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FENSUPP 12.5 Suppositories 5's
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INTRODUCTION
FENSUPP 12.5 SUPPOSITORIES contains Diclofenac which belongs to the group of medicines called Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). It is used to treat pain and inflammation related to sprains, strains and other injuries, post-surgery, gout (excessive uric acid accumulation in joints), backache, rheumatoid arthritis (immune system attack on healthy cells by mistake, causing inflammation), osteoarthritis (flexible tissue at the ends of bones wears down), ankylosing spondylitis (spine inflammation), frozen shoulder, fractures, dislocations, and conditions affecting tendons (Ex. tendonitis, tenosynovitis, bursitis).
FENSUPP 12.5 SUPPOSITORIES is also used to treat juvenile chronic arthritis in children aged 1 to 12 years. During FENSUPP 12.5 SUPPOSITORIES treatment, your doctor may want to give you a check-up regularly.
FENSUPP 12.5 SUPPOSITORIES is not recommended for use in patients with liver or kidney failure, heart problems like heart attack, stroke, or bypass, blood circulation problems, stomach ulcer, holes, or bleeding, or trouble emptying the bowels, diarrhoea or rectal bleeding. Before using FENSUPP 12.5 SUPPOSITORIES, inform your doctor if you have liver, kidney, heart, or bleeding problems, diabetes, porphyria, asthma, or if you are going to have any surgery.
FENSUPP 12.5 SUPPOSITORIES is not recommended for use during pregnancy (especially in last 3 months) and should be used with caution in breastfeeding women. Your child’s doctor may adjust the dose of FENSUPP 12.5 SUPPOSITORIES based on child’s age, weight, and disease condition.
The most common side effects of using FENSUPP 12.5 SUPPOSITORIES are diarrhea, nausea, vomiting, headache, dizziness, skin rash, etc. Call your doctor if any of the symptoms worsen.
USES OF FENSUPP 12.5 SUPPOSITORIES
FENSUPP 12.5 SUPPOSITORIES is used to treat pain and inflammation related to:
- sprains, strains and other injuries, post-surgery, gout
- backache, rheumatoid arthritis, osteoarthritis, ankylosing spondylitis
- frozen shoulder, fractures, dislocations, conditions affecting tendons
- juvenile chronic arthritis (in children aged 1 to 12 years)
HOW FENSUPP 12.5 SUPPOSITORIES WORKS
FENSUPP 12.5 SUPPOSITORIES relieves pain and inflammation by inhibiting the synthesis of prostaglandins (chemicals responsible for inducing pain and inflammation).
DIRECTIONS FOR USE
Use FENSUPP 12.5 SUPPOSITORIES as advised by your physician. It is for rectal use only. Empty your bowels before inserting the medicine and wash your hands. Lie on one side with your knees upwards your chest and gently push FENSUPP 12.5 SUPPOSITORIES pointed end first into your back passage with your finger. Push it in as far as possible.
Put down your legs and, if possible, stay still for a few minutes, and then wash your hands again. Never take FENSUPP 12.5 SUPPOSITORIES by mouth. Your doctor will decide a proper dose and duration for you depending upon your age, body weight and disease condition.
SIDE EFFECTS OF FENSUPP 12.5 SUPPOSITORIES
COMMON
- loss of appetite, diarrhea
- spinning sensation, dizziness, headache
- spots or skin rash
- raised blood levels of liver enzymes
- irritation where the medicine is inserted
UNCOMMON
- fast or irregular heartbeat
- chest pain
RARE
- stomach ulcers or bleeding
- gastritis (inflamed, irritated or swollen stomach lining)
- drowsiness, tiredness
- blood in vomit or stools
- black, tarry stools
- asthma (wheezing, breathlessness, tight chest)
- skin rash and itching
- liver diseases including hepatitis and jaundice
Stop using FENSUPP 12.5 SUPPOSITORIES and contact your doctor immediately if you experience any of the following side effects:
- heart attack (sudden and crushing chest pain)
- heart failure (breathlessness, trouble breathing when lying down, swollen feet or legs)
- early signs of stroke (sudden numbness or weakness in the one side of face, arm or leg; sudden loss or disturbance of vision, speech difficulty, migraine like headache with or without disturbed vision)
- stomach pain, indigestion, nausea, vomiting, gas, heartburn
- bleeding in stomach or intestine (bleeding while emptying your bowel, blood in vomit, black tarry stools)
- allergic reactions (skin rash, itching, bruising, painful red areas, peeling or blister formation)
- bronchospasm (wheezing, breathlessness)
- swelling in face, lips, hands, fingers
- yellowing of skin or eyeballs
- persistent sore throat or high temperature
- sudden change in amount and color of urine
- mild cramping and tenderness in stomach
- Stevens-Johnson syndrome (serious condition with blistering of skin, mouth, eyes, genitals)
- chest pain because of serious allergic rection called Kounis syndrome
- mild cramping and tenderness of the stomach, starting shortly after beginning of treatment, followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of stomach pain
- easy bruising, frequent sore throats or infections
- weakness, slurry speech
HOW TO MANAGE SIDE EFFECTS
Nausea:
Take regular sips of a cold drink. Have ginger or peppermint tea. Stick to simple meals. Avoid eating oily or spicy foods. If symptom persists, contact your doctor.
