INTRODUCTION

SAMERAL 400 TABLET contains S-Adenosyl-L-Methionine which belongs to the group of medicines called Amino acid derivatives. It is used to treat liver problems such as intrahepatic cholestasis (ICP; block in bile flow), liver cirrhosis, hepatitis and alcoholic liver disease in adults.

It can also be used to treat ICP of pregnancy and can reduce the fatigue caused by chronic liver problems. It also helps to reduce joint pain (osteoarthritis), fibromyalgia (severe muscle pain with memory and mood problems), anxiety, depression and other mental illnesses.

Before taking SAMERAL 400 TABLET inform your doctor if you have any kidney problems. You must also inform your doctor if you have bipolar disorder or a previous history of suicidal thoughts as a precaution.

Vitamins such as folic acid and vitamin B12 are essential to enhance the effects of S-Adenosyl-L-Methionine in your body. Therefore, inform your doctor if you have any vitamin deficiencies or anemia as a precaution. You doctor may advise you to take B-vitamin supplements (folic acid and vitamin B12) along with this medicine.

During treatment with SAMERAL 400 TABLET your doctor will routinely monitor the levels of ammonia, folic acid and vitamin B12 in your blood as a precaution and adjust the dose accordingly.

Do not take SAMERAL 400 TABLET without consulting your doctor if you are pregnant or breastfeeding. The most common side effects of taking SAMERAL 400 TABLET are nausea, stomach pain and diarrhea. Consult your doctor if they trouble you.

USES OF SAMERAL 400 TABLET

It is used in adults to treat:

• intrahepatic cholestasis (ICP) in patients with or without liver disease
• intrahepatic cholestasis during pregnancy
• liver diseases (liver cirrhosis, hepatitis and alcoholic liver disease)
• fatigue caused due to chronic liver problems
• anxiety, depression and other mental illnesses
• osteoarthritis (joint pain)
• fibromyalgia (severe muscle pain causing memory and mood changes)

HOW SAMERAL 400 TABLET WORKS

SAMERAL 400 TABLET protects your liver against various toxins (free radicals) and helps your liver to function normally. It improves the levels of glutathione (an antioxidant) in the liver which helps in preventing further liver cell damage.

It also increases the levels of certain chemical messengers (such as dopamine, noradrenaline, adrenaline, serotonin, melatonin) in the brain that can stabilize mood and mental health. It can also reduce the production of certain chemicals in the body that causes pain and inflammation.

DIRECTIONS FOR USE

Take SAMERAL 400 TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not cursh or chew the medicine. It is preferably taken before meals.

Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF SAMERAL 400 TABLET

HOW TO MANAGE SIDE EFFECTS

Nausea or vomiting:

Take this medicine with or just after meals. Stick to simple meals. Avoid eating rich or spicy food. Contact your doctor if nausea worsens.

Diarrhoea:

Drink fluids, such as water or fruit juice in enough quantity to keep yourself hydrated. Don’t take any medicine on your own for treating diarrhoea without talking to your doctor. Contact your doctor if diarrhoea worsen.

WARNING & PRECAUTIONS

PREGNANCY

SAMERAL 400 TABLET is not recommended for use in pregnant women unless considered necessary by the physician. Therefore, consult your doctor before taking it.

BREASTFEEDING

SAMERAL 400 TABLET is not recommended for use in breastfeeding women unless considered necessary by the physician. Therefore, consult your doctor before taking it.

DRIVING AND USING MACHINES

Do not drive or operate any heavy tools or machines if you experience dizziness after taking SAMERAL 400 TABLET as a precaution.

KIDNEY

SAMERAL 400 TABLET should be used with caution in patients with kidney diseases. Therefore, consult your doctor before taking it.

ALLERGY

Do not take SAMERAL 400 TABLET if you are allergic to S-Adenosyl-L-Methionine.

INTERACTIONS

A. Drug-Drug interactions:

Before taking SAMERAL 400 TABLET, inform your doctor if you are taking any of the following medicines such as:

• other medicines used to treat depression (Ex. phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine, moclobemide, fluoxetine, paroxetine, clomipramine, amitriptyline, imipramine etc.)
• levodopa (a medicine used to treat Parkinson’s disease)
• tryptophan (an amino acid used to induce sleep)

Overdosage:

If you or anyone else accidentally took more SAMERAL 400 TABLET, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep SAMERAL 400 TABLET out of sight and reach of children
• Store SAMERAL 400 TABLET below 25°C

FAQs ABOUT SAMERAL 400 TABLET

What is the use of SAMERAL 400 TABLET?

SAMERAL 400 TABLET is used to treat liver problems such as intrahepatic cholestasis (ICP; block in bile flow), liver cirrhosis, hepatitis and alcoholic liver disease in adults. It can also be used to treat ICP of pregnancy and can reduce the fatigue caused by chronic liver problems. It also helps to reduce joint pain (osteoarthritis), fibromyalgia (severe muscle pain with memory and mood problems), anxiety, depression and other mental illnesses.

Can [GBNKEWORD] reduce liver damage?

Yes. SAMERAL 400 TABLET protects your liver against various toxins (free radicals) and helps your liver to function normally. It also improves the levels of glutathione (an antioxidant) in the liver which helps in preventing further liver cell damage.

What is the best time to take SAMERAL 400 TABLET?

