FAMOTIDINE - GENERIC DRUG - PACKAGE LEAFLET - LEAFLETS

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Famotidine - Generic drug - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf Life and Storage

Active ingredients: Famotidine

Famotidine STADA 20 mg film-coated tablets
Famotidine STADA 40 mg film-coated tablets

Why is Famotidine used - Generic drug? What is it for?

Famotidine STADA works by reducing the amount of acid produced by the stomach. It is used to treat some conditions caused by too much acid produced in the stomach. It is a medicine that acts in the gastrointestinal tract and belongs to a group of medicines known as histamine H2 receptor antagonists.

Famotidine EG is used to treat:

symptoms of reflux disease (mild reflux oesophagitis), such as heartburn (Famotidine STADA 20 mg)
mild to moderate "inflammation of the esophagus (digestive tract)" (Famotidine EG 40 mg)
of benign gastric ulcers
of duodenal ulcers
for the prevention of recurrent duodenal ulcers (only with Famotidine EG 20 mg)
treatment of Zollinger-Ellison syndrome. It is a condition caused by an "abnormal production of" gastrin hormone which causes an overproduction of gastric acid.

Contraindications When Famotidine should not be used - Generic drug

DO NOT take Famotidine STADA

if you are allergic (hypersensitive) to famotidine or any of the other ingredients of this medicine. If symptoms of hypersensitivity occur, treatment with Famotidine should be discontinued.
Children should not be treated with Famotidine STADA.

Precautions for use What you need to know before taking Famotidine - Generic drug

Talk to your doctor or pharmacist before taking Famotidine STADA

If you experience any of the following symptoms, tell your doctor immediately:
- an involuntary weight loss

repeated vomiting
difficulty swallowing
blood in the vomit
pale appearance and a sense of weakness (anemia)
blood in the stool

Your doctor may deem it necessary to have you undergo some tests to rule out the possible malignant nature of the disease: famotidine also alleviates the symptoms of cancer and could therefore cause a delay in diagnosis. If the symptoms persist despite the therapy, it will have to be taken in consideration of the need for further investigations.

If you are taking atazanavir at the same time to treat HIV infection (see "Other medicines and Famotidine EG" below).
if you have duodenal ulcer and benign gastric ulcer your doctor may assume that these were caused by a bacterial infection with H. Pylori. In this case you will have to undergo a special therapy under medical supervision to eliminate these bacteria.
If your kidney (renal) function is impaired. Your doctor may prescribe a lower dose of Famotidin STADA (see section 3 "How to take Famotidin STADA").
do not use Famotidine STADA if you have mild gastrointestinal complaints. Consult your doctor

Interactions Which drugs or foods can modify the effect of Famotidine - Generic drug

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you take any of the medicines below, consult your doctor immediately:

Do not take Famotidine STADA

if you are taking probenecid (a medicine to treat gout) at the same time, as probenecid may delay the elimination of famotidine.
at the same time as atazanavir, ritonavir and tenofovir (medicines to treat HIV infection)

The effect of Famotidine STADA is reduced by:

medicines that neutralize stomach acid (antacids). Due to the reduced effect of Famotidine STADA, it should be taken at least 1-2 hours before the antacid.
sulcralfate (medicine to treat ulcers). Normally, the intake of sulcralfate should not take place before 2 hours have elapsed after taking Famotidine STADA.

Famotidine STADA may reduce the effect of:

ketoconazole or itraconazole (medicines to treat fungal infections). Take ketoconazole 2 hours before taking Famotidine STADA.
atazanavir at the same time as ritonavir (medicines to treat HIV infection). Consult your doctor.

Famotidine EG with food and drink

Famotidine STADA can be taken regardless of food.

Warnings It is important to know that:

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy: if you are pregnant, your doctor will only prescribe Famotidine STADA if strictly necessary.

Breastfeeding: if you are taking Famotidine, avoid breastfeeding your baby. Famotidine STADA is excreted in breast milk and there is a possibility that it may affect the gastric acid secretion of the newborn.

Driving and using machines

It is not known whether Famotidine STADA can affect your ability to drive or operate machinery. Do not drive vehicles or operate machinery until you are certain that your abilities are not impaired.

Dose, Method and Time of Administration How to use Famotidine - Generic drug: Posology

Always take this medicine always exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.

Method of administration

Famoditin tablets should be swallowed whole with liquid. The tablets do not need to be taken with meals.