Vomiting:
Get adequate rest. Drink lots of fluids, especially water. Have small sips if you feel sick. Eat when you feel like it – no need to eat or avoid any specific foods. If symptom persists, contact your doctor.
Diarrhoea:
Drink lots of fluids such as water or fruit juices so that you are sufficiently hydrated. If symptom persists, contact your doctor.
Stomach pain:
Try to rest and relax. Eat and drink slowly or try to eat smaller meals in small breaks. Keep a heat pad on your stomach. If symptom persists, contact your doctor.
Indigestion:
Keep your head and shoulders raised up while sleeping so that stomach acid won’t come up. Do not eat 3 to 4 hours before going to sleep and avoid tea, coffee, cola, or alcohol. If symptom persists, contact your doctor.
Headache:
Drink plenty of water and get adequate rest. Try to be relaxed and stress free. Call your doctor before taking any medicine for headache. If headache persists, consult your doctor.
Skin rash:
Avoid hot showers as it can further irritate your skin. Do not scratch the affected area. Use protective clothing when going outdoors. Regularly moisturize your skin. If symptom persists, contact your doctor.
WARNING & PRECAUTIONS
PREGNANCY
FENSUPP 12.5 SUPPOSITORIES is not recommended for use in pregnancy (during last 3 months). If you are pregnant, think you may be pregnant or are planning for a baby, consult your doctor before using FENSUPP 12.5 SUPPOSITORIES.
BREASTFEEDING
FENSUPP 12.5 SUPPOSITORIES should be used with caution in breastfeeding women. Consult your doctor before using it.
DRIVING AND USING MACHINES
Do not drive or operate any machines if you feel dizzy, tired or sleepy after using FENSUPP 12.5 SUPPOSITORIES.
KIDNEY
FENSUPP 12.5 SUPPOSITORIES is not recommended for use in patients with kidney failure. FENSUPP 12.5 SUPPOSITORIES should be used with caution in patients with other kidney problems. Consult your doctor for advice.
LIVER
FENSUPP 12.5 SUPPOSITORIES is not recommended for use in patients with liver failure. FENSUPP 12.5 SUPPOSITORIES should be used with caution in patients with other liver problems. Consult your doctor for advice.
ALLERGY
Do not use FENSUPP 12.5 SUPPOSITORIES if you are allergic to Diclofenac, aspirin, ibuprofen, other NSAIDs, or any of the other ingredients of this medicine.
LUNGS
FENSUPP 12.5 SUPPOSITORIES should be used with caution in patients having asthma. Consult your doctor for advice.
HEART DISEASE
FENSUPP 12.5 SUPPOSITORIES is not recommended for use in patients with heart failure, heart diseases such as heart attack, blood circulation problems, blockage in blood vessels to heart, and in patients who underwent operations to clear or bypass blockages. FENSUPP 12.5 SUPPOSITORIES should be used with caution in patients with angina (chest pain), high blood pressure, raised cholesterol or triglycerides or other heart problems. Consult your doctor for advice.
OTHERS
FENSUPP 12.5 SUPPOSITORIES is not recommended for use if you:
- have or had a stomach or intestinal ulcer, or bleeding in the gut
- had stomach or bowel issues after taking other NSAIDs
- have cerebrovascular disease like stroke or blockages in blood vessels to brain
- have trouble emptying the bowels, diarrhoea or rectal bleeding
Before using FENSUPP 12.5 SUPPOSITORIES, inform your doctor if you:
- have stomach or bowel problems like ulcerative colitis or Crohn’s disease
- have porphyria (a rare genetic condition)
- have any blood or bleeding disorder
- have smoking habit
- have diabetes
- have systemic Lupus Erythematosus (autoimmune condition causing joint pain and inflammation, fever, or skin rashes)
- had undergone or are going to have any gut surgery
Use in Paediatrics:
FENSUPP 12.5 SUPPOSITORIES should be used with caution in children. Your child’s doctor may adjust the dose based on child’s age, weight and disease condition. Consult your child’s doctor for advice.
Use in Geriatrics:
FENSUPP 12.5 SUPPOSITORIES should be used with caution in elderly patients. Consult your doctor for advice.
