make up for a missed dose.
If you have any further questions related to 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.
Common side effects (may affect up to 1 in 10 people): headache, dizziness, constipation, diarrhoea;
Uncommon side effects (may affect up to 1 in 100 people): nausea, vomiting, dry mouth, change in taste, abdominal discomfort or flatulence, loss of appetite, feeling tired, rash, itching, hives.
Very rare side effects (may affect up to 1 in 10,000 people):
Effect on blood cell counts and liver enzymes, jaundice, hepatitis, hypersensitivity reactions such as oedema, spasms of the muscles of the airways (bronchospasm), allergic shock, joint pain, muscle spasms, hair loss, seizures (which may mimic epileptic seizures) , fatigue, drowsiness, sensory disturbances, inflammation of the lungs, chest tightness, reversible mental disorders such as depression, agitation, restlessness, disorientation, confusion and hallucinations, insomnia, severe skin problems, decreased sexual desire, impotence. AV-block with intravenously administered H2-receptor antagonists, prolonged QT interval, especially in patients with impaired renal function.
Adverse drug reactions not definitely attributable to famotidine: Male breast enlargement has been reported rarely.
Reporting adverse reactions
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all possible side effects not listed in this leaflet. You can also report side effects directly by:
Executive Medicines Agency
8 Damyan Gruev St
1303 Sofia
Phone: +35 928903417
website: www.bda.bg
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Famotidine Alkaloid
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date corresponds to the last day of the specified month.
Do not dispose of medicines down the drain or in the household waste container.
Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What Famotidine Alkaloid contains
The active substance is famotidine;
Each film-coated tablet contains 40 mg of famotidine.
The other ingredients are: corn starch; magnesium stearate; lactose monohydrate; cellulose, microcrystalline; silica, colloidal anhydrous; hypromellose; macrogol 4000; titanium dioxide E 171; iron oxide red E 172.
What Famotidine Alkaloid looks like and contents of the pack
The tablets are round, biconvex, pink-red film-coated tablets scored on one side.
The tablets are packed in aluminum and PVC-foil blisters. Boxes containing 10 film-coated tablets and a leaflet.
Marketing Authorization Holder and Manufacturer
License holder
ALKALOID EOOD
g.k. "Motopista" 2,
Ticardo Vaccarini St. No. 2, floor 3, apartment 10
Sofia 1404, R. Bulgaria
Manufacturer
ALK ALOID-INT doo
Slandrova ulica 4,
1231 Ljubljana - Sgpibe P. Slovenia