The recommended dose depends on the severity of the disease and the dosage given in previous treatments. Your doctor will decide how much medicine you should take.

The recommended doses are given below:

Treatment of reflux disease symptoms (e.g. heartburn): 20 mg of famotidine twice daily.

Treatment of mild to moderate inflammation of the esophagus (digestive tract): 40 mg of famotidine twice daily.

Benign gastric ulcers and duodenal ulcers: 40 mg of famotidine before bedtime.

Treatment should be continued for 4-8 weeks. However, this term may be shortened if the doctor believes that the ulcer has healed (for example, through an endoscopic examination). If the examination reveals that the ulcer has not healed, treatment should be continued for another 4 hours. weeks.

Prevention of recurrent duodenal ulcers: 20 mg of famotidine in the evening.

The recommended maintenance dose of 20 mg was administered continuously and effectively in clinical trials of 12 months duration.

Zollinger-Ellison syndrome: In the absence of previous therapy, treatment begins with 20 mg of famotidine to be administered at 6-hour intervals.

Depending on the acid secretion and its clinical response, the doctor may increase the dose while the treatment is continued until the desired acid levels are reached. If administration of a daily dosage of up to 800 mg fails, the doctor may consider an alternative treatment to regulate acid secretion.

If you have previously undergone treatment with similar medicines (for example, other histamine H2 receptor antagonists) you can start treatment with Famotidine at a higher dosage than is usually recommended. Ask your doctor what the correct dosage is. for her.

Treatment should be continued for as long as necessary.

Patients with impaired renal function If your kidney function is reduced your doctor may cut your daily dose in half. The same is true for dialysis patients. Famotidine STADA should be administered at the end of dialysis, or later, as part of the active substance is removed by dialysis.

If you forget to take Famotidine STADA

If you miss a dose, take the tablet as soon as you remember. Then continue the treatment as usual. Do not take a double dose to make up for a forgotten dose. If you are not sure if you missed the dose, please ask your doctor.

If you stop taking Famotidine STADA

If you want to stop taking Famotidine STADA please contact your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Overdose What to do if you have taken an overdose of Famotidine - Generic drug

If you take more Famotidine STADA than you should, contact your doctor immediately or go to the nearest emergency department. Your doctor will try to inhibit absorption and relieve symptoms. To date, no cases of overdose with the active ingredient famotidine have been reported.

Side Effects What are the side effects of Famotidine - Generic drug

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking the medicine and see your doctor immediately if you experience severe allergic / hypersensitivity reactions resulting in difficulty breathing or dizziness (anaphylaxis), swelling of the face or throat (angioneurotic edema), difficulty breathing or wheezing (bronchospasm).

The following side effects have been reported:

Common side effects (may affect up to 1 in 10 people):

headache
dizziness
constipation (constipation)
diarrhea.

Uncommon side effects (may affect up to 1 in 100 people):

dry mouth
nausea, vomiting
gastrointestinal disorders
wind (flatulence)
loss of appetite
rash, itching (prurigo)
tiredness (fatigue)

Rare side effects (may affect up to 1 1000 people):

severe allergic / hypersensitivity reactions resulting in difficulty in breathing or dizziness (anaphylaxis), swelling of the face or throat (angioneurotic edema), difficulty in breathing or wheezing (bronchospasm)
yellowing of the skin or whites of the eyes due to blockage of bile flow (jaundice secondary to intrahepatic cholestasis)
urticaria
joint pain (arthralgia)
increase in laboratory values (transaminases, gamma GT, alkaline phosphatase, bilirubin).

Very rare side effects (may affect up to 1 in 1000 people):

blood changes: decrease in the number of all different types of blood cells (pancytopenia) or decrease in the number of white blood cells (leukopenia, agranulocytosis) or platelets (thrombocytopenia) which can lead to, for example, weakness, fatigue, sudden fever, sore throat, bruising or nosebleed.
reversible psychological disorders (e.g. hallucinations, disorientation, confusion, anxiety, agitation, depression)
tingling or numbness in the hands or feet (paraesthesia)
drowsiness
insomnia
seizures (grand mal)
hair loss
severe skin reactions (e.g. toxic epidermal necrolysis)
muscle cramps
impotence, decreased libido
chest tightness

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister or outer carton after EXP. The expiry date refers to the last day of that month.

Other "> Other Information

What Famotidine STADA contains

The active ingredient is famotidine.

