Befeton

BEFETON^®, solution for injections, 75 mg/3 ml

diclofenac sodium

Please, read this information leaflet completely before taking this medicine as it contains information that is important to you.

- Keep this information leaflet. You may need to read it once more.

- If you have any further questions, please contact your doctor.

- The drug has been prescribed just for you. Do not pass it on to other people. He can harm them, even if their symptoms are the same as yours.

- If you experience any unwilling reactions, contact your doctor. This recommendation applies to any possible unwilling reactions, including those not listed in section 4 of the information leaflet.

CONTENT OF THE INFORMATION LEAFLET

1. What BEFETON^® is and what it is taken for.

2. What you need to know before taking BEFETON^®.

3. Administration of the drug BEFETON^®.

4. Possible unwilling reactions.

5. Storage of the drug BEFETON^®.

6. Contents of the package and other information.

1. WHAT BEFETON^® IS AND WHAT IT IS TAKEN FOR

BEFETON^® is available as an injection solution containing 75 mg of diclofenac sodium in 3 ml, which is administered intramuscularly or intravenously as an infusion.

BEFETON^® is indicated for the treatment of painful conditions such as pain with stones in kidneys, osteoarthritis (joints degeneration) and rheumatoid arthritis (inflammation of joints), back pain, gout (formation of crystals in the joints), injuries and fractures.

BEFETON^® when administered intravenously is used for the treatment and prevention of postoperative pain.

Your doctor will explain you what you are being treated for and tell you more about it.

2. WHAT YOU SHOULD KNOW BEFORE TAKING BEFETON^®

Do not take BEFETON^®

·                     if you are allergic (hypersensitive) to diclofenac sodium, sodium metabisulfite, ibuprofen, aspirin or other NSAIDs, or any other ingredients of BEFETON® (listed in Section 6 of the leaflet-insert).

The signs of a hypersensitivity reaction include swelling of the face and lips (angioedema), labored breathing, chest pain, snuffle, skin rash or any other allergic type reaction.

• if you have or have ever had a stomach or duodenal ulcer, or bleeding in the gastrointestinal tract (this may be bleeding with a bowel movement, fresh blood in the bowel movement or black tarry bowel movement)
• if you have stomach or intestinal problems after taking other NSAIDs.
• if you have heart, kidney or liver failure
• if you have a heart disease and/or cerebrovascular illness, for example, if you have had a heart attack, stroke, mini-stroke (TIA) or blockage of blood vessels in the heart or brain, or thrombus removal surgery
• if you have or have had circulatory problems (disease of peripheral arteries)
• if you are pregnant (more than 6 months)

Warnings and Precautions

• You should take the lowest dose of BEFETON^® drug during as far as shorter periods of time, especially if you are underweight or you are an elderly person.

• BEFETON^® increases the risk of heart attack or stroke. The risk is higher if You are taking high doses for a long period of time. Always follow your doctor's instructions about the dosage and period of the administration of the drug.
• If while taking BEFETON^® you experience any signs or symptoms of problems with the heart or blood vessels, such as chest pain, shortness of breath, weakness or slurred speech, immediately turn to the doctor.
• While you are taking this medicine, your doctor may occasionally inspect you.
•  If you had  stomach problems associated with taking NSAIDs in anamnesis, especially if you are an elderly person. You should immediately inform your doctor if you notice any unusual symptoms.
• As BEFETON^® is an anti-inflammatory drug, it may reduce symptoms of infection, such as headache and high temperature.
• If you feel unwell and need to see a doctor, do not forget to tell him that you are taking BEFETON^®.
•  Tell your doctor if you have recently had or are about to have surgery on the stomach or intestinal tract before taking BEFETON^®, because BEFETON^® can sometimes worsen the healing of wounds in the intestine after operation.

Children

BEFETON^® is not recommended for children.

Adults

The frequence of side reactions to NSAIDs is increased at the elderly people, especially gastrointestinal bleeding and perforations, which can be fatal.

Caution should be exercised at patients receiving concomitant medications which may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective inhibitors of serotonin reuptake inhibitors (SSRIs) or antiplatelet agents such as aspirin.

Other Medicines and BEFETON^®

Tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medications. This includes any herbal products or medicines bought without a prescription.

• Digoxin (used to treat heart problems)

• Lithium (used to treat mental illness)

• Antibiotics called quinolones (for example, ciprofloxacin)

• Cyclosporine and Tacrolimus (used for the treatment of certain inflammatory diseases and after transplantation)

• Methotrexate (used for certain inflammatory and neoplastic diseases)

• Medications that can increase the risk of bleeding, sometimes prescribed for heart problems such as dipyridamole or clopidogrel.

