INTRODUCTION

ZORIFEN MR TABLET is a combination of Aceclofenac and Cyclobenzaprine which belongs to the group of medicines called Non-steroidal anti-inflammatory drugs (NSAIDs) and Skeletal muscle relaxants respectively. It is used to relieve muscle spasm associated with acute, painful musculoskeletal conditions such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis (inflammation of the spine).

Osteoarthritis is defined as a progressive disorder affecting primarily weight-bearing joints, characterized by progressive worsening and loss of cartilage that join bones, pain, motion restriction, deformity and disability.

Rheumatoid arthritis is a long-term, progressive inflammatory disorder of unknown cause characterized by polyarticular (five or more joints) joint involvement and systemic symptoms like tiredness, weakness, fever, loss of appetite and joint pain.

Before taking ZORIFEN MR TABLET, inform your doctor if you have any severe kidney, heart, liver or thyroid problems or if you have stomach ulcers or bleeding problems.

ZORIFEN MR TABLET is not recommended for use in pregnancy. ZORIFEN MR TABLET is not recommended for use in breastfeeding women unless specifically directed by your doctor.

ZORIFEN MR TABLET is not recommended for use in children. The most common side effects of taking ZORIFEN MR TABLET are nausea and dizziness. Inform your doctor if any of the side effects worsen.

USES OF ZORIFEN MR TABLET

• Used to relieve muscle spasm associated with acute, painful musculoskeletal conditions such as osteoarthritis, rheumatoid arthritis and ankylosing spondylitis

HOW ZORIFEN MR TABLET WORKS

ZORIFEN MR TABLET is a combination of Cyclobenzaprine and Aceclofenac, which relieves pain and relaxes the muscles. Cyclobenzaprine is a muscle relaxant which works on the centers in the brain and spinal cord to relieve muscle stiffness or spasm and to improve pain and movement of muscles. Aceclofenac is a non-steroidal anti-inflammatory drug works by blocking the release of certain chemical messengers that cause pain and inflammation (redness and swelling).

DIRECTIONS FOR USE

Take ZORIFEN MR TABLET as advised by your doctor. Swallow the medicine as whole and do not crush or chew the medicine. Your doctor will decide the right dose depends on your age, body weight and disease condition.

SIDE EFFECTS OF ZORIFEN MR TABLET

HOW TO MANAGE SIDE EFFECTS

Nausea:

Take ZORIFEN MR TABLET with or just after meals. Stick to simple meals. Avoid eating oily or spicy food.

Dizziness:

Lie down until dizziness is gone, then get up slowly. Move slowly and carefully, do not hurry. Get adequate rest. Drink plenty of fluids, especially water.

Diarrhea:

Drink lots of fluids, such as water or fruit juice to keep yourself hydrated. Do not consume any medicine on your own without consulting your doctor.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug - Drug interactions:

Before taking ZORIFEN MR TABLET, inform your doctor if you are taking any of the following medicine:

• medicines used to treat depression (Ex. amitriptyline, nortriptyline, selegiline, duloxetine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline)
• medicines used to induce sleep (Ex. pentobarbital, phenobarbital)
• medicines used to relive moderate to severe pain (Ex. tramadol, meperidine)
• medicines used to lower blood pressure (Ex. verapamil, guanethidine, enalapril, lisinopril, losartan, candesartan, hydralazine, methyldopa, clonidine, moxonidine, propranolol, furosemide)
• bupropion (used in smoking cessation)
• lithium (used to treat mood disorders)
• medicines used to treat infections (Ex.  ciprofloxacin, ofloxacin, levofloxacin moxifloxacin)
• medicines used to prevent blood clotting (Ex. warfarin, heparin, clopidogrel)
• methotrexate (used to treat cancer and autoimmune disorders such as arthritis and skin conditions)
• mefipristone (used to terminate early pregnancy)
• medicines used to treat swelling and inflammation (Ex. hydrocortisone, prednisolone)
• medicines used to suppress the immune system after organ transplant (Ex. ciclosporin, tacrolimus)
• zidovudine (used to treat HIV infection)
• medicines used to lower high blood sugar levels (Ex. glibenclamide, gliclazide, tolbutamide)
• painkillers (Ex. aspirin, ibuprofen, naproxen, celecoxib, etoricoxib)

Overdosage:

If you or anyone else accidentally takes too much of ZORIFEN MR TABLET contact your doctor immediately. Symptoms of overdose include drowsiness, fast heartbeat, headache, nausea, vomiting, stomach pain, gastrointestinal irritation or bleeding.

