Buvalor 20mg Patch 2’S

What is BUVALOR 20MG?

BUVALOR 20MG contains Buprenorphine which belongs to a group of medicines called analgesics.

What BUVALOR 20MG is used for?

It is used to relieve moderate, long-lasting pain

Warning & Precautions

Talk to your Doctor if you:

• Are allergic to any of the other ingredients of this medicine
• Have breathing problems
• Suffer from myasthenia gravis (a condition in which the muscles become weak)
• Have previously suffered from withdrawal symptoms such as agitation, anxiety, shaking or sweating upon stopping taking alcohol
• Suffer from seizures
• Have a severe headache or feel sick due to a head injury or increased pressure in your skull (for instance due to brain disease)
• Are feeling light-headed or faint
• Have severe liver problems
• Have ever been addicted to drugs or alcohol
• Have a high temperature
• Have recently had an operation

Pregnancy & Breast Feeding If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Children & Adolescents This medicine is not recommended to children and adolescents below 18 years. Driving & Using Machines Do not drive or operate any machines while taking this medicine as it may cause dizzy, drowsy or have blurred vision.

Interactions

Tell your doctor if you are taking,

• Drugs used to treat depression
• Drugs used to treat seizures
• Rifampicin (used to treat tuberculosis)
• Medicines to treat pain, anxiety, psychiatric or mental disorders
• Clonidine (used to treat blood pressure)
• Codeine, dextromethorphan, noscapine (used to treat cough and cold)
• Antihistamines (used to treat allergies)
• Halothane (used to start or maintain anaesthesia)

Directions & For Use

• Always take this medicine exactly as your doctor has told you
• This medicine is for transdermal use only
• Do not cut or divide the patch or use a higher dose than recommended. You should not apply more than two patches at the same time
• Attach one patch and change it every seventh day, preferably at the same time of day

Before Applying Buprenorphine patch:

• Choose an area of non-irritated, intact skin on your upper arm, outer arm, upper chest, upper back or side of the chest, ask for assistance if you cannot apply the patch yourself
• This patch should be applied to a hairless skin site
• If no suitable hair free sites are available, the hairs should be cut off with a pair of scissors Do not shave them off
• Avoid skin which is red, irritated or has any other blemishes, for instance large scars
• The area of skin you choose must be dry and clean. If necessary, wash it with cold or lukewarm water. Do not use soap, alcohol, oil, lotions or other detergents. After a hot bath or shower, wait until your skin is completely dry and cool. Do not apply lotion, cream or ointment to the chosen area. This might prevent your patch from sticking properly

Applying Buprenorphine patch

• Each transdermal patch is sealed in a sachet. Just before use, cut the sachet along the sealed edge with scissors. Take out the transdermal patch. Do not use the patch if the sachet seal is broken
• The sticky side of the transdermal patch is covered with a transparent protective foil. Carefully peel off one part of the foil. Try not to touch the sticky part of the transdermal patch
• Stick the transdermal patch on to the area of skin you have chosen and remove the remaining foil
• Press the transdermal patch against your skin with the palm of your hand and count slowly to 30 Make sure that the whole transdermal patch is in contact with your skin, especially at the edges

Wearing the transdermal patch

• You should wear the patch for seven days. If the edges of the patch begin to peel off, they may be taped down with a suitable skin tape
• Do not expose the patch to extreme heat (e.g. heating pads, electric blanket, heat lamps, sauna, hot tubs, heated water beds, hot water bottle), external heat may also prevent the patch from sticking properly. If you have a high temperature this may alter the effects of this medicine
• In the unlikely event that your patch falls off before it needs changing, do not use the same patch again. Stick a new one on straight away

Changing the transdermal patch

• Take the old transdermal patch off
• Fold it in half with the sticky side inwards
• Open and take out a new patch. Use the empty sachet to dispose of the old patch. Now discard the sachet safely
• Stick a new transdermal patch on a different appropriate skin site
• You should not apply a new patch to the same site for 3-4 weeks
• Remember to change your patch at the same time of day. It is important that you make a note of the time of day

If you use more BUVALOR 20MG

• If you use more patches than you should, call your doctor or hospital straight away
• Symptoms of overdose: sleepy and sick, breathing difficulties or loss of consciousness

If you forget to use BUVALOR 20MG

• Stick a new patch on as soon as you remember. Also make a note of the date, as your usual day of changing may now be different
• Do not apply additional patches to make up for the forgotten application

If you stop using BUVALOR 20MG

• Do not stop using this patch until your doctor tells to do so

Side Effects

Serious Wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body. Common

• Headache, dizziness, drowsiness
• Constipation, feeling sick
• Itchy skin, rash, redness, inflammation or swelling of the skin at the application site
• Loss of appetite
• Confusion, depression, anxiety, difficulty in sleeping, nervousness, shaking (tremors)
• Shortness of breath
• Abdominal pain or discomfort, diarrhoea, indigestion, dry mouth
• Sweating, rash, skin eruptions
• Tiredness, a feeling of muscle weakness, swelling of hands, ankles or feet

Uncommon

• Mood swings, restlessness, agitation, a feeling of extreme happiness, hallucinations, nightmares
• Changes in taste, difficulty in speaking, reduced sensitivity to pain or touch, tingling or numbness
• Loss of memory, migraine, fainting, problems with concentration or co-ordination
• Dry eyes, blurred vision
• A ringing or buzzing sound in the ears, a feeling of dizziness or spinning
• High or low blood pressure, chest pain, fast or irregular heartbeat
• Cough, hiccups, wheezing
• Dry skin, spasms, aches and pains
• Difficulty in beginning the flow of urine
• Inability to fully empty the bladder

Rare

• Angina (chest pain associated with heart disease)
• Mental disorder
• Swelling of the eyelids or face, a reduction in size of the pupils in the eye
• Difficulty in breathing, worsening of asthma
• A feeling of faintness, especially on standing up
• Difficulty in swallowing
• Local allergic reaction
• Swelling and irritation inside the nose
• Decreased erection, sexual dysfunction
• Flushing of the skin

Very Rare

• Muscle twitching
• Ear pain
• Blisters