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Description

Naklofen Duo is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and other symptoms of arthritis of the joints (eg, osteoarthritis), such as inflammation, swelling, stiffness, and joint pain. However, Naklofen Duo does not cure osteoarthritis and will help you only as long as you continue to use it.

Naklofen Duo topical 3% gel is also used to treat actinic keratosis, a skin problem that may become cancerous if not treated. The exact way that topical Naklofen Duo helps this condition is unknown.Naklofen Duo topical solution is used to treat pain and swelling caused by osteoarthritis of the knees.Naklofen Duo topical patch is used to treat acute pain caused by minor strains, sprains, and contusions (bruises).Naklofen Duo is available only with your doctor’s prescription.

Why it’s used

Naklofen Duo Capsule is used to relieve pain and inflammatory conditions of joints. It is a prescription medicine. This medicine works by restricting the functions of natural enzymes (Cyclooxygenase -1 and Cyclooxygenase-2) in the body which prevents the release of inflammatory agents. Naklofen Duo is also used to relieve pain and inflammatory conditions caused by injuries and diseases affecting body movements. It is also used to relieve pain and inflammation associated with other painful conditions such as fracture, trauma, low back pain, dislocations, dental and other minor operation, tearing or stretching of tissue that connects bones and joints, or pulled muscle.
Naklofen Duo Capsule may also be taken in combination with other medicines to treat certain conditions as recommended by the doctor. Naklofen Duo Capsule is used together with opioid Analgesics for the management of mild to severe pain.
When not to use
Naklofen Duo Capsule cannot be used to treat pain that occurs after or before heart bypass surgery.
Nonsteroidal Anti-inflammatory Drugs
Naklofen Duo belongs to a class of medicines called Nonsteroidal Anti-inflammatory Drugs. Nonsteroidal anti-inflammatory drugs, also called as NSAIDs, help reduce fever, decrease pain, and prevent clotting of blood. NSAIDs also reduce inflammation in the body when used in higher doses.

How to use

Read the directions on the product label, patient guide, or medicine guide provided by the medicine company or your pharmacist before starting to use Naklofen Duo Capsule. If you have any questions related to this medicine, ask your doctor or pharmacist. Use this medicine as recommended by your doctor.
Pain medicines work best if they are used as soon as you feel any signs of pain. Naklofen Duo Capsule may not work well if you delay using it until the symptoms have worsened.
Naklofen Duo Capsule is used with or after food when taken by mouth.

Typical Dosage

The typical dose of Naklofen Duo is 100-200 mg in one day. This medicine is not known to be habit-forming.
This medicine should be used on an as-needed basis.
If using the delayed-release form of this medicine, do not crush or chew the medicine, unless indicated on the package. Crushing or chewing of the medicine can result in unpleasant taste resulting in patients not following the medicine schedule. Crushing or chewing can also release all of the medicine at once, resulting in a decrease of effectiveness and a possible increase in side-effects.
To decrease the possibility of side-effects, you might be recommended to use the extended-release form of this medicine by your doctor. The extended-release medicine helps in maintaining a steady level of the medicine in your body for a longer period of time. Do not crush or chew the medicine, unless indicated on the package or by your doctor.
Naklofen Duo injection is intended to use in the veins only. Inject over 15 seconds every 6 hours as desired.

Talk to Your Doctor

Talk to your doctor if you develop new symptoms.
Your doctor may recommend a lower initial dose of this medicine to see the impact of this medicine on the body. Please follow your doctor’s directions. A lower dose of this medicine may be recommended to reduce the risk of side-effects.

Use in Children

The safety and effectiveness of using Naklofen Duo Capsule in children has not been established.

Avoid Alcohol

Avoid the consumption of alcohol with Naklofen Duo.
Wash your hands thoroughly after handling or coming in contact with Naklofen Duo.

Storage

You should store Naklofen Duo Capsule at 20-25°C (68 to 77°F) for injection and at 15-30°C (59-86°F) for the tablet, away from moisture, and away from light. Store the medicine away from the reach of children and pets.
Medicines may be prescribed for uses other than those listed in the medicine guide. Do not use Naklofen Duo Capsule for conditions for which it was not prescribed. Do not give Naklofen Duo Capsule to other people who might have the same conditions or symptoms that you have. Self-medication may harm them.