• Diuretics

• Drugs for the treatment of high blood pressure.

• Mifepristone used to terminate a pregnancy (including if you have taken it within the last 12 days)

•Drugs for the treatment of diabetes

• Oral steroids (anti-inflammatory drugs)

• Phenytoin (medicines used for the treatment of epilepsy)

• Colestipol and cholestyramine (drugs to lower cholesterol levels.)

• CYP2C9 inhibitors: Sulfinpyrazone and voriconazole

• Other NSAIDs (for painful or inflammatory conditions), including inhibitors COX-2.

• Medications known as SSRIs used for the treatment of depression, such as paroxetine or fluoxetine.

• Medicines used for the  treatment of heart diseases or high blood pressure, such as beta-blockers or ACE inhibitors.

Pregnancy, breastfeeding and fertility

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

Pregnancy

      BEFETON^® should be used during pregnancy only when your doctor decides that the benefit to you is greater than any possible risk to the unborn child.

Do not take BEFETON^® during the last 3 months of pregnancy as this may affect your child's blood circulation and kidneys.

Lactation

Do not take BEFETON^® while breastfeeding as diclofenac is small amounts pass into breast milk.

Fertility

The use of BEFETON^® may make it difficult to conceive. You should consult your doctor if  you are planning to become pregnant, or if you have problems with conceiving a child.

Operation of vehicles and work with mechanisms

BEFETON® may cause dizziness and other undesirable reactions, that make you less attentive.

BEFETON^® contains benzyl alcohol

BEFETON^® contains benzene alcohol, which may cause allergic reactions.

BEFETON^® contains sodium metabisulphite

BEFETON^® contains sodium metabisulphite, which in rare cases may cause severe hypersensitivity reactions and bronchospasm.

BEFETON^® contains sodium

BEFETON^® contains less than 1 mmol (23 mg) of sodium per 3 ml, i.e. essentially does not contain sodium.

3. ADMINISTRATION OF DRUG BEFETON^®

Your doctor will decide when and how to treat you with BEFETON^® .

BEFETON^® is administered intravenously (drip injection into a vein) or intramuscularly (an injection into a muscle). An intramuscular injection is usually administered in the buttocks.

The usual dose is:

Adults

One or two ampoules (75 to 150 mg) every day for one or two days.

Elderly people

Your doctor may prescribe you a dose lower than the usual dose for adults, if you are an  old man.

Children

Not suitable for children

4. POSSIBLE UNWILLING REACTIONS

BEFETON^® is suitable for most people, but like all medicines, it can cause side effects. Side effects can be minimized by using the lowest effective dose for the shortest period of time.

Some side effects may be serious. Tell your doctor immediately if You have noticed the following:

·         Sudden and pressing chest pain (signs of myocardial infarction or heart attack)

·         Shortness of breath, difficult breathing when lying down, swelling of the feet or legs (signs of heart failure)

·         Sudden weakness or numbness of the face, arms or legs, especially on one side body; sudden loss or disorder of vision; sudden difficulty in speaking or the ability to understand speech; sudden migraine headaches occurring for the first time, with or without visual impairment. These symptoms may be an early sign of a stroke.

·         Stomach pain, indigestion, heartburn, flatulence (gases), nausea (or vomit).

·         Any signs of bleeding in the stomach or intestines, such as bowel movements, bloody vomiting or black tarry bowel movements.

·         Allergic reactions, which may include skin rash, itching, bruising,painful red patches, peeling and blistering.

• Wheezing or shortness of breath (bronchospasm).

• Swelling of the face, lips, hands or fingers.

• Yellowing of the skin or whites of the eyes.

• Persistent sore throat or high temperature

• An unexpected change in the amount of urine produced and / or its external view

• Mild abdominal cramps and pain starting shortly after starting treatment with drug BEFETON®, and accompanied by bleeding from the anus or bloody diarrhea, usually within 24 hours of occurrence of abdominal pain.

• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome

If you noticed bruising more than usual or have frequent sore throats or signs of infection, inform your doctor.

The side effects listed below have also been reported.

Common side effects (affects less than 1 out of 1,000 people) may occur in 1-10 out  of 100 patients):

  Stomach pain, heartburn, nausea, vomiting, diarrhea, indigestion, flatulence (gases), loss of appetite, headache, dizziness, skin rash or spots, increased blood levels of liver enzymes, reactions at the injection site (symptoms include redness, swelling, discoloration of the skin, inflammation, pain and hypersensitivity).

