4.6 mg / 24 hours, 9.5 mg / 24 hours and 13.3 mg / 24 hours Depot patches
Rivastigmine
What Orivast is and what it is used for
The active substance in Orivast is rivastigmine.
Rivastigmine belongs to a class of substances called cholinesterase inhibitors. In patients with Alzheimer’s dementia, certain nerve cells in the brain die. This leads to low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other). Rivastigmine works by blocking the enzymes that break down acetylcholine ( acetylcholinesterase and butyrylcholinesterase). By blocking these enzymes, rivastigmine increases the levels of acetylcholine in the brain, thus helping to reduce the symptoms of Alzheimer’s disease.
Orivast is used to treat adult patients with mild to moderate Alzheimer’s dementia, a progressive brain disease that gradually affects memory, intellectual ability, and behavior.
Rivastigmine contained in Orivast may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before using Orivast
Do not use Orivast
- if you are allergic to rivastigmine (the active substance of Orivast) or any of the other ingredients of this medicine (listed in section 6).
- if you have ever had an allergic reaction to a similar type of medicine (carbamate derivatives).
- if you get a skin reaction that spreads beyond the size of the patch, if a more intense local reaction occurs (eg blisters, increasing skin inflammation, swelling) and if it does not improve within 48 hours after removal of the transdermal patch.
If this applies to you, talk to your doctor and do not use Orivast transdermal patches.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Orivast:
- if you have, or have ever had, irregular heartbeat or other heart disease.
- if you have, or have ever had, an active stomach ulcer .
- if you have, or have ever had, difficulty urinating.
- if you have, or have ever had, seizures.
- if you have, or have ever had, asthma or severe respiratory problems.
- if you suffer from tremors.
- if you have low body weight.
- if you get reactions from the stomach or intestines such as. nausea, vomiting and diarrhea. You may become dehydrated (lose too much fluid) if vomiting or diarrhea persists for a long time.
- if you have impaired liver function.
If any of the above applies to you, your doctor may need to check you more closely when you are being treated with this medicine.
If you have not used a patch for more than three days, do not put on a new one until you have talked to your doctor.
Children and young people
There is no relevant use of Orivast in a pediatric population in the treatment of Alzheimer’s disease.
Other medicines and Orivast
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Orivast may affect other anticholinergic medicines, some of which are medicines for stomach cramps or seizures (eg dicyclomine), medicines to treat Parkinson’s disease (eg amantadine), or medicines to prevent motion sickness (eg diphenhydramine, scopolamine, meclozine).
Orivast transdermal patches should not be co-administered with metoclopramide (a medicine used to relieve or prevent nausea or vomiting). Taking both medicines at the same time can cause problems such as stiff joints or tremors in the hands.
If you are going to have surgery while using Orivast transdermal patches, tell your doctor that you are using the medicine, as Orivast transdermal patches may potentiate the effects of certain muscle relaxants during anesthesia.
Caution should be exercised when taking Orivast transdermal patches concomitantly with beta-blockers (medicines such as atenolol for high blood pressure, angina, and other heart conditions). Taking both medicines at the same time can cause problems such as a slower heartbeat ( bradycardia ), which can lead to fainting or unconsciousness.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant, the benefits of using Orivast must be weighed against the possible effects on your unborn baby. Orivast should not be used during pregnancy unless necessary.
You should not breastfeed while you are being treated with Orivast transdermal patches.
Driving and using machines
Your doctor will tell you if you can drive and use machines safely when you have this disease. Unripe transdermal patches can cause fainting spells or you may feel very confused. If you feel dizzy or confused, do not drive, use machines or perform any other tasks that require your attention.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Orivast
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
IMPORTANT:
- Remove the previous day’s patch before putting ONE new patch .
- Use only one patch per day.
- Do not cut the patch into pieces.
- The patch should be pressed firmly with the palm of your hand for at least 30 seconds.
How to start the treatment
Your doctor will tell you which Orivast transdermal patch is most suitable for you.
- Treatment is usually started with Orivast 4.6 mg / 24 hours.
- The usual recommended daily dose is Orivast 9.5 mg / 24 hours per day. If this dose is well tolerated, your doctor may increase the dose to 13.3 mg / 24 hours.
- Use only one Orivast patch at a time and replace the patch with a new one after 24 hours.
During treatment, your doctor may need to adjust your dose to suit your individual needs.
If you have not used a patch for more than three days, do not apply the next patch until you have talked to your doctor. The treatment with transdermal patches can be resumed with the same dose if the treatment has only been interrupted for a maximum of three days. Otherwise, your doctor will restart your treatment with Orivast 4.6 mg / 24 hours.
Urivast can be used with food, drink, and alcohol.