How to take Naklofen Duo

Your dose and how often you take Naklofen Duo will depend on the following factors:
  • age
  • weight
  • patient’s health
  • response to the medicine

Naklofen Duo Dosage

Dosage for painful and stiff joints (osteoarthritis)

Adult
  • Recommended: 100-150 mg/day in divided doses (50 mg twice or thrice a day or 75 mg twice a day)

Dosage for swollen and painful joints (rheumatoid arthritis)

Adult
  • Recommended: 150-200 mg/day in divided doses (50 mg three or four times a day or 75 mg twice a day)

Dosage for inflammation of the spinal joints

Adult
  • Recommended: 100-125 mg/day, taken as 25 mg four times a day, with an extra dose of 25-mg at bedtime if necessary

Minimum Age

18 year

Overdose

What to do if you overdose on Naklofen Duo?
If you have taken more than the recommended dose of Naklofen Duo, an activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) may be given. Passing the contents of the bowels out of the body (osmotic cathartic) within 4 hours of ingestion with large overdose (5 to 10 times the usual dose) should be recommended.
Symptoms of an overdose of Naklofen Duo
If you use too much of this medicine, it could lead to dangerous levels of the medicine in your body. In such cases, symptoms of an overdose may include:
  • coma
  • drowsiness
  • fainting
  • high blood pressure
  • kidney failure
  • lethargy
  • nausea
  • slow and ineffective breathing
  • stomach and intestine bleeding
  • upper abdomen pain (epigastric pain)
  • vomiting
If you think you have overdosed on Naklofen Duo Capsule, call a poison control center immediately.

Precautions while using Naklofen Duo

Before you use Naklofen Duo, tell your doctor of your medical and health history including the following:
  • allergic-type reactions
  • asthma
  • heart disease
  • heart surgery
  • hives
  • stomach and intestinal bleeding
  • ulcer disease
Patients with asthma, hives, allergic-type reactions and ulcer disease may experience severe and rarely fatal allergic reactions. Patients with stomach and intestinal bleeding may experience severe stomach bleeding on using this medicine. Patients with a history of heart disease are at an increased risk of thrombotic heart disease, heart attack, and stroke.
Before you use Naklofen Duo, tell your doctor if you are allergic to it or its ingredients. Your doctor may prescribe an alternative medicine and update your medical records to record this information. Discuss with your doctor if you are allergic to aspirin, or other NSAIDs.
Before having any surgery, discuss with your doctor and dentist about medicines you use including prescription medicines, non-prescription medicines, and herbal supplements.
The use of Naklofen Duo Capsule may change hemoglobin. Blood deficiency (also known as anaemia) can occur in patients using this medicine. Check hemoglobin levels of patients who show any signs and symptoms of anemia.
The use of this medicine may change blood pressure. Using Naklofen Duo may lead to occurrence or worsening of high blood pressure. Blood pressure monitoring is required in the starting and during the course of therapy.
The use of Naklofen Duo Capsule may change transaminases (alanine transaminase and aspartate transaminase). Naklofen Duo increases transaminases levels in the liver which may lead to severe liver reactions. Monitor transaminases within 4 to 8 weeks after taking Naklofen Duo.
The use of this medicine may change bleeding time. Patients with bleeding disorders or taking anticoagulants may experience increased bleeding time when using Naklofen Duo. Such patients should be monitored for platelet function.
The use of this medicine may change Complete blood count. Bleeding can occur in patients taking Naklofen Duo and monitor signs and symptoms of bleeding. Check complete blood count in patients on long-term treatment with Naklofen Duo.

Use when Pregnant

Naklofen Duo is not safe for use in women who are pregnant. If you are pregnant or planning to become pregnant, you should discuss the impact on the fetus with your doctor before you start using this medicine. This medicine may cause harm to an unborn baby such as heart dysfunction (also known as premature closure of the ductus arteriosus). Naklofen Duo belongs to the NSAID class of medicines. NSAIDs should not be taken after 29 weeks of pregnancy as these medicines may cause serious harm to the unborn baby.

If Breastfeeding

Naklofen Duo Capsule should be used while breastfeeding only when required. It is not known whether this medicine passes into breast milk. This medicine should be used during breastfeeding only after considering the importance of the drug to the mother.

If trying to Conceive

Naklofen Duo may impact fertility in women. If you are trying to conceive, discuss with your doctor on the use of this medicine. Use of Naklofen Duo may decrease the conceiving abilities in women planning to become pregnant. Therefore, Naklofen Duo should be discontinued in women having difficulties in conceiving or who are receiving infertility treatment.