Uncommon side effects (may affect 1 to 10 out of 1000 patients):

Fast or irregular heartbeat (arrhythmia), chest pain, heart problems, including heart attack or shortness of breath, difficulty of breathing when lying down, swelling feet or legs (signs of heart failure), especially if you have been taking a higher dose (150 mg per day) for an extended period of time.

Rare side effects (may affect from 1 out of 1,000 to 1 out of 10,000) patients):

Gastric ulcers or bleeding (very rare deaths have been reported, especially among the elderly people), gastritis (inflammation, irritation or swelling of the mucous membrane stomach), hematemesis, diarrhea with blood or bleeding from the anus, black tarry bowel movement, fatigue, skin rash and itching, fluid retention (swollen ankles are related to these symptoms), liver dysfunction, including hepatitis and jaundice, asthma (symptoms may include wheezing, shortness of breath, cough, and tightness in chest), injection site necrosis (dead skin and tissue around the injection site).

Very rare side effects (may affect up to 1 out of  10,000 patients):

Effects on the nervous system:

Inflammation of the lining of the brain (meningitis), tingling or numbness of fingers, tremors, visual disturbances such as blurry or double vision, changes in taste, hearing loss or impairment, tinnitus (tinnitus), insomnia, nightmares, mood changes, depression, anxiety, irritability, mental disorders, disorientation and memory loss, seizures, headaches along with dislike of bright light, fever and stiffness of the neck.

Impact on the digestive system:

Constipation, inflammation of the tongue, mouth ulcers, inflammation of the mouth or lips, diseases of lower intestines (including inflammation of the colon or exacerbation of colitis or Crohn's disease), inflammation of the pancreas.

Effects on the lungs, vessels or blood:

Hypertension (high blood pressure), hypotension (low blood pressure, symptoms of which may include fainting, dizziness), inflammation of the blood vessels (vasculitis), pneumonia (pneumonitis), blood diseases (including anemia).

Effects on  liver or kidneys:

Severe liver and kidney disease, including liver failure, blood or protein presence in the urine.

Effects on skin or hair:

Swelling of the face, severe skin rashes including Stevens-Johnson syndrome, Lyella and other skin rashes that may be aggravated by exposure of sunlight. Hair loss.

Impact on the reproductive system:

Impotence.                                                 

Other side effects, that have also been reported with unknown frequency, include:

Abscess at the injection site, sore throat, confusion, hallucinations, malaise (general feeling of discomfort), inflammation of the optic nerves, disorders of sensitivity, tissue damage at the injection site.

5. HOW TO STORE BEFETHON^®

Store at a temperature not exceeding 25°C.

Store in original packaging, protected from light. Keep out of reach of children.

Do not use this medicine after the expiry date which is indicated on the package.

The expiration d ate refers to the last day of the specified month. After opening throw  all the unused liquid.

Do not throw medicines in wastewater or household waste. Ask your pharmacist how to utilize  the medicines that you no longer take. These measures help protect the environment.

6. CONTENT OF THE PACKAGE AND OTHER INFORMATION

What BEFETON^® contains

The active substance is diclofenac sodium. Each glass ampoule contains 3 ml of liquid, containing 75 mg of diclofenac sodium.

Other ingredients: benzene alcohol; propylene glycol, disodium edetate, sodium metabisulphite, sodium hydroxide, water for injection.

What does BEFETON^® look like?

BEFETON^® is a clear liquid solution from colorless to yellowish color, not containing any visible particles.

BEFETON® is released in 3 ml clear glass ampoules. Ampoules of 10x3 ml are packed in a cardboard box with insert.

Manufactured by the order and under the control of: “Giga Farm” LLC, 3101 Republic of Armenia, city of Gyumri, str. Gogunts, 3/5. Tel: +374 94 000 264, +7 989 633 57 59, e-mail: grg.am@mail.ru.

Registration certificate holder: “Giga Farm” LLC, 3101, the RA, city of Gyumri, str. Gogunts, 3/5, Tel.: +374 94 000 264, +7 989 633 57 59, e-mail: gig.am@mail.ru.

 BEFETON® is a trademark of the “Giga Farm” LLC.

Manufacturer: Divine Laboratories Fvt. Ltd., Block No. 471, Dabhasa, Tal-Padra, district

Vadodara, state of Gujarat, India

Legal status for supply

Only by a doctor's prescription.