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Ropivacaine Altan 10 mg/ml solution for injection
Ropivacaine Altan 10 mg/ml solution for injection
Ropivacaine hydrochloride
1. What Ropivacaine Altan is and what it is used for
2. What you need to know before you use Ropivacaine Altan
3. How to use Ropivacaine Altan
4. Possible side effects
5. How to store Ropivacaine Altan
6. Contents of the pack and other information
Ropivacaine Altan contains ropivacaine hydrochloride which belongs to a group of medicines called local anaesthetics of the amide type.
Ropivacaine Altan is used in adults and children above 12 years of age to numb (anaesthetise) parts of the body. It is used to stop pain happening or to provide pain relief. It can be used to:
Talk to your doctor, pharmacist or nurse before using Ropivacaine Altan.
Special care should be taken to avoid any injection of Ropivacaine Altan directly in a blood vessel in order to prevent from any immediate toxic effect. Injection should not be performed on an inflamed area.
Inform your doctor:
Tell your doctor if you have any of these problems because your doctor may need to adjust the dose of Ropivacaine Altan.
Inform your doctor:
Tell your doctor if you or anyone in your family has porphyria because your doctor may need to use a different anaesthetic.
Use of Ropivacaine Altan in premature infants has not been studied.
Take special care with Ropivacaine Altan:
Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Ropivacaine Altan can affect the way some medicines work and some medicines can have an effect on Ropivacaine Altan.
In particular, tell your doctor if you are taking any of the following medicines:
Your doctor needs to know about these medicines to be able to work out the correct dose of Ropivacaine Altan for you.
Take into account that these instructions may be also for medicines which have been taken/used before or may be taken/used after.
Also tell your doctor if you are taking any of the following medicines:
This is because your body takes longer to get rid of Ropivacaine Altan if you are taking these medicines. If you are taking either of these medicines, prolonged use of Ropivacaine Altan should be avoided.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist or nurse for advice before this medicine is given to you.
Ropivacaine Altan should not be used during pregnancy and breast-feeding unless at the discretion of the doctor it is clearly necessary.
It is not known if ropivacaine hydrochloride passes into breast milk.
Ropivacaine Altan may make you feel sleepy and affect the speed of your reactions. After you have been given Ropivacaine Altan, you should not drive or use tools or machines until the next day.
This medicine contains 3.03 mg sodium (main component of cooking/table salt) in each ml. This is equivalent to 0.15% of the recommended maximum daily dietary intake of sodium for an adult.
Ropivacaine Altan will be given to you by a doctor or, occasionally, by a nurse under medical supervision.
The dose that your doctor gives you will depend on the type of pain relief that you need. It will also depend on your body size, age, and physical condition.
Ropivacaine Altan will be given to you as an injection. The part of the body where it will be used will depend on why you are being given Ropivacaine Altan. Your doctor will give you Ropivacaine Altan in one of the following places:
When Ropivacaine Altan is used in one of these ways, it stops the nerves from being able to pass pain messages to the brain. It will stop you feeling pain, heat or cold in where it is used however you may still have other feelings like pressure or touch.
Your doctor will know the correct way to give you this medicine.
Serious side effects from getting too much Ropivacaine Altan need special treatment and the doctor treating you is trained to deal with these situations. The first signs of being given too much Ropivacaine Altan are usually as follows:
To reduce the risk of serious side effects, your doctor will stop giving you Ropivacaine Altan as soon as these signs appear. This means that if any of these happen to you, or you think you have received too much Ropivacaine Altan, tell your doctor immediately.
More serious side effects from being given too much Ropivacaine Altan include problems with your speech, twitching of your muscles, tremors, trembling, fits (seizures), and loss of consciousness.
If you experience any of these symptoms or you think you may have received too much Ropivacaine Altan tell to your doctor or healthcare personnel immediately.
In case of acute toxicity, healthcare personnel will take the appropriate corrective measures immediately.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Sudden life-threatening allergic reactions (such as anaphylaxis) are rare, affecting 1 to 10 users in 10,000.
Possible symptoms include sudden onset of rash, itching or lumpy rash (hives); swelling of the face, lips, tongue or other parts of the body; and shortness of breath, wheezing or difficulty breathing. If you think that Ropivacaine Altan is causing an allergic reaction, tell your doctor immediately.
Allergic reactions (in most severe cases, anaphylactic shock) have been associated with local anaesthetics.
Very common
(affects more than 1 patients in 10)
Common:
(affects 1 to 10 patients in 100)
Uncommon
(affects 1 to 10 patients in 1,000)
Rare
(affects 1 to 10 patients in 10,000)
In children, the side effects are the same as in adults except for low blood pressure which happens less often in children (affecting less than 1 in 100 children) and being sick which happens more often in children (affecting more than 1 in 10 children).
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not freeze.
Do not use this medicine after the expiry date which is stated on the carton or the label after CAD.
The expiry date refers to the last day of that month.
From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.
Do not throw away any medicines via wastewater or household waste. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Ropivacaine Altan is a clear, colourless solution for injection.
Each container contains 5 ampoules of 10 ml.
Not all pack sizes may be marketed.
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This leaflet was last revised in December 2018