Famotidine STADA 20 mg film-coated tablets: 1 film-coated tablet contains 20 mg of famotidine.

Famotidine STADA 40 mg film-coated tablets: 1 film-coated tablet contains 40 mg of famotidine.

The other ingredients are: Tablet core: Microcrystalline cellulose, maize starch, pregelatinised maize starch, povidone, talc, magnesium stearate. Tablet coating: Hypromellose, talc, titanium dioxide (E171), propylene glycol.

What Famotidine Stada looks like and contents of the pack

Famotidine STADA 20 mg film-coated tablets: White, round, biconvex, film-coated tablets with "20" debossed on one side.

Famotidine STADA 40 mg film-coated tablets: White, round, biconvex, film-coated tablets with "40" debossed on one side.

The film-coated tablets are packed in PVC / PVDC-aluminum blisters. 10, 15, 20, 28, 30, 50, 56, 60, 90, 100, 250, 500, 1000 film-coated tablets. Not all pack sizes may be marketed.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

More information on Famotidine - Generic drug can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

FAMOTIDINA EG 40 MG TABLETS COATED WITH FILM

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

One film-coated tablet contains 40 mg of famotidine

For the full list of excipients, see section 6.1

03.0 PHARMACEUTICAL FORM

Film-coated tablets

White, round, biconvex film-coated tablets debossed with "40" on one side

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

• Duodenal ulcer

• Benign gastric ulcer

• Zollinger-Ellison syndrome

• Treatment of mild to moderate reflux esophagitis

04.2 Posology and method of administration

Dosage instructions

Duodenal ulcers and benign gastric ulcers:

40 mg of famotidine once a day, at bedtime.

Zollinger-Ellison syndrome:

It is recommended, in patients whose Zollinger-Ellison syndrome has not yet been treated with antisecretory drug therapy, to start treatment with the intake of 20 mg of famotidine (for this, coated tablets with 20 mg of famotidine are available) every 6 hours Depending on the patient's acid secretion and clinical response, the dosage should be adjusted as a continuous treatment until desired acid levels are reached (eg.

Patients who have already undergone previous treatment with H2 receptor antagonists can be switched directly to a dosage of famotidine higher than the dosage recommended at the start of treatment. The dosage depends on the severity of the disease and the posology of the previous drugs.

Mild to moderate reflux esophagitis:

In treated mild to moderate reflux esophagitis, a dose of famotidine 40 mg twice daily (corresponding to two Famotidine STADA 40 mg film-coated tablets) is recommended.

Famotidine is mainly eliminated by the kidney. For patients with renal impairment in whom creatinine clearance is less than 30 ml / min, the famotidine daily dosage should be reduced by 50%.

Patients on dialysis must also take doses reduced by 50%. Famotidine STADA 40 mg should be administered at the end or after the dialysis session, as some of the drug is eliminated by dialysis.

Method of administration and duration of treatment

Famotidine STADA 40 mg film-coated tablets should be swallowed whole with liquid. They do not need to be taken with meals.

Duodenal ulcers and benign gastric ulcers:

For duodenal ulcers and benign gastric ulcers under treatment, therapy should be continued for 4-8 weeks. This period, however, can be shortened if endoscopy reveals that the ulcer has healed. If endoscopic examination does not reveal this healing, treatment should be continued for another 4 week period.

Zollinger-Ellison syndrome:

Treatment should be continued until clinical symptoms disappear.

Mild to moderate reflux esophagitis:

Generally the treatment should be continued for 6 weeks, if 6 weeks of treatment does not lead to healing, the treatment should be continued for another 6 weeks.

04.3 Contraindications

Hypersensitivity to the active substance, or to any of the other excipients.

If symptoms of hypersensitivity occur, the administration of Famotidine Stada 40 mg should be discontinued.

There is insufficient information regarding the safety and efficacy of famotidine in children. For this reason, children should not be treated with Famotidine STADA 40 mg.

04.4 Special warnings and appropriate precautions for use

Neoplasm cannot necessarily be ruled out when treatment with Famotidine Stada 40 mg is effective on symptoms. Appropriate diagnostic measures should be undertaken to rule out non-malignancy of an ulcer prior to initiation of famotidine treatment.

Famotidine is mainly excreted via the kidney and is partially metabolised by the liver.

Consequently, caution is recommended in patients with impaired renal function.

The daily dosage of patients with impaired renal function should be reduced (see posology).