SYNOPSIS

MORE INFORMATION

• Keep ZORIFEN MR TABLET out of reach of children
• Store below 30°C

FAQs ABOUT ZORIFEN MR TABLET

Can ZORIFEN MR TABLET be used in infants?

No. ZORIFEN MR TABLET is not recommended for children. Your doctor will decide the correct dose or select a suitable alternative therapy for your child.

Is ZORIFEN MR TABLET safe in pregnancy?

ZORIFEN MR TABLET is not recommended for use in pregnancy. If you are pregnant, think you may be pregnant or are planning to get pregnant, inform your doctor before taking this medicine.

Can ZORIFEN MR TABLET be crushed?

No. Do not break, crush or chew ZORIFEN MR TABLET. Simply swallow it whole with a glass of water. Your doctor will decide the right dose depends on your age, body weight and disease condition.

Can ZORIFEN MR TABLET be stopped?

Continue taking ZORIFEN MR TABLET until your doctor tells you to stop, unless you experience any unwanted effects like nausea, vomiting, fever, tiredness, stomach pain, trouble breathing or swallowing, worsening of your condition or any new symptoms. In such case, contact your doctor right away.

What precautions do I need to follow while taking ZORIFEN MR TABLET?

Patients taking ZORIFEN MR TABLET must inform their doctor about their pre-existing disease conditions like kidney, liver, thyroid or heart problems. Patients should also inform if they are pregnant, breast-feeding, having any allergies, stomach ulcers or bleeding problems. You should avoid drinking alcohol while taking ZORIFEN MR TABLET. Contact your doctor immediately if you have any abnormal symptoms.

Can ZORIFEN MR TABLET cause nausea?

Yes. ZORIFEN MR TABLET may cause nausea. If you feel nauseous, take ZORIFEN MR TABLET with or just after meals. Stick to simple meals. Avoid eating oily or spicy food. Consult your doctor if you experience persistent nausea.

What if I forget to take a dose of ZORIFEN MR TABLET?

If you forget to take a dose of ZORIFEN MR TABLET, take it as soon as you remember and then continue your treatment as usual. Do not take the medicine twice to make up for the forgotten dose. If you have any further doubts, contact your doctor.

REFERENCES

1. Barbara G. Wells, Joseph T. DiPiro, Terry L. Shwinghammer, Cecily V. DiPiro. Osteoarthritis. Rheumatoid Arthritis. Pharmacotherapy handbook. Ninth edition. Page- 926.

2. Adare Pharmaceuticals, Inc. U.S. Food & Drug Administration. [Revised in April 2019] [Accessed on 23rd May 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021777s017lbl.pdf

3. Taj Life Sciences. Aceclofenac Tablets 200 mg. [Accessed on 23rd May 2022] https://tajlifesciences.com/portfolio/aceclofenac-200-mg/

4. Unison Pharmaceuticals Pvt. Ltd. Aceclofenac Controlled Release Tablets 200 mg. [Revised in March 2020] [Accessed on 23rd May 2022] https://www.nafdac.gov.ng/wp-content/uploads/Files/SMPC/a_v7/6.-SmPC-AKILOS.pdf

5. Cyclobenzaprine hydrochloride. Dailymed. [Revised in November 2021] [Accessed on 23rd May 2022] https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b2169957-9083-412c-a175-3071860c2b43

6. Cyclobenzaprine. Medline Plus. [Revised in February 2017] [Accessed on 23rd May 2022] https://medlineplus.gov/druginfo/meds/a682514.html#:~:text=Cyclobenzaprine%20is%20in%20a%20class,allow%20the%20muscles%20to%20relax

USEFUL DIAGNOSTIC TESTS

• Complete blood count (CBC)