Where should your Orivast transdermal patch be affixed
- Before applying the patch, make sure that the skin is clean, dry and hair-free, free of powder, oil, moisturizer or lotion, which may prevent the patch from adhering properly to the skin, free from scratches, rashes and / or irritation.
- If you are already using patches , remove what you are wearing before applying a new one.
- If you have several patches attached to your body at the same time, you may receive an overdose of the medicine, which can be potentially dangerous.
- Apply ONE patch per day in ONLY ONE of the possible locations shown in the following diagram:
- left upper arm or right upper arm
- left or right side of the upper part of the chest ( avoid the breasts themselves )
- left or right side of the upper back
- left or right side of the lower back
Remove the previous day’s patch after 24 hours before putting ONE new patch in ONLY ONE of the following possible places.
When changing patches, you must remove the previous day’s patch before applying the new patch to a new spot on the skin each time (eg on the right side of the body one day, on the left side the next day, on the upper part of the body one day, on the lower part of the body the next day). Do not put a new patch on the same skin surface twice within 14 days.
How to attach your Orivast transdermal patch
Orivast patches are thin, opaque plastic patches that are attached to the skin. Each patch is sealed in a patch envelope, which protects it until it is put on. Do not open the patch envelope or remove the patch until just before you apply it.
- If you are already using patches , carefully remove what you are wearing before applying a new one.
Patients starting treatment for the first time or starting Orivast again after stopping treatment, please start at the next picture.
- Each patch is individually packaged in a sealed patch envelope.
Only open the patch envelope when you are ready to apply the patch.
Cut up the patch envelope along the dotted line and remove the patch from the patch envelope.
- A protective film covers the adhesive side of the patch.
Slowly pull off the overlapping part of the protective film, from top to bottom . Do not apply the adhesive part of the patch.
- Attach the adhesive side of the patch to the upper or lower part of the back, upper arm or chest, and slowly pull off the other part of the protective film from top to bottom . Then press the patch firmly in place for 30 seconds with the palm of your hand and make sure that the edges adhere properly.
- Then press the patch firmly in place for 30 seconds with the palm of your hand and make sure that the edges adhere properly.
If it is helpful, you can write e.g. what a weekday it is with a thin ballpoint pen on the patch.
The patch should be used all the time until it is time to change to a new one. Feel free to try to find different places to attach the patches, places that feel comfortable for you, and where the clothes do not rub against the patch.
How to remove your Orivast transdermal patch
Gently grasp one edge of the patch and slowly pull it away from the skin. If adhesive remains on the skin, you can moisten the area with warm water and mild soap or use baby oil to remove them. Alcohol or other dissolving liquids (nail polish remover or other solvents) should not be used.
You should wash your hands with soap and water when the patch has been removed. If the patch comes in contact with the eyes, or if the eyes turn red after handling the patch, rinse immediately with plenty of water and consult a physician if symptoms persist.
Can you use your Orivast transdermal patch when bathing, swimming, or sunbathing?
- Bathing, swimming or showering should not affect the patch. Make sure that the patch does not come off on such occasions.
- Do not expose the patch to external heat sources (eg excessive sunbathing, sauna, solarium) for a long time.
What to do if Orivast transdermal patches fall off
If a patch falls off, apply a new one for the rest of the day, then change to a new one again at the usual time the next day.
When and for how long should you use your Orivast transdermal patch
- To benefit from your treatment, you need to put on a new patch every day, preferably at the same time every day.
- Use only one patch at a time and replace the patch with a new one after 24 hours.
If you use more Orivast than you should
If you inadvertently apply more than one patch, remove all patches from the skin and tell your doctor that you accidentally applied more than one patch. You may need medical attention. Some people who have inadvertently used too much rivastigmine have experienced nausea, vomiting, diarrhea, high blood pressure, and hallucinations. Slow heart rate and fainting spells can also occur.
If you have ingested too much medicine or if e.g. If a child has ingested the medicine, contact a doctor or hospital by mistake for assessment of the risk and advice.
If you forget to use Orivast
If you find that you have forgotten to apply a patch, apply a new one immediately. You can apply the next patch at the usual time the next day. Do not apply two patches to compensate for a forgotten patch.
If you stop using Orivast
If you stop using the patch, talk to your doctor or pharmacist.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You will likely experience some side effects, especially when you start treatment or when your dose is increased. Usually, the side effects gradually disappear when the body gets used to the drug.