Do not administer Famotidine STADA 40 mg in case of minor gastrointestinal complaints.

In patients with duodenal ulcers and benign gastric ulcers, the presence of H. pylori should be checked. If possible, patients positive for H. pylori should undergo eradication therapy to eliminate the bacteria.

Co-administration of H2 receptor antagonists such as famotidine with atazanavir / ritonavir in combination with tenofovir should be avoided (see section 4.5).

04.5 Interactions with other medicinal products and other forms of interaction

Clinically, no major metabolic interactions with other drugs or substances have been recorded.

During concomitant use of substances whose absorption is affected by gastric pH, a possible change in the absorption of these substances must be considered. Absorption of ketoconazole or itraconazole may be reduced; ketoconazole should be administered 2 hours prior to famotidine administration.

The concomitant use of famotidine and antacids can reduce the absorption of famotidine and lead to lower plasma concentrations of the same. For this reason, famotidine should be administered 1-2 hours before taking an antacid.

Concomitant use of sucralfate inhibits the absorption of famotidine. Therefore, as a rule, sucralfate should not be administered within two hours of taking famotidine.

Administration of probenecid may delay the elimination of famotidine. Concomitant use of probenecid and Famotidine STADA 40 mg should be avoided.

Famotidine has been shown to reduce the bioavailability of atazanavir in a dose-dependent manner. This may be offset by an increase in the atazanavir dose. However, when atazanavir / ritonavir are taken together with tenofovir, no dose dependence of this reduction is demonstrated. Therefore, treatment with a maximum of 20 mg famotidine is recommended for patients taking tenofovir, or, if a higher dose is required, an increase in the atazanavir dose should be considered. Patients taking atazanavir / ritonavir in combination with tenofovir should not be treated with famotidine (see section 4.4).

04.6 Pregnancy and breastfeeding

Data on a limited number of pregnant women treated with famotidine did not indicate any adverse effects of famotidine on pregnancy or on the health of the fetus or newborn. Apart from these data, no other relevant epidemiological data are available. Animal studies do not indicate the development of direct or indirect damage with respect to pregnancy, embryonal / fetal development, parturition or postnatal development (see section 5.3).

Famotidine should only be prescribed to pregnant women after careful consideration of the expected benefits and potential risks.

Famotidine is excreted in breast milk. Since there is a possibility that famotidine affects gastric acid secretion in infants, women undergoing famotidine treatment should avoid breastfeeding.

04.7 Effects on ability to drive and use machines

There are no studies on the effects on the ability to drive and use machines.

04.8 Undesirable effects

In this section, the frequencies of undesirable effects are defined as follows: very common (≥1 / 10); common (≥1 / 100,

Diagnostic tests

Rare: laboratory elevation (transaminase, gamma-GT, alkaline phosphatase, bilirubin).

Disorders of the blood and lymphatic system

Very rare: thrombocytopenia, leukopenia, agranulocytosis and pancytopenia.

Nervous system disorders

Common: headache, dizziness;

Very rare: paraesthesia, somnolence, insomnia, epileptic convulsions (grand mal).

Gastrointestinal disorders

Common: constipation, diarrhea;

Uncommon: dry mouth, nausea, vomiting, gastro-intestinal disturbances, flatulence, loss of appetite.

Skin and subcutaneous tissue disorders

Uncommon: rash, pruritus;

Rare: urticaria;

Very rare: alopecia, severe skin reactions (such as toxic epidermolysis).

Musculoskeletal and connective tissue disorders

Rare: arthralgia;

Very rare: muscle cramps.

General disorders and administration site conditions

Uncommon: fatigue;

Very rare: feeling of tightness in the chest.

Disorders of the immune system

Rare: hypersensitivity reactions (anaphylaxis, angioneurotic edema, bronchospasm).

Hepatobiliary disorders

Rare: intrahepatic cholestasis (visible sign: jaundice).

Diseases of the reproductive system and breast

Very rare: impotence, decreased libido.

Psychiatric disorders

Very rare: Reversible mental disorders (such as hallucinations, disorientation, confusion, anxiety, agitation, depression).

04.9 Overdose

No cases of overdose with famotidine have been reported.

In the event of an overdose, every effort must be made to prevent absorption of the substance and relieve symptoms.

The usual practices for removing unabsorbed material from the gastrointestinal tract should always be used with clinical monitoring and supportive therapy.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic group: H2 histaminergic receptor antagonists / gastrointestinal therapy. ATC code: A02BA03.