Take SAMERAL 400 TABLET approximately at the same time each day. You can take SAMERAL 400 TABLET either in the morning or in the evening as per doctor’s instructions. Taking it at the same time each day will have the best effect and it would also help you remember your daily dose.

Can SAMERAL 400 TABLET be used to reduce anxiety?

SAMERAL 400 TABLET has been shown to reduce anxiety. It works by increasing the levels of certain chemicals within the brain that controls mood and mental health.

How does SAMERAL 400 TABLET works?

SAMERAL 400 TABLET protects your liver against various toxins (free radicals) and helps your liver to function normally. It also increases the levels of certain chemical messengers (such as dopamine, noradrenaline, adrenaline, serotonin, melatonin) in the brain that can stabilize mood and mental health. It can also reduce the production of certain chemicals in the body that causes pain and inflammation.

Can SAMERAL 400 TABLET be used in children?

The safety and effectiveness of SAMERAL 400 TABLET have not been established in children and adolescents (aged below 18 years). Therefore, consult your doctor for advice before taking it.

What to do if I forget to take a dose of SAMERAL 400 TABLET?

If you forget to take a dose of SAMERAL 400 TABLET, take it as soon as you remember. However, if it is time to take the next dose, skip the missed dose and take the next one at regular times. Do not take a double dose of SAMERAL 400 TABLET to compensate a missed dose, as it could lead to toxicity.

Will taking a higher dose of SAMERAL 400 TABLET than the prescribed one be beneficial?

No, taking a higher dose of SAMERAL 400 TABLET will not be effective rather it can lead to toxicity. Always take the dose prescribed by your doctor. If the prescribed dose is not effective for you, consult your doctor for advice. Your doctor might increase the dose or suggest an alternative therapy.

Can SAMERAL 400 TABLET be taken daily?

Yes. SAMERAL 400 TABLET can be taken daily as per your doctor’s instruction. However, if you are doubtful, consult your doctor.

Can SAMERAL 400 TABLET be used in pregnant women?

SAMERAL 400 TABLET is not recommended for use in pregnant women unless considered necessary by the physician. Therefore, consult your doctor before taking it.

How to take SAMERAL 400 TABLET?

Take SAMERAL 400 TABLET as advised by your physician. It is preferably taken before meals. Swallow the medicine with a glass of water. Do not chew or crush the medicine.

Can I stop taking SAMERAL 400 TABLET once I started feeling better?

Do not stop taking SAMERAL 400 TABLET without consulting your doctor as it may make your symptoms re-appear

What are the side effects of SAMERAL 400 TABLET?

The most common side effects of taking SAMERAL 400 TABLET are nausea, stomach pain and diarrhoea. Consult your doctor if they trouble you.

Is SAMERAL 400 TABLET safe?

SAMERAL 400 TABLET is safe at doses prescribed by the doctor. Do not alter the dosage of SAMERAL 400 TABLET without consulting your doctor.

REFERENCES

1. Harsh Mohan. The Liver, Biliary Tract and Exocrine Pancreas. Textbook of Pathology. 6th Edition. 2010. Page – 599.

2. Anup Sharma, MD, PhD, Patricia Gerbarg, MD, Teodoro Bottiglieri, PhD, Lila Massoumi, MD, Linda L. Carpenter, MD, Helen Lavretsky, MD, Philip R. Muskin, MD, Richard P. Brown, MD and David Mischoulon, MD, PhD. S-Adenosylmethionine (SAMe) for neuropsychiatric disorders: A Clinician-Oriented Review of Research. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed Central. December 2017. [Accessed on 25th November 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5501081/

3. AbbVie S.r.L. Abbott Laboratories. Ademetionine butanedisulfonate (Transmetil). [Accessed on 25th November 2022] https://www.medicine.abbott/content/dam/bss/divisionalsites/epd/productpdf/Transmetil%20500mg.pdf

4. La Renon Healthcare Private Limited. Methosam. Ademetionine Enteric Coated Tablets 200mg. [Accessed on 25th November 2022] https://www.larenon.com/wp-content/uploads/2022/04/METHOSAM-LBL-Depression.pdf

5. La Renon Healthcare Private Limited. Cirrosam. Ademetionine Enteric Coated Tablets 400mg. [Accessed on 25th November 2022] https://www.larenon.com/wp-content/uploads/2022/04/Cirrosam-LBL.pdf

6. La Renon Healthcare Private Limited. CIRROSAM (S-Adenosyl L-Methionine 400 mg tablets). [Accessed on 25th November 2022] https://www.larenon.com/wp-content/uploads/2020/06/cirrosam-lbl_Final.pdf

7. Abbott. Heptral 200/400. MIMS.com. [Accessed on 25th November 2022] https://www.mims.com/singapore/drug/info/heptral%20200-400?type=full

8. Central Drug Standard Control Organisation (CDSCO). Ademetionine enteric coated Tablets.200mg/400mg. [Revised in September 2010] [Accessed on 25th November 2022] https://cdscoonline.gov.in/CDSCO/Drugs

9. Leeford Healthcare. Lesamy 200. [Accessed on 25th November 2022] https://www.leeford.in/product/715/lesamy-200

USEFUL DIAGNOSTIC TESTS

• Liver function test
• Bilirubin Direct
• Bilirubin indirect
• Bilirubin Total

AUTHOR DETAILS

Written By Srilekha. R, B.Pharm
Last updated on 26 Nov 2022 | 03:22 PM(IST)