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INTRODUCTION
BOLOFEN XL 20MG CAPSULE contains Baclofen which belongs to the group of medicines called Muscle relaxants. It is used to treat muscle spasms caused due to cerebral palsy, multiple sclerosis, stroke or due to any other nerve or spinal cord disorders.
Before taking BOLOFEN XL 20MG CAPSULE inform your doctor if you have diabetes, hypertension or any problems with your lung, liver, kidney or heart. You must also inform your doctor if you have fits, problems in urination, any mental illness or a previous history of alcoholism or drug abuse.
BOLOFEN XL 20MG CAPSULE should not be used in pregnant or breastfeeding women unless considered necessary by the physician. During treatment with BOLOFEN XL 20MG CAPSULE, your doctor will periodically monitor your health condition through several blood tests and urine tests to avoid the risk of unwanted side effects.
BOLOFEN XL 20MG CAPSULE may causes excessive sleepiness. Therefore, restrict yourself from engaging into hazardous activities that requires complete alertness. Do not drive or handle any heavy tools or machines. Also, avoid consumption of alcohol as it may make you feel more drowsy.
The most common side effects of taking BOLOFEN XL 20MG CAPSULE are drowsiness, confusion, weakness and feeling unsteady or shaky. Consult your doctor if any of the symptoms worsen. You must also inform your doctor immediately if you feel extremely sad or depressed along with thoughts of committing suicide after taking BOLOFEN XL 20MG CAPSULE.
USES OF BOLOFEN XL 20MG CAPSULE
- Treats muscle spasms (painful muscle contractions)
HOW BOLOFEN XL 20MG CAPSULE WORKS
BOLOFEN XL 20MG CAPSULE is a muscle relaxant. It acts by increasing the effects of certain chemical messengers (such as GABA) in the spinal cord that induces muscle relaxation. As a result, it prevents muscle twitching, relieves pain caused due to muscle spasms and improves muscle movement.
DIRECTIONS FOR USE
Take BOLOFEN XL 20MG CAPSULE as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. It is preferably taken with food or milk to avoid nausea.
Your doctor will decide the correct dose and duration of therapy for you depending upon your age, body weight and disease condition.
Do not stop taking BOLOFEN XL 20MG CAPSULE without consulting your doctor as it may cause withdrawal symptoms such as muscle spasms, increased muscle tightness, fast heart rate, fever, confusion, hallucinations, mood changes, mental disorders, feeling attacked or persecuted or convulsions (fits).
SIDE EFFECTS OF BOLOFEN XL 20MG CAPSULE
COMMON
- nausea, vomiting
- tiredness, sleepiness
- weak limbs, muscle pain
- constipation, diarrhoea, dry mouth
- lack of sleep, nightmares
- confusion, hallucination
- breathing difficulties
- vision problems
- urge to pass urine
- feeling unsteady or shaky
- feeling faint due to low blood pressure
- skin rash, sweating
- increased liver enzymes
RARE
- numbness or tingling in hands or feet
- change in sense of taste
- slurred or slow speech
- sexual problems in men, such as impotence
- convulsions (fits)
Stop taking BOLOFEN XL 20MG CAPSULE and inform your doctor immediately if you experience any of the following side effects such as:
- feeling extremely depressed with thoughts of harming or killing themselves (suicidal thoughts)
- signs of severe allergic reactions (such as skin rash, itching, swelling of the face, lips, throat or tongue causing difficulty in breathing or swallowing)
- uncontrollable muscle spasms affecting the eyes, head, neck or body
- irregular or slow heartbeat, breathing difficulties, chest pain
- fainting or seizures (fits)
- behavioural changes (such as aggression, excitement, confusion, restlessness, agitation, irritability, rages, hallucinations, nightmares)
- difficulty in passing urine, bloody urine, painful urination
HOW TO MANAGE SIDE EFFECTS
Nausea:
Take BOLOFEN XL 20MG CAPSULE with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if your nausea worsens.