INTERACTIONS
A. Drug-Drug Interactions:
Before using FENSUPP 12.5 SUPPOSITORIES, inform your doctor if you are taking any of the following medicines:
- medicines used to treat diabetes (Ex. metformin, gliclazide)
- warfarin (used to dissolve blood clots)
- medicines used to remove excess water from body (Ex. spironolactone, furosemide)
- lithium (used for mental health problems)
- methotrexate (used in cancer treatment)
- medicines used to suppress immunity (Ex. ciclosporin, tacrolimus)
- medicines used for bacterial infections (Ex. trimethoprim, ofloxacin, ciprofloxacin)
- other medicines used for pain relief (ex. aspirin, ibuprofen)
- mifepristone (used to terminate pregnancy)
- medicines used to treat high blood pressure and other heart problems (ex. captopril, atenolol, metoprolol, digoxin)
- medicines used to suppress inflammation (Ex. prednisolone, hydrocortisone)
- medicines used in depression (Ex. citalopram, fluoxetine)
- phenytoin (used to treat fits)
- voriconazole (used to treat fungal infections)
- medicines used to lower cholesterol (Ex. colestipol, cholestyramine)
Overdosage:
If you or anyone else accidentally use too much of FENSUPP 12.5 SUPPOSITORIES, consult your doctor immediately or visit the nearby hospital.
SYNOPSIS
| Drug | : | Diclofenac |
| Pharmacological Category | : | Cyclooxygenase Inhibitors |
| Therapeutic Indication | : | Pain and inflammation |
| Dosage Forms | : | Tablet, Capsule, Dispersible tablet, Injection, Infusion, PFS, Eye drops, Gel, Spray, Solution, Liniment, Sachet, Patch, Suppository, Ointment, Spray |
MORE INFORMATION
- Keep FENSUPP 12.5 SUPPOSITORIES out of reach of children
- Store FENSUPP 12.5 SUPPOSITORIES below 30°C
FAQs ABOUT FENSUPP 12.5 SUPPOSITORIES
Is FENSUPP 12.5 SUPPOSITORIES safe to use in patients with high blood pressure?
FENSUPP 12.5 SUPPOSITORIES should be used with caution in patients with high blood pressure and those taking medicines for high blood pressure. Consult your doctor for advice. Your doctor will determine a proper dose of FENSUPP 12.5 SUPPOSITORIES or select a suitable alternative treatment for you according to your condition.
What if I forget to insert a dose of FENSUPP 12.5 SUPPOSITORIES?
If you forget to insert a dose of FENSUPP 12.5 SUPPOSITORIES, do it as soon as you remember. However, omit that dose if it's almost time for the next one. Do not insert FENSUPP 12.5 SUPPOSITORIES two times to make up for the missed dose.
Can FENSUPP 12.5 SUPPOSITORIES make me feel sleepy?
FENSUPP 12.5 SUPPOSITORIES can very occasionally make you feel sleepy or tired. In such case, do not drive or use any machineries after using FENSUPP 12.5 SUPPOSITORIES. Consult your doctor if sleepiness persists.
Can FENSUPP 12.5 SUPPOSITORIES cause bleeding?
FENSUPP 12.5 SUPPOSITORIES can rarely cause bleeding in stomach or intestine, characterized by bleeding while emptying your bowel, blood in vomit, or black tarry stools. See your doctor if you face any of these.
Can FENSUPP 12.5 SUPPOSITORIES be used during pregnancy?
FENSUPP 12.5 SUPPOSITORIES is not recommended for use in pregnancy (especially last 3 months). If you are pregnant, think you may be pregnant or are planning for a baby, consult your doctor before using it. Inform your doctor immediately if you become pregnant during treatment with FENSUPP 12.5 SUPPOSITORIES.
REFERENCES
1. KD. Tripathi. Nonsteroidal Anti-inflammatory Drugs and Antipyretic-Analgesics. Essentials of Medical Pharmacology. Eighth edition. 2019. Page – 221.
2. Toshiaki Nishihata, Hisayo Wada, Akira Kamada. Sustained-release of sodium diclofenac from suppository. International Journal of Pharmaceutics. ScienceDirect. December 1985. [Accessed on 19th August 2022] https://www.sciencedirect.com/science/article/abs/pii/0378517385900730
3. Rashid M, Jaruidi HM. The use of rectal diclofenac for post-cesarean analgesia. Saudi Medical Journal. Europe PMC. February 2000. [Accessed on 19th August 2022] https://europepmc.org/article/med/11533770
4. Novartis Pharma. Electronic Medicines Compendium (EMC). [Revised in September 2021] [Accessed on 19th August 2022] https://www.medicines.org.uk/emc/files/pil.1044.pdf
5. Novartis Pharma AG. Voltaren (Diclofenac suppositories). [Revised in May 2019] [Accessed on 19th August 2022] https://www.novartis.com/sg-en/sites/novartis_sg/files/VoltarenSuppositories-May%202019.SINv1-App120821.pdf
AUTHOR DETAILS
Written By Dr. Jeenal Rajani, Pharm.D.
Last updated on 08 Nov 2022 | 06:11 PM(IST)
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