Famotidine is a competitive antagonist of histaminergic H2 receptors, which leads to the inhibition of gastric acid secretion mediated by H2 receptors. In addition to reducing gastric acidity, famotidine reduces the pepsin content and, to a lesser extent, the volume of basal gastric secretion and gastric secretion obtained on stimulation. No pharmacological effects were observed on the CNS, nor on the immune, cardiovascular systems and respiratory parameters.

The drug takes effect within one hour of oral administration and the maximum effect is observed after 1-3 hours.

Single oral doses of 20 mg and 40 mg effectively inhibited nocturnal basal secretion of gastric acid; mean gastric acid secretion was inhibited by 86% and 94%, respectively, over a period of 10 hours. The same doses, administered in the morning, resulted in food-induced inhibition of gastric acid secretion. , 76% and 84% 3-5 hours after administration and 25% and 30%, respectively, 8-10 hours after administration. In some volunteers who took the 20 mg dose, however, the antisecretory effect disappeared within 6-8 hours. Repeated administrations did not cause drug accumulation.

The nocturnal basal intragastric pH value was raised, for evening doses of 20 and 40 mg of famotidine, to mean values of 5.0 and 6.4, respectively. When famotidine was administered after breakfast, the pH value in both groups treated with 20 or 40 mg of famotidine 3 and 8 hours after administration was raised to about 5.

Famotidine has little or no effect on fasting or postprandial serum gastrin levels. Gastric emptying and exocrine pancreatic function were not affected by famotidine, nor were hepatic and portal blood flow. There was also no effect on endocrine function. Hormone levels of prolactin, cortisol, thyroxine (T4) and testosterone remained unchanged under famotidine treatment.

05.2 Pharmacokinetic properties

The kinetics of famotidine are linear.

Famotidine is rapidly absorbed after oral administration.

Oral bioavailability is approximately 40%.

Peak plasma concentrations are reached 1-3.5 hours after administration. Peak plasma concentrations after administration of 20 mg famotidine are approximately 0.04-0.06 mcg / ml and 0.075 to 0.1 mcg / ml after administration of 40 mg famotidine. Repeated administrations do not produce accumulation of the active ingredient. The absorption of famotidine is not affected by the food ingested at the same time.

Famotidine has only been found in the cerebrospinal fluid in limited quantities. The liquid / plasma ratio 4 hours after oral administration of 40 mg of famotidine was a mean of 0.1.

Famotidine is secreted in breast milk. 6 hours after oral administration, the milk / plasma concentration ratio was 1.78. The plasma elimination half-life is 2.6-4 hours.

More than 30-35% of the active ingredient is metabolized in the liver; a sulfoxide metabolite is produced.

24 hours after oral administration, 25% -30% of the active ingredient is excreted unchanged in the urine; after intravenous administration, 65-70% is excreted unchanged in the urine. Renal clearance is 250-450 ml / min which indicates some degree of tubular secretion. A small amount can be eliminated as sulfoxide.

Kidney failure:

Both renal clearance and total clearance of famotidine decrease with decreasing renal function, without there being an increase in non-renal elimination. The elimination half-life after intravenous injection of a single dose of 20 or 10 mg famotidine is increased to 4.5-9 hours in moderate renal insufficiency (creatinine clearance 60-30 ml / min); at 10-12 hours in severe renal insufficiency (creatinine clearance anuria. The amount of unchanged famotidine excreted in the urine decreases to 60% in patients with moderate renal insufficiency. In case of severe renal insufficiency it is only 25%.

In dialysis patients, the elimination half-life after intravenous administration of 20 mg of famotidine is 7-14 hours, depending on the dialysis technique (haemofiltration, 5-hour hemodialysis or continuous haemofiltration), and 22.5 hours after administration. oral of 20 mg of famotidine.

Impaired liver function:

Famotidine pharmacokinetics remain unchanged in patients with impaired hepatic function.

Kinetics in elderly patients:

Pharmacokinetic studies in elderly patients have shown no signs of any clinically relevant changes in relation to age; however, age-related impairments in renal function should be considered when determining the dosage.

05.3 Preclinical safety data

Preclinical data based on conventional studies of safety pharmacology, repeated toxic dose, genotoxicity, carcinogenic potential and reproductive toxicity, did not reveal any particular risk for humans.