Sleepiness:
Try to rest and relax. Get enough sleep. Avoid driving or operating any tools or machines completely while you are feeling sleepy. Do not consume excessive alcohol, as it could aggravate your sleepiness. Consult your doctor if your sleepiness worsens.
Constipation:
Eat plenty of fiber rich foods such as fresh fruits, vegetables and cereals and drink plenty of water. Exercise more regularly. Consult your doctor if the symptom did not improve.
WARNING & PRECAUTIONS
PREGNANCY
BOLOFEN XL 20MG CAPSULE is not recommended for use in pregnant women unless considered necessary by the physician. Therefore, consult your doctor before taking it.
BREASTFEEDING
BOLOFEN XL 20MG CAPSULE should be used with caution in breastfeeding women. Therefore, consult your doctor before taking it.
DRIVING AND USING MACHINES
Do not drive or operate any heavy tools or machines if you feel drowsy, dizzy or problems with your vision after taking BOLOFEN XL 20MG CAPSULE.
ALCOHOL
Avoid consumption of alcohol while taking BOLOFEN XL 20MG CAPSULE as it may make you feel dizzier or drowsier.
KIDNEY
BOLOFEN XL 20MG CAPSULE should be used with caution in patients with kidney problems. Therefore, consult your doctor before taking it.
LIVER
BOLOFEN XL 20MG CAPSULE should be used with caution in patients with liver problems. Therefore, consult your doctor before taking it.
ALLERGY
Do not take BOLOFEN XL 20MG CAPSULE if you are allergic to Baclofen.
LUNGS
BOLOFEN XL 20MG CAPSULE should be used with caution in patients with lung problems. Therefore, consult your doctor before taking it.
HEART DISEASE
BOLOFEN XL 20MG CAPSULE should be used with caution in patients with heart problems. Therefore, consult your doctor before taking it.
OTHERS
BOLOFEN XL 20MG CAPSULE is not recommended for use if you:
- have ever had a stomach ulcer
Before taking BOLOFEN XL 20MG CAPSULE, inform your doctor if you:
- have ever had stroke in the past
- have epilepsy (fits)
- have any mental illness
- have high blood pressure
- have Parkinson’s disease (shaking, stiffness and difficulty with walking or balance)
- have diabetes
- have difficulties in passing urine
- are an alcoholic or have a history of drug abuse or dependence
- are scheduled for any surgery in the upcoming days
Use in pediatrics:
BOLOFEN XL 20MG CAPSULE can be used in children and adolescents aged below 18 years if prescribed by the physician. However, it is not suitable for use in children weighing below 33kg of body weight. Therefore, consult your doctor for advice.
Use in geriatrics:
BOLOFEN XL 20MG CAPSULE should be used with caution in elderly patients. Therefore, consult your doctor before taking it.
INTERACTIONS
A. Drug - Drug interactions:
Before taking BOLOFEN XL 20MG CAPSULE, inform your doctor if you are taking any of the following medicines such as:
- other medicines used to relax muscles (Ex. tizanidine)
- medicines used to treat mood disorders or depression (Ex. lithium, amitriptyline)
- medicines used to treat high blood pressure (Ex. diltiazem)
- medicines used for pain management (Ex. ibuprofen, morphine)
- medicines used to treat Parkinson’s disease (Ex. levodopa or carbidopa)
- medicines used to treat allergies (Ex. promethazine)
- medicines used to induce sleep (Ex. temazepam)
- medicines used to treat fits (Ex. carbamazepine)
B. Drug- Food interactions:
BOLOFEN XL 20MG CAPSULE can be taken with food or milk.
Overdosage:
If you or anyone else accidentally took more BOLOFEN XL 20MG CAPSULE, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose might include increased drowsiness, difficulties in breathing, feeling faint, muscle weakness, confusion, hallucinations, fits, low blood pressure, slow heartbeat, nausea, vomiting, diarrhoea, excessive saliva production or reflex problems, etc.