Alcohol

Limit drinking alcohol with Naklofen Duo. Consumption of alcohol may cause increased risk of stomach and intestinal bleeding.

Seizures

Naklofen Duo can make you feel sleepy. Be careful, especially while driving, while using heavy machinery, or when doing any activity that needs you to be completely alert. The consumption of alcohol with Naklofen Duo can worsen the sleepiness. Naklofen Duo may cause seizures in some people. Hence, you should discuss with your doctor before performing any activities where a loss of consciousness may cause harm to you or others.

Increase in Risk

This medicine may cause stomach bleeding. Regular use of tobacco or alcohol may increase the risk. Discuss with your doctor if you smoke and drink alcohol regularly. This medicine may increase your sensitivity to sunlight and make you prone to sunburn. If this happens, limit your time outdoors to prevent sunburn. Use a sunscreen and cover your skin.

Long-term Use

Long-term use of this medicine may lead to kidney disorder (Renal Papillary Necrosis), kidney damage, heart attack, stroke, ulcers, and stomach and intestinal bleeding.

Common Side-effects

Following are the common side-effects of this medicine:
  • abdominal pain
  • anorexia
  • diarrhea
  • dizziness
  • dyspepsia
  • flatulence
  • headache
  • nausea
  • rash
  • vertigo
  • vomiting

Infrequent and Rare Side-effects

Following are the infrequent and rare side-effects of this medicine:
  • abnormal sensations in the body
  • abnormal vision
  • accidental injury
  • angioneurotic swelling
  • back pain
  • blurred vision
  • body odor
  • chest pain
  • confusion
  • contact dermatitis
  • decreased appetite
  • diplopia
  • disturbances of sensation
  • drowsiness
  • dry mouth
  • ear pain
  • eye pain
  • feeling of discomfort
  • gastroenteritis
  • glossitis
  • haematuria
  • halitosis
  • hives
  • impotence
  • insomnia
  • irritability
  • lethargy
  • loss of hair
  • loss of hearing
  • melena
  • muscle pain
  • nightmare
  • painful swelling and sores inside the mouth
  • palpitation
  • presence of protein in the urine
  • pruritus
  • purple or red discolored spots on the skin
  • purple spotted allergic
  • skin discoloration
  • swelling
  • taste disturbances
  • tinnitus
  • tiredness
  • tremor
  • visual disturbance
  • weaken memory
  • weakness

ide-effects in Older Adults

Following are the side-effects of this medicine in elderly patients:
  • kidney insufficiency

Mild Allergic Reactions

Following are the symptoms of mild allergic reactions to this medicine:
  • asthma attack
  • hives
The medicine should be discontinued.

Serious Allergic Reactions

Following are the symptoms of serious allergic reactions to this medicine:
  • Stevens-Johnson Syndrome
  • exfoliative dermatitis
  • severe skin reaction
The medicine should be discontinued.
If you experience side-effects or notice other side-effects not listed above, contact your doctor for medical advice.

When should Naklofen Duo be not used?

Pain due to Heart Surgery

This medicine should not be given in patients for pain right before or after heart bypass surgery such as coronary artery bypass graft (CABG) surgery. These patients are at an increased risk of heart failure and stroke.

Allergic to Naklofen Duo, aspirin or other NSAIDs

This medicine should not be used in patients allergic to Naklofen Duo, aspirin or other NSAIDs. These patients may experience serious skin events such as redness and removal of the upper layer of the skin (exfoliative dermatitis), life-threatening drug-induced skin reaction and life-threatening skin reaction (Stevens-Johnson Syndrome), which may result in hospitalization. These patients may have the following symptoms if they use this medicine:
  • skin rash
  • injury in the mucous membrane (mucosal lesions)

History of asthma and hives

This medicine should not be given to patients with a history of asthma and hives. These patients may experience severe and fatal allergic reactions.

Kidney Failure

This medicine should not be given to patients with kidney failure.

Liver Failure

This medicine should not be given to patients with liver failure.

Stomach Ulcer

This medicine should not be given to patients with stomach ulcer.

Heart and Brain Disease

This medicine should not be given to patients with brain disease and heart disease such as heart failure and in reduced blood flow to limbs (peripheral arterial disease).