| Transiderm-Nitro 10 mg/24 hours transdermal patch |
| Glyceryl trinitrate |
WHAT TRANSIDERM-NITRO IS AND WHAT IT IS USED FOR
Transiderm-Nitro widens the blood vessels and thus facilitates the work of the heart.
Transiderm-Nitro is a patch intended for the delivery of nitroglycerin through the skin and into the blood. The active substance is stored in the patch and is released at a steady and low rate for at least 24 hours.
Transiderm-Nitro is used to prevent angina pectoris from occurring in the heart.
BEFORE USING TRANSIDERM-NITRO
Do not use Transiderm-Nitro
– if you are allergic (hypersensitive) to glyceryl nitrate, other nitrates, or to any of the other ingredients in Transiderm-Nitro
– if you are simultaneously treated with phosphodiesterase type 5 (PDE5) inhibitors, e.g. sildenafil for impotence.
– if you have affected blood circulation with very low blood pressure ( shock ) or systolic blood pressure below 90 mmHg
– if you are severely dehydrated.
– if you have heart muscle disease due to a blockage in the heart (such as aortic/mitral stenosis )
– if you have inflammation of the pericardium (pericarditis) or fluid accumulation in the pericardium ( pericardial tamponade )
– if you have increased pressure in the skull
Be especially careful with Transiderm-Nitro
Consult a doctor before starting treatment with Transiderm-Nitro if you:
– have a lack of blood ( anemia )
– have a lack of oxygenation of the blood ( hypoxemia )
– have any disease that affects oxygenation and blood flow (e.g. heart failure or lung disease)
– have recently had a heart attack or acute heart failure
– have low blood pressure
– have the cerebrovascular disease (e.g. cerebral hemorrhage or blood clot in the brain)
– have other cardiovascular diseases
– has reduced thyroid function
To think about during the treatment:
– During periods without a patch, the angina may worsen, contact your doctor if this happens to you.
– If tolerance develops to the patch, the effect of nitroglycerin used under the tongue during exertion can be reduced.
– It is important that you inform the healthcare staff that you are using Transiderm-Nitro during a possible hospital visit. The patch contains an aluminum layer and must be removed before the body is exposed to magnetic fields or electroconvulsive therapy.
Use of other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Medicines against impotence, so-called phosphodiesterase inhibitors type 5 (PDE5), e.g. sildenafil should not be used during treatment with Transiderm-Nitro.
Transiderm-Nitro can affect or be affected by certain medicines used in the treatment of:
– depression (tricyclic antidepressants)
– mental illness (antipsychotic drugs)
– high blood pressure, for example, calcium antagonists, ACE inhibitors, beta-receptor blockers, diuretics
– cancer (amifostine)
– pain, fever, and inflammation known as NSAIDs and acetylsalicylic acid
– migraine (dihydroergotamine)
Use of Transiderm-Nitro with food and drink
Be careful with the simultaneous use of alcohol and Transiderm-Nitro because the blood pressure-lowering effect of Transiderm-Nitro can be enhanced by the simultaneous intake of alcohol.
Pregnancy and breastfeeding
Limited experience with the use of Transiderm-Nitro during pregnancy. Therefore, consult a doctor before use during pregnancy.
It is not known whether Transiderm-Nitro passes into breast milk. Therefore, consult a doctor before use during breastfeeding.
Driving ability and use of machinery
You should not drive a car or use tools and machines if you experience side effects that may affect your ability to react, such as dizziness and a drop in blood pressure.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. 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. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
3. HOW TO USE TRANSIDERM-NITRO
The dose is determined by the doctor, who adjusts it individually for you. Always use Transiderm-Nitro as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The usual dose is 5-10 mg/24 hours (one transdermal patch per day).
With repeated treatment, the effect can be weakened. To avoid this, a break of 8-12 hours is made, during the symptom-free part of the day, by e.g. removing the patch at bedtime and putting on a new one again in the morning.
Instructions for use
Each Transiderm-Nitro comes in an airtight inner package.
1. Tear (do not cut) the notch and remove the patch.
2. Fold down the small flap and slowly pull off the entire white protective plastic (see fig. AB).
3. Attach the patch to a dry, clean and hair-free area on the side of the chest by pressing it against the skin for at least 10-15 seconds. The patch is changed every day and a new patch is then attached to a new place on the chest. The same place should not be used again until after a few days to reduce the risk of skin problems. The skin surface where the patch is attached should not be red or irritated or smeared with skin lotion or cream. If the patch comes off, you can try to attach it again. If that doesn’t work, get a new one and attach it to a new skin surface as soon as possible.
When the patch is removed, it is folded up and disposed of so that children cannot access it.
The patch sticks well and can be kept on during bathing, showering, and physical activity, but should be removed when taking a sauna.
If you used too much Transiderm-Nitro
If you have ingested too much medicine or if e.g. a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Transiderm-Nitro
If you find you forgot to change the patch, change the patch as soon as you can. Then remove the patch at the same time as usual.
If you stop using Transiderm-Nitro
Do not stop treatment without consulting the attending physician. Alternative treatment should be started before treatment with Transiderm-Nitro is finished.
POSSIBLE SIDE EFFECTS
Like all medicines, Transiderm-Nitro can cause side effects, but not everybody gets them.
Very common (affects more than 1 user in 10): Nausea, vomiting.
Common (affects more than 1 in 100 users): Headache. About half of the patients get a headache at the beginning of the treatment. It usually disappears within a week or so.
Uncommon (occurs in fewer than 1 in 100 users): Allergic skin inflammation after contact with the patch, redness, itching, burning, and local skin irritation.
Rare (affects less than 1 in 1,000 users): Palpitations, low blood pressure, sudden feeling of warmth, often with flushing.
Very rare (affects less than 1 in 10,000 users): Dizziness
The slight redness that may occur when removing the patch usually disappears within a couple of hours. To prevent skin irritation, the place on the skin where the patch is attached must be varied.
Frequency not known: (cannot be estimated from available data): Skin rash. Contact your doctor if this affects you seriously.
If any side effects get worse or if you notice any side effects not mentioned in this information, contact your doctor or pharmacist.
HOW TO STORE TRANSIDERM-NITRO
Store out of sight and reach of children
Use before the expiry date stated on the packaging. The expiration date is the last day of the specified month.
Used plasters should be folded with the sticky side inwards and disposed of safely so that children do not have access to the plaster. If your municipality burns household waste, it is fine to throw the patch away with the household waste. Otherwise, the used patch is returned to the pharmacy, preferably in the original packaging. Unused medicine should not be flushed down the toilet or thrown among the household waste. Ask the pharmacy what to do with medicines that are no longer used. These measures will help to protect the environment.
OTHER INFORMATION
Contents declaration
– The active substance is glyceryl trinitrate.
1 patch of 5 mg/24 hours contains Glyceryl trinitrate 25 mg.
1 patch of 10 mg/24 hours contains Glyceryl trinitrate 50 mg.
– Other ingredients are lactose, dimethicone (liquid silicone), and aerosil 200 (anhydrous colloidal silicon dioxide).
– Other components of the patch: copolymer of ethylene-vinyl acetate, and silicone-based adhesive (medical adhesive CH15).
Appearance and package sizes of the medicine
Transiderm-Nitro is supplied in packs of 100 plasters.