SYNOPSIS
| Drug | : | Baclofen |
| Pharmacological Category | : | γ-Aminobutyric acid (GABA) mimetic |
| Therapeutic Indication | : | Muscle Spasms |
| Dosage Forms | : | Tablet, Capsule, Liquid |
MORE INFORMATION
- Keep BOLOFEN XL 20MG CAPSULE out of reach of children
- Store BOLOFEN XL 20MG CAPSULE below 25°C
FAQs ABOUT BOLOFEN XL 20MG CAPSULE
What is the use of BOLOFEN XL 20MG CAPSULE?
BOLOFEN XL 20MG CAPSULE is used to treat muscle spasms caused due to cerebral palsy, multiple sclerosis, stroke or due to any other nerve or spinal cord disorders.
How BOLOFEN XL 20MG CAPSULE works?
BOLOFEN XL 20MG CAPSULE is a muscle relaxant. It acts by increasing the effects of certain chemical messengers (such as GABA) in the spinal cord that induces muscle relaxation. As a result, it prevents muscle twitching, relieves pain caused due to muscle spasms and improves muscle movement.
How to take BOLOFEN XL 20MG CAPSULE?
Take BOLOFEN XL 20MG CAPSULE as advised by your physician. Swallow the medicine with a glass of water. Do not chew or crush the medicine. It is preferably taken with meals or milk to avoid nausea.
What is the best time to take BOLOFEN XL 20MG CAPSULE?
BOLOFEN XL 20MG CAPSULE can be taken during bedtime or while performing activities such as washing, dressing and shaving etc. However, your doctor will decide the best time to take BOLOFEN XL 20MG CAPSULE.
Can I stop taking BOLOFEN XL 20MG CAPSULE once I started feeling better?
No. Do not stop taking BOLOFEN XL 20MG CAPSULE without consulting your doctor as it may make your symptoms re-appear once again or can cause withdrawal symptoms such as increased muscle tightness, fast heart rate, fever, confusion, hallucinations or fits.
Can I take BOLOFEN XL 20MG CAPSULE daily?
Take BOLOFEN XL 20MG CAPSULE as advised by your physician. Your doctor will evaluate your health condition and suggests whether can you take BOLOFEN XL 20MG CAPSULE every day or not.
Will taking a higher dose of BOLOFEN XL 20MG CAPSULE be more effective?
No. Taking a higher dose of BOLOFEN XL 20MG CAPSULE will not be effective rather it would be making you drowsier. 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.
What to do if I forgot to take a dose of BOLOFEN XL 20MG CAPSULE?
If you forgot to take a dose of BOLOFEN XL 20MG CAPSULE, take it as soon as you remember. However, if it is time for the next dose of BOLOFEN XL 20MG CAPSULE, skip the missed dose and take the next one regularly. Do not take a double dose of BOLOFEN XL 20MG CAPSULE to compensate the missed ones. Consult your doctor for advice.
What are the side effects of BOLOFEN XL 20MG CAPSULE?
The most common side effects of taking BOLOFEN XL 20MG CAPSULE are drowsiness, confusion, weakness and feeling unsteady or shaky. Consult your doctor if any of the symptoms worsen.
Is BOLOFEN XL 20MG CAPSULE safe to use in children?
BOLOFEN XL 20MG CAPSULE can be used in children and adolescents aged below 18 years if prescribed by the physician. However, it is not suitable for use in children weighing below 33kg of body weight. Therefore, consult your doctor for advice.
What precautions do I need to follow while taking BOLOFEN XL 20MG CAPSULE?
Patients taking BOLOFEN XL 20MG CAPSULE must inform their doctor about their pre-existing disease conditions like stomach ulcers, kidney, heart or liver problems. Patients should also inform if they have diabetes, hypertension, fits, any mental illness, history of alcoholism or if they are pregnant or breast-feeding. Avoid alcohol consumption. Consult your doctor immediately if you feel extremely depressed with thoughts of committing suicide after taking BOLOFEN XL 20MG CAPSULE.
Who should not take BOLOFEN XL 20MG CAPSULE?
BOLOFEN XL 20MG CAPSULE not recommended for use in patients who are allergic to baclofen. It is also not suitable for use in patients with stomach ulcer or during pregnancy. Therefore, consult your doctor for advice.