Remove the patch and contact your doctor immediately if you get any of the following side effects that may be serious:
Common (may affect up to 1 in 10 people)
- Loss of appetite ( anorexia )
- Dizziness
- Fainting
- Feeling of agitation or fatigue
- Concern
- Depression
- Impaired orienteering ability
- Urinary incontinence (inability to retain urine)
- Urinary tract infection
- Headache
- Rash
- Nausea, vomiting, diarrhea, upper abdominal pain, abdominal pain
- Allergic reaction where the patch has been applied, such as blisters or inflammation of the skin
- Fever ( pyrexia )
- Weight loss
Uncommon (may affect up to 1 in 100 people)
- Heart rhythm disorders (both fast and slow heartbeats)
- Gastric ulcer
- Dehydration (fluid loss)
- Hyperactivity (high activity, restlessness)
- Aggressiveness
Rare (may affect up to 1 in 1,000 people)
- Case
Very rare (may affect up to 1 in 10,000 people)
- Impaired mobility such as stiffness in arms or legs or tremors in hands
No known frequency (frequency can not be calculated from available data)
- Worsening of the symptoms of Parkinson’s disease – such as trembling, stiffness, sluggish gait
- Inflammation of the pancreas (symptoms include severe pain in the upper abdomen, usually with nausea and vomiting)
- Fast or irregular heartbeat
- High blood pressure
- Cramps (seizures)
- Disorders of liver function (yellowing of the skin, yellowing of the whites of the eyes, abnormal dark urine or unexplained nausea, unexplained vomiting, fatigue and loss of appetite)
- Elevated liver values
- Feeling of restlessness
- Seeing things that are not real (hallucinations)
- Skin reactions ( itching , rash, hives , vesicles)
- Allergic skin reaction
- Tremor (shaking)
- Somnolence (strong desire to sleep)
- Nightmares
Remove the patch and contact your doctor immediately if you get any of the above side effects.
Additional side effects that have been seen with rivastigmine capsules or oral solution and that may occur with the patch:
Common (may affect up to 1 in 10 people)
- General malaise
- Feeling of confusion
- Increased sweating
Rare (may affect up to 1 in 1,000 people)
- Intestinal ulcers
- Chest pain – can be caused by heart attack
Very rare (may affect up to 1 in 10,000 people)
- Gastrointestinal bleeding (manifests as blood in the stool or on vomiting)
No known frequency (frequency can not be calculated from available data)
- Some people who have had severe vomiting have had stretch marks in the esophagus
How to store Orivast
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the carton after EXP. and on the patch envelope after EXP.The expiration date is the last day of the specified month.
- Keep the patch in the patch envelope until use. Sensitive to light.
- No special temperature instructions .
- Do not use the patch if you see that it is damaged or if the patch envelope shows signs of opening.
- After removing the patch, fold it double with the adhesive side inwards and press together. Put the used patch back in the plaster envelope and throw it away so that children cannot get hold of it. Do not poke in the eyes with your fingers and wash your hands with soap and water after removing the patch. If your home municipality burns household waste, you can dispose of the patch together with the household waste. Otherwise, return used patches to the pharmacy, preferably in the original packaging.
Contents of the pack and other information
Content declaration
- The active substance in Orivast transdermal patch is rivastigmine.
- Unrivaled 4.6 mg / 24 hours: Each patch that releases 4.6 mg of rivastigmine per 24 hours is 5 cm 2 and contains 9 mg of rivastigmine.
- Unrivaled 9.5 mg / 24 hours: Each patch delivering 9.5 mg rivastigmine per 24 hours is 10 cm 2 and contains 18 mg rivastigmine.
- Univast 13.3 mg / 24 hours: Each patch that releases 13.3 mg rivastigmine per 24 hours is 15 cm2 and contains 27 mg rivastigmine.
- The other ingredients are polyester film, acrylic adhesive, poly (butyl methacrylate-co-methyl methacrylate), silicone adhesive, polyester film coated with fluorine and black printing ink.
What the medicine looks like and contents of the pack
Each transdermal patch is thin and consists of three layers. The outside is semi-transparent, white, and marked with “Rivastigmine” and “4.6 mg / 24h” or “9.5 mg / 24h” or “13.3 mg / 24h”.
Each transdermal patch is sealed in a patch envelope. The patches are available in packs of 7, 30, 60, or 90 transdermal patches and multi-packs of 60 (2×30) or 90 (3×30) transdermal patches.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Orifarm Generics A / S
Energizer 15
DK-5260 Odense S.
Denmark
Manufacturer
Orifarm Generics A / S
Energizer 15
DK-5260 Odense S.
Denmark
info@orifarm.com
and
PHAST Society for Pharmaceutical Quality Standards MBH
Kardinal-Wendel-Strasse 16
66424 Homburg
Germany
Local representative
Orifarm Generics AB
Box 56048
102 17 Stockholm
info@orifarm.com
This medicinal product is authorized under the European Economic Area under the names:
Denmark, Sweden, Norway: Orivast