Does BOLOFEN XL 20MG CAPSULE make me feel sleepy?
BOLOFEN XL 20MG CAPSULE may causes excessive sleepiness. Therefore, restrict yourself from engaging into hazardous activities that requires complete alertness. Do not drive or handle any heavy tools or machines. Also, avoid consumption of alcohol as it may make you feel more drowsy. Consult your doctor if sleepiness worsens.
Can I consume alcohol while taking BOLOFEN XL 20MG CAPSULE?
Avoid consumption of alcohol while taking BOLOFEN XL 20MG CAPSULE as it might make you feel dizzier and drowsier.
Is BOLOFEN XL 20MG CAPSULE safe to use in diabetic patients?
BOLOFEN XL 20MG CAPSULE may alter the blood sugar levels in your body. Therefore, it is necessary to inform your doctor if you have diabetes before taking BOLOFEN XL 20MG CAPSULE as a precaution. Your doctor will closely monitor you blood sugar levels to avoid the risk of side effects.
Can BOLOFEN XL 20MG CAPSULE be taken during pregnancy?
BOLOFEN XL 20MG CAPSULE should be used during pregnancy only if considered necessary by the physician. Therefore, consult your doctor before taking it.
Can the use of BOLOFEN XL 20MG CAPSULE affect the liver?
Yes. BOLOFEN XL 20MG CAPSULE may affect the way your liver work. It can elevate the levels of certain liver enzymes in your body. Therefore, it should be used with caution in patients with liver problems. Consult your doctor before taking it.
Can the use of BOLOFEN XL 20MG CAPSULE affect my sexual life?
BOLOFEN XL 20MG CAPSULE may rarely cause problems in erection and ejaculation in some individuals. Consult your doctor if it troubles you.
REFERENCES
1. KD. Tripathi. Drugs Acting on Peripheral (Somatic) Nervous System. Essentials of Medical Pharmacology. Seventh edition. 2013. Page – 358.
2. Shirin Ghanavatian; Armen Derian. Baclofen. NIH. National Library of Medicine. National Center for Biotechnology Information. PMC. PubMed Central. May 2022. [Accessed on 12th November 2022] https://www.ncbi.nlm.nih.gov/books/NBK526037/
3. Per Ertzgaard, MD, Claudia Campo, MS and Alessandra Calabrese, PhD. FFICACY AND SAFETY OF ORAL BACLOFEN IN THE MANAGEMENT OF SPASTICITY: A RATIONALE FOR INTRATHECAL BACLOFEN. Journal of Rehabilitation Medicine. January 2017. [Accessed on 12th November 2022] https://www.medicaljournals.se/jrm/content/html/10.2340/16501977-2211#:~:text=Baclofen%20was%20significantly%20more%20effective,25%2C%2026%2C%2030)
4. Accord. Electronic Medicines Compendium (EMC). [Revised in November 2020] [Accessed on 12th November 2022] https://www.medicines.org.uk/emc/files/pil.5728.pdf
5. NOVARTIS Pharmaceuticals Australia Pty Limited. Lioresal 10 and 25 mg. [Revised in March 2022]. [Accessed on 12th November 2022] https://www.guildlink.com.au/gc/ws/nv/cmi.cfm?product=nvclrsor10213
6. Camber Pharmaceuticals, Inc. Baclofen Tablet. Dailymed.com. [Revised in October 2021]. [Accessed on 12th November 2022] https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ce48b5de-92d3-424e-ba70-c1f2edb28f66
7. Central Drugs Standard Control Organisation. Baclofen tablets. Baclofen ER Capsule 10 mg/50 mg (Additional Strength). Baclofen E.R capsule (30mg). [Accessed on 12th November 2022] https://cdscoonline.gov.in/CDSCO/Drugs
USEFUL DIAGNOSTIC TESTS
- Random Blood Sugar (RBS)
- Liver Function Test (LFT)
PRODUCT DETAILS
ALTERNATE BRANDS
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